Tenon Medical, Inc. (NASDAQ:TNON) Q4 2024 Earnings Call Transcript

Tenon Medical, Inc. (NASDAQ:TNON) Q4 2024 Earnings Call Transcript March 20, 2025

Tenon Medical, Inc. reports earnings inline with expectations. Reported EPS is $-2.54 EPS, expectations were $-2.54.

Operator: Greetings. And welcome to the Tenon Medical Fourth Quarter and Full Year 2024 Financial Results and Corporate Update Conference Call. As a reminder, this call is being recorded. Your hosts today are Steve Foster, President and Chief Executive Officer; and Kevin Williamson, Chief Financial Officer. Mr. Foster and Mr. Williamson will present results of operations for the fourth quarter and full year ended December 31, 2024, and provide a corporate update. A press release detailing these results was released today and is available on the Investor Relations section of our company’s website, www.tenonmed.com. Before we begin the formal presentation, I’d like to remind everyone that statements made on the call and webcast may include predictions, estimates and other information that may be considered forward-looking.

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’re not obligating ourselves to revise or publicly release the results of any reservation of these forward-looking statements in light of new information or future events. Throughout today’s discussion, we’ll attempt to present some important factors relating to our business that may affect our predictions. For a more complete discussion of these factors and other risks, you should review our quarterly and annually report on file with the Securities and Exchange Commission at www.sec.gov.

At this time, I’ll turn the call over to Tenon Medical’s Chief Executive Officer, Steve Foster. Please go ahead.

Steve Foster: Thank you, Matt, and good afternoon, everyone. I’m pleased to welcome you to today’s fourth quarter and full year 2024 financial results and corporate update conference call for Tenon Medical. Our initiative throughout 2024 to restructure and invest in our sales and marketing program to build market share for our proprietary Catamaran System, led the company to generate revenue growth of 12% to $3.3 million for the full year of 2024. Additionally, gross margin improved by 10 percentage points to 52%, as compared to 42% in the same year ago period, driven by increases in revenue per surgical procedure. During the fourth quarter, we experienced a revenue decline of 4.7% over the prior year quarter, primarily due to reimbursement preauthorization headwinds that we believe to be transient in nature.

We expect future coding clarity combined with our recently published clinical data will positively impact these issues going forward. As we move towards sustainable revenue growth, our stable cost structure is expected to maintain a gross margin performance at recent levels and improve with increases in revenue. In the fourth quarter, we completed the alpha clinical review of our Catamaran SE platform, a second-generation and smaller version of our implant and access profile. The SE extends the line of implant offerings for physicians preferring a smaller Catamaran implant and access profile when performing SI Joint Fusion procedures. During the alpha clinical review, we found that the features of SE are well received across physician specialties and applications.

In particular, the low profile of SE provides a significant flexibility for the physician when doing an SI revision. The full commercial launch of SE is slated for midyear 2025. Underscoring our technical advances, we received three U.S. patents during the fourth quarter related to our Catamaran portfolio. These patents cover advanced codings designed to enhance bone in-growth and fusion, as well as innovative configurations that facilitate the revision of failed SI Joint procedures. These advancements allow for the use of an alternative device without requiring the removal or modification of the original surgical implant. This continued development of our intellectual property portfolio improves our competitive position in the industry and protects the overall portfolio.

The Catamaran SI Joint Fusion System intellectual property portfolio now includes 12 issued U.S. and foreign patents, along with 23 pending U.S. and foreign patent applications. Tenon is committed to funding and executing clinical research that reinforces the clinical safety and effectiveness of our technologies. Our post-market study, called MAINSAIL, is Tenon’s prospective multicenter single arm study that evaluates clinical outcomes of patients with Sacroiliac Joint disruptions or degenerative sacroilitis treated with the Catamaran SI Joint Fusion System. Patients will be evaluated for a period of up to 24 months, reviewing various patient-reported outcomes, radiographic assessments and adverse events. In short, the data collected aims to show that the Catamaran System delivers on its promises.

