Joining me now with more is the CEO of Mona, Stefan Bonsel, joining me right now. Stefan, welcome. Thanks so much for joining us this morning.>> Good morning, Maria. It's good to see you. Thank you for having me.>> I want to talk about this great success that you have had uh with Merc and your scientists have reported uh real breakthroughs with regard to cancer and your phase uh trials this uh this year and at the end of last year. What can you tell us, Stefan. Yes.So we're indeed very excited. We've been w ...

Group 1: Company Overview - Pfizer Inc. is a global pharmaceutical leader focusing on mRNA vaccines, oncology, immunology, and infectious diseases, with notable recognition for its COVID-19 vaccine collaboration with BioNTech [1][2] - The company is advancing its mRNA vaccine portfolio, recently announcing progress with its LP.8.1-adapted COMIRNATY 2025-2026 formula [1] Group 2: Vaccine Development - In September 2025, Pfizer reported positive Phase 3 topline data showing a fourfold increase in neutralizing antibodies in adults aged 65+ and high-risk adults aged 18–64, supporting FDA approval [2] - The adaptive vaccine targets emerging SARS-CoV-2 sublineages, reinforcing Pfizer's strategic direction to maintain vaccine efficacy amid changing pandemic conditions [2] Group 3: Oncology and Specialty Medicines - Pfizer is advancing oncology and specialty medicines, with combination therapy PADCEV plus KEYTRUDA showing improved survival rates in bladder cancer [3] - The company is also progressing with HYMPAVZI for hemophilia treatment, demonstrating its commitment to high-need therapeutic areas [3] Group 4: Research and Development Focus - Despite facing regulatory challenges and patent litigation over Paxlovid, Pfizer continues to invest in R&D and strategic partnerships [4] - The company's focus on adaptive mRNA technology, AI-driven development, and precision medicine highlights its leadership among biotech innovators [4]

Financial Data and Key Metrics Changes - The company reported revenue of $47 million for Q1 2025, exceeding expectations and showing growth of over $4 million from Q4 2024 [7][30] - GAAP net loss before noncontrolling interests was $53 million for Q1 2025, compared to a loss of $23 million in Q1 2024 [30] - Adjusted EBITDA was a negative $11 million for Q1 2025, down from a positive $8 million in Q1 2024 [30][32] - Basic and diluted EPS for Q1 was a loss of $0.21 per share, compared to a loss of $0.09 per share in Q1 2024 [33] Business Line Data and Key Metrics Changes - The Nucleic Acid Production (NAP) segment generated $29 million in revenue for Q1 2025, up $1 million from Q4 2024 [7] - The Biologics Safety Testing (BST) segment reported revenue of $18 million in Q1 2025, an increase of $3 million over Q4 2024 [7][39] - The adjusted EBITDA margin for the BST segment was 70%, indicating strong performance [39] Market Data and Key Metrics Changes - Revenue by customer type in Q1 was 29% from biopharma, 28% from life science and diagnostics, 6% from academia, 7% from CDMO, and 30% through distributors [8] - Revenue by geography was 62% from North America, 15% from EMEA, 15% from Asia Pacific, and 8% from China [8] Company Strategy and Development Direction - The company is focused on a return to growth strategy and building a diversified, predictable franchise as a life science tool provider [11] - The strategy includes vertical integration in the NAP segment to enhance quality, speed, and cost efficiency [9] - The company aims to advance its market leadership in genomic medicines and expand its product and service portfolio [11][20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges of transitioning from a COVID-driven revenue model to a more diversified business [43] - The company is actively monitoring trade dynamics and working to mitigate potential impacts from tariffs [10][44] - There is a strong cash position of $285 million, which is seen as sufficient to manage the current reset period [44] Other Important Information - The company plans to publish its 2024 sustainability report, highlighting its commitment to sustainability and long-term strategic objectives [27][28] - The integration of recent acquisitions is progressing well, enhancing operational capabilities and supply chain control [35] Q&A Session Summary Question: What does the intel tell about the focus areas for new trials and those being discontinued? - Management noted that while preclinical programs were flat, clinical programs showed growth, indicating a focus on later-stage projects due to funding conservatism [50][51] Question: What are the biggest drivers of incremental demand in the next 12-18 months? - Management indicated that clinical progression and new business wins would drive demand, with a focus on expanding from bulk reagent supply to comprehensive service offerings [52][54] Question: Is there an opportunity to take market share with 100% U.S. manufacturing? - Management sees renewed interest in their U.S.-based manufacturing capabilities, which could attract customers looking for alternative suppliers [57][58] Question: What are the buying patterns from biopharma and academic customers? - The response highlighted a mixed environment, with some customers securing long-term funding while others are delaying decisions due to funding uncertainties [63][64] Question: Is there any government work or exposure to BARDA? - Management confirmed that there is no direct government work currently, and past BARDA engagements have been satisfied [69][70] Question: Is there seasonality in BST revenue? - Management indicated that Q1 is typically a high point for BST revenue due to manufacturing cycles, and a seasonal dip is expected in subsequent quarters [74][76]