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Exhibit 99.1
Athenex Provides First Quarter 2022 Financial Results and Business Update
| Reports 1Q product sales of $29.0M, up 42% year-over-year |
| Encouraging interim update from ANCHOR study of KUR-502 presented at ASTCT with 60% overall response rate (ORR) and 6-month complete response (CR) rate of 29% in the NHL cohort |
| Abstract for KUR-501 in GINAKIT2 study accepted at ASGCT; 25% (3/12) ORR with 2 out of 3 responses at dose level 4 (1x108 cells/m2) |
| Corporate reorganization and cost savings initiatives well underway, demonstrated by 28% and 39% reduction in SG&A expenses and R&D expenses, respectively, over the prior year period |
| Raising full-year 2022 product revenue guidance range to 20-25% growth from previous range of 15-20% growth compared to 2021 |
| Management to host conference call and webcast today at 8:00 a.m. ET |
Buffalo, N.Y., May 10, 2022 (GLOBE NEWSWIRE) Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today provided a corporate and financial update for the first quarter ended March 31, 2022.
Our focus for 2022 continues to be on transforming Athenex into a robust, well-positioned cell therapy company with a solid balance sheet. We are proud of the progress we have made since announcing our strategic pivot and remain committed to delivering on cutting operating expenses and executing on additional monetization of noncore assets said Johnson Lau, Chief Executive Officer of Athenex. Our cell therapy programs continue to generate exciting data, which we are looking forward to presenting throughout the year. We believe our NKT cell therapy platform will be the main driver of future growth and will position us to be a differentiated leader in cell therapy space. Our corporate initiatives continue to set us up for successful value creation and allow us to further execute on our ultimate mission of bringing innovative treatments to cancer patients.
Corporate Developments
Business Updates
| Lowered operating expenses in the first quarter of 2022 by 34% versus the prior year period, with additional cost-cutting underway |
| APD/APS division delivered four new product launches and generated 42% growth in product revenues during the first quarter of 2022 versus the prior year period |
| Plan to monetize non-core assets to support development of cell therapy pipeline |
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This was primarily due to a decrease in Oral Paclitaxel product development and medical affairs costs, costs of clinical and regulatory operations, and costs of preclinical operations and included the following: 33 $6.3 million decrease in Oral Paclitaxel product development and medical affairs costs incurred in connection with the potential product launch costs of clinical operations after the completion of the Phase 3 studies for Oral Paclitaxel; $1.7 million decrease in costs of preclinical operations, primarily related to the Orascovery platform; $1.2 million decrease in costs of clinical operations and regulatory affairs after the completion of the Phase 3 study for Oral Paclitaxel; $0.8 million decrease in R&D related compensation expenses; and $0.4 million decrease in drug licensing costs related to licenses for specialty drug products.
However, our expenses could increase as we continue to fund clinical and preclinical development of our research programs by advancing our Cell Therapy programs, certain candidates in our pipeline, our specialty drug products, working capital and other general corporate purposes.
If we are able to sell non-core assets, we may not realize in full the anticipated benefits, savings, and improvements in our strategic pivot efforts, we may not realize the cost savings we anticipate, the cost of disposing of the assets may exceed the cost savings generated, and the process of disposing of the assets may be disruptive to our daily operating activities and our execution of short- and long-term strategies.
We may borrow additional funds on terms that may include restrictive covenants, including covenants that further restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets.
For the three month period ended March 31, 2021, the Company recognized license revenue of $20.5 million, of which $20.0 million was recognized upon the achievement of the first commercial milestone pursuant to the 2017 Almirall out-license arrangement upon the launch of Klisyri in the U.S., and $0.5 million was recognized for an upfront fee upon transferring IP to the customer upon execution of the second 39 amendment to the 2011 PharmaEssentia license agreement.
ATM Offering On August 20,...Read more
On August 20, 2021, we...Read more
As we pursue these strategic...Read more
We anticipate that our SG&A...Read more
Intangible Assets, net Intangible assets...Read more
The difference was primarily due...Read more
Revenue earned by the Global...Read more
Compensation related costs decreased by...Read more
Selling, General, and Administrative Expenses...Read more
Cash Flows The following table...Read more
R&D expenses related to our...Read more
Recent Accounting Pronouncements In the...Read more
We are organized around three...Read more
We believe these advantages include...Read more
This was primarily due to...Read more
Research and Development Expenses R&D...Read more
We expect that certain costs,...Read more
Meanwhile, we anticipate that cost...Read more
Revenues are recorded net of...Read more
Gain (loss) from discontinued operations...Read more
Key Components of Results of...Read more
Debt financing, if available, may...Read more
For the commercial, sales-based royalties,...Read more
Our operating assets increased $3.0...Read more
(2)Cellular therapies have generally not...Read more
Our mission is to improve...Read more
While we are able to...Read more
Revenue Revenue from product sales...Read more
To the extent that we...Read more
The primary use of our...Read more
Identifiable amortizing intangible assets are...Read more
We expect our R&D expenses...Read more
KUR-502 is currently being evaluated...Read more
TCRT-ESO-A2 is an autologous T...Read more
Our obligations under the Senior...Read more
In-process research and development ("IPR&D")...Read more
Our operating liabilities increased by...Read more
Although we believe that the...Read more
503B product sales increased by...Read more
Cost of sales also includes...Read more
We have assembled a strong...Read more
Variable consideration is only included...Read more
The Company?s contracts may contain...Read more
34 Liquidity and Capital Resources...Read more
We have based these estimates...Read more
We have based these estimates...Read more
The changes in fair value...Read more
Going Concern Considerations We have...Read more
Therefore, we believe there is...Read more
The Company amortizes intangible assets...Read more
Where a portion of the...Read more
While we expect our R&D...Read more
Commercial and Global Supply Chain...Read more
(3)Our allogeneic (?off-the-shelf?) CAR-NKT cell...Read more
On February 14, 2022, we...Read more
If we fail to regain...Read more
We are diligently working to...Read more
The Company satisfies these performance...Read more
These increases were offset by...Read more
Financial Statements, Disclosures and Schedules
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Athenex, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ATNX
CIK: 1300699
Form Type: 10-Q Quarterly Report
Accession Number: 0000950170-22-008782
Submitted to the SEC: Tue May 10 2022 11:09:59 AM EST
Accepted by the SEC: Tue May 10 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations