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 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 ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [11] - Current liabilities were reported at $4.7 million, compared to $5.4 million in the previous quarter, while working capital decreased to $32.8 million from $39.2 million [11] - Net cash used in operating activities for Q1 2025 was $7.1 million, an increase from $6.7 million in Q1 2024, primarily due to an increased net loss [12] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, driven by costs associated with the REMEDY two clinical trial and global expansion [12][13] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [13] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [9] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is currently the only novel agent being studied in pregnant women with this condition [8] - The management is also working on expanding the stroke program's enrollment and maintaining momentum through site engagement [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both clinical programs and highlighted the importance of upcoming milestones, including preliminary results from the preeclampsia trial and interim analysis from the stroke program [43] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a focus on sustaining operations while advancing clinical trials [12] Other Important Information - A key opinion leader call regarding preeclampsia is scheduled for May 28, 2025, to educate stakeholders about the disease and the company's clinical trial design [6][8] - The company is actively engaging with high-volume sites to drive enrollment in the stroke program, with a focus on maintaining relationships and expanding geographic reach [33] Q&A Session Summary Question: Clarification on laboratory test results for DM199 - Management confirmed that the main variable affecting the timeline for results is the placental transfer assay, which is being finalized [17] Question: Triggers for Parts 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger the fetal growth restriction cohort, with more details to be shared after upcoming results [19][20] Question: Anticipated read-through from preeclampsia data to AIS development - Management noted that while the indications are unique, positive results in preeclampsia would confirm the activity of the protein being studied [25] Question: Update on stroke program enrollment - Management reported that high-enrolling sites are seeing one to two patients per month, and overall enrollment is above plan, with encouraging momentum [31][32] Question: Expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, but the current focus remains on completing Part 1a and moving into Part 1b [39]

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 - 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]

Financial Data and Key Metrics Changes - The company achieved a record revenue of $16.6 million for the first quarter of 2025, reflecting a 17.5% year-over-year growth [21] - Operating margins improved by over 6.5% year-over-year, with a positive cash flow of $4.4 million [6] - Non-GAAP operating income reached $3.1 million, representing 19% of revenues for the quarter [21] - Non-GAAP net income was $4.1 million or $0.25 per diluted share, compared to $2.8 million or $0.18 per diluted share in the same quarter last year [23] Business Line Data and Key Metrics Changes - The company continues to invest strategically in R&D, with non-GAAP gross R&D expenses of $4.3 million, up 5.8% year-over-year [22] - Sales and marketing expenses increased to $4.2 million, reflecting a focus on promoting offerings to existing and prospective customers [23] Market Data and Key Metrics Changes - The global telecom market is growing, driven by the demand for 5G standalone networks and AI-driven applications [14] - The company is well-positioned to capitalize on the data-centric demands of emerging AI technologies [15] Company Strategy and Development Direction - The strategic objective is to become a key provider of real-time user and service experience insights for AI-powered telecom operators [10] - The company is investing in accelerated computing technologies and Agenetic AI to enhance customer care and service management [10][11] - Partnerships with ServiceNow and NVIDIA are aimed at fast-tracking the development of automated customer experience solutions [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic direction and execution, projecting revenue growth for the sixth consecutive year [7] - The full-year 2025 revenue growth outlook has been raised from 12%-15% to 15%-18%, with a midpoint of $71.1 million [18] Other Important Information - The company ended the first quarter with cash and cash equivalents of $99.1 million and no debt [6] - The company received a grant of $25,000 from the Israel Innovation Authority during the quarter [22] Q&A Session Summary Question: Expansion on Authentic AI functionality and monetization - The company plans to invest in R&D for Generative AI and Agenetic AI use cases, with flexible monetization models being discussed [28] Question: Free cash flow generation and capital use - The company is exploring M&A opportunities and prioritizing actions around its ecosystem [29][30] Question: Growth expectations for customer count and standalone networks - The company projects similar growth rates as seen previously, with increased demand for customer management and real-time user analytics [34] Question: Gross margins and revenue mix - Gross margins typically range from 72% to 76%, influenced by the revenue mix, with less third-party components improving margins this quarter [35][36] Question: ServiceNow relationship and customer base overlap - The partnership with ServiceNow is expected to expand pipeline opportunities, particularly in North America, Europe, and Japan [39] Question: Deployment model with NVIDIA - The integration involves using GPUs that can be installed in standard servers, enhancing performance in user analytics [40][41]

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]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of approximately $8.5 million, or about $0.21 per share, compared to a net loss of $10.6 million, or $0.30 per share, in Q1 2024, reflecting a decrease due to increased tax benefits and lower operating expenses [12][13] - Research and development expenses were $5.8 million for Q1 2025, down from $6.7 million in the prior year, primarily due to lower clinical trial expenses [12] - General and administrative expenses were $3.3 million for Q1 2025, compared to $3.4 million in the prior year [13] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [13] - Cash balance as of March 31, 2025, was $40 million, down from $41.7 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The company initiated the VERSAL-three registrational trial for Versamune HPV plus pembrolizumab, targeting recurrent or metastatic HPV16 positive head and neck cancer, which is projected to become the most prevalent type of head and neck cancer by the mid-2030s [6][8] - The VERSAL-three trial design includes approximately 350 patients, with a two-arm design approved by the FDA [7] Market Data and Key Metrics Changes - The company highlighted the growing population in need of targeted therapies for HPV16 positive head and neck cancer, which is difficult to treat and represents a significant market opportunity [5][6] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, particularly the VERSAL-three trial, which is the first phase three trial in the high-risk HPV16 population [8][54] - The company aims to leverage its strong relationship with the National Cancer Institute to progress its MUC1 program, which is part of a collaborative research agreement [11][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV and pembrolizumab combination to significantly improve patient outcomes, citing encouraging clinical responses and survival data from previous trials [8][27] - The management team emphasized the importance of durability in treatment responses, noting that patients in the VERSAL-two trial had a median overall survival of 30 months compared to the standard of care's 12 months [27][28] Other Important Information - The company raised approximately $11 million through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months [14][15] - The company plans to present updated results from the VERSAL-two study at the upcoming ASCO Annual Meeting [54] Q&A Session Summary Question: Impact of Keytruda head and neck neoadjuvant data on enrollment expectations for Phase III - Management clarified that the KEYNOTE-689 trial focused mainly on HPV negative patients and should not affect enrollment in the VERSAL-three trial, as very few HPV positive patients are eligible for surgery [22][23] Question: Insights on durability from the upcoming ASCO presentation - Management indicated that the upcoming ASCO presentation will provide additional data on durability and survival, highlighting the long-term responses observed in the VERSAL-two trial [24][27] Question: Enrollment status for the VERSAL-three trial - Management stated that enrollment details have not been publicly disclosed yet, as the activation of sites and patient screening processes are ongoing [48][49] Question: Future operating expenses expectations - Management noted that while they do not provide specific financial guidance, they expect a relatively stable trial spend going forward, with higher initial expenses typical in the early stages of a trial [51]