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EX - 99.1 2 ex - 9912021q2.htm EX - 99.1 Exhibit 99.1 Seagen Reports Second Quarter 2021 Financial Results Seagen -Record Quarterly Sales for Each of ADCETRIS , PADCEV and TUKYSA ; Total Net Product Sales of $ 347.3 Million in 2021 , an Increase of 44 Percent Over 2020- -FDA Grants PADCEV Regular Approval and Adds New Indication for Locally Advanced or Metastatic Urothelial Cancer- -Tisotumab Vedotin BLA Under FDA Priority Review with PDUFA Date of October 10 , 2021- -Conference Call Today at 4:30 p.m. ET- BOTHELL , Wash . _ - July 29 , 2021- Seagen Inc. ( Nasdaq : SGEN ) today reported financial results for the second quarter and six months ended June 30 , 2021. The Company also highlighted ADCETRIS® ( brentuximab vedotin ) , PADCEVⓇ ( enfortumab vedotin - ejfv ) and TUKYSA® ( tucatinib ) commercial and development accomplishments , as well as progress across its robust oncology pipeline . " The commercial execution across our three brands continues to be strong , achieving record quarterly net product sales for each of ADCETRIS , PADCEV and TUKYSA , as we bring these important medicines to patients around the world , " said Clay Siegall , Ph.D. , President and Chief Executive Officer of Seagen . " We are investing in clinical trials to maximize the potential of our three approved drugs , and making strong progress with TUKYSA commercialization in the European Union . Looking ahead to the remainder of 2021 , Seagen is poised to add a fourth product , tisotumab vedotin , which has an FDA action date in October 2021 and we expect continued progress across our earlier - stage oncology pipeline with planned clinical data presentations and other development accomplishments . " PROGRAM HIGHLIGHTS PADCEV • Received FDA Regular Approval and Additional Indication for mUC : In July 2021 , Seagen and Astellas announced that the U.S. Food and Drug Administration ( FDA ) granted PADCEV regular approval , in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer ( la / mUC ) who are ineligible for cisplatin - containing chemotherapy and have previously received one or more prior lines of therapy . Cisplatin - ineligible patients typically have limited treatment options and a poor prognosis . Presented Updated Results from Cohort 2 of Pivotal EV - 201 Trial : In June 2021 , updated results were presented at the 2021 American Society of Clinical Oncology ( ASCO ) Annual Meeting for the second cohort of the EV - 201 trial for patients with la / mUC who received prior treatment with an immunotherapy but had not received a platinum - containing chemotherapy and were ineligible for cisplatin chemotherapy . The data showed that with extended follow - up median duration of response increased to 13.8 months . EV - 201 results were also published in The Lancet Oncology and supported expansion of the PADCEV label in July 2021 .