XPro Program for Alzheimer's Disease - XPro1595 is designed to selectively inhibit soluble TNF to treat neurologic disease, with Phase 1b study demonstrating safety and dose-dependent reduction in inflammatory cytokines in cerebrospinal fluid (CSF)[34] - A Phase 2 study of XPro1595 in early Alzheimer's patients with biomarkers of inflammation used an enriched population (n=100) with amyloid and ≥ 2 biomarkers of inflammation, showing a beneficial signal across multiple measures[42, 57] - In the Safety Analysis Set (SAF) population (n=206) for the Phase 2 study, 51% were female, and 95.1% were white[39] - In the mITT population (n=200), 75% were Amyloid-beta (Aβ) positive[39] - The most common Treatment Emergent Adverse Event (TEAE) in the XPro1595 group was Injection Site Reaction (ISR), occurring in 52.5% of patients[54] - The company plans to validate the enriched population in a fully powered trial and anticipates an end-of-Phase 2 meeting with the FDA in Q4 2025[56, 59] CORDStrom Program for RDEB - CORDStrom is an investigational disease-modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic disease affecting an estimated 4000 people in the US, UK, and EU, representing a > $1B peak sales opportunity[64] - A Phase 2 trial of CORDStrom in 30 pediatric patients with RDEB showed beneficial effects with respect to Itch Man Scale, iscorEB clinician score, skin score, and QOL, with no CORDStrom-related serious adverse events reported[66] - The company plans to compile and file a BLA in the US & MAA in UK/EU in 1H 2026[77] INKmune Program for Cancer - INKmune is an off-the-shelf NK cell therapy candidate designed to convert patient's resting NK cells into cancer-killing memory-like NK cells[78] - An INKmune® mCRPC Phase I/II Trial is ongoing, with safety endpoints met and evidence of in-vivo NK cell activation and regression of some tumor lesions by PSMA-PET[80]

HEPLISAV-B Performance and Market Outlook - HEPLISAV-B achieved a quarterly sales record of $92 million, a 31% increase year-over-year compared to $70 million in Q2'24[5] - HEPLISAV-B's total U S quarter-end market share reached approximately 45%, up from approximately 42% in Q2'24[5] - The U S adult Hepatitis B vaccine market is expected to peak at over $900 million by 2030, with HEPLISAV-B projected to reach at least 60% of the total U S market share[5, 25] - In 2024, the HEPLISAV-B total market share was ~$615M and is expected to increase from 44% in 2024 to at least 60% by 2030[25] Financial Highlights - The company's cash, cash equivalents, and marketable securities totaled $614 million as of June 30, 2025[7] - Adjusted EBITDA for FY 2025 is expected to be greater than $75 million[8] - Dynavax completed repurchases under the previously announced $200 million share repurchase program as of June 30, 2025[9] - Total revenues for Q2'25 were $95.4 million, a 29% increase from $73.8 million in Q2'24[53] Pipeline Development - The company expects to report top-line data results for the Shingles vaccine program in August 2025[10] - The U S DoD partnership provides approximately $30 million through 1H'27 to fund additional clinical & manufacturing activities for the Plague vaccine program[10] - The company plans to initiate a Phase 2 clinical trial for the Plague vaccine program in the second half of 2025[10]

Financial Performance - Total subscription revenue has grown significantly from $3.1 million in 2010 to $242.2 million in Q2 2025[3] - Free cash flow increased from $3.975 million in Q2 2024 to $12.047 million in Q2 2025[15] - The company estimates an internal rate of return (IRR) of 30% per average subscription pet[12] Subscription Metrics - Total subscription pets enrolled reached 1,066,354 in Q2 2025[10] - Gross new pets enrolled in Q2 2025 were 62,740, with 53,186 from Core Trupanion[10] - Quarterly average revenue per new pet is $73.77[12] Outlook for 2025 - The company projects revenue between $359 million and $365 million for Q3 2025 and between $1.417 billion and $1.434 billion for the full year[17] - Subscription revenue is expected to be between $251 million and $254 million for Q3 2025 and between $983 million and $992 million for the full year[17] - Adjusted operating income is projected to be between $37 million and $40 million for Q3 2025 and between $141 million and $151 million for the full year[17]

Clinical Progress - Top-line data from the CBeyond study is expected in late Q3/early Q4[15] - A KOL event is scheduled for September 2025 to discuss the mechanism, Phase 2a clinical data expectations, and market positioning[15, 49] Nimacimab's Differentiation and Mechanism - Nimacimab exhibits significantly less brain penetration compared to small molecule CB1 inhibitors[18] - Nimacimab retains potency even in the presence of competition, unlike small molecules[20] - Preclinical data suggests nimacimab enhances weight loss when combined with low-dose tirzepatide[26] - Preclinical data suggests nimacimab prevents weight rebound and shows potential as maintenance therapy, with tirzepatide rebound at 29.7% and nimacimab maintenance at 12.8% in Phase B[31, 33] Market Opportunity - Nearly two-thirds (66.67%) of patients discontinue GLP-1 RA therapy after one year, and over 80% discontinue after two years, highlighting a therapeutic gap[36] - The company believes nimacimab represents a potential multi-billion dollar opportunity in monotherapy, maintenance, and combination therapy for obesity[37]

Financial Performance - Owlet's Q2 2025 revenue reached $26.1 million, representing a 25.9% year-over-year growth[10, 26] - The gross margin for Q2 2025 was 51.3%, an expansion of 180 basis points year-over-year[10, 26] - Adjusted EBITDA for Q2 2025 was $0.3 million, showing a $0.2 million improvement compared to Q2 2024[10, 32] - Total operating expenses for Q2 2025 were $15.3 million, with OpEx as a percentage of revenue at 58.7%, compared to 60.4% in Q2 2024[32] Business Highlights - Owlet experienced a strong 26% year-over-year revenue growth[11] - The company achieved its 9th consecutive quarter of gross margin expansion year-over-year[11] - Owlet marked its 5th consecutive quarter of adjusted EBITDA profitability[11] - Owlet360 subscription service has over 66,000 paying subscribers[11, 17] Dream Sock Performance - Domestic Dream Sock sell-through increased by 37% year-over-year[14] - Dream Sock registry additions grew by 54% year-over-year[14] - Total sell-through units on U.S Amazon Prime Day sales increased 72% year-over-year[14] - Total sell-through units on U.K Amazon Prime Day sales increased 144% year-over-year[14] Updated Guidance - The company updated its FY 2025 revenue guidance to $97 million - $100 million, projecting a 24-28% growth year-over-year[34] - The gross margin guidance for FY 2025 remains at 46% - 50%, including new, increased tariff costs[34] - The company fully expects to be positive in Adj EBITDA, including new, increased tariff costs[34]

Financial Performance - Natera's Q2 2025 revenue reached approximately $547 million, a 32% increase compared to approximately $413 million in Q2 2024[10] - The company processed approximately 853,000 total tests in Q2 2025, reflecting a 12% year-over-year growth from approximately 760,000 tests in Q2 2024[10] - Gross margin was approximately 63% in Q2 2025, up from approximately 59% in Q2 2024, and the company generated approximately $24 million in cash inflow[10] - Natera is increasing its 2025 revenue outlook by $80 million, projecting revenue between $202 billion and $21 billion, with a gross margin between 61% and 64%, and positive cash flow generation[10] Oncology Business - Oncology tests processed in Q2 2025 totaled approximately 189,000, a 51% increase compared to approximately 125,000 in Q2 2024[10] - Clinical oncology experienced growth of approximately 20,000 units over Q1 2025[10] - Signatera demonstrated rapid growth, with clinical test volumes increasing by approximately 20,000 units[15] Product Development and Clinical Trials - Natera launched Fetal Focus, a new NIPT for 5 genes, and reported positive data from the PEDAL clinical trial in organ health[10, 35] - The DARE trial showed that over 99% of 400+ patients who remained Signatera-negative had recurrence-free survival (RFS) with a median follow-up of 274 months[48] - Natera is investing over $150 million in breast cancer clinical trials[55] AI Initiatives - Natera launched AI-based foundation models to support biomarker development, molecular therapeutics, and clinical decision-making[10] - The company is targeting approximately $200 million in value through AI-driven efficiencies[68]

HEI 2Q 2025 Financial Results August 7, 2025 Non-GAAP Financial Information This presentation refers to certain financial measures that were not prepared in accordance with U.S. generally accepted accounting principles, including Core Earnings and Core Net Income. Reconciliations of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Appendix herein. See Appendix for definition of Core Earnings and Core EPS. 2 Continuing Progress to Reposition for th ...

Financial Performance - Puma Biotechnology reported net NERLYNX revenue of $49.2 million in Q2'25, an increase of approximately 11% compared to $44.4 million in Q2'24[6, 7, 9] - The company also saw an increase of about 14% in net revenue from Q1'25 ($43.1 million) to Q2'25 ($49.2 million)[9, 10] - Inventory change improved from -$2.3 million in Q2'24 to -$1.3 million in Q2'25[8] - Inventory change improved from -$4.7 million in Q1'25 to -$1.3 million in Q2'25[11] Sales Volume - Puma Biotechnology sold 2,608 ex-factory bottles of NERLYNX in Q2'25[12] - This represents an approximate 4% increase compared to the 2,515 bottles sold in Q2'24[16] - There was also an approximate 12% increase in bottles sold from Q1'25 (2,338 bottles) to Q2'25 (2,608 bottles)[14, 16] - Inventory change in bottles improved from -132 in Q2'24 to -72 in Q2'25[13] - Inventory change in bottles improved from -250 in Q1'25 to -72 in Q2'25[15] Dosage Trends - Approximately 71% of patients in Q2'25 started NERLYNX at a reduced dose (fewer than 6 pills per day)[17] Global Expansion - NERLYNX has received regulatory approvals and been commercially launched in various regions through partnerships, including Australia/SE Asia, Israel, Canada, Latin America, Europe, Greater China, Middle East, North and West Africa, South Africa, Turkey, and South Korea[22]

Financial Performance - Total product sales excluding Veklury increased by 4% year-over-year (YoY) to $6.9 billion, driven by HIV, Livdelzi, and Trodelvy[8] - Total HIV product sales increased by 7% YoY to $5.1 billion[12] - Oncology product sales increased by 1% YoY to $849 million[12] - Veklury sales decreased by 44% YoY to $121 million[12] - Liver disease product sales decreased by 4% YoY to $795 million[12] - Cell Therapy product sales decreased by 7% YoY to $485 million[12] HIV Business - Biktarvy sales increased by 9% YoY[8] - Descovy sales increased by 35% YoY[8] - FY25 HIV revenue guidance updated to reflect year-to-date (YTD) strength, expecting >7% YoY growth[22] Oncology - Trodelvy sales increased by 14% YoY[8] - Cell Therapy saw a 7% YoY decrease due to evolving competitive landscape[8] Pipeline and Regulatory Updates - FDA approved Yeztugo (lenacapavir) as a twice-yearly injection for HIV prevention[8] - Phase 3 ASCENT-03 & -04 data for Trodelvy in 1L mTNBC showed clinically meaningful results, with FDA filings expected in ~2H 2025[8]

Q2 2025 Earnings Report © 2025 Pinterest. All rights reserved. Non-GAAP Financial Measures To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States ("GAAP"), we use the following non-GAAP financial measures: Adjusted EBITDA, Adjusted EBITDA margin, non-GAAP costs and expenses (including non-GAAP cost of revenue, research and development, sales and marketing, and general and administrative) ...