Tenon announced the first peer-reviewed publication of our interim analysis from the MAINSAIL study in the third quarter of 2024. This interim analysis presents early experiences in the first 33 consecutive patients treated with the Catamaran SI Joint Fusion System across six U.S. clinical sites, the primary and secondary clinical endpoints analysis at six months, and radiographic CT fusion assessment performed by independent reviewers at 12 months. Notable outcomes from this interim analysis include statistically significant reduction in SI Joint pain and disability scoring at six months, a robust safety profile and high patient satisfaction throughout all follow-up time points. Results provided definitive evidence of fusion response at 12 months and efficient surgical technique and procedural workflow.

This peer-reviewed analysis reinforces that the Catamaran System’s minimally invasive inferior posterior approach is safe and effective in the objective of relieving pain and reducing disability in adult patients diagnosed with SI Joint disruptions or degenerative sacroilitis that failed non-surgical treatment. Early results and evaluations solidify our thesis that the Catamaran’s unique design and less invasive inferior posterior approach is functioning as intended to optimize patient outcomes. Of note, the interim data from our study and the over 1,000 surgeries performed today with the Catamaran System demonstrate its exceptional safety profile, benefiting physicians and the patients that they treat. The importance of this clinical research for the company cannot be overstated.

It will be compelling for treating physicians and payers alike within a market segment that is lacking peer-reviewed data. While innovative technologies are exciting for treating physicians, clinical research is required to reinforce the value proposition of the technology. Additionally, this data sets our foundation to achieve positive coverage throughout the payer network. We look forward to the publication of our next interim analysis, which remains imminent. Our ongoing workshop activities, led by a network of valued physician faculty, combined with the robust commercial infrastructure rebuild, have prepared us for rapid expansion going forward. We hosted 24 physicians in Catamaran workshops during the fourth quarter of 2024 and had 93 for the full year of 2023, excuse me, 2024.

Taken together, we entered 2025 with the right foundation and we are now focusing our investments on driving our topline via commercial expansion and focus on our workshop and training programs. In addition, we will be finishing investments and launching our Catamaran SE platform, as well as completing the vital MAINSAIL prospective study. With that, I’ll turn it over to Kevin to discuss our financials in detail.

Kevin Williamson: Thank you, Steve. I will provide a summarized review of our financial results. A full breakdown is available in our press release that crossed the wire this afternoon. Our revenue was $770,000 in the fourth quarter of 2024, a decrease of 4.7%, compared to $808,000 in the fourth quarter of 2023. Revenue for the year ended December 31, 2024, was $3.3 million, an increase of 12%, compared to $2.9 million in the prior year period. The fluctuations in revenue for the three months and year ended December 31, 2024, as compared to the same periods in 2023, were primarily due to a slight decrease and a flat trend, respectively, in the number of surgical procedures in which the Catamaran System was used. Offset by an improved ASP, which was driven by account mix and market access efforts.

The number of procedures in the fourth quarter was impacted by the timing of our restructured sales force, as well as reimbursement pre-authorization delays, leading to fewer surgeries performed during the quarter. With the investments made into our sales force, training program and market access efforts, we believe the reimbursement impacts and timing of our sales force restructure experienced in Q4 will become tailwinds for us moving forward, in combination with our new SE platform and clinical data initiatives. Gross profit in the fourth quarter of 2024 was $353,000 or 46% of revenue, compared to $559,000 or 69% of revenue, in the fourth quarter of 2023. For the year ended December 31, 2024, gross profit was $1.7 million or 52% of revenue, a significant improvement from gross profit of $1.2 million or 42% of revenue, in the prior year period.

Gross margin percentage varied from period-to-period, driven by the absorption of production overhead costs into our standard costs, with operating leverage created by lower fixed costs. Operating expenses totaled $3.5 million for the fourth quarter of 2024, as compared to expenses of $3.7 million in the fourth quarter of 2023. For the year ended December 31, 2024, operating expenses totaled $15.5 million, compared to $17 million in the prior year period. Operating expenses decreased due to the restructuring of our sales operations in 2024 that temporarily reduced sales and marketing expenses, and a decrease in research and development expenses, partially offset by an increase in general and administrative expenses. With continued investment and growth, including expanding our sales reach and prioritizing market access efforts and reimbursement and coverage initiatives, increases in sales and marketing expenses are expected in future quarters.

