Full Press Release Details
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AZIYO BIOLOGICS, INC.
INDEX TO FINANCIAL STATEMENTS
| Report of Independent Registered Public Accounting Firm (PCAOB ID: 238) | F-2 |
| Consolidated Balance Sheets | F-3 |
| Consolidated Statements of Operations | F-4 |
| Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit) | F-5 |
| Consolidated Statements of Cash Flows | F-6 |
| Notes to Consolidated Financial Statements | F-7 |
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Aziyo Biologics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Aziyo Biologics, Inc. and its subsidiaries (the Company ) as of December 31, 2021 and 2020, and the related consolidated statements of operations, of changes in convertible preferred stock and stockholders' equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the consolidated financial statements ). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company's Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has incurred losses and expects losses to continue for the foreseeable future. In August 2022, the Company also exited its Revolving Credit Facility, which had an adverse effect on its liquidity. These conditions raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
March 8, 2022, except with respect to the matters that raise substantial doubt about the Company's ability to continue as a going concern discussed in Note 2, as to which the date is August 31, 2022
We have served as the Company's auditor since 2015.
AZIYO BIOLOGICS, INC.
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except for Share and Per Share Data)
| December 31, | December 31, | |||||
| 2021 | 2020 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash | $ | 30,393 | $ | 39,150 | ||
| Restricted cash | 35 | 382 | ||||
| Accounts receivable, net | 5,996 | 7,166 | ||||
| Inventory | 9,554 | 10,117 | ||||
| Prepaid expenses and other current assets | 1,450 | 2,892 | ||||
| Total current assets | 47,428 | 59,707 | ||||
| Property and equipment, net | 1,200 | 1,162 | ||||
| Intangible assets, net | 18,466 | 21,865 | ||||
| Other assets | 76 | 76 | ||||
| Total assets | $ | 67,170 | $ | 82,810 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,582 | $ | 2,054 | ||
| Accrued expenses | 6,375 | 6,323 | ||||
| Payables to tissue suppliers | 2,467 | 2,295 | ||||
| Current portion of long-term debt | 8,059 | 6,310 | ||||
| Current portion of revenue interest obligation | 2,750 | 2,750 | ||||
| Revolving line of credit | 4,763 | 6,514 | ||||
| Deferred revenue and other current liabilities | 5 | 533 | ||||
| Total current liabilities | 26,001 | 26,779 | ||||
| Long-term debt | 10,410 | 17,811 | ||||
| Long-term revenue interest obligation | 16,540 | 16,633 | ||||
| Other long-term liabilities | 698 | 756 | ||||
| Total liabilities | 53,649 | 61,979 | ||||
| Commitments and contingencies (Note 9) | ||||||
| Stockholders' equity (deficit): | ||||||
| Class A Common stock, $ 0.001 par value, 200,000,000 shares authorized as of December 31, 2021 and December 31, 2020, and 9,245,146 and 7,091,960 shares issued and outstanding , as of December 31, 2021 and December 31, 2020, respectively | 9 | 7 | ||||
| Class B Common stock, $ 0.001 par value, 20,000,000 shares authorized, as of December 31, 2021 and December 31, 2020 and 4,313,406 and 3,134,162 issued and outstanding as of December 31, 2021 and December 31, 2020, respectively | 4 | 3 | ||||
| Additional paid-in capital | 118,599 | 101,080 | ||||
| Accumulated deficit | ( 105,091 ) | ( 80,259 ) | ||||
| Total stockholders' equity | 13,521 | 20,831 | ||||
| Total liabilities and stockholders' equity | $ | 67,170 | $ | 82,810 |
The accompanying notes are an integral part of these consolidated financial statements.
AZIYO BIOLOGICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Data)
| Year Ended | ||||||
| December 31, | ||||||
| 2021 | 2020 | |||||
| Net sales | $ | 47,390 | $ | 42,682 | ||
| Cost of goods sold | 28,368 | 22,121 | ||||
| Gross profit | 19,022 | 20,561 | ||||
| Sales and marketing | 18,825 | 17,565 | ||||
| General and administrative | 13,963 | 10,641 | ||||
| Research and development | 9,266 | 5,954 | ||||
| Total operating expenses | 42,054 | 34,160 | ||||
| Loss from operations | ( 23,032 ) | ( 13,599 ) | ||||
| Interest expense | 5,324 | 5,633 | ||||
| Other (income) expense, net | ( 3,579 ) | 2,567 | ||||
| Loss before provision for income taxes | ( 24,777 ) | ( 21,799 ) | ||||
| Income tax expense | 55 | 26 | ||||
| Net loss | ( 24,832 ) | ( 21,825 ) | ||||
| Accretion of Convertible Preferred Stock | 3,510 | |||||
| Net loss attributable to common stockholders | $ | ( 24,832 ) | $ | ( 25,335 ) | ||
| Net loss per share - basic and diluted | $ | ( 2.38 ) | $ | ( 8.88 ) | ||
| Weighted average common shares outstanding - basic and diluted | 10,444,767 | 2,852,541 |
The accompanying notes are an integral part of these consolidated financial statements.
AZIYO BIOLOGICS, INC.
CONSOLIDATED STATEMENT OF CHANGES IN CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)
(In Thousands, Except Share and Per Share Data)
| Convertible Preferred Stock | Common Stock | Class A Common Stock | Class B Common Stock | Total | ||||||||||||||||||||||||||
| Additional | Stockholder' | |||||||||||||||||||||||||||||
| Number of | Number of | Number of | Number of | Paid-in | Accumulated | Equity | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | (Deficit) | ||||||||||||||||||||
| Balance, December 31, 2019 | 44,550,230 | $ | 44,449 | 648,277 | 1 | 1,826 | ( 56,938 ) | ( 55,111 ) | ||||||||||||||||||||||
| Issuance of Convertible Preferred Stock, net of issuance costs of $ 9 | 5,864,197 | 8,634 | ||||||||||||||||||||||||||||
| Proceeds from stock option exercises | 402 | 2 | 2 | |||||||||||||||||||||||||||
| Accretion of Convertible Preferred stock | 3,510 | ( 2,014 ) | ( 1,496 ) | ( 3,510 ) | ||||||||||||||||||||||||||
| Preferred stock warrant exercises | 405,000 | 405 | 474 | 474 | ||||||||||||||||||||||||||
| Net exercise of Common Stock warrants | 5,204 | |||||||||||||||||||||||||||||
| Conversion of Preferred Stock to Class A and Class B Common Stock upon Initial Public Offering | ( 50,819,427 ) | ( 56,998 ) | 4,232,195 | 4 | 2,398,868 | 2 | 56,992 | 56,998 | ||||||||||||||||||||||
| Conversion of Common Stock to Class A and Class B Common Stock upon Initial Public Offering | ( 653,883 ) | ( 1 ) | 653,883 | 1 | ||||||||||||||||||||||||||
| Issuance of Class A and Class B Common Stock in Initial Public Offering, net of offering costs of $ 7,000 | 2,205,882 | 2 | 735,294 | 1 | 43,021 | 43,024 | ||||||||||||||||||||||||
| Stock-based compensation | 779 | 779 | ||||||||||||||||||||||||||||
| Net loss | ( 21,825 ) | ( 21,825 ) | ||||||||||||||||||||||||||||
| Balance, December 31, 2020 | $ | 7,091,960 | 7 | 3,134,162 | 3 | 101,080 | ( 80,259 ) | 20,831 | ||||||||||||||||||||||
| Proceeds from stock option exercises | 3,305 | 26 | 26 | |||||||||||||||||||||||||||
| Issuance of common stock through Employee Stock Purchase Plan | 27,244 | 208 | 208 | |||||||||||||||||||||||||||
| Issuance of common stock through Private Placement, net of issuance costs of $ 247 | 2,122,637 | 2 | 1,179,244 | 1 | 13,750 | 13,753 | ||||||||||||||||||||||||
| Stock-based compensation | 3,535 | 3,535 | ||||||||||||||||||||||||||||
| Net loss | ( 24,832 ) | ( 24,832 ) | ||||||||||||||||||||||||||||
| Balance, December 31, 2021 | $ | $ | 9,245,146 | $ | 9 | 4,313,406 | $ | 4 | $ | 118,599 | $ | ( 105,091 ) | $ | 13,521 |
The accompanying notes are an integral part of these consolidated financial statements.
AZIYO BIOLOGICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended | ||||||
| December 31, | ||||||
| 2021 | 2020 | |||||
| Net loss | $ | ( 24,832 ) | $ | ( 21,825 ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation and amortization | 3,730 | 3,864 | ||||
| (Gain) loss on (forgiveness)/early extinguishment of debt | ( 3,029 ) | 2,340 | ||||
| Gain on revaluation of revenue interest obligation and other | 227 | |||||
| Amortization of deferred financing costs | 121 | 121 | ||||
| Interest expense recorded as additional revenue interest obligation | 2,654 | 2,682 | ||||
| Interest expense recorded as Convertible Preferred Stock | 39 | |||||
| Stock-based compensation | 3,535 | 779 | ||||
| Operating expense satisfied through Convertible Preferred Stock issuance | 814 | |||||
| Changes in operating assets and liabilities: | ||||||
| Accounts receivable | 1,170 | 64 | ||||
| Inventory | 563 | ( 2,927 ) | ||||
| Prepaid expenses and other | 1,442 | ( 1,455 ) | ||||
| Accounts payable and accrued expenses | ( 420 ) | 1,907 | ||||
| Obligations to tissue suppliers | 172 | ( 191 ) | ||||
| Deferred revenue and other liabilities | ( 552 ) | ( 65 ) | ||||
| Net cash used in operating activities | ( 15,446 ) | ( 13,626 ) | ||||
| INVESTING ACTIVITIES: | ||||||
| Expenditures for property, plant and equipment | ( 369 ) | ( 640 ) | ||||
| Net cash used in investing activities | ( 369 ) | ( 640 ) | ||||
| FINANCING ACTIVITIES: | ||||||
| Proceeds from Initial Public Offering, net of offering costs | 43,024 | |||||
| Proceeds from Private Placement, net of issuance costs | 13,753 | |||||
| Proceeds from exercise of preferred stock warrants | 405 | |||||
| Proceeds from issuance of Convertible Promissory Note | 2,000 | |||||
| Net borrowings (repayments) under revolving line of credit | ( 1,751 ) | 2,286 | ||||
| Proceeds from Convertible Preferred Stock issuance, net | 3,441 | |||||
| Proceeds from stock option exercises | 26 | 2 | ||||
| Proceeds from long-term debt | 2,995 | |||||
| Repayments of long-term debt | ( 2,778 ) | ( 300 ) | ||||
| Payments on revenue interest obligation | ( 2,747 ) | ( 2,645 ) | ||||
| Proceeds from sales of common stock through Employee Stock Purchase Plan | 208 | |||||
| Net cash provided by financing activities | 6,711 | 51,208 | ||||
| Net (decrease) increase in cash and restricted cash | ( 9,104 ) | 36,942 | ||||
| Cash and restricted cash, beginning of period | 39,532 | 2,590 | ||||
| Cash and restricted cash, end of period | $ | 30,428 | $ | 39,532 | ||
| Supplemental Cash Flow and Non-Cash Financing Activities Disclosures: | ||||||
| Cash paid for interest | $ | 4,984 | $ | 5,113 | ||
| Conversion of Convertible Promissory Note to Convertible Preferred Stock | $ | $ | 2,000 | |||
| Forgiveness of SBA PPP loan | $ | 3,029 | $ |
The accompanying notes are an integral part of these consolidated financial statements.
