ThermoGenesis Holdings, Inc. - Quarter Report: 2022 March (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2022.
or
☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition from _____________ to _______________.
| Commission File Number: 333-82900
ThermoGenesis Holdings, Inc. (Exact name of registrant as specified in its charter) | ||
| Delaware (State of incorporation) | 94-3018487 (I.R.S. Employer Identification No.) | |
| 2711 Citrus Road Rancho Cordova, California 95742 (Address of principal executive offices) (Zip Code)
(916) 858-5100 (Registrant’s telephone number, including area code) | ||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||
| Common Stock, $.001 par value | THMO | Nasdaq Capital Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
| Class | Outstanding at May 18, 2022 | |
| Common stock, $.001 par value | 12,829,877 |
ThermoGenesis Holdings, Inc.
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PART I - FINANCIAL INFORMATION
ThermoGenesis Holdings, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
| March 31, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,652,000 | $ | 7,280,000 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $ at March 31, 2022 and December 31, 2021 | 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, net | 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 | ||||||
| Other 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 | ||||
| Accrued payroll and related expenses | 456,000 | 348,000 | ||||||
| Deferred revenue – short-term | 1,159,000 | 719,000 | ||||||
| Convertible promissory note – related party | 10,000,000 | -- | ||||||
| Interest payable – related party | 153,000 | 2,231,000 | ||||||
| Convertible promissory note, net | 1,000,000 | 813,000 | ||||||
| Other current liabilities | 843,000 | 957,000 | ||||||
| Total current liabilities | 15,477,000 | 6,348,000 | ||||||
| Convertible promissory note – related party, net | -- | 9,245,000 | ||||||
| Operating lease obligations – long-term | 338,000 | 398,000 | ||||||
| Deferred revenue – long-term | 1,163,000 | 1,244,000 | ||||||
| Other noncurrent liabilities | 19,000 | 20,000 | ||||||
| Total liabilities | 16,997,000 | 17,255,000 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ par value; shares authorized, outstanding | ||||||||
| Common stock, $ par value; shares authorized; issued and outstanding ( at December 31, 2021) | 13,000 | 12,000 | ||||||
| Additional paid in capital | 258,614,000 | 268,447,000 | ||||||
| Accumulated deficit | (256,833,000 | ) | (264,662,000 | ) | ||||
| Accumulated other comprehensive loss | 45,000 | 31,000 | ||||||
| Total ThermoGenesis Holdings, Inc. stockholders’ equity | 1,839,000 | 3,828,000 | ||||||
| Noncontrolling interests | (557,000 | ) | (431,000 | ) | ||||
| Total equity | 1,282,000 | 3,397,000 | ||||||
| Total liabilities and equity | $ | 18,279,000 | $ | 20,652,000 | ||||
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| Three Months Ended | ||||||||
| 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 | ) | ||||
| Other income (expenses): | ||||||||
| Interest expense | (823,000 | ) | (1,519,000 | ) | ||||
| Other income (expenses) | (4,000 | ) | (1,000 | ) | ||||
| Gain / (loss) on extinguishment of debt | -- | 652,000 | ||||||
| Total other expenses | (827,000 | ) | (868,000 | ) | ||||
| 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 | ) | ||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (2,036,000 | ) | $ | (2,531,000 | ) | ||
| Other comprehensive loss: | ||||||||
| Foreign currency translation adjustments gain (loss) | 14,000 | 1,000 | ||||||
| Comprehensive loss | (2,022,000 | ) | (2,530,000 | ) | ||||
| Comprehensive loss attributable to noncontrolling interests | (126,000 | ) | (118,000 | ) | ||||
| Comprehensive loss attributable to common stockholders | $ | (1,896,000 | ) | $ | (2,412,000 | ) | ||
| Per share data: | ||||||||
| Basic and diluted net loss per common share | $ | (0.16 | ) | $ | (0.21 | ) | ||
| Weighted average common shares outstanding basic and diluted | 12,288,517 | 11,446,366 | ||||||
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Condensed Consolidated Statements of Equity
For the Three Months Ended March 31, 2022 and 2021
(Unaudited)
| Shares | Common Stock | Paid in Capital in Excess of Par | Accumulated Deficit | AOCL* | Non- Controlling interests | Total Equity | ||||||||||||||||||||||
| Balance at January 1, 2022 | 11,911,784 | $ | 12,000 | $ | 268,447,000 | $ | (264,662,000 | ) | $ | 31,000 | $ | (431,000 | ) | $ | 3,397,000 | |||||||||||||
| Adoption of ASU 2020-06 | -- | -- | (10,681,000 | ) | 9,739,000 | -- | -- | (942,000 | ) | |||||||||||||||||||
| Stock-based compensation expense | -- | -- | 42,000 | -- | -- | -- | 42,000 | |||||||||||||||||||||
| Issuance of common stock via at-the-market offering, net | 918,093 | 1,000 | 593,000 | -- | -- | -- | 594,000 | |||||||||||||||||||||
| Related party convertible note price reset | 213,000 | 213,000 | ||||||||||||||||||||||||||
| Foreign currency translation gain | -- | -- | -- | -- | 14,000 | -- | 14,000 | |||||||||||||||||||||
| Net loss | -- | -- | -- | (1,910,000 | ) | -- | (126,000 | ) | (2,036,000 | ) | ||||||||||||||||||
| Balance at March 31, 2022 | 12,829,877 | $ | 13,000 | $ | 258,614,000 | $ | (256,833,000 | ) | $ | 45,000 | $ | (557,000 | ) | $ | 1,282,000 | |||||||||||||
| Shares | Common Stock | Paid in Capital in Excess of Par | Accumulated Deficit | AOCL* | Non-Controlling interests | Total Equity | ||||||||||||||||||||||
| Balance at January 1, 2021 | 8,934,952 | $ | 9,000 | $ | 259,058,000 | $ | (253,283,000 | ) | $ | 16,000 | $ | 70,000 | $ | 5,870,000 | ||||||||||||||
| Stock-based compensation expense | -- | -- | 258,000 | -- | -- | -- | 258,000 | |||||||||||||||||||||
| Issuance of common stock via at- the-market offering, net | 2,976,832 | 3,000 | 6,829,000 | -- | -- | -- | 6,832,000 | |||||||||||||||||||||
| Foreign currency translation gain | -- | -- | -- | -- | 1,000 | -- | 1,000 | |||||||||||||||||||||
| Net loss | -- | -- | -- | (2,413,000 | ) | -- | (118,000 | ) | (2,531,000 | ) | ||||||||||||||||||
| Balance at March 31, 2021 | 11,911,784 | $ | 12,000 | $ | 266,145,000 | $ | (255,696,000 | ) | $ | 17,000 | $ | (48,000 | ) | $ | 10,430,000 | |||||||||||||
* Accumulated other comprehensive loss.
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (2,036,000 | ) | $ | (2,531,000 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 150,000 | 166,000 | ||||||
| Stock-based compensation expense | 42,000 | 258,000 | ||||||
| Amortization of debt discount/premium, net | 213,000 | 908,000 | ||||||
| Reserve for excess and slow-moving inventories | 374,000 | (4,000 | ) | |||||
| Gain on extinguishment of debt | -- | (652,000 | ) | |||||
| Net change in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,442,000 | ) | 556,000 | |||||
| Inventories | (383,000 | ) | (718,000 | ) | ||||
| Prepaid expenses and other assets | 103,000 | 148,000 | ||||||
| Accounts payable | 599,000 | (38,000 | ) | |||||
| Interest payable – related party | (2,078,000 | ) | (1,532,000 | ) | ||||
| Accrued payroll and related expenses | 107,000 | 124,000 | ||||||
| Deferred revenue – short term | 441,000 | 88,000 | ||||||
| Other current liabilities | (112,000 | ) | (603,000 | ) | ||||
| Long-term deferred revenue and other noncurrent liabilities | (137,000 | ) | (122,000 | ) | ||||
| Net cash used in operating activities | (4,159,000 | ) | (3,952,000 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Capital expenditures | (65,000 | ) | (27,000 | ) | ||||
| Net cash used in investing activities | (65,000 | ) | (27,000 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of common stock, net of $87,000 in expenses | 594,000 | 6,832,000 | ||||||
| Net cash provided by financing activities | 594,000 | 6,832,000 | ||||||
| Effects of foreign currency rate changes on cash and cash equivalents | 2,000 | -- | ||||||
| Net increase (decrease) in cash and cash equivalents | (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 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for related party interest | $ | 2,628,000 | $ | 2,082,000 | ||||
| Cash paid for interest | $ | 60,000 | $ | 60,000 | ||||
| Related party convertible note price reset | $ | 213,000 | -- | |||||
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Description of Business
The Company develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s ThermoGenesis Holdings has been a pioneer in, and a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.
