Tenon Medical, Inc.

Greetings and welcome to the Tenon Medical Fourth Quarter and Full Year 2023 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 Steve Van Dyck, Chief Financial Officer. Mr. Foster and Mr. Van Dyck will present results of operations for the fourth quarter and full year and December 31, 2023, 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 would like to remind everyone that statements made on the call and webcast may include predictions, estimates, and other information that might 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 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 information 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 prospectus dated April 26, 2022, particularly under the heading Risk Factors, which is on file with the Securities and Exchange Commission at www.scc.gov. At this time, I'll turn the call over to Tenon Medical's Chief Executive Officer, Steve Foster. Please go ahead, sir.

Thank you, Paul, and good afternoon to everyone.

I am pleased to welcome you to today's fourth quarter and full year 2023 financial results and corporate update conference call for Tenon Medical. The conclusion of 2023 marks a successful first full year of nationwide commercialization of the Catamaran system and operating Tenon Medical as a public company. This success is highlighted by Tenon's significant progress in our revenue growth and improving gross margins. We've entered 2024 from a position of operational strength and continue our focus on building market share. We've made considerable commercialization and technical progress and continue to gain traction in our go-to-market approach with SIA-focused physicians and network partners, adopting our proprietary catamaran system, which we believe has broadened the competitive field of surgical options available for patients with chronic sacroiliac joint pain, or degenerative sacralitis. During the fourth quarter, the catamaran system experienced a 312% increase in the number of surgical procedures from the prior year, which drove strong revenue growth with an increase of 192% year over year. The quarter was also highlighted by a third consecutive quarter of positive gross profit. Moreover, as mentioned in prior quarterly updates, our revenue growth and largely fixed cost structure will continue to fuel our gross margin performance to be sustainable at recent levels. We believe our fourth quarter was a good proof point, as we achieved 69% gross margin, representing a significant sequential increase from 57% gross margin in the third quarter. For the full year of 2023, revenue grew 324% to $2.9 million, Gross profit increased to $1.2 million as compared to a gross loss for the full year of 2022. Continued expansion of our workshop activities during the fourth quarter was supported by our valued physician customers and the robust commercial infrastructure we built. As a reminder, we take a precise go-to-market approach through our workshop and training programs in order to address physicians and medical professionals with extensive backgrounds and experience in SI surgical technologies. We continue to focus on a hybrid approach with our local synthetic model and cadaveric lab workshops to introduce the Catamaran system, creating a timely and efficient process for our physician customers. We supplement these efforts with intensive clinical support and service. Combined, These critical activities are designed to drive acceleration in the number of procedures completed with the Catamaran system, which we've experienced since we began the initiative. Our programs hosted 133 physicians in Catamaran workshops during the full year of 2023. During the fourth quarter, we enhanced our marketing initiatives with participation in a series of immersive physician webinar training programs featuring the Catamaran system. attracting over 60 healthcare providers. Our partnership with Dr. Matthew Davies of Orthopedic Associates of Duluth, Minnesota, provided a physician's perspective of our system as he discussed his clinical experience performing over 50 catamaran procedures. In addition to the presentation, Dr. Davies provided a demonstration of the simple inferior-posterior implantation technique of our unique transfixing SI joint implant. Building on the momentum of the quarter, we expect the number of surgical procedures to continue to grow as our sales team broadens our strategic marketing, promotions, and workshops featuring the Catamaran system. Additionally, we continue to enroll patients in our post-market multi-center clinical study and expect this enrollment to be finalized in the coming quarter. We expect a preliminary glimpse of early data in the coming weeks. Operationally, in November, we were proud to pass a full quality system inspection technique, or Q-SIP, level two inspection conducted by the U.S. Food and Drug Administration. The Q-SIP inspection assesses the medical device manufacturer's compliance with quality system requirements and related regulations. The FDA's pass grade is validation of our ongoing and stringent focus on our quality system, standardized controls, and strict operational procedures at Tenon Medical. Additionally, during the fourth quarter, we entered a $1.25 million secured note financing led by Ascent Special Ventures, which has been fully repaid by the issuance of Series A preferred stock announced in February. We deeply value this investment and vote of confidence from a distinguished investor syndicate as veterans in the medical device industry. With the $2.6 million in proceeds received from the February Series A preferred offering and this corresponding extinguishment of debt, we've bolstered our cash position and refined our balance sheet as we track toward Tenon's next stage of development and growth and commercialization. With that, I'll turn it over to Mr. Van Dyck, our Chief Financial Officer, to discuss our financials.

Thank you, Steve. I'll give us a sync review of our financial results. A full breakdown is available in our press release that crossed the wire this afternoon. Our revenue was $808,000 in the fourth quarter, an increase of 192% compared to $277,000 in the comparable year-ago period. Revenue for the year ended December 31, 2023, was $2.9 million. an increase of 324% compared to the 691,000 in the comparable year-ago period. The increase in revenue for the year ended December 31st, 2023 as compared to 2022 was primarily due to an increase of 312% in the number of surgical procedures in which the catamarans system was used. Gross profit in the fourth quarter was 559,000 or 69% of revenues. compared to a gross loss of 207,000 or a negative 75% of revenues in the comparable year ago quarter. Gross profit in the year ended December 31st, 2023 was 1.2 million compared to a gross loss of 641,000 in the year ended December 31st, 2022. Importantly, we have seen gross margin steadily improve Due to the revenue growth associated with increased number of surgical procedures, operating leverage created due to a lower relative fixed costs and the absorption of more overhead into our standard cost. Operating losses totaled 3.1 million in the fourth quarter compared to a loss of 7.9 million in the fourth quarter of 2022. For the year ended December 31st, 2023 operating losses totaled 15.7 million compared to $18.7 million in the prior year period. Decreases in operating expenses were primarily the result of a decrease in sales and marketing expense as a result of the internalization of our commercial team and the termination of our distribution partnership during the prior period, and decreases in general and administrative expenses. Net loss was $3.1 million for the fourth quarter compared to a loss of $7.9 million in the same period in 2022. For the year ended December 31, 2023, net loss was $15.6 million compared to $18.9 million in the prior year. The company expects to incur additional losses in the future. As of December 31, 2023, cash and cash equivalents and short-term investments totaled $2.4 million as compared to $8.6 million as of December 31st, 2022. As of December 31st, 2023, the company had $1.2 million of outstanding debt related to our secured note offering in November, which has been fully repaid subsequent to quarter end with Series A preferred stock. As of today, the company has no outstanding debt. I will now turn the call back to Steve for closing thoughts.

