Inogen Inc
For the period ended Sep 30, 2024. Filed Nov 8, 2024.
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Sep 30, 2024 · Filed Nov 8, 2024
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Condensed Notes to the Consolidated Financial Statements (unaudited)
Condensed Notes to the Consolidated Financial Statements
- Business overview
Inogen, Inc. (Company or Inogen) was incorporated in Delaware on November 27, 2001. The Company is a medical technology business that primarily develops, manufactures, and markets innovative portable oxygen concentrators (POCs) used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions. Traditionally, these patients have relied on stationary oxygen concentrator systems for use in the home and oxygen tanks or cylinders for mobile use, which the Company refers to as the delivery model. The tanks and cylinders must be delivered regularly and have a finite amount of oxygen, which requires patients to plan activities outside of their homes around delivery schedules and a finite oxygen supply. Additionally, patients must attach long cumbersome tubing to their stationary concentrators simply to enable mobility within their homes. The Company's proprietary Inogen One® and Inogen Rove systems concentrate the air around the patient to offer a source of supplemental oxygen anytime, anywhere with a battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available. The Company's Inogen One and Inogen Rove systems reduce the patient's reliance on stationary concentrators and scheduled deliveries of tanks with a finite supply of oxygen, thereby improving patient quality of life and fostering mobility.
The Company incorporated Inogen Europe Holding B.V., a Dutch limited liability company, on April 13, 2017. On May 4, 2017, Inogen Europe Holding B.V. acquired all issued and outstanding capital stock of MedSupport Systems B.V. (MedSupport) and began operating under the name Inogen Europe B.V. The Company merged Inogen Europe Holding B.V. and Inogen Europe B.V. on December 28, 2018. Inogen Europe B.V. is the remaining legal entity. Inogen completed the acquisition of New Aera, Inc. (New Aera) on August 9, 2019. On September 14, 2023, the Company completed the acquisition of all of the issued and outstanding capital stock of Physio-Assist SAS (Physio-Assist) and its wholly-owned subsidiary PhysioAssist GmbH.
- Basis of presentation and summary of significant accounting policies
The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP).
The results of operations for the three and nine months ended September 30, 2024 shown in this report are not necessarily indicative of results to be expected for the full year ending December 31, 2024. In the opinion of the Company’s management, the information contained herein reflects all adjustments, consisting of only normal recurring adjustments, necessary for a fair presentation of the Company’s results of operations, financial position, cash flows, and stockholders’ equity. Certain footnote disclosures normally included in annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to Securities and Exchange Commission (SEC) rules and regulations relating to interim financial statements. The accompanying consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2024. Except as further described below, there have been no significant changes in the Company’s accounting policies from those disclosed in its Annual Report on Form 10-K filed with the SEC on March 1, 2024.
Basis of consolidation
The consolidated financial statements include the accounts of Inogen, Inc. and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated.
Accounting estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases these estimates and assumptions upon historical experience, existing and known circumstances, authoritative accounting pronouncements and other factors that management believes to be reasonable. Significant areas requiring the use of management estimates relate to revenue recognition, warranty reserves and expense, determining the stand-alone selling price (SSP) and service period of performance obligations, rental asset valuations and write-downs, accounts receivable allowances for bad debts, returns and adjustments, impairment of goodwill, impairment of long-lived assets, stock-based compensation expense, income taxes, fair value of acquired intangible assets and goodwill, and fair value of earnout liabilities. Actual results could differ from these estimates.
Cash, cash equivalents, marketable securities and restricted cash
The Company considers all short-term highly liquid investments with a maturity of three months or less to be cash equivalents. Restricted cash and cash equivalents are considered to be legally restricted as to withdrawal or usage. The Company's restricted cash is a legally restricted deposit held as a compensating balance against its corporate credit card balances.
The Company’s marketable debt securities are classified and accounted for as available-for-sale. Cash equivalents are recorded at cost plus accrued interest, which is considered adjusted cost, and approximates fair value. Marketable debt securities are included in cash equivalents and marketable securities based on the maturity date of the security.
The Company considers investments with maturities greater than three months, but less than one year, to be marketable securities. Investments are reported at fair value with realized and unrealized gains or losses reported in other income (expense).
The Company reviews its investments to identify and evaluate investments that have an indication of possible impairment. Factors considered in determining whether a loss is temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, and the Company's intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Expected credit losses are declines in fair value that are not expected to recover and are charged to other income (expense).
- Acquisitions
On July 10, 2023, the Company entered into a share purchase agreement to acquire Physio-Assist, which is in the business of the design, production, and marketing of medical devices for bronchial decongestion (airway clearance technique) for patients suffering from obstructive respiratory diseases. On September 14, 2023, the Company completed the acquisition of all of the issued and outstanding capital stock of Physio-Assist and its wholly-owned subsidiary PhysioAssist GmbH for a purchase price consisting of $32,250 in cash consideration and the fair value of a potential earnout of $3,178 based on future regulatory clearances.
A potential earnout payment of either $13,000 (without a clinical trial requirement) or $11,000 (with a required clinical trial less related development costs) is dependent upon the achievement of one of two milestones related to U.S. Food and Drug Administration (FDA) de novo authorization or 510(k) clearance for the Simeox Airway Clearance System within four years of the date of the closing of the transaction. The fair value of the earnout liability was measured using the probability weighted expected return methodology and was discounted using a rate and probability that appropriately captures the risk associated with the obligation.
Assets and liabilities of the acquired company were recorded at their estimated fair values at the date of acquisition. The excess purchase price over the fair value of net tangible assets and identifiable intangible assets acquired has been allocated to goodwill. Goodwill represents the expected synergies with the existing business, the acquired assembled workforce, and future cash flows after the acquisition. The fair value assigned to the identifiable intangible assets was determined primarily by using the excess earnings method. The key assumptions included in the excess earnings method included revenue recognized, cost of revenue, and the discount rate.
The purchase accounting for this acquisition has been finalized.
The following table summarizes the allocation of the purchase price over the estimated fair value of the assets acquired and liabilities assumed in the acquisition of Physio-Assist:
| Cash | $2,617 |
|---|---|
| Accounts receivable | 184 |
| Inventories | 296 |
| Other assets | 325 |
| Property and equipment | 82 |
| Operating lease right-of-use asset | 306 |
| Intangible assets | 34,100 |
| Goodwill | 9,755 |
| Total assets acquired | $47,665 |
| Accounts payable and accrued expenses | $1,108 |
| Bank loans | 1,922 |
| Other current liabilities | 376 |
| Operating lease liability | 306 |
| Deferred tax liability - noncurrent | 8,525 |
| Total liabilities assumed | 12,237 |
| Total identifiable net assets | $35,428 |
| Cash consideration | $32,250 |
| Fair value of contingent earnout consideration | 3,178 |
| Total purchase price | $35,428 |
The consolidated financial and operating results reflect the Physio-Assist operations beginning September 14, 2023. The following unaudited pro forma information for the three and nine months ended September 30, 2023 presents total revenue and net loss assuming the acquisition of Physio-Assist had occurred as of January 1, 2023.
| Three months ended | Nine months ended | |
|---|---|---|
| September 30, 2023 | September 30, 2023 | |
| Total revenue | $84,680 | $242,060 |
| Net loss | $(45,321) | $(77,266) |
- Fair value measurements
Cash, cash equivalents, marketable securities and restricted cash
The following table summarizes fair value measurements by level for the assets measured at fair value on a recurring basis for cash, cash equivalents, marketable securities and restricted cash:
| Gross · Cash | ||||||
|---|---|---|---|---|---|---|
| Adjusted · unrealized · and cash · Marketable · Restricted | ||||||
| cost | gains | Fair value | equivalents | securities | cash | |
| Cash | $30,902 | $— | $30,902 | $30,902 | $— | $— |
| Level 1: | ||||||
| Money market accounts | 48,926 | — | 48,926 | 45,335 | — | 3,591 |
| Level 2: | ||||||
| U.S. Treasury securities | 22,151 | 298 | 22,449 | 7,476 | 14,973 | — |
| Institutional Insured Liquidity Deposit Savings | 21,977 | — | 21,977 | 21,977 | — | — |
| Total | $123,956 | $298 | $124,254 | $105,690 | $14,973 | $3,591 |
| Gross · Cash | ||||||
| Adjusted · unrealized · and cash · Marketable | ||||||
| cost · gains · Fair value · equivalents · securities | ||||||
| Cash | $12,611 | $— | $12,611 | $12,611 | $— | |
| Level 1: | ||||||
| Money market accounts | 72,368 | — | 72,368 | 72,368 | — | |
| Level 2: | ||||||
| Corporate bonds | 2,979 | — | 2,979 | — | 2,979 | |
| U.S. Treasury securities | 19,252 | 136 | 19,388 | 19,388 | — | |
| Institutional Insured Liquidity Deposit Savings | 21,125 | — | 21,125 | 21,125 | — | |
| Total | $128,335 | $136 | $128,471 | $125,492 | $2,979 | |
Derivative instruments and hedging activities
The Company records the assets or liabilities associated with derivative instruments and hedging activities at fair value based on Level 2 inputs in other current assets or other current liabilities, respectively, in the consolidated balance sheet. The Company had related payables of $100 and $155 as of September 30, 2024 and December 31, 2023, respectively.
