~ Full Year 2024 Revenue of $3.3 Million, a 12% Increase Compared to Prior Year ~
~ Interim Analysis from MAINSAIL Study Reinforces Safety Profile, Effectiveness and Confirmation of Fusion ~
~ Catamaran® SI Joint Fusion Technology Protected with Robust Patent Portfolio of Twelve U.S. and International Patents ~
~ Introduced Catamaran SE Platform and Successfully Completed Initial Clinical Procedures ~
~ National Commercial Launch of Catamaran SE in Mid-2025 ~
LOS GATOS, CA / ACCESS Newswire / March 20, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon Medical" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today reported financial results for the fourth quarter and year ended December 31, 2024.
Financial Results and Business Updates
Fourth Quarter 2024 Results:
Revenue of $0.8 million, in line with the fourth quarter of 2023.
Gross profit of $353,000, as compared to $559,000 in the fourth quarter of 2023.
Gross margin of 46%, as compared to 69% in the fourth quarter of 2023.
Full Year 2024 Results:
Revenue of $3.3 million, a 12% increase compared to $2.9 million in 2023.
Gross profit of $1.7 million, a 38% increase compared to $1.2 million in 2023.
Gross margin of 52%, a 10 percentage point improvement from 42% in 2023.
Published first interim analysis from MAINSAIL Study:
Reinforces Exceptional Safety Profile.
Statistically Significant Improvement in VAS (Pain) and ODI (Disability) Scores.
Radiographic Proof of Fusion at 12-Month CT.
Granted issuance of three additional U.S. Patents highlighting a commitment to enhancing SI joint stabilization systems and methods, addressing the need for revision of other ineffective SI joint devices and as a patent protection mechanism.
Hosted 23 physicians in targeted workshop activities and Catamaran focused training sessions within the Fourth Quarter.
Successfully completed initial clinical cases (alpha) of Tenon's new Catamaran SE SI Joint Fusion System.
Subsequent Updates
Performed over 1,000 Catamaran System surgical procedures as of March 20, 2025.
Expanded direct sales force entering into new territories with significant SI addressable markets.
Full commercial launch of Catamaran SE expected in mid-2025.
Secured an additional $3M of capital on March 12, 2025 to strengthen balance sheet and fund growth initiatives.
Steve Foster, President and Chief Executive Officer of Tenon Medical, commented, "We are proud of Tenon's solid performance for the full year 2024, which demonstrated revenue growth of 12% compared to the prior year, driven by increases in revenue per surgical procedure and our reconstituted sales and marketing plans. Our restructured sales operation is beginning to deliver results by driving exposure to our newly published clinical data and the new SE platform. During the fourth quarter, we further invested in our sales and marketing initiatives and continued to collect positive responses from initial clinical experiences with the new Catamaran SE in anticipation of a full launch by mid-2025. This platform focuses on reduction in access and implant size, providing options for physicians seeking a smaller profile for primary and revision SI applications. We expect this versatility to result in market share gains and increased adoption as we ramp up our broader market introduction and commercialization.
Additionally, our prospective, multi-center Catamaran SI Joint Fusion System® MAINSAIL study had a preliminary interim analysis published in the early fall. The analysis highlighted impressive results in safety profile and pain / disability scores. 12-month CT scans confirmed that an authentic arthrodesis can be achieved with this innovative technology, as confirmed by independent third party radiologists. These early results confirm that Catamaran delivers on its promises.
Importantly, a key initiative during 2024 was directed at fortifying our competitive position in the industry by protecting our intellectual property portfolio. With the issuance of three US patents during the fourth quarter, the Catamaran® SI Joint Fusion System now comprises twelve issued U.S. and foreign (International) patents, and twenty-three pending U.S. and foreign patent applications. The additional patents recognize the novel Catamaran® SI joint prostheses as a solution to specifically address the need for revision of other ineffective SI joint devices and reinforces our commitment to innovation.
Looking ahead, we are highly focused on increasing sales through our revamped training and education program, participation in trade shows, and marketing efforts throughout 2025. We will maintain balanced financial discipline as we advance Tenon into our next phase of growth with upcoming catalysts, including the full enrollment of our post-market clinical trial for the Catamaran SI Joint Fusion System® and the next release of the study's interim analysis, which remains imminent," concluded Foster.
Fourth Quarter & Full Year 2024 Financial Results
Revenue was $0.8 million in the fourth quarter of 2024, in line with $0.8 million in the comparable year ago period. Revenue for the year ended December 31, 2024, was $3.3 million, an increase of 12%, compared to $2.9 million in year ended December 31, 2023. The number of procedures in the fourth quarter was impacted by our restructured sales operation process, as well as reimbursement pre-authorization delays, leading to fewer surgeries performed during the quarter. Notably, both periods experienced improved ASP driven by account mix and market access efforts.
