Athenex Provides Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Announces Strategic Pivot to Focus on Cell Therapy Programs
Receives FDA Clearance for IND to Expand CD19 CAR-NKT ANCHOR to a Multi-center Study
Implementing Significant Cost Reduction Plan Targeting >50% Reduction in Operating Expenses
Plans to Extend Cash Runway in 2022 Through Monetization of Non-core Assets Consistent with Shift in Focus and Strategy
Management to host conference call and webcast today at
“We are pleased to announce our new vision for the future of
Corporate Developments
Key Program and Business Updates
- Focus R&D resources on developing cell therapy programs
- Discontinue oral discovery program apart from oral paclitaxel
- Reducing operating expenses: With the objective of extending its cash runway, the Company is implementing cost cutting initiatives and workforce reduction to lower operating expenses by over 50%
- Plan to monetize non-core assets consistent with new focus and strategy of company
Key Anticipated Milestones
- Update on ANCHOR data previously presented at ASH in 2021 at ASTCT on
April 23-26, 2022 - Update from KUR-501, our autologous program in pediatric neuroblastoma at the
American Society of Gene & Cell Therapy (ASGCT) annual meeting onMay 16-19, 2022 - Preclinical data presentation of allogeneic GPC3 CAR-NKT cell program in liver cancer at ASCO on
June 3-7, 2022 - Expand CD19 CAR-NKT ANCHOR study to a multi-center study under the newly allowed IND
- Data update from KUR-502 at
American Society of Hematology (ASH) onDecember 10-13, 2022 - Potential regulatory update from MHRA for Oral Paclitaxel in metastatic breast cancer (mBC) in
UK - Data from I-SPY 2 trial of Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H22
- IND filing for KUR-503, our allogeneic CAR-NKT program in liver cancer in 1H23
Fourth Quarter 2021 and Recent Business Highlights
Clinical Programs
- Observed ORR of 80% with 3 CRs and 1 PR out of 5 evaluable patients in data presented from Phase 1 ANCHOR trial of KUR-502 in relapsed/refractory CD19-positive leukemia and lymphoma at the
American Society of Hematology (ASH) Meeting in December. - Announced agreement with the
National Cancer Institute (NCI) to license TCRs targeting KRAS, TP53, and EGFR to combine with our allogeneic platform for application in solid tumors - Received IND clearance from the FDA to expand Phase 1 ANCHOR study of KUR-502 to up to 12 clinical sites
Orascovery
- Initiated the expansion portion of Phase 1/2 trial of Oral Paclitaxel in combination with pembrolizumab in (Non-small Cell
Lung Cancer ) NSCLC
Commercial Update
Klisyri® (tirbanibulin)
- Commercial Partner Almirall reported 3% market share the
U.S. and expects gains to continue - Over 2,000 HCPs have prescribed Klisyri since its launch, and it has access to over 70 million covered lives within the commercial space
- Almirall expects Medicare Part D coverage in 2022
Specialty Pharmaceutical Business
- Athenex Pharmaceutical Division (APD) currently markets a total of 29 products with 54 SKUs.
Athenex Pharma Solutions (APS) currently markets 5 products with 16 SKUs
Fourth Quarter and Full Year 2021 Financial Highlights
Revenues from product sales increased to
License fees and other revenue for three months and year ended
Cost of sales for the three months ended
R&D expenses totaled
SG&A expenses totaled
The Company recorded impairment of
Interest expense totaled
Income tax benefit (expense) for the three months ended
Net loss attributable to
For further details on the Company’s financial results, including the results for the full year ended
2022 Financial Guidance
Athenex’s product sales in 2021 amounted to
Cash Conservation Update
As of
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: International: Passcode: |
1-877-407-0784 1-201-689-8560 13726462 |
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 cell therapy drugs for the treatment of cancer. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Cell therapy based on NKT cells (2) Orascovery, based on a P-glycoprotein inhibitor, and (3) Src Kinase Inhibition. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active, accessible and tolerable treatments. For more information, please visit www.athenex.com.
Forward-Looking Statements
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,” “objective,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “target,” “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: our history of operating losses and our need and ability to raise additional capital to continue as a going concern; our ability to successfully redirect our resources and reduce our operating expenses; our ability to 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; 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; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; the Company’s 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; 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; 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; risks relating to doing business internationally and in
Athenex Contacts
Investors
Email: danlang@athenex.com
Caileigh Dougherty
Email: cdougherty@athenex.com
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
2021 | 2020 | |||||||
(In thousands) | ||||||||
Selected Balance sheet data: | ||||||||
Cash, cash equivalents, and restricted cash | $ | 51,702 | $ | 86,087 | ||||
Short-term investments | 10,207 | 138,636 | ||||||
— | 38,891 | |||||||
Working capital(1) | 37,349 | 229,820 | ||||||
Total assets | 267,448 | 384,329 | ||||||
Long-term debt | 150,337 | 148,279 | ||||||
Total liabilities | 232,996 | 218,981 | ||||||
Non-controlling interests | (16,679 | ) | (14,427 | ) | ||||
Total stockholders' equity | $ | 34,452 | $ | 165,348 | ||||
*working capital: total current assets less total current liabilities | ||||||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands)
(Unaudited)
Three months ended |
Year ended |
|||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(in thousands) | (in thousands) | (in thousands) | (in thousands) | |||||||||||||
Revenue | ||||||||||||||||
Product sales, net | $ | 23,484 | $ | 21,780 | $ | 92,264 | $ | 105,274 | ||||||||
License and other revenue | 1,452 | 28 | 27,917 | 39,117 | ||||||||||||
Total revenue | 24,936 | 21,808 | 120,181 | 144,391 | ||||||||||||
Cost of sales | (20,694 | ) | (18,267 | ) | (82,406 | ) | (95,355 | ) | ||||||||
Gross profit | 4,242 | 3,541 | 37,775 | 49,036 | ||||||||||||
Research and development expenses | (18,269 | ) | (18,307 | ) | (80,197 | ) | (75,904 | ) | ||||||||
Selling, general, and administrative expenses | (13,373 | ) | (31,401 | ) | (72,553 | ) | (96,855 | ) | ||||||||
Impairments | (69,419 | ) | — | (69,419 | ) | — | ||||||||||
Interest income | 27 | 164 | 227 | 874 | ||||||||||||
Interest expense | (5,050 | ) | (4,386 | ) | (20,742 | ) | (11,219 | ) | ||||||||
Loss on extinguishment of debt | — | — | — | (10,278 | ) | |||||||||||
Income tax benefit (expense) | (15 | ) | (8 | ) | 10,604 | (4,088 | ) | |||||||||
Net loss from continuing operations | (101,857 | ) | — | (194,305 | ) | — | ||||||||||
Loss from discontinued operations | (3,225 | ) | — | (7,731 | ) | — | ||||||||||
Net loss | (105,082 | ) | (50,397 | ) | (202,036 | ) | (148,434 | ) | ||||||||
Less: net loss attributable to non-controlling interests | (695 | ) | (904 | ) | (2,268 | ) | (2,255 | ) | ||||||||
Net loss attributable to |
$ | (104,387 | ) | $ | (49,493 | ) | $ | (199,768 | ) | $ | (146,179 | ) | ||||
Net loss per share attributable to |
$ | (0.95 | ) | $ | (0.53 | ) | $ | (1.92 | ) | $ | (1.72 | ) | ||||
Weighted-average shares used in computing net loss per share attributable to |
109,411,482 | 93,326,892 | 103,938,451 | 85,082,868 |

Source: Athenex, Inc.