Athenex, Inc. Reports First Quarter Ended March 31, 2020 Financial Results and Provides Corporate Update
Regulatory filings for tirbanibulin ointment for actinic keratosis submitted to both FDA and EMA
Oral Paclitaxel NDA submission is on track
2020 product sales guidance re-affirmed
Conference call & webcast today at
“We successfully advanced our two lead product candidates towards regulatory submission. The regulatory applications for tirbanibulin have been filed and accepted in both the
“We are continuing with our pre-commercial activities for Oral Paclitaxel, many of which can be completed virtually, to ensure we are well positioned for commercial launch,” continued
First Quarter 2020 and Recent Business Highlights:
Tirbanibulin ointment for actinic keratosis (AK)
- A New Drug Application (NDA) for tirbanibulin ointment for actinic keratosis was filed with the
U.S. Food and Drug Administration(FDA), and the Prescription Drug User Fee Act (PDUFA) target action date has been set as December 30, 2020. Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application.
- A Marketing Authorization Application (MAA) has been submitted to the
European Medicines Agency(EMA) by our partner Almirall and validated.
Oral Paclitaxel for Metastatic Breast Cancer
- The Company participated in a constructive meeting with the FDA, as scheduled, to discuss the clinical section of the NDA for Oral Paclitaxel for the treatment of metastatic breast cancer, and is on track to submit the NDA.
- Athenex Pharmaceutical Division (APD) currently markets a total of 32 products with 59 SKUs.
Athenex Pharma Solutions(APS) currently markets 5 products with 17 SKUs.
- Goal is to launch 7 products in 2020, including a major 503B product.
Financial Results for the First Quarter Ended
Revenue from product sales were
The Company recognized
Cost of sales for the three months ended
Research and development expenses for the three months ended
SG&A expenses for the three months ended
As a result of the foregoing, operating loss for the three months ended
Net loss attributable to
Outlook and Upcoming Milestones:
- An abstract for the ongoing Phase 2 study of Oral Paclitaxel in angiosarcoma has been accepted for presentation in a poster discussion session at the American Society of Clinical Oncology’s (ASCO) upcoming ASCO20 Virtual Scientific Program, which will be held from
May 29 to May 31, 2020.
- FDA acceptance of the NDA for Oral Paclitaxel for metastatic breast cancer.
- PDUFA date of December 30, 2020 for tirbanibulin ointment for actinic keratosis.
The Company expects 2020 year-over-year product sales growth to be in the mid-single digits, from $80.5 million reported in 2019. The product sales guidance for 2020 has taken into account the discontinuation of vasopressin sales and the suspension of operations at the Taihao API plant in 2019, which had meaningful contributions in 2019. In light of the current COVID-19 pandemic, the Company has sold and may continue to sell products that are used to treat COVID-19 patients. The Company currently does not view these revenues as recurring in nature and will provide an update at the appropriate time.
Conference Call and Webcast Information:
The Company will host a conference call and live audio webcast today,
To participate in the call, dial 800-479-1004 (domestic) or 929-477-0324 (international) fifteen minutes before the conference call begins and reference the conference passcode 7976288. The live conference call and replay can also be accessed via audio webcast here http://public.viavid.com/index.php?id=139326 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; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; our ability to integrate CIDAL’s assets into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in
Chief Financial Officer
Corporate Development and Investor Relations
Condensed Consolidated Balance Sheets
|Balance sheet data:|
|Cash and cash equivalents||$||71,983||$||127,674|
|Total stockholders' equity||$||158,236||$||175,855|
* working capital: total current assets less total current liabilities.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended
|(in thousands)||(in thousands)|
|Product sales, net||$||18,547||$||25,163|
|License fees and other revenue||28,388||144|
|Cost of sales||(19,572||)||(19,902||)|
|Research and development expenses||(17,192||)||(24,475||)|
|Selling, general, and administrative expenses||(25,748||)||(15,188||)|
|Income tax expense||(2,881||)||(500||)|
|Less: net loss attributable to non-controlling interests||(289||)||(997||)|
|Net loss attributable to
|Net loss per share attributable to
stockholders, basic and diluted
|Weighted-average shares used in computing net loss per share
Condensed Consolidated Statements of Cash Flows
|Three Months Ended
|Net cash used in operating activities||$||(45,545||)||$||(32,971||)|
|Net cash (used in) provided by investing activities||(10,451||)||52,198|
|Net cash provided by financing activities||732||976|
|Net effect of foreign exchange rate changes||(427||)||1,006|
|Net (decrease) increase in cash and cash equivalents||(55,691||)||21,209|
|Cash and cash equivalents, at beginning of period||127,674||49,794|
|Cash and cash equivalents, at end of period||$||71,983||$||71,003|
Source: Athenex, Inc.