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EX - 99.1 2 ex - 9912021q1.htm EX - 99.1 Exhibit 99.1 Seagen Reports First Quarter 2021 Financial Results -Net Product Sales of $ 302.6 Million in 1Q21 , an Increase of 52 Percent Over 1Q20- Seagen -Significant Regulatory Progress Across Diverse Oncology Pipeline , Including European Commission Approval of TUKYSA , Multiple Applications Under Review Globally for PADCEV , and FDA Acceptance of Tisotumab Vedotin BLA- -Conference Call Today at 4:30 p p.m. ET- BOTHELL , Wash . - April 29 , 2021 Seagen Inc. ( Nasdaq : SGEN ) today reported financial results for the first quarter and three months ended March 31 , 2021. The Company also highlighted ADCETRIS® ( brentuximab vedotin ) , PADCEVⓇ ( enfortumab vedotin - ejfv ) and TUKYSA® ( tucatinib ) commercial and development accomplishments , as well as progress with its lead pipeline programs to treat cancer . " Year - over - year quarterly net product sales growth of 52 percent was driven by rapid adoption of our newest products , PADCEV and TUKYSA , in addition to strong sales of ADCETRIS . We continue to project 2021 total net product sales in our territories of approximately $ 1.3 billion , ” said Clay Siegall , Ph.D. , President and Chief Executive Officer of Seagen . " Looking ahead , we expect continued global progress across the portfolio . This includes TUKYSA launches in Europe following marketing authorizations received in the first quarter . In collaboration with Astellas we are pursuing several PADCEV marketing applications across the United States , Europe , Japan and Latin America . In addition , we are preparing for potential U.S. launch of a fourth drug following FDA acceptance of our tisotumab vedotin BLA submission with Priority Review . We are continuing to deliver cutting - edge innovation and medicines that make a meaningful difference in the lives of cancer patients . ” COMMERCIAL PRODUCTS HIGHLIGHTS PADCEV • Received European Medicines Agency ( EMA ) Acceptance of Marketing Authorization Application ( MAA ) : In March 2021 , Seagen and Astellas announced that the EMA accepted the PADCEV MAA for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD - 1 / L1 inhibitor and who have received a platinum - containing chemotherapy in the neoadjuvant / adjuvant , locally advanced or metastatic setting . PADCEV will be reviewed under accelerated assessment , which means the EMA's Committee for Medicinal Products for Human Use can shorten the MAA evaluation timeframe . Received FDA Filing Acceptance of Two Supplemental Biologics License Applications ( sBLAs ) : In April 2021 , the FDA accepted two PADCEV sBLA submissions for review under the Real - Time Oncology Review pilot program . The applications were granted Priority Review with a target action date of August 17 , 2021. The review of both applications will be conducted under Project Orbis , an initiative of the FDA Oncology Center of Excellence . The first sBLA is based on the phase 3 EV - 301 trial and seeks to convert PADCEV's accelerated approval to regular approval . The second sBLA , based on the pivotal trial EV - 201's cohort 2 , requests an expansion of the current indication to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD - 1 / L1 inhibitor and are ineligible for cisplatin .