Athenex, Inc. Announces First Quarter 2019 Financial Results and Provides Corporate Update
Positive Phase 3 data for KX2-391 featured at 2019 AAD Annual Meeting
Promising early and complete response data reported for Oraxol in cutaneous angiosarcoma
Topline results from Oraxol Phase III clinical trial expected
Presenting four abstracts featuring
Approximately 100% year-over-year increase in Q1 product sales
Conference Call and Live Audio Webcast at 8:00 a.m. Eastern Time today
“In the first quarter of 2019 we continued to make progress across our all our technology platforms and business units as we execute on our corporate strategy to build a global oncology company delivering more effective, safer and tolerable treatments for cancer patients,” stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. “Most notably, we recently reported promising preliminary data from our ongoing pilot study of Oraxol in angiosarcoma, which included three complete responses from the first seven patients to receive at least six weeks of Oraxol monotherapy, all of whom showed visible improvements in the angiosarcoma lesions within one to two weeks. We believe the high response rate and strong safety profile further support the rationale that oral paclitaxel can potentially achieve a more desirable pharmacokinetic profile and a better clinical outcome, giving us greater confidence in our all of our Oraxol clinical programs.”
Dr. Lau continued, “Having achieved target enrollment in our Phase III trial of Oraxol in metastatic breast cancer we look forward to announcing top line results in August. Preparations are underway for regulatory filings for our partnered product KX2-391 in actinic keratosis. We are also working to build out our commercial and manufacturing infrastructure and develop our corporate brand in advance of anticipated proprietary product launches. Finally, we have added to our Board of Directors with four key appointments.”
“We have also strengthened our balance sheet, with a private placement equity offering, completed on
First Quarter 2019 and Recent Business Highlights:
Clinical Programs:
- Presented positive Phase 3 data on KX2-391 in actinic keratosis (AK) at the
American Academy of Dermatology (AAD) annual meeting. Both Phase 3 studies are nearing completion of the one-year follow-up of patients who had complete responses and the final top-line data will be discussed with theFDA at an upcoming pre-NDA meeting. - Oraxol Phase III studies in metastatic breast cancer: Achieved target enrollment of more than 360 patients. Topline results are expected to be available in
August 2019 . - Announced Investigational New Drug (IND) allowance by China’s
National Medical Products Administration (NMPA) to begin registrational related clinical studies in China of TAEST16001 injection in patients with solid tumors- TAEST16001 is a cancer immunotherapy product candidate based on Athenex’s T-cell receptor Affinity Enhanced Specific T-cell (TAEST) technology
- TEAST technology is being developed by Axis Therapeutics, a joint venture between
Athenex and Xiangxue Life Sciences (XLifeSc)
- Reported promising clinical results from a clinical study of Oraxol in cutaneous angiosarcoma. Preliminary data show rapid, visible response to Oraxol monotherapy in the first seven subjects, including three complete responses.
- Presented preclinical data on Oraxol in the treatment of angiosarcoma at the
American Association for Cancer Research (AACR) annual meeting onApril 3, 2019 - Announced acceptance of four abstracts for presentation at the 2019
American Society of Clinical Oncology (ASCO ) annual meeting. Abstract topics include:- Oraxol program in metastatic breast cancer, including information about ongoing Phase III trial and about Phase II trial in
Taiwan (two abstracts) - Preliminary results from Oratecan Phase I study
- Preclinical proof of concept data on Arginine Deprivation Therapy platform
- Oraxol program in metastatic breast cancer, including information about ongoing Phase III trial and about Phase II trial in
Corporate Announcements:
- Appointed new members to the Board of Directors:
John Moore Vierling , MD, FACP, FAASLD, AGAF, tenured Professor of Medicine and Surgery at theBaylor College of Medicine Stephanie Davis , Senior Client Partner atKorn Ferry Jordan S. Kanfer , Managing Director,Convertible and Equity Research atOpti Capital Management John Koh , an independent director ofNSL Ltd. ;Mapletree Industrial Trust , aSingapore listed REIT; Kris Energy; andAurora Mobile Limited (JG)
Commercial Business:
- Athenex Pharmaceutical Division (“APD”) currently markets a total of 29 products with 54 SKUs
- Athenex Pharma Solutions (“APS”) currently markets 6 products in total with 16 SKUs
Financial Results for the First Quarter Ended
Total revenue for the three months ended
Cost of sales for the three months ended
Research and development expenses for the three months ended
Selling, general and administrative expenses for the three months ended
Net loss attributable to
At
On
Outlook and Upcoming Milestones:
- Presentations at the 2019
American Society of Clinical Oncology (ASCO ) annual meeting - Expect to file an IND for Pegtomarginase by mid-2019
- Top line results from Phase 3 trial of Oraxol in metastatic breast cancer,
August 2019 - Expect to conduct a pre-IND meeting with the U.S.
