You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes included in Part II, Item 8 of this Annual Report on Form 10-K. The following discussion and analysis of our financial condition and results of operations contains forward-looking statements about us and our industry that involve substantial risks, uncertainties and assumptions. All statements other than statements of historical facts contained in this item, including statements regarding factors affecting our business, trends and uncertainties, are forward-looking statements. As a result of many factors, including those factors set forth in the "Risk Factors" section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by these forward-looking statements. You should carefully read the "Risk Factors" to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.
Overview
We are a medical device company dedicated to improving the quality of life of people with hearing loss. Our innovative products and go-to-market approach address the major challenges of traditional hearing aid adoption, including social stigma, accessibility and cost.
We believe ourEargo hearing aids are the first ever virtually invisible, rechargeable, completely in-the-canal, FDA-regulated devices indicated to compensate for mild to moderate hearing loss. Our rapid pace of innovation is enabled by our deep industry and technical expertise across mechanical engineering, product design, audio processing, clinical and hearing science, consumer electronics and embedded software design, and is supported by our strategic intellectual property portfolio. We market and sell our hearing aids primarily in a direct-to-consumer format with a personalized, consumer-centric approach. Our commercial organization consists of a marketing team with deep experience in consumer-focused brand and performance marketing, a team of inside sales consultants, and a dedicated customer support team. We believe that our differentiated hearing aids and consumer-oriented approach have fueled the rapid adoption of our hearing aids and high customer satisfaction, as evidenced by over 109,000Eargo hearing aid systems shipped, net of returns, as ofDecember 31, 2022 . To date, all our revenue has been generated from customers inthe United States . For the year endedDecember 31, 2022 , we generated net revenue of$37.2 million , an increase of$5.1 million from the year endedDecember 31, 2021 . Our gross systems shipped during the year endedDecember 31, 2022 were 24,247, compared to 45,136 during 2021. The decrease in shipment volume was largely driven by our decision to temporarily stop accepting insurance benefits as a method of direct payment betweenDecember 8, 2021 andSeptember 15, 2022 . During the year endedDecember 31, 2021 , we recorded adjustments that materially reduced net revenue as discussed in detail below under "-DOJ investigation and settlement and claims audits." Our net losses were$157.5 million ,$157.8 million and$39.9 million for the years endedDecember 31, 2022 , 2021 and 2020, respectively. As ofDecember 31, 2022 and 2021, we had an accumulated deficit of$514.3 million and$356.8 million , respectively. We expect to continue to incur losses for the foreseeable future. As ofDecember 31, 2022 , we had cash and cash equivalents of$101.2 million , which are available to fund operations. As ofDecember 31, 2022 , we had no debt outstanding.
DOJ investigation and settlement and claims audits
As previously disclosed, onSeptember 21, 2021 , we were informed that we were the target of a criminal investigation by the DOJ related to insurance claims we submitted for reimbursement on behalf of our customers covered by various federal employee health plans under the Federal Employee Health Benefits ("FEHB") program, which is administered by theOffice of Personnel Management (the "OPM"). The investigation also pertained to our role in claim submissions to federal employee health plans (collectively, the "DOJ investigation"). Total payments the Company received from the government in relation to claims submitted under the FEHB program, as subject to the DOJ investigation, net of any product returns and associated refunds, were approximately$44.0 million . Also as previously disclosed, the third-party payor with whom historically we had the largest volume, which is one of the carriers contracted with the OPM under the FEHB program ("largest third-party payor"), conducted an audit of insurance claims for reimbursement ("claims") submitted by us (the "Primary Audit"), which included a review of medical records. We were informed by the third-party payor conducting the Primary Audit that the DOJ was the principal contact related to the subject matter of the Primary Audit. In addition to the Primary Audit, we have been subject to a number of other claims audits by additional third-party payors (collectively with the Primary Audit, the "claims audits"). One of these claims audits did not relate to claims submitted under the FEHB program. OnJanuary 4, 2022 , the DOJ confirmed to us that the investigation had been referred to theCivil Division of the DOJ and theU.S. Attorney's Office for the Northern District of Texas and the criminal investigation was no longer active. OnApril 29, 2022 , we entered into a civil settlement agreement with theU.S. government that resolved the previously disclosed DOJ investigation related to our role in claim submissions to various federal employee health plans under the FEHB program. We cooperated fully with the DOJ investigation. We deny the allegations in the settlement agreement, and the settlement is not an 57 -------------------------------------------------------------------------------- admission of liability by us. The allegations did not pertain to the quality or performance of our product. The settlement agreement provided for our payment of approximately$34.4 million to theU.S. government and resolved allegations that we submitted or caused the submission of claims for payment to the FEHB program using unsupported hearing loss-related diagnostic codes. As discussed further in Note 6 to the Consolidated Financial Statements included in this Annual Report on Form 10-K, based on the settlement agreement with theU.S. government, we recorded a settlement liability of$34.4 million in the consolidated balance sheets as ofDecember 31, 2021 . The settlement amount was recorded as a reduction of revenue in the third quarter of 2021. OnMay 2, 2022 , we paid the settlement amount. The settlement with theU.S. government may not resolve all of the claims audits initiated by various third-party payors, and additionally we remain subject to a prepayment review of claims by the payor who conducted the Primary Audit. From the time we learned of the DOJ investigation and untilDecember 8, 2021 , we continued to process orders for customers with potential insurance benefits (including FEHB program members) but suspended all claims submission activities and offered affected customers (i.e., customers using insurance benefits as a method of direct payment for transactions prior toDecember 8, 2021 ) the option to return their hearing aids or purchase their hearing aids without the use of their insurance benefits in case their claim was denied or ultimately not submitted by us to their insurance plan for payment (the "extended right of return").
From
We determined that customer transactions using insurance benefits as a method of direct payment occurring betweenSeptember 21, 2021 (when we learned of the DOJ investigation) andDecember 8, 2021 (when we temporarily stopped accepting insurance benefits as a method of direct payment) did not meet the criteria for revenue recognition and, as a result, we did not recognize revenue for shipments within that timeframe to customers with potential insurance benefits, substantially all of whom were covered under the FEHB program. We previously estimated that a majority of customers with unsubmitted claims would choose to return the hearing aid system if their insurance provider denied their claim or the claim was ultimately not submitted by us for payment, resulting in an increase in expected product returns from sales transactions that occurred prior toSeptember 21, 2021 and recorded during the year endedDecember 31, 2021 . Returns associated with unsubmitted claims reduce the sales returns reserve, with a corresponding reduction in the related accounts receivable at the time the product is returned. We also estimated that, in addition to the customers who chose to return their hearing aid systems, a significant number of customers whose claims were denied by payors or not submitted by us for payment would not pay for or return the hearing aid system, resulting in bad debt expense that was recorded during the year endedDecember 31, 2021 . During the year endedDecember 31, 2022 , we made the determination not to seek payment for approximately$16.1 million from customers with unsubmitted and unpaid claims. We accounted for this decision as a pricing concession (the "Pricing Concession") and, during the year endedDecember 31, 2022 recorded a$16.1 million reduction to our insurance-related accounts receivable balance along with related reduction to net revenue of$11.6 million and an allowance for credit losses balance of$4.5 million for such unsubmitted and unpaid claims. Further, we simultaneously recorded a decrease in our insurance-related sales return reserve of$11.3 million , with a corresponding increase of$11.3 million to net revenue for the year endedDecember 31, 2022 related to unsubmitted and unpaid claims. These changes resulted in a decrease in net revenue of$0.3 million for the year endedDecember 31, 2022 . OnJanuary 5, 2022 , theU.S. District Court for the Northern District of California consolidated three purported securities class actions brought against the Company (as consolidated, the "Securities Class Action"). OnMay 20, 2022 , the lead plaintiffs in the Securities Class Action filed a consolidated amended complaint, which generally alleges that certain of the Company's disclosures about its business, operations and prospects, including reimbursement from third-party payors, violated federal securities laws. Defendants filed a motion to dismiss the consolidated amended complaint onJuly 29, 2022 . The Court granted the defendants' motion to dismiss onFebruary 14, 2023 , and the plaintiffs have untilMarch 16, 2023 , to file a second amended complaint. OnAugust 4, 2022 , theU.S. District Court for the Northern District of California consolidated two verified shareholder derivative complaints brought against certain of our executive officers and current and former members of our board of directors (as consolidated, the "Derivative Action"). The court stayed the consolidated Derivative Action until the resolution of the motion to dismiss the Securities Class Action. See Note 6 of the Notes to Consolidated Financial Statements included in this Annual Report on Form 10-K for more information. 58 --------------------------------------------------------------------------------
As a result of the uncertainty created by the DOJ investigation and the claims audits, we took certain actions including, but not limited to:
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We temporarily restricted our employees from selling Company common stock, ceased granting stock option awards and restricted stock unit ("RSUs") that settle solely in Company common stock, suspended our 2020 Employee Stock Purchase Plan ("ESPP") and temporarily paused the settlement of outstanding RSUs, in each case effective as ofNovember 9, 2021 (collectively, the "employee equity actions"). RSUs that vested onNovember 15, 2021 were settled for$0.1 million in cash during the first quarter of 2022. All RSUs that vested during the year endedDecember 31, 2022 were settled in shares during the reporting period. All outstanding equity awards continued and continue to vest in accordance with their existing vesting schedules.
