Core Insights - Emergent BioSolutions has announced a collaboration with PANTHER to support the Africa CDC-led 'MpOx Study in Africa' (MOSA), aimed at researching treatments for mpox, a virus lacking dedicated antiviral therapy [1] - The MOSA study, launched in 2024, is a double-blind, platform-adaptive clinical trial evaluating treatment options for mpox across multiple African countries, initially funded by the European Union and Africa CDC [1] - An independent data and safety monitoring board (DSMB) reviewed the safety data of MOSA in December 2025, recommending the continuation of the trial with no safety concerns identified [2] Company and Industry Overview - Emergent BioSolutions focuses on protecting public health by delivering life-saving solutions for various health threats, including mpox [5] - PANTHER is an African-led pandemic preparedness platform that aims to enhance regional response to emerging infectious diseases, particularly in Africa [6] - The Africa CDC is a public health agency of the African Union, supporting member states in strengthening health systems and improving disease surveillance and emergency response [8] Study Progress and Impact - The MOSA study represents a significant step in generating evidence for mpox treatment and enhancing Africa's capacity to respond to health threats, with over 61,383 confirmed cases and 296 deaths reported across 32 countries since 2024 [4] - The study will expand to new countries, including Uganda, as part of its efforts to reach the next milestone in patient enrollment [3]

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]

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]