Earnings release
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EX - 99.1 2 ex - 9912021q3.htm EX - 99.1 Exhibit 99.1 Seagen Reports Third Quarter 2021 Financial Results Seagen -Total Net Product Sales of $ 366.5 Million in 3Q21 , an Increase of 37 Percent Over 3Q20- -FDA Granted TIVDAK Accelerated Approval for Previously Treated Recurrent or Metastatic Cervical Cancer- -Completed Enrollment in both PADCEV EV - 103 Trial Cohort K in First - Line Metastatic Urothelial Cancer and in TUKYSA MOUNTAINEER Trial in Previously Treated HER2 - Positive Metastatic Colorectal Cancer- -Entered into Exclusive Worldwide License and Co - Development Agreement with RemeGen for Disitamab Vedotin , a Novel HER2 - targeted Antibody - Drug Conjugate- -Conference Call Today at 4:30 p.m. ET- BOTHELL , Wash . October 28 , 2021 Seagen Inc. ( Nasdaq : SGEN ) reported financial results today for the third quarter and nine months ended September 30 , 2021. The Company also highlighted ADCETRIS® ( brentuximab vedotin ) , PADCEV® ( enfortumab vedotin - ejfv ) , TUKYSA® ( tucatinib ) and TIVDAK ™ ( tisotumab vedotin - tftv ) commercial and development accomplishments , as well as progress across its robust oncology pipeline . “ We reported net product sales of approximately $ 1 billion for the year to date and $ 366 million for the third quarter of 2021 , reflecting growth across our portfolio of approved medicines . We also added a fourth marketed product in September with the U.S. launch of TIVDAK , an important new medicine for women with previously treated metastatic cervical cancer , " said Clay Siegall , Ph.D. , President and Chief Executive Officer of Seagen . “ In addition to strong commercial performance , we continue to work to maximize the potential of our approved drugs through broad clinical development progress . We also expanded our late - stage pipeline by entering a collaboration with RemeGen for disitamab vedotin , a novel HER - 2 targeted antibody - drug conjugate ( ADC ) . Across our early and late - stage pipeline , we are advancing 13 programs for a range of solid tumors and hematologic malignancies , including four programs that are expected to enter the clinic within the next year . " PROGRAM HIGHLIGHTS TIVDAK • • Received FDA Approval : In September 2021 , TIVDAK was granted accelerated approval by the FDA for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy . TIVDAK is the first and only ADC approved in this setting and is Seagen's fourth drug to be approved by the FDA . Seagen is developing TIVDAK in collaboration with Genmab . Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials . Presented Interim Results of Combination Therapy at the European Society for Medical Oncology ( ESMO ) Congress 2021 : In September 2021 , interim results were presented from two cohorts of the phase 1b / 2 innovaTV 205 trial evaluating TIVDAK in a combination regimen for recurrent or metastatic cervical cancer . The combination with carboplatin in the first - line setting and separately the combination with KEYTRUDA ( pembrolizumab ) in previously treated patients showed encouraging , durable antitumor activity . Both combinations demonstrated a manageable and acceptable safety profile .