Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Speaker0 Ladies and gentlemen, thank you for standing by and welcome to ScholarRock's First Quarter Financial Results and Business Update Call. At this time, all participants are in a listen only mode. Following the presentation, we will conduct a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You would then hear an automated message advising your hand is raised. To wit ...

DiaMedica Therapeutics (DMAC) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Rick Pauls - President and Chief Executive OfficerScott Kellen - CFO & Secretary Conference Call Participants Thomas Flaten - Senior Research AnalystMatthew Caufield - VP - Senior Healthcare AnalystChase Knickerbocker - Senior Equity Research Analyst - Healthcare Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio reco ...

Global-E Online (GLBE) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Alan Katz - VP - IRAmir Schlachet - Co-Founder and CEOOfer Koren - CFONir Debbi - Co-Founder and PresidentBrian Peterson - Managing DirectorChris Z - ED - Equity ResearchSamad Samana - Managing DirectorAndrew Bauch - Director - Equity ResearchScott Berg - Managing DirectorMaddie Schrage - Vice PresidentMatthew O'Neill - Managing Director Conference Call Participants Will Nance - AnalystJames Faucette - AnalystBrent Br ...

RADCOM (RDCM) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Benny Eppstein - CEOHadar Rahav - Chief Financial OfficerArjun Bhatia - Co-Group Head - Technology, Media & Communications Conference Call Participants Ryan Koontz - Senior Analyst Operator Ladies and gentlemen, thank you for standing by. Welcome to the Radcom Limited Results Conference Call for the First Quarter of twenty twenty five. All participants are present in listen only mode. Following management's formal presentation ...

Financial Data and Key Metrics Changes - The company recorded revenue of €1.1 million in Q1 2025, a decrease from €1.2 million in Q1 2024, primarily due to temporary softness in the international HD and S market [16] - Total operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization [17] - Cash position was €63 million as of March 31, 2025, down from €85.6 million at the end of 2024 [17] Business Line Data and Key Metrics Changes - The company launched the Genio 2.1 patient software upgrade commercially via a phased approach, which led to certain Genio sites deferring their purchases until the upgrade was available [16] Market Data and Key Metrics Changes - The company is preparing for a U.S. commercial launch of the GENEOS system, with a focus on high-volume hypoglossal nerve stimulation implanting centers [11] - Market research indicates significant demand from patients and physicians for alternatives to current therapies, particularly in the OSA treatment landscape [11][12] Company Strategy and Development Direction - The company aims to penetrate the U.S. market as a smart follower, targeting high-volume centers and developing strong networks with sleep physicians [11][12] - The strategy includes a focus on clinical evidence and patient outcomes, differentiating itself from competitors through unique technology benefits [18] - The company plans to scale up its U.S. commercial team each quarter post-FDA approval [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving PMA approval in Q2 2025, following successful validation of a specific manufacturing process and ongoing site inspection by the FDA [9][20] - The company believes it is positioned for significant growth once FDA approval is obtained, with a strong commercial team and established reimbursement pathways [19][20] Other Important Information - The company has identified an established CPT code (64568) for OSA indications, which is recognized by commercial and government payers [14][77] - The company is actively working with the American Academy of Otolaryngology to educate payers on the GENEOS system's clinical impact [13] Q&A Session Summary Question: What needs to be done at the U.S. inspection? - The FDA requested validation of a specific manufacturing process at the contract manufacturer, which has been completed and accepted [22][26] Question: Can you clarify the physical site inspection status? - The site inspection is actively taking place and can last up to five days, after which a report will be submitted to the FDA [25][36] Question: What is the strategy for outreach to ENT and sleep doctors? - The company plans to differentiate its approach based on clinical data and patient-centric focus, targeting both ENT and sleep physicians [27][29] Question: Is there a statutory response time from the FDA? - After the inspection, a final report will be submitted to the FDA PMA review committee, which will then issue an approval [35][36] Question: Any updates on the Dream Journal publication? - The publication is in the second level of review, and the company expects it to be published before summer [39] Question: What is the pace of OpEx spending going forward? - The company plans to defer costs and investments until FDA approval is achieved, with expectations for R&D and SG&A spending to increase [41][43] Question: How is the commercial launch of GENEOS in Dubai progressing? - The company has successfully implanted the GENEOS system in Dubai and is expanding into other Middle Eastern markets [48][49] Question: What is the status of the ACCESS study? - The company is making progress in enrolling patients for the ACCESS study, with a timeline for completion by summer [50] Question: Will there be a reimbursement team to streamline coverage? - The company has a dedicated market access team to assist with the reimbursement process as they enter new accounts in the U.S. [76] Question: Will CCC be a contraindication in the initial FDA approval? - The company does not expect CCC to be a contraindication but rather an off-label indication, allowing physician discretion [81] Question: How will the company promote the DICE procedure? - The company will not promote off-label uses and will rely on traditional methods to exclude CCC patients [84]

Global-E Online (GLBE) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Alan Katz - VP - IRAmir Schlachet - Co-Founder and CEOOfer Koren - CFONir Debbi - Co-Founder and PresidentBrian Peterson - Managing DirectorChris Z - ED - Equity ResearchSamad Samana - Managing DirectorAndrew Bauch - Director - Equity ResearchScott Berg - Managing DirectorMaddie Schrage - Vice PresidentMatthew O'Neill - Managing Director Conference Call Participants Will Nance - AnalystJames Faucette - AnalystBrent Br ...

