Tenon Medical - Earnings Call - Q2 2025

Transcript

Speaker 4

Greetings and welcome to the Tenon Medical Second Quarter 2025 Earnings Conference Call. At this time, all participants are in online mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Steven Foster, CEO and President. Thank you. You may begin.

Speaker 1

Thank you, Maria, and good afternoon, everyone. I'm pleased to welcome you to today's Second Quarter 2025 Financial Results and Corporate Update Conference Call for Tenon Medical. We recently marked a pivotal step forward for Tenon Medical, highlighted by a strategic acquisition on top of a second quarter that included continued clinical validation and meaningful progress towards diversification of our product offering. Speaking to our recent announcement, a significant focus of our second quarter initiatives was the thorough due diligence and successful completion of the strategic acquisition of CyVantage, which we announced subsequent to quarter end. With integration to take place over the next 60 to 90 days, this transaction delivers active case value, revenue-generating technologies, and a robust pipeline that will continue to scale. The deal significantly enhances our commercial organization and unlocks new pathways through hospital approval processes, distribution networks, and market access.

Importantly, the transaction energizes our commercial infrastructure and the tools and talent to drive sustainable top-line growth. In tandem, we continue to advance the CADM-RAM platform with real-world adoption in complex fine procedures. Dr. Andrew Trontes completed initial CADM-RAM cases demonstrating successful integration into lumbar fusion constructs. These procedures, now supported by FDA clearance for use as an adjunct to thoracolumbar fixation, validate CADM-RAM's role in preparing and immobilizing the SI joint in preparation for fusion while reducing morbidity, blood loss, and operative time. This expanded indication opens a new market opportunity and expands our footprint in the sacral pelvic fixation space. The CADM-RAM SE, our second-generation low-profile implant, remains on track for full commercial launch in the coming weeks. The SE platform has already shown favorable feedback in Alpha review.

Combined with the CyVantage assets, we now offer a multi-product dynamic approach fusion solution that differentiates Tenon in an increasingly competitive sacral pelvic marketplace. In addition to the full commercial launch of the CADM-RAM SE platform this quarter, we are actively preparing for initial Alpha surgeries using the newly developed Symmetry Plus system, expected to begin in Q4 this year. Symmetry Plus represents a next-generation fusion platform designed to further enhance our SI joint portfolio with differentiated features for long-term fusion outcomes. We believe the Symmetry Plus system will complement our existing offerings and support our commitment to delivering true fusion solutions tailored to both primary and adjunctive SI joint procedures. Our clinical progress remains equally strong. We continue to collect important clinical validation through both early adopter experience and our main sale post-market study, which remains on track for the publication of the second interim analysis this quarter.

As the number of enrolled patients grows, we are confident that primary endpoints of VAS and ODI scores, along with patient satisfaction, will show positive trends. The secondary endpoint of fusion assessed via CT scan and confirmed by independent radiologists will reinforce that abiding by AO principles of arthrodesis pays off. We are confident the inclusion of CT scan fusion data, ODI, and VAS scores will provide powerful evidence supporting our CADM-RAM approach. The CyVantage transaction also brings with it meaningful fusion data that will support the approach and technologies currently under development as a result of this transaction. Physician education remains a top priority. In the second quarter, we hosted 16 physician workshops, engaging key opinion leaders to support our long-term adoption strategy and accelerate the learning curve for our new users.

On the financial side, we reduced our operating expenses by 29% year over year, demonstrating a tighter discipline while preserving investments in our growth strategy. We ended the quarter with $7.8 million in cash and no debt, giving us flexibility to continue executing our strategic roadmap with confidence. Looking ahead, Tenon Medical is entering a period of sustained momentum between the CyVantage integration, CADM-RAM SE launch, and upcoming main sale interim data publication. We're poised to execute against key milestones that will expand our addressable market, strengthen our clinical foundation, and drive top-line growth. With that, I'll turn the call over to Kevin Williamson to discuss our financials.

Speaker 2

Thank you, Steve. I will now provide a summarized review of our financial results. A full breakdown is available in our press release that crossed the wire this afternoon. Revenue for the second quarter of 2025 was $564,000, compared to $901,000 in the same period last year. Revenue for the six months ended June 30, 2025, was $1.3 million, compared to $1.6 million in the six months ended June 30, 2024. The year-over-year decline was primarily due to lower procedure volumes and account-mix headwinds in the second quarter of 2025, driven primarily by the strategic shift in our commercial initiatives with the impending CyVantage acquisition. With the transaction now closed, we are already seeing increased volume and interest in the Tenon story, which we expect to be meaningful moving forward.

Gross profit was $245,000, or 43% of revenue, in the second quarter of 2025, compared to $470,000, or 52% of revenue, in the prior year quarter. For the six months ended June 30, 2025, gross profit was $568,000, or 44% of revenue, compared to $940,000, or 58% of revenue for the previous year's period. The decline in gross margin was a result of reduced procedure volumes and lower revenue, with consistent variable direct product costs and relative fixed production overhead costs year over year. Operating expenses totaled $3.1 million in Q2 2025, down from $4.3 million in the prior year period. For the six months ended June 30, 2025, operating expenses totaled $7.1 million, compared to $8.3 million in the prior year period. The 29% reduction in the quarter was driven by lower expenses across G&A, R&D, and sales and marketing.

The reduction in G&A and R&D was primarily driven by disciplined spending and project timing, as well as a reduction in stock-based compensation, which is expected to continue. The reduction in sales and marketing expenses was driven by lower variable expense due to lower revenue, as well as disciplined investment in our commercial infrastructure and sales force, reflecting our focus on the impending acquisition. Net loss for the second quarter was $2.8 million, or $0.36 per share, compared to a net loss of $3.8 million, or $8.16 per share in the second quarter of 2024. For the six months ended June 30, 2025, net loss was $6.4 million, compared to $7.4 million in the same year-ago period. This improvement was primarily attributable to the decrease in operating expenses in the second quarter of 2025.

We ended the quarter with $7.8 million in cash and cash equivalents, compared to $6.5 million as of December 31, 2024. Additionally, the company continues to operate with no outstanding debt, giving us the flexibility to advance our growth strategy, including the integration of CyVantage acquisition, product development, and upcoming launches of CADM-RAM SE and Symmetry Plus, continued focus on clinical data and market access efforts, and rapid expansion of our commercial footprint. In summary, we believe the steps taken this quarter, both financially and strategically, position Tenon Medical well to accelerate growth while maintaining a lean and focused cost structure. I'll now hand the call back to Steven Foster for closing comments.

Speaker 1

Thank you, Kevin. We are energized by this progress made in Q2 and the strong momentum building into the second half of 2025. From the CyVantage acquisition to the launch of CADM-RAM SE and ongoing clinical validation, we are executing across all pillars of our strategy. Tenon remains focused on delivering solutions that promote true biologic fusion and structural stability for patients suffering from sacral pelvic disorders. We're confident in our long-term trajectory and remain committed to driving value for our patients, physicians, and shareholders. I thank you all for attending, and now I'd like to hand the call over to our operator to begin our question and answer session with covering analysts. Maria?

Speaker 4

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press *2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * keys. One moment, please, while we poll for questions. Our first question comes from Scott Robert Henry with AGP. Please proceed with your question.

Speaker 3

Thank you and good afternoon. I'm excited for you with the CyVantage acquisition or merger, however you want to phrase it. I find that smaller companies are often in a race for scale, and you want to achieve scale to leverage the cost and the whole business model. Is that what you're trying to get here? Do you think this could help bring you scale, make the company more viable in the big picture?

Speaker 1

Yeah, hi Scott. This is Steve, and thanks for the great question. You couldn't be more right. I think it gets us a number of things. It certainly gives us a pathway to scale. As we move to a more intensive commercialization, what happens in medical devices is you're trying to leverage and build access. When I say access, I mean access to hospital system contract groups and things of that nature. One of the things that happens here is we combine all of the work that was done in the two organizations in the access part of the equation. This gives salespeople on the street the ability to go and get after these opportunities. That's one. Two, you know, Tenon a month ago was a single product company. Now that's changed.