Accumulated other comprehensive income
The components of accumulated other comprehensive income were as follows:
| Foreign | Unrealized | Accumulated | |
|---|---|---|---|
| currency | gains | other | |
| translation | on marketable | comprehensive | |
| adjustments | securities | income | |
| Balance as of December 31, 2023 | $1,089 | $136 | $1,225 |
| Other comprehensive income | 333 | 161 | 494 |
| Balance as of September 30, 2024 | $1,422 | $297 | $1,719 |
Comprehensive income is the total net earnings and all other non-owner changes in equity.
Earnout liability
The Company has obligations to pay up to $13,000 in an earnout payment for the Physio-Assist acquisition in cash if certain future regulatory results are met. The earnout liability was valued using Level 3 inputs.
The reconciliation of the earnout liability measured and carried at fair value on a recurring basis is as follows:
| Balance as of December 31, 2023 | $10,000 |
|---|---|
| Change in fair value | 1,830 |
| Balance as of September 30, 2024 | $11,830 |
- Balance sheet components
Accounts receivable and allowance for bad debts, returns, and adjustments
Net accounts receivable (gross accounts receivable, net of allowances) balance concentrations by major category as of September 30, 2024 and December 31, 2023 were as follows:
| September 30, | December 31, | |
|---|---|---|
| Net accounts receivable | 2024 | 2023 |
| Rental (1) | $5,460 | $6,401 |
| Business-to-business and other receivables (2) | 28,773 | 35,840 |
| Total net accounts receivable | $34,233 | $42,241 |
(1)
Rental includes Medicare, Medicaid/other government, private insurance, and patient pay.
(2)
Business-to-business receivables included extended terms fortwo customers: 1) one customer had a net accounts receivable balance of$5,055 and $8,639 as of September 30, 2024 and December 31, 2023, respectively; and 2) one customer had a net accounts receivable balance of $4,994 as of December 31, 2023. Each customer received extended payment terms through a direct financing plan offered.
The following table sets forth the accounts receivable allowances as of September 30, 2024 and December 31, 2023:
| September 30, | December 31, | |
|---|---|---|
| Allowances - accounts receivable | 2024 | 2023 |
| Doubtful accounts | $5,026 | $2,341 |
| Sales returns | 506 | 479 |
| Total allowances - accounts receivable | $5,532 | $2,820 |
Concentration of customers and vendors
The Company primarily sells its products to traditional home medical equipment providers, distributors, and resellers in the United States and in foreign countries on a credit basis. The Company also sells its products direct-to-consumers primarily on a prepayment basis. Medicare's service reimbursement programs represented more than 10% of the Company's total revenue for the three and nine months ended September 30, 2023. Two customers represented more than 10% of the Company’s net accounts receivable balance with net accounts receivable balances of $5,055 and $3,730, respectively, as of September 30, 2024 and $8,639 and $4,994, respectively, as of December 31, 2023.
The Company also rents products directly to consumers for insurance reimbursement, which resulted in a customer concentration relating to Medicare’s service reimbursement programs. Medicare’s service reimbursement programs accounted for 57.0% and 69.7% of rental revenue in thenine months ended September 30, 2024 and 2023, respectively, and based on total revenue were 9.6% and 13.7% for thenine months ended September 30, 2024 and 2023, respectively. Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled, net of allowances) amounted to $1,375 or 4.0% of total net accounts receivable as of September 30, 2024 compared to $2,059 or 4.9% of total net accounts receivable as of December 31, 2023.
The Company currently purchases raw materials from a limited number of vendors, which resulted in a concentration of three major vendors. The three major vendors supply the Company with raw materials used to manufacture the Company’s products. For the nine months ended September 30, 2024, the Company’s three major vendors accounted for 20.9%,19.2%, and 10.6%, respectively, of total raw material purchases. For thenine months ended September 30, 2023, the Company’s three major vendors accounted for 29.3%,16.3%, and 9.1%, respectively, of total raw material purchases.
