AIM ImmunoTech Inc. (AIM) Q4 2024 Earnings Conference Call April 01, 2025 08:30 AM ET Company Participants Conference Call Operator - Operator/Introductory AnnouncerThomas Echols - Chief Executive OfficerConference Call Operator - Q&A Moderator Conference Call Participants Ed Wu - Analyst at Ascendant Capital Markets Conference Call Operator Hello and welcome to the AIM Immunotech fourth quarter and full year 2024 update conference call and webcast. As a brief reminder, all participants are currently in a l ...

Financial Data and Key Metrics Changes - The company achieved record annual revenue of $380 million, a 24% increase year-over-year, with fourth quarter revenue reaching $113.4 million, reflecting a strong growth margin of 36.6% [11][28] - Gross profit for Q4 2024 was $41.5 million, an 80% improvement from $23 million in Q4 2023, resulting in a gross margin of 36.6%, up from 22% in the prior year [28][29] - The adjusted EBITDA for Q4 2024 was $8.6 million, compared to a negative $2.6 million in the prior year period, indicating effective strategic execution [35] Business Line Data and Key Metrics Changes - The company reported a significant increase in backlog, growing to $401.3 million, driven by regional demand for technology [19] - The ME6 energy storage system and advancements in silicon-based cell technologies were highlighted as key product innovations [10][18] Market Data and Key Metrics Changes - In the EMEA region, revenue grew by 123% year-over-year to $187.7 million, accounting for nearly half of total revenue [37] - The U.S. market saw a 360% increase in revenue, rising from $3.1 million in 2023 to $14.4 million in 2024, reflecting early adoption by commercial vehicle OEMs [38] - Revenue in the Asia Pacific region declined by 19% year-over-year, from $219.1 million in 2023 to $177.7 million in 2024, due to strategic repositioning away from low-margin segments [39] Company Strategy and Development Direction - The company is focused on improving efficiency and profitability, with a goal of becoming cash flow positive and maintaining strong gross margins while expanding to meet customer demand [15][44] - The Huzhou State 3.2% expansion project is expected to add up to 2 gigawatt hours of production capacity, anticipated to come online in Q1 2025 [16][45] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to continue as a going concern, citing improved operating results and stronger cash positioning [36] - The revenue guidance for 2025 is projected to increase by 18% to 25%, with a target range of $450 million to $475 million [44][46] Other Important Information - The company faced challenges in 2024, including a difficult financing environment and supply constraints, but responded with strategic cost control and operational adjustments [22][48] - The company has made substantial strides in technology innovation, including the unveiling of the ME6 Energy Storage System and advancements in battery technologies [48] Q&A Session Summary Question: What are the expectations for revenue growth in 2025? - The company expects revenue to increase by 18% to 25% year-over-year, with a target range of $450 million to $475 million [44] Question: How is the company addressing challenges in the APAC region? - The company is strategically repositioning away from low-margin segments in China and India, focusing on more profitable opportunities [39] Question: What is the outlook for the EMEA market? - The EMEA market is expected to continue driving significant revenue increases year-over-year, supported by strong commercial traction [46]

Financial Data and Key Metrics Changes - The company is unable to provide detailed financial results due to the deconsolidation of Invizyne's financial statements, which has delayed the filing of the 10-K report [6][14][25] - As of December 31, the combination of cash and securities was $28 million, with Big Idea investments represented by eXoZymes valued at $64 million, totaling approximately $93 million in cash and securities [58] - The stock price as of December 31 was $6.30, with approximately 9.9 million shares outstanding, resulting in a market value of $62 million, indicating a negative market value of $30 million [58][59] Business Line Data and Key Metrics Changes - The company has successfully launched eXoZymes, marking a significant achievement despite challenging market conditions for small IPOs [14][15] - The shareholder count has increased by 12%, reaching approximately 1,800 shareholders [15] - The onboarding of investors through MDB Direct has begun, with over 500 accounts established by year-end [16] Market Data and Key Metrics Changes - There is a growing demand for microcap financing, with investors seeking liquid alternatives, positioning the company as a top curator of public venture opportunities [32] - The traditional venture capital and private equity markets are facing challenges, leading to increased interest from companies looking to go public [30][31] Company Strategy and Development Direction - The primary strategic priority for the company is to expand its investor community, focusing on partnerships with RIAs and angel groups [35][41] - The company aims to present one to two new Big Idea investment opportunities in the next quarter, indicating a robust pipeline of potential investments [52][53] - The company is evolving from a model of episodic deal-making to creating a consistent public venture asset class portfolio [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing number of opportunities being presented, both from community members and through proactive curation [26][27] - The regulatory environment is perceived as improving, which may facilitate new offerings, although there are concerns regarding the FDA's approval timelines [87][88] - The company is focused on maintaining operational efficiencies while managing cash expenditures, with hopes of reducing operational costs over the next 12 months [62] Other Important Information - The company has licensed new assets from Mayo Clinic and is developing this opportunity, although no specific updates were provided [49][50] - The company continues to work with HeartBeam, which is developing groundbreaking technology for self-administered ECGs, with significant market potential [44] Q&A Session Summary Question: Does Lou Basenese still work for the organization? - Lou Basenese has left the company but remains a friend and supporter, focusing on his media presence [65][66] Question: What does the deconsolidation mean for MDB stockholders and eXoZymes' investors? - The deconsolidation will clarify the financials of MDB, separating its performance from eXoZymes, making it easier for investors to understand [70][71] Question: How many Big Idea companies are expected to be established in 2025? - The company anticipates presenting three to four new Big Ideas in 2025, with some companies already in advanced discussions for potential IPOs [80][81] Question: How do you see the regulatory winds changing? - The regulatory environment is expected to improve, facilitating new offerings, although there are uncertainties regarding FDA timelines [87][88] Question: When do you expect to make any type of dividend? - The company aims to wait for a solid footing under eXoZymes before considering any distributions to avoid disrupting the market [92][93] Question: How should shareholders think about the investment in cash and resources relative to value creation? - The company intends to maintain a modest amount of cash for new opportunities while leveraging existing investments to create value [99][100]

Financial Data and Key Metrics Changes - Product revenue for Q4 2024 was $9.2 million, a 25% increase from $7.3 million in Q4 2023, and total product revenue for the full year reached $35.6 million, representing a 15% year-over-year growth [11][39][47] - Gross margin for Q4 2024 improved to 71%, up from 68% in Q4 2023, reflecting a return to normalized production levels [42][50] - Operating loss for 2024 improved by 47% to $16.7 million compared to $31.9 million in 2023, driven by higher revenue and reduced operating expenses [50] Business Line Data and Key Metrics Changes - CytoSorb, the flagship product, generated $35.6 million in core product sales in 2024, with a 15% growth driven by 28% growth in direct sales outside Germany and 22% growth in distributor and partner sales [9][11] - DrugSorb-ATR is in the regulatory process, with marketing applications submitted to the FDA and Health Canada, expected to drive near-term growth opportunities [10][31] Market Data and Key Metrics Changes - The international market for CytoSorb has shown strong growth, particularly in countries that have secured reimbursement for specific applications, while the German market has faced challenges due to post-COVID issues [11][77] - The total addressable market for DrugSorb-ATR in the U.S. and Canada is projected to grow from $300 million today to over $1 billion as Brilinta becomes generic [30][31] Company Strategy and Development Direction - The company aims to restore sales growth in Germany through a reorganization of the direct sales team and strategy, focusing on deeper customer engagement and improved sales representative productivity [24][52] - The strategy includes a controlled market release of DrugSorb-ATR to gather real-world feedback before a broader launch [32][57] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving near cash flow breakeven by the end of 2025 through revenue growth and cost management [15][45] - The company is optimistic about the potential for DrugSorb-ATR to significantly impact revenue and market presence once regulatory approvals are obtained [31][57] Other Important Information - The company identified misstatements in inventory and stock compensation, leading to restatements of previous financial statements [37][38] - Total cash and cash equivalents as of December 31, 2024, were $9.8 million, with a pro forma cash position of approximately $17 million after the rights offering [15][46] Q&A Session Summary Question: Impact of new U.S. administration on DrugSorb regulatory process - Management indicated that while there has been uncertainty regarding FDA staffing, it has not affected review personnel [61] Question: Key factors for controlled launch of DrugSorb - Management highlighted the importance of understanding hospital integration and surgeon usage patterns during the controlled launch [63][64] Question: Growth drivers for CytoSorb sales outside Germany - Management noted strong growth in international markets due to reimbursement success and increased physician adoption [74][75] Question: Metrics for achieving near cash breakeven - Management stated that continued revenue growth and maintaining gross margins above 70% are essential for reaching breakeven [85] Question: Clarification on DrugSorb revenue assumptions - Management confirmed that the breakeven target excludes DrugSorb revenues, focusing solely on core business performance [89] Question: FDA's potential requests during the review process - Management confirmed ongoing interactive discussions with the FDA, indicating a collaborative review process [96]

Unknown Executive Hello. Thank you for joining Wrap's Fourth Quarter and Full Year 2024 Earnings Call. On the call today is CEO and Chairman, Scot Cohen; and President and COO, Jared Novick. Good afternoon, everyone. At this time, I want to remind you that certain statements and assumptions in this conference call contain or are based upon forward-looking information and are being made pursuant to the safe harbor provisions of the federal securities regulations. Such forward-looking statements are subject t ...

Financial Data and Key Metrics Changes - The combined R&D and SG&A expenses for Q4 2024 totaled $3 million, a decrease from $4.6 million in Q4 2023 [49] - Excluding non-cash, stock-based compensation, these amounts were $2.8 million for Q4 2024, compared to $4.3 million for Q4 2023 [50] - Cash operating expenses for 2025 are expected to be in the range of $18-19 million [50] Business Line Data and Key Metrics Changes - The NEPHRO CRRT study has been reduced in size from 166 patients to 70, maintaining a primary endpoint power of 90% [13][30] - The company has added three new clinical study sites, bringing the total to eight enrollment-ready sites [22][29] - The most productive current site has about 20 CRRT patients per month, while new sites are expected to have higher volumes [42][101] Market Data and Key Metrics Changes - The company anticipates a private placement investment of up to $14.8 million, contingent on achieving certain milestones [9] - The financing is structured in three equal tranches of $4.925 million, with the first tranche expected shortly [47] Company Strategy and Development Direction - The company is focused on completing the NEPHRO study by the end of 2025, with a strategic emphasis on reducing operating expenses [46] - The FDA has approved changes to the NEPHRO study protocol, which are expected to enhance enrollment speed and site efficiency [15][28] - The company is actively pursuing additional clinical study sites to meet its enrollment goals [43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the timely development of NIAID and the planned submission of a PMA in Q1 of the following year [8] - The FDA's responsiveness has been highlighted as a key benefit of NIAID's breakthrough designation [14] - Management believes that clinical, regulatory, and commercial risks for the NEPHRO program are low due to extensive prior use of the product in other markets [24] Other Important Information - The company has identified an ideal clinical site profile based on ICU type and nephrologist involvement, which is expected to improve enrollment rates [39][41] - The company has experienced a much shorter activation time for new sites, with the most recent site taking less than four months to activate [42] Q&A Session Summary Question: What were the original thoughts on the movement to exclude certain patients in the previous year? - The original protocol likely excluded patients based on concerns about clinical endpoints related to time on CRRT, which was deemed irrelevant for the current study [60][62] Question: Why have institutions decided not to use heparin? - Institutions cited risks associated with heparin, including its long half-life and systemic anticoagulation effects, which increase bleeding risks in high-risk patients [70][72] Question: Is there a time limit tied to the milestones for the private placement? - There is no specific time limit tied to the milestones for patient enrollment [76] Question: Are there plans to shift PIs to nephrologists at existing sites? - Discussions are ongoing to shift primary responsibilities to nephrologists or broaden patient populations at existing sites [91][92] Question: What gives confidence that phase three data can be achieved by the end of the year? - The company has already engaged with additional sites and believes that the enrollment of patients can be accelerated based on the new site profiles and engagement [112][113]

