Athenex, Inc. (ATNX) 10-K Annual Report March 2019

Full year 2018 revenue was $89.1 million (after accounting for termination of the KX2-391 licensing arrangement in China that would have contributed to $14.5 million licensing fee revenue), compared to $38.0 million in 2017

4Q 2018 revenue was $21.3 million, compared to $14.9 million in 4Q 2017

Conference call and live audio webcast at 8:30 a.m. Eastern Time today

BUFFALO, N.Y., March 11, 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 fourth quarter and year ended December 31, 2018.

“In 2018, we made substantial progress in advancing our pipeline and expanding our technology platforms in oncology as we work towards building a global biopharmaceutical business,” stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. “We are on track to continue this positive momentum in 2019, with the expected completion of our Phase III study of Oraxol in metastatic breast cancer and preparations underway for regulatory filings for KX2-391 in actinic keratosis. We now have a total of 8 product candidates in the clinic, with INDs on 2 further candidates scheduled by mid-year, and we are committed to continuing our strong clinical execution. On the operational front, we continue to build out our commercial infrastructure and global supply chain as we put the plans in place to launch our proprietary products.”

Fourth Quarter 2018 and Recent Business Highlights:

Clinical Programs:

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KX2-391 ointment in actinic keratosis: Positive topline results from two pivotal Phase III studies were featured in a late breaker session at the 2019 American Academy of Dermatology Annual Meeting

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In studies KX01-AK-003 and KX01-AK-004, 44% and 54% of patients, respectively, achieved 100% AK lesion clearance at Day 57. The results were highly statistically significant.

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Safety profile of KX2-391 ointment may be an important competitive advantage; adherence to treatment was greater than 99%

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Oraxol Phase III studies in metastatic breast cancer: Achieved target enrollment of 360 patients. Topline results are expected to be available in mid-2019

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Other Oraxol studies:

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Announced positive results from the second cohort of patients in a global Phase Ib clinical trial of Oraxol plus ramucirumab in gastric cancer patients who failed previous chemotherapies. The Oraxol dose is currently being further escalated to 300 mg/m² in the third cohort of patients and the study is ongoing.

The following information was filed by Athenex, Inc. (ATNX) on Monday, March 11, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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https://last10k.com/sec-filings/report/1300699/000156459019007092/atnx-10k_20181231.htm

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

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

Exhibit 10.44: Material Contract

Exhibit 10.45: Material Contract

Exhibit 10.46: Material Contract

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: 0001564590-19-007092
Submitted to the SEC: Mon Mar 11 2019 8:02:48 AM EST
Accepted by the SEC: Mon Mar 11 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations