CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS
CASI reported fourth quarter 2023 revenue of
Key Highlights for 2023
EVOMELA® (melphalan for injection)
Prior to EVOMELA's entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA's launch in August of 2019, CASI worked closely with therapeutic area experts to improve market awareness and expedite adoption in the Chinese market. In 2023, nearly 10,000 patients were treated with EVOMELA. CASI continues to pursue a similar strategy with respect to marketing efforts and physician visits to further the adoption of stem cell transplantation as a standard of care in the MM treatment setting and will continue working to address the persistent high unmet need in this patient population.
FOLOTYN® (Pralatrexate)
On
BI-1206 (Anti-FcyRIIB antibody)
Along with CASI's partner, BioInvent, CASI continues to progress the development and regulatory framework for BI-1206 in
Inaticabtagene Autoleucel (CNCT-19)
On
Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product comprised of a unique CD19 scFv(HI19a)structure and utilizes leading CMC manufacturing techniques. Inaticabtagene Autoleucel has demonstrated a high level of efficacy, with durable remissions, and substantially improved safety profile with reduced CAR-T related toxicities in the pivotal clinical study for the treatment of adults with r/r B-ALL.
CASI is currently involved in arbitration proceedings against Juventas in relation to Juventas's purported termination of the CNCT-19 Agreements, between the Company and Juventas with respect to the commercialization of Juventas' cell therapy, Inaticabtagene Autoleucel (CNCT-19). On
CB-5339 (VCP/p97 inhibitor)
In
On
CID-103 (Anti-CD38 Mab)
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is closed to further accrual in
Full-Year 2023 Financial Results
- Revenues consist of product sales of EVOMELA®. Revenue was
$34.0 million for the year endedDecember 31, 2023 compared to$38 million for the year endedDecember 31, 2022 . The decrease was mainly attributable to the launch of an undifferentiated generic formulation of melphalan for injection product by a Chinese domestic manufacture. - Costs of revenues were
$13.8 million for the year endedDecember 31, 2023 compared to$15.8 million for the year endedDecember 31, 2022 . Costs of revenues as a percentage of EVOMELA® sales for 2023 and 2022 were 41% and 42%, respectively. - General and administrative expenses for the year ended
December 31, 2023 were$25.4 million , compared with$23.4 million for the year endedDecember 31, 2022 . The increase in general and administrative expenses was primarily attributable to incremental share-based compensation expense recognized due to the option modification inMay 2023 amounted toUS$2.2 million , and increased depreciation expense ofUS$1.2 million due to the full year depreciation expenses of CASI Wuxi's leasehold improvement that started to depreciate inAugust 2022 , offset by decrease of land vacancy fee ofUS$1.3 million in relation to the return of theWuxi land use right. - Selling and marketing expenses for the year ended
December 31, 2023 , were$16.4 million , compared with$14.3 million for the year endedDecember 31, 2022 . The increase was primarily due to increased travel and conference expenses incurred for our commercial activities after the Chinese health authority cancelled the stringent COVID-19 controlled measure inDecember 2022 . - Research and development expenses for the year ended
December 31, 2023 were$9.9 million , compared with$16.0 million for the year endedDecember 31, 2022 . The decrease in R&D expenses is primarily due to CID-103 as we incurred less laboratory tests and decrease in the research and development expenses of generic pharmaceuticals in Wuxi manufacturing facility. - Net loss for the year ended
December 31, 2023 was$26.3 million compared to$40.3 million for the year endedDecember 31, 2022 . - As of
December 31, 2023 , CASI had cash, cash equivalents and short term investment of$29.1 million compared to$48.6 million as ofDecember 31, 2022 .
Further information regarding the Company, including its Annual Report on Form 20-F for the year ended
About
CASI Forward-Looking Statements:
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the
EVOMELA
® is proprietary to
COMPANY CONTACT:
240.864.2643
ir@casipharmaceuticals.com
(Financial Table Follows)
Consolidated Balance Sheets (In USD thousands, except share and per share data) |
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ASSETS |
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Current assets: |
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|
Cash and cash equivalents |
|
$ |
17,083 |
|
$ |
47,112 |
Investment in equity securities, at fair value |
|
|
1,675 |
|
|
2,763 |
Short term investments |
|
|
12,011 |
|
|
1,462 |
Accounts receivable |
|
|
9,551 |
|
|
12,973 |
Receivable from a related party |
|
|
587 |
|
|
— |
Inventories |
|
|
15,877 |
|
|
6,138 |
Prepaid expenses and other |
|
|
2,560 |
|
|
2,975 |
Total current assets |
|
|
59,344 |
|
|
73,423 |
|
|
|
|
|
|
|
Term deposit, non current |
|
|
— |
|
|
3,065 |
Property, plant and equipment, net |
|
|
9,241 |
|
|
11,831 |
Intangible assets, net |
|
|
1,839 |
|
|
1,063 |
Long-term investments |
|
|
1,686 |
|
|
4,398 |
Right of use assets |
|
|
2,392 |
|
|
1,398 |
Other assets |
|
|
766 |
|
|
1,056 |
Total assets |
|
$ |
75,268 |
|
$ |
96,234 |
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LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND SHAREHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
