Catamaran SE platform

Search documents
Tenon Medical(TNON) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:32
Financial Data and Key Metrics Changes - Revenue for the first quarter of 2025 was $726,000, a 1% increase from $719,000 in the first quarter of 2024, primarily driven by an increase in implants for surgical procedures, partially offset by a slight decrease in average selling price (ASP) due to account mix [14][15] - Gross profit for the first quarter of 2025 was $323,000, representing 44% of revenue, compared to $470,000 or 65% of revenue in the same quarter of the previous year [16] - Net loss for the first quarter of 2025 was $3,600,000, consistent with the loss in the same period of 2024 [17][18] Business Line Data and Key Metrics Changes - The upcoming full launch of the new Catamaran SE platform is expected to enhance the product offering for physicians preferring a smaller implant for SI joint fusion procedures [4][5] - The FDA clearance for the Catamaran SI Joint Fusion System for an extended indication to augment thoracolumbar fusion is anticipated to open new market opportunities [5][6] Market Data and Key Metrics Changes - The company received two European patents during the first quarter, enhancing its intellectual property portfolio, which now includes 12 issued patents and 31 pending applications [6] - The Catamaran technology is positioned to address a significant market segment lacking peer-reviewed data, which is crucial for gaining positive coverage from payers [11][12] Company Strategy and Development Direction - The company is focusing on sustainable revenue growth through a stable cost structure and plans to invest heavily in commercial operations, clinical research, and product refinement [12][19] - The strategy includes expanding the sales force and enhancing market access efforts to drive top-line growth [17][19] Management's Comments on Operating Environment and Future Outlook - Management anticipates improvements in the reimbursement environment, which has been a challenge due to coding confusion, and expects this to contribute to incremental growth [22][23] - The launch of the SE platform is viewed as an inflection point that will attract more physicians to adopt the technology [26][27] Other Important Information - The company completed equity financing of $7,100,000 in March 2025, contributing to a cash balance of $10,300,000 at the end of the quarter, with no outstanding debt [12][18] - The ongoing Main Sail study aims to evaluate clinical outcomes for patients treated with the Catamaran system, with interim results showing significant pain reduction and high patient satisfaction [9][10] Q&A Session Summary Question: Expectations for top line revenues trajectory through the year - Management expects incremental growth as reimbursement issues improve and the sales team expands [22][24] Question: Impact of SE launch on revenue - The SE launch is anticipated to be an inflection point, bringing more physicians into the adoption phase [26][27] Question: General and Administrative expenses trends - G&A expenses were lower in the first quarter, and this trend is expected to continue with some additional investments in sales initiatives [28] Question: Expansion of total addressable market due to new indication - The new indication for augmenting spinal fusion is expected to significantly increase the addressable market, particularly in complex spine surgeries [33][36] Question: Physician reaction to new approval and reimbursement considerations - Initial physician reactions are positive, with interest in the sacropelvic component of long constructs, and existing codes are anticipated to apply for the new procedures [37][38] Question: Targeting physicians for workshops - The company has improved its targeting capabilities and is now able to provide training more efficiently at physicians' clinics [40][41]
Tenon Medical(TNON) - 2024 Q4 - Earnings Call Transcript
2025-03-21 02:35
Financial Data and Key Metrics Changes - Revenue for the full year 2024 increased by 12% to $3.3 million compared to $2.9 million in 2023 [6][19] - Gross margin improved by 10 percentage points to 52% for the full year 2024, up from 42% in the prior year [7][22] - Net loss for the fourth quarter of 2024 was $3.1 million, flat compared to the same period in 2023, while the annual net loss decreased to $13.7 million from $15.6 million [24][25] Business Line Data and Key Metrics Changes - Fourth quarter revenue was $770,000, a decrease of 4.7% from $808,000 in the fourth quarter of 2023, primarily due to a decline in the number of surgical procedures [19][20] - The number of procedures in the fourth quarter was impacted by reimbursement pre-authorization delays and the timing of the restructured sales force [21] Market Data and Key Metrics Changes - The company experienced a revenue decline in the fourth quarter due to temporary reimbursement pre-authorization headwinds, which are expected to improve with future coding clarity [7][21] - The Catamaran System's average selling price (ASP) improved due to account mix and market access efforts [20] Company Strategy and Development Direction - The company is focused on expanding its sales and marketing efforts to build market share for the Catamaran System, with a full commercial launch of the Catamaran SE platform planned for mid-2025 [8][9] - Tenon Medical is committed to funding clinical research to reinforce the safety and effectiveness of its technologies, with ongoing studies like MAINSAIL evaluating patient outcomes [12][16] Management's Comments on Operating Environment and Future Outlook - Management anticipates improvements in the reimbursement landscape, noting that significant progress has been made in obtaining clarity on coding and approvals [32][33] - The company expects to incur additional losses in the future but is optimistic about improving its net loss with ongoing investments in growth initiatives [25][24] Other Important Information - The company received three U.S. patents related to its Catamaran portfolio during the fourth quarter, enhancing its competitive position [10][11] - As of December 31, 2024, the company had cash and cash equivalents of $6.5 million, significantly up from $2.4 million a year prior, and no outstanding debt [25][26] Q&A Session Summary Question: Any improvement in the reimbursement landscape now that you have more data? - Management indicated that while they do not control the reimbursement environment, significant progress has been made in obtaining clarity on coding and approvals [32][33] Question: What is the plan for adding sales personnel in 2025? - Management confirmed that they have made significant additions to the sales organization and anticipate having more coverage in key geographies [36][37] Question: How many independent distributors are currently engaged? - Management stated that there are 42 existing independent distributor contracts, with varying sizes of distributorships [41][42]
Tenon Medical(TNON) - 2024 Q4 - Earnings Call Transcript
2025-03-20 22:40
Financial Data and Key Metrics Changes - Revenue for the full year 2024 increased by 12% to $3.3 million compared to $2.9 million in 2023 [6][19] - Gross margin improved by 10 percentage points to 52% for the full year 2024, up from 42% in the prior year [7][22] - Fourth quarter revenue decreased by 4.7% to $770,000 compared to $808,000 in the fourth quarter of 2023 [19][20] - Net loss for the fourth quarter of 2024 was $3.1 million, flat compared to the same period in 2023, while the annual net loss decreased to $13.7 million from $15.6 million [24][25] Business Line Data and Key Metrics Changes - The number of surgical procedures using the Catamaran System showed a slight decrease in the fourth quarter, impacting revenue [20][21] - The alpha clinical review of the Catamaran SE platform was completed, with a full commercial launch expected in mid-2025 [8][9] Market Data and Key Metrics Changes - The reimbursement landscape remains challenging, with delays in pre-authorization impacting the number of procedures performed [19][33] - The company is actively working with decision-makers to improve clarity in the reimbursement environment [32][34] Company Strategy and Development Direction - The company is focused on expanding its sales force and enhancing market access efforts to drive revenue growth [21][37] - Investments are being made in the Catamaran SE platform and the MAINSAIL prospective study to support future growth [18][25] Management's Comments on Operating Environment and Future Outlook - Management anticipates that improvements in reimbursement clarity will positively impact future operations [33] - The company expects to incur additional losses in the future but is optimistic about improving its net loss over time [24][25] Other Important Information - The company received three U.S. patents related to the Catamaran portfolio during the fourth quarter, enhancing its competitive position [10][11] - The Catamaran SI Joint Fusion System's intellectual property portfolio now includes 12 issued patents and 23 pending applications [11] Q&A Session Summary Question: Any improvement in the reimbursement landscape? - Management noted that while they do not control the reimbursement environment, significant progress is being made towards clarity in the space [32][33] Question: Plans for sales perspective in 2025? - The company has made significant additions to its sales organization and anticipates increased coverage in key geographies [36][37] Question: How many independent distributors are currently engaged? - There are 42 existing independent distributor contracts, with varying sizes of distributorships [41][42]