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Our Board of Directors temporarily suspended the non-employee director compensation program with respect to the option awards that would otherwise have been awarded to non-employee directors automatically on the date of our annual meeting of stockholders held onNovember 9, 2021 . InAugust 2022 , our non-employee directors were granted options having an aggregate grant date fair value of$26.80 per share that vested in substantially equal monthly installments betweenNovember 9, 2021 and the date of the 2022 annual meeting of stockholders, and vested options remain outstanding and exercisable until the later ofDecember 31, 2024 or 3 months following a termination of service.
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OnDecember 7, 2021 , we announced a plan to reduce our employee workforce to streamline our organization in response to declines in customer orders since we announced the investigation of the Company by the DOJ. We substantially completed the employee workforce reduction during the fourth quarter of 2021, resulting in a reduction of approximately 27% of our employee workforce, or approximately 90 people.
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OnMay 24, 2022 , we announced a plan to reduce our employee workforce as part of our cost-cutting measures to reduce operating expenses and preserve capital. We substantially completed the employee workforce reduction during the second quarter of 2022, resulting in a reduction of approximately 17% of our employee workforce, or 44 people.
OnJune 24, 2022 , after reviewing all available alternatives to secure the funding needed to support our ongoing operations and pursuit of our business strategies, and a potential sale of the Company, we entered into an agreement (the "Note Purchase Agreement") withPSC Echo, LP (the "PSC Stockholder"), an affiliate ofPatient Square Capital ("Patient Square"), andDrivetrain Agency Services, LLC , as administrative agent and collateral agent. Pursuant to the Note Purchase Agreement, we issued approximately$105.5 million in two tranches of senior secured convertible notes (the "Notes") and agreed to conduct a rights offering for an aggregate of 18.75 million shares of common stock to stockholders as of a record date determined by our Board, at an offering price of$10.0 per share of common stock (the "Rights Offering"). Pursuant to the Rights Offering, which closed onNovember 23, 2022 , we sold an aggregate of approximately 2.9 million shares to our existing stockholders, from which we received net proceeds of$27.6 million , and, in accordance with the terms of the Note Purchase Agreement, the Notes converted into 15,821,299 shares of our common stock (the "Conversion Shares"), in each case, on a post-reverse stock split basis, representing approximately 76.3% of our outstanding common stock as of the date of conversion. In connection with the Note Purchase Agreement, we had also entered into an Investors' Rights Agreement with the PSC Stockholder, pursuant to which, among other things, the PSC Stockholder has the right to nominate a number of directors to our Board that is proportionate to the PSC Stockholder's ownership of the Company, rounded up to the nearest whole number (and which shall in no event be less than one). As a result, following the closing of the Rights Offering and the conversion of the Notes, the PSC Stockholder has the right to nominate six directors to our Board. The PSC Stockholder exercised its right to nominate three directors to the Board,Trit Garg , M.D.,Karr Narula andJustin Sabet-Peyman , inDecember 2022 . As ofMarch 20, 2023 , the PSC Stockholder held 15,821,299 shares, representing approximately 76.3% of our outstanding common stock. As a result of Patient Square's ownership position, we are considered a "controlled company" within the meaning of the marketplace rules (the "Listing Rules") of theNasdaq Stock Market ("Nasdaq") and Patient Square may be able to determine all matters requiring stockholder approval.
Reverse Stock Split
OnOctober 12, 2022 , at our 2022 annual meeting of stockholders, our stockholders approved an amendment to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our common stock, at a ratio in the range of 1-for-5 to 1-for-50, with such ratio to be determined by the Board. OnJanuary 11, 2023 , we announced that the Board had approved a 1-for-20 reverse stock split (the "Reverse Stock Split"), and onJanuary 17, 2023 , the Reverse Stock Split was effected. Our common stock began trading on a split-adjusted basis onJanuary 18, 2023 . All share and per share information presented in this Annual Report on Form 10-K has been retrospectively adjusted to reflect the Reverse Stock Split. 59 --------------------------------------------------------------------------------
Factors affecting our business
Our business priorities include: (i) accessing insurance coverage forEargo hearing aids, including potentially regaining insurance coverage ofEargo hearing aids for government employees under the FEHB program; (ii) refining and expanding our retail strategy; (iii) optimizing our cash-pay business; and (iv) continuing to invest in innovation. We believe that our future performance will depend on many factors, including those described below and in the section titled "Risk Factors" included elsewhere in this Annual Report on Form 10-K.
Our direct-to-consumer and omni-channel business model
We sell our hearing aids primarily on a direct-to-consumer basis, engaging consumers through a mix of digital and traditional marketing as well as select commercial partnership, omni-channel (including retail) and other opportunities that are designed to appeal to prospective customers on a personal level and build our brand. Via our direct-to-consumer model, customers are able to complete purchases over the phone with anEargo sales consultant or directly on our website. TheEargo purchasing experience is designed to be simple and to improve the accessibility of hearing aids. Following theUnited States Food and Drug Administration ("FDA") final rule regarding the creation of a new category of over-the-counter ("OTC") hearing aids (the "OTC Final Rule"), we have focused efforts on transitioning to the new OTC framework and exploring select additional commercial partnerships, omni-channel (including retail) and other opportunities. For example, we have a commercial arrangement with Victra, one of America's largest wireless retailers, to facilitate access to our hearing screeners and demonstrate our devices at approximately 1,500 Victra store locations across the country; customers are also able to purchase or orderEargo hearing aids at such store locations. We believe that the OTC Final Rule may facilitate the opportunity to execute additional commercial partnerships, expanding our customers' ability to learn about our hearing aids, obtain general information about their hearing through our current hearing screeners, and experience our devices in person prior to purchasing or ordering directly at retail locations. Moreover, following the effective date of the OTC Final Rule, we have partnered with certain resellers and other distributors, including benefits managers, to offerEargo hearing aids for sale through their online storefronts or portals. Under these partnerships, we sellEargo hearing aids to resellers at wholesale prices, who in turn offer our products to end-customers through their respective online storefronts or portals. Generally, we fulfill and ship orders placed through these online storefronts or portals directly to end-customers, and we generally do not submit insurance claims on behalf of customers who purchase from one of these authorized resellers, including Victra. We believe these partnerships will help expand consumer access to our hearing aids and allow us to target high-intent customers more efficiently. We continue to look for additional partners to help expand our customer base. Once a customer purchasesEargo hearing aids, whether directly through us or through one of our partners, distributors, or authorized resellers, they are assigned to one of our hearing professionals, who provides complimentary, convenient support by phone, chat or e-mail. Our hearing professionals and customer care team are also available to provide unlimited support for as long as the customer owns anEargo device. Additionally, we provide short, online training videos and other resources that customers can access online. The combination of these services allows us to deliver remote customer support in an efficient and streamlined manner. We believe our business model and consumer-centric focus offer certain advantages relative to traditional sales channels (which are characterized by a business-to-business model in which hearing aid manufacturers rely on a fragmented network of independent audiology clinics to sell their devices to consumers), including in particular the convenience and accessibility of our remote customer support as well as our consumer-centric focus. We offer free online education, convenient consultation and remote customer support, the ability to easily purchase theEargo system, and fast delivery.
Changes to the regulatory landscape
Hearing aids are considered medical devices subject to regulation by the FDA. OnAugust 17, 2022 , the FDA published the OTC Final Rule, which established new regulatory categories for OTC and prescription hearing aids. The OTC Final Rule implements relevant provisions of the FDA Reauthorization Act of 2017 ("FDARA"), which set forth requirements for the FDA to create a new category of OTC hearing aids that are intended to be available without supervision, prescription, or other order, involvement or intervention of a licensed practitioner. Prior to the effective date of the OTC Final Rule, no OTC category of hearing aids existed. Following publication of a proposed rule inOctober 2021 , the FDA issued its OTC Final Rule with requirements for labelling, conditions of sale, performance standards, design requirements and other provisions under which manufacturers may elect to market hearing aids as either OTC or prescription devices, or both. In addition, under FDARA, the OTC hearing aid controls promulgated in the OTC Final Rule preempt any state or local requirement specifically related to hearing products that would restrict or interfere with commercial activity involving OTC hearing aids. The OTC Final Rule became effective onOctober 17, 2022 , although certain previously marketed devices have untilApril 14, 2023 to come into compliance with the OTC Final Rule. We have marketed in the past, and continue to market, certainEargo system devices as Class I air-conduction or Class II wireless air-conduction hearing aids under existing regulations at 21 CFR 874.330 and 874.3305, respectively, both of which are exempt from 510(k) premarket review. InJune 2022 , we submitted a 510(k) premarket notification seeking FDA clearance of expanded labelling 60 -------------------------------------------------------------------------------- for ourEargo 5 andEargo 6 hearing aids under the "self-fitting" regulation at 21 CFR 874.3323. InDecember 2022 , we received FDA 510(k) clearance forEargo 5 andEargo 6 as Class II self-fitting air-conduction hearing aids. Additionally, inJanuary 2023 , we launched theEargo 7 as our third over-the-counter, 510(k) cleared self-fitting device. We plan to market our devices as OTC hearing aids and intend to comply with all applicable OTC regulatory requirements as of the compliance date for currently marketed devices onApril 14, 2023 , or sooner. We may also seek to market certain devices as prescription hearing aids, which would require compliance with separate physical and electronic labeling requirements under the OTC Final Rule. In connection with the OTC Final Rule, we have expended, and will continue to expend, significant time and resources evaluating the OTC Final Rule and ensuring that our devices and processes comply with the new requirements in order to market our products in line with our primary direct-to-consumer business and omni-channel models. It is possible that the OTC Final Rule may lead to additional commercial partnership, omni-channel, including retail, or other opportunities, although there are no assurances that it will do so. The OTC Final Rule and the responses thereto by leading insurance providers could also materially impact our efforts to resume submitting claims for customers with potential insurance benefits or have other unforeseen impacts on our business and results of operations. Please see the Risk Factors titled, "Changes in the regulatory landscape for hearing aid devices could materially impact our direct-to-consumer business model and lead to increased regulatory requirements, and we may be required to seek additional clearance or approval for our products" and "Our hearing aids are subject to extensive government regulation at the federal and state level, and our failure to comply with applicable requirements could harm our business" for more information. Insurance-related business A significant portion of our revenue has historically been dependent on payments from third-party payors; for example, in the year endedDecember 31, 2021 , 44% of total gross systems shipped were to customers with potential insurance coverage. Historically, we submitted claims on behalf of our customers to a concentrated number of third-party payors under certain benefit plans, and substantially all such claims related to the FEHB program. See "-DOJ investigation and settlement and claims audits" for a discussion of the DOJ investigation and settlement as well as claims audits prior to the resumption of our insurance claims submissions practices inSeptember 2022 . BetweenDecember 8, 2021 andSeptember 15, 2022 , we did not accept insurance benefits as a direct method of payment to the Company, a practice we refer to as "direct plan access." In "direct plan access," we submit an insurance claim on behalf of anEargo customer to their insurance plan, or support anEargo customer in their own claim submission, and the customer's insurance benefits are utilized for the purchase, in whole or in part. Common forms of utilization can include, but are not limited to, co-pay, payment by a third-party payor to eitherEargo or the customer, reimbursement by a third-party payor to the customer, or application toward a customer's deductible. Because we do not currently have contracts with any FEHB carriers, third-party payors, or other insurance providers, our products are considered out-of-network with such payors and insurance providers. We do not believe that the reimbursement amounts, patient co-payment amounts, or the claims submission process, including medical necessity and other documentation requirements, depend on whether we are in-network or out-of-network with that FEHB carrier or other FEHB plans. To illustrate, the hearing aid benefit in an FEHB plan is a set amount that covers the hearing aid itself and related fees and supplies, regardless of the plan option and regardless of whether the hearing aid is provided by a preferred, participating, or non-participating provider (i.e., regardless of whether it is in-network or out-of-network), which is not always the case for other benefit categories. However, depending on the FEHB carrier or third-party payor, payment may be made directly to the patient rather than to us ifEargo is out-of-network. Beginning onSeptember 15, 2022 , we resumed our direct plan access insurance-based business, accepting insurance benefits as a method of direct payment in certain limited circumstances, when the customer has undergone additional testing by an independent, licensed healthcare provider to establish medical necessity, with supporting clinical documentation. We are evaluating additional alternatives for testing or establishing medical necessity, including, but not limited to, contracting with third parties or existing networks of licensed healthcare providers, and/or establishing a management services organization, separate from our existing corporate structure, that manages professional entities that employ licensed healthcare providers. These alternatives involve significant time and related activities, including, but not limited to, development of additional internal processes, training, and compliance and quality control programs, coordination with external healthcare providers and professional services organizations, and evaluation of and compliance with state-by-state regulatory requirements. We cannot provide any assurance as to the efficacy of the processes that we have established or the extent to which such processes will need to be changed, or additional processes established, or the associated timing or costs, whether we will be successful in implementing any of them, or the impact that such processes and changes may have on our business and operations. If we are unable to successfully implement at least one of these alternatives for testing, or to otherwise establish additional acceptable processes to support claims that we may submit for reimbursement, we expect that we may not be able to submit future claims in sufficient volume to meaningfully restore or expand the amount of our insurance-based business related to direct plan access. In addition, it is possible that such testing would be required to be conducted in-person, representing a significant change from our past processes and customer experience that may adversely impact the attractiveness of our offerings to customers, and we may not be able to efficiently or effectively integrate such tests into our operating model. Further, the OTC Final 61 -------------------------------------------------------------------------------- Rule may lead payors to take additional actions, such as excluding OTC hearing aids from coverage, further limiting our ability to access insurance coverage, or there may be a delay in accessing insurance coverage as payors seek to address the OTC Final Rule in their offered benefits, if at all, any of which may have a material adverse effect on our financial condition, results of operations or cash flows. We are also seeking to establish relationships with benefits managers or managed care providers. Employer self-funded plans or other health plans may at times offer supplemental benefits, which may include hearing aid benefits or general "over-the-counter" benefits; they may in those cases contract with benefits managers or managed care providers in the administration of such supplemental benefits. In this role, among other things, benefits managers are responsible for selecting benefits vendors, i.e., vendors whose products or services are eligible to be covered by the supplemental benefit. The vendors themselves, orEargo in this role, are not responsible for claims submissions but instead fulfill the product order from the customer through the benefits manager. We cannot provide any assurances that we will be able to maintain or increase our participation in arrangements with third-party payors, insurance carriers, benefits managers, or managed care providers or that we will be adequately reimbursed or otherwise paid by such parties for the products we sell, which may have a material adverse effect on our financial condition, results of operations or cash flows. In light of the DOJ investigation, claims audits and the OTC Final Rule, we have made and may continue to need to make significant changes to our business and operating model, including a potential long-term shift to a model without a meaningful insurance-related business, which would likely result in a sustained increased cost of customer acquisition and require identification of commercial partnership, omni-channel, including retail, or other opportunities, to drive cost efficient acquisition of customers. See "-DOJ investigation and settlement and claims audits" for more information. Please see the Risk Factors titled, "We are subject to risks from legal proceedings, investigations, and inquiries, including a number of recent legal proceedings and investigations, which have had and could continue to have a material adverse effect on our reputation, business, financial condition, cash flows and results of operations, and could result in additional claims and material liabilities," and "We face considerable uncertainty in our business prospects, as a significant portion of our revenue has historically been dependent upon reimbursement from third-party payors participating in the FEHB program, but we have operated on a primarily "cash-pay" basis sinceDecember 8, 2021 . We may be unsuccessful in validating and establishing processes to support the submission of claims for reimbursement from third-party payors participating in the FEHB program in the future. As a result, we have faced a significant reduction in revenue and any failure to establish processes to support reimbursement from third-party payors in the future may significantly and adversely impact our business and growth prospects and our ability to sell our products."
Efficient acquisition of new customers
We have spent significant amounts on sales and marketing designed to build a strong brand, achieve broad awareness of ourEargo system, acquire new customers and convert sales leads. Since our public disclosure of the DOJ investigation onSeptember 22, 2021 and our related decision to temporarily stop accepting insurance benefits as a method of direct payment betweenDecember 8, 2021 andSeptember 15, 2022 , we have experienced and may continue to experience a material decline in sales and gross systems shipped. FromDecember 8, 2021 untilSeptember 15, 2022 , as a result of the DOJ investigation and claims audits (as further described in "-DOJ investigation and settlement and claims audits"), we did not accept insurance as a direct method of payment to the Company (referred to as "direct plan access"). Instead, all sales within such timeframe were to customers we refer to as "cash-pay" or "self-pay" customers, which includes upfront payment, credit card, third-party financing, and third-party distributor, authorized reseller or partner payments. We have refocused our sales and marketing efforts and related spend to prioritize conversion of cash-pay consumer leads into satisfied customers. While we intend to continue to work with third-party payors with the objective of validating and establishing additional processes to support any future claims that we may submit for reimbursement, we may not be able to arrive at additional acceptable processes or submit future claims in sufficient volume to meaningfully restore or expand our insurance-based business. The shift to a primarily "cash-pay" model, with minimal volume from our customers using insurance benefits as a direct method of payment toEargo , will likely result in a sustained increased cost of customer acquisition and require significant sales and marketing investments, based on the historically lower conversion rate for cash-pay customers as compared to direct plan access insurance customers. We anticipate that our expansion into retail locations may allow for a more streamlined sales process; however, it may not ultimately reduce our cost of customer acquisition due to new sales and marketing initiatives related to such expansion. We are currently unable to predict whether our expansion into retail locations will affect the return rate for our cash-pay customers, and the impact any such change may have on our cost of customer acquisition. Further, the low volume of direct plan access insurance customers using insurance as a direct payment method may also necessitate identifying commercial partnerships, omni-channel, including retail, or other opportunities, as well as the potential implementation of cost-savings measures, in order to drive cost-efficient cash-pay customer acquisition and offset the significantly higher return rates as well as the related negative impact on revenue and gross margin historically applicable to cash-pay customers. 62 --------------------------------------------------------------------------------
Sales returns rate
Our return policy generally allows our customers to return hearing aids for any reason within the first 45 days of delivery for a full refund, subject to a handling fee in certain states, and can be extended under certain circumstances, including, for example, the previously extended right of return offered for shipments made prior to 2022 involving insurance payors. Historically, the most commonly cited reason for returning our hearing aids is unsatisfactory fit, which we believe is a by-product of our direct-to-consumer model and online distribution that results in nearly all of our customers ordering our product without trying it first. In addition to unsatisfactory fit, the next most cited reason for returns is that our hearing aids do not provide sufficient audio amplification. We report revenue net of expected returns, which is an estimate informed in part by historical return rates. As such, our returns rate impacts our reported net revenue and gross profit or loss. Sales returns rates, as defined under "-Key business metrics," were 34% and 32% for the years endedDecember 31, 2022 and 2021, respectively. New product introductions Our technical capabilities and commitment to innovation have allowed us to deliver product enhancements on a rapid development timeline and support a compelling new product roadmap that we believe will continue to differentiate our competitive position over the next several years. With the full commercial launch of theEargo 7 inFebruary 2023 , we have now launched seven generations of our hearing aids since 2017, with each iteration having increased functionality and improved sound quality, amplification, noise reduction, physical fit, comfort, water resistance and ease-of-use, as well as reduced costs of goods and better connectivity. We are focused on continuing to launch new versions of theEargo hearing aid devices that further improve these attributes. We believe that the continued introduction of new products is critical to maintaining existing customers, attracting new customers, achieving market acceptance of our products and maintaining or increasing our competitive position in the market. We expect to continue refining and improvingEargo hearing aids, and we have the intention of an approximate annual cadence of new product launches. To this end, we are working on the development of a cost-conscious offering as well as the nextEargo hearing aid model with improved functionality. Accordingly, we expect to continue to invest in research and development to support new product introductions. In connection with our product innovation and iteration, we also need to successfully manage our product transitions to avoid delays in customer purchases, excess or obsolete inventory and increased returns as customers wait for our new products to become available. Our development priorities are focused, in part, on expanding refurbishment capability for returned hearing aids. Our refurbishment capabilities are focused on components and allow us to reuse certain key components from our returned devices.
