Full Press Release Details
CASI PHARMACEUTICALS ANNOUNCES
SECOND QUARTER 2023 BUSINESS AND FINANCIAL UPDATES
BEIJING, China (August
11, 2023) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing
innovative therapeutics and pharmaceutical products, today reported financial results for the quarter ended June 30, 2023.
CASI's Chairman and Chief Executive Officer, commented, "We are pleased to report $9.8 million sales revenue for the
second quarter of 2023. This is a 15% increase compared to the same period last year and an 18% of increase from the first
Dr. He continued, "Advancement,
development, and commercialization of the portfolio remains our strategic focus. We have achieved a major milestone with our partner Juventas
Biotechnology (Tianjin) Co., Ltd. ("Juventas") on the CNCT-19 CAR-T Cell therapy. CNCT-19's New Drug Application (NDA)
was accepted by National Medical Products Administration (NMPA) in December 2022. We are now diligently preparing for the anticipated
CNCT-19 launch in China. We are advancing the clinical development of BI-1206 in combination with rituximab and presently undertaking
the enrollment of patients for the second cohort of the phase I trial in China. We are transitioning the development of CID-103 into China
for the malignant hematology indications. In addition, we acquired global rights for CB-5339 from Cleave Therapeutics in July. On August
1st, we announced the transfer of license of Folotyn in China from Mundipharma International Corporation Limited,
Mundipharma Medical Company, and Acrotech Biopharma Inc. We continue to advance our portfolio by executing on several milestones as well
as bringing in new potential opportunities for synergy in the quarters ahead."
Second Quarter 2023 Financial Highlights
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a
biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China,
the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that
augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its
plan to become a leader by launching medicines in the greater China market, leveraging the Company's China-based regulatory
and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through
its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is
available at www.casipharmaceuticals.com.
Forward-Looking Statements
This news release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or
business performance, strategies, expectations, and goals. Forward-looking statements are subject to numerous assumptions, risks, and
uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking
statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including:
the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational
needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market; the volatility in the market price of our ordinary
shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business
strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution
of our proposed product candidates or future candidates, including with respect to BI-1206, CB-5339 and CID-103; our lack of experience
in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating
to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the
U.S. Food and Drug Administration (FDA), National Medical Products Administration (NMPA), or other regulatory authorities; our inability
to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates
or future candidates, including with respect to our partnerships with Juventas and BioInvent; the risks relating to the need for additional
capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the
risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not
necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement
of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our
products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of
CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution
for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent,
product liability, supply, competition and other risks); risks relating to interests of our largest shareholders and our Chairman and
CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Wuxi. Such factors,
among others, could have a material adverse effect upon our business, results of operations, and financial condition. We caution readers
not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the
factors and risks that could affect our business, financial condition, and results of operations, are contained in our filings with the
U.S. Securities and Exchange Commission, which are available at www.sec.gov.
EVOMELA is proprietary
to Acrotech Biopharma Inc. and its affiliates. FOLOTYN is proprietary
to Mundipharma International Corporation Limited and its affiliates.
CASI Pharmaceuticals, Inc.