Medical Device Products for Automated Cell Processing
The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and CAR-TXpress™ platform for large scale cell manufacturing services. All product lines are reporting as a single reporting segment in the financial statements.
2. Going Concern
At March 31, 2022, the Company had cash and cash equivalents of $3,652,000 and working capital of $(2,283,000). The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company may need to raise additional capital to grow its business, fund operating expenses and make interest payments. The Company’s ability to fund its liquidity needs is subject to various risks, many of which are beyond its control. The Company may seek additional funding through debt borrowings, sales of debt or equity securities or strategic partnerships. The Company cannot guarantee that such funding will be available on a timely basis, in needed quantities or on terms favorable to the Company, if at all. These factors and other indicators raise substantial doubt about the Company’s ability to continue as a going concern within one year from the filing date of this report.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.
3. Summary of Significant Accounting Polices
There have been no material changes in the Company’s significant accounting policies to those disclosed in the 2021 Annual Report.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such Securities and Exchange Commission (SEC) rules and regulations and accounting principles applicable for interim periods. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Events subsequent to the balance sheet date have been evaluated for inclusion in the accompanying condensed consolidated financial statements through the date of issuance.
Operating results for the three-month period ended March 31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in ThermoGenesis Holdings’ Annual Report on Form 10-K for the year ended December 31, 2021.
Principles of Consolidation
The consolidated financial statements include the accounts of ThermoGenesis Holdings and its wholly-owned subsidiaries, ThermoGenesis Corp. and TotipotentRX Cell Therapy, Pvt. Ltd and ThermoGenesis Corp’s majority-owned subsidiary, CARTXpress Bio. All significant intercompany accounts and transactions have been eliminated upon consolidation.
The 20% ownership interest of CARTXpress Bio that is not owned by ThermoGenesis Holdings is accounted for as a non-controlling interest as the Company has an 80% ownership interest in CARTXpress Bio. Earnings or losses attributable to other stockholders of a consolidated affiliated company are classified separately as "non-controlling interest" in the Company's consolidated statements of operations. Net loss attributable to non-controlling interests reflects only its share of the after-tax earnings or losses of an affiliated company. The Company's condensed consolidated balance sheets reflect non-controlling interests within the equity section.
Recently Adopted Accounting Standards
On January 1, 2022, we adopted Accounting Standards Update (“ASU”) 2020-06 “Debt-Debt with Conversion and Other Options (“Subtopic 470-20”) and Derivatives and Hedging-Contracts in Entity’s Own Equity (“Subtopic 815-40”): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity,” using the modified retrospective method. ASU 2020-06 provides guidance on how to account for contracts on an entity’s own equity. This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. Specifically, the ASU eliminated the need for the Company to assess whether a contract on the entity’s own equity (1) permits settlement in unregistered shares, (2) whether counterparty rights rank higher than shareholder’s rights, and (3) whether collateral is required. The Company recognized a cumulative effect of $9,739,000 of initially applying the ASU as an adjustment to the January 1, 2022 opening balance of accumulated deficit. Due to the recombination of the equity conversion component of our convertible debt outstanding, additional paid in capital and the debt discounts of the convertible promissory notes were reduced $10,681,000 and $942,000, respectively.
4. Related Party Transactions
Convertible Promissory Note and Revolving Credit Agreement
In March 2017, ThermoGenesis Holdings entered into a Credit Agreement with Boyalife Asset Holding II, Inc. (the “Lender”). The Lender is a wholly owned subsidiary of the Boyalife Group (USA), Inc., which is owned and controlled by the Company’s Chief Executive Officer and Chairman of our Board of Directors. The Credit Agreement, as amended, grants to the Company the right to borrow up to $10,000,000 (the “Loan”) at any time prior to March 6, 2022 (the “Maturity Date”). As of December 31, 2021, the Company had an outstanding principal balance on the Loan of $10,000,000. On March 4, 2022, the Company amended the Loan extending the Maturity Date by one year to March 6, 2023.
The Credit Agreement and the Convertible Promissory Note issued thereunder (as amended, the “Note”) provide that the principal and all accrued and unpaid interest under the Loan will be due and payable on the Maturity Date, with payments of interest-only due on the last day of each calendar year. The Loan bears interest at 22% per annum, simple interest. The Company has five business days after the Lender demands payment to pay the interest due before the Loan is considered in default. The Loan can be prepaid in whole or in part by the Company at any time without penalty.
The following summarizes the Note:
| Maturity Date | Stated Interest Rate | Conversion Price | Carrying Value | ||||||||||
| At March 31, 2022 | 3/6/2023 | 22 | % | $ | 0.64 | $ | 10,000,000 | ||||||
| At December 31, 2021 | 3/6/2022 | 22 | % | $ | 1.80 | $ | 9,245,000 | ||||||
The Note includes a down round provision that lowers its conversion price if the Company sells shares of common stock at a lower price per share. In February 2022, the Company sold shares of common stock at a price lower than the conversion price of the Note, resulting in a down round triggering event lowering the conversion price of the Note to $0.64 per share. The Company determined that the triggering event created incremental value of $213,000 which was treated as a debt discount and amortized over the remaining term of the Note. A Black-Scholes pricing model was utilized to determine the change in the before and after incremental value of the conversion option with the following inputs:
| Before | After | |||||||
| Conversion Price | $ | 1.80 | $ | 0.64 | ||||
| Term (in years) | 0.02 | 0.02 | ||||||
| Volatility | 39.53 | % | 39.53 | % | ||||
| Dividend rate | 0 | % | 0 | % | ||||
| Risk free rate | 1.97 | % | 1.97 | % | ||||
The Company amortized $213,000 and $827,000 of debt discount to interest expense for the three months ended March 31, 2022 and 2021, respectively. In addition to the amortization, the Company also recorded interest expense of $550,000 for each of the quarters ended March 31, 2022 and 2021. The interest payable balance as of March 31, 2022 and December 31, 2021 was $153,000 and $2,231,000, respectively.
On March 4, 2022, the Company amended the Credit Agreement and the Note to extend the due date by one year to March 6, 2023. No other terms of the Note were changed as a part of the extension. The Company performed a debt extinguishment vs. modification analysis. The analysis determined that the extension would be considered an extinguishment from an accounting standpoint, due to the change in the value of the conversion option. However, no gain or loss was recorded to the consolidated statement of operations for the quarter ended March 31, 2022 as it was determined that the fair value of the Note was $10,000,000 both before and after the extension.
Boyalife Genomics
On March 24, 2022, the Company 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. The agreement provides for a U.S. license to certain existing and future know-how and other intellectual property relating to cell manufacturing and related processes. The Company plans to develop and operate the CDMO cell therapy manufacturing business through a newly formed division named TG Biosynthesis.
Under the terms of the agreement, the Company transferred its remaining 8.64% interest in ImmuneCyte to Boyalife Genomics and agreed to pay a running royalty of 7.5% of its annual net sales of products and services that are covered by one or more of Boyalife Genomics’ granted U.S. patents and a royalty of 5.0% of other products and services covered by other licensed intellectual property. In the quarter ended March 31, 2022, no royalty payments were made to Boyalife Genomics.
Z3 Investment
Also on March 24, 2022, the Company entered into a year Lease Agreement with Z3 Investment LLC, an affiliate of the Company’s Chairman and CEO, beginning April 1, 2022, for approximately 35,475 square feet of laboratory and office space in Rancho Cordova, California. Under the terms of the agreement, monthly rent will be $46,000 per month for the first six months, then increasing to $104,000 per month (with a 4% annual increase) thereafter.
5. Convertible Promissory Note
July 2019 Note
On July 23, 2019, the Company entered into a private placement with the Accredited Investor, pursuant to which the Company issued and sold to such investor an unsecured convertible promissory note in the original principal amount of $1,000,000 (the “July 2019 Note”). The July 2019 Note is convertible into shares of the Company's common stock at a conversion price equal to the lower of (a) $1.80 per share or (b) 90% of the closing sale price of the Company’s common stock on the date of conversion (subject to a floor conversion price of $0.50). The July 2019 Note bears interest at the rate of twenty-four percent (24%) per annum and is payable quarterly in arrears. Unless sooner converted in the manner described below, all principal under the July 2019 Note, together with all accrued and unpaid interest thereupon, will be due and payable three years from the date of the issuance on July 31, 2022.
The following summarizes the July 2019 Note:
| Maturity Date | Stated Interest Rate | Conversion Price | Carrying Value | ||||||||||
| At March 31, 2022 |
| 24 | % | $ | 0.61 | $ | 1,000,000 | ||||||
| At December 31, 2021 |
| 24 | % | $ | 0.91 | $ | 813,000 | ||||||
Amortization of debt discount on the July 2019 Note was $0 and $80,000 for the three months ended March 31, 2022 and 2021, respectively. Interest expense related to the July 2019 Note was $60,000 for both the quarters ended March 31, 2022 and 2021.
6. Stockholders’ Equity
Common Stock
On February 3, 2022, the Company entered into Amendment No. 2 to the At the Market Offering Agreement (the “Offering Agreement”) with H.C. Wainwright & Co., LLC to further increase the maximum aggregate offering price of shares of Common Stock that may be offered and sold from time to time under the Offering Agreement from $15,280,313 to $19,555,261, which enables the Company to sell an additional $4,275,000 of shares after taking into account prior sales under the Offering Agreement (the “Additional Shares”). Amendment No. 2 also amended the Offering Agreement to change the expiration date of the Offering Agreement from August 9, 2022 to the date on which all of the Additional Shares are sold by the Company or until the Offering Agreement is otherwise mutually terminated, subject to the early termination provisions set forth in the agreement. The terms and conditions of the Offering Agreement otherwise remain unchanged. The Company sold a total of 918,093 shares of common stock under the Offering Agreement for aggregate gross proceeds of $681,000 at an average selling price of $0.74 per share, resulting in net proceeds of approximately $594,000 after deducting commissions and other transaction costs of approximately $87,000.
Equity Plans
On January 13, 2022, the Company’s stockholders approved an amendment of the Company’s Amended 2016 Equity Incentive Plan to increase the aggregate number of shares of the Company’s common stock that may be issued under the plan from 392,500 shares to 1,200,000 shares.
Net Loss Per Share
Net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding. The calculation of the basic and diluted earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents noted below is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities consisted of the following at March 31:
| 2022 | 2021 | |||||||
| Common stock equivalents of convertible promissory note and accrued interest | 17,420,222 | 6,449,950 | ||||||
| Warrants – other | 653,248 | 653,248 | ||||||
| Stock options | 342,670 | 889,636 | ||||||
| Total | 18,416,140 | 7,992,834 | ||||||
7. Revenue
The following table summarizes the revenues by product line and type:
| Three Months Ended March 31, 2022 | ||||||||||||||||
| Device Revenue | Service Revenue | Other Revenue | Total Revenue | |||||||||||||
| AXP | $ | 1,711,000 | $ | 55,000 | $ | -- | $ | 1,766,000 | ||||||||
| BioArchive | 155,000 | 298,000 | -- | 453,000 | ||||||||||||
| CAR-TXpress | 199,000 | 43,000 | 71,000 | 313,000 | ||||||||||||
| Manual Disposables | 105,000 | -- | -- | 105,000 | ||||||||||||
| Other | 17,000 | -- | 9,000 | 26,000 | ||||||||||||
| Total | $ | 2,187,000 | $ | 396,000 | $ | 80,000 | $ | 2,663,000 | ||||||||
| Three Months Ended March 31, 2021 | ||||||||||||||||
| Device Revenue | Service Revenue | Other Revenue | Total Revenue | |||||||||||||
| AXP | $ | 225,000 | $ | 39,000 | $ | -- | $ | 264,000 | ||||||||
| BioArchive | 208,000 | 542,000 | -- | 750,000 | ||||||||||||
| CAR-TXpress | 255,000 | 28,000 | 71,000 | 354,000 | ||||||||||||
| Manual Disposables | 129,000 | -- | -- | 129,000 | ||||||||||||
| Other | 7,000 | -- | 13,000 | 20,000 | ||||||||||||
| Total | $ | 824,000 | $ | 609,000 | $ | 84,000 | $ | 1,517,000 | ||||||||
Contract Balances
Generally, all sales are contract sales (with either an underlying contract or purchase order). The Company does not have any material contract assets. When invoicing occurs prior to revenue recognition, a contract liability is recorded (as deferred revenue on the consolidated balance sheet). Revenues recognized during the three months ended March 31, 2022 that were included in the beginning balance of deferred revenue were $446,000. Short-term deferred revenues were $1,159,000 and $719,000 at March 31, 2022 and December 31, 2021, respectively. Long-term deferred revenue was $1,163,000 and $1,244,000 at March 31, 2022 and December 31, 2021, respectively.
Backlog of Remaining Customer Performance Obligations
The following table represents revenue expected to be recognized in the future from the backlog of performance obligations that are unsatisfied (or partially unsatisfied) at the end of the reporting period:
| Remainder of 2022 | 2023 | 2024 | 2025 | 2026 and beyond | Total | |||||||||||||||||||
| Service revenue | $ | 1,075,000 | $ | 666,000 | $ | 184,000 | $ | 83,000 | $ | -- | $ | 2,008,000 | ||||||||||||
| Device revenue (1) | 712,000 | 733,000 | 41,000 | -- | -- | 1,486,000 | ||||||||||||||||||
| Exclusivity fee | 214,000 | 286,000 | 286,000 | 286,000 | 190,000 | 1,262,000 | ||||||||||||||||||
| Other | 10,000 | 13,000 | 13,000 | 13,000 | 140,000 | 189,000 | ||||||||||||||||||
| Total | $ | 2,011,000 | $ | 1,698,000 | $ | 524,000 | $ | 382,000 | $ | 330,000 | $ | 4,945,000 | ||||||||||||
| (1) | Represents the minimum purchase requirements under the distribution agreement the Company signed with its AXP distributor in China. |
8. Concentrations
The Company had certain customers whose revenue individually represented 10% or more of the Company’s total revenue, or whose accounts receivable balances individually represented 10% or more of the Company’s total accounts receivable as follows:
| Accounts Receivable | March 31, 2022 | December 31, 2021 | ||||||
| Customer 1 | 35 | % | -- | |||||
| Customer 2 | 16 | % | -- | |||||
| Customer 3 | 1 | % | 23 | % | ||||
| Customer 4 | 9 | % | 23 | % | ||||
| Three Months Ended March 31, | ||||||||||||||||
| Revenues | 2022 | 2021 | ||||||||||||||
| Customer 1 | $ | 1,271,000 | 48 | % | $ | 151,000 | 10 | % | ||||||||
| Customer 2 | $ | 2,000 | -- | $ | 316,000 | 21 | % | |||||||||
9. Subsequent Events
Effective April 1, 2022, the Company entered into a lease for a 35,745 square foot laboratory, office and manufacturing facility in Rancho Cordova, California for its CDMO business. The lease expires on September 30, 2027.
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward‑Looking Statements
This report contains “forward-looking statements” within the meaning of the safe harbor provisions 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 report, 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 U.S. Food and Drug Administration (“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 the Company’s Form 10-K for the year ended December 31, 2021.
Business Overview
ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”), 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. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.
Our business involves the manufacturing and related service of cell based medical devices, including the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and CAR-TXpress™ platform for large scale cell manufacturing services. The Company and its subsidiaries currently manufacture and market the following products:
Clinical Bio-Banking Applications:
| ● |
AXP® II Automated Cell Separation System – an automated, fully closed cell separation system for isolating stem and progenitor cells from umbilical cord blood, registered as a U.S. FDA 510(k) medical device. |
| ● |
BioArchive® Automated Cryopreservation System – an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications, registered as a U.S. FDA 510(k) medical device. |
Point-of-Care Applications:
| ● |
PXP® Point-of-Care System – an automated, fully closed, sterile system allows for the rapid, automated processing of autologous peripheral blood or bone marrow aspirate derived stem cells at the point-of-care, such as surgical centers or clinics, registered as a U.S. FDA 510(k) medical device. |
| ● |
PXP-LAVARE System – an automated, fully closed system that is designed to wash, re-suspend and volume reduce cell suspensions. It allows for volume manipulation, supernatant or media exchange, and cell washing to occur without comprising cell viabilities and maximizing recoveries, registered as a U.S. FDA 510(k) medical device. |
| ● |
PXP-1000 System – an automated, fully closed system that provides fast, reproducible separation of multiple cellular components from blood with minimal red blood cell contamination, registered as a U.S. FDA 510(k) medical device. |
Large Scale Cell Processing and Biomanufacturing:
| ● |
X-Series® Products for general laboratory use: X-Lab® for cell isolation, X-Wash® System for cell washing and reformulation, X-Mini® for high efficiency small scale cell purification, and X-BACS® System under development for large scale cell purification using our proprietary Buoyancy-Activated Cell Sorting (“BACS”) technology. |
| ● |
CAR-TXpress™ Platform for Clinical Manufacturing – a modular designed, functionally closed manufacturing platform that addresses the critical unmet need for large scale cellular processing and chemistry, manufacturing and controls (“CMC”) needs for manufacturing cellular therapies, including chimeric antigen receptor (“CAR”) T cell therapies. The CAR-TXpress Platform is owned and developed through a subsidiary CAR-TXpress Bio, Inc. (“CARTXpress Bio”) in which the Company owns 80% of the equity interest. |
Planned Expansion of Business-- Contract Development and Manufacturing Services for Cell and Cell-Based Gene Therapies
In March 2022, our Board of Directors approved the planned expansion of the Company’s business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company plans to develop and build-out the capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies by partnering with Boyalife Genomics Tianjin Ltd., a China-based CDMO (“Boyalife Genomics”), to in-license certain know-how and other intellectual property from Boyalife Genomics, and by leasing and building out a cell manufacturing facility in Sacramento, California. We intend to leverage our existing technology and combine it with the in-licensed technologies to develop a proprietary manufacturing platform for cell manufacturing activities.
The Company plans to develop and operate its planned CDMO business through a newly formed division named TG BiosynthesisTM. It is anticipated that TG Biosynthesis 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.
We are targeting the launch of our CDMO services to customers by the end of 2022. The successful development and launch of TG Biosynthesis will require us to raise additional capital, acquire various equipment for the planned operations, hire certain personnel needed to launch the operation, and timely complete the build-out of our leased Sacramento facility. There is no assurance that we will be able to successfully obtain such additional capital resources, as such capital may not be available on reasonable terms, or available at all. We will need to hire, train, and retain additional employees who have experiences in the cell manufacturing field in order for our CDMO business to be successful.
Results of Operations
Three Months Ended March 31, 2022 as Compared to the Three Months Ended March 31, 2021
Net Revenues
Net revenues for the three months ended March 31, 2022 were $2,663,000 compared to $1,517,000 for the three months ended March 31, 2021, an increase of $1,146,000 or 76%. The increase was driven by AXP® disposable sales which increased by approximately $1,500,000 with approximately 600 more cases sold in the first quarter of 2022 as compared to 2021. The primary driver of the change was the COVID-19 pandemic which had a significant impact on our sales first quarter of 2021. Many of our customers choose not to place new orders for AXP disposables in the first quarter last year. As we enter the beginning of 2022, AXP sales returned to a more normal level for the first quarter. This increase was offset by a decrease in BioArchive sales, primarily due to approximately $250,000 less in service revenue, as the result of a large one-time service revenue that was recognized in the first quarter of last year.
| March 31, 2022 |
March 31, 2021 |
|||||||
| AXP |
$ | 1,766,000 | $ | 264,000 | ||||
| BioArchive |
453,000 | 750,000 | ||||||
| CAR-TXpress |
313,000 | 354,000 | ||||||
| Manual Disposables |
105,000 | 129,000 | ||||||
| Other |
26,000 | 20,000 | ||||||
| $ | 2,663,000 | $ | 1,517,000 | |||||
Gross Profit
The Company’s gross profit was $940,000 or 35% of net revenues for the three months ended March 31, 2022, compared to $708,000 or 47% of net revenues for the three months ended March 31, 2021, an increase of $232,000. The increase was driven by the increase in AXP® disposables sold in the quarter ended March 31, 2022, resulting in approximately $700,000 more gross profit. This increase was offset by approximately $250,000 less in BioArchive service revenue in the quarter ended March 31, 2022 as compared to the same period in 2021.
Selling, General and Administrative
Sales, general and administrative expenses for the three months ended March 31, 2022 were $1,693,000 compared to $1,992,000 for the three months ended March 31, 2021, a decrease of $299,000 or 15%. The decrease was primarily due to lower stock compensation expense of approximately $200,000 in the quarter ended March 31, 2022, driven by stock compensation expense incurred in the prior quarter for awards that were subsequently voluntarily surrendered by Company executives later in 2021 and were no longer outstanding in the first quarter of 2022.
Research and Development Expenses
Research and development expenses were $456,000 for the three months ended March 31, 2022, compared to $379,000 for the three months ended March 31, 2021, an increase of $77,000 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 three months ended March 31, 2022 was $823,000, as compared to $1,519,000 for the three months ended March 31, 2021, a decrease of $696,000 or 46%. The decrease was driven by lower amortization of the debt discount related to the Convertible Promissory Note and Revolving Credit Agreement with Boyalife Asset Holding II, Inc. and the July 2019 Note. In the quarter ended March 31, 2021, the Company recorded amortization of debt discount to interest expense for these convertible notes totaling $906,000, as compared to $213,000 for the quarter ended March 31, 2022.
Gain on Extinguishment of Debt
The Company recorded no gain on the extinguishment of debt in the three months ended March 31, 2022 as compared to a gain of $652,000 for the three months ended March 31, 2021. The gain was related to the principal and accrued interest for the Paycheck Protection Program loan the Company received in 2020 and forgiven in March 2021.
Liquidity and Capital Resources
At March 31, 2022, the Company had cash and cash equivalents of $3,652,000 and working capital of ($2,283,000). This compares to cash and cash equivalents of $7,280,000 and working capital of $8,616,000 at December 31, 2021. We have primarily financed operations through private and public placement of equity securities and our line of credit facility.
The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company may need to raise additional capital to grow its business, fund operating expenses and make interest payments. The Company’s ability to fund its liquidity needs is subject to various risks, many of which are beyond its control. The Company may seek additional funding through debt borrowings, sales of debt or equity securities or strategic partnerships. The Company cannot guarantee that such funding will be available on a timely basis, in needed quantities or on terms favorable to the Company, if at all. These factors and other indicators raise substantial doubt about the Company’s ability to continue as a going concern within one year from the filing date of this report.
We manage the concentration of credit risk with our customers and distributors through a variety of methods including, pre-shipment deposits, credit reference checks and credit limits. Although management believes that our customers and distributors are sound and creditworthy, a severe adverse impact on their business operations could have a corresponding material effect on their ability to pay timely and therefore on our net revenues, cash flows and financial condition.
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
ThermoGenesis Holdings is a smaller reporting company as defined by Rule 12b-2 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) and is not required to provide information under this item.
ITEM 4. Controls and Procedures
The Company carried out an evaluation, under the supervision, and with the participation of management, including both the Company’s Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), of the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined by Exchange Act Rule 13a-15(e) or 15d-15(e)) as of March 31, 2022. Disclosure controls and procedures cover controls and other procedures that are designed to ensure that information required to be disclosed by the Company in reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based upon that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have both concluded that the Company’s disclosure controls and procedures were effective as of March 31, 2022.
There were no changes in the Company’s internal controls over financial reporting that occurred during the three months ended March 31, 2022 that have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting. Management believes that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within any company, have been detected.
In the normal course of operations, we may have disagreements or disputes with distributors, vendors or employees. Such potential disputes are seen by management as a normal part of business and while the outcome of such disagreements and disputes cannot be predicted with certainty, except as described below, we do not believe that any pending legal proceedings are material. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
The material set forth in Note 8, “Commitments and Contingencies,” in “Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements” is incorporated herein by reference.
There have been no material changes to the risk factors relating to the Company set forth in f, “Item IA. Risk Factors” of its Annual Report on Form 10-K for the year ended December 31, 2021.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
ITEM 3. Defaults Upon Senior Securities
None.
ITEM 4. Mine Safety Disclosure
Not applicable.
None.
ThermoGenesis Holdings, Inc.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| ThermoGenesis Holdings, Inc. (Registrant) |
||
| Dated: May 19, 2022 |
/s/ Xiaochun (Chris) Xu, Ph.D. |
|
| Xiaochun (Chris) Xu, Ph.D. Chief Executive Officer (Principal Executive Officer) |
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| Dated: May 19, 2022 |
/s/ Jeffery Cauble |
|
| Jeffery Cauble Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |