Tenon Medical, Inc. Q2 FY2024 Earnings Call

Greetings and welcome to the Tenon Medical's Second Quarter 2024 Financial Results and Corporate Update Conference Call. As a reminder, this call is being recorded. Your host today is Steve Foster, President and Chief Executive Officer; and Steve Van Dick, CFO Adviser. Mr. Foster and Mr. Van Dick will present results of operations for the second quarter ended June 30th, 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. 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 this time, I'll turn the call over to Tenon's Medical, Chief Executive Officer, Steve Foster. Please go ahead sir.

Thank you, Maria, and good afternoon to everyone. I'm pleased to welcome you to today's second quarter 2024 financial results and corporate update conference call for Tenon Medical. In the second quarter, 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. 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 improved 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 multi-center, 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 that 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 infusion. 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 rebuild, 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 proven approach that contains costs 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 second quarter 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 Dick, our CFO Adviser, to discuss our financials.

Thanks, Steve. I'll give a succinct view 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 second quarter of 2024, an increase of 21% compared to $743,000 in the comparable year-ago period. Revenue for the six months ended June 30th, 2024, was $1.6 million, an increase of 38% compared to $1.2 million in the six months ended June 30th, 2023. The increase in revenue for the three and six months ended June 30th, 2024, as compared to the same period 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 second quarter 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 30th, 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 second quarter of 2024, largely in line with the expenses of $4.5 million in the second quarter of 2023. For the six months ended June 30th, 2024, operating expenses totaled $8.3 million compared to $9.4 million in the prior period. Decreases in operating expenses were a primary result of the decline in research and development expenses and sales and marketing expenses, offset by an increase in general and administrative expenses. Net loss was $3.8 million for the second quarter of 2024 compared to a loss of $4.3 million in the same period in 2023. For the six months ended June 30th, 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 30th, 2024, cash and cash equivalents totaled $2 million as compared to $2.4 million as of December 31st, 2023. As of June 30th, 2024, the company had no outstanding debt. Lastly, beginning with our third quarter in 2024 earnings call in November, Jay Hanson, 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.

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 second quarter 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. Lastly, on behalf of our Board of Directors and the entire Tenon Medical team, we wish Steve Van Dick the best in his retirement. Steve's financial expertise and leadership has set Tenon up for long-term strategic growth and expansion. Mr. Van Dick will remain with Tenon as a CFO Adviser, 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?

Thank you. We will now begin the question-and-answer session. Our first question comes from Bruce Jackson with The Benchmark Company. Please proceed with your question.

Hi, good afternoon. Thanks for taking my questions. I wanted 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?

Yes. 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. And 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, 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 just to remind, this is a up to 50-patient trial. So, it's a significant portion of the full enrollment.

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

Yes, that's correct. This is the first official publication from the study, Bruce, and it serves as an interim analysis. As we progress and reach larger numbers over six months and 12 months, which are critical milestones, we will continue to follow up with patients for up to 24 months as per the study's protocol, and we will keep providing updates and publications to support our findings. We aim to convey a clear statistical message regarding the capabilities of this technology. So, yes, you will see a regular stream of publications and updates as we gather and analyze the data from the study. Regarding enrollment, it's almost completed; we have just a couple more patients left, and then we will officially close the enrollment. So, we are very close to finishing the initial phase of enrollment.

Okay, great. I have a clarification question regarding the definition of normalized surgical procedures. Is this similar to a same-store sales measure, or could you explain how that is defined?

Yes, that's exactly right. 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.

Okay, great. Congratulations on all of the progress.

Thank you, Bruce. I appreciate it.

Our next question comes from Anthony Vendetti with 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.

You bet. Thanks, Anthony. I 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 positions in our organization in Q1, and so we had a slower Q1. We expanded that pretty dramatically in Q2, almost to an all-time high. And we expect that to continue as we onboard these professionals. They go through their training and are ready to go out and get after it in their assigned geography. So, that will continue to grow. And as we've talked about before, this is our mechanism to fill a proverbial funnel, if you will, with opportunities to show the technology, to train, and put the physicians in a great workshop environment with faculty. So, they can get their questions answered, and get comfortable with the technology. 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 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. Could you provide a bit more detail? Once they complete these workshops, we hope they will adopt the Catamaran system and the technology moving forward. Do most, or some of them, serve as references for other physicians? Are they willing to act as key opinion leaders, and how can we best leverage their experience after the workshop?

Yes, at the workshops, there is typically some work needed with the facilities to obtain approvals and get everything ready for using the technology. Once they become familiar with Catamaran, many physicians, though not all, are eager to teach and share their positive experiences about how it benefits their patients. They can become faculty members in various training events, whether live or virtual, utilizing different methods to accomplish this since peer-to-peer education is incredibly effective. While they may initially listen to company representatives, they are more inclined to trust and learn from their colleagues. Therefore, once they are comfortable with the technology, we actively engage in discussions about their willingness to represent it in training and informational settings.

Okay. And lastly, regarding the sales force, do you have a year-end target for the number of salespeople, or will you be selective and expand only when the right candidates are found?

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. 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 properly focused, etc., are going to be able to deliver the kind of results that we're looking for going forward. And these guys are very experienced, very professional people, and we're really encouraged by some of the new team members that we brought on here in the last four to six months.

Okay. And then lastly, and then I'll hop back in the queue on the follow-up. Yes, so you have the five Territory/Regional Managers and you have the independent distributors, how many independent distributors are there that report or work with your five Regional/Territory Managers?

Yes, indeed. So, 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 relationships with physicians and what have you. We have over 90 of those contracts in place now, and that's growing every single day. 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 within their geography to get that number growing and building and to get that work done.

Okay, great. Thanks so much. I appreciate the color. I'll hop back in the queue.

Indeed. Thank you.

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

Thank you, Maria. So, 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, who would be more than happy to assist. And with that, I wish everyone a good day.

This concluded today's teleconference. You may disconnect your lines at this time. Thank you for your participation.