Kamada (KMDA) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Brian Ritchie - Managing DirectorAmir London - Chief Executive OfficerChaime Orlev - Chief Financial OfficerAnnabel Samimy - Managing Director Conference Call Participants Jim Sidoti - Analyst Operator Greetings, and welcome to the Comida First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a re ...

Allurion Technologies (ALUR) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants None - ExecutiveShantanu Gaur - Founder & CEOJoshua Jennings - Managing Director Conference Call Participants Jason Wittes - Managing Director & Senior Research AnalystNone - AnalystMichael Toomey - US Medtech Analyst Operator Hello, and welcome to the Allurion First Quarter Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question an ...

Kamada (KMDA) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Brian Ritchie - Managing DirectorAmir London - Chief Executive OfficerChaime Orlev - Chief Financial OfficerAnnabel Samimy - Managing Director Conference Call Participants Jim Sidoti - Analyst Operator Greetings, and welcome to the Comida First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a re ...

Financial Data and Key Metrics Changes - Celebrite achieved a 23% year-on-year growth in Annual Recurring Revenue (ARR), reaching $408 million [26] - Adjusted EBITDA grew by 34% year-on-year, resulting in a 22% margin [8][32] - First quarter revenue was $107.5 million, a 20% increase from the previous year, primarily driven by a 21% growth in subscription revenue [30] - Non-GAAP net income was $26.2 million, with diluted non-GAAP EPS growing by 25% [33] Business Line Data and Key Metrics Changes - The Insights product family drove the majority of net ARR expansion, with a significant uplift from transitioning legacy digital forensics licenses [28] - Guardian's ARR growth rate exceeded 100% for the third consecutive quarter, indicating strong adoption [11][30] - Pathfinder is growing in line with the core business, with new enhancements expected to change its adoption trajectory positively [78] Market Data and Key Metrics Changes - The Americas region grew by 27%, with strong performance in state and local government and Latin America [27] - EMEA experienced a 15% expansion, while Asia Pacific saw a 28% growth [27] - The U.S. Federal segment faced modest shortfalls, impacting overall performance [10][26] Company Strategy and Development Direction - Celebrite is focused on growth while managing spending to support bottom-line objectives, with a commitment to expanding its capabilities in AI and cloud technologies [8][24] - The company is doubling down on the intelligence and defense sectors, responding to increased demand driven by geopolitical factors [14][75] - Celebrite is actively pursuing FedRAMP authorization to enhance its federal business opportunities [58] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the second half of 2025, citing a growing pipeline and the potential for recovery in federal spending [13][35] - The company remains cautious about the federal sector's spending environment but sees opportunities for growth in intelligence and defense [12][90] - Management highlighted the importance of their software in addressing rising crime rates and the sophistication of technology used in criminal activities [43][52] Other Important Information - Celebrite held its first user conference, attracting approximately 700 attendees from various agencies and enterprises [18] - The company announced a new spring 2025 release featuring cloud foundation and AI-powered innovations [19] - Celebrite's cash and investments totaled $509.8 million, reflecting a strong balance sheet [34] Q&A Session Summary Question: Is there any deterioration in the demand environment? - Management noted no material change in leadership decision-making and expressed optimism about the pipeline and new opportunities surfacing [42][44] Question: What is the visibility on deal closures? - Management indicated that while there is some slippage, the pipeline is growing, and new projects are accelerating [48][52] Question: Update on FedRAMP certification timing? - Management expects to achieve FedRAMP authorization to operate by the end of Q3 2025, pending sponsorship from a federal agency [59][61] Question: Insights on EMEA efforts? - Management emphasized the importance of demonstrating commitment to global operations and meeting with customers in key regions [66] Question: Why not embed more conservatism in the second half guidance? - Management expressed confidence in the pipeline and the necessity of their software, indicating a belief in a strong second half rebound [71][73]

Smith Douglas Homes (SDHC) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Joe Thomas - SVP of Accounting & FinanceGregory Bennett - President, CEO, Director & Vice ChairmanRuss Devendorf - Executive VP & CFOMike Dahl - Managing Director - Equity ResearchJay McCanless - SVP - Equity Research Conference Call Participants Alex Isaac - Equity Research AnalystRafe Jadrosich - Managing Director & Senior Equity Analyst Operator Thank you for standing by. My name is Tina, and I will be your con ...

Reed's (REED) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Cyril Wallace - CEO & DirectorDouglas McCurdy - CFO Conference Call Participants Sean McGowan - MD & Senior Research AnalystNone - Analyst Operator Good morning, and welcome to Reed's First Quarter twenty twenty five Earnings Conference Call for the three months ended 03/31/2025. My name is Angeline, and I will be your conference call operator for today. We have prepared remarks from Cyril Wallace, Reed's Chief Executive Offic ...

DarioHealth (DRIO) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 morning, ladies and gentlemen, and welcome to the DarioHealth First Quarter twenty twenty five Results Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Wednesday, 05/14/2025. I would now like to turn the conference over to Kat Paralla, Investor Relations Manager at Dario. Kat, please go ahead. Speaker1 Thank you, ...

Lucid Diagnostics (LUCD) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 Good morning, and welcome to the Lucid Diagnostics First Quarter twenty twenty five Business Update Conference Call. Please note this event is being recorded. I would now like to turn the conference call over to Mr. Matt Reilly, Lucid Diagnostics Senior Director of Investor Relations. Please go ahead. Speaker1 Thank you, operator. Good morning, everyone. Thank you for participating in today's business update call. Joining me to ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [15] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in Q1 2024, driven by the ongoing SHIELD II Phase III trial [16] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [16] Business Line Data and Key Metrics Changes - The company is focused on the SHIELD II Phase III trial for DPLEX100, which has recently concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [5][6] - The anticipated top line data from the SHIELD II trial is expected by the end of the current quarter [15] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated to be over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [11] - The company identified four groups of surgeons as potential users for DPLEX100, indicating a significant market opportunity [12] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) in early 2026, with preparations for regulatory submissions already underway [7][8] - The strategy includes finding a U.S. partner with an existing dedicated hospital product sales force to maximize sales potential [9][13] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and the potential to transform the surgical landscape [47] - The company is actively preparing for regulatory submissions and engaging in partnership discussions as they await SHIELD II trial results [8][13] Other Important Information - The company has received Fast Track and Breakthrough Therapy designations for DPLEX100, which may expedite the regulatory process [7] - The company is in advanced discussions with multiple potential partners in the U.S. as they approach pivotal data readout [13] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but anticipates an average of 2.5 vials per procedure at a preliminary price of $600 per vial [20] Question: NDA filing requirements - The NDA will consist of three modules, with the company currently finalizing the CMC and preclinical modules [27] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data [32] Question: Inspection readiness for commercial manufacturing - The company is preparing for FDA inspections and plans to conduct several mock inspections prior to the review [40] Question: Comparison of SSI data pre-COVID and post-COVID - The CDC reported a 3% increase in SSIs in 2023 compared to 2022, marking the first uptick since the COVID pandemic [42]

Financial Data and Key Metrics Changes - First quarter revenue was $5.6 million, a decrease from $9.4 million in the same period in 2024, primarily due to the temporary suspension of sales in France and lower investments in sales and marketing [22][5] - Adjusted net operating loss narrowed by 48% to $5.9 million compared to the prior year, with gross margin expanding to 75% from 73% in the prior year and 45% in the previous quarter [5][22] - Cash and cash equivalents at the end of the first quarter were $20.4 million, providing a runway for achieving FDA approval and profitability [25][12] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased to $3.6 million from $6.1 million in the same period in 2024, driven by increased operating efficiency [23] - Research and development expenses were reduced to $2.6 million from $5.7 million, primarily due to cost reductions related to the IDISSIPPI trial [23] - General and administrative expenses decreased to $5.2 million from $6.4 million, with adjusted expenses at $3.8 million excluding one-time financing costs [24] Market Data and Key Metrics Changes - The company observed over 40% growth quarter over quarter and year over year in its B2B2C model pilot in clinics in Europe [7] - The company expects revenues to ramp as the year progresses with the expansion of the B2B2C model and enhanced sales team onboarding [8] Company Strategy and Development Direction - The company’s 2025 plan focuses on five pillars: a new commercial plan, gaining FDA approval for the Allurion balloon, achieving profitability for the ex-U.S. business, scaling the AI product platform, and resuming commercialization in France [6][7] - The company aims to combine its program with low doses of GLP-1s to create a new standard of care for obesity, targeting a sustained weight reduction of over 20% while maintaining muscle mass [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficiency of the new B2B2C model and the potential for significant shareholder value as millions of patients could be treated with the Elerion program [26][27] - The company is optimistic about completing its PMA submission to the FDA by June and is encouraged by the FDA's feedback during the pre-PMA meeting [12][39] Other Important Information - The company has resumed treating patients in France and is in the final phases of updating marketing collateral to reactivate placements [15] - The company does not expect any impact on gross margin from tariffs for the remainder of the year, as most components are manufactured in the U.S. [12][13] Q&A Session Summary Question: Trends in regional markets, especially with the new marketing strategy - Management noted that mature markets for GLP-1s are creating tailwinds, with patients seeking alternatives and the expansion of the direct sales force expected to drive revenue growth [29][30] Question: Timeline and patient enrollment for the GLP-1 trial - Enrollment is expected to begin in the latter half of this year, with a one-year follow-up and a target of at least 75 subjects across multiple sites in Europe [31][32] Question: Design of the trial arms - The trial will focus on validating previous retrospective work with a single arm prospective trial design, leveraging historical data for comparison [33][34] Question: Future gross margin expectations - Management expects margins to remain in the same range as the first quarter, with potential increases as revenues ramp up [35][36] Question: Details on the pre-PMA meeting and next steps - The FDA was receptive to alternative analyses for the control group data, which could strengthen the overall application [39][40] Question: Current adoption of the Elerion program and GLP-1s - There is organic adoption of the combination therapy in the field, with physicians integrating GLP-1s with the Allurion balloon [45][46] Question: Revenue performance cadence for 2025 - Management anticipates steady revenue increases driven by the onboarding of new sales team members and recovery in France [49][50] Question: Expected costs for the prospective study - The prospective trial is not expected to have a material impact on the budget, as existing patient flow and lower costs overseas will be leveraged [51][52] Question: Regulatory strategy regarding expanded labeling - The focus is on the commercial implications of the study, with potential long-term benefits for discussions with regulators and payers [53][54] Question: Procedure growth trends - Procedure volume is stable, with some growth in certain territories, and management expects a recovery in France in the second half of the year [57][58]