Seagen(US:SGEN)2022-10-27 21:10Financial Performance - Reported a 17% increase in net product sales for Q3 2022 compared to the prior year, with a year-to-date growth of 22%[75] - Total revenues for the nine months ended September 30, 2022, increased to $1.4 billion, a 27% increase from $1.1 billion in the same period of 2021[138] - Net product sales rose by $227 million or 22%, driven by growth from each of the approved medicines[138] - Net product sales for ADCETRIS grew by 14% to $601.4 million for the nine months ended September 30, 2022, compared to $529.3 million in 2021[140] - PADCEV net product sales increased by 33% to $329.1 million for the nine months ended September 30, 2022, compared to $247.2 million in 2021[140] - Collaboration and license agreement revenues surged by 240% to $80.2 million for the nine months ended September 30, 2022, compared to $23.6 million in 2021[148] - Royalty revenues increased by 6% to $111.2 million for the nine months ended September 30, 2022, compared to $104.5 million in 2021[145] - The company expects growth in net product sales in 2022 compared to 2021, primarily driven by higher sales of each approved product[143] Research and Development - The company plans to submit additional IND applications to the FDA in 2022 and 2023 for early-stage clinical candidates[123] - The company is conducting multiple clinical trials, including phase 3 trials for TIVDAK and TUKYSA in various cancer indications[116][118] - Total research and development expenses for the nine months ended September 30, 2022, were $986.5 million, with an expected increase compared to 2021[190] - Research and development expenses for the three months ended September 30, 2022, decreased by 16% to $384.6 million compared to $459.1 million in 2021, primarily due to the $200.0 million upfront license payment made in 2021[165] Product Approvals and Collaborations - Entered into a corporate transaction for a bispecific technology candidate, enhancing the portfolio of targeted drug therapies[75] - Extended TIVDAK's geographic reach through a new partnership for development and commercialization in mainland China, Hong Kong, Macau, and Taiwan[75] - Presented positive results from PADCEV and TUKYSA pivotal clinical trials, supporting supplemental applications to the FDA for potential label expansion[75] - Announced a collaboration with LAVA Therapeutics for the development of LAVA-1223, with an upfront payment of $50 million and potential milestones and royalties[75] - TUKYSA received Breakthrough Therapy designation from the FDA for use in combination with trastuzumab for HER2-positive colorectal cancer[81] - ADCETRIS demonstrated a 41% reduction in risk of death versus standard care in advanced Hodgkin lymphoma, leading to an update in NCCN Guidelines[81] - PADCEV received regular approval from the FDA in July 2021, expanding its indication for urothelial cancer treatment[87] - ADCETRIS is now approved in over 75 countries worldwide, with ongoing collaborations for global commercialization[85] - TUKYSA received marketing authorization in the EU for HER2-positive breast cancer, valid in all EU countries and several others[92] - The collaboration with Merck for TUKYSA aims to accelerate global availability, covering Asia, the Middle East, and Latin America[93] - TIVDAK received accelerated FDA approval for recurrent or metastatic cervical cancer, supported by the innovaTV 204 trial data[94] - TIVDAK is co-developed with Genmab, with a 50:50 cost and profit sharing agreement, and commercialization rights split between the U.S. and other regions[95] - An exclusive collaboration with Zai Lab for TIVDAK in China included a $30 million upfront fee and shared milestone payments[96] Clinical Trial Results - PADCEV demonstrated a 64.5% confirmed objective response rate in combination with pembrolizumab for advanced urothelial cancer[104] - The ongoing EV-302 trial evaluates PADCEV and pembrolizumab against chemotherapy in metastatic urothelial cancer, with dual primary endpoints of progression-free survival and overall survival[105] - TUKYSA's HER2CLIMB trial showed a 9.1-month improvement in overall survival for patients with brain metastases compared to standard treatment[110] - TUKYSA demonstrated a 38.1% confirmed response rate in the MOUNTAINEER trial for HER2-positive metastatic colorectal cancer after a median follow-up of 20.7 months[114] - The median overall survival for patients in the MOUNTAINEER trial was reported at 24.1 months[114] - TIVDAK showed a 41% confirmed objective response rate in a cohort of 33 patients with recurrent or metastatic cervical cancer who had not received prior systemic therapy[119] Financial Outlook and Expenses - The company anticipates a deceleration in the growth rate of PADCEV and TUKYSA sales in 2022 compared to 2021 due to market penetration limits[127] - The company expects cost of sales to increase in 2022 compared to 2021 due to net product sales growth and higher manufacturing costs[164] - Selling, general and administrative expenses for the nine months ended September 30, 2022, were $604.9 million, reflecting a 20% increase from 2021[176] - Cash used in operating activities for the nine months ended September 30, 2022, was $(374.3) million, compared to $(215.6) million in 2021[182] - The company anticipates capital expenditures for a new facility in Everett, Washington, to be approximately $350 million to $400 million through 2024[192] Corporate Responsibility and Diversity - The company aims to increase women in leadership roles and improve diversity in clinical trials as part of its Corporate Responsibility initiatives[81] COVID-19 Impact - The ongoing COVID-19 pandemic has negatively impacted product sales due to challenges in patient access to healthcare settings and diagnosis rates[135] - The company is monitoring the impact of COVID-19 on its operations and has implemented measures to ensure workforce safety while continuing essential activities[126]