iSpecimen Inc. - Quarter Report: 2023 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended June 30, 2023
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___ to ___
Commission File No. 001-40501
iSpecimen Inc.
(Exact name of registrant as specified in its charter)
Delaware |
| 27-0480143 |
(State or other jurisdiction of incorporation | (I.R.S. Employer Identification No.) |
450 Bedford Street, Lexington, Massachusetts 02420
(Address of principal executive offices) (Zip Code)
(781) 301-6700
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
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, par value $0.0001 per share | ISPC | The Nasdaq Stock Market LLC |
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 (§232.405 of this chapter) 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 ☒
As of July 31, 2023, there were 9,065,483 shares of common stock, par value $0.0001 per share, issued and outstanding.
iSPECIMEN INC.
FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 2023
TABLE OF CONTENTS
2
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
iSpecimen Inc.
Condensed Balance Sheets
|
| ||||||
June 30, 2023 | December 31, 2022 | ||||||
ASSETS | (Unaudited) | ||||||
Current assets: |
|
|
|
| |||
Cash and cash equivalents | $ | 2,004,500 | $ | 15,308,710 | |||
Available-for-sale securities | 6,209,491 | — | |||||
Accounts receivable – unbilled |
| 1,098,356 |
| 2,327,789 | |||
Accounts receivable, net of allowance for doubtful accounts of $492,609 and $230,999 at June 30, 2023 and December 31, 2022, respectively |
| 1,458,845 |
| 1,597,915 | |||
Prepaid expenses and other current assets |
| 187,769 |
| 300,434 | |||
Tax credit receivable |
| 12,332 |
| 140,873 | |||
Total current assets |
| 10,971,293 |
| 19,675,721 | |||
Property and equipment, net |
| 163,871 |
| 225,852 | |||
Internally developed software, net |
| 6,300,465 |
| 4,503,787 | |||
Operating lease right-of-use asset | 107,115 | 184,692 | |||||
Security deposits |
| 27,601 |
| 27,601 | |||
Total assets | $ | 17,570,345 | $ | 24,617,653 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
| |||
Current liabilities: |
|
|
|
| |||
Accounts payable | $ | 1,779,920 | $ | 2,459,063 | |||
Accrued expenses |
| 882,274 |
| 1,531,238 | |||
Operating lease current obligation | 107,975 |
| 158,451 | ||||
Deferred revenue |
| 89,601 |
| 132,335 | |||
Total current liabilities |
| 2,859,770 |
| 4,281,087 | |||
Operating lease long-term obligation |
| — |
| 27,396 | |||
Total liabilities |
| 2,859,770 |
| 4,308,483 | |||
Commitments and contingencies (See Note 8) |
|
|
|
| |||
Stockholders’ equity |
|
| |||||
Common stock, $0.0001 par value, 200,000,000 shares authorized, 9,094,274 issued, and 9,063,274 outstanding at June 30, 2023 and 8,956,808 issued and 8,925,808 outstanding at December 31, 2022 |
| 906 |
| 892 | |||
Additional paid-in capital |
| 68,889,903 |
| 68,573,774 | |||
Treasury stock, 31,000 shares at June 30, 2023 and December 31, 2022, at cost |
| (172) |
| (172) | |||
Accumulated other comprehensive income | 688 | — | |||||
Accumulated deficit |
| (54,180,750) |
| (48,265,324) | |||
Total stockholders’ equity |
| 14,710,575 |
| 20,309,170 | |||
Total liabilities and stockholders’ equity | $ | 17,570,345 | $ | 24,617,653 |
See accompanying notes to these unaudited condensed financial statements.
3
iSpecimen Inc.
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | ||||||
Revenue | $ | 1,625,140 | $ | 2,338,688 | $ | 4,575,339 | $ | 4,857,348 | |||||
Operating expenses: | |||||||||||||
Cost of revenue |
| 853,633 |
| 999,743 | 2,000,545 | 2,165,659 | |||||||
Technology |
| 843,099 |
| 635,650 | 1,677,506 | 1,163,173 | |||||||
Sales and marketing |
| 977,748 |
| 950,563 | 2,025,346 | 1,697,994 | |||||||
Supply development |
| 291,360 |
| 242,380 | 614,862 | 424,450 | |||||||
Fulfillment |
| 462,672 |
| 519,994 | 891,692 | 963,788 | |||||||
General and administrative |
| 1,758,451 |
| 1,575,365 | 3,469,633 | 3,385,679 | |||||||
Total operating expenses |
| 5,186,963 |
| 4,923,695 | 10,679,584 | 9,800,743 | |||||||
Loss from operations |
| (3,561,823) |
| (2,585,007) | (6,104,245) | (4,943,395) | |||||||
Other income (expense), net | |||||||||||||
Interest expense |
| (3,535) |
| (42,273) | (7,070) | (80,321) | |||||||
Interest income |
| 110,882 |
| 13,881 | 225,144 | 26,535 | |||||||
Other income (expense), net |
| (29,138) |
| 6,590 | (29,255) | 6,630 | |||||||
Total other income (expense), net |
| 78,209 |
| (21,802) | 188,819 | (47,156) | |||||||
Net loss | $ | (3,483,614) | $ | (2,606,809) | $ | (5,915,426) | $ | (4,990,551) | |||||
Other comprehensive income: | |||||||||||||
Net loss | $ | (3,483,614) | $ | (2,606,809) | $ | (5,915,426) | $ | (4,990,551) | |||||
Unrealized (loss) gain on available-for-sale securities | (18,155) | — | 688 | — | |||||||||
Total other comprehensive income | (18,155) | — | 688 | — | |||||||||
Comprehensive loss | $ | (3,501,769) | $ | (2,606,809) | $ | (5,914,738) | $ | (4,990,551) | |||||
Net loss per share - basic and diluted | $ | (0.39) | $ | (0.30) | $ | (0.66) | $ | (0.57) | |||||
Weighted average shares of common stock outstanding - basic and diluted |
| 9,033,868 |
| 8,821,698 | 9,011,644 | 8,793,723 |
See accompanying notes to these unaudited condensed financial statements.
4
iSpecimen Inc.
Condensed Statements of Changes in Stockholders’ Equity
(Unaudited)
Six Months Ended June 30, 2023 | ||||||||||||||||||||||
Accumulated | ||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||
Common Stock | Treasury Stock | Paid-In | Comprehensive | Accumulated | Stockholders' | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Income |
| Deficit |
| Equity | |||||||
Balance at December 31, 2022 |
| 8,925,808 | $ | 892 | 31,000 | $ | (172) | $ | 68,573,774 | $ | — | $ | (48,265,324) | $ | 20,309,170 | |||||||
Stock-based compensation expense |
| — | — | — |
| — |
| 54,608 |
| — |
| — |
| 54,608 | ||||||||
Vesting of restricted stock | 28,776 |
| 3 | — |
| — | 65,946 | — | — | 65,949 | ||||||||||||
Issuance of common stock through exercise of stock options | 67,736 |
| 7 | — |
| — | 67,729 | — | — | 67,736 | ||||||||||||
Unrealized gain on available-for-sale securities | — | — | — | — | — | 18,843 | — | 18,843 | ||||||||||||||
Net loss |
| — |
| — | — |
| — |
| — |
| — |
| (2,431,812) |
| (2,431,812) | |||||||
Balance at March 31, 2023 |
| 9,022,320 | $ | 902 | 31,000 | $ | (172) | $ | 68,762,057 | $ | 18,843 | $ | (50,697,136) | $ | 18,084,494 | |||||||
Stock-based compensation expense | — | — | — |
| — |
| 29,829 |
| — |
| — |
| 29,829 | |||||||||
Vesting of restricted stock | 37,801 |
| 4 | — |
| — | 94,864 | — | — | 94,868 | ||||||||||||
Issuance of common stock through exercise of stock options | 3,153 |
| — | — |
| — | 3,153 | — | — | 3,153 | ||||||||||||
Unrealized loss on available-for-sale securities | — | — | — | — | — | (18,155) | — | (18,155) | ||||||||||||||
Net loss | — |
| — | — |
| — |
| — |
| — |
| (3,483,614) |
| (3,483,614) | ||||||||
Balance at June 30, 2023 | 9,063,274 | $ | 906 | 31,000 | $ | (172) | $ | 68,889,903 | $ | 688 | $ | (54,180,750) | $ | 14,710,575 |
See accompanying notes to these unaudited condensed financial statements.
5
iSpecimen Inc.
Condensed Statements of Changes in Stockholders’ Equity
(Unaudited)
Six Months Ended June 30, 2022 | |||||||||||||||||||
Additional | Total | ||||||||||||||||||
Common Stock | Treasury Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | ||||||
Balance at December 31, 2021 | 8,733,479 | $ | 873 | 31,000 | $ | (172) | $ | 67,810,289 | $ | (38,019,402) | $ | 29,791,588 | |||||||
Stock-based compensation expense |
| — |
| — | — |
| — |
| 183,410 |
| — |
| 183,410 | ||||||
Vesting of restricted stock units | 3,125 | — | — | — | 781 | — | 781 | ||||||||||||
Issuance of common stock through exercise of stock options | 77,679 | 8 | — | — | 75,269 | — | 75,277 | ||||||||||||
Net loss |
| — |
| — | — |
| — |
| — |
| (2,383,742) |
| (2,383,742) | ||||||
Balance at March 31, 2022 |
| 8,814,283 | $ | 881 | 31,000 | $ | (172) | $ | 68,069,749 | $ | (40,403,144) | $ | 27,667,314 | ||||||
Stock-based compensation expense | — | — | — |
| — | 202,318 | — | 202,318 | |||||||||||
Vesting of restricted stock units | 56,601 | 6 | — | — | 27,024 | — | 27,030 | ||||||||||||
Issuance of common stock through exercise of stock options | 1,827 | — | — | — | 1,827 | — | 1,827 | ||||||||||||
Issuance of common stock in exchange for services | 1,000 | — | — | — | 6,250 | — | 6,250 | ||||||||||||
Net loss | — |
| — | — |
| — |
| — | (2,606,809) | (2,606,809) | |||||||||
Balance at June 30, 2022 | 8,873,711 | $ | 887 | 31,000 | $ | (172) | $ | 68,307,168 | $ | (43,009,953) | $ | 25,297,930 |
See accompanying notes to these unaudited condensed financial statements.
6
iSpecimen Inc.
Condensed Statements of Cash Flows
(Unaudited)
Six Months Ended June 30, | |||||||
| 2023 |
| 2022 | ||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
Net loss | $ | (5,915,426) | $ | (4,990,551) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
|
| |||||
Stock-based compensation expense |
| 245,254 |
| 413,539 | |||
Amortization of internally developed software |
| 934,829 |
| 533,112 | |||
Depreciation of property and equipment |
| 75,726 |
| 9,132 | |||
Bad debt expense |
| 261,610 |
| 269,645 | |||
Accretion of discount on available-for-sale securities | (97,874) | — | |||||
Amortization of debt issuance costs on Term Loan | — | 6,116 | |||||
Change in operating assets and liabilities: |
|
| |||||
Accounts receivable – unbilled |
| 1,229,433 |
| 474,742 | |||
Accounts receivable |
| (122,540) |
| 1,072,721 | |||
Prepaid expenses and other current assets |
| 112,665 |
| (47,832) | |||
Operating lease right-of-use asset | 77,577 | 73,120 | |||||
Tax credit receivable | 128,541 | — | |||||
Accounts payable |
| (679,143) |
| (399,652) | |||
Accrued expenses |
| (648,964) |
| (375,547) | |||
Accrued interest | — | (389) | |||||
Operating lease liability | (77,872) | (72,367) | |||||
Deferred revenue |
| (42,734) |
| (319,766) | |||
Net cash used in operating activities |
| (4,518,918) |
| (3,353,977) | |||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
| |||||
Capitalization of internally developed software |
| (2,731,507) |
| (777,181) | |||
Purchase of property and equipment | (13,745) | — | |||||
Purchase of available-for-sale securities | (7,642,929) | — | |||||
Proceeds from sales and maturities of available-for-sale securities | 1,532,000 | — | |||||
Net cash used in investing activities |
| (8,856,181) |
| (777,181) | |||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
| |||
Proceeds from exercise of stock options | 70,889 | 77,104 | |||||
Proceeds from issuance of common stock in exchange for services | — | 6,250 | |||||
Net cash provided by financing activities |
| 70,889 |
| 83,354 | |||
Net decreases in cash and cash equivalents |
| (13,304,210) |
| (4,047,804) | |||
Cash and cash equivalents at beginning of period |
| 15,308,710 |
| 27,738,979 | |||
Cash and cash equivalents at end of period | $ | 2,004,500 | $ | 23,691,175 | |||
Supplemental disclosure of cash flow information: | |||||||
Cash paid for interest | $ | 7,070 | $ | 74,205 | |||
Supplemental disclosure of non-cash investing and financing activities: | |||||||
Non-cash amounts of lease liabilities arising from obtaining right-of use-assets | $ | — | $ | 333,123 | |||
See accompanying notes to these unaudited condensed financial statements.
7
1.NATURE OF BUSINESS AND BASIS OF PRESENTATION
Business
iSpecimen Inc. (“iSpecimen” or the “Company”) was incorporated in 2009 under the laws of the state of Delaware. The Company has developed and launched a proprietary online marketplace platform that connects medical researchers who need access to subjects, samples, and data, with hospitals, laboratories, and other organizations who have access to them. iSpecimen is a technology-driven company founded to address a critical challenge: how to connect life science researchers who need human biofluids, tissues, and living cells (“biospecimens”) for their research, with biospecimens available (but not easily accessible) in healthcare provider organizations worldwide. The Company’s proprietary platform, the iSpecimen Marketplace platform, is designed to solve this problem and transform the biospecimen procurement process to accelerate medical discovery. The Company is headquartered in Lexington, Massachusetts and its principal market is North America. The Company operates as one
and reporting segment.Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information, and, pursuant to the rules and regulations of Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”), published by the Securities and Exchange Commission (“SEC”) for interim financial statements. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto contained in Amendment No. 1 to the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2022.
Liquidity and Going Concern
The Company has recognized recurring losses and as of June 30, 2023, the Company had working capital of $8,111,523 and accumulated deficit of $54,180,750. The Company also had accounts payable and accrued expenses of $2,662,194 as of June 30, 2023. Additionally, as of June 30, 2023, the Company had cash and cash equivalents of $2,004,500 and available-for-sale securities of $6,209,491, which can be quickly liquidated. Management believes that the Company's existing cash and cash equivalents, and its available-for-sale securities provide the Company with sufficient liquidity to continue its operations for at least the next 12 months from the date these unaudited condensed financial statements are issued. As a result of recurring losses, the continued viability of the Company beyond August 2024 may be dependent on its ability to continue to raise additional capital to finance its operations.
Impact of the Current Economy
The Company’s financial performance is subject to global economic conditions and their impact on the levels of spending by its customer research organizations, particularly discretionary spending for procurement of specimens used for research. Economic recessions may have adverse consequences across industries, including the health and bio-specimen industries, which may adversely affect the Company’s business and financial condition. The Company increased its allowance for doubtful accounts in accounts receivables by $261,610 during the six months ended June 30, 2023 due to a few boutique life sciences customers that have filed for bankruptcy. The Company has enhanced procedures related to its credit check process for new and existing customers in fiscal year 2023 to mitigate the risk to future collectability of receivables.
Changes in general market, economic and political conditions in domestic and foreign economies or financial markets, including fluctuation in stock markets resulting from, among other things, trends in the economy and inflation, as are being currently experienced, may result in a reduction in researchers’ demand for specimens due to the research organization’s inability to obtain funding.
8
To further address the current market conditions, the Company has taken steps, which include but are not limited to, reevaluating its pricing in order to be more competitive, creating campaigns to highlight and fast-track high demand items, and enhancing internal team communications to accelerate the sales cycle.
The Company believes that its business will continue to be resilient through a continued economic downturn or recession, or slowing or stalled recovery therefrom, and that the Company has the liquidity to address its financial obligations and alleviate possible adverse effects on its business, financial condition, results of operations or prospects.
Impact of the Russian-Ukrainian War on the Company’s Operations
The Company’s business was negatively impacted during the first half of 2022 by the ongoing war between Russia and Ukraine. At the start of the war, the Company had approximately $1 million of purchase orders that were slated to be fulfilled by the Company’s supply network in Ukraine and Russia. This supply network was shut down at the start of the war. Ukrainian suppliers were disabled due to war conditions and evacuations and some of the Company’s Russian suppliers were disabled by sanctions. While the Company mobilized to shift these purchase orders to other suppliers in the network, the process of getting specimen collections from other supply sites took time, which caused a delay in the fulfillment of such purchase orders. Alternate suppliers do not have the same favorable unit economics or specimen collection rates, and this impacted the Company’s margins. Additionally, key resources were diverted from operations to resolving the re-fulfillment issues caused by the conflict.
As of June 30, 2023, the Company’s supply sites in Russia that had not been under sanctions were accessible and the Company’s supply sites in Ukraine were mostly reopened. However, logistics and transportation of specimens out of the country of Ukraine remains challenging and not as economically feasible as they were prior to the beginning of the war. Due to the uncertainty caused by the ongoing war, Ukrainian and Russian suppliers may again become inaccessible to the Company. Therefore, as long as the uncertainty continues, the Company’s policy is to ensure at a purchase order level that an order is not solely sourced from the two countries. The short and long term implications of the war are difficult to predict as of the filing date of this report. The imposition of more sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact the Company’s business and the businesses of the Company’s supply partners, especially those in Ukraine and Russia. Because of the highly uncertain and dynamic nature of these events, it is not currently possible to estimate the impact of the war on the Company’s business and the companies from which the Company obtains supplies and distributes specimens.
2.SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of Amendment No. 1 to the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2022. There were no significant changes to these accounting policies during the six months ended June 30, 2023.
Use of Estimates
The preparation of the Company’s unaudited condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the fair value of its common stock and warrants, deferred tax valuation allowances, revenue recognition, stock-based compensation, allowance for doubtful accounts, and accrued expenses amongst others. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates.
9
Investments
The Company’s investments are considered to be available-for-sale as defined under ASC 320, Investments- Debt Securities, and are recorded at fair value. Unrealized gains and losses are included in accumulated other comprehensive income. Purchases and sales of securities are reflected on a trade-date basis. Realized gains or losses are released from accumulated other comprehensive income and into earnings on the statement of operations, and amortization of premiums and accretion of discounts on the U.S treasury bills are recorded in interest expense or income, respectively.
The Company continually monitors the difference between its cost basis and the estimated fair value of its investments. The Company’s accounting policy for impairment recognition requires other-than-temporary impairment charges to be recorded when it determines that it is more likely than not that it will be unable to collect all amounts due according to the contractual terms of the fixed maturity security or that the anticipated recovery in fair value of the equity security will not occur in a reasonable amount of time. Impairment charges on investments are recorded based on the fair value of the investments at the measurement date or based on the value calculated using a discounted cash flow model. Credit-related impairments on fixed maturity securities that the Company does not plan to sell, and for which it is not more likely than not to be required to sell, are recognized in net income. Any non-credit related impairment is recognized as a component of other comprehensive income. Factors considered in evaluating whether a decline in value is other-than-temporary include: the length of time and the extent to which fair value has been less than cost; the financial condition and near-term prospects of the issuer; its intention to hold the investment; and the likelihood that it will be required to sell the investment.
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measurements, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
● | Level 1 — Valuations based on quoted prices for identical assets and liabilities in active markets. |
● | Level 2 — Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. |
● | Level 3 — Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment. |
For certain financial instruments, including cash and cash equivalents, accounts receivable, and accounts payable, the carrying amounts approximate their fair values as of June 30, 2023 and December 31, 2022, respectively, because of their short-term nature. Available-for-sale securities are recorded at fair value and as level 1 investments.
Revenue Recognition and Accounts Receivable
The Company recognizes revenue using the five-step approach as follows: (1) identify the contract with the customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the Company satisfies the performance obligations.
The Company generates revenue by procuring various specimens from hospitals, laboratories, and other supply sites, for the Company’s medical research customers using the Company’s proprietary software, the iSpecimen Marketplace, to identify, locate, and ultimately validate the required specimens to the Company’s customers’ requested specifications. The Company’s performance obligation is to procure a specimen meeting the customer’s specification(s) from a supplier, on a “best efforts” basis, for the Company’s customer at the agreed price per specimen as indicated in the customer’s contract with the Company. The Company does not currently charge suppliers or customers for the use of the Company’s proprietary software. Each customer will execute a material and data use agreement with the Company or agree to online purchase terms, each of which includes terms such as specimen and data use, shipment terms, payment, and cancellation terms. These are then supplemented by purchase orders that specify specimen requirements including detailed
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inclusion/exclusion criteria, quantities to be collected, and pricing. Collectively, these customer agreements represent the Company’s contracts with its customer. Generally, contracts have fixed unit pricing. For certain specimen orders, a refundable customer deposit may be required prior to order fulfillment depending on project set-up requirements, which is presented as deferred revenue. The Company expects to recognize the deferred revenue within the next twelve months.
Specimen collections occur at supply sites within the Company’s network. “Collection” is when the specimen has been removed, or “collected” from the patient or donor. A specimen is often collected specifically for a particular Company order. Once collected, the specimen is assigned by the supplier to the Company and control of the specimen passes to the Company. “Accession” is the process whereby a collected specimen and associated data are registered and assigned in the iSpecimen Marketplace to a particular customer order, which can occur while a specimen is at the supplier site or while at the Company site and it is when control of the specimen passes to the customer. Suppliers may ship specimens to the Company or directly to the customer if specimens must be delivered within a short time period (less than 24 hours after collection) or shipping to the Company is not practical.
The Company has evaluated principal versus agent considerations as part of the Company’s revenue recognition policy. The Company has concluded that it acts as principal in the arrangement as it manages the procurement process from beginning to end, and determines which suppliers will be used to fulfill an order, usually takes physical possession of the specimens, sets prices for the specimens, and bears the responsibility for customer credit risk.
The Company recognizes revenue over time, as the Company has created an asset with no alternative use to the Company, which has an enforceable right to payment for performance completed to date. At contract inception, the Company reviews a contract and related order upon receipt to determine if the specimen ordered has an alternative use by the Company. Generally, specimens ordered do not have an alternative future use to the Company and the performance obligation is satisfied when the related specimens are accessioned. The Company uses an output method to recognize revenue for specimens with no alternative future use. The output is measured based on the number of specimens accessioned. In the rare circumstances where specimens do have an alternative future use, the Company's performance obligation is satisfied at the time of shipment.
Customers are generally invoiced upon shipment. Depending on the quantity of specimens ordered, it may take several accounting periods to completely fulfill a purchase order. In other words, there can be multiple invoices issued for a single purchase order, reflecting the specimens being accessioned over time. However, specimens are generally shipped as soon as possible after they have been accessioned.
