Q3 FY25 Financial Performance - Net sales increased by 1% to $156.9 million, but would have increased by 2% excluding currency impacts[12] - Gross margin improved by 310 basis points to 56.2%[12] - Net income increased by 6% to $21.0 million[12] - Diluted EPS increased by 5% to $1.54[12] Segment Performance - Americas segment sales increased by 4%, representing 50% of global net sales[14] - EIMEA segment sales decreased by 5%, representing 36% of global net sales[17] - Asia-Pacific segment sales increased by 7%, representing 14% of global net sales[21] Growth and Strategy - The company targets mid-to-high single-digit CAGR for total company maintenance product sales[30] - The company is focused on four must-win battles: lead geographic expansion, accelerate premiumization, drive WD-40 Specialist growth, and turbo-charge digital commerce[34] FY25 Guidance (Pro Forma) - Sales growth is narrowed to between 6% and 9% over 2024 pro forma results, with net sales between $600 million and $620 million[53] - Diluted EPS is increased to between $5.30 and $5.60[53]

Financial Highlights - Ondas expects to report approximately $6 million in revenue for Q2 2025, a 6-fold increase compared to Q2 2024[29] - The company estimates its backlog at $22.8 million, adjusted for the expected Q2 2025 revenue[29] - Ondas anticipates total revenue of $25 million for Ondas Holdings in 2025, with at least $20 million expected from OAS[29] - Convertible notes outstanding were reduced to $5.4 million at the end of Q2 2025[29] - The company's cash position is fortified with over $67 million as of Q2 2025[29] Market and Growth Strategy - NATO's commitment to increase defense spending to 5% of GDP by 2035 represents a significant shift, potentially leading to $1.2 trillion in annual defense outlays[40, 41] - The FY2025 bill allocates approximately $21.2 billion to programs relevant to Ondas' capabilities and services for governmental defense and security applications in the U.S[44] - The Optimus drone-in-a-box market is projected to reach $1.5 billion in 2025[118] - The counter-drone market, relevant to Iron Drone Raider, is projected to reach $3 billion in 2025[121] Future Outlook - OAS targets revenue of $40 million in 2026[176] - OAS aims to achieve positive EBITDA in the second half of 2026[174, 180] - OAS projects revenue between $140 million and $150 million and EBITDA between $40 million and $45 million by 2030[180]

Company Overview and Financial Status - Crinetics has a strong financial position with $1.3 billion in cash, cash equivalents, and investments[31] - The company anticipates its first commercial launch this year and holds IP rights into the 2040s[31] Pipeline Programs and Focus - Crinetics is developing paltusotine, with a PDUFA date in September 2025, for acromegaly[27] - The company is developing CRN12755, a TSHR antagonist, for Graves' Hyperthyroidism and Graves' Orbitopathy (TED), with plans for an IND submission[123] - Crinetics is advancing CRN10329, an SST3 agonist, for Autosomal Dominant Polycystic Kidney Disease (ADPKD), with IND-enabling studies ongoing[150] - The company is developing CRN09682, a nonpeptide drug conjugate (NDC), targeting SST2-expressing tumors, currently in Phase 1/2 study[254] Market and Patient Reach - Graves' Hyperthyroidism affects over 3 million individuals in the US, with a significant portion developing TED[75] - ADPKD affects approximately 145,000 diagnosed patients in the US, with 50% developing end-stage kidney disease[130, 131] - The addressable patient population for Graves' Orbitopathy (TED) is up to approximately 170,000 incident cases[120]

Company Strategy & Market Opportunity - Lilly aims to provide freedom from diabetes, eliminate serious health issues caused by obesity, and reduce cardiovascular deaths[10] - The company estimates a significant addressable market of over 170 million patients by 2030 for obesity and related conditions[13] - Outside of the US, the addressable market is expected to be approximately 1 billion patients[15] Orforglipron Development Program - Orforglipron, a GLP-1 small molecule, has a broad development plan including studies for Type 2 Diabetes, obesity, hypertension, and obstructive sleep apnea[20] - In the ACHIEVE-1 trial, all three doses of orforglipron achieved superiority versus placebo in reducing HbA1c levels in patients with Type 2 Diabetes[27] - ACHIEVE-1 trial data showed significant reductions in HbA1c observed as early as 4 weeks, with approximately 3/4 of patients achieving an ADA HbA1c target of less than 7%, and 2/3 reaching HbA1c ≤6.5%[27] - ACHIEVE-1 trial also demonstrated dose-dependent reduction in body weight, with approximately 2/3 of patients achieving ≥5% weight reduction and approximately 1/3 achieving ≥10% weight reduction[30] - Topline results for ATTAIN-1, an orforglipron trial in obesity, are expected in Q3 2025[39] Retatrutide Development Program - Retatrutide is undergoing global development with the TRIUMPH program for obesity and related complications, and the TRANSCEND program for Type 2 Diabetes[41] - Topline results for TRIUMPH-4, a retatrutide trial in knee osteoarthritis pain and overweight or obesity, are expected in Q4 2025[48] Tirzepatide & Early Phase Pipeline - The SURPASS-CVOT trial is designed to evaluate tirzepatide against dulaglutide in patients with established cardiovascular disease[51] - Eloralintide, a selective amylin receptor agonist, showed weight loss up to 11.3% in Phase 1 trials and is well-tolerated with less than 10% incidence of GI side effects[60]

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]