Financial Data and Key Metrics Changes - Net sales increased by 19.9% to $167.1 million in Q1 2025 compared to $139.4 million in Q1 2024 [6][14] - Gross profit rose by 18.8% to $28.6 million, with a gross margin of 17.1% [11][17] - Net income attributable to parent company shareholders decreased to $7.1 million from $8.3 million year over year [20][21] - Diluted income per share was $0.24 compared to $0.27 in the previous year [21] Business Line Data and Key Metrics Changes - Sales of electric power steering (EPS) systems increased by 54% year over year to $73 million, representing approximately 43.7% of total sales [15][14] - Traditional steering products and parts saw a modest increase of 2.3% to $94.1 million [14] - The Henlong subsidiary reported a 37.5% increase in sales of traditional hydraulic steering systems [7] Market Data and Key Metrics Changes - Chinese GDP growth was 5.4% year over year in Q1 2025, consistent with the previous quarter [8] - Combined unit sales of passenger and commercial vehicles in China increased by 11.2% year over year to 7.5 million units [9] - New energy vehicle unit sales grew by 47.1% year over year to 3.1 million units, representing 41.2% of total car sales in China [9][10] Company Strategy and Development Direction - The company aims to maintain a revenue guidance of $700 million for the full fiscal year 2025, based on current market conditions [23] - The strategy includes seeking more market share through competitive pricing, which has resulted in revenue growth [41] - The company is focusing on advanced gearing technologies and expanding its product portfolio to address market opportunities [14] Management Comments on Operating Environment and Future Outlook - Management noted that the Chinese economy has stabilized but still faces challenges, including trade tensions [9][48] - The company anticipates minimal impact from proposed U.S. tariffs on new order flow, with ongoing discussions with North American customers [49] - There is a positive outlook for the EPS product line, with mass production already underway and additional orders from various OEMs [52] Other Important Information - R&D expenses increased by 64% to $8.7 million, primarily due to advancements in EPS technology [11][28] - Operating expenses rose by 41.3%, leading to a 10.5% reduction in income from operations [12][19] - The company has received several awards for product development and supplier cooperation from major vehicle OEMs [13][14] Q&A Session Summary Question: Why did research and development increase by 64% in Q1 2025? - The increase was due to heightened R&D efforts in EPS product development, including staffing and equipment design [28][29] Question: What is the outlook for inventory levels and revenue in 2025? - Inventory increased by approximately 10% due to advanced shipments in response to trade tensions, but revenue is expected to maintain healthy levels [34][35] Question: What is the outlook for gross margin for the rest of 2025? - The gross margin is expected to remain similar to Q1 levels with slight improvements, as the company focuses on gaining market share [41][40] Question: What is the impact of U.S. proposed tariffs on new order flow? - The impact is minimal, with proactive measures taken to manage inventory and maintain order flow [49] Question: Update on the manufacturing of the EPS product for Nanjing Iveco? - Mass production has begun, with additional orders from other OEMs, indicating strong demand for the new EPS product [52] Question: Update on Sentient operation and autonomous driving systems? - Significant progress has been made, with contracts in place for autonomous driving technologies, targeting substantial unit shipments for 2025 [54][56]

PDS Biotechnology (PDSB) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Mike Moyer - Managing DirectorFrank Bedu-Addo - Chief Executive OfficerLars Boesgaard - Chief Financial OfficerMayank Mamtani - Senior Managing Director & Group Head of HealthcareKirk Shepard - Chief Medical Officer Conference Call Participants Joseph Pantginis - MD & Senior Healthcare AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst Operator Greetings, and wel ...

Endava (DAVA) Q3 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Laurence Madsen - Manager - Investor RelationsJohn Cotterell - Chief Executive OfficerMark Thurston - Chief Financial OfficerBryan Bergin - MD - Equity ResearchTyler DuPont - Equity Research AssociateJonathan Lee - Managing Director - Equity ResearchJames Faucette - Managing Director Conference Call Participants Harry Read - Equity Research AnalystJames Friedman - Senior FinTech & IT Services Research AnalystPhani Kanumuri - A ...