The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and the related notes included in Part II, Item 8 of this Annual Report on Form 10-K. This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended ("the Exchange Act"). Forward-looking statements are identified by words such as "believe," "will," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms or similar expressions. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other "forward-looking" information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in this report in Part I, Item 1A - "Risk Factors," and elsewhere in this report. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. These statements, like all statements in this report, speak only as of their date, and we undertake no obligation to update or revise these statements in light of future developments. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.
Overview
We are a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases. Our current product offerings consists of two minimally-invasive, novel catheter-based mechanical thrombectomy systems, which are purpose-built for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE - deep vein thrombosis, or DVT, and pulmonary embolism, or PE. Our ClotTriever product is FDA-cleared for the treatment of DVT. Our FlowTriever product is the first thrombectomy system FDA-cleared for the treatment of pulmonary embolism, or PE, and is also FDA-cleared for clot in transit in the right atrium. We believe the best way to treat VTE and improve the quality of life of patients suffering from this disease is to safely and effectively remove the blood clot. With that in mind, we designed and purpose-built our ClotTriever and FlowTriever systems. The ClotTriever is a mechanical thrombectomy system designed to core, capture and remove large clots from large vessels and is used to treat DVT. The FlowTriever is a large bore catheter-based aspiration and mechanical thrombectomy system designed to remove large clots from large vessels to treat PE. Both products are designed to eliminate the need for thrombolytic drugs. We believe our mission-focused and highly-trained commercial organization provides a significant competitive advantage. Our most important relationships are between our sales representatives and our treating physicians, which include interventional cardiologists, interventional radiologists and vascular surgeons. We recruit sales representatives who have substantial and applicable medical device and/or sales experience. Our front-line sales representatives typically attend procedures, which puts us at the intersection of the patient, product and physician. We have developed systems and processes to harness the information gained from these relationships and we leverage this information to rapidly iterate products, introduce and execute physician education and training programs and scale our sales organization. We market and sell our products to hospitals, which are reimbursed by various third-party payors. OnMay 27, 2020 , we completed our IPO, which resulted in the issuance and sale of 9,432,949 shares of common stock, including 1,230,384 shares sold pursuant to the exercise of the underwriters' over-allotment option, at the IPO price of$19.00 per share. We received net proceeds of approximately$163.0 million from the IPO, after deducting underwriters' discounts and commissions of$12.6 million and offering costs of$3.7 million . 61 --------------------------------------------------------------------------------
Prior to our IPO, our primary sources of capital were private placements of
preferred stock, debt financing arrangements and revenue from sales of our
products. Since inception, we had raised a total of approximately
As of
For the year endedDecember 31, 2021 , we generated revenue of$277.0 million , with a gross margin of 91.1% and net income of$9.8 million , compared to revenue of$139.7 million , with a gross margin of 90.6% and net income of$13.8 million for the year endedDecember 31, 2020 .
COVID-19
SinceDecember 2019 , a novel strain of coronavirus, SARS-CoV-2, and the resulting disease, COVID-19, has spread to most countries, including all 50 states inthe United States . The global healthcare system continues to face an unprecedented challenge as a result of the COVID-19 situation and its impact. COVID-19 has had and may continue to have an adverse impact on aspects of our business, including the demand for our products, operations, and ability to research and develop and bring new products and services to market. In response to the pandemic, inMarch 2020 , many governmental authorities suspended or canceled elective, specialty and other procedures and appointments, and some states and countries issued "stay at home" orders limiting non-essential activities, travel and business operations. These orders significantly decreased the number of procedures performed using our products during March andApril 2020 and otherwise negatively impacted our operations. In response to the impact of COVID-19, we implemented a variety of measures to help manage through the impact and position us to resume operations quickly and efficiently. The results of 2021 reflect some recovery from the declines we experienced in 2020 as a result of COVID-19. However, with disease variants, cases continuing to resurge in certain areas, and hospitals at capacity in some instances due to non-COVID-19 treatments, or staff or other resource constraints, to the extent individuals and hospital systems de-prioritize, delay or cancel deferrable medical procedures, our business, cash flows, financial condition and results of operations may continue to be negatively affected. While we are encouraged by our results for the year endedDecember 31, 2021 , we are aware that the actual and perceived impact of COVID-19 is changing and cannot be predicted. As a result, we cannot assure that our recent procedure volumes are indicative of future results or that we will not experience additional negative impacts associated with COVID-19, which could be significant. We continue to focus our efforts on the health and safety of patients, healthcare providers and employees, while executing our mission of transforming the lives of patients. While we expect the COVID-19 pandemic may continue to negatively impact performance in 2022, we believe the long-term fundamentals remain strong and we will continue to effectively manage through these challenges. Procedure Volume We regularly review various operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions. We believe the number of procedures performed to treat DVT and PE using our products is an indicator of our ability to drive adoption and generate revenue. We believe this is an important metric for our business; however, we anticipate that additional metrics may become important as our business grows. The following table lists the number of procedures performed in each of the three-month periods as indicated: 62 --------------------------------------------------------------------------------
Three Months Ended Procedures(1) Dec 31, 2021 Sept 30, 2021 June 30, 2021 March 31, 2021 Dec 31, 2020 DVT 3,600 3,400 3,000 2,800 2,400 PE 4,100 3,300 2,800 2,700 2,200 7,700 6,700 5,800 5,500 4,600 (1) We define a procedure as any instance in which a physician treats DVT or PE using our products. We estimate the number of procedures performed based on records created by our sales representatives. This metric has limitations as we only have records for the procedures where our sales representatives have notice that a procedure has been performed. Revenue is recognized based on hospital purchase orders, not based on the procedure records created by our sales representatives. Numbers are rounded to the nearest hundred.
Components of our Results of Operations
Revenue
We currently derive substantially all our revenue from the sale of our ClotTriever and FlowTriever products directly to hospitals primarily located inthe United States . Our customers typically purchase an initial stocking order of our products and then reorder replenishment products as procedures are performed. No single customer accounted for 10% or more of our revenue during the years endedDecember 31, 2021 , 2020 and 2019. We expect our revenue to increase in absolute dollars as we expand our sales organization and sales territories, add customers, expand the base of physicians that are trained to use our products, expand awareness of our products with new and existing customers and as physicians perform more procedures using our products. Revenue for ClotTriever and FlowTriever products as a percentage of total revenue is as follows: Years Ended December 31, 2021 2020 2019 ClotTriever 32 % 37 % 38 % FlowTriever 68 % 63 % 62 %
Cost of Goods Sold and Gross Margin
We manufacture and/or assemble all our products at our facility inIrvine, California . Cost of goods sold consists primarily of the cost of raw materials, components, direct labor and manufacturing overhead. Overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management, including stock-based compensation. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalty expense. We expect cost of goods sold to continue to increase in absolute dollars as our revenue grows, we introduce new products, and more of our products are sold; however, we also expect to realize opportunities to increase operating leverage in our expanded manufacturing operations. We calculate gross margin as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, including average selling prices, product sales mix, production and ordering volumes, manufacturing costs, product yields, headcount and cost-reduction strategies. Our gross margin could fluctuate from year to year as we introduce new products, adopt new manufacturing processes and technologies, and as we expand internationally. Treatments using the FlowTriever may involve one or more Triever aspiration catheters and one or more FlowTriever catheters. We charge customers the same price for each FlowTriever procedure, regardless of the number of components used. As a result, changes in the number of components used, the cost of these components and the introduction of additional components can impact our gross margin. 63 --------------------------------------------------------------------------------
Research and Development Expenses
Research and development, or R&D, expenses consist primarily of engineering, product development, clinical studies to develop and support our products, regulatory expenses, and other costs associated with products that are in development. These expenses include employee compensation, including stock-based compensation, supplies, consulting, prototyping, testing, materials, travel expenses, depreciation and an allocation of facility overhead expenses. Additionally, R&D expenses include costs associated with our clinical trials and registries, including clinical study design, clinical study site initiation and study costs, data management, and internal and external costs associated with our regulatory compliance, including the costs of outside consultants and contractors that assist in the process of submitting and maintaining regulatory filings. We expense R&D costs as incurred. We expect R&D to increase as a percentage of revenue in the near term and generally expect R&D expenses as a percentage of revenue to vary over time depending on the level and timing of our new product development efforts, as well as our clinical evidence development, clinical trials and registries and other related activities.
Selling, General and Administrative Expenses
Selling, general and administrative, or SG&A, expenses consist primarily of compensation for personnel, including stock-based compensation, related to selling and marketing functions, physician education programs, commercial operations and analytics, finance, information technology and human resource functions. Other SG&A expenses include sales commissions, travel expenses, promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, physician training, professional services fees (including legal, audit and tax fees), insurance costs, general corporate expenses and facilities-related expenses. We expect SG&A expenses to continue to increase in absolute dollars as we expand our sales and marketing organization and infrastructure to both drive and support the anticipated growth in revenue.
Interest Income
Interest income consists primarily of interest income earned on our cash, cash equivalents and investments.
Interest Expense
Interest expense consists primarily of interest incurred on our outstanding indebtedness and non-cash interest related to the amortization of debt discount and issuance costs associated with our indebtedness.
Change in Fair Value of Warrant Liabilities
Change in fair value of warrant liabilities consists of gains and losses resulting from the remeasurement of the fair value of our preferred stock warrant liabilities at each balance sheet date. Upon the closing of our IPO, our outstanding preferred stock warrants automatically converted into warrants to purchase shares of our common stock. At such time, the final fair value of the warrant liabilities was reclassified to stockholders' equity (deficit) and we will no longer record any related periodic fair value adjustments. 64 --------------------------------------------------------------------------------
Results of Operations
Comparison of the years ended
The following table sets forth our results of operations in dollars and as percentage of revenue for the periods presented (dollars in thousands):
Years Ended December 31, 2021 % 2020 % Change $ Revenue$ 276,984 100.0 %$ 139,670 100.0 %$ 137,314 Cost of goods sold 24,757 8.9 % 13,106 9.4 % 11,651 Gross profit 252,227 91.1 % 126,564 90.6 % 125,663 Operating expenses: Research and development 51,018 18.4 % 18,399 13.2 % 32,619 Selling, general and administrative 190,365 68.7 % 89,746 64.3 % 100,619 Total operating expenses 241,383 87.1 % 108,145 77.5 % 133,238 Income from operations 10,844 4.0 % 18,419 13.1 % (7,575 ) Other income (expense) Interest income 154 0.1 % 484 0.3 % (330 ) Interest expense (295 ) (0.1 %) (1,135 ) (0.8 %) 840 Change in fair value of warrant liabilities - 0.0 % (3,317 ) (2.4 %) 3,317 Other expenses (18 ) 0.0 % (662 ) (0.5 %) 644 Total other expenses, net (159 ) 0.0 % (4,630 ) (3.4 %) 4,471 Income before income taxes$ 10,685 4.0 %$ 13,789 9.7 %$ (3,104 ) Revenue. Revenue increased$137.3 million , or 98.3%, to$277.0 million during the year endedDecember 31, 2021 , compared to$139.7 million during the year endedDecember 31, 2020 . The increase in revenue was due primarily to an increase in the number of products sold as we expanded our sales territories, opened new accounts and achieved deeper penetration of our products into existing accounts, and introduced new products. Revenue for the year endedDecember 31, 2020 was also negatively impacted by a rapid deceleration in the number of products sold due to the COVID-19 pandemic. Cost of Goods Sold and Gross Margin. Cost of goods sold increased$11.7 million , or 88.9%, to$24.8 million during the year endedDecember 31, 2021 , compared to$13.1 million during the year endedDecember 31, 2020 . This increase was due to the increase in the number of products sold and additional manufacturing overhead costs incurred as we invested significantly in our operational infrastructure to support anticipated future growth. Gross margin for the year endedDecember 31, 2021 increased to 91.1%, compared to 90.6% for the year endedDecember 31, 2020 , due primarily to improved operating leverage and a change in product mix. Research and Development Expenses. R&D expenses increased$32.6 million , or 177.3%, to$51.0 million during the year endedDecember 31, 2021 , compared to$18.4 million during the year endedDecember 31, 2020 