A portion of revenue is earned from sales outside the United States. Approximately 76.3% and 76.9% of the non-U.S. revenue for thethree months ended September 30, 2024 and 2023, respectively, were invoiced in Euros. Approximately 78.4% and 78.0% of the non-U.S. revenue for thenine months ended September 30, 2024 and 2023, respectively, were invoiced in Euros. A breakdown of the Company’s revenue from U.S. and non-U.S. sources for the three and nine months ended September 30, 2024 and 2023, respectively, is as follows:
| Three months endedSeptember 30, | Nine months endedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| U.S. revenue | $56,506 | $58,354 | $166,730 | $171,887 |
| Non-U.S. revenue | 32,328 | 25,613 | 88,894 | 67,877 |
| Total revenue | $88,834 | $83,967 | $255,624 | $239,764 |
Inventories
Inventories are stated at the lower of cost and net realizable value, using the first-in, first-out (FIFO) method. The Company records adjustments to inventory for potentially excess, obsolete, slow-moving, or impaired items, and losses on firm purchase commitments as a component of cost of sales in the consolidated statements of comprehensive loss. The Company recorded noncurrent inventory related to inventories that are expected to be realized or consumed after one year of $1,821 and $1,225 as of September 30, 2024 and December 31, 2023, respectively. Noncurrent inventories are primarily related to raw materials purchased in bulk to support long-term expected repairs to reduce costs and are classified in other assets. During the nine months ended September 30, 2024 and 2023, $509 and $1,997, respectively, of inventory was transferred to rental equipment and was considered a noncash transaction in the production and purchase of rental equipment on the consolidated statements of cash flows. Inventories that are considered current consist of the following:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Raw materials and work-in-progress | $17,870 | $18,036 |
| Finished goods | 8,451 | 6,871 |
| Less: reserves | (3,001) | (3,067) |
| Inventories, net | $23,320 | $21,840 |
Property and equipment
Repair and maintenance expense, which includes labor, parts, and freight, for rental equipment was $1,689 and $1,320 for thethree months ended September 30, 2024 and 2023, respectively, and $4,890 and $3,873 for thenine months ended September 30, 2024 and 2023, respectively.
Depreciation and amortization expense related to rental equipment and other property and equipment are summarized below for thethree and nine months ended September 30, 2024 and 2023, respectively.
| Three months endedSeptember 30, | Nine months endedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Rental equipment | $3,247 | $3,364 | $9,554 | $9,680 |
| Other property and equipment | 960 | 1,045 | 3,143 | 3,044 |
| Total depreciation and amortization | $4,207 | $4,409 | $12,697 | $12,724 |
Property and equipment and rental equipment with associated accumulated depreciation is summarized below as of September 30, 2024 and December 31, 2023, respectively.
| September 30, | December 31, | |
|---|---|---|
| Property and equipment | 2024 | 2023 |
| Rental equipment, net of allowances of $3,181 and $2,606, respectively | $65,453 | $67,804 |
| Other property and equipment | 25,760 | 30,357 |
| Property and equipment | 91,213 | 98,161 |
| Accumulated depreciation | ||
| Rental equipment | 32,054 | 31,023 |
| Other property and equipment | 12,561 | 16,822 |
| Accumulated depreciation | 44,615 | 47,845 |
| Property and equipment, net | ||
| Rental equipment, net of allowances of $3,181 and $2,606, respectively | 33,399 | 36,781 |
| Other property and equipment | 13,199 | 13,535 |
| Property and equipment, net | $46,598 | $50,316 |
Long-lived assets
The Company accounts for the impairment and disposition of long-lived assets in accordance with Accounting Standards Codification (ASC) 360— Property, Plant, and Equipment. In accordance with ASC 360, long-lived assets to be held are reviewed for events or changes in circumstances that indicate that their carrying value may not be recoverable. No impairments were recorded for thenine months ended September 30, 2024 and 2023.
Goodwill and other identifiable intangible assets
Goodwill
The changes in the carrying amount of goodwill for thenine months ended September 30, 2024 were as follows:
| Balance as of December 31, 2023 (1) | $10,057 |
|---|---|
| Translation adjustment | 113 |
| Balance as of September 30, 2024 (1) | $10,170 |
(1) Includes $32,894 of accumulated impairment losses as of September 30, 2024 and December 31, 2023.
Intangible assets
The following tables represent the changes in net carrying values of intangible assets as of the respective dates:
| Average | |||||||
|---|---|---|---|---|---|---|---|
| estimated · Gross | |||||||
| useful lives · carrying · Accumulated | |||||||
| September 30, 2024 · (in years) · amount · amortization · Net amount | |||||||
| Developed technology | 10 | $33,677 | $3,508 | $30,169 | |||
| Licenses | 10 | 159 | 159 | — | |||
| Patents and websites | 5 | 4,518 | 4,482 | 36 | |||