Gross profit in the fourth quarter of 2024 was $0.4 million, or 46% of revenues, compared to $0.6 million, or 69% of revenues in the comparable year ago quarter. For the year ended December 31, 2024, gross profit was $1.7 million, or 52% of revenues, compared to a gross profit of $1.2 million, or 42% of revenue, for the year ended December 31, 2023. Gross margin percentage varied from period to period driven by the absorption of production overhead costs into our standard cost and operating leverage created by lower relative fixed costs.
Operating expenses totaled $3.5 million for the fourth quarter of 2024, as compared to expenses of $3.7 million in the fourth quarter of 2023. For the year ended December 31, 2024, operating expenses totaled $15.5 million compared to $17.0 million in the prior year period. Operating expenses decreased due to the restructuring of sales operations that reduced sales and marketing expenses and a decline in research and development driven by a shift to sustaining activities within the Catamaran portfolio, offset by an increase in general and administrative expenses. Continued investment in growth will include sales force expansion, market access programs and reimbursement and coverage initiatives. As a result, increases in sales and marketing expenses are expected in future quarters.
Net loss was $3.1 million for the fourth quarter of 2024, as compared to a loss of $3.1 million in the same period of 2023. For the year ended December 31, 2024, net loss was $13.7 million compared to $15.6 million in the previous year period. The Company expects to incur additional losses in the future.
As of December 31, 2024, cash and cash equivalents totaled $6.5 million, as compared to $2.4 million as of December 31, 2023. As of December 31, 2024, the Company had no outstanding debt. Additionally, Tenon received gross proceeds of $3.0 million from the capital raised in March 2025.
Fourth Quarter Earnings Conference Call
Management will host a conference call at 4:30 p.m. ET (1:30 p.m. PT) today, Thursday, March 20, 2025, to discuss Tenon's fourth quarter and full year 2024 financial results, provide a corporate update, and conclude with Q&A with the Company's covering analyst. To participate, please use the following information:
Date: | Thursday, March 20, 2025 |
Time: | 4:30 p.m. Eastern time |
Dial-in: | 1-877-407-0792 |
International Dial-in: | 1-201-689-8263 |
Webcast: | TNON Conference Call |
Please dial in at least 10 minutes before the start of the call to ensure timely participation.
An audio playback of the call will be available through April 3, 2025 by dialing 1-844-512-2921 (USA) or 1-412-317-6671 (International). The access code will be 13751490. In addition, a webcast replay will be available on Tenon's Investor Relations website at http://ir.tenonmed.com.
About Tenon Medical, Inc.
Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022 Tenon is focused on two commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, and 2) Revision procedures of failed SI Joint implants. For more information, please visit www.tenonmed.com.
The Tenon Medical logo shown above, and Catamaran®, PiSIF®, CAT PiSIF®, ETAD®, Posterior Inferior Sacroiliac Fusion®, CAT SIJ Fusion System®, Catamaran SIJ Fusion System®, Catamaran Inferior Posterior Fusion System®, Catamaran Transfixation Fusion System®, and Catamaran Transfixation Fusion Device® are registered trademarks of Tenon Medical, Inc. MAINSAILTM is also a trademark of Tenon Medical, Inc.
Safe Harbor
This press release contains "forward-looking statements," which are statements related to events, results, activities or developments that Tenon expects, believes or anticipates will or may occur in the future. Forward-looking often contain words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions thereof. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, please review our Annual Report on Form 10-K for the year ended December 31, 2023 on file with the Securities and Exchange Commission at www.sec.gov, particularly the information contained in the section entitled "Risk Factors". We expect to file our Annual Report on Form 10-K for the year ended December 31, 2024 with the Securities and Exchange Commission no later than March 31, 2025. We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.
