Company Overview and Financial Performance - Vericel is a leader in advanced therapies in sports medicine and burn care, combining innovations in biology with medical technologies[5] - The company has a strong financial profile with ~$162 million in cash and investments[9] - Vericel achieved GAAP Net Income positive in 2024[9] - The company is driving high revenue growth and targets high-70% gross margin and high-30% adjusted EBITDA in the mid-term[17] - The company experienced 20% top-line growth in 2024 and expects continued high revenue growth in 2025 and beyond[18] Market Opportunity and Product Expansion - The total addressable market (TAM) opportunity is expanding to over $5 billion in the years ahead[10] - The core TAM is ~$4 billion, with an expanded TAM of ~$5 billion[11, 12] - MACI Arthro, launched in Q3 2024, targets the largest segment of the current MACI addressable market[9] - MACI Ankle study is anticipated to initiate in 2025, potentially increasing the total MACI addressable market to $4 billion[9, 53] - NexoBrid, launched in the U S in Q4 2023, significantly expands the total addressable market in burn care[9]

INCA033989 Clinical Trial Results and Safety - INCA033989 demonstrated a favorable safety profile in ET patients, with only 1 out of 49 patients discontinuing therapy due to treatment-emergent adverse events [101, 135] - INCA033989 led to rapid and sustained normalization of platelet counts in previously treated ET patients [105, 135] - Hematologic responses were achieved early and sustained, with 86% of patients receiving ≥400 mg achieving a response [113, 115] - A reduction in peripheral blood mutCALR VAF was observed in 89% (34/38) of evaluable patients, correlating with hematologic responses [119, 120, 135] - Biomarker analysis supports a reduction in mutCALR stem/progenitor cells and megakaryocytes in patients achieving a hematologic response [121, 127, 135] INCA033989 Mechanism and Preclinical Data - INCA033989 is a high-affinity mutant CALR selective monoclonal antibody that selectively inhibits constitutive JAK/STAT signaling induced by mutCALR [94] - INCA033989 directly inhibits mutCALR+ CD34+ HSPCs and megakaryocytes, without affecting non-mutated, healthy cells [94] - In a mutCALR conditional knock-in mouse model of established MPN, INCA033989 treatment led to platelet normalization, reversal of anemia, and elimination of megakaryocyte hyperplasia in the bone marrow [90, 94] Essential Thrombocythemia (ET) and Unmet Needs - CALR mutations account for 25% of Essential Thrombocythemia cases [19] - Current ET treatments aim to reduce disease-associated risks but do not impact the natural history [26] - There is an unmet need for disease-modifying therapies in ET [25, 43] Future Development Plans - A registrational trial in ET is planned to be initiated by early 2026 [137]

Anito-cel Product Profile and Clinical Data - Anito-cel, a BCMA-directed CAR T-cell therapy, utilizes a novel D-Domain binder, potentially offering a best-in-class efficacy profile, differentiated safety, and rapid manufacturing[7, 8, 9, 15] - Phase 1 data showed a median Progression-Free Survival (PFS) of 30.2 months[17] - In the iMMagine-1 pivotal trial, the Overall Response Rate (ORR) was 97%, with a stringent Complete Response/Complete Response (sCR/CR) rate of 68%[92] - iMMagine-1 demonstrated a 6-month PFS rate of 91.9% and a 12-month PFS rate of 79.3%[98] - iMMagine-1 showed a favorable safety profile, with 85% of patients experiencing < Grade 1 Cytokine Release Syndrome (CRS) and 92% experiencing no Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)[17, 108, 118] Market Opportunity and Commercial Strategy - The Multiple Myeloma (MM) CAR T market is projected to reach approximately $12 billion in the 2L+ setting[7, 19, 21, 55, 61] - Arcellx anticipates a high gross margin of ≥70% at launch for anito-cel, with profitability achievable before reaching $1 billion in anito-cel sales[51, 55] - Post-approval, 90% of US Healthcare Professionals (HCPs) are motivated to prescribe anito-cel[30] - Anito-cel is expected to launch with a large Authorized Treatment Center (ATC) network, projected to be 160+ ATCs, leveraging Kite's infrastructure[17, 33, 62] - Payer coverage for anito-cel is projected to be >80% of US lives within 30 days and >90% within 90 days post-launch[45]

SGR-1505 Development & Rationale - Schrödinger's computational platform aims to improve drug discovery success rates by accurately calculating molecular properties [8, 10] - MALT1 is identified as a key regulator of NF-κB signaling in B-cells and T-cells, making it a potential target for B-cell malignancies where BTK inhibitor resistance develops [18] - The company rapidly designed SGR-1505, a best-in-class MALT1 inhibitor, by modeling 8.2 billion compounds and synthesizing 78 in the SGR-1505 series within 10 months [21] Phase 1 Clinical Trial Results - The Phase 1 study of SGR-1505 showed a favorable safety profile and was well-tolerated in patients with relapsed/refractory B-cell neoplasms [36, 42] - Approximately 43% of patients experienced treatment-related adverse events (TRAEs), and there were no dose-limiting toxicities or deaths due to treatment-emergent adverse events (TEAEs) [44] - SGR-1505 demonstrated strong target engagement, with ~90% inhibition of IL-2 in the majority of PD-evaluable patients treated at ≥150 mg QD and all Q12H doses at steady state [47] - Encouraging preliminary efficacy was observed across a range of B-cell malignancies, including monotherapy signals in CLL and Waldenström macroglobulinemia (WM) [36, 49] Market Opportunity & Future Steps - There is a potential MALT1 opportunity in higher-risk CLL patients, as well as in relapsed/refractory lymphoma where resistance to BTK agents has emerged [29, 60, 67] - The company plans to discuss the recommended Phase 2 dose with the FDA later this year [57] - Preclinical data suggests that combining SGR-1505 with BTK and/or BCL-2 inhibitors may lead to deeper anti-tumor activity [66] - Ibrutinib, a BTK inhibitor, has achieved $10.9 billion in sales, indicating a significant market for B-cell malignancy treatments [68]

Financial Performance & Growth - The company delivered profitable revenue growth, maintaining a "+40% Rule Of" since its IPO in 2021[16] - The company's core business is strong and growing, with a 17% growth in the first half of 2025[19, 283] - Q2 2025 revenue is expected to grow approximately 17% year-over-year, with revenue between $180 million and $184 million[267] - The company's adjusted EBITDA for FY 2025 is expected to be between $52 million and $56 million, with a margin of approximately 32%[267] Platform & Product Innovation - The company is expanding into media optimization and performance measurement via the DV Media AdVantage Platform (MAP), expanding its total addressable market (TAM)[19, 20] - The company launched suitability measurement and activation on Meta and TikTok[18] - The company's CTV measurement volumes have grown from 5% to 11%[18] - The company's AI-powered implementations have doubled, accelerating some development cycles by 20X[18] Market Opportunity & Strategy - The company estimates its total addressable market (TAM) to be $27 billion+, including verification ($21 billion), optimization ($1 billion), and outcomes ($5 billion)[39, 40] - The company is expanding its reach across channels (Social, CTV, retail media), customers (large advertisers, mid-market, performance marketers), and the full-funnel (brand metrics to business outcomes)[48] AI & Data Advantage - The company possesses an independent, differentiated, and scaled proprietary data set to leverage AI, processing 300 billion+ daily signals[45, 46, 204] - The company's hybrid AI approach combines rules-based systems, neural networks, traditional ML, and LLMs for customizable, multimodal, scalable, auditable, and agentic solutions[220] DV Authentic AdVantage & Social Media - 87% of consumers expect brands to avoid unsafe content, and 2/3 will walk away if they don't[84] - A CPG brand using DV Authentic AdVantage saw a 35% decrease in media CPM, a 60% increase in impression volume, and a 10% increase in suitability score[118] - A global footwear company using DV Authentic AdVantage Pre-Bid & Scibids on YouTube experienced a 70% lower cost, a 200% greater volume, and a 30% greater suitability score[124] DV Scibids AI & Outcomes - The company has scaled and upsold DV Scibids AI to 200 clients[144] - DV Scibids AI has driven an average increase of 4x in client ROI and a 67% increase in campaigns optimized[144] - Icelandair maximized bookings at the lowest possible cost, achieving a 10.4x DV Scibids ROI and a 70% reduction in CPA after implementing DV Scibids[145]

Biogen's Strategic Direction - Biogen is broadening its portfolio across Neuro, Immunology & Rare Disease, aiming for long-term sustainable growth[4,17] - Approximately 50% of Biogen's total company revenue is projected to come from outside of MS, including Biosimilars[17] Felzartamab's Potential in Nephrology - Felzartamab targets CD38-expressing cells, offering a differentiated approach for antibody-mediated diseases[27,29] - Phase 3 programs for Felzartamab are underway, targeting Antibody Mediated Rejection (AMR), IgA Nephropathy (IgAN), and Primary Membranous Nephropathy (PMN)[106] Antibody Mediated Rejection (AMR) - Late AMR affects approximately 11,000 patients in the U S, with >75% transplant loss and a median graft survival of ~2 years after diagnosis[36,37,40] - In a Phase 2 study, Felzartamab treatment resulted in >80% biopsy late AMR resolution at week 24, compared to 20% in the placebo group[53] - A Phase 3 study for Felzartamab in late AMR is underway, with data expected in 2027[56] IgA Nephropathy (IgAN) - IgAN affects approximately 130,000 patients in the U S, with up to 40% of patients reaching end-stage kidney disease within 20 years of diagnosis[61] - Phase 2 data showed that with 5 months of Felzartamab treatment, patients had sustained clinical benefit out to 2 years, with ~50% UPCR reduction at 24 months in the 9-dose group[69,71] - A Phase 3 study for Felzartamab in IgAN is designed to demonstrate improvement in kidney function, with data expected in 2029[74] Primary Membranous Nephropathy (PMN) - PMN affects approximately 36,000 patients in the U S, with up to 40% progressing to end-stage kidney disease within 15 years[80,81,103] - Phase 2 data showed robust and sustained reductions in anti-PLA2R and improvements in both newly diagnosed/relapsed (NDR) and refractory PMN patients[103] - A Phase 3 study for Felzartamab in PMN is designed to demonstrate complete remission of proteinuria, with data expected in 2029[100]

Summary of Key Points from the Conference Call Industry or Company Involved - The conference call discusses various aspects of the **American economy**, particularly focusing on the implications of **Donald Trump's "big, beautiful bill"** and its effects on fiscal policy and economic growth. Core Points and Arguments 1. **Impact of Trump's Legislation**: The "big, beautiful bill" passed by the Senate includes trillions in tax reductions and significant spending cuts, which could add $3.4 trillion to budget deficits over the next decade [60][68][90]. 2. **Economic Growth vs. Debt**: While some optimists believe that economic growth will alleviate concerns about rising debt, the bill is unlikely to create a growth boom, as existing tax cuts offer little new stimulus [95][96]. 3. **Long-term Economic Damage**: The bill may have long-term negative effects on the foundations of the American economy, with the debt-to-GDP ratio projected to exceed 106% in about two years [92][100]. 4. **Public Sentiment and Political Dynamics**: The political landscape is shifting, with rising discontent among voters regarding economic management, which could lead to challenges for the current administration [102][105]. 5. **Labour Party's Struggles**: The Labour Party in Britain is facing significant challenges, with polling showing a decline in support and internal rebellions affecting its credibility [102][103][104]. Other Important but Possibly Overlooked Content 1. **China's Data Management**: The discussion touches on China's approach to data as a production factor, which could have implications for international competition and economic strategy [109][110][111]. 2. **Celebrity Brands**: The rise of celebrity brands as a source of business innovation is highlighted, with examples of successful ventures by figures like Kim Kardashian and Hailey Bieber [126][128][130]. 3. **Global Economic Context**: The broader implications of fiscal policies and trade negotiations are discussed, particularly in relation to the potential for new tariffs and their impact on international markets [86][89][90]. This summary encapsulates the key themes and insights from the conference call, providing a comprehensive overview of the current economic landscape and its implications for various stakeholders.

Financial Data and Key Metrics Changes - Subscription revenue for Q1 FY 2026 was $132.9 million, exceeding the guidance range of $129 million to $132 million, with a year-over-year growth of 1.1% on a constant currency basis [14] - Total revenue for Q1 was $152.6 million, reflecting a 1% increase compared to the prior year [15] - Non-GAAP gross profit was $102.4 million, a slight decrease of 0.2% year-over-year, with a non-GAAP gross margin of 67.1% [15] - Adjusted EBITDA for Q1 was $52.2 million, representing a margin of 34.2%, compared to $50.7 million and a margin of 33.6% in the prior year [16] - Net loss for Q1 was $15.5 million, significantly improved from a net loss of $42.8 million in the same period last year [16] - Adjusted operating cash flow was $48 million, with cash at the end of Q1 totaling $230.2 million, an increase of $33 million from the previous quarter [17] Business Line Data and Key Metrics Changes - Professional services and other revenue for Q1 was $19.7 million, showing a year-over-year decline of 0.1%, indicating stabilization in that business [14] Company Strategy and Development Direction - The company is focused on returning to organic growth and enhancing client retention through improved management and long-term partnerships [6] - E2Open is set to combine with WiseTech Global, which will expand its capabilities in supply chain logistics and enhance its market position [8][10] - The strategic partnership aims to leverage both companies' strengths in software innovation and client service [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to grow and innovate despite a volatile business environment [7] - The acquisition by WiseTech is expected to create new opportunities and enhance the value offered to clients [8][19] - The company anticipates closing the acquisition by the end of the calendar year, with ongoing operations as independent entities until then [12] Other Important Information - The company will not provide quarterly guidance moving forward but will maintain full-year guidance [2] - The focus remains on operational efficiency and cost discipline to support growth [16] Summary of Q&A Session Questions and Answers - There was no live Q&A session conducted due to the pending acquisition, and no individual discussions with analysts or investors were held [2]

Financial Data and Key Metrics Changes - The company reported a 9% increase in organic net revenue for Q2, marking the third consecutive quarter of high single-digit growth [7][33] - Gross margin reached a record 62.6%, expanding 140 basis points year-over-year, driven by lower product costs and a favorable channel mix [36][38] - Adjusted diluted EPS increased by 37% year-over-year to $0.22 [38] Business Line Data and Key Metrics Changes - Direct-to-consumer (DTC) sales grew by 10%, with 13 consecutive quarters of positive comparable sales growth [7][22] - The wholesale business also saw growth, up 7%, with notable performance in Europe [7][33] - Women's business grew by 13%, while men's business increased by 6% [33] Market Data and Key Metrics Changes - The Americas net revenues were up 9%, with operating margins increasing to 20.5% [39] - Europe experienced a 15% increase in net revenues, with a 17.2% operating margin [40] - Asia's net revenues were flat due to strategic actions taken to improve structural economics, but DTC grew double digits in several markets [41] Company Strategy and Development Direction - The company is transitioning to a DTC-first model, with over half of its business now coming from owned and operated channels [9][11] - A focus on becoming a full head-to-toe apparel lifestyle brand is evident, with significant growth in lifestyle categories [9][10] - The company is narrowing its focus by divesting from non-core brands like Dockers, allowing for a more concentrated effort on the Levi's brand [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating a challenging global operating environment, citing strong brand equity and consumer connection [11][30] - The company raised its full-year guidance for organic net revenue growth to 4.5% to 5.5% [45] - Despite uncertainties around tariffs, the company believes it is well-positioned to manage potential impacts [44][50] Other Important Information - The company opened 16 net new stores in Q2, expanding its global store network [24] - The loyalty program has nearly 40 million members, contributing to increased consumer engagement and higher average unit retail (AUR) [25] - The company expects to return at least $100 million from the net proceeds of the Dockers sale to shareholders through share repurchases [42] Q&A Session Summary Question: Drivers of demand strength and market share gains - Management noted broad-based growth across all business segments and maintained a top market share position globally and in the U.S. [53][56] Question: Clarification on organic wholesale revenues - Management indicated a prudent approach to wholesale, expecting it to remain flat to slightly positive for the year, with growth driven by digital channels and premium customers [66][70] Question: Marketing initiatives and price increases - The company is investing in brand marketing and has exciting campaigns planned for the fall, with room for further AUR growth across categories [75][80] Question: Margin profile of DTC business - DTC margins have improved significantly, with a focus on revenue per square foot and cost management contributing to this positive trend [95][99] Question: Tariff assumptions and pricing strategy - The company has factored in additional tariffs into its guidance and is implementing strategies to mitigate their impact [103][44]

Financial Data and Key Metrics Changes - The company reported third quarter net sales of $156.9 million, a 1% increase compared to the same period last year, marking a record sales quarter [7][8] - Adjusting for foreign currency translation, net sales would have been $158.6 million, reflecting a 2% increase year over year [8] - Gross margin improved to 56.2%, up from 53.1% last year, driven by higher average selling prices and lower specialty chemical costs [30][31] - Adjusted EBITDA margin was 20%, compared to 19% in the same period last year, with adjusted EBITDA of $30.7 million, up 3% from the prior quarter [36][37] - Operating income improved to $27.4 million, an increase of 1% over the prior period, and diluted earnings per share were $1.54, reflecting a 5% increase [38] Business Line Data and Key Metrics Changes - Maintenance products net sales reached $150.4 million, a 2% year-over-year increase, with year-to-date sales of $435.2 million representing a 6% increase [8][9] - Sales of WD-40 Multi Use Product increased 6% year to date, while WD-40 Specialist products were up 11% year to date [47] - Sales in The Americas increased 4% to $78.2 million, with maintenance products sales up 4% to $75 million [10][11] - EMEA sales declined 5% to $56.7 million, with maintenance products down 3% to $55.6 million [12][13] - Asia Pacific sales increased 7% to $22 million, with maintenance products up 9% to $19.8 million [16][17] Market Data and Key Metrics Changes - The Americas accounted for 50% of global business, while EMEA made up 36% and Asia Pacific contributed 14% [12][17] - Sales in Latin America showed strong growth of 19%, while Turkey experienced a significant decline of nearly 40% [19][70] - Sales in France increased by 9%, 14% in DACH, 13% in Iberia, and 7% in the UK, indicating strong market trends in these regions [14][15] Company Strategy and Development Direction - The company is focused on driving revenue growth in maintenance products and enhancing overall profitability through geographic expansion and premiumization [18][20] - The strategic enablers emphasize operational excellence and a people-first mindset, with a commitment to social responsibility and community support [24][26] - The company is targeting a compound annual growth rate for premiumized products of greater than 10% and for WD-40 Specialist products of greater than 15% [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in concluding the fiscal year with solid growth, despite challenges in certain markets [9][47] - The company narrowed its net sales guidance for fiscal year 2025 to between 6% and 9%, reflecting a clearer view of business performance [42][68] - Management acknowledged potential risks including inflationary pressures and foreign currency fluctuations but remains optimistic about achieving long-term targets [45][72] Other Important Information - The company plans to continue returning capital to stockholders through dividends and share repurchases, with a quarterly cash dividend of $0.94 per share approved [40] - The divestiture of the Home Care and Cleaning business is ongoing, with active discussions with potential buyers [41] Q&A Session Summary Question: Why is the Q4 guidance wide? - Management noted that promotional activity and timing of orders can impact revenue, leading to a wider guidance range [52][54] Question: Will gross margin growth slow next year? - Management indicated that while they are pleased with current margins, they have supply chain initiatives that could offset potential inflationary pressures [55][56] Question: How should G&A costs be viewed moving forward? - Management stated that they are focused on controlling costs and do not expect double-digit increases in G&A expenses [58][60] Question: What is the impact of foreign exchange on Q4? - Management expects a small benefit from foreign exchange in Q4, with some currencies remaining a headwind [61][62] Question: Are tariffs affecting customer order trends? - Management clarified that while there is some exposure to tariffs, substantial supply chain initiatives are mitigating their impact [63][64] Question: What changed in the top line guidance? - Management explained that the guidance reflects a clearer picture of business performance and adjustments for currency fluctuations [67][72]