Financial Data and Key Metrics Changes - In 2024, the company recorded $1.2 million in revenue, a growth of 59% over 2023 [28] - Revenue from the NUQ VET cancer test was $0.8 million, growing by 75% compared to the prior year [28] - Operating expenses were reduced by 23% year-on-year, with second-half operating expenses down 31% [30][34] - Net cash used in operating activities was $25.9 million in 2024, compared to $18.1 million in 2023 [31] Business Line Data and Key Metrics Changes - Approximately 120,000 NUQ VET cancer tests were sold in 2024, more than double the prior year [28] - Revenue from the NUQ Discover pillar was approximately $400,000, with year-on-year growth of 40% [29] - The company recorded its first revenue from NUQ NETS, marking a significant milestone [29] Market Data and Key Metrics Changes - The NUQ VET cancer test is now available in over 20 countries, expanding access significantly [18] - The point-of-care market is noted to be less than 20% of the total market, indicating growth potential [22] Company Strategy and Development Direction - The company aims to sign multiple licensing deals in 2025, focusing on human applications [11][68] - There is a strong interest in out-licensing and supply agreements for both NUQ NETS and the oncology portfolio [12][69] - The strategy includes raising non-dilutive funds, ramping revenues, reducing expenses, and signing commercial deals with large industry players [74] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash neutrality on a full-year basis by 2025 [27] - The company is at a pivotal juncture, ready to revolutionize diagnostics for both animals and humans [12] - Management highlighted the importance of automation in centralized labs to accelerate growth [22] Other Important Information - The company received approximately $1.8 million in non-dilutive funding from Belgian institutions during 2024 [33] - Significant progress was made in clinical studies, with multiple large independent studies completed [10][36] Q&A Session Summary Question: Update on the feline cancer testing program - The feline cancer testing program is on track for completion later this year, with a milestone payment of $5 million expected upon completion [80] Question: Discussion on the Leon study and its implementation - The Leon study is expected to lead to prospective studies and potential implementation in screening regimens [85][90] Question: Insights on quarterly sales trends and outlook for 2025 - Sales were volatile due to large customers ordering in batches, but overall growth was solid with 120,000 tests sold [100][102] Question: Approach to managing financing risks - The company plans to maintain tight control over expenses and cash flows while focusing on licensing agreements [112] Question: Activity in data sharing and licensing agreements - The company has established data rooms for oncology and NETS, which have energized discussions with major companies [118][120]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 decreased 4% to $1.46 million compared to $1.53 million in Q4 2023, while total revenue for the year decreased 3% to $7.28 million compared to $7.47 million in 2023 [15][22] - Gross margin for Q4 2024 decreased 209% to a negative $330,000 compared to a positive $303,000 for Q4 2023, and for the year, gross margin decreased 64% to $469,000 from $1.31 million in the same period of 2023 [19][22] - Net loss for the years ended December 31, 2024 and 2023 was $10.76 million and $11.24 million, respectively, indicating a decrease in overall net loss primarily attributable to a decrease in operating costs [22][23] Business Line Data and Key Metrics Changes - Services and Consulting revenues increased by 31% compared to 2023, driven by new AI and subscription customers, higher service contract pricing, and over $900,000 in new revenue from power consulting work [15] - Cost of revenues for the quarter increased 47% to $1.79 million compared to $1.22 million for Q4 2023, driven by amortization expenses and retention of outside consultants [16][17] - Cost of revenues on technology systems decreased during the period compared to the equivalent period in 2023, in line with the decline in project revenues [17] Market Data and Key Metrics Changes - The company has a backlog representing more than $50 million in revenue, with approximately 45% expected to be recognized in 2025 [26] - A pipeline of business between Duos and APR Energy-related business exceeds $500 million, which may translate into additional contracts and backlog for Duos [27] Company Strategy and Development Direction - The company is diversifying its business into rail technology, edge data centers, and power, aiming to accelerate the timeline to profitability [4][6] - The establishment of two new subsidiaries, Duos Edge AI and Duos Energy, is part of the strategy to capitalize on existing strengths and create a path for faster growth and profitability [11] - The company plans to raise between $10 million and $15 million through its S-3 shelf registration to support the growing edge data center business [29] Management's Comments on Operating Environment and Future Outlook - Management noted that the balance sheet, business backlog, and estimated pipeline are the strongest in the company's history as of December 31, 2024 [12] - The company expects to break even financially in 2025 and anticipates positive adjusted EBITDA by the end of the year [29] - Management expressed optimism about the future, highlighting significant changes in the business over the last 6 to 9 months and the potential for meaningful growth and profitability [55][56] Other Important Information - The company has retired $1 million of debt and expects to retire a further $1.2 million by the end of the year, maintaining reasonable leverage ratios [26] - The company is targeting rural broadband enhancement with its edge data centers, aligning with government funding opportunities [47] Q&A Session Summary Question: Changes in rail safety legislation - Management indicated that while there was significant effort under the Biden administration to push rail safety legislation, the likelihood of comprehensive regulations being passed is currently low [60][61] Question: Impact of tariff uncertainties on customers - Management stated that the threat of tariffs has not yet impacted the business, although there could be potential risks related to raw material costs [62][64] Question: Operational status of data centers - Currently, one data center is fully operational, with two additional centers in Tampa nearing completion, and plans to install 2 to 3 new centers each quarter [70][71] Question: Potential for winning hyperscaler deals - Management confirmed active discussions with several large hyperscalers, indicating interest in both power and edge data center solutions [75]

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