EX-99.1 2 tm2228810d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

 

 

 

www.casipharmaceuticals.com

 

CASI PHARMACEUTICALS ANNOUNCES

THIRD QUARTER 2022 FINANCIAL RESULTS

 

ROCKVILLE, MD. and BEIJING, China (November 14, 2022) 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: [email protected]

 

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(Financial Table Follows)

 

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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 

 

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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)  

 

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