RANCHO CORDOVA, Calif.,
Nov. 12, 2021 /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 third quarter ended September 30, 2021 and provided a corporate
strategic update.
"Personalized treatments are the wave of the future in
healthcare. As more regenerative medicine treatments, such as CAR-T
cell therapies, receive FDA approval, the demand for the
manufacturing of cell therapies is only going to continue to grow,"
stated Chris Xu, Ph.D., Chief
Executive Officer of ThermoGenesis. "At the same time, there is a
significant unmet need for manufacturing of these complex, critical
therapies due to both the high cost and limited global capacity
that continues to persist. As we have reported, ThermoGenesis' high
efficiency, semi-automated 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%. With this in mind,
we are committed to harnessing the power of our unique and
proprietary CAR-TXpress™ platform to pivot from a device-only
company to one focused on providing the industry with cell-based
contract development and manufacturing (CDMO) services."
Dr. Xu continued, "In parallel with these efforts, we have
continued to expand our line of automated cell processing tools. In
September we were awarded a $250,000
Phase I Small Business Innovation Research (SBIR) grant to develop
and test the single-use sterile cell processing disposable that
will be used by the fully automated Quintessence System for
gene-engineered autologous cell therapies. The work taking place as
a result of this grant is another reflection of our pledge to
continue to bring innovative solutions to the industry and will
serve to bolster our product line of automated cell processing
tools to utilize as a CDMO services company. We look forward to
reporting more on this exciting transformation in the coming
months."
Financial Results for the Quarter Ended September 30, 2021
Net revenues. Net revenues for the quarter ended
September 30, 2021, were $3.2 million, compared to $2.4 million for the quarter ended September 30, 2020, an increase of $0.8 million or 34%. The increase was primarily
driven by AXP sales, which rose by $1.1
million or 98% in the three months ended September 30, 2021, as compared to the same
period in 2020.
Gross profit. Gross profit for the quarter ended
September 30, 2021, was $1.1 million, or 35% of net revenue, compared to
$1.5 million, or 64% of net revenues, for the quarter ended
September 30, 2020, a decrease of
$0.4 million or 26%. The decrease was
driven by a refund of $0.8 million
received in the three months ended September
30, 2020, from ImmuneCyte relating to COVID-19 testing kits
which were previously reserved by the Company in a prior quarter,
offset by higher gross profit from AXP disposables.
Selling, general and administrative
expenses. Selling, general and administrative expenses
were $1.7 million for the quarter
ended September 30, 2021, as compared
to $1.8 million for the quarter ended
September 30, 2020, a decrease of
$0.2 million or 9%. The decrease was
driven by lower personnel and stock compensation expenses, offset
by increased consulting expenses in the three months ended
September 30, 2021.
Research and development expenses. Research and
development expenses were $0.5
million for the quarter ended September 30, 2021, compared to $0.7 million for the quarter ended September 30, 2020, a decrease of $0.2 million or 28%. The decrease was driven by
development expenses for the Company's COVID-19 cartridge reader
incurred in the three months ended September
30, 2020, and lower stock compensation expense in the three
months ended September 30, 2021.
Interest Expense. Interest expense for the quarter
ended September 30, 2021, was
$1.5 million, approximately equal to
that incurred during the quarter ended September 30, 2020.
Net loss. For the quarter ended September 30, 2021, the Company reported a
comprehensive loss attributable to common stockholders of
$1.8 million, or ($0.15) per share, based on approximately 11.9
million weighted average basic and diluted common shares
outstanding. This compares to a comprehensive net loss of
$2.5 million, or ($0.37) per share, based on approximately 6.7
million weighted average basic and diluted common shares
outstanding for the quarter ended September
30, 2020.
Adjusted EBITDA. In addition to the results
reported under US GAAP, the Company also uses a non-GAAP measure,
Adjusted EBITDA, to evaluate operating performance and to
facilitate the comparison of our historical results and trends. The
Company uses the metric to determine operational cash flow.
Adjusted EBITDA loss for the quarter ended September 30, 2021, was $0.9 million, as compared to a loss of
$0.7 million for the quarter ended
September 30, 2020, a decrease of
$0.2 million.
Liquidity and Capital Resources. At September 30, 2021, the Company had cash and cash
equivalents totaling $7.6 million,
compared with $7.2 million at
December 31, 2020. Working capital
was $2.1 million at September 30, 2021, as compared to $9.2 million at December
31, 2020.
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, 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, 2020.
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
|
|
|
|
|
|
|
|
September
30,
2021
|
|
December
31,
2020
|
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$7,634,000
|
|
$7,161,000
|
|
|
Accounts
receivable, net
|
|
2,571,000
|
|
1,382,000
|
|
|
Inventories
|
|
5,538,000
|
|
5,877,000
|
|
|
Prepaid
expenses and other current assets
|
|
1,138,000
|
|
878,000
|
|
|
Total current assets
|
|
16,881,000
|
|
15,298,000
|
|
|
|
|
|
|
|
|
|
Inventories,
non-current
|
|
1,784,000
|
|
1,221,000
|
|
|
Equipment and
leasehold improvements, net
|
|
1,339,000
|
|
1,424,000
|
|
|
Right-of-use
operating lease assets, net
|
|
614,000
|
|
730,000
|
|
|
Goodwill
|
|
781,000
|
|
781,000
|
|
|
Other intangible
assets, net
|
|
1,326,000
|
|
1,358,000
|
|
|
Other
assets
|
|
48,000
|
|
48,000
|
|
|
Total assets
|
|
$22,773,000
|
|
$20,860,000
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$1,502,000
|
|
$1,366,000
|
|
|
Other
current liabilities
|
|
13,233,000
|
|
4,777,000
|
|
|
Total current liabilities
|
|
14,735,000
|
|
6,143,000
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities
|
|
1,870,000
|
|
8,847,000
|
|
|
|
|
|
|
|
|
|
ThermoGenesis
Holdings, Inc. stockholders' equity
|
|
6,367,000
|
|
5,800,000
|
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(199,000)
|
|
70,000
|
|
|
Total liabilities and equity
|
|
$22,773,000
|
|
$20,860,000
|
|
ThermoGenesis
Holdings, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months Ended
September 30
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net
revenues
|
$3,158,000
|
|
$2,355,000
|
|
$6,876,000
|
|
$7,797,000
|
Cost of
revenues
|
2,043,000
|
|
844,000
|
|
4,067,000
|
|
7,426,000
|
|
|
|
|
|
|
|
|
Gross profit (loss)
|
1,115,000
|
|
1,511,000
|
|
2,809,000
|
|
371,000
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
Selling,
general and administrative
|
1,677,000
|
|
1,844,000
|
|
7,171,000
|
|
5,913,000
|
Research
and development
|
543,000
|
|
750,000
|
|
1,544,000
|
|
1,937,000
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
2,220,000
|
|
2,594,000
|
|
8,715,000
|
|
7,850,000
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(1,105,000)
|
|
(1,083,000)
|
|
(5,906,000)
|
|
(7,479,000)
|
|
|
|
|
|
|
|
|
Other
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
(1,530,000)
|
|
(1,531,000)
|
|
(4,573,000)
|
|
(6,377,000)
|
Other income
(expenses)
|
843,000
|
|
5,000
|
|
833,000
|
|
(6,000)
|
Gain on
extinguishment of debt
|
--
|
|
--
|
|
652,000
|
|
--
|
Total
other expense
|
(687,000)
|
|
(1,526,000)
|
|
(3,088,000)
|
|
(6,383,000)
|
|
|
|
|
|
|
|
|
Net loss
|
(1,792,000)
|
|
(2,609,000)
|
|
(8,994,000)
|
|
(13,862,000)
|
|
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
(18,000)
|
|
(146,000)
|
|
(269,000)
|
|
(360,000)
|
Net loss attributable
to common stockholders
|
$(1,774,000)
|
|
$(2,463,000)
|
|
$(8,725,000)
|
|
$(13,502,000)
|
|
|
|
|
|
|
|
|
ThermoGenesis
Holdings, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
Nine Months
Ended
September
30,
|
|
2021
|
|
2020
|
Cash flows from
operating activities:
|
|
|
|
Net
cash used in operating activities
|
$(6,294,000)
|
|
$(11,859,000)
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
Capital
expenditures
|
(64,000)
|
|
(23,000)
|
Cash flows from
financing activities:
|
|
|
|
Proceeds from convertible
promissory note-related party
|
--
|
|
4,287,000
|
Payments on finance lease
obligations
|
--
|
|
(32,000)
|
Proceeds from issuance of
common stock, net of expenses
|
6,832,000
|
|
5,580,000
|
Proceeds from the exercise
of options, warrants and pre-funded warrants
|
--
|
|
1,683,000
|
Proceeds from note
payable
|
--
|
|
646,000
|
|
|
|
|
Net
cash provided by financing activities
|
6,832,000
|
|
12,164,000
|
|
|
|
|
Effects of foreign
currency rate changes on cash and cash equivalents
|
(1,000)
|
|
(3,000)
|
Net increase
(decrease) in cash, cash equivalents and restricted cash
|
473,000
|
|
279,000
|
|
|
|
|
Cash, cash
equivalents and restricted cash at beginning of period
|
7,161,000
|
|
4,157,000
|
Cash, cash
equivalents and restricted cash at end of period
|
$7,634,000
|
|
$4,436,000
|
|
|
|
|
ThermoGenesis
Holdings, Inc.
Reconciliation of
Adjusted EBITDA to Net Loss
(Unaudited)
|
|
|
|
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net loss
|
|
$(1,792,000)
|
|
$(2,609,000)
|
|
$(8,994,000)
|
|
$(13,862,000)
|
|
|
|
|
|
|
|
|
|
Deduct:
|
|
|
|
|
|
|
|
|
Interest expense
|
|
(1,530,000)
|
|
(1,531,000)
|
|
(4,573,000)
|
|
(6,377,000)
|
Other
expense
|
|
843,000
|
|
5,000
|
|
833,000
|
|
(6,000)
|
Gain on
extinguishment of debt
|
|
--
|
|
--
|
|
652,000
|
|
--
|
Loss from
operations
|
|
$(1,105,000)
|
|
$(1,083,000)
|
|
$(5,906,000)
|
|
$(7,479,000)
|
|
|
|
|
|
|
|
|
|
Add:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
157,000
|
|
177,000
|
|
477,000
|
|
569,000
|
Stock-based compensation expense
|
|
92,000
|
|
234,000
|
|
2,449,000
|
|
615,000
|
Adjusted
EBITDA
|
|
$(856,000)
|
|
$(672,000)
|
|
$(2,980,000)
|
|
$(6,295,000)
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company defines
adjusted EBITDA as income (or loss) from operations less,
depreciation, amortization, stock compensation and impairment of
intangible assets.
|
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content:https://www.prnewswire.com/news-releases/thermogenesis-holdings-announces-financial-results-for-the-third-quarter-ended-september-30-2021-and-provides-corporate-update-301423301.html
SOURCE ThermoGenesis Holdings, Inc.