Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $144.8 million [23] - Revenues for Q1 2025 were zero, compared to approximately $4.9 million for Q1 2024, with the previous revenue being from a $40 million distribution agreement fully recognized by the end of 2024 [23][24] - Operating expenses for Q1 2025 were approximately $16.2 million for R&D, up from $10.1 million in Q1 2024, and general and administrative expenses were approximately $3.1 million, compared to $1.8 million in Q1 2024 [24] - The net loss for Q1 2025 was approximately $24.4 million, compared to a net loss of approximately $9.8 million for Q1 2024 [25] Business Line Data and Key Metrics Changes - The company is focused on the BLA for daramycin, aimed at treating Duchenne muscular dystrophy (DMD) cardiomyopathy, with a strong emphasis on the safety and efficacy data supporting the application [5][8] - The company has been providing daramycin to all open-label extension patients for over three years, with nearly all HOPE-three patients now in open-label extension [15] Market Data and Key Metrics Changes - The company is negotiating with Nippon Shinyaku for the distribution of deramycin in Europe, with the negotiation period extended through the end of Q2 2025 [18] - The company is also exploring opportunities for its technology in other global markets [18] Company Strategy and Development Direction - The company aims to transition from a translational medicine company to a commercial stage entity, actively working with NS Pharma on launch readiness in the U.S. [12] - The company plans to have over 100 patients transition from clinical to commercial product following potential BLA approval [14] - The company is enhancing its medical leadership to guide physicians through the prescribing process for daramycin [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting the BLA and the unmet need in treating DMD cardiomyopathy, which could lead to FDA approval [5][6] - Management noted that the FDA has not indicated any substantive issues with the application, providing confidence in the ongoing review process [30] - The company has a cash balance of approximately $145 million, with a runway extending into 2027 without additional cash infusions [20] Other Important Information - The company is developing its Stealth Exosome Platform technology as part of a next-generation drug delivery platform, although this program has taken a backseat to daramycin [19] - The company is also working on a vaccine candidate for COVID-19 prevention under Project NextGen, with Phase 1 trials set to start in Q3 2025 [20] Q&A Session Summary Question: Has the site inspection in San Diego occurred? - The site inspection is scheduled for the upcoming quarter, and management feels prepared for it [28] Question: What is the status of negotiations with Nippon Shinyaku for Europe? - The company is actively negotiating and evaluating opportunities for commercialization in Europe, while also preparing to work directly with European authorities [37] Question: What are the key drivers of proof for the efficacy data? - The statistical significance of cardiac MRI data is a key driver, showing very little chance that the data is due to chance [46] Question: What is the plan if the FDA issues a CRL for efficacy? - The company would submit data from the HOPE-three trial for skeletal muscle dysfunction if a CRL is issued [55] Question: What is the plan for the PRV voucher? - The current plan is to sell the PRV voucher to strengthen the balance sheet [72]

Biodesix (BDSX) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Christopher Brinzey - PartnerScott Hutton - President, CEO & DirectorRobin Harper Cowie - CFO Conference Call Participants Daniel Brennan - Senior Equity Research Analyst - Managing DirectorAndrew Brackmann - Equity Research AnalystSung Ji Nam - Managing Director, Senior Equity Research AnalystKyle Mikson - Managing Director & Senior Research AnalystThomas Flaten - Senior Research AnalystBill Bonello - Senior Research Analys ...

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]

Absci (ABSI) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Alexander Khan - VP of Finance & Head of Investor RelationsSean McClain - Founder, CEO & DirectorZach Jonasson - Chief Financial Officer & Chief Business OfficerArseniy Shabashvili - Vice PresidentChristian Stegmann - Senior Vice President of Drug CreationMorgan Gryga - Biotech Equity Research AssociateGeorge Farmer - Managing DirectorDebanjana Chatterjee - DirectorLi Chen - Equity Research Associate Conference Call Participant ...

a.k.a. Brands Holding (AKA) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Emily Schwartz - Head - Investor Relations & CommunicationsCiaran Long - CEOKevin Grant - CFODana Telsey - CEO and Chief Research Officer Conference Call Participants Ryan Meyers - Senior Research AnalystAshley Owens - Vice President & Senior Equity Research AnalystEric Beder - CEO & Senior Research Analyst Operator Please note that this call is being recorded. I will now turn the conference over to our host, Emi ...

Financial Data and Key Metrics Changes - In Q1 2025, the company reported net revenue of $20.4 million, with $17.1 million from MyPlifa, $0.1 million from Olpruva, and $2.3 million in net reimbursements from the French EAP for Aramcholamol [29][30] - Operating expenses for Q1 were $22.8 million, a decrease of $0.6 million compared to the same quarter last year [30] - The net loss for Q1 2025 was $3.1 million, compared to a net loss of $16.6 million in the same quarter a year ago [30][31] - Total cash, cash equivalents, and investments as of March 31, 2025, were $68.7 million, a decrease of $6.8 million from December 31, 2024 [30][31] Business Line Data and Key Metrics Changes - MyPlifa's launch has exceeded expectations, with 122 prescription enrollment forms received since launch, indicating that approximately one-third of diagnosed NPC patients in the U.S. have been enrolled [20][21] - Olpruva received a total of 28 prescription enrollment forms since its initial availability, with five forms received in Q1 2025 [12][27] - The company has achieved 38% of covered lives for MyPlifa, which is in line with expectations at this stage of the launch [21][22] Market Data and Key Metrics Changes - The company is focusing on expanding MyPlifa's availability outside the U.S., with plans for a marketing authorization application in Europe in the second half of the year [11] - The European market for NPC is well established, with approximately 1,100 people estimated to be living with the disease [11] Company Strategy and Development Direction - The company is executing on four strategic pillars: commercial excellence, pipeline and innovation, talent and culture, and corporate foundation [5][8] - The focus is on bringing innovative therapies to patients with rare diseases, with a strong emphasis on MyPlifa as a cornerstone treatment for NPC [17][33] - The company is also assessing strategic alternatives for its Phase III ready asset KP1077 for rare sleep disorders [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early success of MyPlifa and the refined marketing strategy for Olpruva, indicating a strong position for future growth [33] - The company believes it is well positioned to support its strategic priorities and execute on its long-term vision, independent from capital markets [31][32] Other Important Information - The company has successfully monetized its Pediatric Rare Disease Priority Review Voucher, adding $148.3 million of non-dilutive capital to its balance sheet [8][31] - The company is committed to patient access and comprehensive patient services through its in-house program, Amplify Assist [27] Q&A Session Summary Question: Details on the number of patients on MyPlifa and reimbursement status - The company received 122 enrollments since launch, with the majority of patients actively on the drug, while some are in the benefits investigation process [36] Question: Reasons for reimbursement denials for MyPlifa - Initial denials are common for rare disease products, primarily due to prior authorization requirements, but the company has been successful in securing coverage through medical exception processes [39][40] Question: Visibility on patient cohorts and enrollment cadence - The company estimates around 600 undiagnosed patients and 300 diagnosed patients, with ongoing efforts to raise awareness and facilitate treatment [47][59] Question: Inventory levels at the end of the quarter - The company is managing inventory closely and maintaining target levels as it supports patient needs during the early launch phase [50] Question: Qualitative metrics on refill rates and patient retention - The majority of patients receiving active drug have continued to refill, reflecting the clinical benefit and durability of MyPlifa [54] Question: Coverage details and impact on patient access - 38% of covered lives have access to MyPlifa, with ongoing efforts to increase this percentage as more plans evaluate the product [63][64]

Financial Data and Key Metrics Changes - The company's Q1 2025 GAAP net investment income and core NII was $6,800,000 or $0.02 per share, down from $8,000,000 or $0.03 per share in Q4 2024, and below the quarterly distribution of $0.03 per share [6][18] - NAV per share at the end of Q1 was $12.11, representing a 1.6% decrease from the prior quarter, impacted by net realized losses and markdowns totaling $2,600,000 [6][18] - The weighted average effective yield on income-producing debt investments decreased to 12.1% at the end of Q1 from 12.5% in Q4 2024 [9][18] Business Line Data and Key Metrics Changes - Gross capital deployments in Q1 totaled $45,500,000, with net deployments of $26,100,000 after repayments and sales of $19,400,000 [6][9] - The portfolio mix at the end of Q1 consisted of approximately 90.3% first lien, senior secured debt, with a mix of two-thirds sponsor and one-third non-sponsor deals [7][9] - Nonaccrual investments totaled 8.8% of the debt portfolio, up from 7.2% in the prior quarter [13][18] Market Data and Key Metrics Changes - The STRS JV portfolio had an aggregate fair value of $310,200,000 with an average effective yield of 10.8%, down from 11.1% in Q4 [8][20] - The lending market has seen a 25 to 50 basis point increase in pricing due to increased volatility, but most of that premium has dissipated recently [15][18] - The M&A market has slowed significantly, with many deals being put on hold due to uncertainty in the economic environment [41][42] Company Strategy and Development Direction - The company continues to focus on the non-sponsor market, where there are better risk-return profiles and less competition [16][18] - The company added a new coverage region in Nashville, Tennessee, to enhance non-sponsor and off-the-run sponsor origination capabilities [16][18] - The company is actively monitoring the debt capital markets for opportunities to optimize or refinance its capital structure [21][18] Management's Comments on Operating Environment and Future Outlook - Management noted that challenges in the portfolio are more company-specific rather than related to the overall economy, with no signs of a recession yet [10][18] - The company expects a decent amount of refinancing activity in the second half of the year as prepayment penalties on higher-rate deals expire [46][18] - Management is cautious about the environment for deal closures in Q3, anticipating a quiet period due to the current market conditions [42][18] Other Important Information - The company declared a first-quarter distribution of $0.03 per share, consistent with the prior quarter, and will continue to evaluate its quarterly distribution based on core earnings power [22][18] - Cash resources at the end of Q1 were approximately $19,600,000, including $8,200,000 in restricted cash [21][18] Q&A Session Summary Question: Update on Telestream and its return to accrual status - Management indicated progress on restructuring Telestream, hoping to complete it by May, which would allow a portion of the existing debt to return to cash-paying status [26][27] Question: Dividend update and spillover income - Spillover income was approximately $28,400,000, with a current dividend run rate equating to about $8,950,000 in distributions, indicating a shortfall for Q1 [33][35] Question: Market conditions and bid-ask spreads - Management noted that good companies without significant tariff or recession risk are trading at high multiples, while those with risks are seeing buyers being conservative [40][41]

