EX-99.1 2 ex_275406.htm EXHIBIT 99.1 ex_275406.htm

 

Exhibit 99.1

 tg01.jpg

 

ThermoGenesis Holdings Announces Financial Results for the Second Quarter Ended June 30, 2021, and Provides Corporate Update

 

Conference Call to be Held Today at 1:30 p.m. PT/4:30 p.m. ET

 

RANCHO CORDOVA, Calif., August 12, 2021 -- 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 second quarter ended June 30, 2021 and provided a corporate strategic update.

 

“Cell and gene therapies are poised to continue to revolutionize many areas of medicine, and ThermoGenesis has been a pioneer in the development and commercialization of automated cell processing technologies that provide more efficient, higher-quality and cost-effective manufacturing solutions to move these therapies through the clinic and ultimately, to patients in need,” stated Chris Xu, Ph.D., Chief Executive Officer of ThermoGenesis. “Throughout our 35-year history, we have leveraged the inherent flexibility of our proprietary technology platform to meet the ever-changing needs of the industry. Given the sheer volume of clinical trials currently underway in the CAR-T cell therapy field, alone, and the high manufacturing costs and serious capacity limitations of current cell-based contract development and manufacturing (CDMO) services, there remains a serious unmet need to bring these lifesaving therapies to market.”

 

Dr. Xu continued, “Most of the existing players in the CDMO arena do not have proprietary manufacturing technologies which contributes to the market bottlenecks. To capitalize on the inefficiencies in the industry, we are committed to leveraging our high efficiency, semi-automated CAR-TXpress™ platform, which has been shown to reduce the manufacturing costs associated with CAR-T and other cell and gene therapies by up to 70% and plan to transition from a device-only company to a provider of CDMO services for the global cell and gene therapy market. We look forward to reporting more on this exciting transformation in the coming months.”

 

 

 

 

Financial Results for the Quarter Ended June 30, 2021

 

Net revenues. Net revenues for the quarter ended June 30, 2021, were $2.2 million, approximately equal to the quarter ended June 30, 2020. The quarter ended June 30, 2021 had AXP sales increase by $0.4 million or 64% and BioArchive sales increase by $0.1 million or 20%, as compared to the same period in 2020. We believe this is a positive sign, illustrating that cord blood revenues may be starting to return to pre-pandemic levels. While the Company does not have any specific industry data at this time regarding the number of cord blood units stored globally, AXP disposable sales increased by approximately 150 cases in the second quarter of 2021 as compared to 2020. The increased demand for AXP bagsets appears to imply that global cord blood units stored are beginning to pick up. These increases were offset by CAR-TXpress and other sales which decreased by a combined $0.6 million, in the quarter ended June 30, 2021.

 

Gross profit. Gross profit for the quarter ended June 30, 2021, was $1.0 million, or 45% of net revenue, compared to a loss of $2.6 million, or (117)% of net revenues, for the quarter ended June 30, 2020, representing a $3.6 million improvement. The increase was driven by a one-time expense of approximately $3.6 million incurred in the quarter ended June 30, 2020, associated with an inventory reserve expense for the remaining on-hand inventory of COVID-19 testing kits at that time. Additionally, the Company had an increase in gross profit from AXP disposables due to approximately 150 more cases being sold in the quarter ended June 30, 2021, as compared to the same period in 2020. This was offset by a decrease in gross profit from CAR-TXpress, which experienced a sales decline in the same period.

 

Selling, general and administrative expenses. Selling, general and administrative expenses were $3.5 million for the quarter ended June 30, 2021, as compared to $2.0 million for the quarter ended June 30, 2020, an increase of $1.5 million or 77%. The increase was driven primarily by stock compensation expense, which rose by approximately $1.6 million primarily due to the accelerated expense for the stock options that were voluntarily surrendered by Company executives in the quarter ended June 30, 2021.

 

Research and development expenses. Research and development expenses were $0.6 million for the quarter ended June 30, 2021, compared to $0.6 million for the quarter ended June 30, 2020. The quarter ended June 30, 2021, had an increase of approximately $0.1 million in stock compensation expense offset by a decrease of approximately $0.1 million related to lower salaries and benefits, as compared to the same period in 2020.

 

Interest Expense. Interest expense for the quarter ended June 30, 2021, was $1.5 million, as compared to $1.3 million for the quarter ended June 30, 2020, an increase of $0.2 million or 16%. The increase was driven by additional interest expense and amortization of the debt discount related to the Revolving Credit Agreement with Boyalife Asset Holding II, Inc. in the quarter ended June 30, 2021, as compared to the same period in 2020.

 

 

 

Net loss. For the quarter ended June 30, 2021, the Company reported a comprehensive loss attributable to common stockholders of $4.5 million, or ($0.38) per share, based on approximately 11.9 million weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $6.4 million, or ($1.02) per share, based on approximately 6.3 million weighted average basic and diluted common shares outstanding for the quarter ended June 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 June 30, 2021, was $0.9 million, as compared to a loss of $4.7 million for the quarter ended June 30, 2020, an increase of $3.8 million or 81%. The adjusted EBITDA improvement was primarily due to lower inventory reserves of approximately $3.6 million in the quarter ended June 30, 2021.

