electroCore Inc
For the period ended Dec 31, 2023. Filed Mar 13, 2024.
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FY2023 · Filed Mar 13, 2024
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Notes to Consolidated Financial Statements
Note 1. The Company
electroCore, Inc. and its subsidiaries (“electroCore” or the “Company”) is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. The Company’s focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellness and human performance in the United States and select overseas markets.
electroCore, headquartered in Rockaway, NJ, hastwo wholly owned subsidiaries: electroCore UK Ltd andelectroCore Germany GmbH. The Company has paused operations in Germany, with sales into the country and the rest of Europe being managed by electroCore UK Ltd.
Note 2. Summary of Significant Accounting Policies
(a) Basis of Presentation
The accompanying consolidated financial statements were prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and the rules and the regulations of the Securities and Exchange Commission ("SEC").
At a special stockholders meeting held on February 13, 2023, the Company's stockholders approved an amendment to the Company's certificate of incorporation to effect of a reverse stock split of the Company's common stock at a ratio between 1-for-5 to 1-for-50 in order to achieve a minimum bid price of $1.00 per share for a minimum of 10 consecutive trading days, as required for continuing listing of the common stock on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The board of directors authorized a 1-for-15 ratio for the reverse stock split, which became effective on February 15, 2023. The accompanying consolidated financial statements and notes to consolidated financial statements give retroactive effect to the reverse stock split for all periods presented.
(b) Principles of Consolida tion
The accompanying consolidated financial statements include the accounts of electroCore and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
(c) Use of Estimates
The preparation of 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. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include trade credits, rebates, co-payment assistance and sales returns, valuation of inventory, estimated useful life of licensed products, income taxes, stock compensation, and contingencies.
(d) Revenue Recognition
The Company accounts for its revenue transactions under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”). In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies thefive-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied.
The transaction price is based on the consideration that the Company expects to receive in exchange for its products and includes the fixed per-unit price of the product and variable consideration in the form of trade credits, vouchers, rebates, and co-payment assistance. The per-unit price is based on the Company’s established wholesale acquisition cost less a contractually agreed upon distributor discount with the customer.
Trade credits are discounts that are contingent upon a timely remittance of payment and are estimated based on historical experience. Damaged or defective products are replaced at no charge under the Company’s standard warranty. A cash refund is allowed under specific circumstances for undamaged and non-defective returned products. For the years ended December 31, 2023 and 2022, trade credits and discounts were immaterial.
(e) Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents include all highly liquid investments with an original maturity ofthree months or less when purchased.
The following table provides a reconciliation of cash, cash equivalents and restricted cash to the balance reflected on the Consolidated Statement of Cash Flow at December 31, 2023:
| (in thousands) | December 31, 2023 |
|---|---|
| Cash and cash equivalents | $10,331 |
| Restricted cash | 250 |
| Total cash, cash equivalents and restricted cash | $10,581 |
As of December 31, 2023, cash equivalents represented funds held in a money market account and amounted to $4.2 million.
The Company's restricted cash consists of cash that the Company is contractually obligated to maintain in accordance with the terms of its corporate credit card arrangement with Citibank, N.A and established in April 2022.
(f) Concentration of Credit Risk
Cash equivalents are financial instruments that potentially subject the Company to concentration of credit risk. As of December 31, 2023, the Company's cash equivalent securities were largely comprised of money market funds. The Company has established guidelines relative to diversification and maturities that are designed to help ensure safety and liquidity. These guidelines are periodically reviewed to take advantage of trends in yields and interest rates. As of December 31, 2023,95% ofthe Company’s cash and cash equivalents were denominated in U.S. dollars. The balance of the Company's cash is denominated in British pound sterling and is subject to foreign exchange risk. The Company’s cash accounts are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per financial institution in the United States, and up to £85,000 by the Financial Services Compensation Scheme (“FSCS”) per financial institution in the United Kingdom. The Company's cash equivalent securities are insured by the Securities Investor Protection Corp. ("SIPC') up to $500,000 per account, with a limit of $250,000 in cash.