Now we're going to be able to, this is what I notice in this whole thing, right, is that as physicians start to really think about the problems they're trying to solve in the sacral pelvic region, they need flexibility and they need options. Having a one-size-fits-all was starting to become an issue. This gives us a chance to have multiple approaches to the anatomy, multiple formats of implant to address the issue, whether they're dealing with a primary situation, a revision situation, or an adjunctive situation in a bigger procedure. We become more diversified. We get more access out there. To your point, we get to build scale more effectively. Quite candidly, as excited as I am about the products, I'm more excited about the people. These guys are people I've known for many years now. I have great respect for them.

We're bringing some real horsepower to the team that I'm just, it's hard for me to describe how excited I am about it. I think we're going to be able to do things commercially at a much higher clip and in a much more intense way. Very excited about all those parts.

Speaker 3

Okay, that's fantastic. As we try to get our arms around this combined company, I don't know if you can talk to the combined revenue, the combined OpEx, gross margin picture, or will there be filings with that? I just pulled up an 8K. It's pretty long. I don't see any tables in there, but they might be in there. Just trying to get an idea of how we can kind of build a picture of this combined entity.

Speaker 1

Sure. I'll let Kevin comment in a moment, but as part of the transaction and as part of us closing, there are some audited financials being done that need to be completed before we can share the kind of details you're looking for. We need a short period of time here to wrap those things up, and then we'll be able to provide more specifics. Kevin, if you want to comment real quickly, that might be appropriate.

Speaker 2

Yeah, happy to. Scott, there's about a 75-day post-close period to file the audited financials for CyVantage. We should have those filed here come mid-October based on that timeline. I can't speak directly to the numbers, but you know, it is an immediate revenue pickup, meaningful for Tenon Medical with the Symmetry product line that's out there. I think, as Steve mentioned, even more specifically, we're excited for the pickup we believe is going to come from the Symmetry Plus launch that's coming up here in Q4. Immediate revenue now and more to go as Symmetry Plus gets launched in Q4.

Speaker 3

Okay. For clarification, is there anything that needs to be done to complete this merger? Are there any votes, or is this final?

Speaker 2

No, yeah, it's closed. It's closed and approved. The only remaining item to it is filing the audited 2024 financials and then stop review period for 2025 for CyVantage. That's all in the works and have, again, a 75-day post-close period to get those filed with the SEC.

Speaker 3

Okay. Final question, more on the micro side. Obviously, revenues declined in the quarter, but expenses went way down too. I don't know if you're optimizing to get ready for the planned acquisition. How should we think about CADM-RAM, and you also have the SE launch coming up? How should we think about the CADM-RAM revenues sequentially in third quarter and fourth quarter?

Speaker 1

Yeah, this is Steve. I agree. I think it's fair to say Q2, we were a bit obsessed with working through all of this and getting it done with our new CyVantage partners. That was a little bit disruptive for certain. I don't anticipate that softness being ongoing. I really think we'll recover very quickly. We just felt ourselves a bit on hold with adding street personnel, sales personnel, replacing any changes, things of that nature until we got this thing closed. That's kind of where my mind is as it relates to CADM-RAM.

Speaker 3

Fair enough. Based on, I mean, what are we, a month and a half into Q3, are you expecting, I mean, a lot of that stuff is still ongoing, was ongoing. Should we temper our expectations in Q3 and then wait for kind of the Q4 combined rollout? Would that be a reasonable way to think of it?

Speaker 1

I think it is reasonable, and Kevin, go ahead and comment. I think it is reasonable. Certainly in July, we were still wrapping this up. It was very intensive at the end, as you can imagine. Things have really started to turn very quickly now that we're closed. I'm very, very encouraged that we'll recover and recover very quickly.

Speaker 2

Yeah, I'll just add there, Scott. I think the excitement of announcing the deal, officially getting the teams together and getting going here, I think you'll see CADM-RAM revenue back to where you've seen it before, plus the incremental revenue that we're going to pick up from Symmetry immediately. I feel good about where CADM-RAM is at, where CADM-RAM revenue is at. I think a big piece of it that Steve alluded to is leveraging the hospital agreements, hospital approvals, the distributor agreements across both sides, and now starting to kind of cross-sell through the synergies, both products into both sides, and then grow from there. I think you'll see a good bounce back in Q3.

