Financial Data and Key Metrics Changes - Q2 sales increased by 15%, with a gross margin of 70% and EPS up 16% [5][12] - Operating income for Q2 was $16.1 million, reflecting a 12% increase, resulting in an operating margin of 25% [12] - Net income rose by 17% year-over-year to $13.8 million, with fully diluted EPS at $0.60, up 16% [12][14] - Cash from operations reached a record $20.3 million in Q2, with total cash and securities at $319.5 million, an increase of $17 million in the quarter [12][14] Business Line Data and Key Metrics Changes - Sales from catheters increased by 27%, grafts by 19%, and both valvulotomes and shunts by 13% [5] - Organic revenue growth was 15%, driven by 8% price growth and 7% unit growth, particularly in ArteGraft, XenoSure, RestoreFlow, and catheters [9][11] - ArteGraft sales are projected to exceed $2 million for the full year 2025, with Q2 sales of $420,000, up from $185,000 in Q1 [6][34] Market Data and Key Metrics Changes - EMEA region grew by 23%, while the Americas and APAC regions both saw growth of 12% [5] - International autograft launch exceeded expectations, contributing significantly to sales growth [6][34] Company Strategy and Development Direction - The company is focusing on expanding its international presence, with plans for regulatory approvals in Canada, Korea, and Singapore by 2026 [6][8] - A new RestoreFlow distribution facility is being opened in Dublin to support European launches [7] - The company anticipates a full-year revenue of $251 million and 15% organic growth, driven by a growing sales organization and success in global markets [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the global business model despite evolving international trade landscapes, with only a 25% average price increase in China due to tariffs [13] - The company expects lower operating expenses in the second half of the year, contributing to improved operating margins [40][41] - Management raised full-year guidance for revenue, gross margin, operating income, and EPS, reflecting optimism for continued growth [14] Other Important Information - The company ended Q2 with 164 sales representatives and 33 sales managers, with ongoing efforts to expand direct sales in international markets [8] - A packaging-related recall impacted catheter sales temporarily, but stocking orders boosted overall sales in Q2 [10][18] Q&A Session Summary Question: Impact of stocking orders on Q2 results - Management estimated that stocking orders related to the catheter recall contributed approximately $800,000 to Q2 sales [18] Question: Sustainability of price growth - Management indicated that while price growth has been strong, future price increases will depend on market conditions and competitive dynamics [20] Question: Details on unit volume growth - Excluding the impact of the catheter recall, unit growth was around 5%, consistent with previous years [23][24] Question: Sales force expansion plans - The company aims to reach around 165 sales representatives by year-end, with a focus on maintaining a balanced sales force across regions [46][48] Question: International sales growth expectations - Management noted strong growth in Europe and a positive turnaround in the U.S., with expectations for continued growth in both regions [50][52] Question: Regulatory approvals and new product introductions - The company is awaiting approvals for several products in key international markets, including China and Canada, which are expected to drive future growth [105][106]

Financial Performance - Total Q3 revenues reached $1.1 billion[7] - Net product sales hit a record $267 million, a 60% increase over 3Q19[7, 14] - Collaboration & license agreement revenues surged to $758.3 million, primarily due to $725 million in upfront payments from Merck[22] - ADCETRIS U S and Canada net product sales guidance is $650 to $660 million[27] - Royalty revenues guidance increased to $125 to $130 million[27] Product Updates - PADCEV and TUKYSA contributed to net product sales growth[22] - PADCEV data supports global registrations and expanded U S indication[8] - TUKYSA is expanding capabilities to support launch in Europe, with MAA under review[8] - Tisotumab vedotin BLA submission planned under FDA accelerated approval pathway[8] Clinical Trial Data - EV-301 trial showed a hazard ratio of 0.70 (P=0.001) for overall survival and 0.61 (P<0.00001) for progression-free survival with PADCEV[34] - EV-201 Cohort 2 trial showed a 52% objective response rate with PADCEV[34] - Tisotumab Vedotin showed a confirmed ORR of 24%[42] Strategic Collaborations - Received $1.8 billion under Merck collaborations, including upfront payments and prepaid R&D in Q3, and a $1 billion equity investment closed in Q4[7] - Granted Merck exclusive license to commercialize TUKYSA outside U S, Canada, and Europe[8] - Signed worldwide co-development and commercialization agreement with Merck for ladiratuzumab vedotin[8]