| Customer relationships | 4 | 3,007 | 1,513 | 1,494 | |||
| Trade name | 4 | 209 | 54 | 155 | |||
| Commercials | 3 | 494 | 241 | 253 | |||
| Internally developed software | 3 | 2,090 | 435 | 1,655 | |||
| Total | $44,154 | $10,392 | $33,762 | ||||
| Average | |||||||
| estimated · Gross | |||||||
| useful lives · carrying · Accumulated | |||||||
| December 31, 2023 | (in years) | amount | amortization | Net amount | |||
| Developed technology | 10 | $33,303 | $971 | $32,332 | |||
| Licenses | 10 | 185 | 185 | — | |||
| Patents and websites | 5 | 4,518 | 4,429 | 89 | |||
| Customer relationships | 4 | 2,974 | 1,372 | 1,602 | |||
| Trade name | 4 | 206 | 15 | 191 | |||
| Commercials | 3 | 494 | 117 | 377 | |||
| Total | $41,680 | $7,089 | $34,591 | ||||
Annual estimated amortization expense for each of the succeeding fiscal years is as follows:
| September 30, | |
|---|---|
| Remaining 3 months of 2024 | $1,188 |
| 2025 | 4,717 |
| 2026 | 4,585 |
| 2027 | 4,048 |
| 2028 | 3,368 |
| 2029 | 3,368 |
| Thereafter | 12,488 |
| $33,762 | |
Current liabilities
Accounts payable and accrued expenses as of September 30, 2024 and December 31, 2023 consisted of the following:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Accounts payable | $15,459 | $13,454 |
| Accrued inventory (in-transit and unvouchered receipts) and trade payables | 7,263 | 10,054 |
| Accrued purchasing card liability | — | 2,197 |
| Accrued loss on purchase commitments | 1,723 | 2,057 |
| Accrued franchise, sales and use taxes | 457 | 472 |
| Other accrued expenses | 2,126 | 1,908 |
| Total accounts payable and accrued expenses | $27,028 | $30,142 |
Accrued payroll as of September 30, 2024 and December 31, 2023 consisted of the following:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Accrued bonuses | $5,201 | $1,110 |
| Accrued wages and other payroll related items | 3,736 | 4,170 |
| Accrued vacation | 3,590 | 3,194 |
| Accrued severance | 1,667 | 2,284 |
| Accrued employee stock purchase plan deductions | 91 | 308 |
| Total accrued payroll | $14,285 | $11,066 |
- Leases
The Company has entered into operating leases primarily for commercial buildings. These leases have terms that range from 3 years to 11 years, some of which include options toextend the leases for up to 5 years. Rent expense, including short-term lease cost, was $1,132 and $1,008 for thethree months ended September 30, 2024 and 2023, respectively, and $3,341 and $2,944 for thenine months ended September 30, 2024 and 2023, respectively.
In July 2023, the Company entered into an Assignment and Assumption of Lease Agreement in which a third party (Assignee) assumed the rights, title, and interest in the lease, including assumption of lease payments. Notwithstanding the Assignee's assumption of lease payments, Inogen remains the primary obligor under the lease to the landlord. Lease payments assumed by the Assignee are:
| Payments due in the 12-month period ending September 30, | |
|---|---|
| 2025 | $1,136 |
| 2026 | 1,136 |
| 2027 | 1,136 |
| 2028 | 1,136 |
| 2029 | 1,136 |
| Thereafter | 1,893 |
| $7,573 | |
Information related to the Company's right-of-use assets and related operating lease liabilities were as follows:
| Nine months ended | ||
|---|---|---|
| September 30, | ||
| 2024 | 2023 | |
| Cash paid for operating lease liabilities | $3,494 | $3,016 |
| Operating lease cost | 3,298 | 2,923 |
| Non-cash right-of-use assets obtained in exchange for new operating lease obligations | 1,566 | 1,997 |
| Weighted average remaining lease term | 3.3 years | 1.9 years |
| Weighted average discount rate | 5.6% | 3.0% |
| Maturities of lease liabilities due in the 12-month period ending September 30, | |
|---|---|
| 2025 | $3,325 |
| 2026 | 3,641 |
| 2027 | 3,637 |
| 2028 | 3,287 |
| 2029 | 3,089 |
| Thereafter | 5,038 |
| Less imputed interest | (1,870) |
| Total lease liabilities | $20,147 |
| Operating lease liability - current | $2,777 |
| Operating lease liability - noncurrent | 17,370 |
| Total lease liabilities | $20,147 |
- Loss per share
Loss per share (EPS) is computed in accordance with ASC 260—Earnings per Share and is calculated using the weighted average number of common shares outstanding during each period. Diluted EPS assumes the conversion, exercise, or issuance of all potential common stock equivalents (which can include dilution of outstanding stock options, restricted stock units, and restricted stock awards) unless the effect is to reduce a loss or increase the income per share. For purposes of this calculation, common stock subject to repurchase by the Company, options, and other dilutive awards are considered to be common stock equivalents and are only included in the calculation of diluted loss per share when their effect is dilutive.
Basic loss per share is calculated using the Company's weighted-average outstanding common shares. Diluted loss per share is calculated using the Company's weighted-average outstanding common shares including the dilutive effect of stock awards as determined under the treasury stock method.