to develop our new product pipeline and build our clinical evidence base. The increase in R&D expenses was primarily due to increases of$16.1 million of personnel-related expenses as a result of a significant increase in headcount,$5.7 million of product related material and supplies,$4.2 million in licensed technology fees,$2.9 million of clinical study and registry expenses due to increased patient enrollment, and$1.8 million in professional services fees. Selling, General and Administrative Expenses. SG&A expenses increased$100.6 million , or 112.1%, to$190.4 million during the year endedDecember 31, 2021 , compared to$89.7 million during the year endedDecember 31, 2020 . The increase in SG&A costs was primarily due to an increase of$77.3 million in personnel-related expenses as a result of increased headcount across our organization, increased commissions due to higher revenue and increased stock-based compensation expenses, including an$9.2 million in stock-based compensation expense as a result of accelerated vesting of RSUs and stock options, an increase of$5.7 million in professional fees, an increase of$5.6 million in travel and related expenses, an increase of$3.1 million in marketing expenses, an increase of$2.5 million in depreciation and software license fees, an increase of$2.2 million in insurance costs, and an increase of$1.7 million in facility related costs, particularly related to our new facility. 65 -------------------------------------------------------------------------------- Interest Income. Interest income decreased by$0.3 million or 68.2% to$0.2 million for the year endedDecember 31, 2021 , compared to$0.5 million for the year endedDecember 31, 2020 . The decrease in interest income was primarily due to lower interest rates during the year endedDecember 31, 2021 , compared to the year endedDecember 31, 2020 . Interest Expense. Interest expense decreased by$0.8 million or 74.0% to$0.3 million for the year endedDecember 31, 2021 , compared to$1.1 million for the year endedDecember 31, 2020 . This decrease was primarily due to lower average borrowings under our credit facilities during the year endedDecember 31, 2021 . Change in Fair Value of Warrant Liabilities. We recorded no change in fair value of warrant liabilities for the year endedDecember 31, 2021 as no warrants were outstanding during the current year, compared to$3.3 million for the year endedDecember 31, 2020 . Other expenses. Other expenses of$18,000 for the year endedDecember 31, 2021 consisted primarily of foreign currency losses. While other expenses for the year endedDecember 31, 2020 consisted primarily of a$0.7 million loss on extinguishment of debt related to the payoff of our debt facility with Signature Bank.
Comparison of the years ended
For a comparison of our results of operations and cash flows for the years endedDecember 31, 2020 and 2019, see "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our annual report on Form 10-K for the year endedDecember 31, 2020 filed with theSEC onMarch 9, 2021 , which comparative information is incorporated by reference in this Report.
Liquidity and Capital Resources
To date, our primary sources of capital have been the net proceeds we received through private placements of preferred stock, debt financing agreements, the sale of common stock in our IPO, and revenue from the sale of our products. OnMay 27, 2020 , we completed our IPO, including the underwriters full exercise of their over-allotment option, selling 9,432,949 shares of our common stock at$19.00 per share. Upon completion of our IPO, we received net proceeds of approximately$163.0 million , after deducting underwriting discounts and commissions and offering expenses. InAugust 2020 , we repaid in full the$30.0 million of principal owed under the credit facility with Signature Bank. As ofDecember 31, 2021 , we had cash and cash equivalents of$92.8 million , investments in debt securities of$87.3 million and an accumulated deficit of$17.6 million . InSeptember 2020 , we entered into a new revolving Credit Agreement withBank of America which provides for loans up to a maximum of$30 million . As ofDecember 31, 2021 , we had no principal outstanding under the Credit Agreement and the amount available to borrow was approximately$28.2 million .
