ROCKVILLE, Md. and BEIJING, May 12, 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 first quarter of
2022.
Wei-Wu He, Ph.D., CASI's Chairman
and Chief Executive Officer, commented, "We are pleased to report
$9.0 million in EVOMELA®
sales revenue for the first quarter of 2022. This is an increase of
58% compared to the same period last year. Our first commercial
product, EVOMELA has been instrumental in treating patients with
multiple myeloma prior to stem cell transplantation in China. We have achieved our goal for full-year
2021 EVOMELA revenue to reach 100% growth. Our achievements in 2021
provide a great foundation that we plan to build upon throughout
2022 and beyond."
Dr. He continued, "Our strategic focus in 2022 will continue to
advance the development and commercialization of the portfolio.
Through our partner Juventas, the CNCT-19 NDA submission to the
National Medical Products Administration (NMPA) is on track, and we
are in preparation for the anticipated launch in China; We expect the start of the BI-1206
phase I trial in China; We expect
CB-5339 to receive Clinical Trial Application approval from the
NMPA during 2022; Meanwhile, our CID-103's Phase I study continues.
We are excited by our momentum and will continue to execute on
several key milestones across our broad portfolio in the quarters
ahead."
First Quarter 2022 Financial Highlights
- Revenues consist primarily of product sales of EVOMELA. Revenue
was $9.0 million for the three months
ended March 31, 2022, compared to
$5.7 million for the three months
ended March 31, 2021.
- Costs of revenues were $3.8
million for the three months ended March 31, 2022, compared to $2.4 million for the three months ended
March 31, 2021, which included
royalty payment of $1.8 million and
$1.1 million, respectively.
- Research and development expenses for the three months ended
March 31, 2022, were $4.0 million, compared with $5.3 million for the three months ended
March 31, 2021.
- General and administrative expenses for the three months ended
March 31, 2022, were $5.3 million, compared with $5.5 million for the three months ended
March 31, 2021.
- Selling and marketing expenses for the three months ended
March 31, 2022, were $3.3 million, compared with $2.7 million for the three months ended
March 31, 2021.
- As of March 31, 2022, CASI had
cash and cash equivalent of $29.3
million.
Further information regarding the Company, including its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, can be found at
www.casipharmaceuticals.com.
Conference Call
The conference call can be accessed by dialing 1-866-218-2402
(U.S.) or 1-412-902-6605 (international) and ask to be joined into
the CASI Pharmaceuticals call to listen to the live conference
call. Confirmation #: 10165613
This call will be recorded and available for replay by dialing
1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and enter
2360248 to access the replay.
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 LLC and its affiliates.
COMPANY
CONTACT:
Rui Zhang
CASI
Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Xuan Yang
Solebury
Trout
646.378.2975
xyang@soleburytrout.com
|
(Financial Table Follows)
CASI Pharmaceuticals, Inc.
|
Unaudited Condensed
Consolidated Balance Sheets
|
(In thousands, except
share and per share data)
|
|
|
|
|
March 31, 2022
|
|
December 31,
2021
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
29,259
|
|
$
|
38,704
|
|
Investment in equity securities, at fair value
|
|
|
8,225
|
|
|
9,868
|
|
Accounts receivable, net of $0 allowance for doubtful
accounts
|
|
|
10,086
|
|
|
9,803
|
|
Inventories
|
|
|
3,721
|
|
|
1,907
|
|
Prepaid expenses and other
|
|
|
1,404
|
|
|
1,688
|
|
Total current
assets
|
|
|
52,695
|
|
|
61,970
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
|
14,580
|
|
|
12,712
|
|
Intangible assets,
net
|
|
|
11,900
|
|
|
12,203
|
|
Long-term
investments
|
