You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q, and for a full understanding ofEargo's results of operations and financial condition, in conjunction with the consolidated financial statements and notes for the fiscal year endedDecember 31, 2021 contained in the Company's Form 10-K filed onMay 13, 2022 . 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 Quarterly Report on Form 10-Q, 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. We developed theEargo solution to create a hearing aid that consumers actually want to use. Our innovative product 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-canal,United States Food and Drug Administration ("FDA") regulated, exempt Class I or Class II 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 direct to consumers with a personalized, consumer-centric approach. Our commercial organization consists of a talented marketing team with deep experience in consumer-focused brand and performance marketing, a team of inside sales consultants, and a dedicated customer support team that includes audiologists and hearing professionals. We generate revenue from orders processed primarily through our website and over the phone by our sales consultants. 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 97 thousandEargo hearing aid systems sold, net of returns, as ofMarch 31, 2022 . For the three months endedMarch 31, 2022 , we generated net revenue of$9.2 million , a decrease of$12.9 million from the three months endedMarch 31, 2021 . The revenue decline was primarily due to a decrease in the volume ofEargo hearing aid systems shipped that was primarily due to our selling our products on a "cash-pay" basis only during the three months endedMarch 31, 2022 as compared to our having accepted both cash pay and insurance as a method of direct payment during the three months endedMarch 31, 2021 . We previously accepted insurance as a method of direct payment, but suspended all claims submission activities onSeptember 22, 2021 when we learned of the investigation by the DOJ related to our role in customer reimbursement claim submissions to various federal employee health plans under the FEHB program, as discussed in more detail below under "-DOJ investigation and settlement and claims audits." We have sold our products on a "cash-pay" basis only sinceDecember 8, 2021 . To date, all our revenue has been generated from customers inthe United States . Our net losses were$30.6 million and$13.6 million for the three months endedMarch 31, 2022 and 2021, respectively. As ofMarch 31, 2022 , we had an accumulated deficit of$387.5 million . We expect to continue to incur losses for the foreseeable future.
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 reimbursement claims we submitted 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 ("OPM"). The investigation also pertained to our role in customer reimbursement claim submissions to federal employee health plans (collectively, the "DOJ investigation"). Also as previously disclosed, our historically largest third-party payor, one of the carriers contracted with the OPM under the FEHB program ("largest third-party payor"), conducted an audit of insurance reimbursement claims ("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 audits of insurance reimbursement claims submitted to additional third-party payors (collectively with the Primary Audit, the "claims audits"). One of these claims audits does 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. 19 -------------------------------------------------------------------------------- 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 customer reimbursement 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 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. OnMay 2, 2022 , the Company paid the settlement amount. The settlement with theU.S. government may not resolve all of the audits of insurance reimbursement claims by the 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 is denied or ultimately not submitted by us to their insurance plan for payment (the "extended right of return"). Beginning onDecember 8, 2021 , we made the decision to stop accepting insurance benefits as a method of direct payment and it is uncertain when, if ever, we will resume accepting insurance benefits as a method of direct payment. While we intend to work with the government and third-party payors at the appropriate time with the objective of validating and establishing processes to support any future claims that we may submit for reimbursement, we may not be able to arrive at acceptable processes or submit any future claims. Total life-to-date payments we have received throughMarch 31, 2022 from the government in relation to claims submitted under the FEHB program, net of any product returns and associated refunds, were approximately$44 million , which is unchanged fromDecember 31, 2021 . As discussed further in Note 5 to the Unaudited Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q, based on the settlement agreement with theU.S. government, we recorded a settlement liability of$34.4 million in the condensed consolidated balance sheets as ofMarch 31, 2022 andDecember 31, 2021 . The settlement amount was recorded as a reduction of revenue in the third quarter of 2021. We determined that customer transactions using insurance benefits as a method of direct payment occurring subsequent to learning of the DOJ investigation onSeptember 21, 2021 did not meet the criteria for revenue recognition under ASC 606. As such, we did not recognize revenue for shipments to customers with potential insurance benefits, substantially all of whom were covered under the FEHB program, subsequent to that date. 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 that was recorded during the year endedDecember 31, 2021 . Of the$13.7 million sales returns reserve recorded as ofMarch 31, 2022 ,$11.3 million relates to unsubmitted claims that are included in accounts receivable, net. Returns associated with unsubmitted claims will reduce the sales returns reserve, with a corresponding reduction in the related accounts receivable at the time the product is returned. Further, we also estimated 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, resulting in bad debt expense that was recorded during the year endedDecember 31, 2021 . Notwithstanding the settlement, we remain subject to prepayment review of claims by our largest third-party payor before any insurance payments are made. We do not intend to submit any claims through the FEHB program until we are able to establish processes with applicable third-party payors to support the submission of these claims, and we may be unable to do so. While we intend to work as quickly as possible toward establishing processes with applicable third-party payors to support the submission of claims, we cannot provide any assurance as to the timing or costs associated with establishing such processes, if we can do so at all, or the impact that such processes may have on our business and results of operations. Further, the pending over-the-counter ("OTC") hearing aid regulatory framework, if finalized as currently proposed, may lead such payors to take additional actions further limiting our ability to access insurance coverage, which may have a material adverse effect on our financial condition, results of operations or cash flows. In addition, based on our correspondence to date with the OPM and the largest third-party payor, we expect that any such processes will require additional testing by a licensed healthcare provider to establish medical necessity, with supporting clinical documentation. Because our current operating structure does not permit us to perform diagnostic tests, we are evaluating alternatives for testing, including but not limited to accepting clinical documentation and prescriptions from third-party healthcare professionals, contracting with third parties or existing networks, and/or establishing a management services organization. We cannot provide any assurance as to the timing or costs associated with these alternatives, whether we will be successful in implementing them, or the impact that such changes may have on our business and operations. 20 -------------------------------------------------------------------------------- OnJanuary 5, 2022 , theU.S. District Court for the Northern District of California consolidated three purported securities class actions brought against the Company (the "Securities Class Action"). While the lead plaintiffs have not yet filed a consolidated amended complaint, the complaints of the individual lawsuits filed prior to the consolidation generally alleged that certain of the Company's disclosures about its business, operations and prospects, including reimbursements from third-party payors, violated federal securities laws. OnDecember 3, 2021 , a putative stockholder filed a derivative complaint purportedly on the Company's behalf against members of the Company's Board of Directors and the Company as nominal defendant (the "Derivative Action"), alleging (among other things) that the defendants breached their fiduciary duties by allegedly failing to implement and maintain an effective system of internal controls related to the Company's financial reporting, public disclosures, and compliance with laws, rules, and regulations governing the business. See Note 5 of the Notes to Unaudited Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for more information.
As a result of the uncertainty created by the DOJ investigation and the claims audits, we took certain actions including, but not limited to:
• We suspended our practice of granting equity awards, except for new
restricted stock unit grants that we have the option to settle in cash at
the time of vesting, suspended our 2020 Employee Stock Purchase Plan
("ESPP") and deferred the settlement of outstanding restricted stock units
("RSUs"), in each case effective as of
"employee equity actions").
• Our Board of Directors 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 on
• On
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.
Factors affecting our business
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 Quarterly Report on Form 10-Q.
