UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended | |
OR | |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period from _____ to _____ |
Commission File Number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer |
incorporation or organization) | Identification No.) |
(Address of principal executive offices) | (Zip Code) |
(
(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 |
The |
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.
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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the 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 | ◻ |
☒ | 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
As of August 9, 2024, the number of shares of common stock outstanding was
PRECIPIO, INC. AND SUBSIDIARIES
INDEX
2
PART 1. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
PRECIPIO, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except share data)
(unaudited) | ||||||
| June 30, 2024 |
| December 31, 2023 | |||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash | $ | | $ | | ||
Accounts receivable (net of allowance for credit losses of $ |
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Inventories |
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Other current assets |
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Total current assets |
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PROPERTY AND EQUIPMENT, NET |
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OTHER ASSETS: | ||||||
Finance lease right-of-use assets, net | | | ||||
Operating lease right-of-use assets, net | | | ||||
Intangibles, net |
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Other assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
CURRENT LIABILITIES: | ||||||
Current maturities of long-term debt, less debt issuance costs | $ | | $ | | ||
Current maturities of finance lease liabilities |
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Current maturities of operating lease liabilities |
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Accounts payable |
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Accrued expenses |
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Deferred revenue |
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Total current liabilities |
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LONG TERM LIABILITIES: | ||||||
Long-term debt, less current maturities and debt issuance costs |
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Finance lease liabilities, less current maturities |
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Operating lease liabilities, less current maturities |
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Total liabilities |
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COMMITMENTS AND CONTINGENCIES (Note 5) | ||||||
STOCKHOLDERS’ EQUITY: | ||||||
Preferred stock - $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
| ( | ( | |||
Total stockholders’ equity | | | ||||
Total liabilities and stockholders’ equity | $ | | $ | |
See notes to unaudited condensed consolidated financial statements.
3
PRECIPIO, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars in thousands, except per share data)
(unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2024 |
| 2023 | 2024 |
| 2023 | ||||||
SALES: |
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Service revenue, net | $ | | $ | | $ | | $ | | ||||
Product revenue |
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Revenue, net of contractual allowances and adjustments |
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Adjustment for allowance for credit losses |
| ( |
| ( |
| ( |
| ( | ||||
Net sales |
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COST OF SALES: |
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Cost of service revenue |
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Cost of product revenue |
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Total cost of sales |
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Gross profit |
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OPERATING EXPENSES: |
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Operating expenses |
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OPERATING LOSS |
| ( |
| ( |
| ( |
| ( | ||||
OTHER (EXPENSE) INCOME: |
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Interest expense, net |
| ( |
| ( |
| ( |
| ( | ||||
LOSS BEFORE INCOME TAXES |
| ( |
| ( |
| ( |
| ( | ||||
INCOME TAX EXPENSE |
| – |
| – |
| – |
| — | ||||
NET LOSS | $ | ( | $ | ( | $ | ( | $ | ( | ||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | ( | $ | ( | $ | ( | $ | ( | ||||
BASIC AND DILUTED WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING |
| |
| |
| |
| |
See notes to unaudited condensed consolidated financial statements.
4
PRECIPIO, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Dollars in thousands)
(unaudited)
For the Three Months Ended June 30, 2024 | |||||||||||||||||||
Preferred Stock | Common Stock | Additional | |||||||||||||||||
Outstanding | Par |
| Outstanding |
| Par | Paid-in | Accumulated | ||||||||||||
| Shares |
| Value |
| Shares |
| Value |
| Capital |
| Deficit |
| Total | ||||||
Balance, April 1, 2024 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | | |||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock in connection with at the market offering, net of issuance costs | — | — | | — | | — | | ||||||||||||
Issuance of common stock for consulting services | — | — | | — | | — | | ||||||||||||
Stock-based compensation | — |
| — |
| — |
| — |
| |
| — |
| | ||||||
Balance, June 30, 2024 | | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
For the Six Months Ended June 30, 2024 | |||||||||||||||||||
Preferred Stock | Common Stock | Additional | |||||||||||||||||
Outstanding | Par |
| Outstanding |
