0001104659-21-104205.txt : 20210812 0001104659-21-104205.hdr.sgml : 20210812 20210812163240 ACCESSION NUMBER: 0001104659-21-104205 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210812 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210812 DATE AS OF CHANGE: 20210812 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CASI Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0000895051 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 581959440 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20713 FILM NUMBER: 211168125 BUSINESS ADDRESS: STREET 1: 9620 MEDICAL CENTER DR STREET 2: STE 300 CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: 240-864-2600 MAIL ADDRESS: STREET 1: 9620 MEDICAL CENTER DR STREET 2: STE 300 CITY: ROCKVILLE STATE: MD ZIP: 20850 FORMER COMPANY: FORMER CONFORMED NAME: ENTREMED INC DATE OF NAME CHANGE: 19960415 8-K 1 tm2124591d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 12, 2021

 

CASI PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

  

delaware

(State or other jurisdiction of

incorporation or organization)

0-20713

(Commission File Number)

 

58-1959440

(IRS Employer

Identification No.)

 

9620 Medical Center Drive, Suite 300

Rockville, Maryland

(Address of principal executive offices)

 

20850

(Zip Code)

 

(240) 864-2600

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of exchange on which
registered
Common Stock CASI Nasdaq Capital Market

  

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

  

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 12, 2021, CASI Pharmaceuticals, Inc. (the “Company”) issued a press release reporting its financial results for the three and six month periods ending June 30, 2021. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information on this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

  

Item 9.01 Financial Statements and Exhibits.

 

(d)     Exhibits    

 

Exhibit No. Description of Document
   
99.1   Press Release of CASI Pharmaceuticals, Inc., dated August 12, 2021
   
104 Inline XBRL for the cover page of this Current Report on Form 8-K

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CASI PHARMACEUTICALS, INC.
   
  /s/ Larry Zhang
  Larry (Wei) Zhang
  President and Principal Financial Officer

 

Date: August 12, 2021

 

 

 

 

 

 EX-99.1 2 tm2124591d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

www.casipharmaceuticals.com

 

CASI PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2021

FINANCIAL RESULTS

 

-EVOMELA Second Quarter 2021 Revenue Continues Upward Trend;

Revenue Growth Guidance in 2021 Revised to Exceed 80% Over 2020-

- CID-103 Reaches Milestone with Dosing of First Patient –

-Notice of Patent Allowance Issued in China for BI-1206 -

- Company to host Conference Call Today at 8:00 AM. ET -

 

ROCKVILLE, MD. and BEIJING, China (August 12, 2021) 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 second quarter of 2021.

 

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, “We are pleased to report $7.1 million EVOMELA® revenues for the quarter. Based on the current trend, we are revising our guidance for full-year 2021 revenue growth to exceed 80% over 2020. We are proud of our commercial franchise execution for EVOMELA and have expanded to over 100 FTEs on the commercial and marketing teams. In addition to the continued EVOMELA revenue growth, we achieved dosing of first patient of CID-103 in our Phase 1 clinical trial for relapse or refectory multiple myeloma. CID-103 has previously shown encouraging preclinical efficacy, a favorable preclinical safety profile, and greater antibody-dependence cellular cytotoxicity activity over other anti-CD38 mAbs, and we are hopeful this will translate into patient benefit.”

 

Dr. He continued, “We are thrilled with the progress we continue to see throughout our hematology oncology pipeline. Our partner, Juventas, has completed CNCT19’s (CD19 CAR-T) Phase 1 studies of B-ALL and B-NHL in China. The Phase 2 B-NHL and B-ALL registration studies of CNCT19 are currently enrolling in China. Additionally, BioInvent recently announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-FcγRllB antibody BI-1206 is expected to be granted. Together with BioInvent we plan to continue to develop BI-1206 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in Greater China.”

 

Second Quarter 2021 Financial Results

 

·Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $7.1 million for the three months ended June 30, 2021 compared to $2.6 million for the three months ended June 30, 2020. Revenues increased by 173% in the second quarter of 2021 as compared to same quarter in 2020 due to the continued growth in EVOMELA sales.

 

·Costs of revenues were $2.9 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020, which includes royalty payment of $1.4 million and $0.5 million for the same period. Costs of revenues excluding royalty were $1.5 million and $2.0 million for the three months ended June 30, 2021, and 2020. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly in the three months ended June 30, 2021, compared within the three months ended June 30, 2020, due to the new alternate manufacturer now in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.

 

·General and administrative expenses for the three months ended June 30, 2021 were $5.4 million, compared with $4.1 million for the three months ended June 30, 2020.

 

·Selling and marketing expenses for the three months ended June 30, 2021 were $3.4 million, compared with $1.6 million for the three months ended June 30, 2020. The increase in selling and marketing expenses was due to expansion of sales team in China in 2021.

 

 

 

·Acquired in-process R&D expenses for the three months ended June 30, 2021 was $1.06 million, compared to $0 million for the three months ended June 30, 2020.  In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment and accrued €250,000 ($305,000) payment under the terms of the agreement.

 

·Net loss for the three months ended June 30, 2021 was $6.7 million compared to $8.5 million for the three months ended June 30, 2020 due to significant revenue increase. As of June 30, 2021, CASI had cash and cash equivalents of $60.4 million compared to $57.1 million as of December 31, 2020.

 

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, can be found at www.casipharmaceuticals.com.

