Tenon Medical Q4 2023 Earnings Call Transcript

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March 12, 2024

There are 5 speakers on the call.

Operator

Greetings and welcome to the Tenon Medical 4th 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 Dijk, Chief Financial Officer. Mr. Foster and Mr.

Operator

Van Dijk will present results of operations for the Q4 full year ended 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.

Operator

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

Speaker 1

Thank you, Paul, and good afternoon to everyone. I am pleased to welcome you to today's Q4 and full year 2020 3 financial results and corporate update conference call for Tennon Medical. The conclusion of 2023 marks a successful 1st full year of nationwide commercialization of the catamaran system and operating Tenon Medical as a public company. This success is highlighted by Tennon'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.

Speaker 1

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 degenerative sacroiliitis. During the Q4, 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 3rd 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 Q4 was a good proof point as we achieved 69% gross margin representing a significant sequential increase from 57% gross margin in the 3rd quarter.

Speaker 1

For the full year of 2023, revenue grew 324% to $2,900,000 and gross profit increased $1,200,000 as compared to a gross loss for the full year of 2022. Continued expansion of our workshop activities during the Q4 was supported by our valued physician customers and the robust commercial infrastructure we've 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 bottle and catoveric lab workshops to introduce the cataract system, creating a timely and efficient process for our physician customers. We supplement these efforts with intensive clinical support and service.

Speaker 1

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 Q4, 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 Doctor. 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.

Speaker 1

In addition to the presentation, Doctor. Babies 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 multicenter 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.

Speaker 1

Operationally, in November, we were proud to pass a full quality system inspection technique or CUSIP Level 2 inspection conducted by the U. S. Food and Drug Administration. The CUSIP 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 Tennant Medical.

Speaker 1

Additionally, during the Q4, we entered a $125,000,000 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 the distinguished investor syndicate as veterans in the medical device industry. With the $2,600,000 in proceeds received from the February Series A preferred offering and this corresponding extinguishment of debt, we bolstered our cash position and refined our balance sheet as we track toward Tennon's next stage of development and growth in commercialization. With that, I'll turn it over to Mr. Ben Dicke, our Chief Financial Officer to discuss our financials.

Speaker 2

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 4th quarter, an increase of 192% compared to $277,000 in the comparable year ago period. Revenue for the year ended December 31, 2023 was $2,900,000 an increase of 3 24% compared to the 6 $191,000 in the comparable year ago period.

Speaker 2

The increase in revenue for the year ended December 31, 2023 was as compared to 2022 was primarily due to an increase of 312% in the number of surgical procedures in which the catamaran system was used. Gross profit in the 4th quarter was $559,000 or 69 percent 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 31, 2023 was $1,200,000 compared to a gross loss of $641,000 in the year ended December 31, 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 $3,100,000 in the 4th quarter compared to a loss of $7,900,000 in the Q4 of 2022.

Speaker 2

For the year ended December 31, 2023, operating losses totaled $15,700,000 compared to $18,700,000 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 $3,100,000 for the Q4 compared to a loss of $7,900,000 in the same period in 2022. For the year ended December 31, 2023, net loss was $15,600,000 compared to $18,900,000 in the prior year. The company expects to incur additional losses in the future.

Speaker 2

As of December 31, 2023, cash and cash equivalents and short term investments totaled $2,400,000 as compared to $8,600,000 as of December 31, 2022. As of December 31, 2023, the company had $1,200,000 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.

Speaker 1

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 4th quarter with solid momentum in revenue and a 3rd consecutive quarter of positive gross margin. For the year, a 3 12% increase in surgical procedures was followed by a 324% increase in full year revenues. We believe we'll continue this growth trajectory with our expanding commercial infrastructure and seasoned sales management team.

Speaker 1

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 and adjunct to multilevel fusion. We are dedicated to executing our growth objectives as we prioritize improving quality of life of patients suffering from SI joint pain, while pursuing long term value for our shareholders. I thank you all for attending. Now I'd like to hand the call back over to our operator to begin our question and answer session with our covering analysts. Paul?

Operator

Thank you. We'll now be conducting a question and answer session. Our first question is from Bruce Jackson with The Benchmark Company. Please proceed with your question.

Speaker 3

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

Speaker 1

So we thanks Bruce and good to hear from you. We trained 28 physicians over the quarter and 130 3 over the entire year.

Speaker 3

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

Speaker 1

Yes. The study was approved, Bruce, for a 50 patient. We may wind up anywhere between 4050 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 the things we're focused on here.

Speaker 1

1st, safety profile. 2nd, of course, is the efficiency and the effectiveness of the procedure to relieve patients' pain. And then as a secondary end point, the radiographic assessment seeking a healed and fused SI joint. So we see that early glimpse coming here very soon and enrollment wrapping up here shortly.

Speaker 3

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

Speaker 1

Thank you, Bruce.

Operator

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

Speaker 4

Yes, thanks. So you did you trained 28 physicians in the Q4. Do you have a target Steve for per quarter training approximately or a goal for 2024?

Speaker 1

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 1000000 people. If they don't adopt, I'm not making any headway.

Speaker 1

So it's really about targeting, we hope to achieve 25 plus well targeted good profile physicians, everything every single quarter and they really focus our energy. Look, we're 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 areas are sweet spot and we'll continue to build on that as time progresses.

Speaker 4

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?

Speaker 1

Yes. The market is extraordinarily dynamic. There was a new reimbursement codeine 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.

Speaker 1

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 1 quarter to the next or you see cancellations or what have you. But generally speaking, physicians are making progress and 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.

Speaker 4

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 Q4?

Speaker 1

Yes. At the risk of sounding a little over different, the reaction to our Jib technology has been out standing. 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.

Speaker 1

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 in Sprint to get them to that 1st surgery and get them adopted.

Speaker 4

Okay, great. Thanks so much.

Operator

I'll hop back in the queue. Appreciate it.

Speaker 1

Thanks, Anthony.

Operator

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

Speaker 1

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, MZ Group, who'd be more than happy to assist. And with that, I wish everyone a good day.

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Key Takeaways

  • Tenon Medical delivered Q4 revenue of $808,000, up 192% year-over-year, and achieved a 69% gross margin—its third consecutive quarter of positive gross profit.
  • For the full year 2023, revenue grew 324% to $2.9 million and gross profit rose by $1.2 million compared to a loss in 2022, driven by a 312% increase in catamaran surgical procedures.
  • The company trained 133 physicians through workshops in 2023 (28 in Q4) and reached over 60 providers via immersive webinars, targeting high-volume SI joint specialists to accelerate adoption.
  • Operationally, Tenon passed the FDA’s QSIT Level 2 quality inspection, repaid its $125 million secured note with a Series A preferred stock offering, and now stands debt-free with strengthened cash reserves.
  • A post-market multicenter clinical study (40–50 patients) is in its final enrollment phase, with early data on safety, pain relief efficacy, and radiographic fusion expected in the coming weeks.
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Earnings Conference Call
Tenon Medical Q4 2023
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