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Seagen Inc. (SGEN) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Seattle Genetics Inc Wa

CIK: 1060736 Ticker: SGEN

Exhibit 99.1

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Seagen Reports First Quarter 2021 Financial Results

-Net Product Sales of $302.6 Million in 1Q21, an Increase of 52 Percent Over 1Q20-
-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.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.


The following information was filed by Seattle Genetics Inc Wa (SGEN) on Thursday, April 29, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Seattle Genetics Inc Wa's 10-Q Quarterly Report:

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Inside this 10-Q Quarterly Report

Ticker: SGEN
CIK: 1060736
Form Type: 10-Q Quarterly Report
Accession Number: 0001060736-21-000019
Submitted to the SEC: Thu Apr 29 2021 5:10:12 PM EST
Accepted by the SEC: Thu Apr 29 2021
Period: Wednesday, March 31, 2021
Industry: Biological Products No Disgnostic Substances

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