CASI PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2022 FINANCIAL RESULTS

    Author microcapwatchPosted on Categories BiotechTags , , , , , , , , , , , , , ,

    <br /> CASI PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2022 FINANCIAL RESULTS<br />

    PR Newswire



    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




    [email protected]



    INVESTOR CONTACT

    :


    Xuan Yang



    Solebury Trout


    646.378.2975



    [email protected]


    (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)

    Cision
    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.

    PR Newswire
    May 12, 2022 – 4:00 AM PDT