|
|
40,320
|
|
|
40,128
|
|
Right of use
assets
|
|
|
8,809
|
|
|
9,107
|
|
Other assets
|
|
|
1,260
|
|
|
2,178
|
|
Total assets
|
|
$
|
129,564
|
|
$
|
138,298
|
|
|
|
|
|
|
|
|
|
LIABILITIES, REDEEMABLE
NONCONTROLLING INTEREST AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
7,171
|
|
$
|
4,789
|
|
Accrued and other current liabilities
|
|
|
6,701
|
|
|
8,397
|
|
Total current
liabilities
|
|
|
13,872
|
|
|
13,186
|
|
|
|
|
|
|
|
|
|
Deferred
income
|
|
|
2,821
|
|
|
2,828
|
|
Other
liabilities
|
|
|
14,156
|
|
|
14,325
|
|
Total
liabilities
|
|
|
30,849
|
|
|
30,339
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable
noncontrolling interest, at redemption value
|
|
|
23,726
|
|
|
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 March 31, 2022 and
December 31, 2021
|
|
|
|
|
|
|
|
137,335,787
shares and 139,877,032 shares issued at March 31, 2022
and
December 31, 2021, respectively;
|
|
|
|
|
|
|
|
136,062,495
shares and 139,797,487 shares outstanding at
March 31, 2022 and
December 31, 2021, respectively
|
|
|
1,374
|
|
|
1,399
|
|
Additional paid-in
capital
|
|
|
694,180
|
|
|
694,826
|
|
Treasury stock, at
cost: 1,273,292 shares and 79,545 shares held at
March 31, 2022
and December 31, 2021
|
|
|
(9,068)
|
|
|
(8,034)
|
|
Accumulated other
comprehensive income
|
|
|
2,129
|
|
|
1,954
|
|
Accumulated
deficit
|
|
|
(613,626)
|
|
|
(605,643)
|
|
Total stockholders'
equity
|
|
|
74,989
|
|
|
84,502
|
|
Total liabilities,
redeemable noncontrolling interest and stockholders'
equity
|
|
$
|
129,564
|
|
$
|
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
March 31
|
|
|
|
2022
|
|
2021
|
|
Revenues:
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
9,025
|
|
$
|
5,700
|
|
Lease income from a related party
|
|
|
37
|
|
|
36
|
|
Total
revenues
|
|
|
9,062
|
|
|
5,736
|
|
|
|
|
|
|
|
|
|
Costs of
revenues:
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
|
1,977
|
|
|
1,237
|
|
Royalty fee
|
|
|
1,781
|
|
|
1,121
|
|
Total costs of
revenues
|
|
|
3,758
|
|
|
2,358
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
5,304
|
|
|
3,378
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,992
|
|
|
5,258
|
|
General and administrative
|
|
|
5,325
|
|
|
5,502
|
|
Selling and marketing
|
|
|
3,277
|
|
|
2,715
|
|
Acquired in-process research and development
|
|
|
—
|
|
|
5,500
|
|
Total operating
expenses
|
|
|
12,594
|
|
|
18,975
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(7,290)
|
|
|
(15,597)
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest income, net
|
|
|
74
|
|
|
106
|
|
Other income
|
|
|
38
|
|
|
20
|
|
Foreign exchange gain
|
|
|
333
|
|
|
219
|
|
Change in fair value of investments
|
|
|
(1,555)
|
|
|
1,568
|
|
Loss before income tax
expense
|
|
|
(8,400)
|
|
|
(13,684)
|
|
Income tax expense
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(8,400)
|
|
|
(13,684)
|
|
Less: loss attributable
to redeemable noncontrolling interest
|
|
|
(417)
|
|
|
(349)
|
|
Accretion to redeemable
noncontrolling interest redemption value
|
|
|
613
|
|
|
548
|
|
Net loss attributable
to CASI Pharmaceuticals, Inc.
|
|
$
|
(8,596)
|
|
$
|
(13,883)
|
|
|
|
|
|
|
|
|
|
Net loss per share
(basic and diluted)
|
|
$
|
(0.06)
|
|
$
|
(0.11)
|
|
Weighted average number
of common stock outstanding (basic
and diluted)
|
|
|
137,955,910
|
|
|
124,824,588
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,400)
|
|
$
|
(13,684)
|
|
Foreign currency
translation adjustment
|
|
|
248
|
|
|
(172)
|
|
Total comprehensive
loss
|
|
$
|
(8,152)
|
|
$
|
(13,856)
|
|
Less: Comprehensive
loss attributable to redeemable
noncontrolling interest
|
|
|
(344)
|
|
|
(417)
|
|
Comprehensive loss
attributable to common stockholders
|
|
$
|
(7,808)
|
|
$
|
(13,439)
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/casi-pharmaceuticals-announces-first-quarter-2022-financial-results-301545730.html
SOURCE CASI Pharmaceuticals, Inc.