AZIYO BIOLOGICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization and Description of Business
Aziyo Biologics, Inc. (together with its consolidated subsidiaries, "Aziyo or the Company ) is a regenerative medicine company, with a focus on patients receiving implantable medical devices. The Company has developed a portfolio of regenerative products using both human and porcine tissue that are designed to be as close to natural biological material as possible. Aziyo's portfolio of core products span the implantable electronic devices/cardiovascular-related market, the orthopedic/spinal repair market and the soft tissue reconstruction market ( Core Products ). These products are primarily sold to healthcare providers or commercial partners. The Company also sells human tissue products under contract manufacturing and certain other arrangements ( Non-Core Products ) with corporate customers.
Reverse Stock Split and Initial Public Offering
On September 25, 2020, the Company's Board of Directors and stockholders approved an amendment to the Company's amended and restated certificate of incorporation to effect a 1-for-13.9549 reverse stock split of the Company's common stock, which was effected on September 29, 2020. The par value of the common stock was not adjusted as a result of the reverse stock split. Accordingly, all share and share-related information presented in these consolidated financial statements and the accompanying notes has been retroactively adjusted for all periods presented to give effect to the reverse stock split.
On October 13, 2020, in connection with the Company's initial public offering ("IPO"), Aziyo issued and sold 2,941,176 shares of common stock, consisting of 2,205,882 shares of Class A common stock and 735,294 shares of Class B common stock, at a price to the public of $17.00 per share, resulting in net proceeds of approximately $43.0 million, after deducting the underwriting discount of approximately $3.5 million and offering expenses of approximately $3.5 million.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation and Liquidity
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ( GAAP ).
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation.
In accordance with Accounting Standards Update ( ASU ) 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. For the year ended December 31, 2021, the Company incurred a net loss of $24.8 million, and as of December 31, 2021, the Company had an accumulated deficit of $105.1 million. In addition, during the year ended December 31, 2021, the Company used $15.4 million of cash in operating activities. Because of the numerous risks and uncertainties associated with the Company's commercialization and development efforts, the Company is unable to predict when it will become profitable, and it may never become profitable. The Company's inability to achieve and then maintain profitability would negatively affect its business, financial condition, results of operations and cash flows.
In order to mitigate the current and potential future liquidity issues caused by the matters noted above, the Company may seek to raise capital through the issuance of common stock or a new revolving credit facility, restructure its Revenue Interest Obligation (as such term is defined, and further described, in Note 9), or pursue asset sale transactions. However, such transactions may not be successful and the Company may not be able to raise additional equity or debt, restructure its Revenue Interest Obligation, or sell assets on acceptable terms, or at all. The Company completed the refinancing of its Loan Facility and repayment of the Revolving Credit Facility, as described in Note 19, but has not yet entered into a new revolving credit facility. As such, based on its current operating plans, the Company believes there is uncertainty as to whether its future cash flows along with its existing cash, availability under the SWK Loan Facility (described in Note 19) and cash generated from expected future sales will be sufficient to meet the Company's anticipated operating needs through twelve months from the financial statement issuance date. Due to these factors, there is substantial doubt about the Company's ability to continue as a going concern within one year after the issuance of the financial statements.
The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. That is, the accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business.
Certain reclassifications have been made to prior year amounts to conform with current year financial statement presentation. The reclassifications relate to certain executive compensation costs and technical operations expenses at the Company's Richmond, California plant. As follows are the total amounts reclassified for the year ended December 31, 2020 along with the line items in the Consolidated Statement of Operations that were impacted (in thousands).
| Increase (Decrease) From Previously Reported Amounts | |||
| Sales and marketing | $ | 720 | |
| General and administrative | ( 2,591 ) | ||
| Research and development | 1,871 |
These reclassifications did not impact the Company's consolidated earnings or assets for the year ended December 31, 2020.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates and assumptions relating to inventories, receivables, long-lived assets, the valuation of stock-based awards, the valuation of the revenue interest obligation and deferred income taxes are made at the end of each financial reporting period by management. Management continually re-evaluates its estimates, judgments and assumptions, and management's evaluation could change. Actual results could differ from those estimates.
