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Seattle Genetics Inc Wa (SGEN) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

Seattle Genetics Inc Wa

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CIK: 1060736 Ticker: SGEN


Exhibit 99.1
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Seattle Genetics Reports First Quarter 2019 Financial Results

-ADCETRIS® (Brentuximab Vedotin) Net Sales in U.S. and Canada Were $135.0 Million in the First Quarter, an Increase of 42 Percent Over the First Quarter of 2018
-Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer Support Planned 2019 Submission of Biologics License Application-
-Target Enrollment Reached in HER2CLIMB Pivotal Trial of Tucatinib in HER2-Positive Metastatic Breast Cancer; Topline Results Expected in 2019-
-Conference Call Today at 4:30 p.m. ET-

BOTHELL, Wash. — April 25, 2019 — Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the first quarter ended March 31, 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 first quarter we achieved an important milestone toward becoming a multi-product oncology company with the announcement of positive topline results from the pivotal trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer, and we plan to submit an application for approval to the FDA in 2019,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We continue to execute on expanding ADCETRIS use in the two frontline indications, and maintain our 2019 net sales guidance of $610 million to $640 million in the U.S. and Canada. We have also advanced our other late-stage programs, including reaching target enrollment in the HER2CLIMB pivotal trial of tucatinib in HER2-positive metastatic breast cancer. We expect to report topline results from HER2CLIMB in 2019.”

ADCETRIS and Late-Stage Pipeline Highlights
•
ADCETRIS Ex-U.S. Regulatory Activities in Frontline Hodgkin Lymphoma: In February 2019, Takeda received approval from the European Commission to extend the marketing authorization for ADCETRIS to include ADCETRIS in combination with AVD (Adriamycin®, vinblastine and dacarbazine) in adult patients with previously untreated CD30-positive stage IV classical Hodgkin lymphoma. As a result, Seattle Genetics received a $30 million milestone payment from Takeda.
•
Enfortumab Vedotin (EV) Pivotal Trial Positive Topline Results; Data Selected for Oral Presentation at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting: In March 2019, Seattle Genetics and Astellas announced positive topline results from the first cohort of the EV-201 clinical trial that enrolled 128 patients with locally advanced or metastatic urothelial cancer who previously received both platinum chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study (EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The companies plan to submit a Biologics License Application under the U.S. Food and Drug Administration's (FDA) accelerated approval pathway in 2019.
•
Tucatinib HER2CLIMB Pivotal Trial Update: Seattle Genetics previously announced enrollment of 480 patients in the HER2CLIMB trial to enable analysis of the primary endpoint of progression-free survival (PFS), with topline data expected to be reported in 2019. In April 2019, Seattle Genetics achieved

The following information was filed by Seattle Genetics Inc Wa (SGEN) on Thursday, April 25, 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
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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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Inventories (Tables)
Investment And Other Income (Loss), Net
Investment And Other Income (Loss), Net (Details)
Investment And Other Income (Loss), Net (Tables)
Legal Matters
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Net Loss Per Share
Net 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)

Material Contracts, Statements, Certifications & more

Seattle Genetics Inc Wa provided additional information to their SEC Filing as exhibits

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 32.1: Section 1350 Certification
Exhibit 32.2: Section 1350 Certification
Ticker: SGEN
CIK: 1060736
Form Type: 10-Q Quarterly Report
Accession Number: 0001060736-19-000020
Submitted to the SEC: Thu Apr 25 2019 1:45:12 PM EST
Accepted by the SEC: Fri Apr 26 2019
Period: Sunday, March 31, 2019
Industry: Biological Products No Disgnostic Substances

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