Tenon Medical - Q2 2024

Transcript

Operator (participant)

Greetings, and welcome to the Tenon Medical Q2 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 Steve Van Dyck, CFO Advisor. Mr. Foster and Mr. Van Dyck will present results of operations for the Q2 ended June 30, 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 website at www.tenonmed.com.

Anthony Vendetti (Executive Managing Director of Research)

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 would 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 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 annual report on 10-K, dated March 29th, 2024, 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.

Steve Foster (CEO)

Thank you, Maria, and good afternoon to everyone. I'm pleased to welcome you to today's Q2 2024 financial results and corporate update conference call for Tenon Medical. In the Q2, we continued to focus on building market share for our proprietary Catamaran system, supported by our recently restructured operational sales and marketing strategy. We are pleased with the sustained revenue growth and full-year milestone of generating positive gross profit as we successfully resourced all of our U.S. sales regions.

Anthony Vendetti (Executive Managing Director of Research)

We delivered a 21% year-over-year increase in revenue, driven by a 7% rise in surgical procedures utilizing the Catamaran system. Gross profit of $470,000 expanded 142% as compared to the prior year quarter and generated solid gross margin of 52%. With sustainable revenue growth, we believe our stable cost structure will maintain a gross margin performance at recent levels and improve with increases in revenue. Across operations, we've made considerable commercialization and technical advances and remain on the right path during our second year of commercialization.

To provide an update on our restructured sales organization, during Q2, we have reached our 2024 full-year target of sales operations in five geographic regions. With additional operational team members assigned across our now full geographic reach, we are poised for future growth. A significant component of our growth strategy is the investment in clinical research to reinforce the safety and effectiveness of the Catamaran system. Significant progress has been made in this area.

For those new to Tenon, this prospective, multicenter, single-arm, post-market study evaluates the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis 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, this study aims to show the Catamaran system delivers on its promises. As we near completion of enrollment in this study, we have been notified that publication of our interim analysis is now imminent.

This peer-reviewed analysis reinforces that the Catamaran system, utilizing a minimally invasive inferior posterior approach, is safe and effective in relieving pain and reducing disability in adult patients diagnosed with SIJ disruption or degenerative sacroiliitis with a failed non-surgical treatment. We look forward to sharing specific details when publication is complete in the very near future. This early validation provides conviction that the Catamaran transfixing design and less invasive inferior posterior approach is functioning as intended to optimize patient outcomes through short-term stabilization of the joint and long-term fusion.

Of note, the interim data from our study, combined with the over 600 surgeries performed with the Catamaran system to date, is demonstrating an exceptional safety profile, benefiting patients and their physicians alike in delivering on its clinical promises. Our ongoing workshop activities, led by a network of valued physician faculty, combined with the robust commercial infrastructure we've built, have us prepared for rapid expansion. Our goal is to ensure we are precise in the selection of medical professionals with experience in SI surgical technologies and to provide them with world-class workshop opportunities.

Importantly, this is a prudent approach that contains cost and provides higher return value to patients, the cohort of physicians, and Tenon's business overall. We experienced an increase in our interactive training, corresponding with our restructured marketing and sales approach, and hosted 36 physicians in Catamaran workshops during the Q2 of 2024. As clinical data builds from our post-market study, validating the effectiveness of our SI implant and approach, our sales and marketing activities will become more robust and drive our ongoing targeted physician workshop activities.

With that, I'll turn it over to Mr. Van Dyck, our CFO advisor, to discuss our financials.

Steve Van Dyck (CFO Advisor)

Thanks, Steve. I'll give a succinct review of our financial results. A full breakdown is available in our press release that crossed the wire this afternoon. Our revenue was $901,000 in the Q2 of 2024, an increase of 21% compared to $743,000 in the comparable year-ago period. Revenue for the six months ended June 30, 2024, was $1.6 million, an increase of 38% compared to $1.2 million in the six months ended June 30, 2023.

Anthony Vendetti (Executive Managing Director of Research)

The increase in revenue for the three and six months ended June 30, 2024, as compared to the same periods in 2023, was primarily due to increases of 7% and 19%, respectively, in the number of surgical procedures in which the Catamaran system was used. Gross profit in the Q2 of 2024 was $470,000, or 52% of revenues, compared to $194,000, or 26% of revenues, in the comparable year-ago quarter. For the six months ended June thirtieth, gross profit was $940,000, or 58% of revenues, compared to the gross profit of $147,000, or 13% of revenue, for the previous year's period.

Importantly, we have seen gross margins steadily improve due to the revenue growth associated with an increase in the number of surgical procedures, which resulted in a sustainable operating leverage due to lower relative fixed costs and the absorption of more overhead into our standard cost. Operating expenses totaled $4.3 million in the Q2 of 2024, largely in line with the expenses of $4.5 million in the Q2 of 2023. For the six months ended June 30, 2024, operating expenses totaled $8.3 million, compared to $9.4 million in the prior period.

Decreases in operating expenses were primarily a result of a decline in research and development expenses and sales and marketing expenses, offset by increase in general and administrative expenses. Net loss of $3.8 million for the Q2 of 2024, compared to a loss of $4.3 million in the same period in 2023. For the six months ended June 30, 2024, net loss was $7.4 million, compared to $9.1 million in the previous year period. The company expects to incur additional losses in the future. As of June 30, 2024, cash and cash equivalents totaled $2 million, as compared to $2.4 million as of December 31, 2023.

As of June 30, 2024, the company had no outstanding debt. Lastly, beginning with our Q3 in 2024 earnings call in November, Jay Hansen, our Interim Principal Accounting Officer, will join me to deliver the financial results during the earnings call. Additionally, Jay will join today's question and answer session following Steve's closing remarks. I will now turn the call back to Steve.

Steve Foster (CEO)

Thank you, Steve. As we continue to drive momentum in the market, represented by year-over-year increases in our Catamaran procedures, we are regionally prioritizing the scale of the commercialization strategy of our proprietary FDA-cleared surgical implant system. While the commercialization strategy was reorganized during the first half of 2024, we ended the Q2 with year-over-year revenue growth and an attractive gross margin. We believe the upcoming larger cohort of patient post-market data will be a catalyst to drive growth and adoption in the second half of 2024, supported by the expanded penetration of our commercial infrastructure and seasoned sales management team.

Anthony Vendetti (Executive Managing Director of Research)

Lastly, on behalf of our board of directors and the entire Tenon Medical team, we wish Steve Van Dyck the best in his retirement. Steve's financial expertise and leadership has set Tenon up for long-term strategic growth and expansion. Mr. Van Dyck will remain with Tenon as a CFO advisor while we continue our executive search process for a permanent CFO. In short, Steve will be missed. I thank you all for attending, and now I'd like to hand the call back over to our operator to begin the question and answer session with our covering analysts. Maria?

Operator (participant)

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two 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 star key. One moment, please, while we pull for questions. Our first question comes from Bruce Jackson with The Benchmark Company. Please proceed with your question.

Bruce Jackson (Equity Research Analyst)

Hi, good afternoon, and thanks for taking my questions. I want to ask about the publication of the study results. Is this going to be the same six patients that we saw the early data on previously, or will this be a slightly larger group of patients?

Steve Foster (CEO)

Yeah, thanks, Bruce, and good to hear from you. So this will be a larger group of patients. This is an interim analysis, to the degree that we've cleared 33 enrolled patients. Of course, those patients are all at different time points. Some were very recent, some have been 12 months or more post-op. And so what this interim analysis will do, is document the progress that we've made, on all the things that we're measuring. Everything from adverse events to patient outcomes and feedback, and things of that nature. Not to mention everything that happens in the operating room.

Anthony Vendetti (Executive Managing Director of Research)

You know, how long the procedure took, blood loss, all the details of a study like this. So this interim analysis will cover those 33 patients. And as. Just to remind, this is up to a 50-patient trial, so it's a significant portion of the full enrollment.

Bruce Jackson (Equity Research Analyst)

Okay, and then, is the study fully enrolled yet? And is this the type of study where we're gonna keep getting a larger and larger patient base, and we're gonna be getting a stream of publications over the next couple of years?

Steve Foster (CEO)

Yeah, that's exactly right. You know, this is the first formal publication from the study, Bruce, and it's in every way an interim analysis. As we proceed and as we get to bigger and bigger numbers that are hitting six months, 12 months, these critical milestones, and we follow patients up to 24 months in the study and its protocol, we'll continue to provide updates and publications to support. You know, for obvious reasons, you know, we're trying to drive a statistical and clear message about the capabilities of this technology. So, that's what we're doing here. So, yeah, the answer is yes.

Anthony Vendetti (Executive Managing Director of Research)

You'll see a cadence, if you will, of publications and updates from you know as the data is gathered and tabulated, et cetera, as part of the study. You asked about enrollment. Enrollment's virtually finished. We have maybe a couple, couple three more patients to go here, and we'll be closing enrollment officially. So very close to wrapping up the front end and the enrollment.

Bruce Jackson (Equity Research Analyst)

Okay, great. And then, just a clarification question on the definition of normalized surgical procedures. Is this like a same-store sales type of measure, or is it like a. Just tell me what's how that's defined.