| Par | Paid-in | Accumulated | ||||||||||||
Shares |
| Value |
| Shares |
| Value |
| Capital |
| Deficit |
| Total | |||||||
Balance, January 1, 2024 | | $ | — |
| | $ | | $ | | $ | ( | $ | | ||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
Issuance of common stock in connection with at the market offering, net of issuance costs | — | — | | — | | — | | ||||||||||||
Issuance of common stock for consulting services | — | — | | — | | — | | ||||||||||||
Stock-based compensation |
| — |
| — |
| — |
| — |
| |
| — |
| | |||||
Balance, June 30, 2024 |
| | $ | — | | $ | | $ | | $ | ( | $ | |
5
PRECIPIO, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Dollars in thousands)
(unaudited)
For the Three Months Ended June 30, 2023 | |||||||||||||||||||||||||
Preferred Stock | Common Stock | Additional | Noncontrolling | ||||||||||||||||||||||
Outstanding | Par |
| Outstanding |
| Par | Paid-in | Accumulated | Total | Interest in | ||||||||||||||||
| Shares |
| Value |
| Shares (1) |
| Value (1) |
| Capital (1) |
| Deficit |
| Precipio, Inc. |
| Joint Venture |
| Total | ||||||||
Balance, April 1, 2023 | | $ | — | | $ | | $ | | $ | ( | $ | | $ | | $ | | |||||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( |
| — |
| ( | |||||||
Issuance of common stock in connection with at the market offering, net of issuance costs | — | — | | — | | — | | — | | ||||||||||||||||
Issuance of common stock in connection with purchase agreements | — | — | | | | — | | — | | ||||||||||||||||
Stock-based compensation |
| — |
| — |
| — |
| — |
| |
| — |
| |
| — |
| | |||||||
Balance, June 30, 2023 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | | $ | | $ | | |||||||
For the Six Months Ended June 30, 2023 | |||||||||||||||||||||||||
Preferred Stock | Common Stock | Additional | Noncontrolling | ||||||||||||||||||||||
Outstanding | Par |
| Outstanding |
| Par | Paid-in | Accumulated | Total | Interest in | ||||||||||||||||
Shares |
| Value |
| Shares (1) |
| Value (1) |
| Capital (1) |
| Deficit |
| Precipio, Inc. |
| Joint Venture |
| Total | |||||||||
Balance, January 1, 2023 | | $ | — | | $ | | $ | | $ | ( | $ | | $ | | $ | | |||||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( |
| — |
| ( | |||||||
Issuance of common stock in connection with purchase agreements | — | — | | | | — | | — | | ||||||||||||||||
Issuance of common stock in connection with at the market offering, net of issuance costs | — | — | | — | | — | | — | | ||||||||||||||||
Stock-based compensation |
| — |
| — |
| — |
| — |
| |
| — |
| |
| — |
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Balance, June 30, 2023 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | | $ | | $ | |
(1) The common stock and additional paid-in capital for all periods presented reflect the one-for- reverse stock split, which was effected on September 21, 2023
See notes to unaudited condensed consolidated financial statements
6
PRECIPIO, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in thousands)
(unaudited)
Six Months Ended June 30, | ||||||
| 2024 |
| 2023 | |||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash flows used in operating activities: |
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Depreciation and amortization |
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Amortization of operating lease right-of-use asset | | | ||||
Amortization of finance lease right-of-use asset | | | ||||
Amortization of deferred financing costs, debt discounts and debt premiums |
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Stock-based compensation |
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Value of stock issued in payment of services |
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| — | ||
Provision for credit losses |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Inventories |
| ( |
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Other assets |
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Accounts payable |
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Operating lease liabilities | ( | ( | ||||
Deferred revenue | | ( | ||||
Accrued expenses |
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Net cash used in operating activities |
| ( |
| ( | ||
CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of property and equipment |
| ( |
| ( | ||
Net cash used in investing activities |
| ( |
| ( | ||
CASH FLOWS FROM FINANCING ACTIVITIES: |
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Principal payments on finance lease obligations |
| ( |
| ( | ||
Deposits on finance lease right-of-use assets | ( | — | ||||
Issuance of common stock, net of issuance costs | | | ||||
Proceeds from debt |
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| — | ||
Principal payments on long-term debt |
| ( |
| ( | ||
Net cash flows provided by financing activities |
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NET CHANGE IN CASH |
| ( |
| ( | ||
CASH AT BEGINNING OF PERIOD |
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CASH AT END OF PERIOD | $ | | $ | | ||
See notes to unaudited condensed consolidated financial statements.
7
PRECIPIO, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS- CONTINUED
(Dollars in thousands)
(unaudited)
Six Months Ended June 30, | ||||||
2024 |
| 2023 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION | ||||||
Cash paid during the period for interest | $ | | $ | | ||
SUPPLEMENTAL DISCLOSURE OF CONSULTING SERVICES OR ANY OTHER NON-CASH COMMON STOCK RELATED ACTIVITY |
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Purchases of equipment financed through accounts payable | — | | ||||
Operating lease right-of-use assets obtained in exchange for operating lease obligations | — | | ||||
Finance lease right-of-use assets obtained in exchange for finance lease obligations | | — |
See notes to unaudited condensed consolidated financial statements.