 

Liquidity and Capital Resources. At June 30, 2021, the Company had cash and cash equivalents totaling $8.7 million, compared with $7.2 million at December 31, 2020. Working capital was $4.2 million at June 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

 

   

June 30,

2021

   

December 31,

2020

 
   

(Unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 8,668,000     $ 7,161,000  

Accounts receivable, net

    1,242,000       1,382,000  

Inventories

    5,813,000       5,877,000  

Prepaid expenses and other current assets

    354,000       878,000  

Total current assets

    16,077,000       15,298,000  
                 

Inventories, non-current

    2,227,000       1,221,000  

Equipment and leasehold improvements, net

    1,282,000       1,424,000  

Right-of-use operating lease assets, net

    654,000       730,000  

Goodwill

    781,000       781,000  

Other intangible assets, net

    1,334,000       1,358,000  

Other assets

    48,000       48,000  

Total assets

  $ 22,403,000     $ 20,860,000  
                 

LIABILITIES AND EQUITY

               

Current liabilities:

               

Accounts payable

  $ 1,120,000     $ 1,366,000  

Other current liabilities

    10,791,000       4,777,000  

Total current liabilities

    11,911,000       6,143,000  
                 

Long-term liabilities

    2,623,000       8,847,000  
                 

ThermoGenesis Holdings, Inc. stockholders' equity

    8,050,000       5,800,000  
                 

Noncontrolling interests

    (181,000 )     70,000  

Total liabilities and equity

  $ 22,403,000     $ 20,860,000  

 

 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   

Three Months Ended
June 30,

   

Six Months Ended
June 30

 
   

2021

   

2020

   

2021

   

2020

 

Net revenues

  $ 2,201,000     $ 2,242,000     $ 3,718,000     $ 5,442,000  

Cost of revenues

    1,215,000       4,874,000       2,024,000       6,582,000  
                                 

Gross profit (loss)

    986,000       (2,632,000 )     1,694,000       (1,140,000 )
                                 

Expenses:

                               

Selling, general and administrative

    3,502,000       1,978,000       5,494,000       4,070,000  

Research and development

    622,000       578,000       1,001,000       1,187,000  
                                 

Total operating expenses

    4,124,000       2,556,000       6,495,000       5,257,000  
                                 

Loss from operations

    (3,138,000 )     (5,188,000 )     (4,801,000 )     (6,397,000 )
                                 

Other expenses

                               
                                 

Interest expense

    (1,524,000 )     (1,314,000 )     (3,043,000 )     (4,845,000 )

Other income (expenses)

    (10,000 )     (8,000 )     (11,000 )     (11,000 )

Gain on extinguishment of debt

    --       --       652,000       --  

Total other expense

    (1,534,000 )     (1,322,000 )     (2,402,000 )     (4,856,000 )
                                 

Net loss

    (4,672,000 )     (6,510,000 )     (7,203,000 )     (11,253,000 )
                                 

Loss attributable to noncontrolling interests

    (133,000 )     (73,000 )     (251,000 )     (214,000 )

Net loss attributable to common stockholders

  $ (4,539,000 )   $ (6,437,000 )   $ (6,952,000 )   $ (11,039,000 )

 

 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

   

Six Months Ended

June 30,

 
   

2021

   

2020

 

Cash flows from operating activities:

               

Net cash used in operating activities

  $ (5,244,000 )   $ (8,953,000 )
                 

Cash flows from investing activities:

               

Capital expenditures

    (80,000 )     (23,000 )

Cash flows from financing activities:

               

Proceeds from convertible promissory note-related party

    --       4,287,000  

Payments on finance lease obligations

    --       (22,000 )

Proceeds from issuance of common stock, net of expenses

    6,832,000       5,214,000  

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       11,808,000  
                 

Effects of foreign currency rate changes on cash and cash equivalents

    (1,000 )     (5,000 )

Net increase (decrease) in cash, cash equivalents and restricted cash

    1,507,000       2,827,000  
                 

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

  $ 8,668,000     $ 6,984,000  

 

 

 

 

ThermoGenesis Holdings, Inc.

Reconciliation of Adjusted EBITDA to Net Loss

(Unaudited)

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2021

   

2020

   

2021

   

2020

 

Net loss

  $ (4,672,000 )   $ (6,510,000 )   $ (7,203,000 )   $ (11,253,000 )
                                 

Deduct:

                               

Interest expense

    (1,524,000 )     (1,314,000 )     (3,043,000 )     (4,845,000 )

Other expense

    (10,000 )     (8,000 )     (11,000 )     (11,000 )

Gain on extinguishment of debt

    --       --       652,000       --  

Loss from operations

  $ (3,138,000 )   $ (5,188,000 )   $ (4,801,000 )   $ (6,397,000 )
                                 

Add:

                               

Depreciation and amortization

    154,000       193,000       320,000       392,000  

Stock-based compensation expense

    2,099,000       314,000       2,357,000       381,000  

Adjusted EBITDA

  $ (885,000 )   $ (4,681,000 )   $ (2,124,000 )   $ (5,624,000 )

 

The Company defines adjusted EBITDA as income (or loss) from operations less, depreciation, amortization, stock compensation and impairment of intangible assets.