Athenex, Inc. (ATNX) 10-Q Quarterly Report May 2021

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 first quarter ended March 31, 2021.

“We continue to work diligently with our advisers to analyze and respond to the complete response letter received from the FDA on oral paclitaxel plus encequidar (oral paclitaxel). We are collecting additional data and doing additional analyses in support of our application. We expect to have a type A meeting with the FDA before end of the second quarter.” said Johnson Lau, CEO and Chairman of Athenex. “We remain committed to pursuing regulatory approval of oral paclitaxel and aim to bring this important product to market to benefit metastatic breast cancer patients. We hope to align with the FDA, work to resolve its concerns and reach agreement on the path forward required to obtain approval. In parallel, we continue our efforts to deepen our pipeline and are excited to add Kuur Therapeutics and its innovative allogeneic CAR-NKT technology to the Athenex platform.”

First Quarter 2021 and Recent Business Highlights

Clinical Programs

Oral Paclitaxel for Metastatic Breast Cancer

•

Athenex received a Complete Response Letter (CRL) from the US Food & Drug Administration (FDA) for the New Drug Application (NDA) for oral paclitaxel in metastatic breast cancer on February 26, 2021.

Klisyri^® in actinic keratosis

•

Almirall, S.A. (BLM: ALM), Athenex’s U.S. partner, launched Klisyri^® in the U.S. on February 18, 2021, triggering a $20 million milestone payment from Almirall

•

In February 2021, the New England Journal of Medicine published Phase 3 trial results on the efficacy and safety of tirbanibulin ointment for the topical treatment of actinic keratosis of the face or scalp

Cell Therapy

•

Acquired Kuur Therapeutics (privately held), a leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies in May 2021

•

Athenex will pay $70 million upfront, comprised primarily of equity in Athenex common stock, to Kuur shareholders and certain of its former employees and directors

The following information was filed by Athenex, Inc. (ATNX) on Thursday, May 6, 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.

Please wait while we load the requested 10-Q report or click the link below:

https://last10k.com/sec-filings/report/1300699/000156459021024603/atnx-10q_20210331.htm

View differences made from one quarter to another to evaluate Athenex, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ) — *Sample 10-K Year-over-Year (YoY) Comparison*

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were ~~removed~~ , added and changed by Athenex, Inc..

Continue

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 2021 10-K Annual Report includes:

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

Continue

Rating
Learn More

Filter Sentiment:

All

Positive

Negative

Filter Category:

All

Financial

Revenue

Legal

M & A

Other

Filter Subcategory:

All

Geography

Expense

Product

Debt

Cash Flow

Other

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.

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 - Shares Highlight
Additionally, Kuur shareholders and its former employees and directors are eligible to receive up to $115.0 million of milestone payments, which may be paid, at the Company's sole discretion, in either cash or additional common stock of the Company (or a combination of both).
Revenue - Geography Highlight
The decrease was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements in the prior year.
Legal - Other
We also anticipate increases to...Read more
Financial - Expense
We anticipate that our SG&A...Read more
Financial - Expense
SG&A expenses for the three...Read more
Revenue - Product
The difference was primarily due...Read more
Financial - Expense
However, we expect that our...Read more
Revenue - Product
Our operating assets increased $34.7...Read more
Revenue - Product
We are organized around three...Read more
Financial - Expense
This was primarily due to...Read more
Revenue - Product
We have borrowed and, in...Read more
Revenue - Product
API product sales increased by...Read more
Revenue - Geography
The recent surge of COVID-19...Read more
Revenue - Product
We derive our consolidated revenue...Read more
Revenue - Product
If we raise additional funds...Read more
Financial - Debt
Debt financing, if available, may...Read more
M & A - Other
On May 4, 2021, we...Read more
Other - Other
Our mission is to improve...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
Based on the results, the...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
Financial - Expense
R&D expenses for the three...Read more
Other - Other
We have borrowed and, in...Read more
Financial - Expense
Cost of sales also includes...Read more
Other - Other
We have assembled a strong...Read more
Financial - Cash Flow
Capital Resources Since our inception,...Read more
Other - Other
In the normal course of...Read more
Other - Other
We have based these estimates...Read more
Financial - Expense
We also put in place...Read more
Other - Other
We have three operating segments:...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 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: 0001564590-21-024603
Submitted to the SEC: Thu May 06 2021 10:03:10 AM EST
Accepted by the SEC: Thu May 06 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations