Financial Data and Key Metrics Changes - The company reported total revenues of $197.1 million for Q1 2025, representing a year-over-year increase of 43% on an as-reported basis and 32% on an organic basis [7][29] - Adjusted non-GAAP EBITDA was $50.7 million, compared to $37.6 million in the prior year period, reflecting strong operational performance [33] - Adjusted non-GAAP EPS for the quarter was $1.70, up from $1.21 in the prior year [33] Business Line Data and Key Metrics Changes - Revenues from the rare disease segment were $69 million, up 87% from the prior year, driven by strong performance of Cortrophin Gel, which generated $52.9 million in revenues, a 43% increase [30][33] - The generics segment reported revenues of $98.7 million, an increase of 41% year-over-year, attributed to new product launches and strong execution in the base business [14][31] - Revenues from the brands portfolio were $25.1 million, a decrease of 2% from the prior year, indicating a return to more normalized demand levels [30] Market Data and Key Metrics Changes - The overall ACTH category grew 27% to approximately $684 million in 2024, with Cortrophin Gel capturing a significant share of new prescribers [9][10] - The company expects Cortrophin Gel revenues to increase by 34% to 38% in 2025, reaching $265 million to $274 million [10][36] - The retina products, ILUVIEN and YUTIQ, generated revenues of $16.1 million in Q1, with expectations of $97 million to $103 million for the full year [10][36] Company Strategy and Development Direction - The company is focused on expanding its rare disease business, particularly through Cortrophin Gel, and is investing in new clinical trials to support its growth trajectory [20][28] - A strategic emphasis is placed on enhancing market access for ILUVIEN and YUTIQ through specialty pharmacies and Medicare Part D options [23][24] - The company is committed to maintaining a strong U.S. manufacturing footprint, with over 90% of revenues coming from domestically produced goods [16][90] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of Cortrophin Gel, citing a significant unmet medical need and a large addressable market [19][20] - The company anticipates a return to sequential revenue growth in the latter half of 2025, following a modest decline in Q2 [36] - Management acknowledged challenges in the retina segment due to market access issues but remains optimistic about recovery and growth in the second half of the year [11][56] Other Important Information - The company raised its 2025 guidance for total revenues and adjusted non-GAAP EBITDA based on strong Q1 performance and favorable demand trends [7][36] - The company has a strong balance sheet with $149.8 million in unrestricted cash and a gross leverage ratio of 3.5 times [33][34] - The company is preparing for an upcoming trial against CG Oncology regarding a royalty obligation dispute [38][39] Q&A Session Summary Question: How much should the prefilled syringe help Cortrophin? - Management noted that early responses to the prefilled syringe have been positive, as it reduces administration steps, and they expect to update on its progress soon [44] Question: What gives confidence in accelerating ILUVIEN and YUTIQ sales? - Confidence is based on performance outside the U.S., improvements in the sales force, and positive April results from a bespoke commercial approach [54][56] Question: Can you elaborate on the commercial challenges impacting ILUVIEN? - Challenges stemmed from a lack of funding for co-pay support for Medicare patients, affecting access to therapy [62] Question: What indications are driving growth for Cortrophin? - Growth is seen across all specialties, with significant contributions from nephrology, rheumatology, and ophthalmology [88] Question: How does the company view the acquisition of Alimera? - Management remains confident in the long-term opportunity for ILUVIEN and YUTIQ, as evidenced by the recent buyout of a royalty obligation [82]

Core Insights - Castellum, Inc. reported its first year-over-year organic revenue growth as a listed company, with Q1 2025 revenue reaching $11.7 million, up from $11.3 million in Q1 2024 and $10.3 million in Q4 2024, indicating a significant operational turnaround [2][4]. Financial Performance - Revenue for Q1 2025 was $11.7 million, reflecting a year-over-year increase of 3.54% from $11.3 million in Q1 2024 and a quarter-over-quarter increase of 13.59% from $10.3 million in Q4 2024 [2][4]. - The company reported a reduced operating loss of $(1.1) million in Q1 2025, an improvement from $(4.0) million in Q1 2024 and $(1.6) million in Q4 2024, showcasing better cost management and operational efficiency [3]. - Castellum ended the quarter with a cash balance of $13.3 million, an increase from $12.3 million at the end of Q4 2024, highlighting its financial strength [3]. Strategic Developments - During the quarter, Castellum began executing a $103 million contract with the U.S. Navy for the PMA-290 program, which is expected to contribute positively to its 2025 performance [5][6]. - The contract win is seen as a strategic achievement that reinforces the company's business foundation and reflects its capabilities and customer trust [6].