FDA for TAEST16001 injection product under the TCR-T immunotherapy program
Financial Guidance:
The company provides revenue guidance for product sales only. The revenue guidance excludes license and collaboration fees.
Conference Call and Webcast Information:
The Company will host a conference call and live audio webcast today,
To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13689379. The live conference call and replay can also be accessed via audio webcast at https://edge.media-server.com/m6/p/ohu4cnks and on the Investor Relations section of the Company’s website, located at http://ir.athenex.com/, under “Events and Presentations.”
About
Founded in 2003,
Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” "preliminary", “probable,” “project,” "promising,” “seek,” “should,” “will,” "would," and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; competition; intellectual property risks; risks relating to doing business in
CONTACTS
Investor Relations:
Managing Director,
Tel: +1 716-427-2952
Direct: +1 212-915-2564
Chief Financial Officer
Email: randollsze@athenex.com
Corporate Development and Investor Relations
Email: jacquelineli@athenex.com
Athenex, Inc. & Subsidiaries | |||||||
Condensed Consolidated Balance Sheets | |||||||
March 31, | December 31, | ||||||
2019 | 2018 | ||||||
Balance sheet data: | (in thousands) | ||||||
Cash, cash equivalents | $ | 71,003 | $ | 49,794 | |||
Short-term investments | 341 | 57,629 | |||||
Goodwill | 37,589 | 37,495 | |||||
Working capital | 82,933 | 119,143 | |||||
Total assets | 220,307 | 231,095 | |||||
Long-term debt | 47,732 | 46,764 | |||||
Total liabilities | 124,726 | 102,326 | |||||
Non-controlling interests | (11,583 | ) | (10,586 | ) | |||
Total stockholders' equity | $ | 95,581 | $ | 128,769 | |||
Athenex, Inc. & Subsidiaries | |||||||
Condensed Consolidated Statement of Operations | |||||||
Three Months Ended March 31, | |||||||
2019 | 2018 | ||||||
(in thousands) | (in thousands) | ||||||
Revenue | |||||||
Product sales, net | $ | 25,163 | $ | 12,605 | |||
License fees and consulting revenue | 105 | 25,091 | |||||
Grant revenue | 39 | 140 | |||||
Total revenue | 25,307 | 37,836 | |||||
Cost of sales | (19,902 | ) | (11,326 | ) | |||
Gross profit | 5,405 | 26,510 | |||||
Research and development expenses | (24,475 | ) | (21,303 | ) | |||
Selling, general, and administrative expenses | (15,188 | ) | (13,080 | ) | |||
Interest (expense) income | (1,472 | ) | 227 | ||||
Income tax (expense) benefit | (500 | ) | 307 | ||||
Net loss | (36,230 | ) | (7,339 | ) | |||
Less: net loss attributable to non-controlling interests | (997 | ) | (41 | ) | |||
Net loss attributable to Athenex, Inc. | $ | (35,233 | ) | $ | (7,298 | ) | |
Athenex, Inc. & Subsidiaries | |||||||
Condensed Consolidated Statement of Cash Flows | |||||||
Three Months Ended March 31, | |||||||
2019 | 2018 | ||||||
(in thousands) | |||||||
Net cash (used in) operating activities | $ | (32,971 | ) | $ | (12,726 | ) | |
Net cash provided by investing activities | 52,198 | (56,800 | ) | ||||
Net cash provided by financing activities | 976 | 68,981 | |||||
Net effect of foreign exchange rate changes | 1,006 | 478 | |||||
Net increase (decrease) in cash and cash equivalents | 21,209 | (67 | ) | ||||
Cash and cash equivalents at beginning of period | 49,794 | 39,284 | |||||
Cash and cash equivalents at end of period | $ | 71,003 | $ | 39,217 | |||