RANCHO CORDOVA, Calif.,
May 13, 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 first quarter ended March
31, 2021 and provided a corporate strategic update.
First Quarter Achievements:
- On February 3, 2021, the Company
announced that it completed the development process for its new
PXP®-LAVARE System and submitted a Letter to File with an updated
device listing to the U.S. Food and Drug Administration (FDA). The
GMP compliant PXP-LAVARE allows for fast, automated, and reliable
cell washing. It is an optional cell reformulation accessory
designed for use along with the PXP®-1000 System, a 510(k) Class II
medical device designed for isolating various cellular components
from blood.
- On February 17, 2021, the Company
began its 35th year of operation and announced the
alignment of its future corporate strategy by offering cell
processing systems and services to meet the large-scale
manufacturing needs for the expanding number of cell and gene
therapies anticipated to be developed over the next decade,
including CAR-T cell therapy.
"Our continued commitment to develop and improve upon our broad
line of automated tools for the cell and gene therapy field was
exemplified by the first quarter launch of the FDA registered
510(k) device, PXP-LAVARE System," stated Chris Xu, Ph.D., Chief Executive Officer of
ThermoGenesis. "This GMP compliant, optional cell reformation
accessory, designed for use along with the PXP-1000 System, is an
important addition to our full suite of novel, highly efficient
cell processing systems, designed to help meet the critical needs
of the emerging and promising new field of cell and gene
therapy."
Dr. Xu continued, "Cell and gene therapies have become one of
the fastest growing sectors in medicine, with over 1,000 clinical
trials currently underway in CAR-T cell therapy alone. There is a
significant unmet need for manufacturing of these therapies due to
both the high cost and limited global capacity. Our high
efficiency, semi-automated CAR-TXpress™ platform can potentially
reduce 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 leveraging our unique and proprietary CAR-TXpress
platform to transition from a device-only company to one focused on
providing cell-based contract development and manufacturing (CDMO)
services."
Jeff Cauble, Chief Financial
Officer of ThermoGenesis, added, "Although our revenues remain
affected by the COVID-19 pandemic, recently we have seen an
increase in inquiries for orders. We ended the first quarter with
$10 million cash on hand, which is a
75% increase over the same period last year and strengthens the
Company's financial position."
Financial Results for the Quarter Ended March 31, 2021
Net revenues. Net revenues for the quarter ended
March 31, 2021 were $1.5 million compared to $3.2 million for the quarter ended March 31, 2020, a decrease of $1.7 million or 53%. The decrease was
driven by AXP® disposable sales, which declined by $1.9 million with approximately 900 fewer cases
sold in the first quarter of 2021 as compared to 2020. The primary
driver of the decrease was the COVID-19 pandemic which has had a
significant impact on the Company's sales since it began over a
year ago. As the pandemic has begun to subside in the first quarter
of 2021, management is hopeful that the industry will start to turn
around in the second quarter. Inquiries for orders increased in
March and the Company expects revenue to rebound in the second
quarter and return to pre-pandemic levels by the end of 2021. The
decrease in net revenue for the quarter was offset by approximately
$0.3 million more in BioArchive®
sales, primarily due to increased service revenue in the first
quarter of 2021 as compared to 2020.
Gross profit. Gross profit was $0.7 million, or 47% of net revenues, for the
quarter ended March 31, 2021 compared
to $1.5 million, or 47% of net
revenues, for the quarter ended March 31,
2020, a decrease of $0.8
million. The decrease was driven by the decline in AXP®
disposables sold, resulting in approximately $1.1 million less gross profit. This decrease was
offset by approximately $0.3 million
more in BioArchive service revenue and approximately $50,000 more in CAR-TXpress revenue in the
quarter ended March 31, 2021 as
compared to the first quarter of 2020.
Selling, general and administrative
expenses. Selling, general and administrative expenses
were $2.0 million for the quarter
ended March 31, 2021, as compared to
$2.1 million for the quarter ended
March 31, 2020, a decrease of
$0.1 million or 5%. The decrease was
driven by the absence in the first quarter of 2021 of legal and
other expenses related to the Mavericks lawsuit incurred in the
quarter ended March 31,2020, of
approximately $0.2 million and
reduced travel expenses of approximately $60,000 as compared to the first quarter of 2020.
These decreases were offset by increased stock compensation expense
of $164,000 during the current
quarter.
Research and development expenses. Research and
development expenses were $0.4
million for the quarter ended March
31, 2021, compared to $0.6
million for the quarter ended March
31, 2020, a decrease of $0.2
million or 38%. The decrease was driven by lower expenses
for salaries and benefits of approximately $0.2 million in the quarter ended March 31, 2021.
Interest Expense. Interest expense for the three
months ended March 31, 2021 was
$1.5 million, as compared to
$3.5 million for the three months
ended March 31, 2020, a decrease of
$2.0 million or 57%. The decrease was
driven by the accelerated expense of the unamortized debt discount
of $2.5 million for the beneficial
conversion feature associated with the portions of the Revolving
Credit Agreement with Boyalife Asset Holding II, Inc. which were
converted during the first quarter of 2020. The decrease was offset
by approximately $0.5 million more in
debt discount amortization and interest expense related to the
additional draw down from the Loan completed by the Company in
April 2020.
Net loss. For the quarter ended March 31, 2021, the Company reported a
comprehensive loss attributable to common stockholders of
$2.4 million, or ($0.21) per share, based on approximately 11.4
million weighted average basic and diluted common shares
outstanding. This compares to a comprehensive net loss of
$4.6 million, or ($1.11) per share, based on approximately 4.1
million weighted average basic and diluted common shares
outstanding for the quarter ended March 31,
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 March 31, 2021 was $1.2
million, as compared to a loss of $0.9 million for the quarter ended March 31, 2020, an increase of $0.3 million or 31%. The increase in the adjusted
EBITDA loss was due to the decrease of $0.8
million in gross profit driven by lower AXP disposable
sales, offset by the $0.1 million
decrease in selling, general and administrative expenses, the
$0.2 million decrease in research and
development expenses and lower stock compensation expense in the
quarter ended March 31, 2021 of
$0.2 million as compared to the first
quarter of 2020.
Liquidity and Capital Resources. At March 31, 2021, the Company had cash and cash
equivalents totaling $10.0 million,
compared with $7.2 million at
December 31, 2020. Working capital
was to $6.4 million at March 31, 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
|
|
|
|
|
|
|
|
March 31,
2021
|
|
December
31,
2020
|
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$10,014,000
|
|
$7,161,000
|
|
|
Accounts
receivable, net
|
|
826,000
|
|
1,382,000
|
|
|
Inventories
|
|
5,334,000
|
|
5,877,000
|
|
|
Prepaid
expenses and other current assets
|
|
730,000
|
|
878,000
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
16,904,000
|
|
15,298,000
|
|
|
|
|
|
|
|
|
|
Inventories,
non-current
|
|
2,486,000
|
|
1,221,000
|
|
|
Equipment and
leasehold improvements, net
|
|
1,337,000
|
|
1,424,000
|
|
|
Right-of-use
operating lease assets, net
|
|
693,000
|
|
730,000
|
|
|
Goodwill
|
|
781,000
|
|
781,000
|
|
|
Intangible assets,
net
|
|
1,342,000
|
|
1,358,000
|
|
|
Other
assets
|
|
48,000
|
|
48,000
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$23,591,000
|
|
$20,860,000
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$1,328,000
|
|
$1,366,000
|
|
|
Other
current liabilities
|
|
9,163,000
|
|
4,777,000
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
10,491,000
|
|
6,143,000
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities
|
|
2,670,000
|
|
8,847,000
|
|
|
|
|
|
|
|
|
|
ThermoGenesis
Holdings, Inc. stockholders' equity
|
|
10,478,000
|
|
5,800,000
|
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(48,000)
|
|
70,000
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$23,591,000
|
|
$20,860,000
|
|
ThermoGenesis
Holdings, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
|
2021
|
|
2020
|
|
Net
revenues
|
$1,517,000
|
|
$3,200,000
|
|
|
|
|
|
|
Cost of
revenues
|
809,000
|
|
1,708,000
|
|
|
|
|
|
|
Gross profit
|
708,000
|
|
1,492,000
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
Selling,
general and administrative
|
1,992,000
|
|
2,092,000
|
|
|
|
|
|
|
Research
and development
|
379,000
|
|
609,000
|
|
|
|
|
|
|
Total operating
expenses
|
2,371,000
|
|
2,701,000
|
|
|
|
|
|
|
Loss from
operations
|
(1,663,000)
|
|
(1,209,000)
|
|
|
|
|
|
|
Interest
expense
|
(1,519,000)
|
|
(3,531,000)
|
|
Other income
(expenses)
|
(1,000)
|
|
(3,000)
|
|
Gain on
extinguishment of debt
|
652,000
|
|
--
|
|
|
|
|
|
|
Net loss
|
(2,531,000)
|
|
(4,743,000)
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
(118,000)
|
|
(141,000)
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$(2,413,000)
|
|
$(4,602,000)
|
|
|
|
|
|
|
ThermoGenesis
Holdings, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2021
|
|
2020
|
Cash flows from
operating activities:
|
|
|
|
Net
cash used in operating activities
|
$(3,952,000)
|
|
$(2,541,000)
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
Capital
expenditures
|
(27,000)
|
|
(23,000)
|
Cash flows from
financing activities:
|
|
|
|
Proceeds from convertible
promissory note-related party
|
--
|
|
1,869,000
|
Payments on finance lease
obligations
|
--
|
|
(13,000)
|
Proceeds from issuance of
common stock, net of expenses
|
6,832,000
|
|
3,220,000
|
Proceeds from the exercise
of options, warrants and pre-funded warrants
|
--
|
|
57,000
|
Proceeds from note payable
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
6,832,000
|
|
5,133,000
|
|
|
|
|
Effects of foreign
currency rate changes on cash and cash equivalents
|
--
|
|
(5,000)
|
Net increase
(decrease) in cash, cash equivalents and restricted cash
|
2,853,000
|
|
2,562,000
|
|
|
|
|
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
|
$10,014,000
|
|
$6,719,000
|
|
|
|
|
ThermoGenesis
Holdings, Inc.
Reconciliation of
Adjusted EBITDA to Net Loss
(Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
Net loss
|
|
$(2,531,000)
|
|
$(4,743,000)
|
|
|
|
|
|
Deduct:
|
|
|
|
|
Interest expense
|
|
(1,519,000)
|
|
(3,531,000)
|
Other income/expense
|
|
(1,000)
|
|
(3,000)
|
Gain on extinguishment of debt
|
|
652,000
|
|
--
|
Loss from
operations
|
|
$(1,663,000)
|
|
$(1,209,000)
|
|
|
|
|
|
Add:
|
|
|
|
|
Depreciation and amortization
|
|
166,000
|
|
199,000
|
Stock-based compensation expense
|
|
258,000
|
|
67,000
|
Adjusted
EBITDA
|
|
$(1,239,000)
|
|
$(943,000)
|
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:http://www.prnewswire.com/news-releases/thermogenesis-holdings-announces-financial-results-for-the-first-quarter-ended-march-31-2021-and-provides-corporate-update-301291240.html
SOURCE ThermoGenesis Holdings, Inc.