The computation of EPS is as follows:
| Three months endedSeptember 30, | Nine months endedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Numerator—basic and diluted: | ||||
| Net loss | $(5,963) | $(45,719) | $(26,131) | $(75,894) |
| Denominator: | ||||
| Weighted average common shares - basic common stock (1) | 23,751,168 | 23,231,217 | 23,589,836 | 23,129,795 |
| Weighted average common shares - diluted common stock | 23,751,168 | 23,231,217 | 23,589,836 | 23,129,795 |
| Net loss per share - basic common stock | $(0.25) | $(1.97) | $(1.11) | $(3.28) |
| Net loss per share - diluted common stock (2) | $(0.25) | $(1.97) | $(1.11) | $(3.28) |
| Denominator calculation from basic to diluted: | ||||
| Weighted average common shares - basic common stock (1) | 23,751,168 | 23,231,217 | 23,589,836 | 23,129,795 |
| Stock options and other dilutive awards | 764,761 | 149,236 | 620,943 | 301,309 |
| Weighted average common shares - diluted common stock | 24,515,929 | 23,380,453 | 24,210,779 | 23,431,104 |
| Shares excluded from diluted weighted average shares: | ||||
| Stock options | — | 57,364 | — | 54,498 |
| Restricted stock units and restricted stock awards | 252,576 | 1,186,231 | 337,866 | 849,398 |
| Shares excluded from diluted weighted average shares | 252,576 | 1,243,595 | 337,866 | 903,896 |
(1)
Unvested restricted stock units and restricted stock awards are not included as shares outstanding in the calculation of basic earnings per share. Vested restricted stock units and restricted stock awards are included in basic earnings per share if all vesting and performance criteria have been met. Performance-based restricted stock units and restricted stock awards are included in the number of shares used to calculate diluted earnings per share as long as all applicable performance criteria are met, and their effect is dilutive. Restricted stock awards are eligible to receive all dividends declared on the Company’s common shares during the vesting period; however, such dividends are not paid until the restrictions lapse.
(2)
Due to net losses for the three and nine months ended September 30, 2024 and September 30, 2023, diluted loss per share is the same as basic.
- Income taxes
The Company accounts for income taxes in accordance with ASC 740— Income Taxes. Under ASC 740, income taxes are recognized for the amount of taxes payable or refundable for the current period and deferred tax liabilities and assets are recognized for the future tax consequences of transactions that have been recognized in the Company’s consolidated financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided when it is more likely than not that some portion, or all, of the deferred tax asset will not be realized. As of December 31, 2023, the Company recorded a full valuation allowance of $59,968. As of September 30, 2024, the Company continued to record a valuation allowance against its domestic deferred tax assets.
The Company accounts for uncertainties in income tax in accordance with ASC 740-10— Accounting for Uncertainty in Income Taxes. ASC 740-10 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. This accounting standard also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.
The Company recognizes interest and penalties on taxes, if any, within its income tax provision on its consolidated statements of comprehensive loss.
- Stockholders’ equity
The Company has a 2014 Equity Incentive Plan (2014 Plan) under which the Company granted restricted stock units, restricted stock awards, performance units, performance shares, and options to purchase shares of its common stock. As of September 30, 2024, awards with respect to 309,330 shares of the Company’s common stock were outstanding.
The Company’s stockholders approved the adoption of the Amended and Restated 2023 Equity Incentive Plan (2023 Plan) on June 5, 2024 that provides for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any parent and subsidiary corporation’s employees, and for the grant of nonstatutory stock options, restricted stock, restricted stock units, restricted stock awards, stock appreciation rights, performance units and performance shares to its employees, directors and consultants and its parent and subsidiary corporations’ employees and consultants. The 2023 Plan became effective June 7, 2024. The number of shares of common stock reserved for issuance under the 2023 Plan was: (i)1,600,000 shares, plus (ii) (A)2,027,790 shares that, as of immediately before the termination or expiration of the 2014 Plan, had been reserved but not issued under any 2014 Plan awards and are not subject to any awards granted under the 2014 Plan, plus (B) any shares subject to awards granted under the 2014 Plan or the 2012 Plan that, after the 2014 Plan is terminated or expired, expire or otherwise terminate without having been exercised or issued in full or are forfeited to or repurchased by the Company due to failure to vest with the maximum number of shares that may be added to the 2023 Plan under subsection (ii) above equal to 2,950,000 shares.
As of September 30, 2024, awards with respect to 1,406,814 shares of the Company's common stock were outstanding, and 2,367,813 shares of common stock remained available for issuance under the 2023 Plan. The shares available for issuance under the 2023 Plan will be increased by any shares returned to the 2014 Plan as a result of expiration or termination of awards.
Pursuant to the Nasdaq inducement grant exception, during the nine months ended September 30, 2024, the Company issued 225,000 shares of common stock to a certain new hire issuable upon (i) the vesting of a maximum of 75,000 time-based restricted stock units granted, and (ii) the vesting of a maximum of 150,000 shares of performance-based restricted stock units granted to induce the employee to accept employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
Stock options
Options expiredten years from the date of grant and vest overone-year terms. The activity for stock options under the Company’s stock plans for thenine months ended September 30, 2024 is as follows:
| Remaining | |||||
|---|---|---|---|---|---|
| weighted- | |||||
| Weighted- · average · Per share | |||||
| average · contractual · average | |||||
| Price per · exercise · terms · intrinsic | |||||
| Options | share | price | (in years) | value | |
| Outstanding as of December 31, 2023 | 20,000 | $83.30 | $83.30 | 0.36 | $— |
| Forfeited | (10,000) | 83.30 | 83.30 | ||
| Expired | (10,000) | 83.30 | 83.30 | ||
| Outstanding as of September 30, 2024 | — | — | — | — | — |
| Vested and exercisable as of September 30, 2024 | — | — | — | — | — |
| Vested and expected to vest as of September 30, 2024 | — | $— | $— | — | $— |
The total intrinsic value of options exercised during the nine months ended September 30, 2024 and 2023 was $0 and $735, respectively. As of September 30, 2024, all stock-based compensation expense for options granted under the 2014 and 2023 Plans was recognized.
Stock incentive awards
The Company grants restricted stock units (RSUs) under the 2014 and 2023 Plans (Stock Awards). The Stock Awards vest either based solely on the satisfaction of time-based service conditions or on the satisfaction of time-based service conditions combined with performance market criteria. Stock Awards are subject to forfeiture if the holder’s services to the Company terminate before vesting.
Stock Awards granted with only time-based service vesting conditions generally vest over three-year andfour-year service periods, as defined in the terms of each award. Stock Awards that vest based on the satisfaction of time-based service conditions combined with performance criteria generally vest over athree-year service and performance period, based on performance and/or market conditions established at the time of the award. The portion of the Stock Award that is earned may equal or be more or less than the targeted number of shares subject to the Stock Award depending on whether the performance criteria are met.
Stock Awards activity for thenine months ended September 30, 2024 is summarized below:
| Weighted- | ||||||
|---|---|---|---|---|---|---|
| average | ||||||
| grant | ||||||
| Performance · date fair | ||||||
| and · value | ||||||
| Restricted stock units · Time-based · time-based · Total · per share | ||||||
| Unvested restricted stock units as of December 31, 2023 | 1,146,404 | 346,688 | 1,493,092 | $14.67 | ||
| Granted | 857,447 | 587,768 | 1,445,215 | 7.23 | ||
| Vested | (389,244) | — | (389,244) | 18.03 | ||
| Forfeited/canceled | (292,994) | (314,925) | (607,919) | 14.26 | ||
| Unvested restricted stock units as of September 30, 2024 (1) | 1,321,613 | 619,531 | 1,941,144 | $8.65 | ||
| Unvested and expected to vest restricted stock units outstanding as of September 30, 2024 | 1,499,262 | $8.69 | ||||
(1) Outstanding restricted stock units are based on the maximum payout of the targeted number of shares.
As of September 30, 2024, the unrecognized compensation cost related to unvested employee restricted stock units was $9,289, excluding estimated forfeitures. This amount is expected to be recognized over a weighted average period of 1.8 years.
Employee stock purchase plan
The Company’s 2014 Employee Stock Purchase Plan (ESPP) provides for the grant to all eligible employees an option to purchase stock under the ESPP, within the meaning Section 423 of the Internal Revenue Code. The ESPP permits participants to purchase common stock through payroll deductions of up to 15% of their eligible compensation, which includes a participant’s base straight time gross earnings, incentive compensation, bonuses, overtime, and shift premium, but exclusive of payments for equity compensation and other similar compensation. A participant may purchase a maximum of 1,500 shares during a purchase period. Amounts deducted and accumulated by the participant are used to purchase shares of the Company’s common stock at the end of each six-month period. The purchase price of the shares will be 85% of the lower of the fair market value of the Company’s common stock on the first trading day of each offering period or on the exercise date. The offering periods are currently approximately six months in length beginning on the first business day on or after March 1 and September 1 of each year and ending on the first business day on or after September 1 and March 1 approximately six months later.
As of September 30, 2024, a total of 585,409 shares of common stock were available for sale pursuant to the ESPP.
The number of shares available for sale under the ESPP is increased annually on the first day of each fiscal year by an amount equal to the least of:
179,069 shares;
1.5% of the outstanding shares of the Company’s common stock on the last day of the Company’s immediately preceding fiscal year; or
such other amount as may be determined by the administrator.
For 2024, an additional 179,069 shares were added to the ESPP share reserve pursuant to the provision described above.
Stock-based compensation
Stock-based compensation expense recognized for thethree and nine months ended September 30, 2024 and 2023, was as follows:
| Three months ended · Nine months ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Stock-based compensation expense by type of award: | ||||
| Restricted stock units and restricted stock awards | $1,362 | $1,682 | $5,367 | $8,164 |
| Employee stock purchase plan | 112 | 97 | 337 | 320 |
| Total stock-based compensation expense | $1,474 | $1,779 | $5,704 | $8,484 |
Employee stock-based compensation expense was calculated based on awards of stock options, restricted stock units and restricted stock awards ultimately expected to vest based on the Company’s historical award cancellations. ASC 718 –Compensation-Stock Compensation requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
For thethree and nine months ended September 30, 2024 and 2023, respectively, stock-based compensation expense recognized under ASC 718, included in cost of revenue, research and development expense, sales and marketing expense, and general and administrative expense was as follows:
| Three months ended · Nine months ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Cost of revenue | $123 | $164 | $448 | $401 |
| Research and development | 68 | 358 | 453 | 1,192 |
| Sales and marketing | 363 | (255) | 1,221 | 1,177 |
| General and administrative | 920 | 1,512 | 3,582 | 5,714 |
| Total stock-based compensation expense | $1,474 | $1,779 | $5,704 | $8,484 |
- Commitments and contingencies
Purchase obligations
The Company had approximately $60,800 of outstanding purchase orders due within one year with its outside vendors and suppliers as of September 30, 2024. The Company has $1,723 and $2,057 accrued within accounts payable and other accrued expenses in the consolidated balance sheets as of September 30, 2024 and December 31, 2023, respectively, related to estimated losses for firm commitment contractual obligations under these agreements. Losses on these firm commitment contractual obligations are recognized based upon the terms of the respective agreement and similar factors considered for the write-down of inventory, including expected sales requirements as determined by internal sales forecasts.
Warranty obligation
The following table identifies the changes in the Company’s aggregate product warranty liabilities for the nine-month and twelve-month periods ended September 30, 2024 and December 31, 2023, respectively:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Product warranty liability at beginning of period | $23,478 | $19,913 |
| Accruals for warranties issued | 8,562 | 9,843 |
| Adjustments related to preexisting warranties (including changes in estimates) | 986 | 5,014 |
| Settlements made (in cash or in kind) | (7,351) | (11,292) |
| Product warranty liability at end of period | $25,675 | $23,478 |
Contract liabilities
Contract liabilities primarily consist of deferred revenue related to lifetime warranties on direct-to-consumer sales revenue when cash payments are received in advance of services performed under the contract. The contract with the customer states the final terms of the sale, including the description, quantity, and price of each product or service purchase. The decrease in deferred revenue related to lifetime warranties for the nine months ended September 30, 2024 was primarily driven by $3,964 of revenue recognized that were included in the deferred revenue balances as of December 31, 2023, partially offset by $1,442 of payments received in advance of satisfying performance obligations. Deferred revenue related to lifetime warranties was $10,793 and $13,315 as of September 30, 2024 and December 31, 2023, respectively, and is classified within deferred revenue - current and deferred revenue - noncurrent in the consolidated balance sheets.
Legislation and HIPAA
The healthcare industry is subject to numerous laws and regulations of federal, state, and local governments. These laws and regulations include, but are not necessarily limited to, matters such as licensure, accreditation, government healthcare program participation requirements, reimbursement for patient services, and Medicare and Medicaid fraud and abuse. Compliance with government laws and regulations can be subject to future government review and interpretation as well as regulatory actions unknown or unasserted at this time. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted to ensure health insurance portability, reduce healthcare fraud and abuse, guarantee security and privacy of health information, and enforce standards for health information. The Health Information Technology for Economic and Clinical Health Act (HITECH Act), in part, imposes notification requirements of certain security breaches relating to protected health information. The Company is not aware of any pending claims against it under the HIPAA and HITECH regulations that are applicable to the Company’s business.
Legal proceedings
The Company is party to various legal proceedings and investigations arising in the normal course of business. The Company carries insurance, subject to specified deductibles under the policies, to protect against losses from certain types of legal claims. At this time, the Company does not anticipate that any of these other proceedings arising in the normal course of business will have a material adverse effect on the Company’s business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.
- Foreign currency exchange contracts and hedging
As of September 30, 2024 and September 30, 2023, the Company’s total non-designated and designated derivative contracts had notional amounts totaling approximately $51,810 and $0, respectively, and $10,414 and $1,613, respectively. These contracts were comprised of offsetting contracts with the same counterparty, each expires withinone totwo months. During thenine months ended September 30, 2024 and 2023, these contracts had, net of tax, an unrealized gain (loss) of $0 and an unrealized gain of $53.
The nonperformance risk of the Company and the counterparty did not have a material impact on the fair value of the derivatives. During the nine months ended September 30, 2024, there wereno ineffective portions relating to these hedges and the hedges remained effective through their respective settlement dates. During thenine months ended September 30, 2023, there wereno ineffective portions related to these hedges. As of September 30, 2024, the Company hadno designated hedges andfour non-designated hedges. As of September 30, 2023, the Company hadthree designated hedges andone non-designated hedge.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.