Based on our current planned operations, we expect that our cash and cash equivalents, short-term investments and available borrowings will enable us to fund our operating expenses for at least 12 months from the date hereof.
66 -------------------------------------------------------------------------------- If our available cash balances and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements including because of lower demand for our products as a result of the risks described in this Annual Report, we may seek to sell additional common or preferred equity or convertible debt securities, enter into an additional credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our platform technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available on reasonable terms, or at all.
Cash Flows
The following table summarizes our cash flows for each of periods indicated (in thousands): Years Ended December 31, 2021 2020 Net cash provided by (used in): Operating activities$ 25,486 $ 1,912 Investing activities (51,022 ) (55,437 ) Financing activities 4,073 144,115
Effect of foreign exchange rate on
cash and cash equivalents (402 )
-
Net increase (decrease) in cash and cash equivalents
Net Cash Provided by (Used in) Operating Activities
Net cash provided by operating activities for the year endedDecember 31, 2021 was$25.5 million , consisting primarily of net income of$9.8 million and non-cash charges of$30.0 million , offset by an increase in net operating assets of$14.3 million . The increase in net operating assets was primarily due to increases in accounts receivable of$14.3 million and inventories of$10.5 million to support the growth of our operations, an increase in prepaid and other assets of$3.4 million primarily from prepaid insurance, which were partially offset by increases in accounts payable of$3.5 million and accrued liabilities of$26.0 million due to timing of payments, increased headcount and growth of our operations, lease prepayments for lessor's owned leasehold improvements of$14.8 million and a decrease in operating lease liabilities of$0.8 million . The non-cash charges primarily consisted of$25.4 million in stock-based compensation expense,$3.0 million in depreciation, and$1.3 million in amortization of the right-of-use assets. Net cash provided by operating activities for the year endedDecember 31, 2020 was$1.9 million , consisting primarily of net income of$13.8 million and non-cash charges of$9.3 million , offset by an increase in net operating assets of$21.2 million . The increase in net operating assets was primarily due to increases in accounts receivable of$16.7 million and inventories of$6.6 million to support the growth of our operations, an increase in prepaid and other assets of$2.5 million primarily from prepaid insurance, which were partially offset by increases in accounts payable of$0.5 million and accrued liabilities of$4.1 million due to timing of payments and growth of our operations. The non-cash charges primarily consisted of$3.3 million in change in fair value of the preferred stock warrant liabilities, stock-based compensation of$3.5 million ,$1.4 million in depreciation, and$0.6 million in loss on extinguishment of debt.
Net cash used in investing activities for the year endedDecember 31, 2021 was$51.0 million , consisting of$134.4 million of purchases of short-term investments coupled with$13.6 million of purchases of property and equipment, offset by$97.0 million in maturities of short-term investments. 67 -------------------------------------------------------------------------------- Net cash used in investing activities for the year endedDecember 31, 2020 was$55.4 million , consisting of purchases of short-term securities of$50.0 million and purchases of property and equipment of$5.4 million .
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the year endedDecember 31, 2021 was$4.1 million , consisting of$5.6 million of proceeds from the issuance of common stock under our employee stock purchase plan and$0.9 million of proceeds from exercise of stock options, offset by$2.4 million of tax payments related to vested RSUs. Net cash provided by financing activities for the year endedDecember 31, 2020 was$144.1 million primarily consisting of net IPO proceeds of$164.4 million and net proceeds of$10.0 million received from additional borrowings under the credit facility with Signature Bank, partially offset by the$30.3 million repayment of the amount outstanding under the credit facility.
