Core Viewpoint - Outlook Therapeutics, Inc. has appointed Laura Cantrell as Vice President of Corporate Strategy and Business Development to enhance its strategic initiatives and shareholder value during a critical phase of the company's evolution [3][4]. Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to improve the standard of care for retinal diseases [6]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD, with a commercial launch already commenced in Germany and the UK [6]. Leadership Appointment - Laura Cantrell brings over 20 years of experience in global corporate strategy, business development, and portfolio leadership within the biotechnology and pharmaceutical sectors [4][5]. - Cantrell has held senior roles at notable companies such as Medivation, BeiGene, Sobi, Axovant Sciences, and Genentech/Roche, and has been involved in significant licensing and acquisition initiatives, including Medivation's $14 billion acquisition by Pfizer [4][5]. Strategic Focus - In her new role, Cantrell will lead the business development strategy, focusing on strategic partnerships, licensing opportunities, and corporate development initiatives to support the company's growth [3][4]. - The company aims to advance its mission of delivering a differentiated ophthalmic formulation of bevacizumab while maximizing long-term shareholder value [3].

Strategic Transformation - Galapagos is executing a strategic transformation, including the intention to wind down the cell therapy business, subject to works council consultations[13, 17] - The company expects to be cash flow neutral to positive by YE26, excluding BD and currency fluctuations[18] - A lean organization of 35-40 employees is expected by YE26, focused on transformative business development[18, 60] Financial Performance & Outlook - Nine-month total revenues increased by 6% to €211.4 million[64] - R&D expenses increased by 48% to €351.9 million[64] - An impairment loss of €204.8 million was recorded for the Cell Therapy business[64, 70] - The company anticipates approximately €2.975 - €3.025 billion in cash and investments at YE25[24] Business Development Strategy - Business development is a core strategy, leveraging a unique partnership with Gilead[37, 38] - The company is open to opportunities across diseases, modalities, geographies, and deal types[51] - A disciplined approach to capital deployment aims to maximize near- and long-term value creation[39, 40]

Financial Data and Key Metrics Changes - Consolidated revenues for Q1 2025 totaled $550.1 million, a 4.2% increase from Q1 2024 [21] - Consolidated gross profit was $20.3 million, reflecting a 53.1% increase year-over-year, with a gross profit margin of 3.7% compared to 2.5% in the prior year [21] - Net loss attributable to common stock was $17.9 million, or a diluted loss per share of $0.20, an improvement from a net loss of $25.1 million or $0.35 per share in the same period last year [22] - Adjusted EBITDA for Q1 2025 was $24.2 million, approximately 20% higher than the prior year [22] Business Line Data and Key Metrics Changes - U.S. Gas segment revenue totaled $197.7 million, a year-over-year decrease of 12.7%, with a gross profit margin of -7.5% [23][25] - Canadian Gas segment revenue was $39.8 million, down 2.9% year-over-year, but the segment margin improved to 17.8% from 7.5% [26] - Union Electric segment revenue increased by 7.1% year-over-year to $175.5 million, with a core growth of 32.7% driven by increased bid project activity [26] - Nonunion Electric segment revenue rose by 41.9% year-over-year to $137.1 million, with gross profit increasing to 11.9% from 2.9% [27] Market Data and Key Metrics Changes - The U.S. Gas segment faced adverse weather conditions impacting performance, but improvements were noted in March and April [19][25] - The nonunion electrical segment benefited from strong market trends in the Sunbelt and Southeast regions, driven by storm damage recovery efforts [20] Company Strategy and Development Direction - The company is focused on implementing a unified business development strategy to enhance growth and market positioning [11][31] - A significant increase in the sales pipeline was reported, approaching $12 billion in revenue opportunities, with a record booking quarter of $1.2 billion in Q1 2025 [14] - The company aims to improve capital efficiency and reduce working capital levels as part of its strategic priorities [29] Management's Comments on Operating Environment and Future Outlook - Management does not anticipate significant impacts from the global trade war or tariffs in 2025, citing a resilient business model [8][30] - The outlook for full-year 2025 remains unchanged, with expectations to deliver between $2.6 billion and $2.8 billion in revenues [29][30] - Management expressed confidence in maintaining a positive trajectory across segments, with strong growth anticipated in the coming quarters [21][32] Other Important Information - The company has made significant progress in enhancing its pipeline management and sales strategies, fostering a growth-oriented culture [12][31] - Capital expenditures for Q1 2025 were $23.2 million, down from $24.6 million in the prior year [28] Q&A Session Summary Question: Can you talk about the trajectory for 2025 and how you expect to reach the upper end of revenue guidance despite a weaker Q1 in U.S. Gas? - Management noted that the gas business faced weather-related challenges in January and February but recovered in March and April, with work under contract supporting the revenue guidance [35][36] Question: Can you discuss the key findings of the strategic review? - Key findings included the need for a fully integrated sales pipeline, improved cross-selling capabilities, a cultural shift towards identifying more work for customers, and aligning KPIs with growth and profitability [38][39][40] Question: How would you frame the loss in the U.S. Gas segment relative to expectations? - Management acknowledged that weather impacts are uncontrollable but emphasized efforts to migrate the business to regions less affected by weather to achieve profitability earlier in the year [45][46] Question: What is the visibility and cadence expected for bookings moving forward? - Management indicated strong visibility for Q2 bookings and anticipated some lumpiness in Q3, with Q4 expected to be robust due to MSA renewals and new bid work [49][51] Question: Can you clarify the guidance for adjusted EBITDA? - Management confirmed that while they are cautious, the bookings and backlog are pushing towards the upper end of the revenue guidance, and they do not foresee margin erosion [55][57] Question: Can you provide details on the new MSAs and their risk profile? - Management stated that the new work aligns with existing services and customers, maintaining the same risk profile without significant changes [60][61] Question: What will be needed to achieve full-year EBITDA margin? - Management indicated that no radical changes are necessary, and they are on track to meet the full-year guidance based on current backlog and expected bookings [67][68]