Steve Foster (CEO)

Yes, that's exactly right. You know, what we're doing is assessing total surgical procedures. And of course, everything with revenue fluctuates based on average selling price and things of that nature. So, that's what we're referring to there, is the number of procedures that have actually been done.

Bruce Jackson (Equity Research Analyst)

Okay, great. Congratulations on all of the progress.

Steve Foster (CEO)

Thank you, Bruce. I'm appreciative.

Anthony Vendetti (Executive Managing Director of Research)

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

Thank you. Steve, I was wondering if you could just talk about the physician workshops, how many were hosted this past quarter. What’s the expectation for the rest of this year? Just a little color on that would be great.

Steve Foster (CEO)

You bet. Thanks, Anthony. Appreciate the question. So we hosted 36 sessions in Q2, and that was a significant increase over Q1. As mentioned, in the prepared statements, we did restructure our selling organization, some of the, some of the positions in our organization in Q1, and so we had a slower Q1. We expanded that pretty dramatically in Q2, almost to an all, all-time high, and we, we expect that to continue as we onboard these professionals. They go through their training, and they're ready to go out and get after it in their assigned geography. So that'll continue to grow.

Anthony Vendetti (Executive Managing Director of Research)

As we've talked about before, this is our mechanism to fill a proverbial funnel, if you will, with opportunities, you know, to show the technology, to train, put the, put the physicians in a great workshop environment with faculty so they can get their questions answered, get comfortable with the technology. And of course, we hope that a large percentage of them will adopt the technology and begin using it in their clinical practice. So, critical, critical, critical for us to train effectively and to execute these workshops effectively. And we think that's not only happening but expanding very quickly now with our new team.

That's great to hear. Maybe just a little more color. So once they obviously complete these workshops, the hope is that they, you know, adopt the Catamaran system and the technology going forward. Do most of them or some of them act as references for other physicians? Are they willing to act as, let's say, KOLs? Or how can you best utilize their experience once they attend the workshop?

Steve Foster (CEO)

Yeah, indeed. Of course, after the workshop, there's some work to do, usually with their facilities and things like that, to get approvals and the facilities and get things squared away so they can begin using the technology. Yes, absolutely. Once they get experienced with Catamaran, many, not all, but many of the physicians love to teach. They love to pass the word on if they're satisfied with what they're using and how it treats their patients. And they can. They can become faculty, either in live training events, virtual training events, all different kinds of pathways to get that job done.

Anthony Vendetti (Executive Managing Director of Research)

Because quite candidly, there's nothing more powerful, in our world than peer-to-peer work in education. You know, they'll, they'll listen to us company guys, for a while, but they like to hear from their colleagues. Absolutely, Anthony, you know, once they get comfortable with the technology, we're always in conversations about their willingness to represent, if you will, the technology in training environments and informational environments.

Okay, and then lastly, you were mentioning about the sales force. Do you have a target for the end of the year in terms of the number of salespeople? Or is it, you know, you're going to be selective and grow when you get the right people in place?

Steve Foster (CEO)

Well, we were very selective, so we've fully filled now all five of our sales regions around the country. These area sales managers are assigned to building that geography through independent distribution networks, right? As things get too big for them to manage, certainly, we'll contemplate expanding to more regions and things like that. But right now, we feel like those five regions, you know, properly focused, et cetera, are gonna be able to deliver the kind of results that we're looking for going forward. These guys are very experienced, very professional people, and we're really encouraged by some of the new team members that we've brought on here in the last four to six months.

Anthony Vendetti (Executive Managing Director of Research)

Okay. And then lastly, and then I'll hop back into you on the follow-up to that. So you have the five territory slash regional managers, and you have the independent distributors. How many independent distributors are there, that report or work with your five regional slash territory managers?

Steve Foster (CEO)

Yeah, indeed. So they, of course, they don't report to them. They're independent by their definition. But our area sales managers partner with these independent distributors and frankly, our company across the board, internally and externally, partners with these guys out in the field who are present in the operating room, who have the relationships with physicians and what have you. We have over 90 of those contracts in place now, and that's growing every single day.

Anthony Vendetti (Executive Managing Director of Research)

And of course, when they come on board, there's some work to do to train and prepare them to represent the technology well and what have you. So all of that work is ongoing, but it starts with these new area sales managers, their network, with independent distributors when they're within their geography, to get that number growing and building and to get that work done.

Okay, great. Thanks so much. I appreciate the call. I'll hop back to you, too.

Steve Foster (CEO)

Indeed. Thank you.

Operator (participant)

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

Steve Foster (CEO)

Thank you, Maria. I'd like to thank everyone for joining us on 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, who would be more than happy to assist. With that, I wish everyone a good day.