The Company is closely monitoring the impact of the COVID-19 pandemic on its business. In March 2020, the World Health Organization declared COVID-19 a global pandemic and recommended various containment and mitigation measures worldwide. Since that time, the number of procedures performed using the Company's products has decreased significantly, as governmental authorities in the United States have recommended, and in certain cases required, that elective, specialty and other non-emergency procedures and appointments be suspended or canceled in order to avoid patient exposure to medical environments and the risk of potential infection with COVID-19, and to focus limited resources and personnel capacity on the treatment of COVID-19 patients. As a result, beginning in March 2020, a significant number of procedures using the Company's products have been postponed or cancelled, which has negatively impacted sales of its products. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and will likely continue to reduce the Company's net sales and negatively impact its business, financial condition and results of operations while the pandemic continues.
Net Loss per Share Attributable to Common Stockholders
The Company calculates basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required for participating securities. The Convertible Preferred Stock was considered a participating security through the completion of the IPO (see Note 12). The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income (loss) for the period had been distributed. Under the two-class method, the net loss attributable to common stockholders is not allocated to the Convertible Preferred Stock as the holders of the preferred stock do not have a contractual obligation to share in losses.
Our common stock has a dual class structure, consisting of Class A common stock and Class B common stock. Other than voting rights, the Class B common stock has the same rights as the Class A common stock, and therefore both are treated as the same class of stock for purposes of the earnings per share calculation. Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average shares outstanding during the period. For purposes of the diluted net income (loss) per share attributable to common stockholders' calculation, Convertible Preferred Stock, stock options, and preferred and common stock warrants are considered to be common stock equivalents. All common stock equivalents have been excluded from the calculation of diluted net loss per share attributable to common stockholders, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for both periods presented.
Fair Value of Financial Instruments
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 measures, 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.
The estimated fair value of financial instruments disclosed in the financial statements has been determined by using available market information and appropriate valuation methodologies. The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature.
Cash and Restricted Cash
The Company maintains its cash balances at banks and financial institutions. The balances are insured up to the legal limit. The Company maintains cash balances that may, at times, exceed this insured limit.
Under the provisions of the Revolving Credit Facility (see Note 8), the Company has a lockbox arrangement with the banking institution whereby daily lockbox receipts are contractually utilized to pay down outstanding balances on the Revolving Credit Facility debt. Lockbox receipts that have not yet been applied to the Revolving Credit Facility are classified as restricted cash in the accompanying consolidated balance sheets. The following table provides a reconciliation of cash and restricted cash included in the consolidated balance sheets to the amounts included in the statements of cash flows (in thousands).
| December 31, | ||||||
| 2021 | 2020 | |||||
| Cash | $ | 30,393 | $ | 39,150 | ||
| Restricted cash | 35 | 382 | ||||
| Total cash and restricted cash shown in statements of cash flows | $ | 30,428 | $ | 39,532 |
Accounts Receivable and Allowances
Accounts receivable in the accompanying balance sheets are presented net of allowances for doubtful accounts and other credits. The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables.
The Company evaluates the collectability of accounts receivable based on a combination of factors. In circumstances where a specific customer is unable to meet its financial obligations to the Company, a provision to the allowance for doubtful accounts is recorded to reduce the net recognized receivable to the amount that is reasonably expected to be collected. For all other customers, a provision to the allowance for doubtful accounts is recorded based on factors including the length of time the receivables are past due, the current business environment and the Company's historical experience. Provisions to the allowance for doubtful accounts are recorded to general and administrative expenses. Account balances are charged off against the allowance when it is probable that the receivable will not be recovered. The Company's allowance for doubtful accounts was approximately $0.1 million as of December 31, 2021 and 2020.
Inventories, consisting of purchased materials, direct labor and manufacturing overhead, are stated at the lower of cost or net realizable value, with cost determined generally using the average cost method. Inventory write-downs for unprocessed and certain processed donor tissue are recorded based on the estimated amount of inventory that will not pass the quality control process based on historical data. At each balance sheet date, the Company also evaluates inventories for excess quantities, obsolescence or shelf life expiration. This evaluation includes analysis of the Company's current and future strategic plans, historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products, general market conditions and a review of the shelf life expiration dates for products. To the extent that management determines there is excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products prior to their expiration, the Company adjusts the carrying value to estimated net realizable value.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed on the straight-line method over the following estimated useful lives of the assets:
| Processing and research equipment | 5 to 10 years | |
| Office equipment and furniture | 3 to 5 years | |
| Computer hardware and software | 3 years |
Leasehold improvements are amortized on the straight-line method over the shorter of the lease term or the estimated useful life of the asset.
Repairs and maintenance costs are expensed as incurred.
Purchased intangible assets with finite lives are carried at acquired fair value, less accumulated amortization. Amortization is computed over the estimated useful lives of the respective assets.
The Company periodically evaluates the period of depreciation or amortization for long-lived assets to determine whether current circumstances warrant revised estimates of useful lives. The Company reviews its property and equipment and intangible assets for impairment whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. Impairment exists when the carrying value of the company's asset exceeds the related estimated undiscounted future cash flows expected to be derived from the asset. If impairment exists, the carrying value of that asset is adjusted to its fair value. A discounted cash flow analysis is used to estimate an asset's fair value, using assumptions that market participants would apply. The results of impairment tests are subject to management's estimates and assumptions of projected cash flows and operating results. Changes in assumptions or market conditions could result in a change in estimated future cash flows and could result in a lower fair value and therefore an impairment, which could impact reported results. There were no impairment losses for the years ended December 31, 2021 and 2020.
The Company's revenue is generated from contracts with customers in accordance with ASC 606. The core principle of ASC 606 is that the Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The ASC 606 revenue recognition model consists of the following five steps: (1) identify the contracts with a 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 entity satisfies a performance obligation.
As noted above, the Company enters into contracts to primarily sell and distribute products to healthcare providers or commercial partners, or are produced and sold under contract manufacturing arrangements with corporate customers which are billed under ship and bill contract terms. Revenue is recognized when the Company has met its performance obligations pursuant to its contracts with its customers in an amount that the Company expects to be entitled to in exchange for the transfer of control of the products to the Company's customers. For all product sales, the Company has no further performance obligations and revenue is recognized at the point control transfers which occurs either when: i) the product is shipped via common carrier; or ii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement.
A portion of the Company's product revenue is generated from consigned inventory maintained at hospitals and from inventory physically held by direct sales representatives. For these types of products sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized.
The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in sales and marketing costs. Shipping and handling costs were approximately $0.3 million for both the years ended December 31, 2021 and 2020.
Contracts with customers state the final terms of the sale, including the description, quantity, and price of each implant distributed. The payment terms and conditions in the Company's contracts vary; however, as a common business practice, payment terms are typically due in full within 30 to 60 days of delivery. The Company, at times, extends volume discounts to customers.
The Company permits returns of its products in accordance with the terms of contractual agreements with customers. Allowances for returns are provided based upon analysis of the Company's historical patterns of returns matched against the revenues from which they originated. The Company records estimated returns as a reduction of revenue in the same period revenue is recognized.
The Company recognizes rent expense by the straight-line method over the lease term. Funds received from the lessor used to reimburse the Company for the cost of leasehold improvements are recorded as a deferred credit resulting from a lease incentive and are amortized over the lease term as a reduction of rent expense.
Stock-Based Compensation Plans
The Company accounts for its stock-based compensation plans in accordance with FASB Accounting Standards Codification ( ASC ) 718, Accounting for Stock Compensation. FASB ASC 718 requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors, including employee stock options and restricted stock. Stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense on a straight-line basis over the requisite service period of the entire award.
Research and Development Costs
Research and development costs, which include mainly salaries, outside services and supplies, are expensed as incurred.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash. At December 31, 2021 and 2020, the Company maintained $30.9 million and $40.0 million, respectively, in bank deposit accounts that are in excess of the $0.25 million insurance provided by the Federal Deposit Insurance Corporation in one federally insured financial institution. The Company has not experienced any losses in such accounts.
Comprehensive Income (Loss)
Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the years ended December 31, 2021 and 2020, the Company's net loss equaled its comprehensive loss and accordingly, no additional disclosure is presented.
The Company uses the asset and liability method of accounting for income taxes. Deferred income taxes are recorded to reflect the tax consequences on future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized.
The Company is subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, the Company recognizes tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more likely than not (greater than 50%) of being realized upon settlement. The Company's policy is to recognize interest and/or penalties related to income tax matters in income tax expense.
Note 3. Recently Issued Accounting Standards
In March 2020, the Financial Accounting Standards Board ( FASB ) issued ASU 2020-04, Reference Rate Reform (Topic 848), Facilitation of the Effects of Reference Rate Reform on Financial Reporting. The ASU provides temporary relief from some of the existing rules governing contract modifications when the modification is related to the replacement of the London Interbank Offered Rate ( LIBOR ) or other reference rates discontinued as a result of reference rate reform. The ASU specifically provides optional practical expedients for contract modification accounting related to contracts subject to ASC 310, Receivables, ASC 470, Debt, ASC 842, Leases, and ASC 815, Derivatives and Hedging. The ASU also establishes a general contract modification principle that entities can apply in other areas that may be affected by reference rate reform and certain elective hedge accounting expedients. For eligible contract modifications, the principle generally allows an entity to account for and present modifications as an event that does not require contract remeasurement at the modification date or reassessment of a previous accounting determination. That is, the modified contract is accounted for as a continuation of the existing contract. The standard was effective upon issuance on March 12, 2020, and the optional practical expedients can generally be applied to contract modifications made and hedging relationships entered into on or before December 31, 2022. Borrowings under the Company's term loan facility and revolving line of credit bear interest based on LIBOR or an alternate rate. Provisions currently provide the Company with the ability to replace LIBOR with a different reference rate in the event that LIBOR ceases to exist.
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, which clarifies and simplifies certain aspects of the accounting for income taxes. The standard is effective for years beginning after December 15, 2020, and interim periods within annual periods beginning after December 15, 2020. The adoption of this standard on January 1, 2021 did not have a material impact on the Company's consolidated financial statements.
In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivative and Hedging (Topic 815), and Leases (Topic 842), Effective Dates. The FASB deferred the effective dates of the new credit losses standard for all entities except filers with the Securities and Exchange Commission (the SEC ) that are not smaller reporting companies (SRCs) to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Board also aligned the effective dates of ASU 2017-04 on goodwill impairment with the new effective dates of the credit losses standard. The FASB deferred the effective dates of its new standards on hedging and leases for entities that are not public business entities (PBEs) (and for leases, for entities that are not non-for-profit (NFP) entities that have issues, or are conduit bond obligors for, certain securities; and are not employee benefit plans (EBPs) that file or furnish financial statements with or to the SEC) to fiscal years beginning after December 15, 2020, and interim periods in the following year. The FASB is also reconsidering its philosophy on establishing effective dates for major standards for private companies, NFPs, EBPs and smaller public companies. The board has developed a two-bucket approach that would give these entities more time to implement major new standards. The Company is evaluating this standard to determine if adoption will have a material impact on the Company's consolidated financial statements.