Scholar Rock (NasdaqGS:SRRK) Conference Call Summary Company Overview - **Company**: Scholar Rock - **Focus**: Development of Apitegromab for the treatment of spinal muscular atrophy (SMA) Key Points Regulatory Updates - Scholar Rock has resubmitted its Biologics License Application (BLA) for Apitegromab to the FDA, aiming to expedite access for SMA patients [4][10] - The previous approvability issue was related to observations from a routine inspection at the Catalent Indiana facility, which is owned by Novo Nordisk [4][6] - The resubmission includes both the Catalent Indiana facility and a second fill-finish facility, providing multiple paths to FDA approval [8][9] - The anticipated review period for the resubmission is up to six months, with a PDUFA date expected in late September 2026 [9][10] Clinical and Market Potential - Apitegromab is positioned to be the first muscle-targeted treatment to improve motor function in SMA, addressing significant unmet needs in the patient community [5][15] - The company is preparing for a U.S. launch and anticipates a mid-2026 decision from the European Medicines Agency (EMA) for its Marketing Authorization Application (MAA) [10][14] Supply Chain and Manufacturing - The inclusion of a second fill-finish facility in the BLA is intended to strengthen the supply chain and support growing demand [7][8] - Scholar Rock is confident in the readiness of both facilities, with commercial Apitegromab expected to be available several months before the PDUFA date [9][68] - The company has made significant progress in preparing the second facility, which is already in good standing with the FDA [52][64] Pricing Strategy - Pricing discussions are ongoing, with considerations for the rarity and severity of SMA, as well as the compelling clinical data supporting Apitegromab [26][88] - The company aims to establish a pricing strategy that reflects the unique value of Apitegromab while ensuring broad access for patients [58][89] Competitive Landscape - The discontinuation of a competitor's myostatin program may enhance Scholar Rock's market position, as it is the only company with a successful therapy targeting myostatin [85][88] - The company is focused on maintaining a robust supply chain to meet the needs of the SMA community across 50 countries [25][97] Financial Considerations - Scholar Rock has a solid cash position and anticipates minimal incremental cash burn leading up to approval [86] - The company is prepared for the financial implications of the launch, including potential revenue from a Priority Review Voucher (PRV) upon approval [86] Additional Insights - The management team expressed gratitude for the collaborative efforts with the FDA and Novo Nordisk, emphasizing the urgency to bring Apitegromab to patients [15][20] - The company is committed to transparency and ongoing communication with stakeholders regarding the progress of the BLA and market readiness [75][78] This summary encapsulates the critical updates and strategic insights from Scholar Rock's recent conference call, highlighting the company's commitment to addressing the needs of SMA patients through innovative therapies and robust regulatory engagement.

Financial Data and Key Metrics Changes - For the full year 2025, the loan facilitation volume reached RMB 129 billion, a year-on-year increase of approximately 28% [4] - Revenue for 2025 was RMB 6.22 billion, up approximately 7.3% year-on-year, while net income was RMB 1.54 billion, reflecting a year-on-year increase of approximately 45.4% [4] - In Q4 2025, loan facilitation volume was RMB 24.2 billion, a decrease of 12.6% from Q4 2024, with net revenue at RMB 1,090.2 million, down 22.4% year-on-year [17][18] - The net margin for Q4 2025 declined to 9.2% from previous levels due to short-term pressures on profitability [33] Business Line Data and Key Metrics Changes - The company added approximately 407,000 new borrowers in Q4 2025, reflecting a year-on-year decline [5] - Repeat borrowing contributed 79.4% of loan facilitation volume, an increase of 6.7 percentage points compared to the same period last year [5] - The 90+ day delinquency ratio was 2.03% at the end of Q4 2025, indicating ongoing risk management challenges [7] Market Data and Key Metrics Changes - The facilitation volume in Indonesia increased by approximately 187% year-on-year, while registered users grew by approximately 119% year-on-year [10] - The total loan facilitation volume for the full year grew approximately 105% year-on-year, with registered users up approximately 110% year-on-year [11] Company Strategy and Development Direction - The company is focusing on compliance as a foundation and innovation as an engine to solidify its technological base and build resilience against cyclical fluctuations [16] - The 4+2 strategy will undergo a key upgrade in 2026, reorganizing core pillars into production and non-production tracks to enhance operational efficiency [8][9] - The company aims to deepen its localization strategy in overseas markets while expanding partnerships with local financial institutions [41] Management's Comments on Operating Environment and Future Outlook - Management noted that 2025 was marked by deepening regulation and standardized development, impacting the external environment [4] - The company expects loan facilitation volume for Q1 2026 to be between RMB 18.5 billion and RMB 19.5 billion, maintaining a cautious approach amid ongoing uncertainty [16][36] - Management expressed optimism about early signs of stabilization and improvement in asset quality following several quarters of rising risk [35] Other Important Information - The company completed cash dividend distributions totaling $41.1 million in 2025, representing an increase of over 50% year-on-year [15] - The company has established a volunteer service team that has grown to 120 members, completing 28 activities and accumulating nearly 3,800 hours of service [13][14] Q&A Session Summary Question: Trends in risk metrics and customer acquisition strategy - Management indicated that risk levels peaked in November 2025 and began to decline in December, leading to a more selective approach in customer acquisition [22][24] - The structured risk management approach has improved risk metrics by approximately 25%-30% [28] Question: Expectations for growth amid regulatory tightening - Management reported a total facilitation volume of RMB 129 billion for 2025, with revenue and net profit reaching RMB 6.2 billion and RMB 1.54 billion respectively [31] - The company anticipates continued pressure on profitability due to declining pricing and risk metrics but believes it is well-positioned for moderate growth in the medium to long term [35]

Financial Data and Key Metrics Changes - T1 Energy ended 2025 with improved liquidity and a fully ramped factory that met production targets, raising over $440 million in the fourth quarter to support growth initiatives [21][22] - The equity market capitalization expanded by more than 11 times from spring lows to year-end, reflecting strong investor confidence [21] - Net sales were $16 million lower than expected due to inventory sales tied to regulatory changes, and $22.7 million lower due to customer offtake true-ups [23][24] Business Line Data and Key Metrics Changes - T1 produced a total of 2.79 GW of solar modules in 2025, meeting the annual production target [13] - The G1 Dallas facility achieved record production and sales in Q4, with quarterly production and sales surpassing 1 GW for the first time [9][11] - The company is maintaining production and sales targets of 3.1-4.2 GW for G1 in 2026, with expectations for improved margin performance [11][14] Market Data and Key Metrics Changes - T1 is in discussions for nearly 13 GW of merchant sales opportunities and over 10 GW of advanced offtake pursuits from major U.S. utilities and developers, totaling a market opportunity of 41 GW [20] - The company anticipates higher indicative pricing in the merchant market, which could lead to declining production costs [11] Company Strategy and Development Direction - T1's strategy focuses on building a fully integrated domestic solar supply chain in the U.S., with the G2 Austin solar cell fab as a key component [4][19] - The company plans to stack additional EBITDA streams through organic and inorganic opportunities while executing core objectives [4][12] - T1 aims to enhance profitability and capital structure by driving efficiencies at G1 Dallas and optimizing production costs [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in T1's ability to navigate the bridge year to G2, with expectations for significantly better operations in 2026 [25][26] - The company is optimistic about the implications of recent industry developments, including Elon Musk's announcements regarding domestic solar capacity, which could create additional momentum for T1 [31][32] - Management highlighted the importance of U.S. energy independence and the role of solar in meeting rising electricity demand [33] Other Important Information - T1 completed a series of transactions to preserve eligibility for Section 45X tax credits and validated the ability to monetize these credits [8] - The company is actively marketing its legacy European assets, with significant interest from potential partners [48] Q&A Session Summary Question: Update on remaining raise for phase one - Management confirmed confidence in closing the remaining $350 million in April, emphasizing the importance of selecting the right capital sources [40][41] Question: Customer situation and new contracts - Treaty Oak was confirmed as a new customer, while others remain confidential; management is optimistic about securing additional contracts [43][44] Question: European assets and potential cash raise - Management is exploring full divestment or partnership options for legacy assets in Norway and Finland, with a robust market for power pricing [46][48] Question: Shift in IP to EverVolt and margins - Management clarified that the licensing agreement with EverVolt does not involve tariffs and is expected to enhance compliance and reduce risks [53][56]

