Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [9] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [10] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [7][8] - Neurosurgery Navigation revenue grew 70% to $3.3 million, attributed to higher sales of new product offerings [8] - Capital Equipment and Software revenue decreased 63% to $500,000 due to fewer new placements of navigation and laser units [9] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, expanding its installed base [19][50] - The single-use consumables business saw a growth rate of 104%, driven by increased orders from biopharma partners [13] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - The company is focused on expanding its global installed base and generating scale for novel treatments [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain regulatory approval within two years [15] - The recent partnership with Overland Capital provides the company with foundational funding to execute its strategy [6][12] - Management anticipates that revenue growth will outpace expense growth for the full year [11][56] Other Important Information - The company has implemented a new subscription program called Pathfinder, allowing hospitals to access technology through an annual fee [21] - The Pathfinder program will smooth out capital revenue recognition over time [22] Q&A Session Summary Question: Opportunities with Incremental Capital - Management sees opportunities to accelerate hiring and expand preclinical resources in response to pharma partners' requests [29] Question: Neuro Franchise Growth Expectations - Management believes the neuro franchise can grow significantly more than 20% throughout the year, with potential upside based on product adoption [33] Question: MRI vs. OR Procedure Mix - Management anticipates a shift towards more procedures being performed in the operating room, especially as new drug therapies are introduced [39] Question: GLP Certification Timeline - Management expects to achieve GLP certification by the end of the year, with pent-up demand from pharma partners for studies once certified [42][44]

Summary of Bio-Techne (TECH) 2025 Conference Call Company Overview - **Company**: Bio-Techne (TECH) - **Date**: May 13, 2025 - **Key Speakers**: Kim Kelderman (CEO), Jim Hipple (CFO) Key Highlights Financial Performance - **Fiscal 3Q Results**: Reported a solid 6% growth despite macroeconomic headwinds [3][4] - **Protein Sciences Segment**: Achieved 7% growth, driven by core reagents and instrumentation for protein detection [4] - **Diagnostics and Special Segment**: Growth was muted at 2%, influenced by timing of orders rather than market conditions [5][6] - **EBITDA Margins**: Maintained strong margins at 34.9%, reflecting operational efficiencies [6] Market Exposure and Headwinds - **U.S. Academic Exposure**: 21% of revenues from academic business, with 12% from U.S. academic institutions [7] - **NIH Funding Impact**: Approximately 50% of academic revenue is exposed to NIH funding, which has created uncertainty [8] - **Consumables vs. Equipment**: Consumables (80% of business) remained steady, while equipment sales were more volatile due to budget uncertainties [10] Regulatory and Policy Environment - **Tariff Exposure**: Estimated exposure of $20 million from tariffs, but proactive measures have mitigated this risk [24][25] - **Biopharma Sector**: Comprises 50% of revenues, with large pharma showing double-digit growth while biotech remained flat due to funding challenges [35][38] Strategic Focus - **Cell and Gene Therapy**: Significant focus on GMP reagents, with a strong pipeline of customers in clinical studies [46][48] - **Spatial Business**: Competitive instruments showing double-digit growth, leveraging a large reagent portfolio [52][53] - **M&A Strategy**: Continued focus on acquisitions that align with high-margin reagent sales, with a disciplined approach to valuation [56][57] Future Outlook - **Q4 Expectations**: Anticipated continued uncertainty, with large pharma expected to drive growth while biotech remains challenged [60][61] - **Fiscal Year 2026 Guidance**: Uncertainty prevails, with hopes for stabilization in the coming months to provide clearer guidance [62][63] Additional Insights - **Market Dynamics**: The consolidation in the research reagents market has changed competitive dynamics, but the company remains well-positioned due to its strong portfolio and technical sales force [42][44] - **Regulatory Discussions**: Positive sentiment around cell and gene therapies, with a focus on maintaining high regulatory standards to avoid negative industry impacts [49][50] This summary encapsulates the key points discussed during the Bio-Techne conference call, highlighting the company's performance, market challenges, strategic initiatives, and future outlook.

Core Viewpoint - OXB will participate in the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) from May 13 to May 17, 2025, showcasing its expertise in viral vector development and manufacturing [1][2]. Group 1: Event Participation - OXB will exhibit at Booth 1611, allowing delegates to meet its team of viral vector experts and explore its capabilities in lentiviral, AAV, and other viral vector types [2]. - The company will contribute to the scientific program with an industry-sponsored symposium, five poster presentations, and two oral presentations [2]. Group 2: Presentations and Topics - The industry-sponsored symposium is titled "Accelerate Time to Clinic: A Process and Analytics Platform Approach" [3]. - Poster presentations will cover various topics, including: - "The 3 Rs of Replication-Competent Lentivirus (RCL) Formation Risk: Real, Rare, or Artificial?" - "Enhancing Titers of Therapeutic Lentiviral Vectors using PKC Agonists" - "Optimising the Production of the 4th Generation Lentiviral Vector (LV) TetraVecta™ System: Towards Plug-and-Play LV Manufacturing" - "The Impact of Individual Helper Genes on AAV Productivity" [4]. Group 3: Oral Presentations - Oral presentations will include: - "Enhancing Upstream Processes for High-Yield, High-Quality AAV Vector Production Using a Novel In-House Cell Line" - "Diving Deeper: Using a SYBR Gold Capsid Ejection Assay as an Orthogonal Method of Measuring Potency and VP1 Deamidation in AAV9 Drug Product Samples" [6]. Group 4: Company Background - OXB is a global quality and innovation-led contract development and manufacturing organization (CDMO) specializing in cell and gene therapy, with 30 years of experience in viral vectors [9][10]. - The company collaborates with leading pharmaceutical and biotechnology firms, providing expertise in various viral vector types, including lentivirus and AAV [9]. - OXB's capabilities range from early-stage development to commercialization, supported by robust quality-assurance systems and regulatory expertise [9].

Financial Data and Key Metrics Changes - The company reported Q1 revenue of $23.9 million, representing a 30% year-over-year increase, primarily driven by a 33% increase in the cell processing platform revenue [14][17] - GAAP gross margin for Q1 2025 was 63%, consistent with Q1 2024, while adjusted gross margin remained at 66% [14][15] - Adjusted EBITDA for Q1 2025 was $5.7 million, or 24% of revenue, compared to $2.6 million, or 14% of revenue in the prior year [17][18] Business Line Data and Key Metrics Changes - Cell processing revenue increased to $21.6 million, a 33% year-over-year increase and a 6% sequential increase from Q4 last year [6][7] - The biopreservation media (BPM) product line continues to be a significant driver, with 80% of BPM revenue coming from the top 20 customers [8][9] - Approximately 60% of BPM revenue comes from direct sales, with 40% from distribution channels [9] Market Data and Key Metrics Changes - The company estimates that its BPM products are used in at least 70% of relevant commercially sponsored cell and gene therapy (CGT) trials in the U.S., with a share of late-stage clinical trials exceeding 75% [10] - The company has a strong position in the market, with only homebrew formulations as meaningful alternatives to its offerings [11] Company Strategy and Development Direction - The company is focused on delivering leading solutions to the cell and gene therapy market and is committed to sustainable growth throughout 2025 [7][13] - The acquisition of Panthera CryoSolutions is aimed at expanding the biopreservation portfolio and enhancing scientific capabilities [13] - The company is optimistic about long-term industry fundamentals but acknowledges near-term uncertainties from factors like tariffs and NIH funding cuts [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating potential headwinds with minimal impact on financial results [71] - The company reaffirmed its full-year revenue guidance of $95.5 million to $99 million, with growth led by the cell processing platform [14][19] Other Important Information - The company ended the quarter with over $100 million in cash, providing a solid foundation for growth initiatives [7] - Adjusted operating income for Q1 2025 was $900,000, compared to an adjusted operating loss of $2.4 million in Q1 2024 [17] Q&A Session Summary Question: Insights on clinical side demand trends - Management noted that clinical customers showed reasonable performance, with growth driven primarily by commercial customers [22][23] Question: Details on the Panthera acquisition - The acquisition was timed to leverage proven technology and aims to develop next-generation cryopreservation products [26][27] Question: Current status of pricing changes - Management indicated that they are more than halfway through pricing adjustments for key customers, with a gradual implementation over three years [33][34] Question: Impact of tariffs and NIH funding - Management assessed that they have limited exposure to tariffs and NIH funding cuts, with minimal impact expected on their cost of goods [39][40] Question: Future M&A pipeline and CapEx projects - The company is exploring small tuck-in acquisitions and has plans for significant CapEx projects, including facility expansions [46][47] Question: Potential for media swaps with Panthera products - Management indicated that switching costs for customers to change biopreservation media are significant, making it unlikely for existing commercial products to switch [52][54] Question: Ability to pass on tariff costs to customers - Management confirmed that they could implement surcharges for any material increases in costs due to tariffs [55][56]

