Athenex, Inc. (ATNX) 10-Q Quarterly Report November 2020

BUFFALO, N.Y., November 5, 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 third quarter ended September 30, 2020.

“Our New Drug Application (NDA) filing for Oral Paclitaxel was accepted with priority review and a target action date of February 28, 2021,” stated Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. “Oral Paclitaxel has a compelling efficacy, and tolerability profile that we believe positions it to potentially become the chemotherapy of choice in metastatic breast cancer. Our supply chain is in place and we are finalizing our commercial plans, with the goal of launching in the U.S. upon approval in the first quarter of 2021.”

“During the quarter, we strengthened our balance sheet with a successful equity financing, raising net proceeds of $118.7 million,” continued Dr. Lau. “This provides us with additional resources and financial flexibility to invest in and expand our commercial infrastructure, as well as to pursue label expansion initiatives for Oral Paclitaxel and continued development of our pipeline. The planned commercial launch of Oral Paclitaxel will also be funded by the other financings we recently announced with Oaktree and Sagard Healthcare Royalty Partners, which provide a total of $225 million and $50 million, respectively, based on associated milestones.”

Third Quarter 2020 and Recent Business Highlights:

Clinical Programs:

Oral Paclitaxel for Breast Cancer

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The U.S. Food and Drug Administration (FDA) accepted an NDA for Oral Paclitaxel for the treatment of metastatic breast cancer and has granted the application Priority Review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of February 28, 2021.

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Launched two new study arms of the I-SPY 2 TRIAL, sponsored by Quantum Leap Healthcare Collaborative, to evaluate Oral Paclitaxel in combination with GSK’s dostarlimab in Stage 2/3 HER2+ and HER2- breast cancer patients.

Tirbanibulin Ointment for Actinic Keratosis

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Under the PDUFA, the FDA has set a target action date for tirbanibulin ointment as December 30, 2020.

The following information was filed by Athenex, Inc. (ATNX) on Thursday, November 5, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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

Financial - Shares Highlight
However, a lack of sustained recovery or further deterioration in market conditions related to the general economy and the industries in which we operate, a sustained trend of weaker than anticipated financial performance, further decline in our share price for a sustained period of time, or an increase in the market-based weighted average cost of capital, among other factors, could significantly impact the impairment analysis and may result in future impairment charges that, if incurred, could have a material adverse effect on our financial condition and results of operations.

Revenue - Product Highlight
In addition, the Revenue Interest Financing Agreement provides that if certain events ("Put Option Events") occur, including certain bankruptcy events, non-payment of Payments, a change of control, an out-license or sale of all of the rights in and to Oral Paclitaxel in the U.S. (other than any out-licensing transaction that includes all or substantially all of the U.S. and European development and commercialization rights to Oral Paclitaxel with a pharmaceutical company with global annual revenues for its most recently completed fiscal year that is greater than or equal to $500.0 million attributable to its oncology business) and (subject to applicable cure periods) non-compliance with the covenants in the Revenue Interest Financing Agreement, Sagard may require us to repurchase its interests in the Payments at the Put/Call Price.
Other - Other Highlight
We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets.
Other - Other Highlight
We may borrow additional funds on terms that may include restrictive covenants, including covenants that further restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets.
Financial - Expense Highlight
The increase is primarily attributable to increases in cost of sales, SG&A costs, and losses related to the extinguishment of debt.
Financial - Debt
The first tranche of $100.0...Read more
Financial - Expense
We expect to incur significant...Read more
Revenue - Product
The difference was primarily due...Read more
Revenue - Product
Our operating assets increased $26.3...Read more
Revenue - Product
Our operating assets increased $4.2...Read more
Other - Other
Net cash used in operating...Read more
Financial - Expense
SG&A expenses for the three...Read more
Financial - Expense
SG&A expenses for the nine...Read more
Financial - Shares
We granted the underwriters a...Read more
Other - Other
In the normal course of...Read more
Revenue - Product
We are organized around three...Read more
Revenue - Geography
The increase was primarily attributable...Read more
Financial - Expense
Our operating liabilities decreased by...Read more
Financial - Expense
R&D expenses for the three...Read more
Financial - Expense
R&D expenses for the nine...Read more
Revenue - Product
We have borrowed and, in...Read more
Financial - Debt
An additional three debt tranches...Read more
Revenue - Product
Our operating liabilities increased by...Read more
Financial - Shares
In connection with our entry...Read more
Financial - Shares
In connection with the Assignment,...Read more
Financial - Shares
In connection with the Assignment,...Read more
Financial - Shares
In connection with our entry...Read more
Revenue - Product
We derive our consolidated revenue...Read more
Revenue - Product
If we raise additional funds...Read more
Financial - Debt
Additional debt financing, if available,...Read more
Revenue - Product
This increase was primarily attributable...Read more
Other - Other
Our mission is to improve...Read more
Financial - Shares
In September 2020, we completed...Read more
Revenue - Product
Revenue from product sales increased...Read more
Revenue - Product
Revenue from product sales increased...Read more
Financial - Shares
To the extent that we...Read more
Financial - Shares
To the extent that we...Read more
Financial - Expense
The primary use of our...Read more
Other - Other
In September 2020, we announced...Read more
Financial - Shares
Our obligations under the Senior...Read more
Other - Other
Although we believe that the...Read more
Other - Other
Outlook We have borrowed and,...Read more
Financial - Expense
Cost of sales also includes...Read more
Other - Other
The first and second tranches...Read more
Financial - Expense
This was primarily due to...Read more
Other - Other
We have assembled a strong...Read more
Revenue - Product
This increase was primarily attributable...Read more
Financial - Cash Flow
Capital Resources Since our inception,...Read more
Other - Other
We have based these estimates...Read more
Financial - Expense
We also put in place...Read more
Other - Other
As a result of the...Read more
Other - Other
We have three operating segments:...Read more
Financial - Expense
We expect that our expenses...Read more
Financial - Income
The increase in income tax...Read more
Financial - Shares
Private Placements On December 9,...Read more
Financial - Expense
We expect our R&D expenses...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

Exhibit 10.2: Material Contract

Exhibit 10.3: Material Contract

Exhibit 10.4: Material Contract

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: 0001564590-20-050950
Submitted to the SEC: Thu Nov 05 2020 10:02:16 AM EST
Accepted by the SEC: Thu Nov 05 2020
Period: Wednesday, September 30, 2020
Industry: Pharmaceutical Preparations