Financial Data and Key Metrics Changes - As of December 31, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash of $98.1 million, compared to $52.6 million as of December 31, 2023, indicating a significant increase in financial resources [24] - Research and development expenses were $34.4 million for the full year ended December 31, 2024, up from $31.1 million in 2023 [25] - General and administrative expenses rose to $29.9 million for the full year ended December 31, 2024, compared to $19 million in 2023, primarily due to commercial launch preparation costs [25][26] - The net loss for the full year ended December 31, 2024, was $63.7 million, or $1.55 loss per common share, compared to a net loss of $54.2 million, or $2.53 loss per common share in 2023 [26] Business Line Data and Key Metrics Changes - The company is preparing for the potential launch of PD Cell for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), with an estimated 750 RDEB patients in the U.S. who may be candidates for treatment [10][11] - The estimated cumulative revenue potential for PD Cell in the U.S. is over $2 billion, based on a conservative treatment cost of $1.5 million per patient [12] Market Data and Key Metrics Changes - The company anticipates activating treatment centers in the U.S. to begin patient biopsies approximately three months after the PDUFA date, with a gradual ramp-up in treatment capacity expected [7][16] - The payer mix indicates that 60-65% of lives are covered by commercial plans, 30-35% by Medicaid, and less than 10% by Medicare, highlighting the market access landscape [18] Company Strategy and Development Direction - The company is focused on securing FDA approval for PD Cell and launching it as a new treatment for RDEB patients, with significant growth potential anticipated in 2025 [76] - The strategy includes onboarding five treatment centers initially, with plans to gradually increase the number of centers as manufacturing capacity ramps up [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date and the potential approval of PD Cell, which is expected to transform the treatment paradigm for RDEB patients [6][8] - The company is optimistic about the interest from payers and the clinical value of PD Cell, which addresses a significant unmet medical need in the RDEB treatment landscape [18] Other Important Information - The company has received a priority review designation from the FDA for PD Cell, which may qualify it for a Priority Review Voucher (PRV) upon approval [25][59] - The company is also exploring potential markets outside the U.S., including Europe and Asia, for future deployment of PD Cell [64][66] Q&A Session Summary Question: Is the FDA satisfied with the work done on the CMC side? - Management believes they have addressed all FDA requests from the previous CRL and have had multiple touchpoints with the agency, indicating a positive outlook [30][31] Question: What percentage of patients at the treatment centers may be eligible for PD Cell? - Approximately 30% of the estimated 750 RDEB patients are located in seven centers of excellence, with discussions ongoing about patient eligibility [34] Question: What is the primary reason for patients to seek PD Cell therapy? - The key reason is the need for durable wound closure, which significantly impacts the quality of life for patients with chronic wounds [37] Question: Will there be a patient backlog upon launch? - Management anticipates a patient backlog initially due to limited manufacturing capacity, which will gradually increase as production ramps up [44] Question: What is the company's strategy for physician education and patient awareness? - The company plans to engage in physician education and leverage advocacy groups to raise awareness within the tight-knit RDEB patient community [52][53]

Financial Data and Key Metrics Changes - Total revenue for 2023 was $143.3 million, an 11% decrease compared to 2022, with ex-COVID revenue decreasing 4% [10] - Q4 revenue was $32.7 million, representing a 26% year-over-year decrease, and a 23% decline when excluding COVID-related revenue from Q4 2022 [21] - Adjusted gross margin for Q4 was 35%, up from 32% in the prior year, primarily due to product mix and lower warranty expenses [23] - Adjusted operating loss for Q4 2023 was $9.3 million, compared to $8.2 million in Q4 2022 [25] - Adjusted EBITDA for Q4 2023 was $700,000, down from $1.7 million in the prior year but increased sequentially by $3.8 million from Q3 [26] Business Line Data and Key Metrics Changes - Cell processing platform revenue for 2023 declined 4% to $65.8 million, with a 6% decrease in biopreservation media revenue, partially offset by a 9% increase in other cell processing tools [10] - Biostorage and services platform revenue decreased 2% to $25.9 million, but grew 61% when excluding prior year COVID-related revenue [12] - Freezer and thaw platform revenue declined 23% to $15.1 million, primarily due to a difficult capital equipment environment [13] Market Data and Key Metrics Changes - The top 20 media customers accounted for 78% of media revenue, which was up slightly by 1% year-over-year [11] - Customers with commercially approved therapies accounted for an estimated 52% of direct media revenue in 2023, compared to 49% in 2022 [11] - The cell and gene therapy (CGT) industry is expected to grow at a 20% to 25% CAGR through 2033 [7] Company Strategy and Development Direction - The company is refocusing on higher margin recurring revenue streams and divesting freezer product lines to improve financial performance [6][14] - The company aims to leverage its market position in biopreservation media to drive adoption of other tools and services in its portfolio [89] - The 2024 revenue guidance is set between $95.5 million and $100 million, reflecting a cautious approach despite some optimism in market conditions [18] Management's Comments on Operating Environment and Future Outlook - Management noted that 2023 was a challenging year for the CGT industry, but there are early signs of stabilization and momentum [9] - The company expects a sustained recovery as 2024 progresses, with a focus on managing inventory normalization [9] - Management expressed confidence in the company's position to benefit from the growth of the CGT market, despite a cautious outlook for 2024 [89] Other Important Information - The company is in the process of divesting its freezer product lines, with two signed letters of intent (LOIs) and expects to close these transactions within 45 to 60 days [31][45] - The cash and marketable securities balance at December 31, 2023, was $52.3 million, up from $42.2 million at September 30, 2023 [27] Q&A Session Summary Question: Does the LOI allow the company to move the freezer assets to discontinued operations? - Management stated that a signed document is required to move them into discontinued operations, and they are working on finalizing the legal documents [31][32] Question: Can you discuss the steps taken to achieve positive EBITDA? - Management highlighted a reduction in force and control over discretionary expenses as key factors contributing to positive EBITDA [34][35] Question: How confident is the company about concluding the freezer sale? - Management expressed a 70% to 80% confidence level regarding the completion of the freezer sale within the expected timeframe [45][46] Question: What are the expectations for media revenue in 2024? - Management indicated that the first half of 2024 might be flat compared to the second half of 2023, with expectations of an uptake in the latter half [49] Question: What is the impact of the freezer business on adjusted EBITDA? - Management noted that they do not provide specific information on segment reporting but will clarify post-divestiture [81]