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Press Release

CASI Pharmaceuticals Announces Third Quarter 2020 Financial Results

- EVOMELA Third Quarter 2020 Revenue Exceeds Expectations; Company Increasing EVOMELA Full-Year Revenue Guidance for 2020 -
- Expands Pipeline with First-In-Class Anti-FcyRIIB Monoclonal Antibody with Potential Application Across Multiple Tumor Types -
-Co-Commercial Clinical Asset, CNCT-19 (CD19 CAR-T), Phase 1 Enrollment Progressing Ahead of Schedule; Registration Trials Now Expected to Be Initiated by the end of 2020 -

- Company to Host Conference Call Today at 4:30 p.m. ET
ROCKVILLE, Md. and BEIJING, Nov. 9, 2020 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results and business highlights for the third quarter of 2020.
Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, “We are pleased to report that EVOMELA revenues for Q3 were $4.2 million. For the full year 2020 revenue, we expect to exceed $14 million, performing better than we had previously forecasted. We are thrilled with the progress we are seeing across our hematology oncology product portfolio. With our recently announced partnership with BioInvent, we gained exclusive Greater China development and commercialization rights to BI-1206, a first-in-class anti-FcyRIIB monoclonal antibody. BI-1206 has broad potential clinical applications across multiple tumor types in many first line indications and in refractory settings, which we look forward to exploring.”
Dr. He continued, “With respect to our commercial asset CNCT-19 (CD19 CAR-T), our partner Juventas is making good progress with their current Phase 1 trials in B-NHL and B-ALL, and is expecting to initiate registration trials by the end of 2020. We expect to initiate our Phase 1 study for CID-103 (anti-CD38 monoclonal antibody) in the EU during the first quarter of 2021. We will continue to execute on a number of key milestones across our broad portfolio in the quarters ahead. In parallel, our team will continue tactically evaluating additional strategic opportunities that complement our growing portfolio.”
Third Quarter 2020 Financial Results
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, can be found at www.casipharmaceuticals.com.

  • Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenues were $4.2 million for the three months ended September 30, 2020 compared to $2.7 million for the three months ended September 30, 2019.
  • Costs of revenues were $1.8 million for the three months ended September 30, 2020 compared to $2.6 million for the three months ended September 30, 2019. The decrease in cost of revenues is a result of the transfer to a new manufacturer, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.
  • Research and development expenses for the three months ended September 30, 2020 were $2.8 million, compared with $1.8 million for the three months ended September 30, 2019. The increases in R&D expenses are primarily due to increases in 2020 R&D expenses incurred related to the development of CID-103, and costs associated with the EVOMELA post marketing study.
  • General and administrative expenses for the three months ended September 30, 2020 were $5.3 million, compared with $8.0 million for the three months ended September 30, 2019. The decrease in general and administrative expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.
  • Selling and marketing expenses for the three months ended September 30, 2020 were $2.1 million, compared with $975,000 for the three months ended September 30, 2019. The increase is due to selling costs related to commercial sales of EVOMELA that began in August of 2019.
  • Acquired in-process R&D expenses for the three months ended September 30, 2020 was $10.9 million, compared to $0 million for the three months ended September 30, 2019. Expense of $0.6 million relates to 2020 milestone fees paid to Pharmathen due to the first submission to the National Medical Products Administration in China for Octreotide which was achieved during 2020 and $10.3 million relates to milestone fees paid to Juventas.
  • Net loss for the third quarter of 2020 was $16.8 million compared to $9.7 million for the same period in 2019.
  • As of September 30, 2020, the Company had cash and cash equivalents of $74.6 million compared to $44.9 million as of June 30, 2020. As reported, the Company consummated an underwritten public offering in July 2020 generating gross proceeds of approximately $43.7 million.

Conference Call
The Company will host a conference call reviewing the third quarter highlights today at 4:30 p.m. ET. The conference call can be accessed by dialing (833) 647-4459 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), (580) 86567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 8835514.
This call will be recorded and available for replay by dialing (855) 589-2056 (U.S.) or (404)-537-3406 (international) and enter 8835514 to access the replay.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) 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 over 70 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, revenue growth, 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 we assume no duty to update forward-looking statements. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors.
EVOMELA® is proprietary to Acrotech Biopharma LLC and its affiliates.

(Financial Table Follows)
Download the press release and financial table as a PDF

CASI
Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
September 30, 2020December 31, 2019
ASSETS

Current
assets:

Cash and cash equivalents$74,592$53,621

Investment in equity securities,
at fair value

1,796 625

Accounts receivable, net of $0
allowance for doubtful accounts

4,0781,293
Inventories 720 4,542
Prepaid expenses and other1,7941,420
Assets held-for-sale 298 3,221

Total
current assets

83,278 64,722

Property
and equipment, net

984985

Intangible
assets, net

13,015 13,674

Long-term
investments

27,56914,038

Right
of use assets 

9,015 8,708

Other
assets

377 504

Total
assets

$134,238 $102,631

LIABILITIES,
REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS’ EQUITY

Current
liabilities:

Accounts payable $2,697 $5,113

Accrued and other current
liabilities

2,858 2,834

Total
current liabilities

5,555 7,947

Deferred
income

2,270  

Other
liabilities

13,615 1,019

Total
liabilities

21,440 8,966

Commitments
and contingencies

Redeemable
noncontrolling interest, at redemption value

21,271 20,670

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, 2020 and December 31, 2019;
124,023,374 shares and 97,851,243 shares issued at September 30, 2020 and
December 31, 2019, respectively; 123,943,829 shares and 97,771,698 shares outstanding
at September 30, 2020 and December 31, 2019, respectively

1,240 979
Additional paid-in capital656,639606,686

Treasury stock, at
cost: 79,545 shares held at September 30, 2020 and
December 31, 2019

(8,034) (8,034)

Accumulated other comprehensive
loss

(1,507)(2,728)
Accumulated deficit (556,811) (523,908)

Total
stockholders’ equity

91,527 72,995

Total
liabilities, redeemable noncontrolling interest and stockholders’ equity

$134,238 $102,631


CASI Pharmaceuticals, Inc.

Unaudited
Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands,
except per share data)

Three Months Ended September 30Nine Months Ended September 30
2020201920202019
Revenues:
Product sales$4,205 $2,749 $10,215 $2,749
Lease income 37 38 104 38

Total
revenues

4,242 2,787 10,319 2,787

Costs
and expenses:

Costs of revenues 1,828 2,648 7,556 2,648
Research and development2,803 1,829 7,682 7,375
General and administrative 5,347 7,977 13,490 20,669
Selling and marketing2,062 975 4,879 975

(Gain) loss on disposal of intangible
assets

    (450) 48
Impairment of intangible assets   1,537  

Acquired in-process research and
development

10,862   11,943 5,849

Total
costs and expenses

22,902 13,429 46,637 37,564

Loss
from operations

(18,660)(10,642)(36,318)(34,777)

Non-operating
income/(expense):

Interest
income, net

432 414 775 783

Other
income

20   47  

Foreign
exchange (losses) gains

(526)719 (278)1,269

Change
in fair value of investment in equity securities

1,978 (160) 2,287 (355)
Net loss (16,756) (9,669) (33,487) (33,080)

Less:
(loss)/ income attributable to redeemable noncontrolling interest

(309) (23) (584) 53

Accretion
to redeemable noncontrolling interest redemption value

506 245 1,185 406

Net loss
attributable to CASI Pharmaceuticals, Inc.

$(16,953) $(9,891) $(34,088) $(33,539)

Net loss
per share (basic and diluted)

$(0.14) $(0.10) $(0.32) $(0.35)

Weighted
average number of common shares outstanding (basic and diluted)

117,940 95,891 105,922 95,753

Comprehensive
loss:

Net loss $(16,756) $(9,669) $(33,487) $(33,080)

Foreign
currency translation adjustment

2,383 (1,836) 1,221 (2,636)

Total
comprehensive loss

$(14,373) $(11,505) $(32,266) $(35,716)

Less:
Comprehensive (loss)/income attributable to redeemable noncontrolling
interest 

(309) (23) (584) 53

Comprehensive
loss attributable to common stockholders

$(14,064) $(11,482) $(31,682) $(35,769)
COMPANY CONTACT:
CASI Pharmaceuticals, Inc.
Rui Zhang
240-864-2643
ir@casipharmaceuticals.com
INVESTOR CONTACT:
Solebury Trout
Xuan Yang
646-378-2975
xyang@troutgroup.com

About Us

CASI is a U.S. NASDAQ-listed biopharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China, through which substantially all of our operations are conducted.

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