Athenex, Inc. Reports Second Quarter Ended June 30, 2020 Financial Results and Provides Corporate Update
Regulatory progress for Oral Paclitaxel and tirbanibulin ointment is on track
Continued momentum in building commercialization infrastructure and supply chain for Oral Paclitaxel
Announced two financing agreements for up to
Product sales guidance for 2020 raised to mid-teens percentage growth y/y
Conference call and live webcast at
“So far, 2020 has been a very productive year at
“We have strengthened our balance sheet by accessing non-dilutive capital,” continued
Second Quarter 2020 and Recent Business Highlights:
Tirbanibulin Ointment for Actinic Keratosis (AK)
- The U.S. Food and Drug Administration (FDA) has set a PDUFA target action date for tirbanibulin ointment as December 30, 2020.
- A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) by the Company’s partner Almirall and validated.
Oral Paclitaxel for Metastatic Breast Cancer
Athenexwill provide an update on its NDA submission after a response from the FDA becomes available.
Oral Paclitaxel in Cutaneous Angiosarcoma -- ASCO 2020 Presentation
Athenexpresented interim data from an ongoing Phase II clinical trial of Oral Paclitaxel monotherapy in elderly patients with unresectable cutaneous angiosarcoma, an aggressive malignancy with no FDA approved treatment.
- The interim data showed a clinical benefit rate (CR+PR+SD) of 100% in 22 evaluable patients receiving Oral Paclitaxel treatment. All 22 patients experienced reduction in tumor size. Complete responses (CR) were observed in 27.3% of patients (6/22), partial responses (PR) were observed in 22.7% of patients (5/22), and stable disease was observed in 50% of patients (11/22).
- Product sales growth in the second quarter was 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 56 SKUs.
Athenex Pharma Solutions(APS) currently markets 6 products with 18 SKUs.
Athenexentered into a $225 millionloan agreement with funds managed by Oaktree Capital Management, L.P.(“Oaktree”)
- Entered into a $50 million Revenue Interest Financing agreement with
Sagard Healthcare Royalty Partners, LP. (“Sagard”)
Robert J. Spiegel, MD to the Company’s Board of Directors. Dr. Spiegelwas most recently Chief Medical Officer of PTC Therapeutics, and had a 26-year tenure at Schering-Plough, where he attained the title of Chief Medical Officer.
Teresa Bair, Esq. to Executive Officer as General Counsel and Senior Vice President, Administration.
Financial Results for the Second Quarter Ended
Revenue from product sales increased to
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
In the three months ended
Net loss attributable to
Financial Results for the Six Months Ended
Revenue from product sales increased to
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:
- FDA response to the NDA for Oral Paclitaxel for metastatic breast cancer.
- PDUFA date of December 30, 2020 for tirbanibulin ointment for actinic keratosis.
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 2021. 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 extend the Company’s cash runway into 2022.
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 13706637. The live conference call and replay can also be accessed via audio webcast at link and also on the Investor Relations section of the Company’s website, located at http://ir.athenex.com/.
About Athenex, Inc.
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; 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
Corporate Development and Investor Relations
Condensed Consolidated Balance Sheets
|Balance sheet data:|
|Cash, cash equivalents, and restricted cash||$||116,901||$||127,674|
|Total stockholders’ equity||$||126,246||$||175,855|
* working capital: total current assets less total current liabilities
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|(in thousands)||(in thousands)||(in thousands)||(in thousands)|
|Product sales, net||$||40,167||$||22,033||$||58,714||$||47,196|
|License fees and other revenue||5||164||28,393||308|
|Cost of sales||(33,006||)||(16,942||)||(52,578||)||(36,844||)|
|Research and development expenses||(22,015||)||(18,507||)||(39,207||)||(42,982||)|
|Selling, general, and administrative expenses||(17,486||)||(17,169||)||(43,234||)||(32,357||)|
|Loss on extinguishment of debt||(7,230||)||—||(7,230||)||—|
|Income tax expense||(106||)||(405||)||(2,987||)||(905||)|
|Less: net loss attributable to non-controlling interests||(600||)||(74||)||(889||)||(1,071||)|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares used in computing net loss per share attributable to
Condensed Consolidated Statements of Cash Flows
|Six Months Ended
|Net cash used in operating activities||$||(70,068||)||$||(37,773||)|
|Net cash provided by investing activities||18,125||4,764|
|Net cash provided by financing activities||41,573||104,698|
|Net (decrease) increase in cash, cash equivalents, and restricted cash||(10,370||)||71,689|
|Cash, cash equivalents, and restricted cash, at beginning of period||127,674||49,794|
|Net effect of foreign exchange rate changes||(403||)||715|
|Cash, cash equivalents, and restricted cash, at end of period||$||116,901||$||122,198|
Source: Athenex, Inc.