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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. |
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Athenex, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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
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