Financial Data and Key Metrics Changes - The company ended the first quarter of 2025 with cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [8] - Research and development expenses for the three months ended March 31, 2025, were approximately $3.4 million, a decrease from approximately $7.1 million for the same period in 2024, reflecting a reduction in patient follow-up activities and personnel costs [9] - General and administrative expenses for the same period were $3 million, down from $4.9 million in 2024, primarily due to reduced pre-commercialization and personnel costs [9] - The net loss for the first quarter of 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, during the same period in 2024, showing a substantial improvement in financial performance [9] Business Line Data and Key Metrics Changes - The company is focusing on its PDC platform and radio conjugate pipeline, particularly the iapofacine I-131 for treating Waldenstrom's macroglobulinemia, which has shown promising efficacy and safety in clinical trials [5][6] - The company is also advancing its solid tumor-focused radioisotope programs, including treatments for pancreatic cancer and triple-negative breast cancer, highlighting the versatility of its delivery platform [6] Market Data and Key Metrics Changes - The company is seeking guidance from the EMA for conditional approval of iapofacine I-131 based on the Phase II CLOVER WM study, which supports a rapid market entry for this treatment in Europe [5][6] - The company anticipates that the European market for its products is significant, especially given the higher utilization rates of rituximab in Europe compared to the U.S. [40] Company Strategy and Development Direction - The company has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, including mergers, acquisitions, partnerships, and licensing arrangements, to maximize shareholder value [6][8] - The company is committed to advancing its clinical development pipeline and addressing the unmet medical needs in the relapsed-refractory market [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for iapofacine I-131, noting the strong data from clinical trials and the potential for conditional approval in Europe [35][36] - The management highlighted the high unmet medical need in the patient population, particularly for those who have failed previous treatments, reinforcing the importance of their therapeutic candidates [31][32] Other Important Information - The company is preparing for Phase I and Phase Ib studies for its earlier-stage radio conjugates, CLR121225 and CLR121.125, which are expected to provide valuable insights into their therapeutic potential [13][14] - The initiation of these trials is contingent upon securing necessary funding, which is critical for advancing the company's pipeline [16] Q&A Session Summary Question: Regarding the application for conditional approval in Europe - The management discussed the potential benefits of running a Phase III trial against rituximab in earlier lines of therapy, noting the challenges and increased costs associated with larger study sizes [18][21] Question: What is the weakest competitor arm for the Phase III trial? - Management indicated that there is limited data on the efficacy of many treatments in the relapsed-refractory setting, suggesting that the choice of comparator will be based on current treatment paradigms and patient needs [24][27] Question: How does the company assess the commercial opportunity in Europe? - The management expressed optimism about the European market, citing the higher utilization of rituximab and the potential for increased volume despite lower pricing compared to the U.S. [32][40]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $89.3 million, exceeding initial expectations due to strong performance in CTV and digital out of home channels [18] - Adjusted EBITDA for Q1 2025 was $1.8 million, also higher than expectations, reflecting operational control and margin discipline [19] - On a GAAP basis, the net loss for Q1 2025 was $8.3 million, compared to a net income of $11.8 million in Q1 2024 [23] - Non-GAAP net income for Q1 2025 was $5.4 million, down from $22.6 million in Q1 2024 [23] - Cash position remains strong with nearly $360 million in net cash [19] Business Line Data and Key Metrics Changes - Digital out of home revenue grew by 80% year over year, now representing 19% of total revenue, up from 6% last year [21] - CTV revenue increased by 31% year over year, representing 12% of total revenue compared to 5% last year [21] - Retail media vertical grew by 33% year over year, outperforming the broader market [17] - Web revenue declined by 28% year over year, now representing 46% of total revenue compared to 37% in the same quarter last year [21] Market Data and Key Metrics Changes - The company noted a healthy pipeline going into the rest of 2025, contributing to the stabilization of web revenue [34] - The acquisition of GreenBids is expected to expand the total addressable market into new lower funnel performance opportunities [26] Company Strategy and Development Direction - The company is focused on building Perion One as an outcome-driven platform to create long-term value for CMOs and shareholders [6] - The acquisition of GreenBids is seen as a significant leap forward, enhancing technology and expanding capabilities in walled garden platforms [12][26] - The company is committed to investing in customers, people, and technology to drive long-term value [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to return to a high cash flow conversion rate and maintain a strong financial position [24] - The guidance for full year 2025 has been raised, reflecting improved outlook and stronger market position [28] - Management highlighted the importance of performance-based campaigns in the current market environment [63] Other Important Information - The company has expanded its share repurchase program to $125 million, reinforcing long-term confidence in its value [25] - The integration of GreenBids technology into Perion One is expected to happen immediately, with significant contributions anticipated in 2026 [45] Q&A Session Summary Question: What factors contributed to the increased guidance? - Management indicated that strong Q1 performance and the acquisition of GreenBids allowed for the increase in guidance, with a healthy pipeline contributing to future growth [34] Question: What is the expected impact of the GreenBids acquisition on revenue? - Management stated that while GreenBids is already profitable, the full impact of the acquisition will be seen in 2026, with synergies contributing to growth [40][41] Question: How is the message of the PerionOne platform being received by CMOs? - Management reported positive responses from CMOs regarding the unified offering and the custom algorithm through AI, indicating a strong market need [52] Question: What is the strategy to capitalize on the expanded total addressable market? - Management emphasized the importance of performance-based campaigns and the ability to reduce waste in advertising spend, which aligns with current market trends [59][63]

