3/20/2025

speaker
Matt
Conference Call Host/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 31st, 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 action results that 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 annual report filed with the Securities and Exchange Commission at www.sec.gov. At this time, I'll turn it over to Tenon Medical's Chief Executive Officer, Steve Foster. Please go ahead.

speaker
Steve Foster
Chief Executive Officer

Thank you, Matt, and good afternoon, everyone. I'm pleased to welcome you to today's fourth quarter and full year 2024 financial results in 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 mid-year 2025. Underscoring our technical advances, we received three U.S. patents during the fourth quarter related to our Catamaran portfolio. These patents cover advanced coatings designed to enhance bone ingrowth 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, multi-center, 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 main sales 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 US 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 sacralitis 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 to date 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 top line 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.

speaker
Moderator
Conference Call Facilitator

With that, I'll turn it over to Kevin to discuss our financials in detail. Thank you, Steve.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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