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Seattle Genetics Inc Wa (SGEN) SEC Filing 10-Q Quarterly report for the period ending Sunday, June 30, 2019

Seattle Genetics Inc Wa

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CIK: 1060736 Ticker: SGEN


Exhibit 99.1
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Seattle Genetics Reports Second Quarter 2019 Financial Results

-Record ADCETRIS® (Brentuximab Vedotin) Net Sales in U.S. and Canada of $159.0 Million in the Second Quarter, an Increase of 30 Percent Over the Second Quarter of 2018-
-Biologics License Application Submitted to FDA for Enfortumab Vedotin to Treat Advanced or Metastatic Urothelial Cancer Based on Results from the EV-201 Pivotal Trial-
-Topline Results from Tucatinib HER2CLIMB Pivotal Trial Expected in 2019-
-Conference Call Today at 4:30 p.m. ET-

BOTHELL, Wash. — July 16, 2019
 — Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the second quarter and six months ended June 30, 2019. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.
“In the second quarter, we achieved record ADCETRIS net sales in the U.S. and Canada, reflecting growth in frontline CD30-expressing peripheral T-cell lymphomas as well as frontline advanced Hodgkin lymphoma,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are also making substantial progress with our late-stage programs, delivering on several key goals. The Biologics License Application for enfortumab vedotin was submitted to the FDA for patients with locally advanced or metastatic urothelial cancer, taking us another step closer to becoming a multi-product oncology company. Additionally, we expect to report topline data from the tucatinib pivotal trial, HER2CLIMB, in HER2-positive metastatic breast cancer later this year and from the tisotumab vedotin pivotal trial, innovaTV 204, in metastatic cervical cancer in the first half of 2020.”

Program Highlights
ADCETRIS
•
Ex-U.S. Approvals for ADCETRIS in Frontline Hodgkin Lymphoma (HL): In May 2019, ADCETRIS in combination with AVD (Adriamycin®, vinblastine and dacarbazine) was approved by Health Canada for patients with previously untreated stage IV HL. Also, in June 2019, Takeda received an additional approval for ADCETRIS in frontline HL that resulted in a $7.5 million milestone payment to Seattle Genetics.
•
Additional Analyses of ECHELON-1 and ECHELON-2 Trials Presented at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting: A three-year update of the ECHELON-1 trial continued to show superior clinical activity of ADCETRIS in combination with AVD compared to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) in frontline stage III and IV HL. Separately, analyses of clinical trials in T-cell lymphomas, including the ECHELON-2 trial, showed that responses were observed in patients across all levels of CD30 expression.
Enfortumab Vedotin
•
Enfortumab Vedotin Biologics License Application (BLA) Submitted to FDA: In July 2019, Seattle Genetics and Astellas Pharma, Inc. submitted a BLA to the U.S. Food and Drug Administration (FDA) for enfortumab vedotin to treat 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. The submission is based on positive results

The following information was filed by Seattle Genetics Inc Wa (SGEN) on Tuesday, July 16, 2019 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:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Comprehensive Income (Loss)
Condensed Consolidated Statements Of Stockholders' Equity
Acquisition Of Cascadian
Acquisition Of Cascadian (Tables)
Acquisition Of Cascadian - Additional Information (Details)
Acquisition Of Cascadian - Schedule Of Business Acquisition, Unaudited Pro Forma Information (Detail)
Acquisition Of Cascadian - Schedule Of Purchase Price Allocation Of Assets Acquired And Liabilities Assumed (Details)
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Fair Value - Summary Of Fair Value Hierarchy Of Assets Carried At Fair Value And Measured On A Recurring Basis (Details)
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Investment And Other Income (Loss), Net
Investment And Other Income (Loss), Net (Details)
Investment And Other Income (Loss), Net (Tables)
Legal Matters
Legal Matters (Details)
Net Income (Loss) Per Share
Net Income (Loss) Per Share (Tables)
Net Income (Loss) Per Share - Additional Information (Details)
Net Income (Loss) Per Share - Schedule Of Basic And Diluted Net Income (Loss) Per Share (Details)
Operating Leases
Operating Leases (Tables)
Operating Leases - Additional Information (Details)
Operating Leases - Future Minimum Lease Payments (Details)
Operating Leases - Lease Cost (Details)
Operating Leases - Summary Of Balance Sheet Information (Details)
Revenue From Contracts With Customers
Revenue From Contracts With Customers (Tables)
Revenue From Contracts With Customers - Additional Information (Details)
Revenue From Contracts With Customers - Summary Of Collaboration And License Agreement Revenues By Collaborator (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Policies)
Ticker: SGEN
CIK: 1060736
Form Type: 10-Q Quarterly Report
Accession Number: 0001060736-19-000030
Submitted to the SEC: Tue Jul 16 2019 1:19:05 PM EST
Accepted by the SEC: Tue Jul 16 2019
Period: Sunday, June 30, 2019
Industry: Biological Products No Disgnostic Substances

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