Investor Contact
Shannon Devine / Rory Rumore
MZ North America
203-741-8811
tenon@mzgroup.us
Tenon Medical, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share data)
| December 31, |
|
| December 31, |
| |||
| 2024 |
|
| 2023 |
| |||
Assets |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 6,535 |
|
| $ | 2,428 |
|
Accounts receivable, net |
|
| 863 |
|
|
| 518 |
|
Inventory, net |
|
| 606 |
|
|
| 554 |
|
Prepaid expenses and other current assets |
|
| 206 |
|
|
| 389 |
|
Total current assets |
|
| 8,210 |
|
|
| 3,889 |
|
Fixed assets, net |
|
| 752 |
|
|
| 961 |
|
Deposits |
|
| 51 |
|
|
| 51 |
|
Operating lease right-of-use asset |
|
| 399 |
|
|
| 646 |
|
Deferred offering costs |
|
| 431 |
|
|
| 798 |
|
TOTAL ASSETS |
| $ | 9,843 |
|
| $ | 6,345 |
|
|
|
|
|
|
|
|
| |
Liabilities and Stockholders' EQUITY |
| |||||||
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 369 |
|
| $ | 433 |
|
Accrued expenses |
|
| 910 |
|
|
| 808 |
|
Current portion of accrued commissions |
|
| 303 |
|
|
| 470 |
|
Current portion of operating lease liability |
|
| 287 |
|
|
| 256 |
|
Convertible notes payable and accrued interest, net of debt discount of $0 and $77 at December 31, 2024 and 2023, respectively |
|
| - |
|
|
| 1,173 |
|
Total current liabilities |
|
| 1,869 |
|
|
| 3,140 |
|
Accrued commissions, net of current portion |
|
| 1,862 |
|
|
| 1,999 |
|
Operating lease liability, net of current portion |
|
| 141 |
|
|
| 428 |
|
Total liabilities |
|
| 3,872 |
|
|
| 5,567 |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
| |
Stockholders' equity: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.001 par value; 4,500,000 shares authorized at December 31, 2024 and 2023; 256,968 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively |
|
| 3,300 |
|
|
| - |
|
Series B convertible preferred stock, $0.001 par value; 491,222 shares authorized at December 31, 2024 and 2023; 86,454 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively |
|
| 452 |
|
|
| - |
|
Common stock, $0.001 par value; 130,000,000 shares authorized at December 31, 2024 and 2023; 3,138,804 and 325,039 shares issued and outstanding at December 31, 2024 and 2023, respectively |
|
| 3 |
|
|
| - |
|
Additional paid-in capital |
|
| 70,962 |
|
|
| 55,897 |
|
Accumulated deficit |
|
| (68,746 | ) |
|
| (55,073 | ) |
Accumulated other comprehensive loss |
|
| - |
|
|
| (46 | ) |
Total stockholders' equity |
|
| 5,971 |
|
|
| 778 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
| $ | 9,843 |
|
| $ | 6,345 |
|
Tenon Medical, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except per share data)
| Years Ended December 31, |
| ||||||
| 2024 |
|
| 2023 |
| |||
Revenue |
| $ | 3,277 |
|
| $ | 2,928 |
|
Cost of sales |
|
| 1,566 |
|
|
| 1,687 |
|
Gross Profit |
|
| 1,711 |
|
|
| 1,241 |
|
|
|
|
|
|
|
|
| |
Operating Expenses |
|
|
|
|
|
|
|
|
Research and development |
|
| 2,603 |
|
|
| 3,163 |
|
Sales and marketing |
|
| 5,109 |
|
|
| 6,778 |
|
General and administrative |
|
| 7,765 |
|
|
| 7,027 |
|
Total Operating Expenses |
|
| 15,477 |
|
|
| 16,968 |
|
|
|
|
|
|
|
|
| |
Loss from Operations |
|
| (13,766 | ) |
|
| (15,727 | ) |
|
|
|
|
|
|
|
| |
Other Income (Expense) |
|
|
|
|
|
|
|
|
Gain on investments |
|
| 183 |
|
|
| 167 |
|
Interest expense |
|
| (34 | ) |
|
| (21 | ) |
Other expense, net |
|
| (56 | ) |
|
| - |
|
Total Other Income (Expense), net |
|
| 93 |
|
|
| 146 |
|
Net Loss |
| $ | (13,673 | ) |
| $ | (15,581 | ) |
Net Loss Per Share of Common Stock |
|
|
|
|
|
|
|
|
Basic and diluted |
| $ | (11.26 | ) |
| $ | (68.64 | ) |
|
|
|
|
|
|
|
| |
Weighted-Average Shares of Common Stock Outstanding |
|
|
|
|
|
|
|
|
Basic and diluted |
|
| 1,214 |
|
|
| 227 |
|
|
|
|
|
|
|
|
| |
Consolidated Statements of Comprehensive Loss: |
|
|
|
|
|
|
|
|
Net loss |
| $ | (13,673 | ) |
| $ | (15,581 | ) |
Unrealized loss on investments |
|
| - |
|
|
| 16 |
|
Foreign currency translation adjustment |
|
| 46 |
|
|
| 38 |
|
Total Comprehensive Loss |
| $ | (13,627 | ) |
| $ | (15,527 | ) |
SOURCE: Tenon Medical, Inc.
View the original press release on ACCESS Newswire