Financial Data and Key Metrics Changes - The company reported Q1 revenue of $23.9 million, representing a 30% year-over-year increase, primarily driven by a 33% increase in the cell processing platform revenue [13][15] - GAAP gross margin for Q1 2025 was 63%, consistent with Q1 2024, while adjusted gross margin remained at 66% [13][14] - Adjusted EBITDA for Q1 2025 was $5.7 million, or 24% of revenue, compared to $2.6 million, or 14% of revenue in the prior year [15][16] Business Line Data and Key Metrics Changes - Cell processing revenue increased to $21.6 million, a 33% year-over-year increase and a 6% sequential increase from Q4 last year [6][15] - The biopreservation media (BPM) product line continues to be the primary driver of revenue, with top 20 customers accounting for approximately 80% of BPM revenue [6][7] - The company expects continued growth from commercial customers, with around 40% of BPM revenue coming from customers with approved commercial therapies [7][12] Market Data and Key Metrics Changes - Approximately 60% of BPM revenue comes from direct sales, while 40% is through distribution [7] - The company estimates its BPM products are used in at least 70% of relevant commercially sponsored cell and gene therapy trials in the U.S., with a share of late-stage clinical trials exceeding 75% [8][9] Company Strategy and Development Direction - The company is committed to delivering leading solutions to the cell and gene therapy market and has reaffirmed its full-year revenue guidance of $95.5 million to $99 million [12][13] - The acquisition of Panthera CryoSolutions is aimed at expanding the biopreservation portfolio and enhancing scientific capabilities, with a focus on developing next-generation cryopreservation products [12][26] - The company is actively monitoring potential near-term headwinds from tariffs and NIH funding cuts but does not expect any material impact on its financial outlook [12][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating potential headwinds with minimal impact on financial results, emphasizing the strength of the balance sheet with over $100 million in cash [6][68] - The company remains optimistic about long-term industry fundamentals despite recognizing near-term uncertainties [12][68] Other Important Information - The company expects adjusted gross margin for the full year to be in the mid-60s, with a reduction in GAAP net loss and expansion in adjusted EBITDA margin due to higher expected revenue [18] - The company has a cash and marketable securities balance of $107.6 million as of March 31, 2025 [16] Q&A Session Summary Question: Insights on clinical side demand trends - Management noted that clinical customers buying directly showed reasonable performance, with growth driven primarily by commercial customers [21][22] Question: Rationale behind Panthera acquisition - The acquisition was timed to leverage proven technology and enhance the development of next-generation cryopreservation products [24][26] Question: Current status of pricing changes - Management indicated that they are more than halfway through pricing adjustments for key customers, with a gradual implementation over three years [31][32] Question: Impact of tariffs and NIH funding - Management assessed that they have limited exposure to tariffs and NIH funding cuts, with most products manufactured in the U.S. [37][39] Question: Future M&A pipeline - The company is exploring small tuck-in acquisitions similar to Panthera, with a strict filter criteria for potential targets [32][33] Question: Incremental OpEx from Panthera acquisition - Expected incremental OpEx from the Panthera acquisition is around $1 million for the remaining nine months of the year [60]

Financial Data and Key Metrics Changes - Cryoport reported $41 million in revenue from continuing operations for Q1 2025, representing a 10% year-over-year growth and contributing to significant adjusted EBITDA improvement [10] - The company confirmed its revenue guidance for fiscal year 2025 in the range of $165 million to $172 million, indicating a 7.5% growth compared to fiscal year 2024 [13] Business Line Data and Key Metrics Changes - Life sciences services revenue increased by 17% year-over-year, driven by a 33% growth in support for commercial cell and gene therapies [10] - Life sciences services now account for 56% of total revenue, reflecting the increasing development and commercialization of cell and gene therapies [10] - The life sciences products business showed a 2% year-over-year growth, indicating demand stabilization [12] Market Data and Key Metrics Changes - Cryoport supported 19 commercial therapies and 711 clinical trials as of March 31, representing approximately 70% of cell and gene therapy trials [11] - The company anticipates up to 17 additional application filings and four therapy approvals for the remainder of 2025, indicating a robust pipeline [11] Company Strategy and Development Direction - The strategic partnership with DHL, involving the sale of Cryo PDP for an enterprise value of $195 million, is expected to enhance Cryoport's positioning in Asia Pacific and EMEA [12][13] - The partnership aims to leverage DHL's global scale and capabilities, allowing Cryoport to sharpen its focus on core life sciences service offerings in the regenerative medicine space [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth forecast despite potential tariff impacts, stating that they have taken steps to diversify the supply chain [14][15] - The company does not expect tariffs to significantly impact core support for clinical trials or commercial therapies [15] - Management remains optimistic about the commercial revenue ramp-up and the maturation of commercial therapies [44] Other Important Information - The company reported a significant increase in service gross margins year-over-year, with expectations for continued margin improvements [34] - The onboarding process for EntegraCell is progressing smoothly, with multiple commercial contracts already in place [65] Q&A Session Summary Question: Update on the launch of Entegrisel and client adoption - Management sees the market positively, with commercial revenue continuing to ramp and growth in clinical trials [20] Question: Contingent consideration impact on adjusted EBITDA - Management clarified that contingent consideration was backed out, and adjusted EBITDA improved significantly compared to Q1 of the previous year [29] Question: Response to potential tariffs and macro environment - Management indicated no significant tariff impact on cell and gene therapy, with continued commercial revenue growth [41][42] Question: Supply chain initiatives and margin improvements - Management stated that while they cannot quantify the impact of supply chain initiatives on margins, they expect strong gross margins to continue [54] Question: Impact of the new FDA director on therapy modalities - Management expressed optimism about the new FDA director's qualifications and the continued interest in cell and gene therapy [56] Question: Demand for new product launches - Management reported positive reception and ongoing adoption for new products, with expectations for substantial contributions in the future [62]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 was $10.4 million, down 8% from $11.3 million in the first quarter of 2024 [20][21] - Core revenue remained stable at $8.2 million, reflecting a slight increase of 1% year-over-year [21] - Gross margin decreased to 86% from 88% year-over-year, while non-GAAP adjusted gross margin remained stable at 83% [23] Business Line Data and Key Metrics Changes - Instrument revenue was $1.4 million, down from $1.9 million in the first quarter of 2024, impacted by cautious capital spending from customers [21][22] - License revenue was stable at $2.5 million, while processing assembly (PA) revenue increased to $3.9 million from $3.4 million year-over-year [21] - SPL program-related revenue was $2.1 million, down from $3.2 million in the first quarter of 2024 [22] Market Data and Key Metrics Changes - 57% of core revenue was derived from SPL customers, up from 53% in the first quarter of 2024, indicating a healthy balance of early-stage to clinical-stage customers [22] - The company noted a cautious environment for capital equipment purchasing decisions among customers, leading to some hesitance in capital expenditures [10][42] Company Strategy and Development Direction - The company is focused on executing its growth plan for 2025 and beyond, despite macro uncertainties [8][10] - MaxSite is committed to enhancing operational efficiency and making targeted investments to drive long-term returns [23][24] - The integration of SecureDx is progressing smoothly, allowing the company to expand its offerings in the cell and gene therapy space [12][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term health of the business, despite recent regulatory changes at the FDA [31][34] - The company anticipates continued strong demand in the cell and gene therapy market, with a focus on safety assessments [12][34] - Management reiterated guidance for core revenue growth of 8% to 15% for 2025, including at least $2 million from SecureDx [24][25] Other Important Information - The company is seeking shareholder approval to delist from AIM and maintain a single listing on NASDAQ [19] - MaxSite ended the first quarter with $174.7 million in cash equivalents and investments, with no debt [24] Q&A Session Summary Question: Regulatory changes and their impact - Management indicated that it is too early to assess the impact of recent FDA leadership changes, but they do not foresee any regulatory risks affecting their business [30][34] Question: Cost savings from operational review - The company expects to save approximately $100,000 annually from delisting, and has begun realizing savings from personnel reductions [35][36] Question: Changes in customer funding strategies - Management noted some constraints on capital expenditures but remains confident in their guidance for the year [42][43] Question: SecureDx acquisition integration - The integration is going well, with opportunities to expand into in vivo customers and complementary delivery systems [51][52] Question: SPL revenue performance - SPL revenue of $2.1 million exceeded expectations, with confidence in achieving the full-year guidance of $5 million [55][56] Question: Future product launches - The company has a robust product pipeline and plans to launch meaningful products this year [64][65] Question: Pipeline and portfolio management - Management noted a status quo in program rationalization among customers, with no significant expansion observed [71][73] Question: Revenue cadence for the year - Management is comfortable modeling incremental growth, particularly in the latter half of the year, based on identified opportunities [76][77]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 was $10.4 million, an 8% decline from $11.3 million in the first quarter of 2024 [20] - Core revenue remained stable at $8.2 million, showing a slight increase of approximately 1% year-over-year [21] - Gross margin decreased to 86% in Q1 2025 from 88% in Q1 2024, while non-GAAP adjusted gross margin remained stable at 83% [23] Business Line Data and Key Metrics Changes - Instrument revenue was $1.4 million, down from $1.9 million in Q1 2024, impacted by cautious capital spending from customers [21][22] - License revenue was stable at $2.5 million compared to $2.6 million in the prior year [21] - Processing assembly (PA) revenue increased to $3.9 million from $3.4 million year-over-year, indicating strong performance [21] Market Data and Key Metrics Changes - 57% of core revenue was derived from SPL customers in Q1 2025, up from 53% in Q1 2024, reflecting a healthy balance of early-stage to clinical-stage customers [22] - SPL program-related revenue was $2.1 million in Q1 2025, down from $3.2 million in Q1 2024, indicating variability in milestone revenue [22] Company Strategy and Development Direction - The company is focused on executing its growth plan for 2025 and beyond, adapting to macro uncertainties while maintaining operational focus [8][12] - MaxSite is committed to enhancing its product offerings and capital allocation initiatives, aiming for profitability with its existing balance sheet [10][18] - The integration of SecureDx is progressing smoothly, with expectations to deliver at least $2 million in revenue for the year [12][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of the cell and gene therapy market, despite current market challenges [12][20] - The company is closely monitoring customer spending and expects cautious capital expenditure decisions to continue [11][44] - Management reiterated guidance for core revenue growth of 8% to 15% for 2025, assuming no significant changes in the operating environment [24][25] Other Important Information - The company announced plans to seek shareholder approval for delisting from AIM and maintaining a single listing on NASDAQ [19] - MaxSite finished Q1 2025 with total cash equivalents and investments of $174.7 million and no debt [24] Q&A Session Summary Question: Regulatory changes and their impact - Management indicated that recent FDA leadership changes have not raised concerns among customers regarding regulatory hurdles, maintaining confidence in the cell and gene therapy market [30][36] Question: Cost savings from operational review - The company expects to save approximately $100,000 annually from delisting and has begun realizing savings from personnel reductions [37][38] Question: Changes in customer funding strategies - Management noted some constraints on capital expenditure but remains confident in achieving annual guidance despite these challenges [42][44] Question: SecureDx acquisition integration - The integration of SecureDx is progressing well, with opportunities to expand into in vivo customer segments [50][52] Question: SPL revenue performance - SPL revenue of $2.1 million exceeded expectations, with management confident in achieving the full-year guidance of $5 million [55][56] Question: Future product launches - The company has a robust product pipeline and plans to launch new products this year, enhancing its total addressable market [63][65] Question: Pipeline and portfolio management - Management observed a status quo in program rationalization among customers, with no significant expansion noted [69][72] Question: Revenue cadence for the year - Management is comfortable modeling incremental growth in revenue, particularly in the latter half of the year, based on identified opportunities [73][75]

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]