Critical Accounting Policies and Estimates
Management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance withU.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. While our significant accounting policies are more fully described in Note 2 to our audited consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company sells its products primarily to hospitals inthe United States utilizing the Company's direct sales force. The Company recognizes revenue for arrangements where the Company has satisfied its performance obligation of shipping or delivering the product. For sales where the Company's sales representative hand-deliver products directly to the hospitals, control of the products transfers to the customers upon such hand delivery. For sales where products are shipped, control of the products transfers either upon shipment or delivery of the products to the customer, depending on the shipping terms and conditions. Revenue from product sales is comprised of product revenue, net of product returns, administrative fees and sales rebates.
The Company sells to a diversified base of customers and, therefore, believes there is no material concentration of credit risk.
68 --------------------------------------------------------------------------------
occurs with the transfer of control of the Company's product to its customers, either upon shipment or delivery of the product.
Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring goods. The amount of revenue recognized is based on the transaction price, which represents the invoiced amount, net of administrative fees and sales rebates, where applicable. The Company provides a standard 30-day unconditional right of return period. The Company establishes estimated provisions for returns at the time of sale based on historical experience. Historically, the actual product returns have been immaterial to the Company's consolidated financial statements.
As of
Revenue for ClotTriever and FlowTriever products as a percentage of total revenue was derived as follows:
Years Ended December 31, 2021 2020 2019 ClotTriever 32 % 37 % 38 % FlowTriever 68 % 63 % 62 %
The Company offers payment terms to its customers of less than three months and these terms do not include a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price.
The Company offers its standard warranty to all customers. The Company does not sell any warranties on a standalone basis. The Company's warranty provides that its products are free of material defects and conform to specifications, and includes an offer to repair, replace or refund the purchase price of defective products. This assurance does not constitute a service and is not considered a separate performance obligation. The Company estimates warranty liabilities at the time of revenue recognition and records it as a charge to cost of goods sold. The warranty liability as ofDecember 31, 2021 and 2020 and warranty cost recognized for the years endedDecember 31, 2021 , 2020 and 2019 were not significant. Costs associated with product sales including commissions are recorded in SG&A expenses. The Company applies the practical expedient and recognizes commissions as expense when incurred because the amortization period is less than one year.
Cash, Cash Equivalents and Short-Term Investments
The Company considers cash on hand, cash in demand deposit accounts including money market funds, and instruments with a maturity date of 90 days or less at date of purchase to be cash and cash equivalents. The Company maintains cash, cash equivalent and restricted cash balances with banks. At times, the cash and cash equivalent balances may exceed federally insured limits. The Company does not believe that this results in any significant credit risk as the Company's policy is to place its cash and cash equivalents in highly-rated financial institutions. Investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company determines the appropriate classification of its investments in available-for-sales debt securities at the time of purchase. Available-for-sale debt securities with maturities greater than 12 months from the balance sheet date are classified as long-term investments on the consolidated balance sheets. Unrealized gains and losses are excluded from earnings and reported as a component of comprehensive income (loss). The Company periodically evaluates whether declines in fair values of its marketable securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company's ability and intent to hold the marketable security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to 69 -------------------------------------------------------------------------------- sell the security or it is more likely than not it will be required to sell any marketable securities before recovery of its amortized cost basis. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on marketable securities are included in other income (expenses), net on the condensed consolidated statements of operations. The cost of investments sold is based on the specific-identification method. Interest on marketable securities is included in interest income.
Accounts Receivable, net
Trade accounts receivable are recorded at the invoiced amount, net of any allowance for credit losses. The Company evaluates the expected credit losses of accounts receivable, considering historical credit losses, current customer-specific information and other relevant factors when determining the allowance. An increase to the allowance for credit losses results in a corresponding increase in selling, general and administrative expenses. The Company charges off uncollectible receivables against the allowance when all attempts to collect the receivable have failed. Despite the Company's efforts to minimize credit risk exposure, customers could be adversely affected if future economic and industry trends, including those related to COVID-19, change in such a manner as to negatively impact their cash flows. The full effects of COVID-19 on the Company's customers are highly uncertain and cannot be predicted. As a result, the Company's future collection experience can differ significantly from historical collection trends. If the Company's clients experience a negative impact on their cash flows, it could have a material adverse effect on the Company's results of operations and financial condition.
Upon adoption of Accounting Standard Update ("ASU") 2016-13, the Company did not
recognize an adjustment to the beginning balance of retained earnings as of
Inventories, net
The Company values inventory at the lower of the actual cost to purchase or manufacture the inventory or net realizable value for such inventory. Cost, which includes material, labor and overhead costs, is determined on the first-in, first out method, or FIFO. The Company regularly reviews inventory quantities in process and on hand, and when appropriate, records a provision for obsolete and excess inventory. The Company writes down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements based on future demand and as compared to remaining shelf life. The estimate of excess quantities is subjective and primarily dependent on the Company's estimates of future demand for a particular product. If the estimate of future demand is inaccurate based on actual sales, the Company may increase the write down for excess inventory for that component and record a charge to inventory impairment in the accompanying consolidated statement of operations and comprehensive income (loss).
Right-of-use Assets and Lease Liabilities
The Company determines if an contractual arrangement contains a lease at its inception and determines the classification of a lease, as either operating or finance, at commencement. Right-of-use assets and lease liabilities are recorded based on the present value of future lease payments which factors in certain qualifying initial direct costs incurred as well as any lease incentives received. If an implicit rate is not readily determinable, the Company utilizes inputs from third-party lenders to determine the appropriate discount rate. Lease expense for operating lease payments are recognized on a straight-line basis over the lease term. Lease terms may factor in options to extend or terminate the lease. The Company adheres to the short-term lease recognition exemption for all classes of assets (i.e. facilities and equipment). As a result, leases with an initial term of twelve months or less are not recorded on the balance sheet and are recognized on a straight-line basis over the lease term. In addition, for certain equipment leases, the Company accounts for lease and non-lease components, such as services, as a single lease component, as permitted. 70 --------------------------------------------------------------------------------
Stock-based Compensation
We maintain an equity incentive plan that permits the grant of share-based awards, such as stock grants and incentives and non-qualified stock options to employees, directors, consultants and advisors. We also offer an employee stock purchase plan which allows participating employees to purchase shares of our common stock at a discount through payroll deductions. We recognize equity-based compensation expense for awards of equity instruments to employees and directors based on the grant date fair value of those awards. We estimate the fair value of our stock option awards made to employees and non-employees based on the estimated fair values as of the grant date using the Black-Scholes option-pricing model, net of estimated forfeitures. The fair value of restricted stock unit ("RSU") awards is determined based on the number of units granted and the closing price of the Company's common stock as of the grant date. The fair value of each purchase under the employee stock purchase plan ("ESPP") is estimated at the beginning of the offering period using the Black-Scholes option pricing model. The model requires us to make a number of assumptions including expected volatility, expected term, risk-free interest rate and expected dividend yield. We expense the fair value of our equity-based compensation awards on a straight-line basis over the requisite service period, which is the period in which the related services are received.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Management assesses the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. As ofDecember 31, 2021 and 2020, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company's policy is to recognize interest and penalties related to the underpayment of income taxes as a component of provision for income taxes.
Recent Accounting Pronouncements
Please refer to Note 2 to our audited consolidated financial statements appearing under Part 2, Item 8 for a discussion of new accounting standards updates that may impact us.
JOBS Act Accounting Election
The JOBS Act allows an emerging growth company to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. EffectiveDecember 31, 2021 , the Company was no longer an "emerging growth company" within the meaning of the JOBS Act and can no longer take advantage of this extended transition period. Prior toDecember 31, 2021 , the Company had elected to use this extended transition period and, as a result, our financial statements may not have been comparable to companies that comply with public company effective dates. 71
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