8
PRECIPIO, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For the Three and Six Months Ended June 30, 2024 and 2023
1. BUSINESS DESCRIPTION
Business Description.
Precipio, Inc., and its subsidiaries, (collectively, “we”, “us”, “our”, the “Company” or “Precipio”) is a healthcare biotechnology company focused on cancer diagnostics. Our mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services.
Our products and services aim to deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses. We develop innovative technologies in our laboratory where we design, test, validate, and use these products clinically. We believe these technologies improve diagnostic outcomes across various diseases within the hematologic field. We then commercialize these technologies as proprietary products that serve the global laboratory community in furtherance of our mission to eliminate or greatly reduce the prevalence of misdiagnosis. To deliver our strategy, we have structured our organization to develop diagnostic products, including our laboratory and research and development (“R&D”) facilities located in New Haven, Connecticut and Omaha, Nebraska, respectively, which house teams that collaborate on the development of new products and services. We operate clinical laboratory improvement amendment (“CLIA”) laboratories in both New Haven, Connecticut and Omaha, Nebraska where we provide essential blood cancer diagnostics to office-based oncologists in many states nationwide. To deliver on our strategy of mitigating misdiagnoses we rely heavily on our CLIA laboratory to support R&D beta-testing of the products we develop, in a clinical environment.
The development of laboratory products involves a qualified facility; highly skilled laboratory staff; and access to viable patient specimens to conduct development and testing. Our CLIA laboratory in New Haven, which is operated by our pathology services division, encapsulates these components, and also generates revenue for us which covers costs associated with operating this laboratory. This structure of utilizing our clinical lab to obtain samples and utilize the equipment and staffing to develop, test and validate our products, significantly reduces the development costs and timeline for our products. This also enables us to accelerate the time to market of new product development and launch.
Furthermore, as a clinical laboratory, we are always the first user of every product we develop, which allows us to optimize important laboratory functions such as workflow, inventory management, regulatory and billing issues. As a vendor, this places us as a reputable user of our own products, and we believe gains us significant credibility with existing and prospective customers. Furthermore, because we use our products as part of our day-to-day operations, we are able to deliver a high level of hands-on, experienced support to customers, improving their experience with our products.
Our Products Division commercial team generates direct sales and works with our key distributors. Global healthcare distributors, such as ThermoFisher, McKesson, and Cardinal Health, have partnered with us to form the backbone of our go-to-market strategy and enable us to access laboratories around the country that can benefit from using our diagnostic products.
Our operating structure promotes the harnessing of our proprietary technology and genetic diagnostic expertise to bring to market our robust pipeline of innovative solutions designed to address the root causes of misdiagnoses.
Going Concern.
The condensed consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America (“GAAP”) applicable for a going concern, which assume that the Company will realize its assets and discharge its liabilities in the ordinary course of business and do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company has incurred substantial operating losses and has used cash in its operating activities for the past several years. For the six months ended June 30, 2024, the Company had a net loss of $
9
2024, the Company had an accumulated deficit of $
To meet its current and future obligations the Company has taken the following steps to capitalize the business:
● | On April 14, 2023, the Company entered into a sales agreement with AGP, pursuant to which the Company may offer and sell its common stock having aggregate sales proceeds of up to $ |
Notwithstanding the aforementioned circumstances, there remains substantial doubt about the Company’s ability to continue as a going concern for the next twelve months from the date these condensed consolidated financial statements were issued. There can be no assurance that the Company will be able to successfully achieve its initiatives summarized above in order to continue as a going concern over the next twelve months from the date of issuance of this Quarterly Report Form 10-Q.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation.
The accompanying condensed consolidated financial statements are presented in conformity with GAAP. As required under GAAP, pursuant to a 1-for-, unless otherwise indicated, the Company has adjusted all share amounts, per share data, share prices, exercise prices and conversion rates set forth in these notes and the accompanying condensed consolidated financial statements. As of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023, the condensed consolidated financial statements are unaudited and reflect all adjustments (consisting of only normal recurring adjustments) that are necessary for a fair presentation of the financial position and operating results for the interim periods. These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2023 contained in our Annual Report on Form 10-K, filed with the SEC on March 29, 2024. The results of operations for the interim periods presented are not necessarily indicative of the results for fiscal year 2024.
reverse stock split which was effected on September 21, 2023Recently Adopted Accounting Pronouncements.
