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Athenex, Inc. (ATNX) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Athenex, Inc.

CIK: 1300699 Ticker: ATNX

Exhibit 99.1

Athenex, Inc. Announces Third Quarter 2019 Financial Results

Oral presentation of Phase III Oral Paclitaxel data at the San Antonio Breast Cancer Symposium

NDA submissions for Oral Paclitaxel and tirbanibulin ointment are on track

$19.2 million of product sales in Q3 2019, a 45% year-over-year increase

Raising full year 2019 guidance to 35% to 40% year-over-year growth

Conference call and live audio webcast at 8:00 a.m. Eastern Time today

BUFFALO, N.Y., November 7, 2019 — 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 third quarter of 2019.

“We continue to make strong progress across the board, bringing us closer to our goal of becoming a fully integrated global pharma company,” stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. “We have several major catalysts upcoming, including two anticipated NDA submissions. We are also scheduled to deliver an oral presentation to discuss the Phase III data for Oral Paclitaxel in metastatic breast cancer at the San Antonio Breast Cancer Symposium in December. We have been strategic in building out and integrating our clinical and manufacturing operations in order to maximize the commercial opportunities of our rapidly advancing pipeline. We believe we are in a strong position to develop multiple, potentially successful therapies in the future.”

Mr. Jeffrey Yordon, Chief Operating Officer of Athenex, commented, “We are continually optimizing our commercial infrastructure, developing the market, and building awareness of our Athenex Oncology brand in anticipation of commercial launch of Oral Paclitaxel. We have finalized our staffing and organizational plan, and intend to make additional key hires next year, including medical science liaisons and regional sales leaders, with the full sales team expected to come on board in the months leading up to potential approval. In addition to late-stage pipeline progress, we once again achieved strong revenue growth for our existing commercial business. We plan to continue launching additional products in the remainder of 2019 and into next year.”

Third Quarter 2019 and Recent Business Highlights:

Clinical Programs:

Phase III Study of Oral Paclitaxel and Encequidar for Metastatic Breast Cancer

 

   

Study met primary endpoint showing statistically significant improvement in overall response rate for oral paclitaxel and encequidar (“Oral Paclitaxel”) compared to IV paclitaxel.

 

   

Strong trend in progression-free survival (PFS) and overall survival (OS) of Oral Paclitaxel compared to IV paclitaxel.

 

   

Proportion of confirmed responders with duration of response >150 days was 2.5 times higher for Oral Paclitaxel than IV paclitaxel.

 

   

Neuropathy was less frequent with Oral Paclitaxel compared to IV paclitaxel.

 

   

Planning to meet with the FDA and present data at SABCS.

Other Oral Paclitaxel Developments

 

   

European Commission granted orphan designations for paclitaxel and for encequidar for the treatment of soft tissue sarcoma.


The following information was filed by Athenex, Inc. (ATNX) on Thursday, November 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-Q Quarterly 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 2019 10-K Annual Report includes:

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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 (Parenthetical) (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Additional Information (Detail)
Accrued Expenses - Schedule Of Accrued Expensest (Detail)
Acquisitions
Acquisitions - 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 - 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)
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 Balances By Reportable Segments (Detail)
Revenue Recognition - Summary Of Receivables And Contract Liabilities From Contracts With Customers (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 - Additional Information (Detail)

Material Contracts, Statements, Certifications & more

Athenex, Inc. provided additional information to their SEC Filing as exhibits

Ticker: ATNX
CIK: 1300699
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-19-042473
Submitted to the SEC: Tue Nov 12 2019 6:07:49 AM EST
Accepted by the SEC: Tue Nov 12 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations

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