Financial Data and Key Metrics Changes - The company reported a net loss of $22 million in Q1 2025 compared to a net income of $6.2 million in the prior year, primarily due to higher general and administrative expenses and increased marketing costs [13] - Adjusted EBITDA decreased to $4.1 million from $22.2 million year-over-year, with adjusted earnings per share dropping to $0.03 from $0.20 [26][27] - Revenue growth was 5.3% on a constant currency basis, but reported revenue was roughly flat year-over-year due to tough comparisons from Q1 2024 [12] Business Line Data and Key Metrics Changes - Paid content revenue grew by 2.8% on a constant currency basis, driven by strength in Japan, but was offset by declines in Korea and the rest of the world [16] - Advertising revenue increased by 13.6% on a constant currency basis, with strong performance in Korea and Japan, while the rest of the world saw a decline [17] - IP Adaptation revenue surged by 20.7% year-over-year on a constant currency basis, with significant growth in Japan [18] Market Data and Key Metrics Changes - In Japan, revenue grew by 9.4% on a constant currency basis, with all revenue streams contributing positively [22] - Korea experienced a revenue growth of 3.6% on a constant currency basis, driven by advertising and IP adaptations, despite a decline in paid content [20] - The rest of the world saw a revenue decline of 4% year-over-year, with significant drops in paid content and advertising [23] Company Strategy and Development Direction - The company is focused on expanding its presence in Japan and leveraging local content to drive growth in other markets [6] - Investments are being made in the English language platform to enhance user experience and engagement, with a focus on onboarding and content discovery [7][11] - The company aims to maintain a resilient business model that can withstand potential market downturns, emphasizing the value of microtransactions and free content [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate current macroeconomic uncertainties and highlighted the importance of ongoing investments in marketing and infrastructure [30] - The company anticipates revenue growth in Q2 2025 in the range of 2.2% to 5.2% on a constant currency basis, with adjusted EBITDA expected between $500,000 and $5.5 million [27][29] - Management remains optimistic about long-term growth prospects, particularly in newer markets and through product innovations [36] Other Important Information - The company is addressing a security issue that affected Wattpad, which contributed to a decline in MAU in the rest of the world [14][63] - A change in methodology by Nabor for measuring MAU in Korea has impacted reported metrics, but the company believes this will not affect long-term growth potential [21][44] 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, driven by content flow and product innovation [35] Question: Importance of local content in local markets - Management emphasized the significance of local creator IP and the ability to publish globally, showcasing successful adaptations and partnerships [39] Question: MAU decline in Korea and future growth potential - Management noted that while Korea has high penetration, the focus should be on constant currency revenue growth, which was positive despite MAU fluctuations [44] Question: Update on advertising revenue in North America - Management indicated that North America remains a significant opportunity, with ongoing investments in product and selling organization to drive future growth [47] Question: Impact of global franchises on monetization - Management stated that global franchises enhance the core paid content margin structure and attract a larger audience [52] Question: Changes to the English app and product rollout - Management confirmed extensive product innovations based on global learnings, with promising results from AB testing indicating significant potential for user engagement [56][72] Question: Security update on Wattpad and user impact - Management clarified that Wattpad's issues primarily affected MAU but did not significantly impact paid content revenue, and they are working to resolve these issues [63] Question: Engagement of licensed IP in the U.S. market - Management noted that engagement levels depend on the specific IP, but there is potential for licensed IP to drive user engagement and attract new users [81]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported total revenues of $3,400,000, primarily from WICANT, with gross product margins around 88% [16][17] - The GAAP net loss was $9,700,000 or $0.10 per share, a significant improvement from a net loss of $20,300,000 or $0.44 per share in Q1 2024 [17] - Non-GAAP net loss for Q1 2025 was $7,800,000 or $0.08 per share, compared to $17,800,000 or $0.38 per share in the same period last year [17][18] Business Line Data and Key Metrics Changes - WICANT's dispensed applicator units increased by 16.7% over Q4 2024, surpassing 10,000 units for the first time since its launch [6][7] - Collaboration revenues totaled $17,000 in Q1 2025, related to the supply of applicators to Torii Pharmaceutical [16] Market Data and Key Metrics Changes - The company is focusing on territories with high prevalence of molluscum and has established strong insurance coverage, leading to improved sales force productivity [8][9] - The company is expanding its distribution network by adding local independent pharmacies alongside national specialty pharmacy partners [9] Company Strategy and Development Direction - The company is executing a focused commercialization strategy aimed at driving demand for WICANT, which is expected to become the standard of care for molluscum contagiosum [19] - The clinical pipeline includes advancing the phase three program for WICANT in treating common warts and the development of BP315 for basal cell carcinoma [7][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing positive feedback from healthcare professionals and improved patient access [19] - The company is exploring opportunities to strengthen its balance sheet while advancing commercial and clinical development efforts [18] Other Important Information - The company appointed Dr. Noah Rosenberg as Chief Medical Officer and Dr. Gavin Corcoran to the Board of Directors, enhancing its leadership team [13][14] Q&A Session Summary Question: Discussion on targeting pediatricians and summer demand - Management noted an increasing number of pediatricians prescribing WICANT, with marketing efforts aimed at building awareness for the treatment [22][25] Question: Conversion time between accounts receivable and revenue - The company offers sixty-day payment terms to distributors, expecting stabilization in cash conversion as inventory levels normalize [31][32] Question: Overall TAM for molluscum and coverage split - Management indicated a significant percentage of pediatric patients are covered under Medicaid, while dermatologists have a higher percentage of commercial pay [36] Question: Trends in reordering and applicators per patient - The company is seeing solid growth in customer retention and reordering, indicating positive clinician experiences with the product [42][43]

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Greetings. Welcome to Vaxart Business Update and First Quarter twenty twenty five Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Speaker1 Good afternoon, and w ...