Thank you, Steve. With the accelerating pace of catamaran procedures and continued expansion of our sales and marketing efforts, we're very optimistic for continued growth in the commercialization of our proprietary, FDA-cleared surgical implant system. We ended the fourth quarter with solid momentum and revenue and a third consecutive quarter of positive gross margin. For the year, a 312% increase in surgical procedures is followed by a 324% increase in full-year revenues. We believe we will continue this growth trajectory with our expanding commercial infrastructure and seasoned sales management team. We continue to reinforce our commitment to validating and differentiating patient outcomes and radiographic assessment with ongoing post-market clinical studies and expect to expand the application of our distinct product offering to address SI revision surgery, adjunct to multi-level fusion. We are dedicated to executing our growth objectives as we prioritize improving the quality of life of patients suffering from SI joint pain while pursuing long-term value for our shareholders. I thank you all for attending, and I would like to hand the call back over to our operator to begin our question and answer session with our covering analysts. Paul?

Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. Confirmation tone will indicate your line is in the question queue. You may press star two if you'd 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 star key.

One moment, please, while we poll for questions. Our first question is from Bruce Jackson with The Benchmark Company.

Please proceed with your question.

Hi, guys. Thanks for taking my questions. Just real quick, how many surgeons did you train during the quarter?

Thanks, Bruce, and good to hear from you. We trained 28 physicians over the quarter and 133 over the entire year.

Okay, super. And then with the post-approval study, what's the final enrollment number?

Yeah, the study was approved, Bruce, for a 50 patient. We may wind up anywhere between 40 and 50 on this thing when we feel like we've got a good data set cooking and what have you. So very much towards the tail end of that enrollment. Expect for it to wrap up here in the coming quarter. And as I mentioned, very excited about getting an early glimpse at, you know, the things we're focused on here. First, safety profile. Second, of course, is the efficiency and the effectiveness of the procedure to relieve patient's pain. And then as a secondary endpoint, the radiographic assessment, you know, seeking a healed and fused SI joint. So, we see that early glimpse coming here very soon and enrollment wrapping up here shortly.

Okay, great. That's it for me. Thank you.

Thank you, Bruce.

Our next question is from Anthony Vendetti with the Maxim Group. Please proceed with your question.

Yes, thanks. So, you trained 28 physicians in the fourth quarter. Do you have a target, Steve, for per quarter training approximately or a goal for 2024?

Sure, Anthony. Of course, we do have objectives and goals there internally. And really, we focus primarily on quality rather than quantity. I could train a million people. If they don't adopt, I'm not making any headway. So it's really about targeting. We hope to achieve 25-plus goals well-targeted, good-profile physicians every single quarter, and they really focus our energy. Look, we're a relatively small operation. We need to aim small, miss small, and really focus our energies to make sure we finish and we're successful in achieving adoption. So probably right in that 25 to 30 area is our sweet spot, and we'll continue to build on that as time progresses.

Okay, great. And then... From a utilization perspective, I know it's early, and so it could be a little lumpy quarter to quarter, but what trends are you seeing in terms of the utilization of the catamaran system?

Yeah, you know, the market is extraordinarily dynamic. There was a new reimbursement coding that came out in 2024. That always creates a lot of questions in the marketplace and things of that nature. Very dynamic. What I can tell you is that the number of procedures is still growing. The space is seeing a lot of innovation and a lot of dynamic activity. Certainly, you're right, with a relatively small base of customers, we do see some lumpiness here and there as patients defer from one quarter to the next or you see cancellations or what have you. But generally speaking, physicians are making progress in making SI a part of their practice. There's some work there in the diagnostic component of the equation in particular to start building SI as part of their offering and their practice. a lot of progress there and a lot of growth in this marketplace.

Okay, excellent. And then lastly, just I believe you launched a new instrumentation kit. What's been the reception from that? And then just general thoughts on the physicians that you gleaned from the fourth quarter.

Yeah, at the risk of sounding a little over exuberant, the reaction to our jib technology has been outstanding. It's a smaller profile, and that doesn't just mean a smaller incision for the patient. It also means improved visualization during the radiographic process for the physician, and that's extraordinarily important. They need to see the surrounding landmarks and what have you, This new profile is really allowing them to do that. So the reaction has been outstanding. As to the customers that we trained and put through workshops in Q4, of course, that begins the process of moving them towards adoption, getting approvals at their facilities and things of that nature. And we continue to work through that and sprint to get them to that first surgery and get them adopted.

Okay, great. Thanks so much. I'll hop back in the queue. Appreciate it. Thanks, Anthony.

Thank you. There are no further questions at this time. I would now like to turn the call back over to Mr. Foster for his closing remarks.

Thank you, Paul. I'd like to thank each of you for joining the 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 and Z Group. We'd be more than happy to assist.

And with that, I wish everyone a good day. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.