ROCKVILLE, Md. and BEIJIN, Nov. 14,
2022 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI), a U.S. biopharmaceutical company focused on
developing and commercializing innovative therapeutics and
pharmaceutical products, today reported financial results for the
third quarter of 2022.
Wei-Wu He, Ph.D., CASI's Chairman
and Chief Executive Officer, commented, "We are pleased to
report $10.2 million in
EVOMELA® sales revenue for the third quarter of
2022. This is a 26% of increase compared to the same
period last year. Our teams in both China and US delivered strong performance
despite the continued COVID lockdown in several major cities in
China. Since the third quarter, the COVID-19 pandemic has
gradually spread nationwide in China, with many small to medium-sized cities
upgrading their control measures. The implementation of these
enhanced pandemic control measures is expected to adversely impact
our sales activities for the remainder of the year."
Dr. He continued, "Advancement, development, and
commercialization of the portfolio remains our strategic focus.
Through our partner Juventas, the CNCT-19 New Drug
Application (NDA) submission to the National Medical Products
Administration (NMPA) is on track, and we are in preparation for
the anticipated CNCT-19 launch in China. As we continue the development of the
regulatory framework for BI-1206 in China, we were pleased with the recent dosing
of the first patient in the BI-1206 phase I trial in China. We expect CB-5339 to receive Clinical
Trial Application approval from the NMPA in early 2023; Meanwhile,
our CID-103's Phase I study continues. We plan to build on the
momentum to drive our portfolio forward by executing on several
milestones in the quarters ahead."
Third Quarter 2022 Financial Highlights
- Revenues consist primarily of product sales of EVOMELA. Revenue
was $10.2 million for the three
months ended September 30, 2022,
compared to $8.1 million for the
three months ended September 30,
2021.
- Costs of revenues consist primarily of the cost of inventories
of EVOMELA and sales-based royalties related to the sale of
EVOMELA. Costs of revenues were $4.2
million for the three months ended September 30, 2022, compared to $3.4 million for the three months ended
September 30, 2021.
- Research and development expenses for the three months ended
September 30, 2022, were $3.9 million, compared with $2.9 million for the three months ended
September 30, 2021. The increase of
research and development expenses for the three months periods was
mainly due to expense incurred for BI-1206 and CID-103.
- General and administrative expenses for the three months ended
September 30, 2022, were $4.8 million, compared with $5.3 million for the three months ended
September 30, 2021.
- Selling and marketing expenses for the three months ended
September 30, 2022, were $3.6 million, compared with $3.4 million for the three months ended
September 30, 2021.
- Acquired in-process R&D expenses for the three months ended
September 30, 2022 and 2021, were
both nil.
- As of September 30, 2022, CASI
had cash and cash equivalents of $29.2
million.
Further information regarding the Company, including its
Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, can be found at
www.casipharmaceuticals.com.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The majority of the
Company's operations are now located in China. 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 is executing its plan to become a
biopharmaceutical leader by launching medicines in the greater
China market, leveraging its
China-based regulatory, clinical
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. The Company has built a
commercial team of more than 100 hematology and oncology sales and
marketing specialists based in 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 common stock; the outbreak of the
COVID-19 pandemic and its effects on global markets and supply
chains; the risk of substantial dilution of existing stockholders
in future stock 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; our ability to design and
implement a development plan for our ANDAs held by CASI Wuxi; 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
stockholders and our Chairman and CEO that differ from our other
stockholders; 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.
COMPANY CONTACT:
Rui
Zhang
CASI Pharmaceuticals, Inc.
Phone: 240.864.2643
Email: ir@casipharmaceuticals.com
(Financial Table Follows)
CASI
Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
September 30, 2022
|
|
December 31,
2021
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
26,742
|
|
$
|
38,704
|
|
Restricted
cash
|
|
|
2,500
|
|
|
—
|
|
Investment in equity
securities, at fair value
|
|
|
6,309
|
|
|
9,868
|
|
Accounts receivable,
net of $0 allowance for doubtful accounts
|
|
|
12,560
|
|
|
9,803
|
|
Inventories
|
|
|
5,773
|
|
|
1,907
|
|
Prepaid expenses and
other
|
|
|
1,728
|
|
|
1,688
|
|
Total current
assets
|
|
|
55,612
|
|
|
61,970
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
|
13,867
|
|
|
12,712
|
|
Intangible assets,
net
|
|
|
10,049
|
|
|
12,203
|
|
Long-term
investments
|
|
|
39,780
|
|
|
40,128
|
|
Right of use
assets
|
|
|
7,666
|
|
|
9,107
|
|
Other assets
|
|
|
932
|
|
|
2,178
|
|
Total assets
|
|
$
|
127,906
|
|
$
|
138,298
|
|
|
|
|
|
|
|
|
|
LIABILITIES, REDEEMABLE
NONCONTROLLING INTEREST AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,098
|
|
$
|
4,789
|
|
Bank
borrowings
|
|
|
3,000
|
|
|
—
|
|
Accrued and other
current liabilities
|
|
|
23,651
|
|
|
8,397
|
|
Total current
liabilities
|
|
|
29,749
|
|
|
13,186
|
|
|
|
|
|
|
|
|
|
Deferred
income
|
|
|
2,488
|
|
|
2,828
|
|
Other
liabilities
|
|
|
12,455
|
|
|
14,325
|
|
Total
liabilities
|
|
|
44,692
|
|
|
30,339
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable
noncontrolling interest, at redemption value
|
|
|
21,503
|
|
|
23,457
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Preferred stock, $1.00
par value: 5,000,000 shares authorized and 0 shares issued
and
|
|
|
—
|
|
|
—
|
|
Outstanding
|
|
|
|
|
|
|
|
Common stock, $0.01 par
value:
|
|
|
|
|
|
|
|
250,000,000
shares authorized at September 30, 2022 and
December 31, 2021
|
|
|
|
|
|
|
|
13,733,459 shares
and 13,987,578 shares issued at September 30, 2022
and
December 31, 2021, respectively;
|
|
|
|
|
|
|
|
13,606,130 shares
and 13,979,624 shares outstanding at
September 30, 2022
and December 31, 2021, respectively
|
|
|
1,373
|
|
|
1,399
|
|
Additional paid-in
capital
|
|
|
696,213
|
|
|
694,826
|
|
Treasury stock, at
cost: 127,329 shares and 7,954 shares held at
September 30, 2022 and
December 31, 2021
|
|
|
(9,068)
|
|
|
(8,034)
|
|
Accumulated other
comprehensive income
|
|
|
(1,951)
|
|
|
1,954
|
|
Accumulated
deficit
|
|
|
(624,856)
|
|
|
(605,643)
|
|
Total stockholders'
equity
|
|
|
61,711
|
|
|
84,502
|
|
Total liabilities,
redeemable noncontrolling interest and stockholders'
equity
|
|
$
|
127,906
|
|
$
|
138,298
|
|
CASI
Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss
(In thousands, except share and per share data)
|
|
|
|
Three Months Ended
September 30
|
|
Nine Months Ended
September 30
|
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
|
10,213
|
|
|
8,075
|
|
$
|
27,788
|
|
$
|
20,900
|
|
Lease income from a
related party
|
|
|
—
|
|
|
37
|
|
|
60
|
|
|
110
|
|
Total
revenues
|
|
|
10,213
|
|
|
8,112
|
|
|
27,848
|
|
|
21,010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of
revenues
|
|
|
4,247
|
|
|
3,417
|
|
|
11,555
|
|
|
8,757
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
5,966
|
|
|
4,695
|
|
|
16,293
|
|
|
12,253
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,905
|
|
|
2,895
|
|
|
11,748
|
|
|
10,408
|
|
General and
administrative
|
|
|
4,849
|
|
|
5,259
|
|
|
15,694
|
|
|
16,249
|
|
Selling and
marketing
|
|
|
3,566
|
|
|
3,433
|
|
|
10,241
|
|
|
9,508
|
|
Acquired in-process
research and development
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,555
|
|
Total operating
expenses
|
|
|
12,320
|
|
|
11,587
|
|
|
37,683
|
|
|
42,720
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(6,354)
|
|
|
(6,892)
|
|
|
(21,390)
|
|
|
(30,467)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
(expense)/income, net
|
|
|
(13)
|
|
|
79
|
|
|
101
|
|
|
261
|
|
Other income
|
|
|
11
|
|
|
487
|
|
|
60
|
|
|
540
|
|
Foreign exchange
gains/(losses)
|
|
|
637
|
|
|
(6)
|
|
|
2,325
|
|
|
289
|
|
Change in fair value of
investments
|
|
|
696
|
|
|
(3,687)
|
|
|
(2,012)
|
|
|
(205)
|
|
Impairment loss of
long-term investments
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(865)
|
|
Loss before income tax
expense
|
|
|
(5,023)
|
|
|
(10,019)
|
|
|
(20,916)
|
|
|
(30,447)
|
|
Income tax
expense
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(5,023)
|
|
|
(10,019)
|
|
|
(20,916)
|
|
|
(30,447)
|
|
Less: loss attributable
to redeemable noncontrolling interest
|
|
|
(738)
|
|
|
(314)
|
|
|
(1,703)
|
|
|
(980)
|
|
Accretion to redeemable
noncontrolling interest redemption value
|
|
|
916
|
|
|
519
|
|
|
2,264
|
|
|
1,586
|
|
Net loss attributable
to CASI Pharmaceuticals, Inc.
|
|
$
|
(5,201)
|
|
$
|
(10,224)
|
|
$
|
(21,477)
|
|
$
|
(31,053)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
(basic and diluted)
|
|
$
|
(0.38)
|
|
$
|
(0.73)
|
|
$
|
(1.57)
|
|
$
|
(2.30)
|
|
Weighted average number
of common stock outstanding (basic
and diluted)
|
|
|
13,606,130
|
|
|
13,979,636
|
|
|
13,668,553
|
|
|
13,486,024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,023)
|
|
$
|
(10,019)
|
|
$
|
(20,916)
|
|
$
|
(30,447)
|
|
Foreign currency
translation adjustment
|
|
|
(3,127)
|
|
|
15
|
|
|
(6,420)
|
|
|
848
|
|
Total comprehensive
loss
|
|
$
|
(8,150)
|
|
$
|
(10,004)
|
|
$
|
(27,336)
|
|
$
|
(29,599)
|
|
Less: Comprehensive
loss attributable to redeemable noncontrolling interest
|
|
|
(2,074)
|
|
|
(309)
|
|
|
(4,218)
|
|
|
(712)
|
|
Comprehensive loss
attributable to common stockholders
|
|
$
|
(6,076)
|
|
$
|
(9,695)
|
|
$
|
(23,118)
|
|
$
|
(28,887)
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/casi-pharmaceuticals-announces-third-quarter-2022-financial-results-301676268.html
SOURCE CASI Pharmaceuticals, Inc.