BEIJING, Nov. 14,
2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI), a biopharmaceutical company focused on developing
and commercializing innovative therapeutics and pharmaceutical
products, today reported business and financial results for the
third quarter ended September 30,
2023.
Dr. Wei-Wu He, Chairman and CEO
of CASI Pharmaceuticals, stated, "We are delighted to announce that
our partner Juventas has received approval from the China National
Medical Products Administration (NMPA) for Inaticabtagene
Autoleucel (anti-CD 19 CAR-T Cell Therapy) for the treatment of
B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. As exclusive marketing partner of
Juventas, we are extremely proud of this achievement. This marks a
significant milestone as Inaticabtagene Autoleucel is the first
commercialized cell therapy for B-ALL in China. Our sales and marketing team is
actively preparing for the commercial launch."
Dr. He further added, "Our sales revenue for the third quarter
of 2023 was $8.8 million,
representing a decrease of 13.5% compared to the same period last
year and a decrease of 10% from the second quarter of 2023. The
third quarter EVOMELA® sales performance was impacted by
the recent launch of an undifferentiated generic formulation of
melphalan for injection product. Despite market challenges, CASI
remains committed to advancing our product pipeline. Some of our
noteworthy recent achievements include the license transfer of
Folotyn® with an expected launch in Q1 2024, progress in
the clinical development of BI-1206, transitioning CID-103
development to China for malignant
hematology indications, and the acquisition of global rights for
CB-5339 from Cleave Therapeutics. CASI Pharmaceuticals continues to
strive for milestones and seek new synergistic opportunities in the
coming quarters."
Third Quarter 2023 Financial Highlights
- Revenue consists of product sales of EVOMELA®.
Revenue was $8.8 million for the
three months ended September 30,
2023, compared to $10.2
million for the three months ended September 30, 2022.
- Costs of revenues were $3.6
million for the three months ended September 30, 2023, compared to $4.2 million for the three months ended
September 30, 2022. The decrease is
in line with the decrease in revenue.
- Research and development expenses for the three months ended
September 30, 2023 were $2.4 million, compared with $3.9 million for the three months ended
September 30, 2022. The decrease is
mainly attributable to reduced research and development expenses on
certain projects, such as CID-103.
- General and administrative expenses for the three months ended
September 30, 2023 were $5.5 million, compared with $4.8 million for the three months ended
September 30, 2022.
- Selling and marketing expenses for the three months ended
September 30, 2023 were $2.5 million, compared with $3.6 million for the three months ended
September 30, 2022. The decrease is
mainly attributable to reduced commercial activities given the
recent market environment.
- As of September 30, 2023, CASI
had cash, cash equivalents and short-term investments of
$34.2 million.
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 shareholder 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.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
Phone: 240.864.2643
Email: ir@casipharmaceuticals.com
|
CASI
Pharmaceuticals, Inc.
Unaudited Condensed
Consolidated Balance Sheets
(In thousands, except
share and per share data)
|
|
|
September 30,
2023
|
December 31,
2022
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
19,976
|
47,112
|
|
Short-term
investments
|
14,246
|
1,462
|
|
Investment in equity
securities, at fair value
|
1,375
|
2,763
|
|
Accounts
receivable
|
11,656
|
12,973
|
|
Inventories
|
8,830
|
6,138
|
|
Prepaid expenses and
other
|
2,034
|
2,975
|
|
Total current
assets
|
58,117
|
73,423
|
|
|
|
|
Term deposit, non
current
|
-
|
3,065
|
|
Property and
equipment, net
|
9,497
|
11,831
|
|
Intangible assets,
net
|
273
|
1,063
|
|
Long-term
investments
|
3,607
|
4,398
|
|
Right of use
assets
|
1,119
|
1,398
|
|
Other
assets
|
1,615
|
1,056
|
|
Total assets
|
74,228
|
96,234
|
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
2,563
|
3,289
|
|
Accrued and other
current liabilities
|
9,264
|
11,816
|
|
Income tax
payable
|
-
|
1,900
|
|
Total current
liabilities
|
11,827
|
17,005
|
|
|
|
|
Other
liabilities
|
11,967
|
12,297
|
|
Total
liabilities
|
23,794
|
29,302
|
|
|
|
|
Redeemable
noncontrolling interest, at redemption value
|
21,640
|
22,358
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
Ordinary
shares
|
1
|
1
|
|
Additional paid-in
capital
|
695,683
|
691,766
|
|
Treasury
shares
|
(9,604)
|
(9,330)
|
|
Accumulated other
comprehensive loss
|
(1,619)
|
(703)
|
|
Accumulated
deficit
|
(655,667)
|
(637,160)
|
|
Total shareholders'
equity
|
28,794
|
44,574
|
|
|
|
|
Total liabilities,
redeemable noncontrolling interest and shareholders'
equity
|
74,228
|
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
|
|
Nine months
ended
|
|
September 30,
2023
|
September 30,
2022
|
|
September 30,
2023
|
September 30,
2022
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
Product
sales
|
8,838
|
10,213
|
|
27,005
|
27,788
|
|
Lease income from a
related party
|
-
|
-
|
|
-
|
60
|
|
Total
revenues
|
8,838
|
10,213
|
|
27,005
|
27,848
|
|
|
|
|
|
|
|
Costs of
revenues
|
3,648
|
4,247
|
|
11,012
|
11,555
|
|
|
|
|
|
|
|
Gross profit
|
5,190
|
5,966
|
|
15,993
|
16,293
|
|
|
|
|
|
|
|
Research and
development
|
2,399
|
3,905
|
|
7,547
|
11,748
|
|
General and
administrative
|
5,521
|
4,849
|
|
18,967
|
15,694
|
|
Selling and
marketing
|
2,518
|
3,566
|
|
11,300
|
10,241
|
|
Foreign exchange
gain
|
(153)
|
(637)
|
|
(168)
|
(2,325)
|
|
Total operating
expense
|
10,285
|
11,683
|
|
37,646
|
35,358
|
|
|
|
|
|
|
|
Loss from
operations
|
(5,095)
|
(5,717)
|
|
(21,653)
|
(19,065)
|
|
|
|
|
|
|
|
Interest income
(expense), net
|
161
|
(13)
|
|
502
|
101
|
|
Changes in fair value
of investments
|
10
|
696
|
|
(1,068)
|
(2,012)
|
|
Other
income
|
473
|
11
|
|
1,899
|
60
|
|
Loss before income tax
expense and share of net loss in an equity investee
|
(4,451)
|
(5,023)
|
|
(20,320)
|
(20,916)
|
|
Income tax
expense
|
-
|
-
|
|
-
|
-
|
|
Net loss before share
of net loss in an equity investee
|
(4,451)
|
(5,023)
|
|
(20,320)
|
(20,916)
|
|
Share of net loss in
an equity investee
|
(15)
|
-
|
|
(47)
|
-
|
|
Net loss
|
(4,466)
|
(5,023)
|
|
(20,367)
|
(20,916)
|
|
Less: loss attributable
to redeemable noncontrolling interest
|
(600)
|
(738)
|
|
(1,860)
|
(1,703)
|
|
accretion
to redeemable noncontrolling interest redemption value
|
769
|
916
|
|
2,376
|
2,264
|
|
Net loss attributable
to CASI Pharmaceuticals, Inc.
|
(4,635)
|
(5,201)
|
|
(20,883)
|
(21,477)
|
|
|
|
|
|
|
|
Weighted average number
of ordinary shares outstanding (basic and diluted)
|
13,378,175
|
13,606,130
|
|
13,354,123
|
13,668,553
|
|
Net loss per share
(basic and diluted)
|
(0.35)
|
(0.38)
|
|
(1.56)
|
(1.57)
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
Net loss
|
(4,466)
|
(5,023)
|
|
(20,367)
|
(20,916)
|
|
Foreign currency
translation adjustment
|
(171)
|
(3,127)
|
|
(2,150)
|
(6,420)
|
|
Total comprehensive
loss
|
(4,637)
|
(8,150)
|
|
(22,517)
|
(27,336)
|
|
|
|
|
|
|
|
Less: comprehensive
loss attributable to redeemable noncontrolling interest
|
(746)
|
(2,074)
|
|
(3,094)
|
(4,218)
|
|
Comprehensive loss
attributable to ordinary shareholders
|
(3,891)
|
(6,076)
|
|
(19,423)
|
(23,118)
|
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SOURCE CASI Pharmaceuticals