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Last10K.com | 10-K Annual Report Mon Mar 02 2020
Exhibit 99.1
Athenex, Inc. Reports Fourth Quarter and Year Ended December 31, 2019 Financial Results and
Provides Corporate Update
| • | Tirbanibulin ointment NDA for actinic keratosis was submitted |
| • | Oral Paclitaxel NDA submission is on track; Final FDA meeting scheduled for early April |
| • | Presentation of Oral Paclitaxel Phase 3 results at SABCS received broad positive reception |
| • | 43% y/y increase in product revenue and 14% y/y increase in total revenue for 2019 |
| • | Conference call & webcast today at 8:00am Eastern Time |
BUFFALO, N.Y., February 27, 2020 — 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 announced its financial results and business highlights for the fourth quarter ended December 31, 2019.
“Following a very successful and productive 2019, our team’s immediate focus is to execute on regulatory approval of our two most advanced candidates, Oral Paclitaxel and tirbanibulin ointment. Both of these products have the potential to change the standard of care in their respective markets,” stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. “We have been making the necessary investments in our manufacturing and commercial infrastructure to ensure a successful launch for Oral Paclitaxel upon approval. Our goal is to establish Oral Paclitaxel as the treatment of choice for patients receiving chemotherapy for metastatic breast cancer.”
Fourth Quarter 2019 and Recent Business Highlights:
Clinical Programs:
Tirbanibulin ointment for actinic keratosis (AK)
| • | A New Drug Application (NDA) was submitted to the FDA. |
Oral Paclitaxel for metastatic breast cancer
| • | Results presented at 2019 San Antonio Breast Cancer Symposium (SABCS) showed that Oral Paclitaxel had superior response and overall survival benefit compared to IV paclitaxel in the treatment of metastatic breast cancer. |
| • | Incidence and severity of neuropathy were less frequent with Oral Paclitaxel compared to IV paclitaxel. |
| • | Oral Paclitaxel abstract accepted for Press Program at SABCS. |
| • | Final FDA meeting has been scheduled for early April and the Company plans to submit an NDA in the US shortly thereafter. |
Corporate Announcements:
| • | Expanded strategic partnership with Guangzhou Xiangxue Pharmaceutical through a licensing agreement for Oral Paclitaxel, Oral Irinotecan, and tirbanibulin ointment, in China, Hong Kong and Macao. Athenex is entitled to receive aggregate payments of up to $200 million, including an initial license payment of $30 million, and double-digit tiered royalties on commercial sales. |
| • | In December 2019, closed a private placement equity offering of 3.95 million shares of common stock at a price of $15.30 per share. Net proceeds from the offering were approximately $59.4 million. |
Commercial Business:
| • | Athenex Pharmaceutical Division (APD) currently markets a total of 30 products with 59 SKUs. |
| • | Athenex Pharma Solutions (APS) currently markets 5 products with 16 SKUs. |
| • | Goal is to launch 7 products in 2020, including a major 503B product. |
The following information was filed by Athenex, Inc. (ATNX) on Thursday, February 27, 2020 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.
View differences made from one year to another to evaluate Athenex, Inc.'s financial trajectory
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Athenex, Inc..
Assess how Athenex, Inc.'s management team is paid from their Annual Proxy
Athenex, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2020 10-K Annual Report includes:
- Voting Procedures
- Board Members
- Executive Team
- Salaries, Bonuses, Perks
- Peers / Competitors
SEC Filing Tools
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 Assets (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)
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
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)
Material Contracts, Statements, Certifications & more
Athenex, Inc. provided additional information to their SEC Filing as exhibits
Exhibit 4.2: Instruments Defining The Rights Of Security Holders, Including Indentures
Exhibit 21.1: Subsidaries Of The Registrant
Exhibit 23.1: Consents Of Experts And Counsel
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-K Annual Report
Accession Number: 0001564590-20-008138
Submitted to the SEC: Mon Mar 02 2020 4:02:13 PM EST
Accepted by the SEC: Mon Mar 02 2020
Period: Tuesday, December 31, 2019
Industry: Pharmaceutical Preparations
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