CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2022 FINANCIAL RESULTS

 

ROCKVILLE, Md. and BEIJIN, Nov. 14, 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 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)

 
 

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SOURCE CASI Pharmaceuticals, Inc.

 
 
Company Codes: NASDAQ-SMALL:CASI
 

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