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Athenex, Inc. (ATNX) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2020

Athenex, Inc.

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CIK: 1300699 Ticker: ATNX

Exhibit 99.1

Athenex Provides Fourth Quarter and Full Year 2020 Corporate and Financial Update

 

  •  

Receipt of Complete Response Letter from the FDA for Oral Paclitaxel Plus Encequidar

 

  •  

Klisyri® (tirbanibulin) received FDA approval and launched commercially on February 18, 2021

 

  •  

The New England Journal of Medicine published Phase III trial data on the efficacy and safety of Klisyri®

 

  •  

Product sales in 4Q20 grew 54.4% Y/Y to $21.8 million

 

  •  

2021 product sales (excluding proprietary products) expected to be in line with 2020

 

  •  

Management to host conference call and webcast today at 8:00 a.m. ET

Buffalo, N.Y., March 1, 2021 (GLOBE NEWSWIRE) – Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today provided a corporate and financial update for the fourth quarter and full year ended December 31, 2020.

Oral Paclitaxel Plus Encequidar Update

As announced by Athenex in a separate press release this morning, the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Company’s New Drug Application (NDA) for oral paclitaxel and encequidar for the treatment of metastatic breast cancer. In the CRL, the FDA expressed the following:

 

  •  

Concerns about safety risks associated with increase in neutropenia-related sequelae

 

  •  

Concerns regarding the primary endpoint assessment conducted by the Blinded Independent Central Review (BICR)

 

  •  

Recommendation that Athenex conduct a new clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.

“We are surprised and disappointed by the FDA’s decision to issue a complete response letter for oral paclitaxel and encequidar,” said Johnson Lau, Chief Executive Officer of Athenex. “Based on the clinical benefits demonstrated by the Phase III trial results, we are committed to exploring our available options to obtain approval for oral paclitaxel and encequidar. Additionally, we will undertake a thorough review of our organization to best position ourselves to create value for all stakeholders as we move forward.”

Fourth Quarter 2020 and Recent Business Updates

Clinical Programs:

Oral Paclitaxel Plus Encequidar for Metastatic Breast Cancer

 

  •  

Athenex received a Complete Response Letter from the FDA for the NDA for oral paclitaxel for metastatic breast cancer

The following information was filed by Athenex, Inc. (ATNX) on Monday, March 1, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Athenex, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:

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Inside Athenex, Inc.'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 Operations And Comprehensive Loss
Consolidated Statements Of Stockholders Equity
Consolidated Statements Of Stockholders Equity (Parenthetical)
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Additional Information (Detail)
Accrued Expenses - Schedule Of Accrued Expensest (Detail)
Accumulated Other Comprehensive Loss
Accumulated Other Comprehensive Loss (Tables)
Accumulated Other Comprehensive Loss - Schedule Of Accumulated Other Comprehensive Loss (Detail)
Acquisitions
Acquisitions - Additional Information (Detail)
Business And Economic Collaborative Agreements
Business And Economic Collaborative Agreements - Additional Information (Detail)
Business Segment, Geographic, And Concentration Risk Information
Business Segment, Geographic, And Concentration Risk Information (Tables)
Business Segment, Geographic, And Concentration Risk Information - Additional Information (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Customer Revenue And Accounts Receivable Concentration (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Depreciation, Amortization And Assets By Segment (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Property And Equipment By Geographical Segment (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Revenue By Geographical Segment (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Revenue By Product Group (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Revenue By Segments (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Segment Information (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Future Minimum Payments Under Non-Cancelable Leases (Detail)
Company And Nature Of Business
Company And Nature Of Business - Additional Information (Detail)
Debt And Lease Obligations
Debt And Lease Obligations (Tables)
Debt And Lease Obligations - Additional Information (Detail)
Debt And Lease Obligations - Schedule Of Future Minimum Payments And Maturities Of Leases (Detail)
Debt And Lease Obligations - Schedule Of Supplemental Balance Sheet Information Related To Leases Of Debt (Detail)
Debt And Lease Obligations - Schedule Of Supplemental Cash Flow Information Related To Leases (Detail)
Debt And Lease Obligations - Summary Of Balances Of Debt (Detail)
Debt And Lease Obligations - Summary Of Balances Of Debt (Parenthetical) (Detail)
Debt And Lease Obligations - Summary Of Components Of Lease Expense (Detail)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Detail)
Fair Value Measurements - Schedule Of Assets And Liabilities Measured At Fair Value On A Recurring Basis (Detail)
Goodwill And Intangible Assets, Net
Goodwill And Intangible Assets, Net (Tables)
Goodwill And Intangible Assets, Net - Additional Information (Detail)
Goodwill And Intangible Assets, Net - Goodwill (Detail)
Goodwill And Intangible Assets, Net - Schedule Of Expected Amortization Expense Of Finite-Lived Intangible Assets (Detail)
Goodwill And Intangible Assets, Net - Summary Of Identifiable Intangible Asset, Net (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Components Of Loss Before Income Tax Expense (Detail)
Income Taxes - Components Of The Income Tax Expense (Detail)
Income Taxes - Schedule Of Income Tax Expense Differs From The Federal Statutory Rate (Detail)
Income Taxes - Schedule Of Net Deferred Income Tax Liabilities (Detail)
Inventories
Inventories (Tables)
Inventories - Schedule Of Inventories (Detail)
Net Loss Per Share Attributable To Athenex, Inc. Common Stockholders
Net Loss Per Share Attributable To Athenex, Inc. Common Stockholders (Tables)
Net Loss Per Share Attributable To Athenex, Inc. Common Stockholders - Schedule Weighted Average Outstanding Shares Of Common Stock Equivalents Excluded From The Calculation Of Diluted Net Loss Per Share (Detail)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Additional Information (Detail)
Property And Equipment, Net - Schedule Of Property, Plant And Equipment (Detail)
Related Party Transactions
Related Party Transactions - Additional Information (Detail)
Restricted Cash
Restricted Cash - Additional Information (Detail)
Revenue Recognition
Revenue Recognition (Tables)
Revenue Recognition - Additional Information (Detail)
Revenue Recognition - Schedule Of Company's Revenue For Reportable Segment By Country Based On Locations Of Customer (Detail)
Revenue Recognition - Summary Of Accounts Receivable Balances By Reportable Segments (Detail)
Revenue Recognition - Summary Of Receivables And Contract Liabilities From Contracts With Customers (Detail)
Schedule Ii - Valuation And Qualifying Accounts
Schedule Ii - Valuation And Qualifying Accounts (Detail)
Selected Quarterly Financial Data (Unaudited)
Selected Quarterly Financial Data (Unaudited) (Tables)
Selected Quarterly Financial Data (Unaudited) - Schedule Of Quarterly Results Of Operations (Unaudited) (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Detail)
Stock-Based Compensation - Schedule Of Stock Option Activity (Detail)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Cost (Detail)
Stock-Based Compensation - Schedule Of Weighted-Average Assumptions Used As Inputs To Black-Scholes Option Pricing Model (Detail)
Subsequent Events
Subsequent Events - Additional Information (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Summary Of Significant Accounting Policies - Property, Plant And Equipment, Useful Life (Detail)
Ticker: ATNX
CIK: 1300699
Form Type: 10-K Annual Report
Accession Number: 0001564590-21-009879
Submitted to the SEC: Mon Mar 01 2021 4:23:58 PM EST
Accepted by the SEC: Mon Mar 01 2021
Period: Thursday, December 31, 2020
Industry: Pharmaceutical Preparations

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