Financial Data and Key Metrics Changes - The company reported record revenue of $49.6 million for Q4 2025, an 8% increase year-over-year, and full-year revenue of $182.9 million, up 21% from the previous year [3][4] - A net loss of $88.4 million was recorded for Q4, compared to a net loss of $2.1 million in the prior year, primarily due to a non-cash goodwill and intangible impairments charge of $91.8 million [3][10] - Adjusted EBITDA for Q4 was $4.6 million, representing a 9.3% margin, which was below the near-term expectation of 12% due to lower sports betting margins and higher marketing costs [4][11] Business Line Data and Key Metrics Changes - Meridianbet generated $35.2 million in revenue for Q4, a 15% increase year-over-year, and accounted for 68% of total company revenue with a gross margin of approximately 70% [6][17] - Expanse Studios experienced significant growth, with revenue increasing 435% year-over-year in Q4, and the operator network expanding from 184 to 1,344 sites [19] - The RKings and Classics for a Cause segment delivered revenue of $43.8 million in 2025, up 35% year-over-year, but saw a decline in new registrations due to a strategic shift towards higher value users [20] Market Data and Key Metrics Changes - Meridianbet's registrations grew 72% year-over-year to 1.2 million, with active users up 35% and depositors growing 40% [17] - The company operates in 18 licensed markets, with significant growth potential in existing jurisdictions through increased market share and brand awareness [16] Company Strategy and Development Direction - The company aims to focus on organic growth investments in core markets, continued debt management, and potential strategic M&A opportunities [12] - Meridianbet's strategic priorities include scaling operations in Brazil, expanding AI capabilities, and pursuing licensing opportunities in high-growth regions [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2026 with a strong balance sheet and operational discipline, emphasizing the importance of delivering on guidance and maintaining clarity in communication [4][22] - The company anticipates approximately $50 million in revenue for Q1 2026, representing a 17% growth from 2025, and $6.1 million in adjusted EBITDA, a 9% growth from the previous year [4][22] Other Important Information - The rebranding to Meridian Holdings is complete, aligning the corporate identity with the most recognized brand [4] - The impairment charge recognized was due to a sustained decline in the company's share price, which triggered an interim quantitative impairment test [9][10] Q&A Session Summary Question: What are the expectations for revenue growth in 2026? - The company expects Meridianbet's revenue to climb approximately 25% in Q1 2026 compared to Q1 2025, driven by strong user acquisition and market penetration [18] Question: How is the company addressing the decline in new registrations in the RKings segment? - The decline is part of a deliberate shift in acquisition strategy towards higher value users, with expectations of reversing this trend to growth in Q1 2026 [20]

Financial Data and Key Metrics Changes - As of December 31, 2025, the company held approximately EUR 230.9 million in cash equivalents and short-term deposits, bolstered by significant financing events in 2025, including EUR 108 million from structured financing and EUR 139.4 million from a public offering [13][14] - R&D expenses for the full year were EUR 87 million, reflecting the prioritization of the pipeline, while G&A expenses totaled EUR 47.9 million, including EUR 20.3 million in non-cash share-based compensation [14][15] Business Line Data and Key Metrics Changes - The company has focused all resources on lanifibranor and MASH, selling global rights to odiparcil for up to $90 million in potential milestone payments and royalties [4] - The NATiV3 trial, a pivotal phase III clinical trial, completed enrollment in April 2025 with over 1,000 patients, exceeding original targets [12] Market Data and Key Metrics Changes - An estimated 18 million people in the U.S. live with MASH, with only about 10% diagnosed, a 25% increase from 2024 estimates [6] - Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a treating physician [6] Company Strategy and Development Direction - The company aims to advance lanifibranor towards approval for patients with MASH, with a top-line readout expected in Q4 2026 [3] - The strategic decision to concentrate resources on lanifibranor is expected to enhance the company's operational focus and market readiness [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that if the NATiV3 trial replicates the 18% fibrosis improvement seen in phase