Once a specimen that has no alternative future use and for which the Company has an enforceable right to payment has been accessioned, the Company records the offset to revenue in accounts receivable -- unbilled. Once the specimen has been shipped and invoiced, a reclassification is made from accounts receivable-unbilled to accounts receivable.
Customers are generally given fourteen days from the receipt of specimens to inspect the specimens to ensure compliance with specifications set forth in the purchase order documentation. Customers are entitled to either receive replacement specimens or receive reimbursement of payments made for such specimens. The Company has a nominal history of returns for nonacceptance of specimens delivered. When this occurs, the Company gives the customer credit for the returns. The Company has not recorded a returns allowance.
The following table summarizes the Company’s revenue for the three and six months ended June 30:
Three months ended June 30, | Six months ended June 30, | |||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | |||||
Specimens – contracts with customers | $ | 1,522,108 | $ | 2,207,820 | $ | 4,234,485 | $ | 4,580,206 | ||||
Shipping and other |
| 103,032 |
| 130,868 | 340,854 | 277,142 | ||||||
Revenue | $ | 1,625,140 | $ | 2,338,688 | $ | 4,575,339 | $ | 4,857,348 |
The Company carries its accounts receivable at the invoiced amount less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable to determine if an allowance for doubtful accounts is necessary, based on economic conditions and each customer’s payment history. Receivables are written off when deemed uncollectible, with any future recoveries
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recorded as income when received. As of June 30, 2023 and December 31, 2022, the Company had an allowance for doubtful accounts of $492,609 and $230,999, respectively.
The Company applies the practical expedient to account for shipping and handling activities as fulfillment cost rather than as a separate performance obligation. Shipping and handling costs incurred are included in cost of revenue.
Internally Developed Software, Net
The Company capitalizes certain internal and external costs incurred during the application development stage of internal-use software projects until the software is ready for its intended use. Amortization of the asset commences when the software is complete and placed into service and is recorded in operating expenses. The Company amortizes completed internal-use software over its estimated useful life of five years on a straight-line basis. Costs incurred during the planning, training and post-implementation stages of the software development life cycle are classified as technology costs and are expensed to operations as incurred.
Impairment of Long-Lived Assets
Management reviews long-lived assets for impairment when circumstances indicate the carrying amount of an asset may not be recoverable. An impairment loss is recognized when expected cash flows are less than the asset’s carrying value. Long-lived assets consist of property and equipment and internal-use software. No impairment charges were recorded for the six months ended June 30, 2023 and 2022.
Stock-Based Compensation
The Company records stock-based compensation for options granted to employees, non-employees, and to members of the board of directors for their services to the Company based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period. Forfeitures are recognized when they occur.
The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of Company-specific historical and implied volatility data, the estimate of expected volatility is primarily based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its stock-based awards.
The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of its common stock.
The fair value of the Company's common stock is equal to the closing price on the specified grant date.
Restricted Stock Units
The Company recognizes stock-based compensation expense from restricted stock units (the “RSUs”) ratably over the specified vesting period. The fair value of RSUs is determined to be the closing share price of the Company's common stock on the grant date.
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Common Stock Warrants
The Company accounts for common stock warrants as either equity instruments or liabilities, depending on the specific terms of the warrant agreement. The warrants shall be classified as a liability if 1) the underlying shares are classified as liabilities or 2) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets. The measurement of equity-classified nonemployee stock-based payments is generally fixed on the grant date and are considered compensatory. For additional discussion on warrants, see Note 9.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss applicable to stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, the potential impact of common stock to be issued upon conversion of stock options and warrants to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to stockholders were the same for all periods presented.
The table below provides potentially dilutive common stock equivalents excluded from diluted net loss per share as of June 30:
2023 |
| 2022 | ||
Shares issuable upon vesting of RSUs | 168,641 | 367,118 | ||
Shares issuable upon exercise of stock options | 345,987 | 171,154 | ||
Shares issuable upon exercise of PIPE Warrant (defined below) to purchase common stock | 1,312,500 | 1,312,500 | ||
Shares issuable upon exercise of Lender Warrant (defined below) to purchase common stock | 12,500 | 12,500 | ||
Shares issuable upon exercise of Underwriter Warrant (defined below) to purchase common stock | 90,000 | 90,000 |
Recently Adopted Accounting Standards
In June 2016, the FASB issued ASU 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which changes the impairment model for most financial assets and certain other instruments. For receivables, loans and other instruments, entities will be required to use a new forward-looking “expected loss” model that generally will result in the earlier recognition of allowance for losses. In addition, an entity will have to disclose significantly more information about allowances and credit quality indicators. The new standard is effective for the Company for fiscal years beginning after December 15, 2022. The Company adopted this new standard as of January 1, 2023. ASU 2016-13 did not have a material impact on the Company’s financial statements.
3.AVAILABLE-FOR-SALE SECURITIES
The Company purchased U.S. treasury bills in the six months ended June 30, 2023 and has classified them as available-for-sale securities. The amortized cost, gross unrealized gains and losses, and fair value for available-for-sale securities as of June 30, 2023 are as follows:
| | Gross | Gross | |||||||||
Amortized | unrealized | unrealized | ||||||||||
| cost |
| gains | losses | Fair value | |||||||
Available-for-sale securities: | ||||||||||||
U.S. Treasury Bills | $ | 6,208,803 | $ | 26,230 | $ | (25,542) | $ | 6,209,491 | ||||
Total Available-for-sale securities: | $ | 6,208,803 | $ | 26,230 | $ | (25,542) | $ | 6,209,491 |
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The Company did not have any realized gains or losses in the six months ended June 30, 2023. Maturities of the U.S. Treasury bills are all due within the year. Marketable securities in an unrealized loss position as of June 30, 2023 were not deemed impaired at acquisition and subsequent declines in fair value are not deemed attributed to declines in credit quality. The Company believes that it is more likely than not that it will receive a full recovery of par value on the securities, although there can be no assurance that such recovery will occur.
4.PROPERTY AND EQUIPMENT, NET
Property and equipment, net consisted of the following at the dates indicated:
June 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Website | $ | 285,377 | $ | 285,377 | ||
Computer equipment and purchased software |
| 90,304 |
| 84,589 | ||
Equipment |
| 35,449 |
| 35,449 | ||
Furniture and fixtures |
| 87,184 |
| 87,184 | ||
Leasehold improvements |
| 68,471 |
| 60,441 | ||
Total property and equipment |
| 566,785 |
| 553,040 | ||
Accumulated depreciation |
| (402,914) |
| (327,188) | ||
Total property and equipment, net | $ | 163,871 | $ | 225,852 |
Depreciation expense for property and equipment was $37,137 and $4,420 for the three months ended June 30, 2023 and 2022, respectively, and $75,726 and $9,132 for the six months ended June 30, 2023 and 2022, respectively.
5.INTERNALLY DEVELOPED SOFTWARE, NET
During the six months ended June 30, 2023 and 2022, the Company capitalized $2,731,507 and $771,181, respectively, of internally developed software costs in connection with the development and continued enhancement of the technology platform and web interfaces. Capitalized costs primarily consist of software costs, payroll, and payroll-related costs for the Company’s employees. The Company recognized $501,502 and $266,893 of amortization expense associated with capitalized internally developed software costs during the three months ended June 30, 2023 and 2022, respectively. The Company recognized $934,829 and $533,112 of amortization expense associated with capitalized internally developed software costs during the six months ended June 30, 2023 and 2022, respectively.
6.SEVERANCE
Dr. Christopher Ianelli
On September 19, 2022, the Company received a notice of departure from Dr. Christopher Ianelli to vacate his position of Chief Executive Officer and President of the Company, effective as of October 24, 2022 (the “Ianelli Separation Date”), as a result of the non-renewal of his Executive Employment Agreement dated June 21, 2021. Dr. Ianelli continued to serve on the Company’s board of directors until his resignation on July 7, 2023.
The Company entered into a Separation Agreement with Dr. Ianelli, dated October 24, 2022 (the “Ianelli Separation Agreement”). Pursuant to the Ianelli Separation Agreement, the Company shall pay severance equal to 12 months of base salary in effect as of the Ianelli Separation Date in the amount of $350,000. The severance payments shall be paid in equal installments commencing on the Company’s first regular payroll date after the Ianelli Separation Date and ending on the 12-month anniversary of the Ianelli Separation Date. In the year ended December 31, 2022, the Company recognized a severance expense and corresponding liability in the amount of $376,400 for Dr. Ianelli’s severance payment and COBRA benefits.
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On January 1, 2023, the Company accrued an additional $23,580 in severance expense and liability which represents the employer’s portion of the applicable taxes on the remaining severance payments. As of June 30, 2023, the balance of the severance, COBRA benefits and employer taxes liabilities was $142,935 and is recorded on the balance sheet.
Jill Mullan
On September 20, 2022, the Company received a notice of departure from Jill Mullan to vacate the position of Chief Operating Officer of the Company, effective as of October 24, 2022. At the time the notice of departure was received from Ms. Mullan, she had received an executive employment agreement for the renewal of her employment with the Company. Ms. Mullan continued to serve on the Company’s board of directors until May 24, 2023, the end of the term of her directorship.
The Company and Ms. Mullan executed a separation agreement on October 28, 2022 with an effective date of October 24, 2022. The Company recognized $325,000 in severance expense for Ms. Mullan on November 4, 2022, the date on which her separation agreement revocation period expired. The severance expense is recorded within general and administrative expense on the statement of operations and the corresponding liability is recorded in accrued liabilities on the balance sheet.
On January 1, 2023, the Company accrued an additional $21,896 in severance expense and liability which represents the employer’s portion of the applicable taxes on the remaining severance payments. As of June 30, 2023, the balance of the severance and employer taxes liabilities was $121,457 and is recorded on the balance sheet.
7. FAIR VALUE MEASUREMENTS
The following table sets forth the Company’s assets to be measured at fair value on a recurring basis and their respective classification within the fair value hierarchy as of June 30, 2023:
Fair Value at June 30, 2023 | ||||||||||||
Total |
| Level 1 |
| Level 2 |
| Level 3 | ||||||
Assets: | ||||||||||||
Available-for-sale securities | $ | 6,209,491 | $ | 6,209,491 | $ | — | $ | — | ||||
Total Assets | $ | 6,209,491 | $ | 6,209,491 | $ | — | $ | — |
As of June 30, 2023, the Company did not have any liabilities measured at fair value on a recurring basis.
8.COMMITMENTS AND CONTINGENCIES
Leases
The Company has one operating lease of office space in Lexington, Massachusetts, which will expire on February 28, 2024.
Leases with an initial term of twelve months or less are not recorded on the balance sheet date, and the Company does not separate lease and non-lease components of contracts. There are no material residual guarantees associated with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease agreements.
The Company’s lease agreement does not provide an implicit borrowing rate. Therefore, the Company used a benchmark approach to derive an appropriate imputed discount rate. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an imputed rate, which was used to discount its real estate lease liabilities. The Company used estimated incremental borrowing rates for its active real estate lease. The calculated incremental borrowing rate was 5.96%, which was calculated based on the remaining lease term of 1.92 years as of January 1, 2022.
There was no sublease rental income for the six months ended June 30, 2023, and the Company is not the lessor in any lease arrangement, and there have been no related-party lease agreements.
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Lease Costs
The table below presents certain information related to the lease costs for the Company’s operating lease for the six months ended June 30, 2023:
Operating lease expense | $ | 82,157 | |
Short-term lease expense |
| 2,500 | |
Total lease cost | $ | 84,657 |
Lease Position as of June 30, 2023
Right-of-use lease assets and lease liabilities for the Company’s operating lease as of June 30, 2023 were recorded in the balance sheet as follows:
Assets | |||
Operating lease right-of-use assets | $ | 107,115 | |
Total lease assets | $ | 107,115 | |
Liabilities | |||
Current liabilities: | |||
Operating lease liability – current portion | $ | 107,975 | |
Noncurrent liabilities: | |||
Operating lease liability – net of current portion | — | ||
Total lease liability | $ | 107,975 | |
Lease Terms and Discount Rate
The table below presents certain information related to the weighted average remaining lease term and the weighted average discount rate for the Company’s operating leases as of June 30, 2023:
Weighted average remaining lease term (in years) – operating leases | 0.67 | | ||
Weighted average discount rate – operating leases |
| 5.96% | |
Undiscounted Cash Flows
Future lease payments included in the measurement of lease liabilities on the balance sheet are as follows:
| |||
2023 (excluding the six months ended June 30, 2023) | $ | 82,802 | |
2024 |
| 27,600 | |
Total future minimum lease payments | 110,402 | ||
Less effect of discounting | (2,427) | ||
Present value of future minimum lease payments | $ | 107,975 |
Rent expense for the three months ended June 30, 2023 and 2022 amounted to $42,078 and $44,281, respectively. Rent expense for the six months ended June 30, 2023 and 2022 amounted to $84,657 and $89,238, respectively.
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Cash Flows
Supplemental cash flow information related to the operating lease for the six months ended June 30, 2023 was as follows:
Non-cash operating lease expense (operating cash flow) | $ | 77,577 | |
Change in operating lease liabilities (operating cash flow) | $ | (77,872) |
Sales Tax Payable
The majority of the Company’s customers are researchers, universities, hospitals, and not-for-profit entities that are believed by the Company to have a research and development (“R&D”) tax exemption that generally excludes them from paying sales taxes, with a few exceptions in some tax jurisdictions, provided they have a R&D tax exemption certificate. The main types of specimens the Company sells are blood, blood plasma, human tissue, human parts, and human bodily fluids. Certain of these products are typically not taxable in some states regardless of the buyer’s tax exemption status. The Company historically has not collected sales tax in states where it had sales. Had the Company contemporaneously collected and remitted sales tax for all customers and in all jurisdictions where it would have been required, there would have been no material impact on the Company’s financial statements.
As a result of an entity-wide risk assessment process that commenced in the second quarter of 2023, the Company engaged external tax consultant advisors to complement internal resources and efforts to provide support in assessing the appropriate sales tax treatment associated with the Company’s products for all prior years in which the Company had generated revenue, to assist with the collection and tracking of Voluntary Disclosure Agreements (“VDAs”) where a potential tax liability may exist and to assist with the implementation of a sales tax software platform solution for the calculation, collection, and remittance of sales tax for all non-exempt future sales.
From the Company’s inception through the filing date of this report, the Company now believes it is probable that an obligation to collect and remit sales tax existed for certain of its sales of products to certain of its customers. Currently, the Company is in the early stage of analyzing its product sales, on an invoice-by-invoice basis, to determine which products are subject to sales tax in each jurisdiction. In addition, the Company is in the early stage of determining which of its customers are exempt from sales tax, and which customers who were not exempt from sales tax have already paid compensating use tax. Part of this process includes requesting and obtaining exemption letters from its customers or proof of payment of their compensating use tax. For all customers that are not exempt from the payment of sales tax and have not remitted use tax, the Company intends to invoice such customers for past sales tax due. However, the Company’s ability to collect the tax due on such invoices is uncertain. Therefore, the Company does not have sufficient information to reasonably estimate the minimum or maximum amount of its sales tax liability as of the date of this report. The Company is also in the process of identifying in which states there may be a need to file VDAs with relevant taxing jurisdictions regarding its failure to collect and remit sales tax obligations. As of June 30, 2023, the Company had not recorded an accrual for the probable sales tax liability nor the interest and penalties likely to be imposed by the taxing jurisdictions for the current and prior reporting periods in the financial statements. The Company will record a liability when the amount of its liability becomes reasonably estimable.
Revenue Share from Sequencing of Specimens
The Company has determined that it has a contingent liability arising from a certain amendment to one of its contracts signed during the three-month period ended June 30, 2023 with suppliers from which it procured Formalin-Fixed Paraffin-Embedded (“FFPE”) blocks specimens for its project utilizing sequencing. The contract amendment provided that the Company is required to pay the supplier 20% of the revenue derived from sales of the sequenced blocks after it generates $150,000 of sales revenue. The Company considered the revenue share to be probable and estimable as of June 30, 2023, and therefore recorded a liability of $30,000 in its accrued expenses on the balance sheet as of June 30, 2023.
Legal Proceedings
From time to time the Company is involved in litigation, claims, and other proceedings arising in the ordinary course of business. Such litigation and other proceedings may include, but are not limited to, actions relating to employment law and misclassification, intellectual property, commercial or contractual claims, or other consumer protection statutes. Litigation and other disputes are inherently
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unpredictable and subject to substantial uncertainties and unfavorable resolutions could occur. As of June 30, 2023, there was no material litigation against the Company.
9.STOCKHOLDERS’ EQUITY
The Company’s authorized capital is 250,000,000 shares, of which (1) 200,000,000 shares are common stock, par value $0.0001 per share and (2) 50,000,000 are preferred stock, par value $0.0001 per share, which may, at the sole discretion of the Company’s board of directors, be issued in one or more series.
Common Stock
During the six months ended June 30, 2023, the Company issued 70,889 shares of common stock for cash exercises of options of $70,889.
Warrants
Underwriter Warrant
In connection with the Company's underwriting agreement with ThinkEquity, a division of Fordham Financial Management, Inc. and the representative of the Company’s IPO underwriters, the Company issued to ThinkEquity a warrant to purchase up to 90,000 shares of common stock (the "Underwriter Warrant"). The Underwriter Warrant is exercisable at a per share exercise price of $10.00 and is exercisable at any time and from time to time, in whole or in part, during the
- and one-half year period commencing 180 days from the effective date of the IPO registration statement. The Underwriter Warrant became exercisable on or after December 16, 2021 (six months from the effective date of the offering) and expires on June 15, 2026. Upon issuance of the Underwriter Warrant, as partial compensation for its services as an underwriter, the fair value of approximately $0.4 million was recorded as equity issuance costs in the year ended December 31, 2021. As of June 30, 2023, the Underwriter Warrant had not been exercised, and had a weighted average exercise price of $10.00 per share and a remaining weighted average time to expiration of 2.96 years.Lender Warrant
In connection with a term loan (“Term Loan”) entered into with Western Alliance Bank (the “Lender”) on August 13, 2021, the Company issued a warrant to the Lender (the “Lender Warrant”) to purchase 12,500 shares of common stock of the Company. The Lender Warrant is exercisable at a per share exercise price of $8.00 and is exercisable at any time on or after August 13, 2021 through August 12, 2031. The Company determined that the Lender Warrant was equity-classified. As of June 30, 2023, the Lender Warrant had not been exercised, and had a weighted average exercise price of $8.00 per share and a remaining weighted average time to expiration of 8.13 years.
PIPE Warrants
On December 1, 2021, the Company completed a private placement (the “PIPE”) in which the Company issued warrants (the “PIPE Warrants”) to purchase up to an aggregate of 1,312,500 shares of common stock. These PIPE Warrants have an exercise price of $13.00 per share and are immediately exercisable upon issuance and will expire on the - and one-half-year anniversary of the issuance date. As of June 30, 2023, the PIPE Warrants had not been exercised, and had a weighted average exercise price of $13.00 per share and a remaining weighted average time to expiration of 4.0 years.
10.STOCK-BASED COMPENSATION
Stock Incentive Plans
2021 Plan
In March 2021, the Company adopted the iSpecimen Inc. 2021 Stock Incentive Plan, which was subsequently amended in June 2021 and then on May 25, 2022 (the “2021 Plan”). The 2021 Plan was adopted to enhance the Company’s ability to attract, retain and motivate
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employees, officers, directors, consultants, and advisors by providing such persons with equity ownership opportunities and performance-based incentives. The 2021 Plan authorizes options, restricted stock, RSUs and other stock-based awards. The Company's board of directors, or any committee to which the board of directors delegates such authority, has the sole discretion in administering, interpreting, amending, or accelerating the 2021 Plan. Awards may be made under the 2021 Plan for up to 608,000 shares of the Company's common stock, and the 2021 Plan was made effective with the completion of the IPO.
On May 24, 2023, at the Company’s annual meeting of stockholders, the stockholders approved an amendment to the 2021 Plan to increase the number of shares under the 2021 Plan from 608,000 shares of common stock to 1,869,500 shares of common stock.
During the six months ended June 30, 2023 and 2022, 163,419 and 166,793 equity awards were issued under the 2021 Plan, respectively. During the three months ended June 30, 2023 and 2022, 45,172 and 155,793 equity awards were issued under the 2021 Plan, respectively. As of June 30, 2023, there were 1,283,763 shares of common stock available for future grants under the 2021 Plan.
2013 Plan
The iSpecimen Inc. 2013 Stock Incentive Plan (the “2013 Plan”) was adopted on April 12, 2013 and subsequently amended on July 29, 2015. The aggregate number of shares of common stock that may be issued pursuant to the 2013 Plan was 1,713,570.
No equity awards were issued under the 2013 Plan during the six months ended June 30, 2023 and 2022. According to the 2013 Plan which was adopted by the Company’s board of directors on April 12, 2013, no awards shall be granted under the 2013 Plan after the completion of ten years from the date on which the 2013 Plan was adopted by the Company’s board of directors. Therefore, as of April 13, 2023, no further shares from the remaining shares balance of 3,681 can be granted under the 2013 Plan.
Stock Options
The Company granted 162,672 stock options during the six months ended June 30, 2023. The Company did
grant any stock options in the six months ended June 30, 2022. The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes-Merton option pricing model during the six months ended June 30:2023 | 2022 | ||||
Assumptions: |
|
|
|
| |
Risk-free interest rate |
| 0.37% – 0.39% | — | ||
Expected term (in years) |
| 0.61 – 4.00 | — | ||
Expected volatility |
| 59.35% –59.95% | — | ||
Expected dividend yield |
| — | — |
A summary of stock option activity under the 2021 Plan and 2013 Plan is as follows:
Weighted | ||||||||||
Average | ||||||||||
Weighted | Remaining |
| ||||||||
Options | Average | Contractual Term |
| Aggregate | ||||||
| Outstanding |
| Exercise Price |
| in Years |
| Intrinsic Value | |||
Balance at December 31, 2022 |
| 297,559 | $ | 2.69 |
| 6.96 | $ | 63,237 | ||
Granted |
| 162,672 | 1.42 | — | — | |||||
Exercised |
| (70,889) | 1.00 | — | 48,494 | |||||
Cancelled/forfeited |
| (43,355) | 3.59 | — | — | |||||
Balance at June 30, 2023 |
| 345,987 | $ | 2.23 |
| 8.61 | $ | 12,267 | ||
Options exercisable at June 30, 2023 |
| 121,666 | $ | 3.05 |
| 7.47 | $ | 8,770 |
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The aggregate intrinsic value in the table above represents the difference between the Company's stock price as of the balance sheet date and the exercise price of each in-the-money option on the last day of the period. The aggregate intrinsic value of stock options exercised was $48,494 and $91,018 during the six months ended June 30, 2023 and 2022, respectively.
