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Seattle Genetics Inc Wa (SGEN) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Seattle Genetics Inc Wa

CIK: 1060736 Ticker: SGEN


Exhibit 99.1
sgen.jpg

Seattle Genetics Reports Fourth Quarter and Full Year 2018 Financial Results

-ADCETRIS® (Brentuximab Vedotin) Net Sales in U.S. and Canada of $476.9 Million in 2018, Including $132.1 Million in the Fourth Quarter-
-ADCETRIS Approved by FDA in Combination with Chemotherapy for Frontline CD30-Expressing PTCL-
-Top-line Data from Enfortumab Vedotin Pivotal Trial in Metastatic Urothelial Cancer Expected in the First Quarter of 2019-
-Conference Call Today at 4:30 p.m. ET-

BOTHELL, Wash. — February 7, 2019 — Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the fourth quarter and year ended December 31, 2018. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.
“During 2018, we received FDA approval for two ADCETRIS frontline indications, a major accomplishment that significantly expands the number of patients eligible to benefit from treatment. These approvals for frontline advanced Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma (PTCL) were based on phase 3 data showing superior efficacy of the ADCETRIS-containing regimens compared to combination chemotherapy agents that have been used for decades,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Additionally, we made progress in 2018 with our late-stage clinical programs, leading to important anticipated milestones this year. Notably, we expect to report top-line data in the first quarter of 2019 from the pivotal trial of enfortumab vedotin in metastatic urothelial cancer and to report top-line data later in the year from the pivotal trial of tucatinib in HER2-positive metastatic breast cancer. Taken together, we are positioned to establish ADCETRIS as the standard of care in the frontline setting in both advanced Hodgkin lymphoma and CD30-expressing PTCL, and realize our vision of becoming a company with multiple oncology products addressing unmet medical needs.”
ADCETRIS Program Highlights
New Indication for CD30-Expressing Frontline PTCL: In November 2018, the U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with chemotherapy for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. The approval is based on the successful outcome of the ECHELON-2 phase 3 clinical trial. The FDA granted Breakthrough Therapy Designation in this setting and reviewed the application under the Real-Time Oncology Review Pilot Program leading to approval less than two weeks after submission of the supplemental Biologics License Application (BLA).
New Indication in Canada: Health Canada approved ADCETRIS for the treatment of adult patients with primary cutaneous ALCL or CD30-expressing mycosis fungoides who have had prior systemic therapy.
Multiple Abstracts at ASH: In addition to the presentation of ECHELON-2 data, which were also simultaneously published in The Lancet, ADCETRIS was featured in more than 30 data presentations at the 60th American Society of Hematology (ASH) annual meeting from both corporate and investigator-led


The following information was filed by Seattle Genetics Inc Wa (SGEN) on Thursday, February 7, 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-K Annual 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-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Comprehensive Loss (Parenthetical)
Consolidated Statements Of Stockholders' Equity
Accounts Payable And Accrued Liabilities - Schedule Of Accounts Payable And Accrued Liabilities (Detail)
Accrued Liabilities
Accrued Liabilities (Tables)
Acquisition Of Cascadian
Acquisition Of Cascadian (Tables)
Acquisition Of Cascadian - Additional Information (Details)
Acquisition Of Cascadian - Schedule Of Business Acquisition, Unaudited Pro Forma Information (Details)
Acquisition Of Cascadian - Schedule Of Purchase Price Allocation Of Assets Acquired And Liabilities Assumed (Details)
Collaboration And License Agreements
Collaboration And License Agreements - Additional Information (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Noncancelable Obligations (Detail)
Employee Benefit Plan
Employee Benefit Plan - Additional Information (Detail)
Fair Value
Fair Value (Tables)
Fair Value - Additional Information (Details)
Fair Value - Summary Of Debt Securities (Details)
Fair Value - Summary Of Fair Value Hierarchy Of Assets Carried At Fair Value And Measured On A Recurring Basis (Detail)
In-License Agreements
In-License Agreements (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Schedule Of Company's Pre-Tax Loss By Jurisdiction (Detail)
Income Taxes - Schedule Of Deferred Tax Assets (Detail)
Income Taxes - Schedule Of Effective Income Tax Rate (Detail)
Income Taxes - Schedule Of Reconciliation Of Beginning And Ending Amount Of Unrecognized Tax Benefits (Detail)
Inventories
Inventories (Tables)
Inventories - Schedule Of Inventories (Detail)
Investment And Other Income, Net
Investment And Other Income, Net (Tables)
Investment And Other Income, Net - Additional Information (Details)
Investment And Other Income, Net - Schedule Of Investment And Other Income, Net (Details)
Manufacturing Facility Acquisition
Manufacturing Facility Acquisition (Tables)
Manufacturing Facility Acquisition - Summary Of Purchase Price Allocated To Assets Acquired And Liability Assumed Based On Estimated Fair Values (Detail)
Organization And Business
Organization And Business (Policies)
Property And Equipment
Property And Equipment (Tables)
Property And Equipment - Schedule Of Property And Equipment (Detail)
Property And Quipment - Additional Information (Detail)
Quarterly Financial Data (Unaudited)
Quarterly Financial Data (Unaudited) (Tables)
Quarterly Financial Data (Unaudited) - Schedule Of Quarterly Financial Data (Detail)
Revenue From Contracts With Customers
Revenue From Contracts With Customers (Tables)
Revenue From Contracts With Customers - Additional Information (Details)
Revenue From Contracts With Customers - Schedule Of Revenue From Contracts With Customers Impacts (Details)
Revenue From Contracts With Customers - Summary Of Collaboration And License Agreement Revenues By Collaborator (Details)
Revenue From Contracts With Customers - Summary Of Revenue From Contracts With Customers Cumulative Effect (Details)
Share-Based Compensation
Share-Based Compensation (Tables)
Share-Based Compensation - 2007 Equity Incentive Plan - Additional Information (Detail)
Share-Based Compensation - Employee Stock Purchase Plan - Additional Information (Detail)
Share-Based Compensation - Ltip Activity - Additional Information (Details)
Share-Based Compensation - Rsu Activity - Additional Information (Detail)
Share-Based Compensation - Schedule Of Ltip Equity Activity (Details)
Share-Based Compensation - Schedule Of Non-Vested Restricted Stock Units (Detail)
Share-Based Compensation - Schedule Of Stock Option Activity (Detail)
Share-Based Compensation - Schedule Of Stock Options Valuation Assumptions (Detail)
Share-Based Compensation - Share-Based Compensation Expense - Additional Information (Detail)
Share-Based Compensation - Stock Option Activity - Additional Information (Detail)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Detail)
Stockholders' Equity - Schedule Of Common Stock Reserved For Future Issuance (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Summary Of Significant Accounting Policies - Schedule Of Concentration Of Accounts Receivable Attributable To Certain Major Distributors (Detail)
Summary Of Significant Accounting Policies - Schedule Of Intangible Assets (Detail)
Summary Of Significant Accounting Policies - Schedule Of Percent Of Revenue Associated With Each Major Distributor Or Collaborator (Detail)
Summary Of Significant Accounting Policies - Schedule Of Property And Equipment, Estimated Useful Lives (Detail)
Summary Of Significant Accounting Policies - Schedule Of Weighted-Average Shares Excluded From Number Of Shares Used To Calculate Basic And Diluted Net Loss Per Share (Detail)
Ticker: SGEN
CIK: 1060736
Form Type: 10-K Annual Report
Accession Number: 0001060736-19-000010
Submitted to the SEC: Thu Feb 07 2019 12:10:57 PM EST
Accepted by the SEC: Thu Feb 07 2019
Period: Monday, December 31, 2018
Industry: Biological Products No Disgnostic Substances

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