II, lanifibranor could be positioned as a leading oral therapy for MASH [7] - The company is preparing for commercialization in anticipation of potential approval, with a focus on addressing the unmet medical needs in the MASH patient population [5][16] Other Important Information - The company has strengthened its leadership team to align with the demands of the opportunity presented by lanifibranor [5] - The anticipated top-line readout in Q4 2026 is viewed as a significant inflection point for both the company and patients with MASH [16] Q&A Session Summary Question: Can you update us on the performance of the trial in terms of dropouts? - The dropout rate is below 30%, which was the threshold set for the trial, and the trial is well-powered to detect the primary endpoint [22][24] Question: How are you thinking about the performance of the 800 versus the 1200 milligram dose? - The 800 mg dose may catch up to the 1200 mg dose over time, and both doses are expected to have strong efficacy with potentially different tolerability profiles [25][26] Question: What are your expectations for the overall market interest? - The company believes that replicating an 18% effect on fibrosis would provide a strong market opportunity, especially in the F3 diabetic patient population [20] Question: What quality control protocols are in place for analyzing biopsy samples? - The clinical team has extensive experience in NASH trials, ensuring quality control at various stages of the biopsy process [31][33] Question: What is the expected effect size for the primary endpoint in NATiV3? - The trial is powered to over 90% on a primary endpoint of composite fibrosis improvement and MASH resolution, with a conservative view on effect size compared to phase II data [38][39] Question: How do you view the overlap of MASH and type 2 diabetes? - There are approximately 18 million patients with undiagnosed MASH in the U.S., with a significant portion also having diabetes, indicating a robust market opportunity [72][73] Question: What steps are being taken for regulatory and commercial readiness? - The regulatory team is fully staffed, and the company is focused on strategic commercial execution, preparing for a potential launch following positive trial data [105][106]

Investor Presentation March 2026 Safe harbor statement Statements in this presentation regarding TD SYNNEX that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are inherently uncertain, and stockholders and other potential investors must recognize that actual results may differ materially from TD SYNNEX expectations as a result of a variety of fact ...

Financial Data and Key Metrics Changes - Revenue for fiscal year 2025 was $229 million, up 72% year-over-year [28] - Operating loss for fiscal year 2025 was $150 million, compared to an operating loss of $28 million in 2024 [28] - Net loss for 2025 was $209 million, or $0.38 loss per share, compared to a net loss of $7 million, or $0.02 loss per share in 2024 [28] - Adjusted EBITDA for 2025 was $29 million, down from $31 million in 2024 [29] Business Line Data and Key Metrics Changes - The company has shifted focus entirely to North American HPC infrastructure development, moving away from Bitcoin mining [4][5] - The decision to focus on colocation rather than GPU rental was made based on increased customer demand for leasing megawatts [8][39] Market Data and Key Metrics Changes - The company has secured over 2 gigawatts in its pipeline, positioning itself as a regional leader in high-demand markets [6][13] - The demand for power and land for AI infrastructure is expected to remain high, with significant barriers to entry in the markets of Pennsylvania, Washington, and Quebec [13][14] Company Strategy and Development Direction - The company is rebranding as Keel Infrastructure, emphasizing its role as an infrastructure developer for HPC and AI [5][11] - The strategy includes a disciplined exit from Bitcoin mining, with plans to reinvest capital into HPC and AI infrastructure [12][23] - The company aims to complete permitting and lease execution in 2026, with revenue generation expected to commence in 2027 [12][84] Management's Comments on Operating Environment and Future Outlook - Management believes that the demand for power will remain a structural bottleneck for AI infrastructure deployment in the coming years [15] - The company is confident in its ability to execute its development plans and deliver value to shareholders [24][35] Other Important Information - The company successfully raised $588 million in a convertible offering, significantly enhancing its liquidity [30] - The current cash position stands at $520 million, providing flexibility for advancing development projects [32] Q&A Session Summary Question: What were the major drivers for the decision to focus on colocation instead of GPU rental? - The decision was based on increasing customer conversations indicating that the best