The weighted average grant date fair value of stock options issued in the six months ended June 30, 2023 was $0.52. The following table sets forth the recorded stock options compensation expense of the Company during the three and six months ended June 30:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
Operating expenses: | 2023 | 2022 | 2023 | 2022 | ||||||||
Technology | $ | 2,475 | $ | 1,023 | $ | 5,106 | $ | 2,034 | ||||
Sales and marketing | 623 | 1,695 | 1,498 | 2,772 | ||||||||
Supply development |
| 446 |
| 348 |
| 820 |
| 653 | ||||
Fulfillment | 681 | 1,055 | 1,325 | 1,881 | ||||||||
General and administrative | 26,343 | 27,824 | 54,883 | 54,160 | ||||||||
Total stock options expense | $ | 30,568 | $ | 31,945 | $ | 63,632 | $ | 61,500 |
A total of $185,260 of unamortized compensation expense as of June 30, 2023 will be recognized over the remaining requisite service period of 2.42 years. During the six months ended June 30, 2023 and 2022, the Company received proceeds of $70,889 and $77,104, respectively, from the exercise of stock options.
Restricted Stock Units
A summary of RSUs activity under the 2021 Plan and 2013 Plan is as follows:
Weighted | |||||
RSUs | Average Grant | ||||
| Outstanding | Date Fair Value | |||
Unvested Balance at December 31, 2022 |
| 267,505 | $ | 5.43 | |
Granted |
| 747 | 1.62 | ||
Vested |
| (66,577) | 5.36 | ||
Forfeited |
| (33,034) | 5.29 | ||
Unvested Balance at June 30, 2023 |
| 168,641 | $ | 5.47 |
The Company recorded RSUs compensation expense during the three and six months ended June 30 as follows:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
Operating expenses: | 2023 | 2022 | 2023 | 2022 | ||||||||
Technology | $ | 32,876 | $ | 25,198 | $ | 67,653 | $ | 38,598 | ||||
Sales and marketing | 18,959 | 26,092 | 30,814 | 40,259 | ||||||||
Supply development |
| 2,824 |
| 10,948 |
| 2,824 |
| 18,145 | ||||
Fulfillment | 17,608 | 24,330 | 39,052 | 37,960 | ||||||||
General and administrative | 21,862 | 110,835 | 41,279 | 217,077 | ||||||||
Total RSU expense | $ | 94,129 | $ | 197,403 | $ | 181,622 | $ | 352,039 |
As of June 30, 2023, the total unrecognized stock-based compensation expense related to unvested RSUs was $890,912, and it is expected to be recognized on a straight-line basis over a weighted average period of approximately 2.37 years.
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11.INCOME TAXES
As of June 30, 2023 and December 31, 2022, the Company had federal net operating loss carryforwards of approximately $47,750,000 and $40,800,000, respectively, of which approximately $13,000,000 expires at various periods through 2037 and approximately $34,750,000 and $27,800,000, respectively, can be carried forward indefinitely. As of June 30, 2023 and December 31, 2022, the Company had state net operating loss carryforwards of approximately $29,600,000 and $25,000,000, respectively, that expire at various periods through 2043, respectively. As of June 30, 2023 and December 31, 2022, the Company had federal and state tax credits of approximately $1,860,000 and $1,094,000, respectively, available for future periods that expire at various periods through 2043. The Company has recorded a full valuation allowance against net deferred income tax assets due to a history of losses generated since inception.
Due to changes in ownership provisions of the Internal Revenue Code of 1986 (the “IRC”), the availability of the Company's net operating loss carryforwards may be subject to annual limitations under Section 382 of the IRC against taxable income in the future period, which could substantially limit the eventual utilization of such carryforwards.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
References in this report (the “Quarterly Report”) to “we,” “us” or the “Company” refer to iSpecimen Inc. The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the financial statements and the notes thereto contained elsewhere in this Quarterly Report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Special Note Regarding Forward-Looking Statements
This Quarterly Report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected and projected. All statements, other than statements of historical fact included in this Quarterly Report including, without limitation, statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding the Company’s financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. Words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify such forward-looking statements. Such forward-looking statements relate to future events or future performance, but reflect management’s current beliefs, based on information currently available. A number of factors could cause actual events, performance, or results to differ materially from the events, performance and results discussed in the forward-looking statements. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the “Risk Factors” section of Amendment No. 1 to the Company’s Annual Report on Form 10-K/A filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 30, 2023. The Company’s securities filings can be accessed on the EDGAR section of the SEC’s website at www.sec.gov. Except as expressly required by applicable securities law, the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Overview
We were incorporated in 2009 under the laws of the state of Delaware. Our mission is to accelerate life science research and development via a single global marketplace platform, the iSpecimen Marketplace, which connects researchers to subjects, specimens, and associated data. We are headquartered in Lexington, Massachusetts. We operate as one operating and reporting segment.
The iSpecimen Marketplace is an automated search and request platform for researchers seeking human biospecimens, and a full suite of fulfillment and management tools for biospecimen providers. The platform taps into information management systems found in biobanks and laboratories for specimen data, and electronic Medical Records to gain insights into the patient populations to support specimen collections directly from research subjects.
Researchers can search this data using our intuitive web-based user interface to obtain specimens more efficiently. They can instantly find the specific specimens they need for their studies, request quotes for these specimens or for custom collections directly from research subjects, place orders, and track and manage their specimens and associated data across projects.
Biospecimen providers also gain efficiencies using the iSpecimen Marketplace, not only because the platform provides instant access to a large researcher base, but because the technology orchestrates the bioprocurement workflow from specimen request to fulfillment. Specimen providers can access intuitive dashboards to view requests, create proposals, and track and manage their orders.
Finally, the platform helps with administrative and reporting functions for researchers, suppliers, and our internal personnel, including user and compliance management.
The iSpecimen Marketplace is composed of four major functional areas: search, fulfillment, data, and administrative reporting. We continue to invest in the evolution of these areas to improve engagement with the platform and liquidity across it. Our core business objective is to retain and grow both researcher and supplier usage of our platform to support biospecimen procurement, as well as to position the Company to explore other adjacent business opportunities that can benefit from the use of the iSpecimen Marketplace.
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The iSpecimen Marketplace currently supports the supply chain management and bioprocurement process for specimens and associated data. We generate revenue by procuring various specimens from hospitals, laboratories, and other supply sites, which comprise our global network, and delivering them to our medical research customers using our proprietary software. Costs paid to acquire specimens from hospitals and laboratories generally vary depending upon the sample type, collection requirements, and data provided. We generally operate in a “just in time” fashion, meaning we procure specimens from our suppliers and distribute specimens to our customers after we obtain an order for specimens from a research client. Generally, we do not speculatively purchase and bank samples in anticipation of future, unspecified needs. We believe our approach offers many advantages over a more traditional inventory-based supplier business model. In a fast-paced industry where personalized and precision medicine are growing at extraordinary rates, having access to hundreds of biorepositories to source supplies of biospecimens, rather than being limited to sourcing such biospecimens from a limited number of biorepositories under our management, substantially reduces the risks associated with a limited source of supply and provides us with the ability to avoid many of the operational constraints inherent in an industry where inventory turnover and cash conversion cycles can be lengthy.
Impact of the Current Economy
The Company’s financial performance is subject to global economic conditions and their impact on levels of spending by our customer research organizations, particularly discretionary spending for procurement of specimens used for research. Economic recessions may have adverse consequences across industries, including the health and bio-specimen industries, which may adversely affect our business and financial condition. We increased our allowance for doubtful accounts in accounts receivables by $261,610 during the six months ended June 30, 2023 due to a few boutique life sciences customers that have filed for bankruptcy. We have enhanced procedures related to our credit check process for new and existing customers in fiscal year 2023 to mitigate the risk to future collectability of receivables.
Changes in general market, economic and political conditions in domestic and foreign economies or financial markets, including fluctuation in stock markets resulting from, among other things, trends in the economy and inflation, as are being currently experienced, may result in a reduction in researchers’ demand for specimens due to the research organization’s inability to obtain funding.
To further address the current market conditions, the Company has taken steps, which include but are not limited to, reevaluating its pricing in order to be more competitive, creating campaigns to highlight and fast-track high demand items, and enhancing internal team communications to accelerate the sales cycle.
We believe that our business will continue to be resilient through a continued economic downturn or recession, or slowing or stalled recovery therefrom, and that we have the liquidity to address our financial obligations and alleviate possible adverse effects on our business, financial condition, results of operations or prospects.
Impact of the Russian-Ukrainian War on Our Operations
Our business was negatively impacted during the first half of 2022 by the ongoing war between Russia and Ukraine. At the start of the war, we had approximately $1 million of purchase orders that were slated to be fulfilled by our supply network in Ukraine and Russia. This supply network was shut down at the start of the war. Ukrainian suppliers were disabled due to war conditions and evacuations and some of our Russian suppliers were disabled by sanctions. While we mobilized to shift these purchase orders to other suppliers in the network, the process of getting specimen collections from other supply sites took time, which caused a delay in the fulfillment of such purchase orders. Alternate suppliers do not have the same favorable unit economics or specimen collection rates, and this impacted our margins. Additionally, key resources were diverted from operations to resolving the re-fulfillment issues caused by the conflict.
As of June 30, 2023, our supply sites in Russia that had not been under sanctions were accessible and our supply sites in Ukraine were mostly reopened. However, logistics and transportation of specimens out of the country of Ukraine remains challenging and not as economically feasible as they were prior to the beginning of the war. Due to the uncertainty caused by the ongoing war, Ukrainian and Russian suppliers may again become inaccessible to us. Therefore, as long as the uncertainty continues, our policy is to ensure at a purchase order level that an order is not solely sourced from the two countries. The short and long-term implications of the war are difficult to predict as of the filing date of this report. The imposition of more sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business and the businesses of our supply partners, especially those in Ukraine
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and Russia. Because of the highly uncertain and dynamic nature of these events, it is not currently possible to estimate the impact of the war on our business and the companies from which we obtain supplies and distribute specimens.
Known Trends, Demands, Commitments, Events or Uncertainties Impacting Our Business
Chief Executive Officer Initiatives
Under the direction of Ms. Curley, our Chief Executive Officer, the Company’s mission to accelerate life sciences research and development, pursuant to a single global marketplace platform, remains unchanged from that of prior management. Ms. Curley continues to review the Company’s structure, processes, and resources to evaluate and identify areas for improvement, and has been focused on creating and ensuring a runway for growth and scale for our business. The focus of our activities is directed at increasing our revenue in the second half of 2023 with new revenue enhancement initiatives that are underway and increasing our cross-functional team communications to help improve execution.
One of our key new revenue enhancement initiatives is to identify, through sequencing runs, high value cancer patients which possess specific mutations in donor FFPE blocks. We have invested in active repetitive screening to create a virtual inventory available for our research customers in areas of high value. This initiative is extremely valuable, not only to our business, but we believe, for the entire industry. The power of our supplier network makes this initiative possible and when paired with the search functionality of our proprietary iSpecimen Marketplace, it provides an easier solution than what currently exists in our industry. We have successfully launched our first pilot and anticipate a modest level of revenue from this initial sequencing run, starting at the end of the third quarter of 2023. This is the first of several sequencing runs we anticipate performing throughout 2023 for this initiative.