Email: ir@casipharmaceuticals.com
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
| June 30, 2023 | December 31, 2022 | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | 16,915 | 47,112 | ||||||
| Short-term investments | 19,851 | 1,462 | ||||||
| Investment in equity securities, at fair value | 2,028 | 2,763 | ||||||
| Accounts receivable | 12,529 | 12,973 | ||||||
| Inventories | 7,767 | 6,138 | ||||||
| Prepaid expenses and other | 1,914 | 2,975 | ||||||
| Total current assets | 61,004 | 73,423 | ||||||
| Term deposit, non current | - | 3,065 | ||||||
| Property and equipment, net | 10,122 | 11,831 | ||||||
| Intangible assets, net | 537 | 1,063 | ||||||
| Long-term investments | 3,636 | 4,398 | ||||||
| Right of use assets | 1,368 | 1,398 | ||||||
| Other assets | 1,207 | 1,056 | ||||||
| Total assets | 77,874 | 96,234 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | 2,374 | 3,289 | ||||||
| Accrued and other current liabilities | 9,533 | 11,816 | ||||||
| Income tax payable | - | 1,900 | ||||||
| Total current liabilities | 11,907 | 17,005 | ||||||
| Other liabilities | 12,124 | 12,297 | ||||||
| Total liabilities | 24,031 | 29,302 | ||||||
| Redeemable noncontrolling interest, at redemption value | 21,617 | 22,358 | ||||||
| Shareholders' equity: | ||||||||
| Ordinary shares | 1 | 1 | ||||||
| Additional paid-in capital | 695,224 | 691,766 | ||||||
| Treasury shares | (9,604 | ) | (9,330 | ) | ||||
| Accumulated other comprehensive loss | (1,594 | ) | (703 | ) | ||||
| Accumulated deficit | (651,801 | ) | (637,160 | ) | ||||
| Total shareholders' equity | 32,226 | 44,574 | ||||||
| Total liabilities, redeemable noncontrolling interest and shareholders' equity | 77,874 | 96,234 |
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three months ended | Six months ended | |||||||||||||||
| June 30, 2023 | June 30, 2022 | June 30, 2023 | June 30, 2022 | |||||||||||||
| Revenues | ||||||||||||||||
| Product sales | 9,820 | 8,550 | 18,167 | 17,575 | ||||||||||||
| Lease income from a related party | - | 23 | - | 60 | ||||||||||||
| Total revenues | 9,820 | 8,573 | 18,167 | 17,635 | ||||||||||||
| Costs of revenues | 3,986 | 3,550 | 7,364 | 7,308 | ||||||||||||
| Gross profit | 5,834 | 5,023 | 10,803 | 10,327 | ||||||||||||
| Research and development | 2,614 | 3,851 | 5,148 | 7,843 | ||||||||||||
| General and administrative | 7,701 | 5,520 | 13,446 | 10,845 | ||||||||||||
| Selling and marketing | 4,820 | 3,398 | 8,782 | 6,675 | ||||||||||||
| Foreign exchange loss (gain) | 44 | (1,355 | ) | (15 | ) | (1,688 | ) | |||||||||
| Total operating expense | 15,179 | 11,414 | 27,361 | 23,675 | ||||||||||||
| Loss from operations | (9,345 | ) | (6,391 | ) | (16,558 | ) | (13,348 | ) | ||||||||
| Interest income, net | 139 | 40 | 341 | 114 | ||||||||||||
| Changes in fair value of investments | (938 | ) | (1,153 | ) | (1,078 | ) | (2,708 | ) | ||||||||
| Other income | 89 | 11 | 1,426 | 49 | ||||||||||||
| Net loss before share of net loss in an equity investee | (10,055 | ) | (7,493 | ) | (15,869 | ) | (15,893 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Share of net loss in an equity investee | (15 | ) | - | (32 | ) | - | ||||||||||
| Net loss | (10,070 | ) | (7,493 | ) | (15,901 | ) | (15,893 | ) | ||||||||
| Less: loss attributable to redeemable noncontrolling interest | (593 | ) | (548 | ) | (1,260 | ) | (965 | ) | ||||||||
| accretion to redeemable noncontrolling interest redemption value | 762 | 735 | 1,607 | 1,348 | ||||||||||||
| Net loss attributable to CASI Pharmaceuticals, Inc. | (10,239 | ) | (7,680 | ) | (16,248 | ) | (16,276 | ) | ||||||||
| Weighted average number of ordinary shares outstanding (basic and diluted) | 13,344,548 | 13,606,130 | 13,341,897 | 13,700,282 | ||||||||||||
| Net loss per share (basic and diluted) | (0.77 | ) | (0.56 | ) | (1.22 | ) | (1.19 | ) | ||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | (10,070 | ) | (7,493 | ) | (15,901 | ) | (15,893 | ) | ||||||||
| Foreign currency translation adjustment | (2,177 | ) | (3,541 | ) | (1,979 | ) | (3,293 | ) | ||||||||
| Total comprehensive loss | (12,247 | ) | (11,034 | ) | (17,880 | ) | (19,186 | ) | ||||||||
| Less: comprehensive loss attributable to redeemable noncontrolling interest | (1,789 | ) | (1,800 | ) | (2,348 | ) | (2,144 | ) | ||||||||
| Comprehensive loss attributable to ordinary shareholders | (10,458 | ) | (9,234 | ) | (15,532 | ) | (17,042 | ) |