opportunity is to remain a pure play infrastructure developer and owner [39] Question: Can you update on the lease execution strategy and potential timing? - The strategy remains consistent, focusing on securing the best terms for leases to maximize shareholder value [40][41] Question: What permits are still pending at the various sites? - Permitting is a complex process with progress being made across multiple sites, with expectations to achieve full permitted status in the coming months [46][47] Question: Can you clarify the sequencing between notice to proceed and lease execution? - Customers are likely to want notice to proceed before committing to a lease, particularly investment-grade counterparties [56] Question: What is the timeline for data center construction and revenue generation? - Revenue generation is expected to commence in 2027, with all three projects anticipated to come online and start delivering megawatts [84]

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Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and short-term investments increased to $59.9 million from $44.1 million in 2024, while current liabilities decreased slightly to $5.1 million from $5.4 million [16] - Net cash used in operating activities rose to $29.1 million in 2025 from $22.1 million in 2024, primarily due to an increase in net loss [17] - Research and development expenses increased to $24.6 million in 2025 from $19.1 million in 2024, driven by the continuation and global expansion of the ReMEDy2 clinical trial [17][18] Business Line Data and Key Metrics Changes - The preeclampsia program showed significant progress with positive interim results from a phase II trial, indicating DM199's potential to reduce blood pressure and improve blood flow to the placenta [5][6] - The stroke program, ReMEDy2, achieved nearly 70% enrollment of the required 200 participants for interim analysis, with 61 active sites globally [12][13] Market Data and Key Metrics Changes - The company is expanding its clinical trials into the U.K. and Europe, indicating a broader market reach for DM199 [13][10] - Regulatory clearance from Health Canada for a global phase II clinical trial of DM199 in early onset preeclampsia marks a significant milestone for the company [9] Company Strategy and Development Direction - The company aims to position DM199 as a first-in-class disease-modifying therapy for preeclampsia and other vascular-related conditions, focusing on improving patient outcomes through innovative treatment approaches [5][7] - Plans to initiate a global phase II study for early onset preeclampsia are underway, with a focus on patient safety and efficacy [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash position, anticipating it will fund clinical studies and operations through the end of 2027 [16] - The management highlighted the importance of DM199's safety profile, which is expected to facilitate broader use in community hospitals and academic centers upon approval [48] Other Important Information - The company is evaluating alternative animal models for reproductive toxicology studies in response to FDA requests, indicating ongoing regulatory engagement [11][26] - A recent publication in the Journal of Hypertension underscores the need for new treatment approaches for resistant hypertension, further validating DM199's potential [14] Q&A Session Summary Question: Update on rabbit preclinical trials for U.S. IND approval - Management is in discussions with the FDA regarding appropriate preclinical models and will provide updates once discussions are finalized [21][26] Question: Key learnings for early onset preeclampsia cohort - Management plans to use subcutaneous administration for early onset studies and is focused on selecting sites experienced in managing preeclampsia [27][28] Question: Risk of DM199 crossing the placental barrier - Management believes DM199 will not cross the placental barrier based on previous studies, with the protein size being significantly larger than the threshold for crossing [33] Question: Enrollment challenges in the ReMEDy2 trial - Enrollment has been slower due to staffing challenges at certain sites, but recent support and hiring are expected to accelerate enrollment [40] Question: Commercialization access for DM199 - Management believes the safety profile of DM199 will facilitate broad use in both small community hospitals and large academic centers [48]

2025 Sustainability Performance Diana SCHILLAG, Executive Committee Member, Group General Secretary, notably supervising Sustainability and Healthcare Louis-François RICHARD, Group VP Head of Sustainability Guillaume DE SMEDT, Deputy Group VP Sustainability Paris, March 31, 2026 ©Air Liquide - Adrien Daste THIS DOCUMENT IS PUBLIC 2025 Sustainability Performance - March 31, 2026 Agenda Q&A 2 THIS DOCUMENT IS PUBLIC 2025 Sustainability Performance - March 31, 2026 Environment: all objectives reached or exceed ...