CASI PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2022 FINANCIAL RESULTS

 

ROCKVILLE, Md. and BEIJING, May 12, 2022 /PRNewswire/ -- CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.), 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)

 

 

 

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SOURCE CASI Pharmaceuticals, Inc.

 
 
Company Codes: NASDAQ-SMALL:CASI
 

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