CI&T (CINT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Cesar Gon - CEOBruno Guicardi - Co-Founder of CI&T and President of North America & Europe OperationsStanley Rodrigues - Chief Financial OfficerVitor Tomita - VP - Equity ResearchGustavo Farias - Associate DirectorBryan Bergin - MD - Equity ResearchPuneet Jain - Associate - Equity ResearchBruno Guicardi - Co-Founder of CI&T and President of North America & Europe OperationsMaria Clara Infantozzi - Equity Research Associate Cesar ...

Financial Data and Key Metrics Changes - Inovio reported a net loss of $19.7 million or $0.51 per share for Q1 2025, compared to a net loss of $30.5 million or $1.31 per share for Q1 2024, indicating a significant improvement in financial performance [25] - Operating expenses decreased from $31.5 million in Q1 2024 to $25.1 million in Q1 2025, representing a 20% reduction [25] - The company ended Q1 2025 with $68.4 million in cash and short-term investments, down from $94.1 million at the end of 2024, with an estimated cash runway into Q1 2026 [25] Business Line Data and Key Metrics Changes - The primary focus remains on the submission of the Biologics License Application (BLA) for INO-3107, aimed at treating recurrent respiratory papillomatosis (RRP) [6][14] - The company resolved manufacturing issues related to the Selectra device and initiated device design verification testing, which is crucial for BLA submissions [7][10] Market Data and Key Metrics Changes - RRP is a rare HPV-related disease affecting approximately 14,000 people in the US, with ongoing market research indicating a significant need for non-surgical treatment options [16][17] - The current standard of care involves multiple surgeries, which do not address the underlying disease, highlighting the potential market opportunity for INO-3107 [17][18] Company Strategy and Development Direction - Inovio aims to submit the BLA for INO-3107 by mid-2025, with a goal of receiving FDA acceptance by the end of the year and a potential PDUFA date in mid-2026 [6][14] - The company is also advancing its DNA encoded monoclonal antibody (dMAb) technology, which could offer significant advantages over traditional monoclonal antibody production methods [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO-3107 to change the treatment paradigm for RRP, emphasizing the importance of reducing the number of surgeries for patients [6][74] - The company is focused on maintaining or improving clinical benefits seen to date and plans to submit a proposed protocol for a supplemental BLA in the future [15] Other Important Information - Inovio has been actively engaging with the RRP community and presenting data at scientific conferences to raise awareness of INO-3107 [11][12] - The company is refining its go-to-market model and planning further build-out of its commercial organization [19] Q&A Session Summary Question: Additional details on the COSM presentation - Management confirmed that the focus will be on surgery counts and additional data will be submitted for peer review [28][29] Question: Number of MSLs to onboard and epidemiology data - Management acknowledged that the 14,000 figure is likely an underestimate and ongoing research is being conducted to refine this number [31][32] Question: Expectation for surgery sparing claim in the label - Management indicated that while it is too early to predict FDA terminology, the clinical benefit of reduced surgeries is clear [38][39] Question: Update on registrational strategy outside the US - Management confirmed that discussions with European regulators are ongoing and aligned with trial design expectations [40] Question: Initial indication for dMAb technology - Management stated that while specific indications are not disclosed, the technology has broad applications beyond monoclonal antibodies [42] Question: Priority review status concerns - Management expressed confidence that the unique benefits of INO-3107 would support its case for accelerated approval despite potential competition [46][47] Question: Plans to add more data to the filing - Management confirmed that the clinical package is complete and ready for submission [48][50] Question: Pricing considerations for the initial treatment regimen - Management indicated that pricing discussions have been favorable, with comparisons to similar products