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Athenex, Inc. (ATNX) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Athenex, Inc.

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CIK: 1300699 Ticker: ATNX

Exhibit 99.1

Athenex Provides Third Quarter 2021 Corporate and Financial Update

Held FDA Type A Meeting for oral paclitaxel in metastatic breast cancer

Klisyri® launched in Europe

ANCHOR Phase 1 interim results accepted for poster presentation at 2021 ASH

3Q product sales were $27.0M, up 9% year-over-year

Company now expects full year product sales revenue in 2021 to decrease by 6-12% compared to 2020

Management to host conference call and webcast today at 10:00 a.m. ET

Buffalo, N.Y., November 4, 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 third quarter ended September 30, 2021.

“Following our recent Type A meeting with U.S. FDA to discuss our New Drug Application for oral paclitaxel and encequidar (Oral Paclitaxel) in metastatic breast cancer, we determined that deploying our resources towards other ongoing clinical programs of Oral Paclitaxel and our cell therapy programs would be a better way to maximize value for all of our shareholders and stakeholders,” said Johnson Lau, Chief Executive Officer of Athenex. “Our management team is focused on advancing the clinical pipeline where we believe Athenex has a strong competitive advantage, as well as exploring various other approaches for our assets that will unlock shareholder value. We are particularly pleased with the continued positive momentum and increasing visibility of our cell therapy programs.”

Third Quarter 2021 and Recent Business Highlights

Clinical Programs

Orascovery

 

  •  

Held a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Oral Paclitaxel in metastatic breast cancer.

 

  •  

Presented positive interim data from a Phase 1 trial evaluating Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid malignancies at ESMO 2021.

 

  •  

Received confirmation from the Innovative Licensing and Access Pathway (ILAP) in the UK that encequidar in combination with oral anticancer medicines has been awarded the innovative medicine designation, the Innovation Passport. ILAP was set up by the UK Medicines & Healthcare products Regulatory Agency (MHRA) and other UK government agencies to efficiently accelerate the time to market and facilitating patient access to innovative medicines.

Cell Therapy

 

  •  

Interim data from the ongoing Phase 1 ANCHOR trial evaluating KUR-502 in patients with CD19-positive relapsed or refractory lymphoma and leukemia have been accepted for poster presentation at the 2021 ASH Annual Meeting.

The following information was filed by Athenex, Inc. (ATNX) on Thursday, November 4, 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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Assess how Athenex, Inc.'s management team is paid from their Annual Proxy

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

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

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Inside Athenex, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Schedule Of Accrued Expenses (Detail)
Business Combination - Additional Information (Details)
Business Combination - Schedule Of Unaudited Pro Forma Consolidated Financial Information (Details)
Business Combination - Summary Of Purchase Price And Initial Estimates Of Fair Values Of Assets And Liabilities Acquired (Details)
Business Combination - Summary Of Purchase Price And Initial Estimates Of Fair Values Of Assets And Liabilities Acquired (Parenthetical) (Details)
Business Combinations
Business Combinations (Tables)
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)
Contingent Consideration
Contingent Consideration (Tables)
Contingent Consideration - Additional Information (Detail)
Contingent Consideration - Schedule Of Reconciliation Of Contingent Consideration Liability Related To Acquisition (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)
Income Taxes
Income Taxes - Additional Information (Detail)
Intangible Assets, Net
Intangible Assets, Net (Tables)
Intangible Assets, Net - Additional Information (Details)
Intangible Assets, Net - Summary Of Identifiable Intangible Asset, Net (Details)
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 Outstanding Shares Of Common Stock Equivalents Excluded From The Calculation Of Diluted Net Loss Per Share (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 And Contract Assets Balances By Reportable Segments (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 Event
Subsequent Event - Additional Information (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Additional Information (Details)

Material Contracts, Statements, Certifications & more

Athenex, Inc. 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
Ticker: ATNX
CIK: 1300699
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-054283
Submitted to the SEC: Thu Nov 04 2021 9:26:45 AM EST
Accepted by the SEC: Thu Nov 04 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations

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