Recruitment and retention of personnel
Our success depends in part upon our continued ability to recruit, retain and motivate high-quality employees, including management, administrative, our clinical and scientific personnel and our direct sales force (among others), and competition for qualified personnel can be intense due to the limited number of individuals possessing the requisite training, skill and experience we require. As a result of uncertainty created by the DOJ investigation and the claims audits, we temporarily suspended our practice of granting equity awards, suspended our employee stock purchase plan and deferred the settlement of outstanding restricted stock units, in each case effective as ofNovember 9, 2021 . We resumed granting RSUs onMarch 18, 2022 and resumed granting stock option awards onAugust 23, 2022 . However, as ofFebruary 1, 2023 , we have again suspended our practice of granting RSUs. In addition, onDecember 7, 2021 , we announced a plan to reduce our employee workforce to streamline our organization in response to declines in customer orders since we announced the DOJ investigation. We substantially completed the employee workforce reduction during the fourth quarter of 2021, resulting in a reduction of approximately 27% of our employee workforce, or approximately 90 people. OnMay 24, 2022 , we announced a plan to further reduce our employee workforce as part of continued cost-cutting measures to reduce operating expenses and preserve capital. We substantially completed the employee workforce reduction during the second quarter of 2022, resulting in a reduction of approximately 17% of our employee workforce, or 44 people. Future suspension of equity awards, including of our practice of granting RSUs, and reductions in workforce, in addition to any negative perceptions of employment with us as a result of the DOJ investigation, the settlement with theU.S. government, and the claims audits, could continue to adversely affect employee morale and have a material adverse impact on our ability to recruit, retain and motivate the high-quality employees critical to our operations, which in turn could have a material adverse effect on our business, results of operations and financial condition.
Macroeconomic environment
Our business, results of operation and financial condition are dependent on macroeconomic conditions. We face domestic as well as global macroeconomic challenges, particularly in light of the effects of the COVID-19 pandemic, inflationary trends, uncertainty or volatility in the market (including recent and potential disruption in the banking system and financial markets) and geopolitical events (such as the conflict inUkraine and tensions across theTaiwan Strait ). We believe the COVID-19 pandemic accelerated the pace of consumer awareness of our vertically integrated remote customer support model and facilitated customer adoption of the same. Shelter-in-place restrictions and increased reluctance of consumers to conduct 63 -------------------------------------------------------------------------------- in-person activities, particularly among older individuals that comprise a majority of the population needing hearing aids, resulted in increased knowledge of our business and sales and a potential acceleration of consumer acceptance of our primarily direct-to-consumer business model. However, we cannot be sure whether this trend in consumer behavior will persist or if consumers will instead return to pre-pandemic patterns. In addition, the benefits of such trends in consumer behavior, to the extent they persist, may be outweighed by other macroeconomic factors, including, but not limited to, inflationary pressures, financial market volatility, and slower growth or recession, which can adversely impact consumer confidence and result in lower discretionary consumer spending. If these macroeconomic pressures continue or increase, we may experience an adverse impact on demand for our products. Additionally, our business is also subject to disruptions in the banking system and financial markets and other uncertainties or volatility in the markets. For example, onMarch 10, 2023 , theFederal Deposit Insurance Corporation (the "FDIC") took control and was appointed receiver ofSilicon Valley Bank ("SVB"). Although theFDIC ultimately announced that it would pay all deposits, including deposits that exceededFDIC -insured amounts, we and other SVB customers initially were not able to access our accounts and faced significant uncertainty about whether and when we would be able to fully access amounts held through SVB, which would have had several follow-on consequences with respect to our ability to meet our near-term payment obligations. If other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition. In addition, even if we lack exposure to the uncertainty or volatility of one or more financial institutions, the impact of financial institution volatility on our partners, customers or suppliers may also impact our business and financial condition. We rely on a number of international suppliers and manufacturers, including our primary manufacturer, Pegatron Corporation, who is headquartered inTaiwan , which exposes us to foreign operational and political risks such as changes in trade policies and export regulations betweenthe United States and other countries or geopolitical conflict. Additionally, although we believe the COVID-19 pandemic has largely resulted in favorable consumer trends for our business, travel restrictions, factory closures and disruptions in global supply chains have resulted in industry-wide component supply shortages (such as in semiconductors), and we may not be able to obtain adequate inventory on a timely basis or at all. To date, increases in component pricing have occurred but have not had a material impact on supply continuity or gross margin. We have taken steps to monitor our supply chain and actions to address limited supply and increasing lead times, including outreach to critical suppliers and spot market purchases. While we have not experienced any significant disruptions to our supply chain that have impacted our ability to service customers or our access to necessary raw materials and component parts for the manufacture of our products to date, disruptions have occurred across a number of industries and we cannot provide any assurance that future disruptions will not emerge as a result of the ongoing supply chain issues, inflation, the COVID-19 pandemic, geopolitical events or other extrinsic factors. Future disruptions in our supply chain, including the sourcing of certain components and raw materials, such as semiconductor and memory chips, as well as increased logistics costs, could impact our revenue and gross margins. For a further discussion of trends, uncertainties and other factors that could impact our operating results, see the section titled "Risk Factors" in Item 1A of Part I in this Annual Report on Form 10-K.
Key business metrics
To analyze our business performance, determine financial forecasts and help develop long-term strategic plans, we review the following key business metrics, each of which is an important measure that represents the state of our business:
•
Gross systems shipped. We define our gross systems shipped as the number of hearing aid systems shipped during the period. Since our public disclosure of the DOJ investigation onSeptember 22, 2021 and our related decision to temporarily stop accepting insurance benefits as a method of direct payment betweenDecember 8, 2021 andSeptember 15, 2022 , we have experienced and may continue to experience a material decline in gross systems shipped. Beginning onSeptember 15, 2022 , we resumed accepting insurance benefits as a method of direct payment in certain limited circumstances and for which revenue is and has been recognized. Continued negative publicity, including in relation to the DOJ investigation and settlement, the claims audits, and other legal proceedings could further harm our reputation and lead to a further decline in gross systems shipped. See "-DOJ investigation and settlement and claims audits" and "-Factors affecting our business."
•
Sales returns rates. Sales returns rates are determined by management at the end of each reporting period to estimate the percentage of products for which we have recorded revenue during that period that are expected to be returned. This determination is informed in part by historical actual return rates. Sales returns rates do not represent actual returns during a period as customers may return the product for a period of time that can extend beyond the period end, which can result in a hearing aid being returned after the period in which the revenue from its sale was recognized. If actual returns differ from the sales returns rate determined at period end or new factors arise, indicating a rate of return that is different from the original estimated sales returns rate, revenue is adjusted in subsequent periods to reflect the actual returns made. Such an adjustment to revenue is not included in the sales returns rates disclosed in the table below. 64 --------------------------------------------------------------------------------
The following table details the number of gross systems shipped and sales returns rates for the periods presented below:
Three months ended Mar 31, Jun 30, Sep 30, Dec 31, Mar 31, Jun 30, Sep 30, Dec 31, 2021 2021 2021 2021 2022 2022 2022 2022 Gross systems shipped 11,704 12,548 13,117 7,767 5,773 4,455 5,156 8,863 Sales returns rate 23.2 % 24.1 % 46.4 % 34.0 % 33.9 % 33.3 % 32.3 % 34.9 % During the twelve months endedDecember 31, 2022 and 2021,Eargo shipped 24,247 and 45,136 gross hearing aid systems, respectively, of which less than 1% and 44%, respectively, were to customers with potential insurance coverage. We made the decision to temporarily stop accepting insurance benefits as a method of direct payment betweenDecember 8, 2021 andSeptember 15, 2022 . BeginningSeptember 2022 , we resumed accepting insurance benefits as a method of direct payment in certain limited circumstances and for which revenue is and has been recognized. Additionally, during the fourth quarter of 2022, we shippedEargo hearing devices to Victra, our retail partner, for in-person customer sales at its approximately 1,500 store locations acrossthe United States , for which we recognize revenue upon shipment to our retail partner. We believe these key business metrics provide useful information to help investors understand and evaluate our business performance. Gross systems shipped is a key measure of sales volume, which drives potential revenue, while sales returns rates are an indicator of expected reductions to revenue and an indicator of change in customer mix and factors affecting the returns rates by customer type. However, as discussed elsewhere in this report, our sales volume, sales returns rate and revenue during the current period were not consistent with the prior periods as a result of the DOJ investigation and settlement and claims audits. See "-DOJ investigation and settlement and claims audits." Due to the historically higher return rate for cash-pay customers as compared to insurance customers, we expect that revenue, gross profit and gross margin may remain depressed as compared to prior periods for so long as there is minimal volume from our customers using insurance benefits as a direct method of payment toEargo ; however, we are currently unable to predict whether the expansion of our omni-channel strategy (including retail and other partners) will affect our return rate for cash-pay customers, and the impact any such change may have on our revenue, gross profit and gross margin.