Ms. Curley has also reviewed our technology roadmap and has been green-lighting projects to accelerate development timelines. We are committed to investing in and developing our technology. In the six months ended June 30, 2023, we capitalized approximately $2,732,000 of internally developed software costs with plans to invest at lower levels for the remainder of the year. We anticipate that these investments will increase revenue opportunities and result in operational efficiencies, positively impacting our liquidity, capital resources and results of operations in the future with a less than two-year rate of return on the investment.
We have identified and are addressing opportunities to match specimen requests more effectively to the inventory and capabilities of our supplier network. We believe that during the second half of 2023, this will result in an increase in the utilization rate of our supplier network, which currently is heavily skewed toward the top 10-15% of our suppliers. Our initiative designed to reduce or eliminate supplier concentration is underway. We expect the re-leveling of our network will result in higher match rates, market depth and improved time-to-match.
Our iSpecimen Marketplace Onsite Program, which offers additional support to our biospecimen provider partners, is underway and we have begun to appoint iSpecimen Marketplace Onsite coordinators, whose responsibility is to field all requests made by the provider partner and submit proposals on behalf of the provider partner, resulting in streamlined sample-related management and reducing strain on existing staff and product pipelines.
Market Conditions
In order to address a downturn in the industry that impacted our financial results during the three months ended June 30, 2023, we have revised our sales approach as detailed below, which we believe, will put us in a better position, to obtain favorable results faster for the remainder of 2023 and also recognize revenue more in line with historical levels. The majority of our customers are economically impacted by the availability of funding. We believe that the reduction in revenue in the second quarter was a result of the potential of a global economic slowdown at the end of the first quarter and that uncertainty negatively impacted on the equity markets for our industry. These economic challenges negatively impacted spending by our customers, having a direct effect on our revenue results for the second quarter of 2023. Specifically, in the second quarter of 2023, we experienced a substantial decline in the receipt of purchase orders from our customers. Due to this decline in purchase orders from customers, we also experienced a lower backlog of purchase orders compared to prior quarters. This adversely impacted on our ability to fulfill orders and generated lower levels of revenue in the second quarter of 2023.
During the second quarter of 2023 we focused on launching several new initiatives with the express purpose of increasing our success rates for converting quotes to secured purchase orders, with the goal of reinstating our fulfillment of orders to the levels achieved in
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quarters prior to the second quarter of 2023. By the end of the second quarter of 2023, we began to see the results of those efforts as evidenced by an increase in the level of our backlog compared to the beginning of the second quarter of 2023. Based on the increase in our backlog by the end of the second quarter, we believe that this downturn in revenue for the second quarter of 2023 represents a temporary downturn and that we have taken the required actions to address these issues which, we believe, will allow us to achieve better results for the third quarter of 2023 and beyond.
Mitigating Concentration Risks – Cash
As of December 31, 2022, we maintained all of our cash with one financial institution and our cash balance with this financial institution was in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit. If this bank fails in the future, we may not be able to immediately (or ever) recover our cash in excess of the FDIC insured limits which would adversely impact our operating liquidity and could negatively impact our operations, results of operations and financial performance.
Since the March 2023 failure and FDIC takeover of Silicon Valley Bank and the inability of its customers to readily access their cash deposits, there has been a heightened risk and greater focus on the potential failures of other banks in the future. In order to reduce the risks associated with maintaining all of our cash at a single bank, we have diversified our holdings by purchasing U.S Treasury bills at a different financial institution. As of June 30, 2023, we had a balance of approximately $6.2 million of U.S. Treasury bills at a financial institution that is different from where our cash is held. The Company will continue to assess other opportunities to ensure the safeguarding of our assets.
Components of Our Results of Operations
Revenue
We generate revenue by procuring various specimens from hospitals, laboratories, and other supply sites for our medical research customers using our proprietary software, the iSpecimen Marketplace, to identify, locate, and ultimately validate the required specimens to our customers’ requested specifications. The Company’s performance obligation is to procure a specimen meeting the customer specification(s) from a supplier, on a “best efforts” basis, for our customer at the agreed price per specimen as indicated in the customer contract with the Company. We do not currently charge suppliers or customers for the use of our proprietary software. Each customer will execute a material and data use agreement with the Company or agree to online purchase terms, each of which includes terms such as specimen and data use, shipment terms, payment, and cancellation terms. These are then supplemented by purchase orders that specify specimen requirements including detailed inclusion/exclusion criteria, quantities to be collected, and pricing. Collectively, these customer agreements represent the Company’s contracts with its customer. Generally, contracts have fixed unit pricing. For certain specimen orders, a refundable customer deposit may be required prior to order fulfillment depending on project set-up requirements, presented as deferred revenue. The Company expects to recognize the deferred revenue within the next twelve months.
We recognize revenue over time, as we have created an asset with no alternative use and we have an enforceable right to payment for performance completed to date. At contract inception, we review a contract and related order upon receipt to determine if the specimen ordered has an alternative use to us. Generally, specimens ordered do not have an alternative future use to us and our performance obligation is satisfied when the related specimens are accessioned. We use an output method to recognize revenue for specimens with no alternative future use. The output is measured based on the number of specimens accessioned.
Customers are typically invoiced upon shipment. Depending on the quantity of specimens ordered, it may take several accounting periods to completely fulfill a purchase order. In other words, there can be multiple invoices issued for a single purchase order, reflecting the specimens being accessioned over time. However, specimens are generally shipped as soon as possible after they have been accessioned.
Cost of Revenue
Cost of revenue primarily consists of the purchase price to acquire specimens from hospitals and laboratories, inbound and outbound shipping costs, supply costs related to samples, payment processing and related transaction costs, and costs paid to the supply sites to support sample collections. Shipping costs upon receipt of products from suppliers are recognized in cost of revenue.
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Technology
Technology costs include payroll and related expenses for employees involved in the development and implementation of our technology, software license and system maintenance fees, outsourced data center costs, data management costs, depreciation and amortization, and other expenses necessary to support technology initiatives. Collectively, these costs reflect the efforts we make to offer a wide variety of products and services to our customers. Technology and data costs are generally expensed as incurred.
A portion of technology costs are related to research and development. Costs incurred for research and development are expensed as incurred, except for software development costs that are eligible for capitalization. Research and development costs primarily include salaries and related expenses, in addition to the cost of external service providers.
Sales and Marketing
Sales and marketing costs primarily consist of payroll and related expenses for personnel engaged in marketing and selling activities, including salaries and sales commissions, travel expenses, public relations, and social media costs, ispecimen.com website development and maintenance costs, search engine optimization fees, advertising costs, direct marketing costs, trade shows and events fees, marketing and customer relationship management software, and other marketing-related costs.
Supply Development
We have agreements with supply partners that allow us to procure specimens from them and distribute these samples to customers. Supply development costs primarily include payroll and related expenses for personnel engaged in the development and management of this supply network, related travel expenses, regulatory compliance costs to support the network, and other supply development and management costs.
Fulfillment
Fulfillment costs primarily consist of those costs incurred in operating and staffing operations and customer service teams, including costs attributable to assess the feasibility of specimen requests, creating and managing orders, picking, packaging, and preparing customer orders for shipment, responding to inquiries from customers, and laboratory equipment and supplies.
General and Administrative
General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses for human resources, legal, finance, and executive teams, associated software licenses, facilities, and equipment expenses, such as depreciation and amortization expense and rent, outside legal expenses, insurance costs, and other general and administrative costs.
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Financial Operations Overview and Analysis for the Three and Six Months Ended June 30, 2023 and 2022 (Unaudited)
Comparison of the Three Months Ended June 30, 2023 and 2022
Three Months Ended June 30, | Change |
| ||||||||||
2023 | 2022 | Dollars | Percentage |
| ||||||||
Revenue |
| $ | 1,625,140 |
| $ | 2,338,688 |
| $ | (713,548) |
| (31) | % |
Operating expenses: | ||||||||||||
Cost of revenue |
| 853,633 |
| 999,743 |
| (146,110) |
| (15) | % | |||
Technology |
| 843,099 |
| 635,650 |
| 207,449 |
| 33 | % | |||
Sales and marketing |
| 977,748 |
| 950,563 |
| 27,185 |
| 3 | % | |||
Supply development |
| 291,360 |
| 242,380 |
| 48,980 |
| 20 | % | |||
Fulfillment |
| 462,672 |
| 519,994 |
| (57,322) |
| (11) | % | |||
General and administrative |
| 1,758,451 |
| 1,575,365 |
| 183,086 |
| 12 | % | |||
Total operating expenses |
| 5,186,963 |
| 4,923,695 |
| 263,268 |
| 5 | % | |||
Loss from operations |
| (3,561,823) |
| (2,585,007) |
| (976,816) |
| (38) | % | |||
Other income (expense), net | ||||||||||||
Interest expense |
| (3,535) |
| (42,273) |
| 38,738 |
| 92 | % | |||
Interest income |
| 110,882 |
| 13,881 |
| 97,001 |
| 699 | % | |||
Other expense, net | (29,138) | 6,590 | (35,728) | (542) | % | |||||||
Other income (expense), net |
| 78,209 |
| (21,802) |
| 100,011 |
| 459 | % | |||
Net loss | $ | (3,483,614) | $ | (2,606,809) | (876,805) |
| (34) | % |
Revenue
Revenue decreased by approximately $714,000, or 31%, from approximately $2,339,000 for the three months ended June 30, 2022 to approximately $1,625,000 for the three months ended June 30, 2023. This was primarily due to a decrease of 2,322, or 33%, in specimen count from 7,004 specimens in the three months ended June 30, 2022 to 4,682 specimens in the three months ended June 30, 2023. The effect of the decrease in specimen count was offset by a change in the specimen mix which caused the average selling price per specimen to increase by $13, or 4%, from approximately $334 in the three months ended June 30, 2022 to $347 in the three months ended June 30, 2023.
Cost of Revenue
Cost of revenue decreased by approximately $146,000, or 15%, from approximately $1,000,000 for the three months ended June 30, 2022 to approximately $854,000 for the three months ended June 30, 2023, which was attributable to a 33% decrease in the number of specimens accessioned for the current period compared to the same period in the prior year, offset by a $40 or 28% increase in the average cost per specimen.
Technology
Technology expenses increased by approximately $207,000, or 33% from approximately $636,000 for the three months ended June 30, 2022 to approximately $843,000 for the three months ended June 30, 2023. The increase was related to increases in headcount and payroll and related expenses of approximately $75,000, amortization of internally developed software of approximately $234,000, offset by decreases in professional fees unrelated to internally developed software of approximately $99,000 and in general and administrative expenses of approximately $3,000.
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Sales and Marketing Expenses
Sales and marketing expenses increased by approximately $27,000, or 3%, from approximately $951,000 for the three months ended June 30, 2022 to approximately $978,000 for the three months ended June 30, 2023. The increase was attributable to increases due to hiring more sales personnel, professional fees of approximately $72,000, payroll and related expenses of approximately $58,000, travel expenses of approximately $6,000, offset by a decrease in external marketing expenses of approximately $109,000.
Supply Development
Supply development expenses increased by approximately $49,000, or 20%, from approximately $242,000 for the three months ended June 30, 2022 to approximately $291,000 for the three months ended June 30, 2023. The increase was primarily attributable to increases in professional fees of approximately $104,000, offset by decreases in payroll and related expenses of approximately $53,000, and travel expenses of approximately $2,000.
Fulfillment
Fulfillment costs decreased by approximately $57,000, or 11%, from approximately $520,000 for the three months ended June 30, 2022 to approximately $463,000 for the three months ended June 30, 2023. The decrease was primarily attributable to decreases in payroll and related expenses of approximately $69,000 for personnel engaged in pre-sales feasibility assessments and post-sales fulfillment activities, offset by an increase in operating expenses of approximately $12,000.