Net loss was $3.1 million for the quarter — for the fourth quarter of 2024, flat as compared to the same period of 2023. For the year ended December 31, 2024, net loss was $13.7 million, compared to $15.6 million in the previous year period. While we expect to continue to improve our net loss, the company does expect to incur additional losses in the future. Now turning to the balance sheet, as of December 31, 2024, cash and cash equivalents totaled $6.5 million, as compared to $2.4 million as of December 31, 2023. We enter 2025 with a healthy balance sheet that is fortified with ample cash runway to accelerate investment in our growth initiatives, which was further boosted by $3 million in gross proceeds received from the capital raise last week.

Lastly, as of December 31, 2024, the company has no outstanding debt. I will now turn the call back to Steve for closing thoughts.

Q&A Session

Operator: Thank you, Kevin. [Operator Instructions] First question here is from Anthony Vendetti from Maxim Group. Please go ahead.

Anthony Vendetti: Oh! Yeah. Hi, Steve. How are you doing?

Steve Foster: Hi, Anthony.

Anthony Vendetti: So just in terms of the reimbursement landscape now, any improvement in that, pre-approvals, now that you have more data, maybe just talk a little bit about how that’s progressing at this point?

Steve Foster: Yeah. Thanks, Anthony. Yeah. Of course, Tenon Medical directly, of course, doesn’t control the reimbursement environment per se. We’re certainly active participants and in working through the various decision makers, et cetera, to bring the clarity necessary in the space. I do anticipate that that is moving to sort of an ultimate conclusion here. It’s difficult to be really clear on, hey, on this date, it’s all going to be squared away. It’s a process. But great progress has been made. I think people are working hard and in good faith to get there. And as soon as we get that clarity, I think what’s important is the coders themselves at each individual, physician office or site, as well as the payers, et cetera, are seeking clarity on, hey, look, how does this work?

What are the definition of these codes? When are they going to stop changing? Things of that nature. And we do believe great progress is being made in that regard. Before that happens, there’s just questions that slow the process down, right? We’re still having good success getting procedures approved, but it requires some additional time and going through appeal processes and things like that that are really just sort of slowing things down right now.

Anthony Vendetti: Okay. As you look at the full year 2025, what do you think you need to do from a sales perspective or do you have a plan to incrementally add some sales people or you’re actively looking to add them now? Maybe just elaborate on that. Thanks.

Steve Foster: Yes. That was really our mission in and throughout 2024. We made some significant additions to our sales organization. They’re coming online as we speak here and most are now in place. We do anticipate we’ll have more horsepower, if you will, out there in the field, more coverage in key geographies and what have you. So the answer to your question is yes. We moved up to a bigger number of sales territories. And again, to reinforce, right, we have direct regional and area sales managers who interface with independent distributors to cover, to train and to handle the distribution of our technology out there in the field.

Anthony Vendetti: Okay. And so all those direct area sales manager positions are filled. And just remind me, Steve, how many do you have right now?

Steve Foster: They are filled and there are six of them across the country.

Anthony Vendetti: Okay. And then the independent distributors that you work with, what is the total sales, it’s not your sales force, but how many sales people in aggregate make up the independent sales team?

Steve Foster: Yeah. We have 42 existing independent distributor contracts out there. Now, some of those are relatively small distributorships with one or two people involved. Others are larger organizations. We have 42 total contracts out there, so formalized, if you will, engagement with an independent distributor in a specifically defined geography per the contract.

Anthony Vendetti: Okay. Great. That’s helpful. Thanks so much. I’ll hop back in the queue.

Steve Foster: Thanks, Anthony.

Operator: Thank you. This concludes the question-and-answer session. I’d like to turn the floor back to Mr. Foster for any closing comments.

Steve Foster: Well, thank you, Matt. I appreciate it. And I’d like to thank each of you for joining our earnings conference call today and look forward to continue to update you on our ongoing progress and growth. If we’re unable to answer any of your questions, please reach out to our IR firm, MZ Group, who would be more than happy to assist. With that, I wish everyone a good day.

Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you again for your participation.