Financial Data and Key Metrics Changes - Total operating expenses decreased to $3.7 million in Q1 2025 from $6.2 million in Q1 2024 [16] - Research and development (R&D) costs significantly dropped to approximately $600,000 in Q1 2025 from $4 million in the same period in 2024, primarily due to reduced costs associated with the ReAssure trial [17] - General and administrative (G&A) expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities [18] - The net loss on a U.S. GAAP basis was $4.9 million in Q1 2025, compared to a net loss of $7.1 million in Q1 2024 [18] - On a non-GAAP basis, the net loss was $3.3 million in Q1 2025, down from $5.8 million in Q1 2024, reflecting lower R&D expenses [19] Business Line Data and Key Metrics Changes - The company is preparing for the potential commercialization of Orlynda, targeting the U.S. market for uncomplicated urinary tract infections [6][10] - The addressable market for Orlynda is estimated at 26 million prescriptions annually for at-risk patients, with a potential net sales of over $250 million if a 1% market share is captured [9] Market Data and Key Metrics Changes - The U.S. market for uncomplicated urinary tract infections generates approximately 40 million prescriptions annually, with a significant portion for at-risk patients [8] - New competition is emerging, with a product approved in April 2024 and another from GlaxoSmithKline expected to launch in the second half of 2025, increasing urgency for Orlynda's market entry [10] Company Strategy and Development Direction - The company aims to launch Orlynda by Q4 2025, emphasizing the urgency due to the lack of innovation in the therapy area over the past 25 years [7][14] - The commercialization strategy involves phased launches based on antibiotic resistance rates, physician prescription volumes, and managed care access [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market dynamics for Orlynda, highlighting the significant need for new therapies for at-risk patients [14] - There are no major hurdles anticipated before the launch, with product manufacturing already in place [30] Other Important Information - The company repaid outstanding principal and interest on exchangeable notes in January 2025, reducing debt significantly [13] - Cash and cash equivalents were reported at $12.7 million as of March 2025, with expectations to fund operations into 2026 [19] Q&A Session Summary Question: Can you elaborate on the maturity of conversations with potential commercial partners? - Management indicated ongoing discussions but noted that many potential partners may not see the timing as right for a partnership [26][28] Question: Are there any outstanding rate-limiting steps ahead of Orlynda's launch later this year? - Management stated there are no significant hurdles remaining, with all necessary product available for launch [30]

Gauzy (GAUZ) Q1 2025 Earnings Call May 13, 2025 08:30 AM ET Speaker0 Good morning and welcome to Gossilenisen First Quarter twenty twenty five Earnings Conference Call. Today's call is being recorded and we have allocated one hour for prepared remarks and Q and A. At this time, I would like to turn the conference over to Dan Scott, Investor Relations. Thank you. You may begin. Speaker1 Thank you, operator, and thank you everyone for joining us today. Hosting the call today are Gauzy's CEO and Co Founder, Ey ...

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HUYA (HUYA) Q1 2025 Earnings Call May 13, 2025 08:00 AM ET Company Participants Junhong Huang - Acting Co-CEO, Senior VP & DirectorRaymond Lei - Acting Co-CEO & CFONelson Cheung - Vice President, Equity Research Conference Call Participants Ritchie Sun - AnalystYanyan Xiao - VP - Research Analyst Operator Posted online. You can also view the earnings press release by visiting the IR website at ir.huya.com. A replay of the call will be available on the IR website soon. Participants of management on today's c ...

Acurx Pharmaceuticals (ACXP) Q1 2025 Earnings Call May 13, 2025 08:00 AM ET Company Participants Robert Shawah - Co-Founder & CFODavid Luci - Co-Founder, President, CEO & DirectorJoanne Lee - Biotech Equity Research AssociateJames Molloy - Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals Operator Greetings, and welcome to the Accurix Pharmaceuticals First Quarter twenty twenty five Financial Results and Business Update. At this time, all participants are in a listen only mode. A ...

Financial Data and Key Metrics Changes - The company reported net sales of $4 million for Q1 2025, with a revenue guidance for the full year of $35 million to $45 million from T Cellra sales [4][5][50] - The average turnaround time from apheresis to release was 27 days, beating the target of 30 days [6] - The company achieved a 100% manufacturing success rate from its U.S. T Cell manufacturing center [6][31] Business Line Data and Key Metrics Changes - A total of 21 patients have been treated with T Cellra in 2025, with 13 in Q1 and 8 in early Q2 [4] - The company invoiced 14 T Cellra treatments in 2025 to date, with 6 in Q1 [5] - The company expects to have approximately 30 authorized treatment centers (ATCs) operational by the end of 2025, which is a year earlier than initially anticipated [4][5] Market Data and Key Metrics Changes - The company has seen effective patient access to T Cellra with no patient denials to date [6] - The annual incidence rate for eligible patients diagnosed with synovial sarcoma is approximately 1,000, which aligns with the company's expectations [68] Company Strategy and Development Direction - The company is focused on the successful launch of T Cellra and is preparing for the launch of Letocell, anticipated in 2026 [8] - The company is reviewing strategic options with Cowen as advisors to explore opportunities that benefit patients and shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the revenue guidance based on the number of patients treated and the operational efficiency of ATCs [50] - The company has had three formal meetings with the FDA in the last six months, indicating a positive regulatory environment [28] Other Important Information - The company has implemented cost reduction actions and a restructuring plan that impacted Q1 spending [46] - The gross margin in Q1 was around 78%, with expectations of normalizing to about 70% in the long run [66] Q&A Session Summary Question: Clarification on apheresis patients invoiced - Management confirmed that most apheresis patients invoiced in Q1 were from the prior quarter, with expectations for invoicing the majority in the coming month [10][11] Question: Trends in patient referrals and screening - Management expects incremental growth quarter on quarter without specific seasonalization, driven by increased awareness and onboarding of ATCs [16][18] Question: Impact of regulatory changes - Management noted that the FDA remains engaged and has not indicated any issues with the regulatory process [28] Question: Key learnings from the early launch - The onboarding of treatment centers has occurred faster than anticipated, and the manufacturing success rate has been exceptional [29][31] Question: Financing and liquidity concerns - The company paid down $25 million of financing obligations to manage its balance sheet and leverage [42][45] - The company has less than twelve months of cash runway, and detailed cash guidance was deemed inappropriate due to various influencing factors [46][47]