Speaker 3

Okay. Great. Thank you both for taking the questions.

Speaker 1

Thank you, Scott.

Speaker 4

Our next question comes from Nicholas Sherwood with Maxim. Please proceed with your question.

Speaker 0

Hi, thank you. Kind of talking about the acquisition, what sort of is the incremental physician and hospital network that you've kind of acquired through the acquisition? Have you begun cross-selling to the sort of legacy physician partners from both Tenon and CyVantage, or are you still waiting for everything to be integrated before you begin doing that?

Speaker 1

Yeah, thanks for the question. A couple of things. Yeah, there's going to be overlap between the two groups, if you will, at the physician level, as well as at the hospital and facility level, right? Our challenge is to integrate that and leverage that as best we can, right? The reality is Tenon had some access and contracting and pricing stuff done. So did CyVantage. Some of it overlaps. Some of it's incremental. It builds from day one, gives us a chance to reinforce that group and then continue to expand from there. As to the sales folks and cross-selling, that is happening immediately. We're not waiting for the audits to be done or anything like that. We've already begun the training process to get everyone prepared to sell across the portfolio, position it appropriately, support it appropriately, what have you.

Our folks are very consultative out there with the physicians and their staff, and so all of that process has begun in earnest and will continue to do so probably for the next 60 days or so.

Speaker 0

Okay, perfect. Thanks for that detail. What is the reimbursement landscape for the Symmetry product and the Symmetry Plus product? Is it a similar, like Medicare reimbursement code as the CADM-RAM SE system? Does it have private payer coverage? Can you talk about how that exists and any synergies there with the acquisition?

Speaker 1

Yeah, certainly. You know, the SI joint, there are three distinct CPT codes that cover SI procedures. The CyVantage technology is coming over, participates with those codes just like CADM-RAM does. I would position that as very similar, right? Coverage goes to supporting these technologies with data. I mentioned in the prepared comments that not only are we excited about this second interim analysis coming out from our main sale trial and reinforcing that CADM-RAM delivers on its promises, but the CyVantage portfolio also brings prospective data to the mix that shows that Symmetry, and we believe also Symmetry Plus, can deliver on very specific aspects of safety and effectiveness. We feel like we're well positioned with data to continue the pursuit of proper coverage of these technologies. No new incremental codes or anything like that. The CyVantage technology participates with the SI codes that are in existence.

Speaker 0

Okay, that makes sense. My last question is just what kind of color can you give us on this Symmetry Plus launch? Do we have an idea of when that will be, kind of how much of a catalyst we expect that to be for the top line? Just kind of break down what you're thinking.

Speaker 1

Excellent. Yeah, really excited about it. It is a lateral approach technology that will be state-of-the-art and really bringing some features that we believe are going to be very compelling for physicians. From a timing perspective, we anticipate Alpha surgeries beginning in the October timeframe with that technology. When I refer to Alpha, these are our physician advisors, our close relationship physicians who use these technologies and give us specific feedback. What do they like? What do they not like? What needs to be tweaked, etc.? Candidly, the number of tweaks will determine the timing of a full-scale launch. Usually, those things run two to three months, and then we build out, make any changes, build out inventory, and execute on a full launch.

I think what would be fair is saying in October, November, December will be an Alpha, and then you'll see a launch of that technology in the early part of next year.

Speaker 0

Okay, perfect. That ends my questions, and I'll return to the queue. Thank you for answering them.

Speaker 1

Thank you.

Speaker 4

I would now like to turn the call back over to Mr. Foster for his closing remarks.

Speaker 1

Great. Thank you, Maria. I'd like to thank each of you for joining our earnings conference call today and look forward to continuing to update you on our ongoing progress and growth. If we were unable to answer any of your questions, please reach out to our IR firm, MZ Group. We'd be more than happy to assist. With that, I wish you a good day.

Speaker 4

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.