General and Administrative Expenses
General and administrative expenses increased by approximately $183,000, or 12%, from approximately $1,575,000 for the three months ended June 30, 2022 to approximately $1,758,000 for the three months ended June 30, 2023. The increase was attributable to increases in directors’ and officers’ insurance of approximately $157,000, professional fees of approximately $123,000, depreciation expenses of $33,000, advertising expense of approximately $15,000, utilities and facilities expenses of approximately $4,000, offset by decreases in payroll and related expenses of approximately $125,000, and travel expense of approximately $24,000.
Other Income (Expense), Net
Other income (expense), net, increased by approximately $100,000, or 459%, from approximately $22,000 of other expense net, for the three months ended June 30, 2022 to approximately $78,000 of other income, net, for the three months ended June 30, 2023. The increase in other income (expense), net, was attributable to increases in interest income of approximately $97,000, and a decrease in interest expense of approximately $39,000, offset by an increase in other expense of approximately $36,000.
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Comparison of the Six Months Ended June 30, 2023 and 2022
Six Months Ended June 30 | Change |
| ||||||||||
2023 | 2022 | Dollars | Percentage |
| ||||||||
Revenue |
| $ | 4,575,339 |
| $ | 4,857,348 |
| $ | (282,009) |
| (6) | % |
Operating expenses: | ||||||||||||
Cost of revenue |
| 2,000,545 |
| 2,165,659 |
| (165,114) |
| (8) | % | |||
Technology |
| 1,677,506 |
| 1,163,173 |
| 514,333 |
| 44 | % | |||
Sales and marketing |
| 2,025,346 |
| 1,697,994 |
| 327,352 |
| 19 | % | |||
Supply development |
| 614,862 |
| 424,450 |
| 190,412 |
| 45 | % | |||
Fulfillment |
| 891,692 |
| 963,788 |
| (72,096) |
| (7) | % | |||
General and administrative |
| 3,469,633 |
| 3,385,679 |
| 83,954 |
| 2 | % | |||
Total operating expenses |
| 10,679,584 |
| 9,800,743 |
| 878,841 |
| 9 | % | |||
Loss from operations |
| (6,104,245) |
| (4,943,395) |
| (1,160,850) |
| (23) | % | |||
Other income (expense), net | ||||||||||||
Interest expense |
| (7,070) |
| (80,321) |
| 73,251 |
| 91 | % | |||
Interest income |
| 225,144 |
| 26,535 |
| 198,609 |
| 748 | % | |||
Other expense, net | (29,255) | 6,630 | (35,885) | (541) | % | |||||||
Other income (expense), net |
| 188,819 |
| (47,156) |
| 235,975 |
| 500 | % | |||
Net loss | $ | (5,915,426) | $ | (4,990,551) | (924,875) |
| (19) | % | ||||
Revenue
Revenue decreased by approximately $282,000, or 6%, from approximately $4,857,000 for the six months ended June 30, 2022 to approximately $4,575,000 for the six months ended June 30, 2023. This was primarily due to a decrease in average selling price per specimen of $64, or 16%, from approximately $407 in the six months ended June 30, 2022 to $343 in the six months ended June 30, 2023. The decrease in average selling price per specimen was offset by an increase of 1,383, or 12%, in specimen count from 11,928 specimens in the six months ended June 30, 2022 to 13,311 specimens in the six months ended June 30, 2023.
Cost of Revenue
Cost of revenue decreased by approximately $165,000, or 8%, from approximately $2,166,000 for the six months ended June 30, 2022 to approximately $2,001,000 for the six months ended June 30, 2023, which was attributable to a 17% decrease in the average cost per specimen impacted by the specimen mix during the six month period ended June 30, 2023 over the same period in 2022, offset by a 12% increase in the number of specimens accessioned during the six months ended June 30, 2023 over the same period in the prior year.
Technology
Technology expenses increased by approximately $515,000, or 44%, from approximately $1,163,000 for the six months ended June 30, 2022 to approximately $1,678,000 for the six months ended June 30, 2023. The period over period increase was related to increases in
payroll and related expenses of approximately $178,000 and in amortization of approximately $402,000, offset by decreases in general operating expense of approximately $39,000 and professional fees of approximately $26,000.
Sales and Marketing Expenses
Sales and marketing expenses increased approximately $327,000, or 19%, from approximately $1,698,000 for the six months ended June 30, 2022 to approximately $2,025,000 for the six months ended June 30, 2023. The period over period increase was primarily attributable to an increase in payroll and related expenses of approximately $372,000, and an increase in general operating expenses related to sales and marketing of approximately $168,000, offset by a decrease in external marketing expense of approximately $213,000.
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Supply Development
Supply development expenses increased approximately $191,000, or 45%, from approximately $424,000 for the six months ended June 30, 2022 to approximately $615,000 for the six months ended June 30, 2023. The period over period increase was primarily attributable to increases in professional fees of approximately $263,000 and general supply development expenses of approximately $6,000, offset by a decrease in payroll and related expenses of approximately $78,000.
Fulfillment
Fulfillment costs decreased approximately $72,000, or 7%, from approximately $964,000 for the six months ended June 30, 2022 to approximately $892,000 for the six months ended June 30, 2023. The decrease was primarily attributable to a decrease in payroll and related expenses of approximately $86,000 for personnel engaged in pre-sales feasibility assessments and order fulfillment, offset by an increase in general operating expenses related to fulfillment of approximately $14,000.
General and Administrative Expenses
General and administrative expenses increased approximately $84,000, or 2%, from approximately $3,386,000 for the six months ended June 30, 2022 to approximately $3,470,000 for the six months ended June 30, 2023. The period over period increase was attributable to increases in professional fees of approximately $164,000, directors’ and officers’ insurance of approximately $72,000, and depreciation expense of approximately $67,000, offset by decreases in compensation costs of approximately $135,000, software costs of approximately $81,000, and general operating expenses of approximately $3,000.
Other Income (Expense), net
Other income (expense), net, increased by approximately $236,000, or 500%, from approximately $47,000 of other expense net, for the six months ended June 30, 2022 to approximately $189,000 of other income, net, for the six months ended June 30, 2023. The increase in other income (expense), net, was attributable to increases in interest income of approximately $199,000, and a decrease in interest expense of approximately $73,000, offset by an increase in other expense of approximately $36,000.
Liquidity and Capital Resources
Change | |||||||||||||
June 30, 2023 | December 31, 2022 | Dollars | Percentage | ||||||||||
Balance Sheet Data: | |||||||||||||
Cash and cash equivalents | $ | 2,004,500 | $ | 15,308,710 | $ | (13,304,210) | (87) | % | |||||
Available-for-sale securities | 6,209,491 | — | 6,209,491 | 100 | % | ||||||||
Working capital | 8,111,523 | 15,394,634 | (7,283,111) | (47) | % | ||||||||
Total assets | 17,570,345 | 24,617,653 | (7,047,308) | (29) | % | ||||||||
Total stockholders' equity | 14,710,575 | 20,309,170 | (5,598,595) | (28) | % |
Six Months Ended June 30, | Change |
| |||||||||||
| 2023 |
| 2022 |
| Dollars |
| Percentage |
|
| ||||
Statement of Cash Flow Data: | |||||||||||||
Net cash flows used in operating activities | $ | (4,518,918) | $ | (3,353,977) | $ | (1,164,941) | (35) | % | |||||
Net cash flows used in investing activities |
| (8,856,181) |
| (777,181) |
| (8,079,000) |
| (1,040) | % | ||||
Net cash flows provided by financing activities |
| 70,889 |
| 83,354 |
| (12,465) |
| (15) | % | ||||
Net decrease in cash and cash equivalents | $ | (13,304,210) | $ | (4,047,804) | $ | (9,256,406) |
In November 2022, we paid off the outstanding principal balance of $3,500,000 and outstanding interests on our Term Loan. As of December 31, 2022, we had a balance of cash and cash equivalents of approximately $15,309,000. During the six months ended June 30, 2023, to reduce the risks associated with maintaining all our cash at a single bank, we diversified our cash into investments by
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purchasing U.S. Treasury bills with maturities ranging from one to six months. The U.S. Treasury bills have been classified as available-for-sale securities. As of June 30, 2023, we had a balance of cash and cash equivalents of approximately $2,000,000 and available-for-sale securities of approximately $6,200,000, with a sum of both classifications totaling approximately $8,200,000. We also had working capital of approximately $8,100,000 as of June 30, 2023, and no longer have any debt that could decrease our liquidity.
Since inception, we have relied upon raising capital to finance our operations. In the six months ended June 30, 2023, we invested approximately $2.7 million of cash on developing our Marketplace technology to bring it closer to revenue feasibility. We intend to continue to use our existing cash to further develop our technology, grow our supply network, increase our marketing and sales presence, scale our operations, and for working capital and general corporate purposes.
We believe our cash and cash equivalents, along with our available-for-sale securities, together with the anticipated cash flow from operations will be sufficient to meet our working capital, and capital expenditure requirements for at least the next 12 months. The liquidity we derive from cash flows from operations is, to a large degree, predicated on our ability to process our unbilled receivables and collect our receivables in a timely manner. In the event that revenue during the next 12 months continues to fall short of our projections or if our plans or assumptions change, including if inflation begins to have a greater impact on our business or if we decide to move forward with any activities that require more outlays of cash than originally planned, we may need to raise additional capital sooner than expected.
Our ability to obtain capital to implement our growth strategy over the longer term will depend on our future operating performance, financial condition and, more broadly, on the availability of equity and debt financing. Capital availability will be affected by prevailing conditions in our industry, the global economy, the global financial markets, and other factors, many of which are beyond our control. Specifically, as a result of recent volatility and weakness in the public markets, due to, among other factors, uncertainty in the global economy and financial markets, it may be much more difficult to raise additional capital, if and when it is needed, unless the public markets become less volatile and stronger at such time that we seek to raise additional capital. In addition, any additional debt service requirements we take on could be based on higher interest rates and shorter maturities and could impose a significant burden on our results of operations and financial condition, and the issuance of additional equity securities could result in significant dilution to stockholders.
Cash Flows
Operating Activities
For the six months ended June 30, 2023, net cash used in operating activities was approximately $4,519,000 which consisted of a net loss of approximately $5,915,000 offset by non-cash charges of approximately $1,420,000, which included $935,000 related to amortization of internally developed software, $245,000 in stock-based compensation, $262,000 in bad debt expense, and $76,000 related to depreciation and amortization of property and equipment, offset by $98,000 of amortization of discount on available-for-sale securities. Total changes in assets and liabilities of approximately $23,000 were attributable to a $122,540 increase in accounts receivable, a $679,143 decrease in accounts payable, a $649,000 decrease in accrued expenses, a $77,872 decrease in operating lease liability, a $42,734 decrease in deferred revenue, offset by a $1,229,433 decrease in accounts receivables-unbilled, a $112,665 decrease in prepaid expenses and other current assets, a $77,577 decrease in right-of-use asset, and a $128,541 decrease in tax credit receivable.
