Athenex, Inc. Reports Third Quarter Ended September 30, 2020 Financial Results and Provides Corporate Update
FDA accepted and granted priority review of NDA for Oral Paclitaxel in metastatic breast cancer
PDUFA dates for tirbanibulin ointment and Oral Paclitaxel set for December 30, 2020 and
Four abstracts featuring Oral Paclitaxel accepted for presentation at San Antonio Breast Cancer Virtual Symposium
Product sales in Q3 2020 were
Conference call and live webcast at
“Our New Drug Application (NDA) filing for Oral Paclitaxel was accepted with priority review and a target action date of February 28, 2021,” stated Dr.
“During the quarter, we strengthened our balance sheet with a successful equity financing, raising net proceeds of
Third Quarter 2020 and Recent Business Highlights:
Oral Paclitaxel for Breast Cancer
U.S.Food and Drug Administration (FDA) accepted an NDA for Oral Paclitaxel for the treatment of metastatic breast cancer and has granted the application Priority Review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of February 28, 2021.
- Launched two new study arms of the I-SPY 2 TRIAL, sponsored by Quantum Leap Healthcare Collaborative, to evaluate Oral Paclitaxel in combination with GSK’s dostarlimab in Stage 2/3 HER2+ and HER2- breast cancer patients.
Tirbanibulin Ointment for Actinic Keratosis
- Under the PDUFA, the FDA has set a target action date for tirbanibulin ointment as December 30, 2020.
TCRT-ESO-A2, a TCR-T cell therapy, for NY-ESO-1 positive solid tumors
- FDA has allowed the investigational new drug (IND) application for TCRT-ESO-A2, an autologous T-cell receptor (TCR)-T cell therapy. TCRT-ESO-A2 is being developed by
Axis Therapeutics Limited, a joint venture between Athenexand Xiangxue Life Sciences Limited.
- Product sales growth in the third quarter was primarily driven by sales of specialty pharmaceutical products used to treat patients hospitalized with COVID-19.
- Athenex Pharmaceutical Division (APD) currently markets a total of 30 products with 54 SKUs.
- Athenex Pharma Solutions (APS) currently markets 6 products with 18 SKUs.
Corporate Financing Highlights:
- Completed an underwritten follow-on public offering of a total of 11.5 million shares generating net proceeds of
- Entered into a $50 million revenue interest financing agreement with
Sagard Healthcare Royalty Partners, LP. (“Sagard”).
Financial Results for the Third Quarter Ended September 30, 2020
Revenue from product sales increased to
Pursuant to the 2019 Xiangxue License Agreement and an out-licensing agreement with PharmaEssentia, we recognized
Cost of sales totaled
R&D expenses totaled
SG&A expenses totaled
Interest income consisted of interest earned on our short-term investments, which totaled
In the three months ended
For the three months ended
Net loss attributable to
On August 4, 2020, Athenex entered into a Revenue Interest Financing (RIF) agreement with Sagard Healthcare Royalty Partners, LP. The agreement provides Athenex with $50 million of capital upon FDA approval of Oral Paclitaxel for the treatment of metastatic breast cancer. In exchange for funding this capital, Sagard will receive quarterly payments equal to a mid-single digit royalty of worldwide net sales of Oral Paclitaxel. The Company expects that the proceeds from the financing will be used to fund the development and commercialization of Oral Paclitaxel and other general corporate purposes. Also, in connection with this agreement, Sagard and certain of its co-investors have purchased by assignment $50 million of outstanding loans and undrawn commitments from funds managed by Oaktree, becoming lenders under Athenex’s $225 million term loan facility entered into between Oaktree and Athenex in June 2020.
Outlook and Upcoming Milestones:
- Four abstracts featuring Oral Paclitaxel have been accepted for presentation at the San Antonio Breast Cancer Virtual Symposium, to take place
December 8-11, 2020.
- FDA has set a PDUFA target action date of December 30, 2020 for tirbanibulin ointment for the treatment of actinic keratosis.
- FDA has set a PDUFA target action date of
February 28, 2021for Oral Paclitaxel for the treatment of metastatic breast cancer.
Upcoming Investor Events (each to be conducted virtually):
- SVB Leerink’s Oncology 1x1 Day,
November 19, 2020 Evercore ISI3rd Annual HealthCONx, December 1-3, 2020
Athenex provides revenue guidance for product sales only. The Company is raising its product sales guidance for the full year 2020 from mid-teens growth as previously communicated to at least low twenties percentage growth year-over-year, from
The Company believes that the existing cash, cash equivalents, restricted cash, and short-term investments will be sufficient to fund current operating plans into the second quarter of 2022. The Company plans to access additional milestone-based, non-dilutive capital available under the Senior Credit Agreement with Oaktree and Revenue Interest Financing Agreement with Sagard upon achievement of such funding milestones, and if such funding milestones are achieved, the additional capital provided by such is expected to further extend the Company’s cash runway into 2023.
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 13711719. The live conference call and replay can also be accessed via audio webcast here and also on the Investor Relations section of the Company’s website, 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 platform technologies: (1) Orascovery, based on 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,
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; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at our Chongqing facilities; 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|
|Balance sheet data:|
|Cash, cash equivalents, and restricted cash||$||157,309||$||127,674|
|Total stockholders' equity||$||212,235||$||175,855|
*working capital: total current assets less total current liabilities
|Condensed Consolidated Statements of Operations|
|Three Months Ended
||Nine Months Ended
|(in thousands)||(in thousands)||(in thousands)||(in thousands)|
|Product sales, net||$||24,780||$||19,237||$||83,494||$||66,433|
|License fees and other revenue||10,696||127||39,089||435|
|Cost of sales||(24,510||)||(17,071||)||(77,088||)||(53,915||)|
|Research and development expenses||(18,390||)||(19,588||)||(57,597||)||(62,570||)|
|Selling, general, and administrative expenses||(22,220||)||(16,283||)||(65,454||)||(48,640||)|
|Loss on extinguishment of debt||(3,048||)||—||(10,278||)||—|
|Income tax expense||(1,093||)||(114||)||(4,080||)||(1,019||)|
|Less: net loss attributable to non-controlling interests||(462||)||(29||)||(1,351||)||(1,100||)|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares used in computing net loss per share attributable to
|Condensed Consolidated Statements of Cash Flows|
|Nine Months Ended
|Net cash used in operating activities||$||(97,088||)||$||(74,120||)|
|Net cash (used in) provided by investing activities||(58,404||)||2,588|
|Net cash provided by financing activities||185,328||108,051|
|Net increase in cash, cash equivalents, and restricted cash||29,836||36,519|
|Cash, cash equivalents, and restricted cash, at beginning of period||127,674||49,794|
|Net effect of foreign exchange rate changes||(201||)||592|
|Cash, cash equivalents, and restricted cash, at end of period||$||157,309||$||86,905|
Source: Athenex, Inc.