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
Raising full year 2019 guidance to 35% to 40% year-over-year growth
Conference call and live audio webcast at
“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.”
Third Quarter 2019 and Recent Business Highlights:
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
FDAand present data at SABCS.
Other Oral Paclitaxel Developments
European Commissiongranted orphan designations for paclitaxel and for encequidar for the treatment of soft tissue sarcoma.
- Presented three posters at
European Society for Medical Oncology Congress2019 demonstrating the results from clinical studies of Oral Paclitaxel for patients with a number of advanced solid tumor types as well as in combination with ramucirumab, an anti-VEGFR2 antibody therapy.
Tirbanibulin Ointment for Actinic Keratosis (AK)
Almirallannounced a progress update on the program, including AK recurrence rates in those patients who had complete clearance at the primary evaluation endpoint on day 57 and who were followed quarterly in the 12-month extension period. Athenexcompleted pre-NDA consultation with the FDA.
Almirallreiterated its expectations for launch of tirbanibulin ointment in the US and Europein Q1 2021 and Q2 2021, respectively.
Phase I Clinical Study of KX2-361 Oral
Xiangxue Pharmaceuticalinitiated a Phase I study in China. KX2-361 is the second compound derived from Athenex’s Src kinase inhibition platform, for the treatment of glioblastoma multiforme.
Daniel Lang, MD, as President of Axis Therapeutics Limited(Axis) and Senior Director of Corporate Development at Athenex.
- Completed construction of new API (active pharmaceutical ingredients) facility in
- The 440,000-square-foot facility is expected to commence operations in the first half of 2020.
- The construction of the facility is part of Athenex’s strategy for vertical integration to capture value across the supply chain.
- Athenex Pharmaceutical Division (APD) currently markets a total of 31 products with 59 SKUs.
- Athenex Pharma Solutions (APS) currently markets 5 products with 13 SKUs.
- Goal is to launch 3-5 products in the remainder of 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
The Company received a
Financial Results for the Nine Months Ended
Product sales increased to
Total revenue for the nine months ended
Cost of sales for the nine months ended
Research and development expenses for the nine months ended
Selling, general and administrative expenses for the nine months ended
Net loss attributable to
Outlook and Upcoming Milestones:
- Oral presentation of Phase III results for Oral Paclitaxel at the San Antonio Breast Cancer Symposium (
December 13, 2019)
- Expect to submit an NDA for tirbanibulin ointment in actinic keratosis (Q1 2020)
- Expect to submit an NDA for Oral Paclitaxel in metastatic breast cancer (Q1 2020)
Raising Financial Guidance:
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 13694941. The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website, located at http://ir.athenex.com/.
Founded in 2003,
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
Chief Financial Officer
Corporate Development and Investor Relations
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|September 30,||December 31,|
|Balance sheet data:||(in thousands)|
|Cash, cash equivalents, and restricted cash||$||86,905||$||49,794|
|Working capital *||123,573||119,143|
|Total stockholders' equity||$||134,826||$||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 September 30,||Nine Months Ended September 30,|
|(in thousands)||(in thousands)||(in thousands)||(in thousands)|
|Product sales, net||$||19,237||$||13,309||$||66,433||$||37,385|
|License fees and consulting revenue||115||5,096||325||30,278|
|Cost of sales||(17,071||)||(11,965||)||(53,915||)||(32,734||)|
|Research and development expenses||(19,588||)||(51,202||)||(62,570||)||(99,077||)|
|Selling, general, and administrative expenses||(16,283||)||(11,493||)||(48,640||)||(37,390||)|
|Income tax (expense) benefit||(114||)||30||(1,019||)||286|
|Less: net loss attributable to non-controlling interests||(29||)||(11,090||)||(1,100||)||(11,222||)|
|Net loss attributable to Athenex, Inc.||$||(34,758||)||$||(46,170||)||$||(102,022||)||$||(90,327||)|
|Net loss per share attributable to Athenex, Inc. common
stockholders, basic and diluted
|Weighted-average shares used in computing net loss per share
attributable to Athenex, Inc. common stockholders, basic and
Condensed Consolidated Statements of Cash Flows
|Nine Months Ended September 30,|
|Net cash used in operating activities||$||(74,120||)||$||(75,315||)|
|Net cash provided by (used in) investing activities||2,588||(81,125||)|
|Net cash provided by financing activities||108,051||168,364|
|Net effect of foreign exchange rate changes||592||(100||)|
|Net increase in cash and cash equivalents||37,111||11,824|
|Cash, cash equivalents, and restricted cash at beginning of period||49,794||39,284|
|Cash, cash equivalents, and restricted cash at end of period||$||86,905||$||51,108|
Source: Athenex, Inc.