Core Insights - TOMI Environmental Solutions, Inc. reported a 42% increase in revenue for Q1 2025 compared to the previous quarter, driven by strong demand for its product lines and recurring solution sales [2][3] - The company achieved a gross margin of 60.4%, slightly up from 60.2% in the prior year, and reduced its operating loss to $(754,000) from $(1,226,000) year-over-year [6] - Net loss decreased to $(256,000) or $(0.01) per share, compared to $(1,310,000) or $(0.07) per share in the same period last year [6] Financial Performance - Net sales for Q1 2025 were $1,577,000, up from $1,114,000 in Q1 2024, marking a significant year-over-year growth [6] - SteraMist product-based revenues increased to $1,000,000 from $743,000, reflecting a $257,000 rise due to heightened demand for various SteraMist solutions [6] - Service-based revenue also grew by 56%, reaching $577,000 compared to $371,000 in the prior year [6] Market Trends and Business Development - Domestic revenue surged by 80% to $1,192,000 from $662,000, attributed to increased demand for solutions and services [6] - The sales backlog as of March 31, 2025, was $1,225,000, an increase of $348,000 from December 31, 2024 [6] - A significant contract was secured for a SteraMist iHP Custom Engineered System at a university in Rhode Island, valued at approximately $450,000 [6] Strategic Partnerships and Expansion - TOMI announced the deployment of SteraMist iHP technology at NASA Johnson Space Center, indicating expansion into the aerospace sector [6] - An OEM partnership with Pharma Biotech System Components was established to enhance the SteraMist Integrated System [6] - The company is expanding into aquaculture with a new partner, Algafeed, further diversifying its market reach [7]

Core Viewpoint - Genie Energy Ltd. has demonstrated strong financial performance in Q1 2025, with significant revenue and net income growth, outperforming the broader market trends [1][2][3]. Financial Performance - Total revenues increased by 14.3% year over year to $136.8 million, up from $119.7 million, driven by a 17.8% rise in Genie Retail Energy segment revenues [2]. - Net income attributable to common stockholders rose 30.9% to $10.6 million, translating to diluted EPS of 40 cents, up from 30 cents in Q1 2024 [3]. - Non-GAAP net income increased 24.7% to $11.1 million, with non-GAAP EPS rising to 42 cents from 33 cents [3]. Operational Strength & Customer Growth - Genie Retail Energy reported net additions of over 48,000 meters, ending the quarter with 413,000 meters and 402,000 residential customer equivalents, reflecting increases of 13.3% and 15.6% respectively [4]. - The company maintained a customer churn rate of 5.5%, consistent with the previous year [5]. - Income from operations for Genie Retail Energy rose 18.2% year over year to $16.8 million, while adjusted EBITDA increased 17.1% to $17.1 million [6]. Renewables Segment Performance - Genie Renewables experienced a 40% year-over-year drop in revenues to $4.3 million due to exiting the commercial-scale solar project business [7]. - Despite the decline, Diversegy, the energy brokerage arm, saw a 55% increase in revenues, contributing significantly to the segment [7]. - Genie Renewables posted a loss from operations of $0.9 million, wider than the $0.6 million loss in Q1 2024, reflecting ongoing investments in utility-scale projects [8]. Management Insights & Strategic Direction - CEO Michael Stein noted the normalization of margins in the retail energy business and credited customer retention programs for maintaining churn rates [9]. - CFO Avi Goldin highlighted strong cash flow generation and disciplined cost management, with SG&A expenses rising only 4.3% year over year [10]. Guidance & Future Outlook - Management reaffirmed full-year adjusted EBITDA guidance of $40-$50 million, anticipating continued strength in Genie Retail Energy and contributions from the solar development pipeline [11]. Shareholder Returns & Financial Position - In the quarter, Genie Energy repurchased approximately 127,000 shares for $1.9 million and paid a quarterly dividend of 7.5 cents per share, returning a total of $3.9 million to shareholders [12]. - As of March 31, 2025, the company held $210.2 million in cash and marketable securities, up from $201 million at the end of 2024 [12].