Components of our results of operations
See the discussion under "-DOJ investigation and settlement and claims audits," which describes a variety of circumstances currently affecting our business and results of operations, and which require that we continually evaluate and adapt our business model and expenditures as new information becomes available.
Revenue, net
We generate revenue primarily from the sale ofEargo hearing aid systems. We market a variety of models of hearing aids, each at different price points, and we periodically offer discounts and promotions, including holiday promotions. For product sales, control is transferred upon shipment to the customer. We report revenue net of expected returns, which is an estimate informed in part by historical return rates. Since learning of the DOJ investigation, we temporarily suspended all insurance claims submissions and, fromDecember 8, 2021 untilSeptember 15, 2022 , did not accept insurance as a direct method of payment. Instead, we focused our efforts on cash-pay customers, which includes upfront payment, credit card payments, third-party financed payments and distributor payments. Historically, cash-pay customers have had significantly higher return rates than customers with potential insurance benefits, and therefore the potential long-term shift to primarily cash-pay sales may adversely impact revenue, net. Beginning onSeptember 15, 2022 , we resumed accepting insurance benefits as a method of direct payment in certain limited circumstances.
Cost of revenue and gross margin
Cost of revenue consists of expenses associated with the cost of finished goods, freight, personnel costs, consumables, product warranty costs, transaction fees, reserves for excess and obsolete inventory, depreciation and amortization, and related overhead. Our gross margin has been and will continue to be affected by a variety of factors, including sales volumes, product mix, channel mix, pricing strategies, sales returns rates, costs of finished goods, product warranty claim rates and refurbishment strategies, and our ability to service insurance customers and any potential actions insurance providers may take following the implementation of theFDA's new OTC hearing aid regulatory framework that may limit our ability to access insurance coverage. We expect our gross margin to remain depressed for so long as there is minimal volume from our customers using insurance benefits as a direct method of payment toEargo , unless we can successfully target and convert new customers with a similarly low rate of return. 65 --------------------------------------------------------------------------------
Research and development expenses
Research and development ("R&D") expenses, consist primarily of engineering and product development costs to develop and support our products, regulatory expenses, non-recurring engineering and other costs associated with products and technologies that are in development, as well as related overhead costs. These expenses include personnel-related costs, including salaries and stock-based compensation, supplies, consulting fees, prototyping, testing, materials, travel expenses, depreciation and allocated facility overhead costs. Additionally, R&D expenses include internal and external costs associated with our regulatory compliance and quality assurance functions and related overhead costs.
Sales and marketing expenses
Our sales and marketing expenses have generally been the largest component of our operating expenses and consist primarily of personnel-related costs, including salaries and stock-based compensation, direct and channel marketing, advertising and promotional expenses, consulting fees, public relations costs and allocated facility overhead costs. Sales and marketing personnel include our direct sales force consisting of inside sales consultants, hearing professionals, marketing professionals and related support personnel. We expect our sales and marketing expenses to fluctuate over time as a percentage of revenue. In response to the factors discussed in "-DOJ investigation and settlement and claims audits," we have reduced sales and marketing resources that were previously focused on insurance customers to prioritize the conversion of cash-pay consumers into satisfied customers, including the 2021 and 2022 reductions in force.
General and administrative expenses
Our general and administrative expenses consist primarily of compensation for executive, finance, legal, information technology and administrative personnel, including stock-based compensation. Other significant expenses include professional fees for legal and accounting services, transaction fees, consulting fees, recruiting fees, information technology costs, corporate insurance, bad debt expense, general corporate expenses and allocated facility overhead costs. Excluding the costs associated with the DOJ investigation, we expect our general and administrative expenses will increase in absolute dollars in future periods as a result of operating as a public company, including expenses related to compliance with the rules and regulations of theSEC , and those of theNasdaq Stock Market , additional insurance costs, investor relations activities and other administrative and professional services, as well as professional service and legal fees and expenses related to shareholder litigation that has been filed and that may be filed in the future.
Interest income
Interest income consists of interest earned on cash and cash equivalents.
Interest expense
Interest expense consists of interest related to borrowings under our debt obligations. In connection with the fair value option, we elected to present interest expense related to the Notes in the changes in fair value.
Change in fair value of convertible notes
We elected on issuance to account for the Notes at fair value until their settlement. The change in fair value of the convertible notes is recognized in the consolidated statements of operations, with the exception of changes in fair value due to instrument-specific credit risk, which are recorded as a component of other comprehensive income, if present.
Loss on extinguishment of debt
The loss on extinguishment of debt arose from the early repayment of long-term
debt under our 2018 Loan Agreement in
Income tax provision
We use the asset and liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Due to our historical operating performance and our recorded cumulative net losses in prior fiscal periods, our net deferred tax assets have been fully offset by a valuation allowance. Financial statement effects of uncertain tax positions are recognized when it is more-likely-than-not, based on the technical merits of the position, that it will be sustained upon examination. Interest and penalties related to unrecognized tax benefits are included within the provision for income tax. 66 --------------------------------------------------------------------------------
Results of operations
Comparison of the years ended
We made the decision to temporarily stop accepting insurance benefits as a method of direct payment betweenDecember 8, 2021 andSeptember 15, 2022 as a result of the DOJ investigation and claims audits (as further described in "-DOJ investigation and settlement and claims audits"). Beginning in late 2021, as a result of the impact of the DOJ investigation on the Company's business and financial condition, we shifted our strategy to limit our costs, conducted a reduction in force and took other precautionary measures to preserve capital and liquidity. As a result, the following comparison of the 2022 and 2021 fiscal years reflect a trend of decreasing expenditures due to the implementation of capital and liquidity preservation measures. Year ended December 31, Change (dollars in thousands) 2022 2021 Amount % Revenue, net$ 37,248 $ 32,122 $ 5,126 16.0 % Cost of revenue 22,988 27,956 (4,968 ) (17.8 ) Gross profit (loss) 14,260 4,166 10,094 242.3 Operating expenses: Research and development 18,813 25,232 (6,419 ) (25.4 ) Sales and marketing 52,947 85,759 (32,812 ) (38.3 ) General and administrative 54,259 49,882 4,377 8.8 Total operating expenses 126,019 160,873 (34,854 ) (21.7 ) Loss from operations (111,759 ) (156,707 ) 44,948 (28.7 ) Other income (expense), net: Interest income 1,196 21 1,175 * Interest expense (549 ) (1,068 ) 519 (48.6 ) Change in fair value of convertible notes (45,503 ) - (45,503 ) * Loss on extinguishment of debt (772 ) - (772 ) * Total other income (expense), net (45,628 ) (1,047 ) (44,581 ) * Loss before income taxes (157,387 ) (157,754 ) 367 (0.2 ) Income tax provision 100 - 100 * Net loss and comprehensive loss$ (157,487 ) $ (157,754 ) $ 267 (0.2 )% * Not Meaningful Revenue, net Year ended December 31, Change (dollars in thousands) 2022 2021 Amount % Revenue, net$ 37,248 $ 32,122 $ 5,126 16.0 % Gross systems shipped during 2022 were 24,247, compared to 45,136 in 2021, of which less than 1% and 44%, respectively, were to customers with potential insurance coverage. The decrease in shipment volume was largely driven by our decision to temporarily stop accepting insurance benefits as a method of direct payment in the fourth quarter of 2021. BeginningSeptember 2022 , we resumed accepting insurance benefits as a method of direct payment in certain limited circumstances and for which revenue is and has been recognized. Additionally, during the fourth quarter of 2022, we shippedEargo hearing devices to Victra, our retail partner, for in-person customer sales at its approximately 1,500 store locations acrossthe United States , for which we recognize revenue upon shipment to our retail partner. Revenue, which is reported net of consideration payable to customers and expected returns, increased by$5.1 million , or 16.0%, from$32.1 million during the year endedDecember 31, 2021 to$37.2 million during the year endedDecember 31, 2022 . InSeptember 2022 , we made the determination not to seek payment for approximately$16.1 million from customers with unsubmitted and unpaid claims, or the Pricing Concession. This decision resulted in a reduction in net revenue of$0.3 million for the year endedDecember 31, 2022 after the remeasurement of the corresponding sales return reserve and the utilization of the related allowance for expected credit losses. During the year endedDecember 31, 2021 , the$34.4 million settlement amount associated with the DOJ investigation was recorded as a reduction in revenue. Additionally, we previously estimated that a majority of customers with unsubmitted claims as ofDecember 31, 2021 would choose to return the hearing aid system if their insurance provider denied their claim or the claim was ultimately not submitted by us for payment, resulting in an increase in expected product returns from such transactions that occurred prior toSeptember 21, 2021 . As a result, we recorded$13.3 million of estimated sales returns as a reduction in revenue in the third quarter of 2021 related to shipments to customers with potential insurance benefits. Further, we did not recognize revenue and related sales 67 --------------------------------------------------------------------------------
returns reserve on approximately 2,230
Cost of revenue, gross profit, and gross margin
Year ended December 31, Change (dollars in thousands) 2022 2021 Amount % Cost of revenue$ 22,988 $ 27,956 $ (4,968 ) (17.8 )% Gross profit 14,260 4,166 10,094 242.3 % Gross margin 38.3 % 13.0 % Cost of revenue decreased by$5.0 million , or 17.8%, from$28.0 million during 2021 to$23.0 million during 2022. The change was primarily due to the decrease in the volume ofEargo hearing aid systems shipped, partially offset by charges related to certain slow moving inventory items. Gross margin increased to 38.3% during 2022, compared to 13.0% during 2021. The increase in gross margins is primarily due to revenue-related adjustments made in 2021, including the$34.4 million settlement amount associated with the DOJ investigation, the expected increase in product returns from customers with unsubmitted claims, as well as the approximately 2,230Eargo hearing aid systems shipped during the year endedDecember 31, 2021 , for which no revenue was recognized as the transactions did not meet criteria for revenue recognition. Estimated sales returns are recorded as a reduction in revenue. The$18.2 million of estimated sales returns recorded during 2022 significantly decreased from the$37.7 million of estimated sales returns recorded during 2021. The reduction is attributable primarily to$13.3 million recorded during the year endedDecember 31, 2021 for estimated sales returns related to the expected increase in product returns from shipments to customers with potential insurance benefits and the reduction in the number of our gross systems shipped during the year endedDecember 31, 2022 .
Research and development (R&D)
Year endedDecember 31 , Change
(dollars in thousands) 2022 2021 Amount %
Research and development
R&D expenses decreased by$6.4 million , or 25.4%, from$25.2 million during 2021 to$18.8 million during 2022. The change was primarily due to the impact of decreased headcount, a net decrease of$5.5 million in personnel and personnel-related costs due in part to a decrease in stock-based compensation, primarily related to the suspension of our ESPP inNovember 2021 and a reduction in cumulative compensation costs of$1.8 million recognized during the year endedDecember 31, 2022 related to the non-achievement of certain performance targets for restricted stock units. Additionally, during the year endedDecember 31, 2022 , there was a net decrease of$1.1 million in third-party costs subsequent to the commercial launches ofEargo 5 inJuly 2021 andEargo 6 inJanuary 2022 . Sales and marketing Year ended December 31, Change (dollars in thousands) 2022 2021 Amount % Sales and marketing$ 52,947 $ 85,759 $ (32,812 ) (38.3 )% Sales and marketing expenses decreased by$32.8 million , or 38.3%, from$85.8 million during 2021 to$52.9 million during 2022. The change was primarily due to decreases in direct marketing, advertising and promotional expenses of$19.5 million due to a reduction in media spend following our decision to temporarily stop accepting insurance benefits as a method of direct payment onDecember 8, 2021 , and decreases in personnel and personnel-related costs of$13.3 million due to decreased headcount and suspension of our ESPP inNovember 2021 . General and administrative Year ended December 31, Change (dollars in thousands) 2022 2021 Amount % General and administrative$ 54,259 $ 49,882 $ 4,377 8.8 % General and administrative expenses increased by$4.4 million , or 8.8%, from$49.9 million during 2021 to$54.3 million during 2022. This change was primarily due to an increase of$6.6 million in general corporate costs primarily related to legal, accounting, consulting and other professional fees driven by activities related to the DOJ investigation and compliance matters and increase in 68 -------------------------------------------------------------------------------- insurance overhead costs as a result of operating as a public company, and$5.7 million in third-party costs related to the issuance of the Notes. The increase was partially offset by a net decrease in bad debt expense during the year endedDecember 31, 2022 . During the year endedDecember 31, 2021 our bad debt expense was higher by$8.9 million , based on our estimate that a significant number of customers whose claims are denied by insurance providers or not submitted by us for payment may not pay for or return the hearing aid system.
Interest income
Year endedDecember 31 , Change
(dollars in thousands) 2022 2021 Amount %
Interest income
Interest income increased by$1.2 million , from$0.1 million during 2021 to$1.2 million during 2022. The increase in interest income was primarily attributable to the increased interest rates on cash balances during 2022. Interest expense Year ended December 31, Change (dollars in thousands) 2022 2021 Amount % Interest expense$ (549 ) $ (1,068 ) $ 519 (48.6 )% Interest expense decreased by$0.5 million , or 48.6%, from$1.1 million during 2021 to$0.6 million during 2022. The decrease in interest expense was primarily attributable to the repayment of long-term debt under our 2018 Loan Agreement inJune 2022 and our accounting policy election to account for the Notes at fair value and include interest expense related to the Notes in the changes in fair value.
Change in fair value of convertible notes
Year ended December 31, Change (dollars in thousands) 2022 2021 Amount %
Change in fair value of convertible notes
The change in fair value of convertible notes payable of$45.5 million for the year endedDecember 31, 2022 represents the difference between the fair value of the Notes at issuance and the fair value of the Conversion Shares on the dates of settlement. Prior to the closing of the Rights Offering, the fair value of the Notes was estimated as a combination of our equity, an option on our equity valued using the Black-Scholes option pricing model, and a short position in a bond valued under the discounted cash flow model. The conversion date fair value of the Notes was estimated based on the closing price of the Company's common stock adjusted for the impact of certain legal restrictions on the Conversion Shares.
Loss on extinguishment of debt
Year ended December 31, Change (dollars in thousands) 2022 2021 Amount %
Loss on extinguishment of debt
Loss on extinguishment of debt of
69 --------------------------------------------------------------------------------
Comparison of the years ended
Year ended December 31, Change (dollars in thousands) 2021 2020 Amount % Revenue, net$ 32,122 $ 69,154 $ (37,032 ) (53.6 )% Cost of revenue 27,956 21,873 6,083 27.8 Gross profit 4,166 47,281 (43,115 ) (91.2 ) Operating expenses: Research and development 25,232 12,045 13,187 109.5 Sales and marketing 85,759 49,525 36,234 73.2 General and administrative 49,882 20,582 29,300 142.4 Total operating expenses 160,873 82,152 78,721 95.8 Loss from operations (156,707 ) (34,871 ) (121,836 ) 349.4 Other income (expense), net: Interest income 21 37 (16 ) (43.2 ) Interest expense (1,068 ) (1,920 ) 852 (44.4 ) Other income (expense), net - (1,474 ) 1,474
*
Loss on extinguishment of debt - (1,627 ) 1,627
*
Total other income (expense), net (1,047 ) (4,984 ) 3,937
(79.0 ) Loss before income taxes (157,754 ) (39,855 ) (117,899 ) 295.8 Income tax provision - - - - Net loss and comprehensive loss$ (157,754 ) $ (39,855 ) $ (117,899 ) 295.8 % * Not Meaningful Revenue, net Year ended December 31, Change (dollars in thousands) 2021 2020 Amount % Revenue, net$ 32,122 $ 69,154 $ (37,032 ) (53.6 )% Gross systems shipped during 2021 were 45,136, compared to 38,243 in 2020. The increase in shipment volume was largely driven by a continued expansion in national marketing efforts and customer adoption of our telecare model. However, revenue, which is reported net of consideration payable to customers and expected returns, decreased by$37.0 million , or 53.6%, from$69.2 million during the year endedDecember 31, 2020 to$32.1 million during the year endedDecember 31, 2021 . The$34.4 million settlement amount associated with the DOJ investigation was recorded as a reduction in revenue during the year endedDecember 31, 2021 . Additionally, we estimated that a majority of customers with unsubmitted claims will choose to return the hearing aid system if their insurance provider denies their claim or the claim is ultimately not submitted by us for payment, resulting in an increase in expected product returns from such transactions that occurred prior toSeptember 21, 2021 . As a result, we recorded$13.3 million of estimated sales returns as a reduction in revenue in the third quarter of 2021 related to shipments to customers with potential insurance benefits. Further, we did not recognize revenue and related sales returns reserve on approximately 2,230Eargo hearing aid systems shipped during third and fourth quarters of 2021 subsequent to learning of the DOJ investigation, as these transactions did not meet the criteria for revenue recognition. We recognized revenue on approximately 42,910Eargo hearing aid systems shipped to customers during 2021, a 12.2% increase compared to the 38,243Eargo hearing aid systems for which revenue was recognized during 2020. The impact on revenue from an increase in the volume of shipments was offset by the$34.4 million settlement amount, the increase in expected returns from customers with potential insurance benefits and with unsubmitted claims as ofDecember 31, 2021 , and by the hearing aid systems shipped for which we did not recognize revenue.
Cost of revenue, gross profit, and gross margin
Year ended December 31, Change (dollars in thousands) 2021 2020 Amount % Cost of revenue$ 27,956 $ 21,873 $ 6,083 27.8 % Gross profit 4,166 47,281 (43,115 ) (91.2 )% Gross margin 13.0 % 68.4 % 70
-------------------------------------------------------------------------------- Cost of revenue increased by$6.1 million , or 27.8%, from$21.9 million during 2020 to$28.0 million during 2021. The change was primarily due to the increase in the volume ofEargo hearing aid systems shipped, product mix shift towardsEargo 5 which has a higher average product cost, and higher depreciation and software amortization related to theEargo 5 commercial launch inJuly 2021 . Gross margin decreased to 13.0% during 2021, compared to 68.4% during 2020. The decrease in gross margins is primarily due to the$34.4 million settlement amount associated with the DOJ investigation, the expected increase in product returns from customers with unsubmitted claims, the approximately 2,230Eargo hearing aid systems shipped during the third and fourth quarters of 2021 for which we did not recognize related revenue, and a product mix shift towardsEargo 5, which has a higher cost of goods per product sold. Estimated sales returns are recorded as a reduction in revenue. The$37.7 million of estimated sales returns recorded during 2021 is an increase of$15.0 million from the$22.7 million of estimated sales returns recorded during 2020. This change is primarily due to$13.3 million of estimated sales returns recorded during the third quarter of 2021 related to the expected increase in product returns from shipments to customers with potential insurance benefits.
Research and development (R&D)
Year endedDecember 31 , Change
(dollars in thousands) 2021 2020 Amount %
Research and development
R&D expenses increased by$13.2 million , or 109.5%, from$12.0 million during 2020 to$25.2 million during 2021. The change was primarily due to a net increase of$10.6 million in personnel and personnel-related costs, which includes the impact of increased headcount and an increase in stock-based compensation of$6.1 million , and a net increase of$1.8 million in third-party costs related to current and future product development initiatives. Sales and marketing Year ended December 31, Change (dollars in thousands) 2021 2020 Amount % Sales and marketing$ 85,759 $ 49,525 $ 36,234 73.2 % Sales and marketing expenses increased by$36.2 million , or 73.2%, from$49.5 million during 2020 to$85.8 million during 2021. The change was primarily due to increases in direct marketing, advertising and promotional expenses of$18.9 million , partially driven by increased rates due to decreased cable TV viewership in our core demographic, and an increase in personnel and personnel-related costs of$17.3 million , which includes the impact of increased headcount (a trend that was reversed in the fourth quarter of 2021 as further described in the introductory paragraph to this "-Results of operations" and "-DOJ investigation and settlement and claims audits"), higher commissions from increased sales and an increase in stock-based compensation of$9.6 million . General and administrative Year ended December 31, Change (dollars in thousands) 2021 2020 Amount % General and administrative$ 49,882 $ 20,582 $ 29,300 142.4 % General and administrative expenses increased by$29.3 million , or 142.4%, from$20.6 million during 2020 to$49.9 million during 2021. This change was primarily due to an increase in general corporate costs of$14.3 million , an increase in personnel and personnel-related costs of$9.7 million , and a net increase in bad debt expense of$7.3 million . The change in general corporate costs includes$8.4 million in legal and other professional fees as a result of the DOJ investigation as well as increased costs as a result of operating as a public company. The change in personnel and personnel-related costs includes compensation-related costs as a result of increased headcount as well as an increase in stock-based compensation of$6.3 million . The$7.3 million net increase in bad debt expense is primarily based on our estimate that, in addition to the customers who choose to return their hearing aid systems, a significant number of customers whose claims are denied by insurance providers or not submitted by us for payment may not pay for or return the hearing aid system. Interest expense Year ended December 31, Change (dollars in thousands) 2021 2020 Amount % Interest expense$ (1,068 ) $ (1,920 ) $ 852 (44.4 )% 71
-------------------------------------------------------------------------------- Interest expense decreased by$0.9 million , or 44.4%, from$1.9 million during 2020 to$1.1 million during 2021. The decrease in interest expense was primarily attributable to lower long-term debt balance outstanding and lower related interest rate during 2021 as compared 2020.
Other income (expense), net
Year endedDecember 31 , Change
(dollars in thousands) 2021 2020 Amount %
Other income (expense), net $ -
Other income (expense), net during 2020 consisted primarily of adjustments to the fair value of our convertible preferred stock warrant liabilities prior to their reclassification to additional paid-in capital upon the closing of our IPO inOctober 2020 . There was no similar expense in the comparable period of 2021.
Liquidity and capital resources
Sources of liquidity and operating capital requirements
Since our inception, we have incurred net losses and negative cash flows from operations. We have funded our operations primarily from the net proceeds received from the sale of our equity securities, indebtedness and revenue from the sale of our products.
On
Pursuant to the Note Purchase Agreement, the PSC Stockholder agreed to purchase up to an additional$25.0 million of Notes if the Company completed the Rights Offering within 150 days after the First Tranche Closing and the existing stockholders ofEargo subscribed to purchase less than 3,750,000 shares of newly issued common stock in such Rights Offering. The Rights Offering expired onNovember 17, 2022 and existing stockholders ofEargo subscribed for an aggregate of approximately 2.9 million shares of common stock. OnNovember 23, 2022 , the Rights Offering was consummated, and we received net proceeds of approximately$27.6 million from existing stockholders. In accordance with the terms of the Note Purchase Agreement, onNovember 25, 2022 , the PSC Stockholder purchased an additional approximately$5.5 million of aggregate principal amount of Notes (the "Second Tranche Notes"). OnNovember 23, 2022 , the First Tranche Notes converted into an aggregate of 15,000,000 shares of our common stock, and onNovember 25, 2022 the Second Tranche Notes converted into an aggregate of 821,299 shares of our common stock, in each case pursuant to the Note Purchase Agreement. Following such conversion, the PSC Stockholder beneficially owned approximately 76.3% of the outstanding common stock. As ofDecember 31, 2022 , we had no debt outstanding. As ofDecember 31, 2022 , we had cash and cash equivalents of$101.2 million , which are available to fund our operations. Cash and cash equivalents include amounts deposited in financial institutions regulated by theFDIC . TheFDIC insures cash deposits of up to$250,000 . We regularly maintain cash balances in deposit accounts in excess of theFDIC insured limits. Additionally, our cash equivalents are held in accordance with cash sweep arrangements with financial institutions, which amounts are invested in money market accounts that are neither included on the balance sheets of such financial institutions nor insured by theFDIC . According to our cash sweep arrangements, we believe we should be recognized by theFDIC as the owner of such assets in the event of such financial institution's failure, such as theMarch 10, 2023 closure of SVB. While we have regained access to our funds at SVB and are evaluating our banking relationships, future disruptions of financial institutions where we bank or disruptions of the financial services industry in general could adversely affect our ability to access our cash and cash equivalents. If we are unable to access our cash and cash equivalents as needed, our financial position and ability to operate our business could be adversely affected. In addition, even if we lack exposure to the uncertainty or volatility of one or more financial institutions, the impact of financial institution volatility on our partners, customers or suppliers may also impact our business and financial condition. Our net losses were$157.5 million ,$157.8 million and$39.9 million for the years endedDecember 31, 2022 , 2021 and 2020, respectively. We had an accumulated deficit of$514.3 million as ofDecember 31, 2022 . We expect to incur additional substantial losses in the foreseeable future. We believe that without any future financing, our current resources are insufficient to satisfy our obligations as they become due within one year after the date that the financial statements are issued. Our negative cash flows and current lack of financial resources raise substantial doubt as to our ability to continue as a going concern. 72 -------------------------------------------------------------------------------- We anticipate our future operating requirements will be substantial and that we will need to raise significant additional resources to fund our operations through equity or debt financing, or some combination thereof. We are currently exploring fundraising opportunities to meet these capital requirements. If we are unable to raise additional funding to meet our operational needs, we will be forced to limit or cease our operations. In addition to our current capital needs, we regularly consider fundraising opportunities and may decide, from time to time, to raise capital based on various factors, including market conditions and our plans of operation. We may seek funds through borrowings or through additional rounds of financing, including private or public equity or debt offerings. Uncertainty in the market generally due to increasing interest rates and inflation may make it challenging to raise additional capital, and such capital may not be available to us on acceptable terms on a timely basis, or at all. If adequate funds are not available, or if the terms of potential funding sources are unfavorable, our business and our ability to develop our technology and our products would be harmed. Furthermore, any new equity or convertible debt securities we issue may result in the dilution of our stockholders, and any debt financing may include covenants that restrict our business. Our expected future capital requirements and ability to raise additional capital will depend on many forward-looking factors, including but not limited to the following:
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investor confidence in our ability to continue as a going concern;
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the timing, receipt and amount of sales from our current and future products;
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the costs involved in resolving third-party claims audits, as well as other legal proceedings (including the shareholder class action and derivative actions discussed in Note 6 to the Consolidated Financial Statements included in this Annual Report on Form 10-K), and their duration and impact on our business generally;
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the availability of insurance coverage for our hearing aid devices, and any costs associated with reimbursement and compliance, including following the implementation of the OTC Final Rule (which may lead insurance providers to take actions limiting our ability to access insurance coverage), and any resulting changes to our business model, including a potential long-term shift to a model that generally excludes insurance benefits as a method of direct payment toEargo , which would likely result in a sustained increased cost of customer acquisition;
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the cost and timing of expanding our sales, marketing and distribution capabilities;
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any expenses, as well as the impact to our business and operating model, as a result of changes in the regulatory landscape for hearing aid devices;
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the cost of manufacturing, either ourselves or through third-party manufacturers, our products;
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the terms, timing and success of any other licensing, partnership, omni-channel, including retail, or other arrangements that we may establish;
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any product liability or other lawsuits related to our current or future products;
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the expenses needed to attract, hire and retain skilled personnel;
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the extent of our spending to support research and development activities and the expansion of our product offerings;
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the costs associated with being a public company;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing our intellectual property portfolio; and
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the extent to which we acquire or invest in businesses.
Our liquidity is subject to various risks, including the risks identified in the section titled "Risk Factors" in Item 1A of Part I. While the extent to which we are able to validate and establish additional processes to support the submission of claims for reimbursement to health plans, including those under the FEHB program, and the future impacts of the implementation of theFDA's new OTC hearing aid regulatory framework (which may lead insurance providers to take actions limiting our ability to access insurance coverage) are difficult to assess or predict at this time, since the announcement of the DOJ investigation and our related decision to temporarily stop accepting insurance benefits as a method of direct payment betweenDecember 8, 2021 andSeptember 15, 2022 , there has been and may continue to be a significant reduction in shipments, revenue and gross margin which could in the future negatively impact our liquidity and working capital, including by impacting our ability to access any additional capital. 73
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Cash flows
The following table summarizes our cash flows for the periods indicated:
Twelve months ended December
31,
(in thousands) 2022
2021
Net cash used in operating activities
(3,087 ) (7,587 ) Net cash provided by financing activities 111,129
4,358
Net decrease in cash and cash equivalents $ (9,262 )
Operating activities In 2022, cash used in operating activities was$117.3 million , attributable to a net loss of$157.5 million , partially offset by non-cash charges of$69.4 million and a net change in our net operating assets and liabilities of$29.2 million . Non-cash charges primarily consisted of$45.5 million related to the change in fair value of convertible notes,$10.0 million in stock-based compensation,$5.7 million in debt issuance costs from convertible notes,$5.5 million in depreciation and amortization expense,$1.1 million in non-cash operating lease expense,$0.8 million in loss on extinguishment of debt, and$0.7 million in bad debt expense. The change in our net operating assets and liabilities was primarily due to the payment of$34.4 million settlement liability associated with the DOJ investigation, a$9.9 million decrease in sales returns reserve and a$2.8 million decrease in accounts payable. These changes were partially offset by a$9.9 million decrease in accounts receivable, a$4.3 million decrease in prepaid expenses and other current and noncurrent assets, a$3.7 million increase in accrued expenses and a$0.7 million decrease in inventories. In 2021, cash used in operating activities was$98.5 million , attributable to a net loss of$157.8 million , partially offset by non-cash charges of$43.2 million and a net change in our net operating assets and liabilities of$16.1 million . Non-cash charges primarily consisted of$27.7 million in stock-based compensation that includes the amounts recorded upon the suspension of the ESPP in the fourth quarter of 2021,$9.6 million in bad debt expense,$4.2 million in depreciation and amortization expense, and$1.1 million in non-cash operating lease expense. The change in our net operating assets and liabilities was primarily due to the$34.4 million settlement liability associated with the DOJ investigation, a$9.5 million increase in sales returns reserve, and a$3.1 million increase in accounts payable. These changes were partially offset by a$18.4 million increase in accounts receivable, a$7.4 million increase in prepaid expenses and other current and noncurrent assets and a$3.0 million increase in inventories.
Investing activities
In 2022, cash used in investing activities was$3.1 million , which consisted of$2.8 million related to the purchase of property and equipment and$0.3 million in payments for costs related to the development of internal use software capitalized during 2021. In 2021, cash used in investing activities was$7.6 million , which consisted of$3.8 million in capitalized costs related to the development of internal use software,$2.9 million in cash paid for acquisition of a business, and$0.9 million related to the purchase of property and equipment.
Financing activities
In 2022, cash provided by financing activities was$111.1 million . This was primarily attributable to$99.7 million in net proceeds from issuance of the Notes and$27.6 million in net proceeds from issuance of our common stock upon the Rights Offering closing, offset by$16.2 million relating to the repayment of long-term debt under the 2018 Loan Agreement.
In 2021, cash provided by financing activities was
Critical accounting 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. generally accepted accounting principles. Our significant accounting policies and methods used in the preparation of our consolidated financial statements are described in Note 2 of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. The preparation of the consolidated financial statements requires us to make estimates and assumptions regarding 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. The estimates, assumptions and judgments described below involve a substantial level of estimation uncertainty and as a result have had or are reasonably likely to have a material impact on our consolidated financial statements, results of operations and financial condition. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. 74 --------------------------------------------------------------------------------
Revenue recognition-sales returns reserve
Revenue is recorded net of expected returns, which are estimated based on analysis of various factors including historical returns, current economic trends, and changes in customer demand.
As ofDecember 31, 2022 and 2021, we recorded a sales returns reserve of$3.9 million and$13.8 million , respectively, in the consolidated balance sheets. We recorded$18.2 million of estimated sales returns as a reduction in revenue during 2022 based on our estimated returns of products sold during the year, which includes$13.3 million recorded during the third quarter of 2021 primarily based on our estimate that a majority of customers with unsubmitted claims will choose to return the hearing aid system if their insurance provider denies their claim or the claim is ultimately not submitted by us for payment (as further described in "-DOJ investigation and settlement and claims audits"). See also the caption "Sales returns reserve" under Note 4 of the Notes to the Consolidated Financial Statements included in this Annual Report on Form 10-K. The estimated sales returns recorded during the third quarter of 2021 included$5.1 million related to transactions that occurred during the first and second quarters of 2021. These estimates are inherently subject to estimation uncertainty because they assume the potential actions that a substantial number of our insurance pay customers may take as a result of the unavailability of insurance benefits as a direct payment method, which increases the probability of higher returns. If actual returns differ from our estimates or new factors arise indicating a rate of return that is different from our original estimate, an adjustment to revenue in a subsequent period will be recorded, which could have a material impact on our results of operations.
Accounts receivable-estimated credit losses
Accounts receivable is recorded net of an allowance for expected credit losses, which is based on our historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of our customers.
As ofDecember 31, 2022 and 2021, we recorded an allowance for credit losses of$0.2 million and$4.8 million , respectively, in the consolidated balance sheets. We recorded$0.7 million and$9.6 million in bad debt expense during the years endedDecember 31, 2022 and 2021, respectively. Bad debt expense recorded in 2021 was primarily based on our estimate that, in addition to the customers who choose to return their hearing aid systems, a significant number of customers with an extended right of return whose claims are denied by insurance providers or are not submitted by us for payment may not pay for or return the hearing aid system. Of the$9.6 million recorded to bad debt expense during the year endedDecember 31, 2021 ,$5.8 million relates to submitted claims that have been denied or have not been paid and were written off during 2021. During the year endedDecember 31, 2022 , we released$4.5 million from the allowance for credit losses balance as part of the Pricing Concession. See the captions "DOJ investigation and settlement and claims audits" and "Allowance for credit losses" in the Notes 1 and 4 to our Consolidated Financial Statements included in this Annual Report on Form 10-K. As similarly described in "Revenue recognition-sales returns reserve" above, estimates with respect to the actions of our customers, in this case relating to non-payment, are subject to estimation uncertainty, particularly because any attempt to predict the behavior of individual customers can be affected by a variety of external factors. If actual credit losses differ from our estimates or new factors arise indicating credit losses that are different from our original estimate, it could have a material impact on our future operating expenses and results of operations.
Stock-based compensation-valuation of equity awards
The valuation model used for calculating the estimated fair value of stock options and purchase rights granted under the employee stock purchase plan is the Black-Scholes option-pricing model. The Black-Scholes model requires us to make assumptions and judgments about the variables used in the calculations, including the expected term (weighted-average period of time that the stock-based awards are expected to be outstanding), the expected volatility of our common stock, the related risk-free interest rate and the expected dividend. We have elected to recognize forfeitures of stock options as they occur.
The Black-Scholes option-pricing model requires the use of highly subjective assumptions which determine the fair value of stock-based awards. These assumptions include:
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Fair value of common stock. For grants prior to our IPO inOctober 2020 , the fair value of our common stock underlying share-based awards was estimated on each grant date by our board of directors. In order to determine the fair value of our common stock underlying option grants, our board of directors considered, among other things, valuations of our common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by theAmerican Institute of Certified Public Accountants Practice Guide , Valuation of Privately-Held-Company Equity Securities Issued as Compensation. For all grants subsequent to our IPO inOctober 2020 , the fair value of common 75 --------------------------------------------------------------------------------
stock was determined by using the closing price per share of common stock as reported on the Nasdaq Global Select Market.
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Expected term. The expected term represents the period that share-based awards are expected to be outstanding. The expected term for option grants is determined using the simplified method. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the share-based awards.
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Expected volatility. Since we had been privately held and did not have any trading history for our common stock and subsequent to our IPO have limited trading history for our common stock, the expected volatility was estimated based on the average volatility for comparable publicly traded companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty.
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Risk-free interest rate. The risk-free interest rate is based on the
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Expected dividend. We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero.
Recent accounting pronouncements
See Note 2 to our consolidated financial statements appearing under Part II, Item 8 for more information about recent accounting pronouncements, the timing of their adoption, and our assessment.
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