Athenex Provides Third Quarter 2021 Corporate and Financial Update
Held FDA Type A Meeting for oral paclitaxel in metastatic breast cancer
Klisyri® launched in
ANCHOR Phase 1 interim results accepted for poster presentation at 2021 ASH
3Q product sales were
Company now expects full year product sales revenue in 2021 to decrease by 6-12% compared to 2020
Management to host conference call and webcast today at
“Following our recent Type A meeting with
Third Quarter 2021 and Recent Business Highlights
- Held a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Oral Paclitaxel in metastatic breast cancer.
- Presented positive interim data from a Phase 1 trial evaluating Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid malignancies at ESMO 2021.
- Received confirmation from the
Innovative Licensingand Access Pathway (ILAP) in the UKthat encequidar in combination with oral anticancer medicines has been awarded the innovative medicine designation, the Innovation Passport. ILAP was set up by the UK Medicines & Healthcare products Regulatory Agency (MHRA) and other UKgovernment agencies to efficiently accelerate the time to market and facilitating patient access to innovative medicines.
- Interim data from the ongoing Phase 1 ANCHOR trial evaluating KUR-502 in patients with CD19-positive relapsed or refractory lymphoma and leukemia have been accepted for poster presentation at the 2021 ASH Annual Meeting.
- The U.S. Patent and Trademark Office allowed patent claims around the NKT cellular immunotherapy platform developed by
Athenexand the Center for Cell and Gene Therapyat Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital.
- Opened enrollment in Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors).
- Athenex’s partner, Almirall (Almirall, S.A., BME: ALM), launched Klisyri® (tirbanibulin) in Germany and the UK. Klisyri received approval by the European Commission and the UK MHRA in July and August of 2021, respectively, for the topical treatment of actinic keratosis (AK) of the face and scalp in adults.
Specialty Pharmaceutical Business
- Athenex Pharmaceutical Division (APD) currently markets a total of 33 products with 64 SKUs.
Athenex Pharma Solutions(APS) currently markets 5 products with 16 SKUs.
Michael Smolinskipromoted to Chief Scientific Officer. Dr. Smolinskihas been with Athenexfor 13 years and previously served as Vice President of Preclinical Operations.
Key Anticipated Milestones
- ANCHOR Phase 1 poster presentation at 2021 ASH in December
- Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022
- Almirall to continue phased roll-out of Klisyri in other European countries in 2022
Third Quarter 2021 Financial Highlights
Revenues from product sales increased to
License fees and other revenue decreased by
Cost of sales for the three months ended
R&D expenses for the three months ended
SG&A expenses for the three months ended
Interest expense totaled
Income tax expense for the three months ended
Net loss attributable to
For further details on the Company’s financial results, including the results for the nine months ended
In terms of product sales guidance, the Company is limiting financial guidance to the existing
Cash Conservation Update
Conference Call and Webcast Information
To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:
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 under “Events and Presentations”, located at http://ir.athenex.com/.
About Athenex, Inc.
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 technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, 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. For more information, please visit www.athenex.com.
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, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to pivot our business and to find new uses for the capacity at our Dunkirk manufacturing facility, once operational; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to our ability to successfully integrate the business of Kuur into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital to continue as a going concern; uncertainties around our ability to enter into new financing agreements as we are unable to meet funding conditions under our existing financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its ongoing impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Selected Balance sheet data:|
|Cash, cash equivalents, and restricted cash||$||90,094||$||86,087|
|Total stockholders' equity||$||135,879||$||165,348|
|*working capital: total current assets less total current liabilities|
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
|Three months ended
||Nine months ended
|(in thousands)||(in thousands)||(in thousands)||(in thousands)|
|Product sales, net||$||27,035||$||24,780||$||68,780||$||83,494|
|License and other revenue||5,262||10,696||26,465||39,089|
|Cost of sales||(25,644||)||(24,510||)||(61,712||)||(77,088||)|
|Research and development expenses||(17,731||)||(18,390||)||(61,928||)||(57,597||)|
|Selling, general, and administrative expenses||(22,794||)||(22,220||)||(66,145||)||(65,454||)|
|Income from government grant||2,459||—||2,459||—|
|Loss on extinguishment of debt||—||(3,048||)||—||(10,278||)|
|Income tax benefit (expense)||(262||)||(1,093||)||10,619||(4,080||)|
|Less: net loss attributable to non-controlling interests||(679||)||(462||)||(1,573||)||(1,351||)|
|Net loss attributable to
|Net loss per share attributable to
basic and diluted
|Weighted-average shares used in computing net loss per share
Source: Athenex, Inc.