Athenex, Inc. Announces Second Quarter 2019 Financial Results, Positive Phase III Results on Oral Paclitaxel plus Encequidar and Increased Product Sales Guidance
Positive Phase III results of Oral Paclitaxel show statistically significant improvement in overall response rate in metastatic breast cancer
Company is preparing two NDA submissions following successful Phase III studies announced within the last twelve months
Expanded clinical pipeline with FDA’s allowance of the IND application for PT01 (Pegtomarginase)
Approximately 92% year/year increase in Q2 product sales
Raising product sales guidance to 30% - 35% year/year growth in 2019
Conference call and live audio webcast at 8:00 a.m. Eastern Time today
“Athenex has continued to execute successfully across all of our strategic objectives in our development programs as well as our commercial operations and readiness,” stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. “We are particularly excited about today’s announcement of success in our Phase III study of oral paclitaxel and encequidar in metastatic breast cancer. We believe the success of this program serves to derisk our technology platform and provides further validation as we continue advancing our other Orascovery candidates (including docetaxel, cabazitaxel, irinotecan, topotecan and eribulin) and combination therapies.”
Second Quarter 2019 and Recent Business Highlights:
Phase III study of oral paclitaxel and encequidar for metastatic breast cancer
- Primary efficacy endpoint met in Phase III clinical trial of oral paclitaxel and encequidar (Oral Paclitaxel) versus IV paclitaxel in patients with metastatic breast cancer. Oral Paclitaxel showed a statistically significant improvement compared to IV paclitaxel with an ORR of 36% compared to 24% based on intention-to-treat analysis (p = 0.01). Oral Paclitaxel also showed statistically significant improvement compared to IV paclitaxel based on other analyses on populations excluding non-evaluable patients (which would give higher response rates), with p ≤ 0.01 in all analyses.
- Results also showed that the proportion of confirmed responders with a duration of response more than 150 days was 2.5 times higher in Oral Paclitaxel versus IV paclitaxel.
- There were strong trends in progression-free survival (p = 0.077) and overall survival (p = 0.11) favoring Oral Paclitaxel over IV paclitaxel.
- Neuropathy was less frequent with Oral Paclitaxel compared to IV paclitaxel.
- Plan to request a pre-NDA meeting as soon as possible and present data at a major upcoming scientific meeting.
- Reported promising clinical results from a clinical study of oral paclitaxel and encequidar in cutaneous angiosarcoma. Preliminary data show rapid, visible response to oral paclitaxel and encequidar monotherapy in the first seven subjects, including three complete responses.
- Four posters featuring the Company’s products/technologies were presented at the 2019 American Society of Clinical Oncology (
ASCO) Annual Meeting.
- Preliminary positive clinical activity signals observed in a cohort of patients with psoriasis treated with tirbanibulin ointment (formerly known as KX2-391) in a Phase I clinical trial.
The U.S. Food and Drug Administration( FDA) allowed the Company’s Investigational New Drug (IND) application for the clinical investigation of PT01 (Pegtomarginase) for the treatment of patients with advanced malignancies.
- Launched new brand, Athenex Oncology, and corresponding website, AthenexOncology.com, during the 2019 ASCO Annual Meeting.
- Strategically expanded presence in
Europeand Latin Americato grow the Company’s global clinical research and development capacity and maximize the global potential of its pipeline.
- Formed a subsidiary in the U.K. and established offices in Manchester.
- Entered into a definitive agreement to acquire certain assets of CIDAL Limited, a contract research organization (CRO) with headquarters in Guatemala and operations in various countries in Latin America.
- Voluntarily suspended production activities at its active pharmaceutical ingredient (API) plant in
Chongqing(Taihao API plant). This decision was made based on discussions with the Department of Emergency Management of Chongqing(DEMC) related to concerns raised about the location of our plant. The DEMC has been evaluating the safety of all chemical and other plants in the region after recent accidents at other plants. In the meantime, the Company has been working on the build-out of the new API plant in Chongqing, and the plant is expected to commence operations in the first half of 2020.
- Athenex Pharmaceutical Division (APD) currently markets a total of 30 products with 58 SKUs.
- Athenex Pharma Solutions (APS) currently markets 5 products in total with 13 SKUs.
- Goal is to launch 9-12 products in 2019.
Financial Results for the Quarter Ended
Product sales 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
On May 7, 2019, the Company closed a private placement transaction in which it issued 10 million shares of common stock to three institutional investors (
The Company received a
Financial Results for the Six Months Ended
Product sales reached
Total revenue for the six months ended
Cost of sales for the six months ended
Research and development expenses for the six months ended
Selling, general and administrative expenses for the six months ended
Net loss attributable to
Outlook and Upcoming Milestones:
- Intend to submit results from Phase III clinical trial of oral paclitaxel and encequidar in metastatic breast cancer for presentation at a major upcoming scientific meeting and for peer review publication (Q4 2019 / H1 2020)
- Expect to request a pre-NDA meeting as soon as possible for oral paclitaxel and encequidar in metastatic breast cancer (Q4 2019)
- Expect to file an NDA for tirbanibulin ointment in actinic keratosis (Q1 2020)
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 13691069. The live conference call and replay can be accessed via audio webcast at http://public.viavid.com/index.php?id=134662 and also on the Investor Relations section of the Company’s website, located at http://ir.athenex.com/.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on non-absorbed P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple locations in Chongqing, China; and
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,” “goal,” “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; our ability to integrate CIDAL’s assets into our existing operations; competition; intellectual property risks; risks relating to doing business in
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Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|June 30,||December 31,|
|Balance sheet data:||(in thousands)|
|Cash, cash equivalents, and restricted cash||$||122,198||$||49,794|
|Working capital *||154,372||119,143|
|Total stockholders' equity||$||167,207||$||128,769|
|*Working capital: total current assets - total current liabilities|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|(in thousands)||(in thousands)||(in thousands)||(in thousands)|
|Product sales, net||$||22,033||$||11,471||$||47,196||$||24,076|
|License fees and consulting revenue||105||91||210||25,182|
|Cost of sales||(16,942||)||(9,443||)||(36,844||)||(20,769||)|
|Research and development expenses||(18,507||)||(26,572||)||(42,982||)||(47,875||)|
|Selling, general, and administrative expenses||(17,169||)||(12,817||)||(32,357||)||(25,897||)|
|Interest (expense) income||(1,279||)||368||(2,751||)||595|
|Income tax (expense) benefit||(405||)||(51||)||(905||)||256|
|Less: net loss attributable to non-controlling interests||(74||)||(91||)||(1,071||)||(132||)|
|Net loss attributable to Athenex, Inc.||$||(32,031||)||$||(36,859||)||$||(67,264||)||$||(44,157||)|
|Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted||$||(0.44||)||$||(0.58||)||$||(0.96||)||$||(0.71||)|
|Weighted-average shares used in computing net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted||73,114,392||63,310,219||70,079,771||62,487,328|
Condensed Consolidated Statements of Cash Flows
|Six Months Ended June 30,|
|Net cash used in operating activities||$||(37,773||)||$||(38,029||)|
|Net cash provided by (used in) investing activities||4,764||(56,553||)|
|Net cash provided by financing activities||104,698||69,099|
|Net effect of foreign exchange rate changes||715||267|
|Net increase (decrease) in cash and cash equivalents||72,404||(25,216||)|
|Cash, cash equivalents, and restricted cash at beginning of period||49,794||39,284|
|Cash, cash equivalents, and restricted cash at end of period||$||122,198||$||14,068|
Source: Athenex, Inc.