Financial Data and Key Metrics Changes - Revenue growth in Q3 increased by 21% to $200.2 million compared to $166 million in the same quarter last year [21] - The company reported a net loss of $3.4 million or $0.12 per share, an improvement from a net loss of $14.6 million or $0.53 per share in Q3 of the previous year [23] - Adjusted EBITDA improved to breakeven in the quarter compared to a loss of $10 million in the same quarter last year [23] - Gross margin increased to $12.9 million or 6.4% in Q3, up from $5.6 million or 3.4% in the prior year [21] Business Line Data and Key Metrics Changes - Storage and Thermal Solutions segment revenue increased by 77% to $96.1 million compared to $54.3 million in the same quarter last year [24] - Utility and Power Infrastructure segment revenue rose by 27% to $58.7 million, benefiting from increased work volume [25] - Process and Industrial Facilities segment revenue decreased to $45.4 million from $65.6 million, primarily due to the completion of a large renewable diesel project [26] Market Data and Key Metrics Changes - The company’s backlog grew by nearly 8% sequentially to over $1.4 billion, with a book-to-bill ratio of 1.5 [18] - The U.S. LNG export demand is projected to increase by 45%, supporting elevated infrastructure spending [16] - The company has a $7 billion pipeline of project opportunities, indicating strong future growth potential [17] Company Strategy and Development Direction - The company is restructuring to create a more efficient organization, including eliminating senior-level positions and decentralizing business development [8][9] - The decision to exit the Northeast transmission and distribution service line was made due to competitive disadvantages and insufficient project awards [11] - The focus remains on delivering sustainable long-term shareholder value by building a resilient growth-oriented platform [12] Management Comments on Operating Environment and Future Outlook - Management noted that while macroeconomic uncertainties exist, the underlying demand environment remains strong [13] - The company revised its fiscal 2025 revenue guidance down by 10% to $770 million to $800 million, reflecting the impact of exiting the transmission and distribution business [15][31] - Management expressed confidence in achieving a sustainable and profitable growth trajectory moving into fiscal 2026 and beyond [17] Other Important Information - The company is actively collaborating with customers to find cost optimization opportunities and is optimizing its supply chain [14] - The company’s liquidity increased to $247.1 million, with zero debt, providing financial strength to support backlog execution [30] Q&A Session Summary Question: Can you walk us through the decision-making process to exit the transmission and distribution business? - Management indicated that competitive dynamics made it difficult to win work at acceptable margins, leading to the decision to wind down the business [35][36] Question: What are the potential cost savings from exiting that business? - The exit will result in cost savings and reallocation of resources to other segments, as the transmission and distribution business was operating at a loss [38] Question: Are the revenue adjustments due to deferrals or cancellations? - Management clarified that some revenue was deferred due to delays in contract awards, while some projects were still expected to move forward [39][40] Question: What is the opportunity profile for smaller projects as the company reengages in them? - Management emphasized the importance of smaller projects for building client relationships and strengthening execution teams, indicating a renewed focus on these foundational elements [42][43] Question: How might the geopolitical macroeconomic environment influence customer spending? - Management believes that despite uncertainties, the demand for energy infrastructure will continue to rise, supporting future business growth [50][52]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 increased by 21% to $200.2 million compared to $166 million in Q3 2024, driven by growth in storage and utility segments [21][31] - Gross margin improved to $12.9 million or 6.4% in Q3 2025 from $5.6 million or 3.4% in Q3 2024 [21][22] - The company reported a net loss of $3.4 million or $0.12 per share, an improvement from a net loss of $14.6 million or $0.53 per share in the same quarter last year [23] Business Line Data and Key Metrics Changes - Storage and Thermal Solutions segment revenue surged by 77% to $96.1 million in Q3 2025 from $54.3 million in Q3 2024, driven by specialty vessel projects [23][24] - Utility and Power Infrastructure segment revenue rose by 27% to $58.7 million compared to $46.1 million in the prior year, benefiting from natural gas peak shaving projects [25] - Process and Industrial Facilities segment revenue decreased to $45.4 million from $65.6 million, primarily due to the completion of a large renewable diesel project [26] Market Data and Key Metrics Changes - The company anticipates a 45% increase in U.S. LNG export demand, supporting elevated energy infrastructure spending [16] - The EIA projects an 8% increase in natural gas demand over the next six years, indicating strong growth potential in the electrical infrastructure market [17] Company Strategy and Development