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 stop accepting insurance benefits as a method of direct payment, we have experienced and may continue to experience a material decline in gross systems shipped. Beginning onDecember 8, 2021 , as a result of the DOJ investigation and claims audits (as further described in "-DOJ investigation and settlement and claims audits") we do not currently accept insurance as a direct method of payment, and all sales from such date are considered by us to be "cash-pay," which includes upfront payment, credit card, third-party financing, and distributor payment. 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 work with the government and third-party payors at the appropriate time with the objective of validating and establishing the process to support any future claims that we may submit for reimbursement, we may not be able to arrive at an acceptable process or submit any future claims. The shift to a model that excludes insurance as a direct method of payment 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 customers with potential insurance benefits. Further, the exclusion of 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
Changes to the regulatory landscape
Hearing aids are considered medical devices subject to regulation by the FDA. We currently market our products pursuant to the FDA regulatory framework for air-conduction hearing aids, which are classified as Class I or Class II devices exempt from premarket review procedures. In addition, while applicable FDA regulations establish certain "conditions for sale" of all hearing aids, including that prospective hearing aid users must have a medical evaluation by a licensed physician within the six months prior to hearing aid dispensation or sign a waiver of medical evaluation, the FDA has stated that it does not intend to enforce these medical evaluation and 21 -------------------------------------------------------------------------------- waiver requirements prior to the dispensing of Class I air-conduction and Class II wireless air-conduction hearing aids to individuals 18 years of age and older. Accordingly, while we are required to comply with other FDA requirements, including specific hearing aid labeling requirements and provision of a User Instructional Brochure, our products have not been reviewed by the FDA and are not dispensed by licensed physicians. The regulatory landscape for hearing aid devices has been subject to recent changes that may alter or increase our requirements for regulatory compliance. The FDA Reauthorization Act of 2017 ("FDARA") set forth a process 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. The language in FDARA is not self-implementing, and onOctober 20, 2021 , the FDA published the Proposed Rule to establish new regulatory categories for OTC and prescription hearing aids. The Proposed Rule also includes revised requirements for labeling, conditions for sale, performance standards and other provisions applicable to either OTC or prescription hearing aids, or both. Under the Proposed Rule, devices that require 510(k) clearance to come into compliance with the new requirements would need to be cleared by the effective date of the Final Rule to continue marketing. For all other currently marketed devices, the proposed compliance date is 180 days after the effective date of the Final Rule (240 days after the publication of the Final Rule). We market theEargo system devices as Class I air-conduction hearing aids or Class II wireless air-conduction hearing aids, both of which are exempt from 510(k) premarket review. Our hearing aids may be marketed under the current FDA framework during theFDA's rulemaking proceeding. However, we cannot know to what extent the Final Rule may differ from the Proposed Rule. Once the FDA issues a Final Rule, we will need to expend time and resources evaluating the Final Rule and ensuring that our devices and processes come into compliance with the new requirements in order to market our products in line with our primary direct-to-consumer business and omni-channel models in the future. It is possible that a finalized regulatory framework for OTC hearing aids may lead to additional commercial partnership, omni-channel, including retail, or other opportunities, although there are no assurances that it will do so. The 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 Factor titled, "Changes in the regulatory landscape for hearing aid devices could render our direct-to-consumer business model contrary to applicable regulatory requirements, and we may be required to seek additional clearance or approval for our products" for more information.
Omni-channel marketing and distribution activities through commercial partnerships
Eargo's self-administered hearing screens are intended to be part of our retail customer experience and are expected to be located in physical retail settings so customers can obtain general information regarding their hearing and seeEargo hearing aids in person. We also have a select number of commercial partnerships to, among other things, facilitate the retail experience, and we intend to continue to pursue additional opportunities for in-person customer engagement. We believe that if the Proposed Rule by the FDA regarding an OTC regulation of hearing aids is finalized in substantially the same form as proposed, the Final Rule will facilitate negotiation and execution of additional retail opportunities in the future.
Third-party payors
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. As described in Note 2 of the Notes to Unaudited Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q, approximately 95% and 93% of our gross accounts receivable as ofMarch 31, 2022 andDecember 31, 2021 , respectively, were for customers with potential insurance benefits, substantially all of whom were covered under the FEHB program. Furthermore, approximately 92% and 90% of our gross accounts receivable as ofMarch 31, 2022 andDecember 31, 2021 , respectively, were related to shipments ofEargo hearing aids to customers insured under a single insurance plan whose claims are processed through our largest third-party payor, which conducted the Primary Audit. We remain subject to a prepayment review of claims by the payor who conducted the Primary Audit. In addition to the Primary Audit, we are currently subject to a number of other ongoing audits of insurance reimbursement claims. One of these claims audits does not relate to claims submitted under the FEHB program. During the claims audits, the third-party payors (including our largest third-party payor) conducting such claims audits have generally suspended payments for, and in some cases denied, claims we submitted on behalf of customers, other than one third-party payor that has continued to process claims for payment throughout its ongoing audit. We recorded a sales returns reserve of$13.7 million and$13.8 million as ofMarch 31, 2022 andDecember 31, 2021 , respectively, largely related to our estimate that a majority of customers with unsubmitted claims will choose to return the hearing aid system if 22 -------------------------------------------------------------------------------- their insurance provider denies their claim or the claim is ultimately not submitted by us for payment. We recorded an allowance for credit losses of$4.7 million and$4.8 million as ofMarch 31, 2022 andDecember 31, 2021 , respectively, primarily related to insurance claims receivable due from third-party payors and end-users as we 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 and claims that have not yet and may never be submitted by us for payment may not pay for or return the hearing aid system. While we intend to work with third-party payors at the appropriate time with the objective of validating and establishing processes to support any future claims that we may submit for reimbursement, we may not be able to arrive at acceptable processes or submit any future claims. For example, we do not currently conduct in-person hearing tests, as they run counter to our primary direct-to-consumer business and omni-channel models. Based on our correspondence to date with the OPM and the largest third-party payor, we expect that any such processes to support claims for reimbursement will require additional testing by a licensed healthcare provider to establish medical necessity, with supporting clinical documentation. Because our current operating structure does not permit us to perform diagnostic tests, we are evaluating alternatives for testing, including but not limited to accepting clinical documentation and prescriptions from third-party healthcare professionals, contracting with third parties or existing networks, and/or establishing a management services organization. We cannot provide any assurance as to the timing or costs associated with these alternatives, whether we will be successful in implementing them, or the impact that such changes may have on our business and operations. 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. In light of the DOJ investigations, claims audits and pending OTC hearing aids regulatory framework, we may need to make significant changes to our business and operating model, including a potential long-term shift to a model that excludes insurance as a direct method of payment, 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 cash-pay 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 "cash pay" only basis sinceDecember 8, 2021 . Following the civil settlement with theU.S. government onApril 29, 2022 , 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." 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 the extended right of return offered for shipments involving insurance payors. Historically, the most commonly cited reason for returning our hearing aids is unsatisfactory fit, which we believe is a byproduct 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 32% for the year endedDecember 31, 2021 and 34% for the three months endedMarch 31, 2022 .
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 5 inJuly 2021 and the launch ofEargo 6 inJanuary 2022 , we have now launched six 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 23 -------------------------------------------------------------------------------- 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 include full refurbishment, conversion, and components, and allow us to refurbish and resell or reuse certain 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 suspended our practice of granting equity awards (except for new restricted stock unit grants that we have the option to settle in cash at the time of vesting), suspended our employee stock purchase plan and deferred the settlement of outstanding restricted stock units, in each case effective as ofNovember 9, 2021 . 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. Both the suspension of equity awards and reduction 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. COVID-19 pandemic We believe the COVID-19 pandemic has accelerated the pace of consumer awareness of our vertically integrated telecare model and has facilitated customer adoption of the same. Shelter-in-place restrictions and increased reluctance of consumers to conduct in-person activities, particularly among older individuals that comprise a majority of the population needing hearing aids has resulted in increased knowledge of our business and sales. We cannot be sure this trend will continue. Although we believe the COVID-19 pandemic has largely resulted in favorable trends for our business, we have experienced business disruptions, particularly at ourCalifornia headquarters, where a majority of our employees have been working remotely (which we permitted as an accommodation to our employees despite the fact that we were never required to close our facilities because we were deemed to have an essential workforce under the relevantCalifornia COVID-19 measures). Moreover, 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 been impacted by any disruptions to our supply chain that have impacted our ability to service customers or 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 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 sales and gross margins.
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. However, we have not recorded
revenue and related sales returns reserve for approximately 670 shipments of
during the three months ended
of the DOJ investigation, and approximately 1,560 of such shipments during
the three months ended
DOJ investigation on
accepting insurance benefits as a method of direct payment, we have
experienced and may continue to experience a material decline in gross
systems shipped. Continued negative publicity, including in relation to the
DOJ investigation, 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." 24
--------------------------------------------------------------------------------
• 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.
The following table details the number of gross systems shipped and sales returns rates for the periods presented below:
Three months ended March 31, June 30, September 30, December 31, March 31, 2021 2021 2021 2021 2022
Gross systems shipped 11,704 12,548 13,117 7,767 5,773 Sales returns rate 23.2 % 24.1 % 46.4 % 34.0 % 33.9 % 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 we are unable to accept insurance benefits as a direct method of payment.
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 from the sale ofEargo hearing aid systems, accessories and, to a lesser extent, sales of extended warranties, with the majority of our revenue coming from sales of ourEargo hearing aid systems. Following the launch ofEargo 6 inJanuary 2022 , we currently offer four versions of our hearing aid systems, the Eargo Max, the Eargo Neo HiFi, theEargo 5, and theEargo 6, 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 have suspended all insurance claims submissions and, beginning onDecember 8, 2021 , do not currently accept insurance as a direct method of payment. Instead, we are currently focused on "cash-pay" customers, which includes upfront payment, credit card, third-party financing and distributor payment. Historically, cash-pay customers have had significantly higher return rates than customers with potential insurance benefits, and therefore the current shift to cash-pay only sales may adversely impact revenue, net.
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 in the future and any potential actions insurance providers may take following the anticipated implementation of a pending OTC hearing aid regulatory framework that may limit our ability to access insurance coverage (which OTC framework may also generally result in additional compliance or other regulatory requirements forEargo ).
We expect our gross margin to remain depressed for so long as we are unable to accept insurance benefits as a direct method of payment unless we can successfully target and convert new customers with a similarly low rate of return.
25 --------------------------------------------------------------------------------
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. The uncertainty regarding the anticipated implementation of a pending OTC hearing aid regulatory framework will require that we evaluate our R&D expenses as new information becomes available.
Sales and marketing expenses
Our sales and marketing expenses are 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 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 as part of the reduction in force announced onDecember 8, 2021 .
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, 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.
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. 26 --------------------------------------------------------------------------------
Results of operations
Comparison of the three months ended
Three months ended March 31, Change (dollars in thousands) 2022 2021 Amount % Revenue, net$ 9,176 $ 22,048 $ (12,872 ) (58.4 )% Cost of revenue 5,491 6,297 (806 ) (12.8 ) Gross profit 3,685 15,751 (12,066 ) (76.6 ) Operating expenses: Research and development 5,847 4,778 1,069 22.4 Sales and marketing 13,290 16,855 (3,565 ) (21.2 ) General and administrative 14,934 7,487 7,447 99.5 Total operating expenses 34,071 29,120 4,951 17.0 Loss from operations (30,386 ) (13,369 ) (17,017 ) 127.3 Other income (expense), net: Interest income 5 11 (6 ) (54.5 ) Interest expense (264 ) (263 ) (1 )
0.4
Total other income (expense), net (259 ) (252 ) (7 )
2.8 Loss before income taxes (30,645 ) (13,621 ) (17,024 ) 125.0 Income tax provision - - - -
Net loss and comprehensive loss
125 % * Not meaningful Revenue, net Three months ended March 31, Change (dollars in thousands) 2022 2021 Amount % Revenue, net$ 9,176 $ 22,048 $ (12,872 ) (58.4 )% Revenue decreased by$12.9 million , or 58.4%, from$22.0 million during the three months endedMarch 31, 2021 , to$9.2 million during the three months endedMarch 31, 2022 , primarily due to a decrease in the volume ofEargo hearing aid systems shipped from 11,704 gross systems shipped during the three months endedMarch 31, 2021 to 5,773 during the three months endedMarch 31, 2022 as we no longer accepted insurance as a method of direct payment as ofDecember 8, 2021 . The decrease in revenue was also attributable to an increase in sales returns rate as we operated on a cash-pay basis only during the three months endedMarch 31, 2022 , whereas we accepted both cash pay and insurance as a direct method of payment in the comparable period. We have experienced a historically higher return rate for cash-pay customers as compared to insurance customers.
Cost of revenue, gross profit, and gross margin
Three months ended March 31, Change (dollars in thousands) 2022 2021 Amount % Cost of revenue$ 5,491 $ 6,297 $ (806 ) (12.8 )% Gross profit 3,685 15,751 (12,066 ) (76.6 )% Gross margin 40.2 % 71.4 % Cost of revenue decreased by$0.8 million , or 12.8%, from$6.3 million during the three months endedMarch 31, 2021 to$5.5 million during the three months endedMarch 31, 2022 . The change was primarily due to the decrease in the volume ofEargo hearing aid systems shipped. Gross margin decreased to 40.2% during the three months endedMarch 31, 2022 , compared to 71.4% during the three months endedMarch 31, 2021 . The change in gross margin percentage was primarily due to an increase in sales returns rates, an increase in cost of goods per product sold due to a change in product mix, and an increase in amortization of capitalized software costs subsequent to the launch ofEargo 5 inJuly 2021 andEargo 6 inJanuary 2022 . 27 --------------------------------------------------------------------------------
Research and development (R&D)
Three months endedMarch 31 , Change
(dollars in thousands) 2022 2021 Amount %
Research and development
R&D expenses increased by$1.1 million , or 22.4%, from$4.8 million during the three months endedMarch 31, 2021 to$5.8 million during the three months endedMarch 31, 2022 . The change was primarily due to a net increase of$0.8 million in personnel and personnel-related costs due in part to a decrease in the amount of internal use software development costs being capitalized subsequent to the launch ofEargo 5 inJuly 2021 andEargo 6 inJanuary 2022 . Sales and marketing Three months ended March 31, Change (dollars in thousands) 2022 2021 Amount % Sales and marketing$ 13,290 $ 16,855 $ (3,565 ) (21.2 )% Sales and marketing expenses decreased by$3.6 million , or 21.2%, from$16.9 million during the three months endedMarch 31, 2021 to$13.3 million during the three months endedMarch 31, 2022 . The change was primarily due to decreases in direct marketing, advertising and promotional expenses of$1.8 million due to a reduction in media following our decision to stop accepting insurance benefits as a method of direct payment onDecember 8, 2021 and decreases in personnel and personnel-related costs of$1.8 million , which includes a$1.2 million decrease in stock-based compensation.
General and administrative
Three months endedMarch 31 , Change
(dollars in thousands) 2022 2021 Amount %
General and administrative
General and administrative expenses increased by$7.4 million , or 99.5%, from$7.5 million during the three months endedMarch 31, 2021 to$14.9 million during the three months endedMarch 31, 2022 . This change was primarily due to an increase in general corporate costs of$7.3 million , which includes a$6.7 million increase in legal and other professional fees as a result of the DOJ investigation.
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. As ofMarch 31, 2022 , we had$15.0 million in principal outstanding under the 2018 Loan, which matures inSeptember 2024 with interest-only payments untilJuly 2022 . Interest on the 2018 Loan accrues at a per annum rate equal to theWall Street Journal prime rate plus 1.0%, or 4.50% as ofMarch 31, 2022 .
As of
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. 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. 28 -------------------------------------------------------------------------------- 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. Additional 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 longer term future capital requirements and ability to raise additional capital will depend on many forward-looking factors and are not limited to the following:
• investor confidence in our ability to continue as a going concern;
• the timing, receipt and amount of sales from our current and future products;
• the costs involved in resolving the third-party claims audits and potential
recoupment of previous claims paid, as well as other legal proceedings
(including the shareholder class action and derivative suits discussed in
Note 5 to the Unaudited Condensed Consolidated Financial Statements included
in this Quarterly Report on Form 10-Q), and their duration and impact on our
business generally (particularly with respect to our ability in future
periods to accept insurance as a direct method of payment);
• the availability of insurance coverage for our hearing aid devices, and any
costs associated with reimbursement and compliance, including the
anticipated implementation of a pending OTC regulatory framework (which may
lead insurance providers to take actions limiting our ability to access
insurance coverage and may also generally result in additional compliance or
other regulatory requirements for us), and any resulting changes to our
business model, including a potential long-term shift to a model that
excludes insurance benefits as a method of direct payment to
would likely result in a sustained increased cost of customer acquisition;
• the cost and timing of expanding our sales, marketing and distribution
capabilities and our continued success in reducing our customer acquisition
costs;
• 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;
• the cost of manufacturing, either ourselves or through third-party manufacturers, our products; • the terms, timing and success of any other licensing, partnership,
omni-channel, including retail, or other arrangements that we may establish;
• any product liability or other lawsuits related to our current or future
products; • the expenses needed to attract, hire and retain skilled personnel;
• the extent of our spending to support research and development activities
and the expansion of our product offerings; • the costs associated with being a public company;
• the duration and severity of the COVID-19 pandemic and its impact on our
business and financial markets generally;
• the costs involved in preparing, filing, prosecuting, maintaining, defending
and enforcing our intellectual property portfolio; and • 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 II. While the extent to which we are able to validate and establish processes to support the submission of claims for reimbursement to health plans, including those under the FEHB program, if at all, in the future, and the future impacts of the anticipated implementation of a pending OTC hearing aid regulatory framework (which may lead insurance providers to take actions limiting our ability to access insurance coverage and may also generally result in additional compliance or other regulatory requirements forEargo ) are difficult to assess or predict at this time, since the announcement of the DOJ investigation and our related decision to stop accepting insurance benefits as a method of direct payment, 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.
Contractual obligations and commitments
There have been no changes to our contractual obligations and commitments
included in our Annual Report on Form 10-K for the fiscal year ended
29 --------------------------------------------------------------------------------
Cash flows
The following table summarizes our cash flows for the periods indicated:
Three months ended March 31, (in thousands) 2022 2021
Net cash used in operating activities
(942 ) (1,370 ) Net cash provided by financing activities 24 118 Net decrease in cash$ (21,268 ) $ (10,561 ) Operating activities During the three months endedMarch 31, 2022 , cash used in operating activities was$20.4 million , attributable to a net loss of$30.6 million , partially offset by a net change in our net operating assets and liabilities of$5.2 million and non-cash charges of$5.1 million . Non-cash charges primarily consisted of$3.0 million in stock-based compensation,$1.4 million in depreciation and amortization expense and$0.4 million in non-cash operating lease expense. The change in our net operating assets and liabilities was primarily due to a$3.0 million increase in accounts payable,$1.3 million decrease in prepaid expenses and other current assets,$0.7 million decrease in other assets and$0.3 million increase in other current and noncurrent liabilities. During the three months endedMarch 31, 2021 , cash used in operating activities was$9.3 million , attributable to a net loss of$13.6 million and a net change in our net operating assets and liabilities of$2.0 million , partially offset by non-cash charges of$6.3 million . Non-cash charges primarily consisted of$5.1 million in stock-based compensation and$0.7 million in depreciation and amortization expense. The change in our net operating assets and liabilities was primarily due to a$1.6 million decrease in accrued expense, a$1.6 million increase in account receivable and a$1.4 million decrease in sales return reserve. These changes were partially offset by a$1.4 million increase in other current and noncurrent liabilities,$0.7 million increase in account payable and$0.6 million decrease in prepaid expenses and other current assets.
Investing activities
During the three months endedMarch 31, 2022 , cash used in investing activities was$0.9 million , which consisted of$0.7 million related to the purchase of property and equipment and approximately$0.3 million in capitalized costs related to the development of internal use software. During the three months endedMarch 31, 2021 , cash used in investing activities was$1.4 million , which consisted of$1.1 million in capitalized costs related to the development of internal use software and$0.3 million related to the purchase of property and equipment.
Financing activities
During the three months ended
During the three months ended
Critical accounting estimates
Management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles. The preparation of these unaudited condensed 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. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. 30 -------------------------------------------------------------------------------- There have been no significant changes in our critical accounting estimates as compared to the critical accounting estimates disclosed in the section titled "Management's Discussion and Analysis of Financial Condition and Operations" included in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 .
Recent accounting pronouncements
See Note 2 of the Notes to Unaudited Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for more information about recent accounting pronouncements, the timing of their adoption, and our assessment.
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