 

Conference Call

 

The Company will host a conference call reviewing the second quarter highlights today at 8:00 a.m. ET. The conference call can be accessed by dialing (833) 420-0382 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5639775. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

 

This call will be recorded and available for replay by dialing (800) 859-2056 (U.S.) or (404) 537-3406 (international) and enter 5639775 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 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., which is located in Beijing, China. The Company has built a commercial team of more than 80 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; 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; 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:

CASI Pharmaceuticals, Inc.

240.864.2643

ir@casipharmaceuticals.com

INVESTOR CONTACT:

Bob Ai

Solebury Trout 646-389-6658

bai@soleburytrout.com

 

# # #

 

(Financial Table Follows)

 

 

 

CASI Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

 

   June 30, 2021   December 31, 2020 
ASSETS          
Current assets:          
Cash and cash equivalents  $60,357   $57,064 
Investment in equity securities, at fair value   12,588    9,309 
Accounts receivable, net of $0 allowance for doubtful accounts   5,767    4,645 
Inventories   3,475    1,356 
Prepaid expenses and other   1,318    1,651 
Total current assets   83,505    74,025 
           
Property, plant and equipment, net   3,348    2,062 
Intangible assets, net   12,691    13,210 
Long-term investments   34,679    29,442 
Right of use assets   9,797    8,696 
Other assets   506    299 
Total assets  $144,526   $127,734 
           
LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $5,519   $3,669 
Accrued and other current liabilities   2,488    3,015 
Bank borrowings   1,548    826 
Notes payable   466    466 
Total current liabilities   10,021    7,976 
           
Deferred income   2,354    2,351 
Other liabilities   14,654    13,834 
Total liabilities   27,029    24,161 
           
Commitments and contingencies (Note 18)          
           
Redeemable noncontrolling interest, at redemption value (Note 11)   22,697    22,033 
           
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 June 30, 2021 and December 31, 2020          
 139,877,032 shares and 124,023,374 shares issued at June 30, 2021 and December 31, 2020, respectively;          
 139,797,487 shares and 123,943,829 shares outstanding at June 30, 2021 and December 31, 2020, respectively   1,399    1,240 
Additional paid-in capital   690,539    658,246 
Treasury stock, at cost: 79,545 shares held at June 30, 2021 and December 31, 2020   (8,034)   (8,034)
Accumulated other comprehensive income   1,159    589 
Accumulated deficit   (590,263)   (570,501)
Total stockholders’ equity   94,800    81,540 
Total liabilities, redeemable noncontrolling interest and stockholders' equity  $144,526   $127,734 

 

 

 

CASI Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

 

   Three Months Ended June 30   Six Months Ended June 30 
   2021   2020   2021   2020 
Revenues:                    
Product sales  $7,125   $2,638   $12,825   $6,010 
Lease income   37    33    73    67 
Total revenues   7,162    2,671    12,898    6,077 
                     
Costs and expenses:                    
Costs of revenues   2,982    2,517    5,340    5,728 
Research and development   2,255    1,862    7,513    4,879 
General and administrative   5,423    4,085    10,925    8,143 
Selling and marketing   3,360    1,557    6,075    2,817 
Loss on disposal of property, plant, equipment   65    —    65    — 
Gain on disposal of intangible assets   —    —    —    (450)
Impairment of intangible assets   —    1,537    —    1,537 
Acquired in-process research and development   1,055    —    6,555    1,081 
Total costs and expenses   15,140    11,558    36,473    23,735 
                     
Loss from operations   (7,978)   (8,887)   (23,575)   (17,658)
Non-operating income/(expense):                    
Interest income, net   76    153    182    343 
Other income   33    27    53    27 
Foreign exchange gains (losses)   76    (115)   295    248 
Change in fair value of investments   1,914    324    3,482    309 
Impairment loss of long-term investments   (865)   —    (865)   — 
Net loss   (6,744)   (8,498)   (20,428)   (16,731)
Less: loss attributable to redeemable noncontrolling interest   (317)   (166)   (666)   (275)
Accretion to redeemable noncontrolling interest redemption value   519    362    1,067    679 
Net loss attributable to CASI Pharmaceuticals, Inc.  $(6,946)  $(8,694)  $(20,829)  $(17,135)
                     
Net loss per share (basic and diluted)  $(0.05)  $(0.09)  $(0.16)  $(0.17)
Weighted average number of common shares outstanding (basic and diluted)   139,797,487    100,921,137    132,352,399    99,847,186 
                     
Comprehensive loss:                    
Net loss  $(6,744)  $(8,498)  $(20,428)  $(16,731)
Foreign currency translation adjustment   1,005    (336)   833    (1,162)
Total comprehensive loss  $(5,739)  $(8,834)  $(19,595)  $(17,893)
Less: Comprehensive loss attributable to redeemable noncontrolling interest   14    (166)   (403)   (275)
Comprehensive loss attributable to common stockholders  $(5,753)  $(8,668)  $(19,192)  $(17,618)

 

 

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DE 0-20713 58-1959440 9620 Medical Center Drive Suite 300 Rockville MD 20850 240 864-2600 false false false false Common Stock CASI NASDAQ false XML 8 R1.htm IDEA: XBRL DOCUMENT v3.21.2
Cover
Aug. 12, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 12, 2021
Entity File Number 0-20713
Entity Registrant Name CASI PHARMACEUTICALS, INC.
Entity Central Index Key 0000895051
Entity Tax Identification Number 58-1959440
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 9620 Medical Center Drive
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Rockville
Entity Address, State or Province MD
Entity Address, Postal Zip Code 20850
City Area Code 240
Local Phone Number 864-2600
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock
Trading Symbol CASI
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

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