Direction - The company is restructuring to create a more efficient organization, including eliminating senior positions and decentralizing business development [8][11] - Matrix is winding down its Northeast transmission and distribution service line due to competitive disadvantages, while continuing to focus on electrical infrastructure services [12][13] - The strategic focus remains on delivering sustainable long-term shareholder value through a resilient growth-oriented platform [13] Management's Comments on Operating Environment and Future Outlook - Management noted macroeconomic uncertainties due to U.S. trade and environmental policies, but believes the underlying demand environment remains strong [14] - The company revised its fiscal 2025 revenue guidance down by 10% to $770 million to $800 million, while still expecting strong year-over-year growth [15][31] - Management expressed confidence in achieving a sustainable and profitable growth trajectory, supported by a $7 billion pipeline of project opportunities [17] Other Important Information - The company reported a backlog increase of nearly 8% sequentially to over $1.4 billion, with a book-to-bill ratio of 1.5 [18] - Cash flow from operating activities was $31.2 million for Q3 and $76.8 million year-to-date, with available liquidity increasing to $247.1 million [30] Q&A Session Summary Question: Can you walk us through the decision-making process to exit the transmission and distribution business? - Management indicated that competitive dynamics made it difficult to win work at acceptable margins, leading to the decision to wind down the business without a positive backlog [35][36] Question: What are the potential cost savings from exiting the business? - The exit will result in cost savings and reallocation of resources to the electrical instrumentation business, with the business operating at a loss previously [38] Question: Are the revenue guidance adjustments due to deferrals or cancellations? - Management clarified that some revenue was deferred due to delays in contract negotiations and project awards, but they expect strong spending on energy infrastructure in the coming years [39][42] Question: What is the opportunity profile for smaller projects as the company reengages in them? - Management emphasized the importance of smaller projects for building client relationships and strengthening execution teams, indicating a need to pursue these opportunities more effectively [43][44] Question: How might the geopolitical macroeconomic environment influence customer spending? - Management expressed confidence that despite uncertainties, the global demand for energy will continue to rise, supporting infrastructure investments [51][53]

Core Viewpoint - Sabre Corporation reported a break-even bottom line for Q1 2025, missing the earnings estimate of 1 cent per share, compared to a loss of 2 cents per share in the same quarter last year [1] Financial Performance - Sabre's revenues for Q1 2025 were $776.62 million, which was 1.77% below the Zacks Consensus Estimate and represented a 0.8% decline year over year [1] - The adjusted EBITDA for Q1 2025 was $149.6 million, an improvement from $142 million in the previous year, with an adjusted EBITDA margin of 19.3%, up 110 basis points year over year [6] Segment Performance - Travel Solutions segment revenues decreased by 2% year over year to $702.13 million, primarily due to lower air bookings and the impact of previously demigrated carriers [2] - Distribution revenues, a sub-division of Travel Solutions, fell by 0.5% to $569 million, affected by lower air bookings but partially offset by increased average booking fees and hotel distribution bookings [3] - IT Solutions revenues were $133 million, down 6% year over year, attributed to customer demigrations [4] - Hospitality Solutions segment revenues increased to $85.2 million from $78.8 million in the prior year, driven by positive customer deployments and CRS transaction growth [5] Cash Flow and Balance Sheet - At the end of Q1 2025, Sabre had cash, cash equivalents, and restricted cash of $672 million, down from $745.5 million in the previous quarter [6] - Cash used in operating activities was $81 million, resulting in a negative free cash flow of $98 million during the quarter [7] Guidance - For 2025, Sabre expects revenue growth in the high single digits, with the Zacks Consensus Estimate for revenues at $3.23 billion, indicating a year-over-year growth of 6.57% [8] - Adjusted EBITDA is forecasted to be approximately $630 million for 2025, with expectations of generating over $200 million in cash flow throughout the year [8] - For Q2 2025, Sabre anticipates revenue growth in flat to low single digits and an adjusted EBITDA of $140 million [9]

