ROCKVILLE, MD., and BEIJING, Feb. 16,
2021 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI), a U.S. biopharmaceutical company focused on
developing and commercializing innovative therapeutics and
pharmaceutical products, today announced preliminary and unaudited
revenues for the fourth quarter and full-year 2020 and provided an
update on key highlights for 2021.
Wei-Wu He, Ph.D., CASI's Chairman
and Chief Executive Officer, commented, "We have taken a number of
important strides as an organization in 2020, with four strategic
pillars underpinning our overall corporate strategy: (1) Steady
growth through ongoing business development, punctuated by the
announcement of our licensing agreement with BioInvent in the
fourth quarter, (2) Continued pre-commercialization preparations
ahead of anticipated China NDA filing of CNCT19, CD19 CAR-T
program, (3) Continued progress with respect to our current
clinical pipeline, and (4) Strategic marketing execution and
physician education with our commercial product, EVOMELA. Thanks to
the tireless efforts of the CASI team, we have been able to
successfully drive these initiatives forward and position ourselves
for continued execution excellence in 2021."
Dr. He continued, "While the ongoing pandemic continues to
present an array of headwinds from a macro perspective, our plans
for 2021 are no less ambitious. We will continue to evaluate
potential partners and/or assets that are tactically aligned with
our own strategic growth objectives. We also expect to provide
several key pipeline updates this year and remain on track to
initiate our CID-103 study in multiple myeloma patients in the
first quarter, while closely collaborating with our partners,
Juventas and BioInvent, as they continue to execute internally. Our
commercial team is making extensive preparations for the launch of
CNCT19, for which Juventas is expecting to file a New Drug
Application (NDA) with the National Medical Product Administration
(NMPA) in 2021. And finally, we are pleased by the steady growth we
have observed with EVOMELA, which has benefitted substantially from
our continued marketing efforts and the manufacturing change we
made in the second quarter; we look forward to reporting on our
continued progress in the months to come."
Preliminary and Unaudited Fourth Quarter and Unaudited
Full-Year 2020 Revenues, Cash Position, and 2021
EVOMELA® (melphalan for injection) Revenue
Guidance
- The Company anticipates that it will report EVOMELA revenue of
approximately $4.8 million for the
fourth quarter ended December 31,
2020, and approximately $15
million for the full-year ended December 31, 2020, exceeding its projected
$14 million guidance, and
representing a 269% percent increase over 2019 revenue of
$4.1 million.
- The Company is targeting full-year 2021 revenue guidance of
more than 50% growth over 2020 for EVOMELA.
- CASI expects to report approximately $57.1 million of cash and cash equivalents as of
December 31, 2020.
- The Company's fourth quarter and full-year 2020 revenues are
preliminary and are subject to the completion of the Company's 2020
audit. Complete fourth quarter and full-year 2020 financial results
will be reported in March.
Key Highlights for 2021
CASI plans to continue to advance pipeline products through
clinical trial stages in China and
globally.
- As previously announced, CNCT19 received Breakthrough Therapy
Designation based on initial data from the ongoing single-arm,
open-label, non-randomized, dose-escalation, Phase 1 study designed
to determine the safety and efficacy of CNCT19 in B-ALL. The Phase
2 registration study in patients with B-NHL is currently enrolling,
and we expect Juventas to initiate the Phase II registration study
in B-ALL in Q1 2021. The commercial team is making preparations for
the launch of CNCT19, for which Juventas is expecting to file an
NDA with the NMPA in 2021.
- Recently, the Company's partner BioInvent presented early
clinical data from their Phase 1/2a trial on BI-1206. Objective
responses (2CRs, 4 PRs) were demonstrated in 6 out of 9 patients
evaluated, providing exciting evidence that BI-1206 has the
potential to restore the activity of rituximab in non-Hodgkin's
lymphoma patients who have relapsed after treatment with rituximab.
CASI intends to file an IND for BI-1206 with the NMPA in 2021 to
start the clinical trials in China.
- Prior to EVOMELA's entry into the Chinese market, an average of
800 stem cell transplants per year were conducted in the multiple
myeloma (MM) treatment setting. Following EVOMELA's launch in
August of 2019, CASI worked closely with KOLs to drive market
awareness and expedite adoption in the Chinese market. In 2020,
more than 2,600 patients were treated with EVOMELA, representing a
more than threefold increase over the previous year's median usage.
CASI continues to pursue a similar strategy with respect to
marketing efforts and physician visits to further accelerate the
adoption of stem cell transplantation as a standard of care in the
MM treatment setting and will continue working to address the
persistent high unmet need in this patient population.
- Based on the current environment and timetable of our clinical
sites, CASI is targeting the CID-103 Phase 1 study initiation in
the first quarter of 2021.
- Additionally, CASI plans to continue its commitment to actively
engage in business development opportunities that will bring
meaningful therapies to patients that fit within its product
portfolio this year.
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 including,
without limitation, statements regarding expected operating
results, such as revenue growth, and the timing of clinical trials
and regulatory approvals. 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.
These statements are neither promises nor guarantees, but involve
known and unknown risks, uncertainties and other important factors.
Actual results could differ materially from those currently
anticipated due to a number of factors, including: the difficulty
of executing our business strategy in China; the development of major public health
concerns, including the coronavirus or other pandemics arising in
China or elsewhere; 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 FDA, 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 volatility in the market price of our common stock;
risks relating to the need for additional capital and the
uncertainty of securing additional funding on favorable terms if at
all; risks associated with CID-103, CNCT19, and our other
early-stage products under development; risks that result in
preclinical and early clinical models are not necessarily
indicative of later 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; the lack of success in the clinical
development of any of our products; and our dependence on third
parties. 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:
Weihao Xu
Chief Financial
Officer
CASI Pharmaceuticals,
Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Jennifer
Porcelli
Solebury
Trout
646.378.2962
jporcelli@troutgroup.com
|
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SOURCE CASI Pharmaceuticals, Inc.