Conference Call to be Held Today at
1:30 p.m. PT/4:30 p.m. ET
RANCHO
CORDOVA, Calif., May 19, 2022
/PRNewswire/ -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a
market leader in automated cell processing tools and services in
the cell and gene therapy field, today reported financial and
operating results for the first quarter ended March 31, 2022 and provided a corporate strategic
update.
First Quarter 2022 Highlights
- On March 24, 2022, entered into a
License and Technology Access Agreement with Boyalife Genomics
Tianjin Ltd. (Boyalife Genomics), a China-based contract development and
manufacturing organization (CDMO) and an affiliate of
ThermoGenesis' Chairman and Chief Executive Officer, Chris Xu, Ph.D., providing a U.S. license to
certain existing and future know-how and other intellectual
property relating to cell manufacturing and related processes.
ThermoGenesis plans to develop and operate the CDMO cell therapy
manufacturing business through a newly formed division named TG
Biosynthesis.
- Additionally, on March 24, 2022,
signed a Lease Agreement with Z3 Investment LLC, another affiliate
of Dr. Xu, for approximately 35,475 square feet of laboratory and
office space in Sacramento,
California. The space is currently planned to be built-out
to create a state-of-the-art, current good manufacturing practice
(cGMP) compliant facility with 12 cGMP clean room suites.
"With six CAR-T therapies now approved by the U.S. Food and Drug
Administration (FDA), an estimated 350+ U.S. companies working in
the cell therapy arena, and more than 1,000 pipeline assets in
clinical development, worldwide, the need for cGMP manufacturing of
these extremely complex, personalized and potentially life-saving
therapies is as important as ever," stated Dr. Xu. "Our recently
signed agreements with Boyalife Genomics and Z3 Investment position
us to address this demand with additional intellectual property and
the the ability to rapidly scale up a large cGMP facility in order
to leverage our proprietary automated and semi-automated cell
processing technologies, including the CAR-TXpress™ platform, to
begin offering world-class CDMO services."
Dr. Xu continued, "The CAR-TXpress™ platform is capable of
meaningfully reducing processing time, improving cell recovery, and
potentially cutting the manufacturing costs associated with CAR-T
and other cell and gene therapies by up to 70%, and we look forward
to launching our new TG Biosynthesis division, currently
planned for late 2022, which we anticipate will provide
high-quality development and manufacturing capabilities, cell and
tissue processing development, quality systems, regulatory
compliance, and other cell manufacturing solutions for clients with
therapeutic candidates in various stages of development."
Financial Results for the Quarter Ended March 31, 2022
Net revenues. Net revenues for the first quarter
ended March 31, 2022, were
$2.7 million, compared to
$1.5 million for the first quarter
ended March 31, 2021, an increase of
approximately $1.2 million or 76%.
The increase was driven by AXP® disposable sales, which increased
by approximately $1.5 million with
approximately 600 more cases sold in the first quarter of 2022 as
compared to 2021. The increase was offset by a decrease in
BioArchive sales, primarily due to lower service revenue in the
current quarter.
Gross profit. Gross profit for the quarter ended
March 31, 2022, was $0.9 million, or 35% of net revenue, compared to
$0.7 million, or 47% of net revenues, for the first quarter
ended March 31, 2021, an increase of
$0.2 million. The increase was driven
by the increase in AXP® disposables sold in the quarter ended
March 31, 2022, resulting in
approximately $0.7 million more gross
profit.
Selling, general and administrative expenses. Selling,
general and administrative expenses were $1.7 million for the first quarter ended
March 31, 2022, as compared to
$2.0 million for the quarter ended
March 31, 2021, a decrease of
$0.3 million or 15%. The decrease was
primarily due to lower stock compensation expense in the quarter
ended March 31, 2022.
Research and development expenses. Research and
development expenses were $0.5
million for the three months ended March 31, 2022, compared to $0.4 million for the three months ended
March 31, 2021, an increase of
$0.1 million or 20%. The increase was
driven by higher expenses for salaries and benefits in the quarter
ended March 31, 2022.
Interest Expense. Interest expense for the first
quarter ended March 31, 2022 was
$0.8 million compared to $1.5 million for the quarter ended March 31, 2021, a decrease of $0.7 million or 46%. The decrease was driven by
lower amortization of the debt discount on convertible
promissory notes.
Net loss. For the quarter ended March 31, 2022, the Company reported a
comprehensive loss attributable to common stockholders of
$1.9 million, or ($0.16) per share, based on approximately 12.3
million weighted average basic and diluted common shares
outstanding. This compares to a comprehensive net loss of
$2.4 million, or ($0.21) per share, based on approximately 11.4
million weighted average basic and diluted common shares
outstanding for the first quarter ended March 31, 2021.
Conference Call and Webcast Information
ThermoGenesis
will host a conference call today at 1:30
p.m. PT/4:30 p.m. ET. To
participate in the conference call, please dial 1-844-889-4331
(domestic), 1-412-380-7406 (international) or 1-866-605-3852
(Canada). To access a live webcast
of the call, please visit:
https://thermogenesis.com/investors/news-and-events/events-webcasts.
A webcast replay will also be available on ThermoGenesis'
website for three months. To access the replay, please visit:
https://thermogenesis.com/investors/news-and-events/events-webcasts.
About ThermoGenesis Holdings, Inc.
ThermoGenesis
Holdings, Inc. develops, commercializes, and markets a range of
automated technologies for CAR-T and other cell-based therapies.
The Company currently markets a full suite of solutions for
automated clinical biobanking, point-of-care applications, and
automation for immuno-oncology, including its semi-automated,
functionally closed CAR-TXpress™ platform, which streamlines
the manufacturing process for the emerging CAR-T immunotherapy
market. For more information about ThermoGenesis, please
visit: www.thermogenesis.com.
Forward-Looking Statements
This press release contains
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. The forward-looking
statements involve risks and uncertainties that could cause actual
results to differ materially from the forward-looking statements
contained herein. When used in this press release, the words
"anticipate," "believe," "estimate," "expect" and similar
expressions as they relate to the Company, or its management are
intended to identify such forward-looking statements. Actual
results, performance or achievements could differ materially from
the results expressed in or implied by these forward-looking
statements. Readers should be aware of important factors that, in
some cases, have affected, and in the future could affect, actual
results to differ materially from those expressed in any
forward-looking statements made by or on behalf of the
Company. These factors include without limitation, the
ability to obtain capital and other financing in the amounts and at
the times needed to launch new products, market acceptance of new
products, the nature and timing of regulatory approvals for both
new products and existing products for which the Company proposes
new claims, realization of forecasted revenues, expenses and
income, initiatives by competitors, price pressures, failure to
meet FDA regulated requirements governing the Company's products
and operations (including the potential for product recalls
associated with such regulations), risks associated with initiating
manufacturing for new products, failure to meet Foreign Corrupt
Practice Act regulations, legal proceedings, uncertainty associated
with the COVID-19 pandemic, and other risk factors listed from time
to time in our reports with the Securities and Exchange Commission
("SEC"), including, in particular, those set forth in ThermoGenesis
Holdings' Form 10-K for the year ended December 31, 2021.
Company Contact:
Wendy Samford
916-858-5191
ir@thermogenesis.com
Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com
Financials
|
ThermoGenesis
Holdings, Inc.
|
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
March 31,
2022
|
|
December 31,
2021
|
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$3,652,000
|
|
$7,280,000
|
|
|
Accounts
receivable, net
|
|
2,175,000
|
|
733,000
|
|
|
Inventories
|
|
5,893,000
|
|
5,373,000
|
|
|
Prepaid
expenses and other current assets
|
|
1,474,000
|
|
1,578,000
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
13,194,000
|
|
14,964,000
|
|
|
|
|
|
|
|
|
|
Inventories,
non-current
|
|
1,197,000
|
|
1,709,000
|
|
|
Equipment and leasehold
improvements, net
|
|
1,224,000
|
|
1,261,000
|
|
|
Right-of-use operating
lease assets, net
|
|
525,000
|
|
571,000
|
|
|
Goodwill
|
|
781,000
|
|
781,000
|
|
|
Intangible assets,
net
|
|
1,310,000
|
|
1,318,000
|
|
|
Other assets
|
|
48,000
|
|
48,000
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$18,279,000
|
|
$20,652,000
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$1,866,000
|
|
$1,280,000
|
|
|
Other
current liabilities
|
|
13,611,000
|
|
5,068,000
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
15,477,000
|
|
6,348,000
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities
|
|
1,520,000
|
|
10,907,000
|
|
|
|
|
|
|
|
|
|
ThermoGenesis Holdings,
Inc. stockholders' equity
|
|
1,839,000
|
|
3,828,000
|
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(557,000)
|
|
(431,000)
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$18,279,000
|
|
$20,652,000
|
|
|
ThermoGenesis
Holdings, Inc.
|
|
Condensed
Consolidated Statements of Operations
|
|
(Unaudited)
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
|
|
Net revenues
|
$2,663,000
|
|
$1,517,000
|
|
|
|
|
|
|
|
Cost of
revenues
|
1,723,000
|
|
809,000
|
|
|
|
|
|
|
|
Gross profit
|
940,000
|
|
708,000
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
Selling,
general and administrative
|
1,693,000
|
|
1,992,000
|
|
|
|
|
|
|
|
Research
and development
|
456,000
|
|
379,000
|
|
|
|
|
|
|
|
Total operating
expenses
|
2,149,000
|
|
2,371,000
|
|
|
|
|
|
|
|
Loss from
operations
|
(1,209,000)
|
|
(1,663,000)
|
|
|
|
|
|
|
|
Interest
expense
|
(823,000)
|
|
(1,519,000)
|
|
|
Other income
(expenses)
|
(4,000)
|
|
(1,000)
|
|
|
Gain on extinguishment
of debt
|
--
|
|
652,000
|
|
|
|
|
|
|
|
Net loss
|
(2,036,000)
|
|
(2,531,000)
|
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
(126,000)
|
|
(118,000)
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$(1,910,000)
|
|
$(2,413,000)
|
|
|
|
|
|
|
|
ThermoGenesis
Holdings, Inc.
|
|
Condensed
Consolidated Statements of Cash Flows
|
|
(Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2022
|
|
2021
|
|
Cash flows from
operating activities:
|
|
|
|
|
Net
cash used in operating activities
|
$(4,159,000)
|
|
$(3,952,000)
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
Capital
expenditures
|
(65,000)
|
|
(27,000)
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
Proceeds from issuance of
common stock, net of expenses
|
594,000
|
|
6,832,000
|
|
|
|
|
|
|
|
|
|
Effects of foreign
currency rate changes on cash and cash equivalents
|
2,000
|
|
--
|
|
Net increase (decrease)
in cash, cash equivalents and restricted cash
|
(3,628,000)
|
|
2,853,000
|
|
|
|
|
|
Cash and cash
equivalents at beginning of period
|
7,280,000
|
|
7,161,000
|
|
Cash and cash
equivalents at end of period
|
$3,652,000
|
|
$10,014,000
|
|
|
|
|
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SOURCE ThermoGenesis Holdings, Inc.