Financial Data and Key Metrics Changes - Consolidated revenues for Q1 2025 totaled $550.1 million, a 4.2% increase from Q1 2024 [22] - Consolidated gross profit was $20.3 million, reflecting a 53.1% increase year-over-year, with a gross profit margin of 3.7% compared to 2.5% in Q1 2024 [22] - Net loss attributable to common stock was $17.9 million, or a diluted loss per share of $0.20, improved from a net loss of $25.1 million or $0.35 per share in the same period last year [23] - Adjusted EBITDA for Q1 2025 was $24.2 million, approximately 20% higher than the prior year [23] Business Line Data and Key Metrics Changes - U.S. Gas segment revenue totaled $197.7 million, a year-over-year decrease of 12.7%, with a gross profit margin declining to -7.5% from -1.8% [24][25] - Canadian Gas segment revenue was $39.8 million, down 2.9% year-over-year, but the segment margin improved to 17.8% from 7.5% [26] - Union Electric segment revenue increased by 7.1% year-over-year to $175.5 million, with core Union Electric segment growth of 32.7% [26] - Nonunion Electric segment revenue rose by 41.9% to $137.1 million, with gross profit margin increasing to 11.9% from 2.9% [27] Market Data and Key Metrics Changes - The U.S. Gas segment faced adverse weather conditions early in the year but showed improvement in March [20] - The nonunion electrical segment benefited from strong market trends in the Sunbelt and Southeast regions [21] Company Strategy and Development Direction - The company is focused on implementing a unified business development strategy aimed at high growth pipeline development and securing new awards [12][14] - The sales pipeline is approaching $12 billion in revenue opportunities, with a record booking quarter of $1.2 billion in Q1 2025 [15] - The company aims to enhance capital efficiency and reduce working capital levels to improve free cash flow [29] Management's Comments on Operating Environment and Future Outlook - Management does not anticipate significant impacts from the global trade war or tariffs in 2025, citing a resilient business model [8][30] - The outlook for full-year 2025 remains unchanged, with expectations to deliver between $2.6 billion and $2.8 billion in revenues [29][30] - Management expressed confidence in maintaining a positive trajectory across segments and delivering strong growth in upcoming quarters [22] Other Important Information - The company has made significant progress in enhancing its pipeline management and sales strategies [31] - The first quarter is typically the slowest period due to seasonal winter weather, but the company expects to see improved performance in subsequent quarters [22] Q&A Session Summary Question: Can you discuss the trajectory for 2025 despite the weaker Q1 in U.S. Gas? - Management noted that the gas business faced weather-related challenges in January and February but recovered in March and April, with expectations to meet budgeted performance for the year [35][36] Question: What were the key findings of the strategic review? - Key findings included the need for a fully integrated sales pipeline, improved cross-selling capabilities, a cultural shift towards identifying more work for customers, and aligning KPIs with growth and profitability [38][39][40][41] Question: How does the U.S. Gas segment's loss compare to expectations? - Management acknowledged that weather impacts profitability, but efforts are being made to migrate the business to regions less affected by adverse weather [45][46] Question: What is the visibility on bookings moving forward? - Management indicated strong visibility on bookings for Q2 and expects to achieve the 1.1 times book-to-bill target for the full year [48][49] Question: Can you clarify guidance on adjusted EBITDA? - Management confirmed that while they are cautious, the strong bookings and backlog are pushing towards the upper end of revenue guidance, with no expected margin erosion [54][56] Question: What is the risk profile of new MSAs? - Management stated that the new work aligns with existing services and does not change the risk profile, focusing on maintaining the same type of contracts with established customers [58][60] Question: What is the outlook for margins based on the strategic review? - Management indicated that no radical changes are needed to achieve full-year EBITDA margin guidance, as the backlog and expected bookings are on track [65][66]