In June 2022, the Financial Accounting Standards Board (the “FASB”) issued ASU 2022-03, Fair Value Measurement (Topic 820) (“ASU 2022-03”). The amendments in ASU 2022-03 clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. The amendments also clarify that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction. The amendments in this Update also require additional disclosures for equity securities subject to contractual sale restrictions. The Company adopted this guidance on January 1, 2024. The adoption of this standard was not material to our condensed consolidated financial statements.
10
In August 2020, the FASB issued 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.” This ASU amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related earnings per share (“EPS”) guidance for both Subtopics. The Company adopted this guidance on January 1, 2024. The adoption of this standard was not material to our condensed consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an annual and interim basis, primarily through enhanced disclosures of significant segment expenses. The guidance will be effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 and requires retrospective application to all periods presented upon adoption, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this guidance will have on its condensed consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”) which is intended to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 requires additional disaggregation of the reconciliation between the statutory and effective tax rate for an entity and of income taxes paid, both of which are disclosures required by current GAAP. The amendments improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. The amendments in ASU 2023-09 apply to all entities that are subject to Topic 740, Income Taxes. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted. ASU 2023-09 is effective for the Company beginning January 1, 2025. Adoption of ASU 2023-09 is expected to enhance the usefulness of income tax disclosures and is not expected to have a material impact on the Company’s financial position, results of operations or cash flow.
Loss Per Share.
Basic loss per share is calculated based on the weighted-average number of common shares (including pre-funded warrants) outstanding during each period. Diluted loss per share includes shares issuable upon exercise of outstanding stock options, warrants or conversion rights that have exercise or conversion prices below the market value of our common stock. Shares of the Company’s common stock underlying pre-funded warrants are included in the calculation of basic and diluted loss per share due to the negligible exercise price of the pre-funded warrants. Options, warrants and conversion rights pertaining to
The following table summarizes the outstanding securities not included in the computation of diluted net loss per share:
June 30, | ||||
| 2024 |
| 2023 | |
Stock options |
| |
| |
Warrants |
| |
| |
Preferred stock |
| |
| |
Total |
| |
| |
11
3. LONG-TERM DEBT
Long-term debt consists of the following:
Dollars in Thousands | ||||||
| June 30, 2024 |
| December 31, 2023 | |||
Connecticut Department of Economic and Community Development (DECD) | $ | | $ | | ||
DECD debt issuance costs |
| ( |
| ( | ||
Financed insurance loan |
| — |
| | ||
Business loan agreement | | — | ||||
Total long-term debt |
| |
| | ||
Current portion of long-term debt |
| ( |
| ( | ||
Long-term debt, net of current maturities | $ | | $ | |
Department of Economic and Community Development.
On January 8, 2018, the Company entered into an agreement with the Connecticut Department of Economic and Community Development (“DECD”) by which the Company received a loan of $
Amortization of the debt issuance costs were less than $
Financed Insurance Loan.
The Company finances certain of its insurance premiums (the “Financed Insurance Loans”). In July 2023, the Company financed $
Business Loan Agreement.
On May 1, 2024, the Company entered into a Business Loan and Security Agreement (the “Loan Agreement”) with Altbanq Lending LLC, pursuant to which the Company obtained a loan in the principal amount of $
The Company has the right, at its discretion, to request the lender to loan an additional amount of up to $
As of June 30, 2024 and December 31, 2023, the outstanding balance of $
12
4. ACCRUED EXPENSES
Accrued expenses at June 30, 2024 and December 31, 2023 are as follows:
(dollars in thousands) |
| June 30, 2024 |
| December 31, 2023 | ||
Accrued expenses | $ | | $ | | ||
Accrued compensation |
| |
| | ||
Accrued franchise, property and sales and use taxes | | | ||||
CHC temporary funding assistance | | — | ||||
Accrued interest |
| |
| | ||
$ | | $ | |
The Company uses Change Healthcare (“CHC”), a healthcare technology company owned by UnitedHealth Group, to process some of its patient claims billings. In February 2024, CHC announced that it had experienced a cyberattack and as a result had to temporarily shut down some of its information technology systems. This system shut down caused delays in billing and reimbursement processes to CHC’s customers and, as a result, CHC established a Temporary Funding Assistance Program to help bridge the gap in short-term cash flow needs for customers affected by the disruption of its services due to the cyberattack. Funding distributed through this program is interest free and has no other fees or costs associated with it. As of June 30, 2024, CHC’s systems have yet to be fully restored. After CHC’s systems resume 100% of standard operations, any funds provided through the program will have to be repaid to CHC at a future date to be mutually agreed to by CHC and the Company.
