Athenex Provides Second Quarter 2021 Corporate and Financial Update
Updated investors on FDA Type A Meeting for oral paclitaxel
Klisyri® approved by the
KUR-501 GD2 CAR-NKT Phase 1 data in neuroblastoma presented at ASGCT 2021
Abstract for oral paclitaxel + pembrolizumab Phase 1 combination study accepted for
Management to host conference call and webcast today at
“During the second quarter, we held a Type A meeting with the FDA to discuss the path forward for oral paclitaxel and encequidar in metastatic breast cancer and the deficiencies that were raised in the Complete Response Letter (CRL) we received in February,” said
“Our acquisition of Kuur Therapeutics and its innovative allogeneic CAR-NKT technology was a strategically important development for
Second Quarter 2021 and Recent Business Highlights
Oral Paclitaxel and Encequidar
Athenexheld a Type A meeting with the US Food & Drug Administration(FDA) regarding the New Drug Application (NDA) for oral paclitaxel in metastatic breast cancer during second quarter 2021. The Company is evaluating the optimal design for a new clinical study which it plans to present to the FDA in 4Q 2021.
- An abstract “Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of oral paclitaxel + encequidar in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies” has been accepted for e-Poster presentation at the
European Society for Medical Oncology (ESMO) Congress2021.
- Presented data from a Phase 1 study (GINAKIT2) of KUR-501 in neuroblastoma at the annual meeting of the
American Society of Geneand Cell Therapy(ASGCT) 2021. The data showed one complete response and one partial response out of 11 evaluable and heavily pre-treated pediatric neuroblastoma patients. The therapy was well tolerated with only one Grade 2 CRS.
- Continued to enroll patients in a Phase 1 study (ANCHOR) evaluating KUR-502 in patients with relapsed/refractory CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
- Received IRB approval to conduct a Phase 1 trial of TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 positive solid tumors).
- Almirall, S.A. (BLM: ALM), Athenex’s partner, received marketing authorization of Klisyri® from the
European Commissionin July 2021for the topical treatment of actinic keratosis (AK) on the face or scalp in adults. The approval followed receipt of a positive opinion from the CHMP of the European Medicines Agencyin May 2021. Athenexentered into license agreements for tirbanibulin with Seqirus (a subsidiary of CSL Limited) and AVIR Pharma, expanding its international commercial partnerships for tirbanibulin in Australia and New Zealand, and Canada, respectively.
Specialty Pharmaceutical Business
- Athenex Pharmaceutical Division (APD) currently markets a total of 34 products with 61 SKUs.
Athenex Pharma Solutions(APS) currently markets 4 products with 16 SKUs.
- 503B operations at the Dunkirk Facility expected to commence in Q4 2021.
Athenexhas accepted the resignation of its Chief Financial Officer, Randoll Sze, effective August 13, 2021. Mr. Steven Adams, the company’s current Corporate Controller, will take on the role of Interim Chief Accounting Officer until a permanent CFO is appointed.
Key Anticipated Milestones
- Plan to discuss the design of a new clinical study for oral paclitaxel in metastatic breast cancer with the FDA in Q4 2021
- Launch of Klisyri® in a major European market in 2H 2021
- Abstract on the ANCHOR Phase 1 study submitted to ASH 2021
- Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors) to initiate enrollment in 3Q 2021
- Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022
Second Quarter 2021 Financial Highlights
Revenues from product sales decreased to
License fees and other revenue increased 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 benefit for the three months ended
Net loss attributable to Athenex for the three months ended June 30, 2021 was $34.3 million, or (
For further details on the Company’s financial results, including the results for the six 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:
Domestic: (877) 407-0784
International: (201) 689-8560
The live conference call and replay can also be accessed by audio webcast here and also under “Events and Presentations” at the Investor Relations section of the Company’s website, located at https://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, uncertainties around regulatory reviews and approvals; our ability to agree with the FDA on a new clinical study for oral paclitaxel that is capital and time efficient; 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; uncertainties around our ability to meet funding conditions under our 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
CONDENSED CONSOLIDATED BALANCE SHEETS
|Selected Balance sheet data:|
|Cash, cash equivalents, and restricted cash||$||93,441||$||86,087|
|Total stockholders' equity||$||169,880||$||165,348|
|*working capital: total current assets less total current liabilities|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
|Three months ended
||Six months ended
|(in thousands)||(in thousands)||(in thousands)||(in thousands)|
|Product sales, net||$||21,385||$||40,167||$||41,745||$||58,714|
|License and other revenue||538||5||21,203||28,393|
|Cost of sales||(19,663||)||(33,006||)||(36,068||)||(52,578||)|
|Research and development expenses||(21,127||)||(22,015||)||(44,197||)||(39,207||)|
|Selling, general, and administrative expenses||(21,231||)||(17,486||)||(43,351||)||(43,234||)|
|Loss on extinguishment of debt||—||(7,230||)||—||(7,230||)|
|Income tax benefit (expense)||11,035||(106||)||10,881||(2,987||)|
|Less: net loss attributable to non-controlling interests||(341||)||(600||)||(894||)||(889||)|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares used in computing net loss per share attributable to
Source: Athenex, Inc.