Financial Data and Key Metrics Changes - The company reported overall revenue growth of 18% in Q1 2025, driven primarily by Tyvaso DPI revenues [17][18] - Non-GAAP net income for Q1 2025 was $22 million, representing a 43% increase compared to the same period in 2024 [20] - Net income for Q1 2025 was $13 million, a 24% increase from $11 million in Q1 2024 [19] Business Line Data and Key Metrics Changes - The endocrine business experienced a 20% growth in new prescriptions (NRxs) and a 14% growth in total prescriptions (TRxs) [4] - Tyvaso collaboration generated $30 million in royalty revenue and $29 million in manufacturing revenue for Q1 2025 [5][18] - Afrezza net revenues increased by 3% year-over-year to $15 million, although impacted by one-time adjustments and shipment timing [18] Market Data and Key Metrics Changes - The orphan lung opportunity market is projected to exceed $1 billion by the end of the decade, with a focus on the US and Japan [9] - The company anticipates significant revenue potential from pediatric patients, estimating that a 10% market share could yield $150 million in net revenue [22] Company Strategy and Development Direction - The company is focusing on expanding its pediatric market strategy for Afrezza, which will differ significantly from the adult market approach [65] - The strategy includes leveraging positive clinical data and enhancing educational outreach to healthcare providers [62][64] - The company aims to maintain a strong financial position with minimal debt while pursuing growth opportunities in its pipeline [3] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Afrezza, particularly with the anticipated pediatric indication approval [17][21] - The company is optimistic about the upcoming catalysts, including the completion of key trials and potential new product launches [21][24] - Management acknowledged the challenges posed by the macroeconomic environment but believes the company is well-positioned to navigate these headwinds [86] Other Important Information - The company has activated 85% of its sites for the MannKind 101 study across four countries, with 55 patients randomized and minimal dropouts [12] - The company is preparing for several upcoming scientific conferences to present new data and engage with the medical community [24] Q&A Session Summary Question: Can you provide initial thoughts on the Phase 2/3 trial design for MannKind 201? - Management indicated that discussions with the FDA are ongoing and that the trial design will likely involve several dose arms compared to placebo [28][30] Question: Are you looking to measure FVC in the IPF study? - Management confirmed that they are considering multiple doses and will analyze the data for a delta from placebo [34][35] Question: What is the rationale behind the label update for adults? - Management explained that the update aims to improve dosing efficiency and enhance adult uptake, with a focus on scaling faster [44][45] Question: How do you see the treatment landscape evolving for IPF? - Management noted the challenges in treating IPF and emphasized the potential for their inhaled therapies to provide better tolerability and efficacy [52][54] Question: How is the company managing supply chain impacts? - Management stated that the majority of manufacturing is US-based, minimizing tariff impacts, and they are confident in managing supply chain challenges [46][48]

Financial Data and Key Metrics Changes - The company achieved record total net revenue of $52.6 million for the first quarter, with MACI revenue of $46.3 million, Epicel revenue of $5 million, and NexoBrid revenue of $1.3 million [13] - MACI revenue grew by 15% year-over-year, which adjusts to approximately 17% growth when accounting for one fewer selling day in the quarter [14] - NexoBrid revenue increased by 207% year-over-year and 31% sequentially [14] - The net loss for the quarter was $11.2 million, or $0.23 per share, with non-GAAP adjusted EBITDA of $3.2 million, representing 6% of net revenue [16] Business Line Data and Key Metrics Changes - MACI had a strong quarter with record revenue exceeding $46 million, driven by strong underlying fundamentals and a growing surgeon customer base [6][5] - NexoBrid's revenue growth was significant, with over 200% increase compared to the previous year, indicating strong market penetration [10] - Epicel revenue was lower than anticipated due to a high percentage of canceled cases, but there was a strong start to the second quarter with graft volumes exceeding the first quarter [11][12] Market Data and Key Metrics Changes - The company expects total revenue growth of 22% to 25% for the second quarter, with MACI revenue projected to be approximately $54 million [18] - The addressable market for MACI is estimated at 60,000 patients annually, with significant opportunities in femoral condyle and trochlear defects [26][20] Company Strategy and Development Direction - The company is advancing the MACI Ankle Development Program and plans to initiate a Phase III clinical study in the second half of the year, which represents a substantial long-term growth driver [20] - The company plans to expand its MACI sales force in the second half of the year to support growth driven by MACI Arthro [10][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about strong second quarter performance based on positive trends observed in the first quarter, reaffirming full-year revenue guidance of 20% to 23% growth [5][17] - The company anticipates minimal impact from tariffs due to its domestic manufacturing and significant safety stock of materials [17] Other Important Information - The company generated $6.6 million in operating cash flow and ended the quarter with approximately $162 million in cash and no debt [16] - Management raised profitability guidance for the year, expecting gross margins to reach 75% and adjusted EBITDA margins to reach 26% [18] Q&A Session Summary Question: Can you discuss the market opportunity for femoral condyle and trochlear specifically? - Management indicated that the MACI Arthro instruments are designed for femoral condyle defects, which represent a significant portion of the addressable market, and there is potential for treating trochlear defects as well [26][27] Question: How do you see seasonality and pacing for MACI in the second half of the year? - Management noted that while MACI typically follows a prescriptive pattern, strong leading indicators suggest potential for stronger growth in the second half of the year [32][33] Question: What is the contribution of MACI Arthro to first quarter numbers? - Management acknowledged that while there was some incremental impact from MACI Arthro, the full effect is expected to be seen in the second half of the year [38][40] Question: How have recent trade war headlines impacted international views on MACI? - Management stated that they are evaluating potential for MACI outside the U.S. but will consider tariffs and trade impacts before making decisions [92] Question: Can you provide insights on conversion rates for MACI Arthro procedures? - Management indicated that it is early to assess conversion rates, but they expect higher rates over time due to the less invasive nature of the procedure [57][66] Question: What are the dynamics of cross-selling opportunities between Epicel and NexoBrid? - Management confirmed that they are seeing biopsies from previously dormant accounts and expect this trend to continue as they cross-sell products [61] Question: Can you elaborate on the sales force expansion plans? - Management indicated that while the expansion is not full-scale this year, they are preparing to add resources to support expected growth [80][81]

Financial Data and Key Metrics Changes - Total revenue grew 22% year over year to $106.5 million in Q1 2025, driven by increased sales for VivGuard, Zejula, and NUZYRA [29][30] - Operating loss improved by 20% to $56.3 million, and adjusted loss from operations decreased by 25% to $37.1 million [16][30] - The company reaffirmed its full-year revenue guidance of $560 million to $590 million, anticipating significant sales growth in the latter part of the year [8][30] Business Line Data and Key Metrics Changes - VivGuard sales are expected to grow faster than total revenue growth, with a rebound in patient volumes observed in March and April after a seasonal decline [12][36] - Other products, including Zejula and NUZYRA, delivered sequential growth supported by NRDL access, with early contributions from OGTYRO and ZACDURO [15] - The company is preparing for upcoming NRDL cycles targeting IV renewal for gMG and initial listing of the SC formulation [14] Market Data and Key Metrics Changes - The company noted a significant opportunity in the gMG market in China, with approximately 70,000 patients, and less than 10% currently receiving newer biologic therapies [63] - The competitive landscape for gMG is expected to benefit from the introduction of new therapies, which will enhance overall market education and treatment options [63] Company Strategy and Development Direction - The company aims to expand its global R&D pipeline, with a focus on differentiated and high-potential assets, including GL1310 and other novel therapies [9][10] - Investments are being made to accelerate the global R&D pipeline, with plans to present updated Phase I data at ASCO [10][20] - The company is committed to achieving profitability by Q4 2025, leveraging operational efficiencies and a robust late-stage opportunity pipeline [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and surpassing $2 billion by 2028, with strong momentum expected to carry into the 2030s [9] - The management team highlighted the importance of strategic initiatives to extend treatment duration and improve patient access [12][14] - The company remains optimistic about its financial position, ending Q1 with a cash position of $857.3 million [31] Other Important Information - The company is advancing its internal pipeline while also considering external opportunities for in-licensing [102][103] - Regulatory discussions with the FDA are ongoing, with no significant changes noted in the approval process despite recent leadership changes at the FDA [53][105] Q&A Session Summary Question: Can you provide more color on VIBGART's sequential change? - Management indicated that the sequential decline was influenced by seasonality and inventory dynamics, with confidence in recovery based on strong patient volumes in April [33][36] Question: Are you comfortable with consensus estimates for VIBGART and fiscal year revenues? - Management reaffirmed their revenue guidance and expressed confidence that VIBGART sales would grow faster than overall business rates [42][44] Question: How do recent FDA changes impact Zai Lab? - Management noted no anticipated impact from tariffs and indicated that FDA interactions have remained productive [50][53] Question: What is the competitive landscape for gMG in China? - Management believes that new approvals will benefit the market and enhance treatment options for patients [63] Question: What is the strategy regarding in-house developed assets? - The company plans to maintain a balanced approach between in-house development and external licensing opportunities [102][103]