|
$ |
4,438 |
|
$ |
3,289 |
Accrued and other current liabilities |
|
|
12,288 |
|
|
11,816 |
Income tax payable |
|
|
— |
|
|
1,900 |
Total current liabilities |
|
|
16,726 |
|
|
17,005 |
|
|
|
|
|
|
|
Long term borrowing |
|
|
18,895 |
|
|
— |
Other liabilities |
|
|
15,482 |
|
|
12,297 |
Total liabilities |
|
|
51,103 |
|
|
29,302 |
|
|
|
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|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable noncontrolling interest, at redemption value |
|
|
— |
|
|
22,358 |
|
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
|
|
Ordinary shares, |
|
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500,000,000 shares authorized |
|
|
|
|
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13,790,127 shares and 13,733,459 shares issued at |
|
|
|
|
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13,378,175 shares and 13,457,625 shares outstanding at |
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1 |
|
|
1 |
Additional paid-in capital |
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|
695,785 |
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|
691,766 |
|
|
|
(9,604) |
|
|
(9,330) |
Accumulated other comprehensive loss |
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|
(1,200) |
|
|
(703) |
Accumulated deficit |
|
|
(660,817) |
|
|
(637,160) |
Total shareholders' equity |
|
|
24,165 |
|
|
44,574 |
Total liabilities, redeemable noncontrolling interest and shareholders' equity |
|
$ |
75,268 |
|
$ |
96,234 |
Consolidated Statements of Operations and Comprehensive Loss (In USD thousands, except share and per share data) |
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Year Ended |
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2023 |
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2022 |
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2021 |
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Revenues: |
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|
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Product sales |
|
$ |
33,879 |
|
$ |
38,047 |
|
$ |
30,020 |
Sublicensing revenue from a related party |
|
|
— |
|
|
5,000 |
|
|
— |
Lease income from a related party |
|
|
— |
|
|
60 |
|
|
148 |
Total revenues |
|
|
33,879 |
|
|
43,107 |
|
|
30,168 |
|
|
|
|
|
|
|
|
|
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Total costs of revenues |
|
|
13,827 |
|
|
15,827 |
|
|
12,557 |
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|
|
|
|
|
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Gross Profit |
|
|
20,052 |
|
|
27,280 |
|
|
17,611 |
|
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|
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|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
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Research and development |
|
|
9,861 |
|
|
15,996 |
|
|
14,422 |
General and administrative |
|
|
25,387 |
|
|
23,449 |
|
|
23,701 |
Selling and marketing |
|
|
16,450 |
|
|
14,326 |
|
|
14,705 |
Other operating income |
|
|
(6,366) |
|
|
— |
|
|
— |
Acquired in-process research and development |
|
|
— |
|
|
— |
|
|
6,555 |
Loss on disposal of long-lived assets |
|
|
— |
|
|
2,058 |
|
|
65 |
Foreign exchange gain |
|
|
(200) |
|
|
(3,241) |
|
|
(321) |
Impairment of intangible assets |
|
|
— |
|
|
8,724 |
|
|
— |
Total operating expenses |
|
|
45,132 |
|
|
61,312 |
|
|
59,127 |
|
|
|
|
|
|
|
|
|
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Loss from operations |
|
|
(25,080) |
|
|
(34,032) |
|
|
(41,516) |
|
|
|
|
|
|
|
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Non-operating income (expense): |
|
|
|
|
|
|
|
|
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Interest income, net |
|
|
614 |
|
|
127 |
|
|
321 |
Other income |
|
|
764 |
|
|
44 |
|
|
558 |
Change in fair value of investments |
|
|
(581) |
|
|
(8,895) |
|
|
5,660 |
Gain from sale of an equity investment |
|
|
— |
|
|
5,325 |
|
|
— |
Impairment loss of long-term investments |
|
|
(2,009) |
|
|
— |
|
|
(865) |
Loss before income tax benefit (expense) and share of net loss in an equity investee |
|
|
(26,292) |
|
|
(37,431) |
|
|
(35,842) |
Income tax benefit (expense) |
|
|
81 |
|
|
(1,980) |
|
|
— |
Net loss before share of net loss in an equity investee |
|
|
(26,211) |
|
|
(39,411) |
|
|
(35,842) |
Share of net loss in an equity investee |
|
|
(48) |
|
|
(846) |
|
|
— |
Net loss |
|
|
(26,259) |
|
|
(40,257) |
|
|
(35,842) |
Less:Loss attributable to redeemable noncontrolling interest |
|
|
(2,602) |
|
|
(8,740) |
|
|
(700) |
Accretion to redeemable noncontrolling interest redemption value |
|
|
3,281 |
|
|
9,497 |
|
|
1,512 |
Deemed dividends to |
|
|
22 |
|
|
— |
|
|
— |
Net loss attributable to |
|
$ |
(26,960) |
|
$ |
(41,014) |
|
$ |
(36,654) |
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic and diluted) |
|
$ |
(2.02) |
|
$ |
(3.01) |
|
$ |
(2.69) |
Weighted average number of ordinary shares outstanding (basic and diluted) |
|
|
13,360,185 |
|
|
13,647,455 |
|
|
13,610,441 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(26,259) |
|
$ |
(40,257) |
|
$ |
(35,842) |
Foreign currency translation adjustment |
|
|
(1,118) |
|
|
(4,513) |
|
|
1,977 |
Total comprehensive loss |
|
$ |
(27,377) |
|
$ |
(44,770) |
|
$ |
(33,865) |
Less: Comprehensive loss attributable to redeemable noncontrolling interest |
|
|
(3,223) |
|
|
(10,596) |
|
|
(88) |
Comprehensive loss attributable to ordinary shareholders |
|
$ |
(24,154) |
|
$ |
(34,174) |
|
$ |
(33,777) |
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