For the six months ended June 30, 2022, net cash used in operating activities was approximately $3,354,000, which consisted of a net loss of approximately $4,991,000 offset by non-cash charges of approximately $1,232,000, which included $533,000 related to amortization of internally developed software, $414,000 in stock-based compensation, $270,000 in bad debt expense, $9,000 related to depreciation and amortization of property and equipment, and $6,000 of amortization of discount on the Term Loan with the Lender. Total changes in assets and liabilities of approximately $405,000 were attributable to a $475,000 decrease in accounts receivable-unbilled, a $1,073,000 decrease in accounts receivable, partially offset by a $400,000 decrease in accounts payable, a $376,000 decrease in accrued expenses, a $320,000 decrease in deferred revenue, and a $48,000 increase in prepaid expenses and other current assets.
Investing Activities
Net cash used in investing activities was approximately $8,856,000 and $777,000 for the six months ended June 30, 2023 and 2022, respectively. Net cash used in investing activities for the six months ended June 30, 2023 consisted of $2,731,507 of capitalization of internally developed software, $7,642,929 of purchase of available-for-sale securities, and $13,745 of purchases of property and
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equipment, offset by $1,532,000 of proceeds from sale and maturities of available-for-sale securities. Net cash used in investing activities for the six months ended June 30, 2022 consisted of $777,181 of capitalization of internally developed software.
Financing Activities
Net cash provided by financing activities was approximately $71,000 and $83,000 for the six months ended June 30, 2023 and 2022, respectively. Net cash provided by financing activities for the six months ended June 30, 2023 consists of $71,000 received from the exercise of stock options. Net cash provided by financing activities for the six months ended June 30, 2022 consists of $77,000 received from the exercise of stock options and $6,250 proceeds from issuance of common stock in exchange for services.
Effects of Inflation and Supply Chain Shortages
Our operations are heavily reliant on specimen availability, and as a result, we often receive more requests than we can fulfill. While the Company is subject to these types of supply chain constraints that are specific to the specimen industry, we have not been affected by the more common supply chain issues currently affecting the economy, specifically surrounding transportation. Due to the small size of the packages that we ship, our carriers were able to continue making timely deliveries during the six months ended June 30, 2023.
We have experienced negative effects of inflation in certain areas of our business due to the high rates of inflation in the world’s current economy. This inflation is affecting employee salaries, which account for a significant portion of our operating costs. Additionally, the costs of supplies have been affected by inflation; however, these costs are not significant to the Company’s results.
Inflation has not had a significant impact on the cost of specimens due to our long-term contracts maintained with vendors, which include revenue sharing plans.
Non-GAAP Financial Measure
To supplement our financial statements, which are prepared and presented in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), we use adjusted earnings before interest, taxes, depreciation, and amortization (“Adjusted EBITDA”), a non-GAAP financial measure, to understand and evaluate our core operating performance. This non-GAAP financial measure, which may be different than similarly titled measures used by other companies, is presented to enhance investors’ overall understanding of our financial performance and should not be considered a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP.
We define our non-GAAP financial measure of Adjusted EBITDA as net loss, excluding income tax benefit, depreciation and amortization, stock-based compensation expense and interest expense.
We believe that Adjusted EBITDA provides useful information about our financial performance, enhances the overall understanding of our past performance and future prospects, and allows for greater transparency with respect to a key metric used by our management for financial and operational decision-making. We believe that Adjusted EBITDA helps identify underlying trends in our business that otherwise could be masked by the effect of the expenses that we exclude in Adjusted EBITDA. In particular, we believe the exclusion of the change in fair value of derivative liabilities on the bridge notes and convertible notes provides a useful supplemental measure in evaluating the performance of our operations and provides better transparency into our results of operations.
We are presenting the non-GAAP measure of Adjusted EBITDA to assist investors in seeing our financial performance through the eyes of management, and because we believe this measure provides an additional tool for investors to use in comparing our core financial performance over multiple periods with other companies in our industry.
Adjusted EBITDA should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. There are a number of limitations related to the use of Adjusted EBITDA compared to net loss, the closest comparable GAAP measure. Some of these limitations are that:
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The following table presents a reconciliation of Adjusted EBITDA to net loss, the most comparable GAAP financial measure, for each of the periods presented:
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||
2023 |
| 2022 |
| 2023 |
| 2022 | |||||||
Net loss | $ | (3,483,614) | $ | (2,606,809) | $ | (5,915,426) | $ | (4,990,551) | |||||
Depreciation and amortization |
| 538,640 |
| 271,312 |
| 1,010,555 |
| 542,244 | |||||
Stock-based compensation |
| 124,697 |
| 229,348 |
| 245,254 |
| 413,539 | |||||
Interest expense |
| 3,535 |
| 42,273 |
| 7,070 |
| 80,321 | |||||
Adjusted EBITDA | $ | (2,816,742) | $ | (2,063,876) | $ | (4,652,547) | $ | (3,954,447) |
Critical Accounting Policies
We have chosen accounting policies that we believe are appropriate to accurately and fairly report our operating results and financial condition in conformity with GAAP. We apply these accounting policies in a consistent manner. Our significant accounting policies are discussed in Note 2, “Summary of Significant Accounting Policies,” in our financial statements included in Amendment No. 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2022.
The application of critical accounting policies requires that we make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. These estimates and assumptions are based on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. We evaluate these estimates and assumptions on an ongoing basis. If actual results ultimately differ from previous estimates, the revisions are included in results of operations in the period in which the actual amounts become known. The critical accounting policies that involve the most significant management judgments and estimates used in preparation of our financial statements or are the most sensitive to change from outside factors, are discussed in “Part II. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Amendment No. 1 to the Company’s Annual Report on the Form 10-K/A for the year ended December 31, 2022. There have been no material changes in our critical accounting policies and procedures during the six months ended June 30, 2023.
JOBS Act Transition Period
On April 5, 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.
We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002 and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth
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company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) December 31, 2026; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable for smaller reporting companies.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the fiscal quarter ended June 30, 2023, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. These controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, in a manner to allow timely decisions regarding required disclosures. Based on this evaluation, management has concluded that our disclosure controls and procedures were not effective as of June 30, 2023 due to the following material weakness in internal control over financial reporting:
● | The Company did not design and maintain adequate controls to maintain appropriate documentation for the tax exempt status of its customers, calculate and collect sales tax at point of sale, and subsequently report and remit in a timely manner to the relevant tax jurisdictions sales tax obligations. |
Notwithstanding the existence of the material weakness described above, management believes that the condensed financial statements included in this Form 10-Q fairly present, in all material respects, our financial position, results of operations and cash flows as of and for the periods presented, in conformity with GAAP.
Management’s Plan for Remediation
The material weakness described above was identified as a result of an entity-wide risk assessment process that commenced in the quarter ended June 30, 2023. The Company is in the process of implementing a remediation plan to improve our internal control over financial reporting and to remediate the related control deficiencies that led to the material weakness. In response to these deficiencies, management, with the oversight of the Audit Committee of the Board of Directors, has identified and implemented steps to remediate the material weakness.
The Company began implementing the remediation plan during the second quarter of fiscal 2023. The following remedial measures are designed to address the material weakness and to continue to improve our internal control over financial reporting.
● | We have engaged external tax advisors to complement internal resources and efforts and provide support in assessing the appropriate sales tax treatment associated with the Company’s products for all prior years in which the Company had generated revenue, will implement a sales tax software platform solution for the calculation, collection, and remittance of sales tax for all non-exempt future sales, and assist with the collection and tracking of Voluntary Disclosure Agreements received from states where a potential tax liability may exist. |
● | We will design and implement enhanced policies, procedures and controls related to the calculation, collection, and remittance of sales tax to relevant jurisdictions. |
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● | We will train appropriate personnel in the effective design and execution of our enhanced policies, procedures, and controls, including the importance of the ongoing, consistent effective execution of such procedures and controls. |
We are committed to the remediation of the material weakness and expect to successfully implement enhanced control processes. However, as we continue to evaluate, and work to improve our internal control over financial reporting, management may determine that additional measures to address control deficiencies or modifications to the remediation plan are necessary. Therefore, we cannot assure you when we will be able to fully remediate such weakness, nor can we be certain that additional actions will not be required or what the costs may be of any such additional actions. Moreover, we cannot assure you that additional material weaknesses will not arise in the future.
Changes in Internal Control Over Financial Reporting
We are in the process of implementing certain changes to our internal controls to remediate the material weakness described above. Except as noted above, there were no changes in the Company’s internal control over financial reporting during the three months ended June 30, 2023 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
None.
Item 1A. Risk Factors.
Other than as described below, there have been no material changes with respect to risk factors previously disclosed in Amendment No. 1 to the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2022, filed with the SEC on March 30, 2023.
We have identified a material weakness in our internal controls over financial reporting that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate a material weakness or if we otherwise fail to establish and maintain effective control over financial reporting, our ability to accurately and timely report our financial results could be adversely affected.
We are required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act, which requires management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of our controls over financial reporting. Although we are required to disclose changes made in our internal controls and procedures on a quarterly basis, we are not required to make our first annual assessment of our internal controls over financial reporting pursuant to Section 404 until the later of (i) the year following our first annual report required to be filed with the SEC or (ii) the date we are no longer an emerging growth company. This assessment needs to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting, as well as a statement that our independent registered public accounting firm has issued an opinion on the effectiveness of our internal control over financial reporting, provided that our independent registered public accounting firm is not required to attest to the effectiveness of our internal control over financial reporting until our first annual report required to be filed with the SEC, following the later of the date we are deemed to be an “accelerated filer” or a “large accelerated filer,” each as defined in the Exchange Act, or the date we are no longer an emerging growth company, as defined in the JOBS Act. We could be an emerging growth company for up to five years after the date of our initial public offering.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis. In the second quarter of 2023, the Company engaged external tax consultant advisors to complement internal resources and efforts to provide support in assessing the Company’s tax liability associated with products for all prior years in which the Company had generated revenue, to assist with the collection and tracking of VDAs where a potential tax liability may exist and to assist with the implementation of a sales tax software platform solution for the calculation, collection, and remittance of sales tax for all non-exempt future sales. From the Company’s inception through present, the Company now believes it is probable that a sales tax liability existed for certain of its sales of products to certain of its customers; however, due to the complexity and uncertainty around the application of these rules by taxing authorities, results may vary materially from the Company’s expectations. Currently, the Company does not have sufficient information to reasonably estimate a minimum or maximum amount of the sales tax liability as of the date of this report. The Company is also in the process of identifying where there may be a need to file VDAs with relevant taxing jurisdictions regarding its failure to collect and remit sales tax obligations. As of June 30, 2023, the Company had not recorded an accrual for the probable sales tax liability nor the interest and penalties likely to be imposed by the taxing jurisdictions for the current and prior reporting periods in the financial statements. The Company will record a liability when the amount of the liability becomes reasonably estimable.
We also may identify future material weaknesses in our internal controls over financial reporting or fail to meet the demands that will be placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act, and we may be unable to accurately report our financial results, or report them within the timeframes required by law or stock exchange regulations. We cannot assure that additional material weaknesses will not exist or otherwise be discovered, any of which could adversely affect our reputation, financial condition and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
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Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
None.
Item 6. Exhibits
The following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report.
No. | Description of Exhibit |
10.1 | |
31.1* | |
31.2* | |
32.1** | |
101.INS* | Inline XBRL Instance Document |
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.SCH* | Inline XBRL Taxonomy Extension Schema Document |
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* | Inline XBRL Taxonomy Extension Labels Linkbase Document |
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104* | Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
* | Filed herewith. |
** | Furnished. |
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
iSpecimen Inc. | ||
Date: August 2, 2023 | By: | /s/ Tracy Curley |
Name: | Tracy Curley | |
Title: | Chief Executive Officer, Chief Financial Officer and Treasurer (Principal Executive Officer and Principal Financial and Accounting Officer) |
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