During the six months ended June 30, 2024, the Company received approximately $
5. COMMITMENTS AND CONTINGENCIES
The Company is involved in legal proceedings related to matters, which are incidental to its business. Also, the Company is delinquent on the payment of outstanding accounts payable for certain vendors and suppliers who have taken or have threatened to take legal action to collect such outstanding amounts. See below for a discussion on these matters.
PURCHASE COMMITMENTS
The Company has entered into purchase commitments for reagents from suppliers. These agreements started in 2011 and run through 2025. The Company and the suppliers will true up the amounts on an annual basis. The future minimum purchase commitments under these and other purchase agreements are approximately $
LITIGATIONS
CPA Global provides us with certain patent management services. On February 6, 2017, CPA Global claimed that we owed approximately $
LEGAL AND REGULATORY ENVIRONMENT
The healthcare industry is subject to numerous laws and regulations of federal, state and local governments. These laws and regulations include, but are not limited to, matters such as licensure, accreditation, government healthcare program participation requirement, reimbursement for patient services and Medicare and Medicaid fraud and abuse.
13
Government activity has increased with respect to investigations and allegations concerning possible violations of fraud and abuse statutes and regulations by healthcare providers.
Violations of these laws and regulations could result in expulsion from government healthcare programs together with the imposition of significant fines and penalties, as well as significant repayments for patient services previously billed. Management believes that the Company is in compliance with fraud and abuse regulations, as well as other applicable government laws and regulations. While no material regulatory inquiries have been made, compliance with such laws and regulations can be subject to future government review and interpretation, as well as regulatory actions unknown or unasserted at this time.
6. LEASES
The Company leases administrative facilities and laboratory equipment through operating lease agreements. In addition, we rent various equipment used in our diagnostic lab and in our administrative offices through finance lease arrangements. Our operating leases include both lease (e.g., fixed payments including rent) and non-lease components (e.g., common area or other maintenance costs). The facility leases include
Operating leases result in the recognition of ROU assets and lease liabilities on the balance sheet. ROU assets represent our right to use the leased asset for the lease term and lease liabilities represent our obligation to make lease payments. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Lease expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less are not recorded on the balance sheet. The primary leases we enter into with initial terms of 12 months or less are for equipment.
The Company also recognizes ROU assets from finance leases in connection with its HemeScreen Reagent Rental (“HSRR”) program. For certain customers in the HSRR program, the Company leases diagnostic testing equipment and then subleases the equipment to the customer. Finance lease ROU assets and finance lease liabilities are recognized at the lease commencement date, and at the sublease commencement date the finance lease ROU asset is derecognized and is recorded as cost of sales in the condensed consolidated statements of operations. There were
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The balance sheet presentation of our operating and finance leases is as follows:
(dollars in thousands) | ||||||
Classification on the Condensed Consolidated Balance Sheet | June 30, 2024 | December 31, 2023 | ||||
Assets: | ||||||
Operating lease right-of-use assets, net | $ | | $ | | ||
Finance lease right-of-use assets, net (1) | | | ||||
Total lease assets | $ | | $ | | ||
Liabilities: | ||||||
Current: | ||||||
Current maturities of operating lease liabilities | $ | | $ | | ||
Current maturities of finance lease liabilities | | | ||||
Noncurrent: | ||||||
Operating lease liabilities, less current maturities | | | ||||
Finance lease liabilities, less current maturities | | | ||||
Total lease liabilities | $ | | $ | |
(1) | As of June 30, 2024 and December 31, 2023, finance lease right-of-use assets included |
As of June 30, 2024, the estimated future minimum lease payments, excluding non-lease components, are as follows:
(dollars in thousands) |
| Operating Leases | Finance Leases | Total | |||||
June 30, | June 30, | June 30, | |||||||
2024 | 2024 | 2024 | |||||||
2024 (remaining) | $ | | $ | | $ | | |||
2025 |
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2026 |
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2027 |
| — | |
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2028 | — | | | ||||||
Total lease obligations |
| |
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| | |||
Less: Amount representing interest |
| ( |
| ( |
| ( | |||
Present value of net minimum lease obligations |
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| |
| | |||
Less, current portion |
| ( |
| ( |
| ( | |||
Long term portion | $ | | $ | | $ | |
Other information as of June 30, 2024 and December 31, 2023 is as follows:
June 30, | December 31, | ||
2024 | 2023 | ||
Weighted-average remaining lease term (years): | |||
Operating leases | |||
Finance leases | |||
Weighted-average discount rate: | |||
Operating leases | |||
Finance leases |