in the rare disease space [56][57] Question: Plans for disclosing baseline characteristics in the confirmatory trial - Management confirmed that the patient population will be representative of the normal RRP population, focusing on HPV serotypes [69][70]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $16,500,000, up 28% year over year, exceeding guidance [17] - Annual contract value (ACV) plus royalties reached $66,800,000, a 15% increase year over year, marking a record high [17] - Remaining performance obligations (RPO) were $88,900,000, representing a 19% year over year increase, also a new high for the company [17] - Non-GAAP gross profit was $15,300,000 with a gross margin of 92% [17] - Non-GAAP operating loss was $3,200,000, a 40% improvement compared to the prior year [20] - Free cash flow was positive at $2,700,000 for the quarter, benefiting from early customer payments [21] Business Line Data and Key Metrics Changes - The company achieved several key design wins, including major contracts from top global technology companies and automotive OEMs [8][9] - Adoption of technology in advanced semiconductor companies continues to grow, with significant projects in AI and automotive sectors [9][10] - The FlexGen product, an AI-driven smart NOC IP technology, is being evaluated by over 20 customers, with expectations for revenue generation in the second half of the year [10] Market Data and Key Metrics Changes - The automotive sector remains robust, with ongoing design projects for future vehicles, including electric and autonomous driving technologies [12][13] - The company is seeing increased outsourcing of silicon system IP needs as customers seek efficiency and cost reduction [15][22] - The global economic uncertainty has not led to deal cancellations but may impact royalty revenues due to customer confidence [14][22] Company Strategy and Development Direction - The company is focusing on innovation and expanding ecosystem collaborations, including joining the Intel Foundry Accelerator Program [12] - The strategy includes enhancing customer support and product development through new engineering centers and partnerships [13] - The company aims to remain a neutral player in the system IP market, capitalizing on the trend of outsourcing due to increasing design complexity [42][73] Management's Comments on Operating Environment and Future Outlook - Management acknowledges economic uncertainty but maintains that licensing activity remains robust [30][32] - The company has not adjusted its overall FY 2025 revenue guidance, citing strong customer demand despite potential short-term headwinds [22][26] - There is optimism regarding the deal pipeline and customer interest in outsourcing system IP products [26][73] Other Important Information - The company received multiple awards for innovation, highlighting its technological advancements and market recognition [11] - The opening of a new engineering and customer support center in Krakow, Poland, aims to enhance product development and customer service [13] Q&A Session Summary Question: Changes in customer behavior due to tariffs and trade environment - Management noted some replanning of projects in China but observed an increased willingness to outsource system IP to commercial vendors [29][30] Question: Expectations for FlexGen revenue and traction - Management reported positive feedback from customers evaluating FlexGen, anticipating substantial bookings and revenue in the second half of the year [35][36] Question: Accelerated decision timelines by customers - Management indicated that while design cycles are being accelerated, licensing activity remains steady without significant changes in decision-making timelines [41][42] Question: Interest from joining the Intel Foundry Alliance - Management expects increased business opportunities from joining the alliance, particularly with Intel's commitment to commercial solutions [46] Question: Market size for system IP - Management estimated the system IP market to be between $1 billion and $1.2 billion, with significant growth potential as more companies outsource [59][60] Question: Underlying technological changes prompting outsourcing - Management highlighted the increasing complexity of designs, particularly with AI and chiplets, driving the need for commercial IP solutions [62][63]

Hyperfine (HYPR) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Webb Campbell - Investor RelationsMaria Sainz - CEO, President & DirectorBrett Hale - CFO & Chief Administrative OfficerYuan Zhi - Managing Director Conference Call Participants Frank Takkinen - Senior Research AnalystNone - Analyst Operator Thank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Hyperfine Q1 twenty twenty five Earnings ...

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]

Financial Data and Key Metrics Changes - The company's first quarter revenue was $17.3 million, a 117% increase compared to $8 million in the first quarter of 2024 [37] - Product sales reached $14 million, up 76% from $8 million in the same quarter last year, driven by increased sales of Alkindi Sprinkle and the addition of Incralyx [38] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [39] - Adjusted EBITDA for the first quarter was $3.7 million, compared to $500,000 in the prior year [43] - The total net loss was $1.6 million, compared to a net loss of $800,000 in the prior year [43] Business Line Data and Key Metrics Changes - The acquisition and relaunch of Incralyx and Dalzan contributed to strong growth in existing products [6] - Alkindi Sprinkle has shown consistent growth for 17 consecutive quarters, with an increase in new patient referrals in 2025 [16] - The company expects to reach approximately 80,000,000 annual revenue run rate by the end of 2025 [38] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and commercial infrastructure to raise awareness of severe primary IGF-1 deficiency [8] - The market for ET400 is estimated to have around 5,000 adrenal insufficiency patients under nine years of age, presenting a compelling opportunity [18] Company Strategy and Development Direction - The company aims to become a leading player in the ultra-rare disease market, with a focus on expanding its product portfolio through acquisitions and licensing [31] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [13] - The company is also developing ET700, an extended-release version of Galzin, to address dosing challenges and improve patient outcomes [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of existing products and the potential for new product approvals in the near future [6] - The company is optimistic about the upcoming launch of ET400, expecting rapid uptake and significant revenue impact in subsequent quarters [60] - Management noted that the tariff situation is not a major concern, as most products are produced in the U.S. and the impact of European purchases is minimal [34][35] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team and commercial activities for product relaunches [41] - The company reported a cash balance of $17.4 million and generated $2.1 million in operating cash flow during the quarter [43] Q&A Session Summary Question: Update on Incralyx label expansion meeting with FDA - The meeting request has been submitted, and the company expects to have it in the coming weeks, likely in July [45] Question: Recent interactions with FDA regarding ET400 - The company is on track for approval within two weeks, with the final step being labeling discussions [47] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients and expects to meet or exceed revenue goals this year [56] Question: Expected timing for commercial revenue from ET400 - The launch is expected around the approval date, with revenue anticipated in Q3 [59] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a strong uptake and zero copay for patients, improving access significantly [70]

Fractyl Health (GUTS) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Brian Luque - Head - IR & Corporate DevelopmentHarith Rajagopalan - Co-Founder, CEO & DirectorLisa Davidson - CFO & TreasurerChi Fong - VP - Equity ResearchAvraham Novick - Biotech Equity Research AssociateMichael Difiore - Managing DirectorWhitney Ijem - Managing Director Operator Good afternoon, and welcome to Fractal Health's First Quarter twenty twenty five Financial Results and Business Updates Call. As a reminder ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4.2 million, a 37% increase from $3.1 million in Q1 2024, primarily driven by higher instrument consumable and service revenue [23] - Gross profit for Q1 2025 was $2.1 million, representing a gross margin of 49%, compared to $1.4 million and 44% in Q1 2024 [26] - Net loss for Q1 2025 was $19.9 million, compared to $20.7 million in Q1 2024 [28] - Free cash flow loss was approximately $12.1 million for Q1 2025, with expectations of a full-year loss in the range of $40 million to $45 million [28][29] Business Line Data and Key Metrics Changes - Product revenue for Q1 2025 was $2.9 million, including $5,000 from related party revenue, consisting of sales of proteograph instruments and consumable kits [23] - Service revenue for Q1 2025 was $1.2 million, including $47,000 from related party revenue, primarily from STACK service projects [25] - Other revenue was $60,000 for Q1 2025, consisting of lease and shipping revenue [26] Market Data and Key Metrics Changes - Approximately 30% of total revenue comes from academic and government entities, with expectations of weakening in these segments for 2025 [31][44] - The company has seen a stabilization in revenue and instrument placement between academic, government, and biopharma sectors in Q1 2025 [44] Company Strategy and Development Direction - The company aims to focus on four key growth drivers in 2025: expanding the user base, driving larger cohort studies, continuing product innovation, and enabling customers to generate actionable biological insights [35] - The company is making concentrated investments in R&D to execute its product roadmap while continuing its share repurchase program [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term vision despite near-term macroeconomic volatility, including tariffs and government funding challenges [6][8] - The company reiterated its full-year 2025 revenue guidance of $17 million to $18 million, representing 24% year-over-year growth at the midpoint [8][30] - Management acknowledged potential impacts from tariffs and government funding uncertainties but remains optimistic about the demand for proteomics technology [31][32] Other Important Information - The company ended Q1 2025 with approximately $285 million in cash, cash equivalents, and investments, which is seen as a key differentiator in the current environment [9][29] - The company has initiated a Strategic Instrument Placement Program (SIPP) to help customers with capital constraints, allowing them to access instruments through upfront purchases of consumable kits [18] Q&A Session Summary Question: Can you walk us through the magnitude of the Discovery Life Sciences project? - Management confirmed it is a significant 10,000 sample study aimed at understanding potential biomarker signatures, expected to take 12 to 18 months [37][38] Question: What are the updated expectations for U.S. academic and government customers? - Management indicated that academic and government revenue is expected to decline, but Q1 showed stabilization in revenue and instrument placements [44][46]

WhiteHorse Finance (WHF) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Robert Brinberg - PresidentStuart Aronson - CEO & DirectorJoyson Thomas - CFO & Principal Accounting OfficerMelissa Wedel - Vice President, U.S. Equities ResearchRobert Dodd - Director - Finance Operator Good afternoon. My name is Margo, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the WhiteHorse Finance First Quarter twenty twenty five Earnings Conference Call. Our hosts ...

Financial Data and Key Metrics Changes - The company reported a net loss of $22 million in the quarter compared to a net income of $6.2 million in the prior year, driven by higher general and administrative expenses and marketing costs [13] - Adjusted EBITDA was $4.1 million in the quarter, down from $22.2 million in the same quarter of the previous year [26] - Revenue grew 5.3% on a constant currency basis, but reported revenue was roughly flat year over year [12] Business Line Data and Key Metrics Changes - Paid content revenue grew 2.8% on a constant currency basis year over year, driven by strength in Japan, offset by declines in Korea and the rest of the world [17] - Advertising revenue increased by 13.6% on a constant currency basis, with strong performance in Korea and Japan, but a decline in the rest of the world [18] - IP Adaptation revenue saw a 20.7% increase year over year on a constant currency basis, with significant growth in Japan [19] Market Data and Key Metrics Changes - In Korea, revenue grew 3.6% year over year on a constant currency basis, primarily driven by advertising and IP adaptations [20] - Japan posted revenue growth of 9.4% on a constant currency basis, with all revenue streams contributing positively [22] - The rest of the world experienced a revenue decline of 4% year over year on a constant currency basis [24] Company Strategy and Development Direction - The company is focused on building a local creator ecosystem in Japan and expanding its cross-border strategy by taking Japanese content to other markets [6] - Investments are being made in the English language platform to enhance user experience and engagement [7][10] - The company aims to leverage its flywheel of creators, content, and users to generate profitable growth over the long term [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the resilience of the business model despite potential market downturns, citing a low average revenue per paying user [10] - The company anticipates revenue growth in the range of 2.2% to 5.2% for the second quarter of 2025 [29] - Management is closely monitoring market health and believes in the long-term growth potential of newer markets [35] Other Important Information - The company faced challenges with a security upgrade affecting search engine indexing, which contributed to a decline in web MAU [14] - The gross profit for the quarter was $71.6 million, resulting in a gross margin of 22%, down from 25.2% in the prior year [25] - The company is making significant changes to its English language web comic app to improve user engagement [60] Q&A Session Summary Question: User growth initiatives and investment cadence - Management highlighted strong long-term growth signs in newer markets, particularly a 19% increase in English-speaking platform MAU [35] Question: Importance of local content in local markets - Management emphasized the significance of local creator IP and partnerships to enhance global reach and engagement [39] Question: MAU decline in Korea and future growth potential - Management noted that while Korea has high penetration, constant currency revenue growth of 3.6% indicates potential for future growth [46] Question: Update on advertising revenue in North America - Management stated that North America advertising is still in early stages, with a focus on building foundational products for future growth [49] Question: Impact of global franchises on monetization - Management clarified that global franchises have historically contributed positively to the core paid content margin structure [53] Question: Security update on Wattpad and user impact - Management confirmed that Wattpad's issues significantly impacted total MAU declines, but it is not a major contributor to paid content revenue [66] Question: Engagement levels of licensed IP in the U.S. - Management indicated that engagement levels depend on the specific IP, but there is potential for licensed IP to drive user engagement [85]