(g) Accounts Receivable
Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company maintains an allowance for credit losses for estimated losses inherent in its accounts receivable portfolio. Management considers an account receivable to be past due when it is not settled under its stated terms. In establishing the required allowance, management considers historical losses adjusted to take into account current market conditions and customers financial condition, the amount of receivables in dispute, and the current receivables aging and current payment patterns. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. During the years ended December 31, 2023 and 2022, the Company's allowance for credit losses was immaterial. The Company does not have any off balance sheet credit exposure related to its customers.
(h) Inventories
Inventory, which consists of raw materials, work-in-process and finished product, is stated at the lower of cost or net realizable value. Inventory is valued on a first-in first-out basis. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.
The Company evaluates inventory with respect to its operating cycle and classifies inventory as current or long-term on its balance sheet. Based upon estimated production needs and current inventory levels, the Company determined the amount of inventory necessary for the next twelve months. Any amounts over this projection are reclassified as Inventories, noncurrent.
In addition, the Company’s product is subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain units of product no longer meet quality specification or become obsolete, the Company records a charge to cost of goods sold to write down such unmarketable inventory tozero.
(i) Property and Equipment
Property and equipment are stated at historical cost. Depreciation is computed by the straight-line method based on the estimated useful lives of the respective assets, as discussed below. Amounts expended for maintenance and repairs are charged to expense as incurred.
Depreciation and leasehold improvement amortization is computed using the following estimated useful lives:
| Machinery and equipment | 3–15 years |
|---|---|
| Leasehold improvements | Lesser of estimated useful life or remaining term of lease |
| Furniture and fixtures | 5–10 years |
| Computer equipment | 5 years |
(j) Leases
The Company determines if an arrangement is a lease at inception. For each lease, the lease term is determined at the commencement date and includes renewal options and termination options when it is reasonably certain that the Company will exercise that option. Operating leases with lease terms greater thanone year are included in operating lease right-of-use (“ROU”) assets and current and long-term operating lease liabilities in the Company’s consolidated balance sheets.
Operating lease ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term using an estimated rate of interest the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease ROU assets are based on the liability adjusted for any prepaid or deferred rent and lease incentives. The incremental borrowing rate was utilized to discount lease payments over the expected term given that the Company’s operating leases do not provide an implicit rate. The Company estimates the incremental borrowing rate to reflect the profile of secured borrowing over the expected term of the leases based on the information available at the later of the date of adoption or the lease commencement date. Rent expense for the operating lease is recognized on a straight-line basis over the lease term.
(k) Cloud Computing Arrangement
Implementation costs for the Company’s cloud computing arrangement (“CCA”) are capitalized and amortized using the straight-line method over the life of the arrangement. The Company has capitalized implementation costs incurred in implementing its cloud computing arrangements, which is a hosting arrangement that is a service contract per FASB Accounting Standards Update (“ASU”)2018-15. These costs include payroll costs of employees devoting time to the project and external direct costs for materials and services are capitalized. Software maintenance and training costs are expensed in the period in which they are incurred. The capitalized costs are included as a component of other assets. The accompanying Consolidated balance sheet as of December 31, 2023 includes a total of $1.2 million of such capitalized costs which were fully amortized as of December 31, 2023. For the years ended December 31, 2023 and 2022, the Company recorded CCA amortization expense of $235,000 and $282,000, respectively.
(l) Licensed Products
The Company licenses a portion of its devices through its cash pay channels. The cost of these licensed devices is capitalized and included in Other Assets in the accompanying Consolidated Balance Sheets at December 31, 2023 and December 31, 2022, and is being recognized as cost of goods sold on the straight-line method over the estimated 12-36 month useful life of the devices. If certain licensed devices are returned and no longer meet quality specifications or the carrying amount of certain licensed devices are no longer deemed to be recoverable, the Company records a charge to cost of goods sold to write down such licensed devices tozero. The net book value of these licensed devices at December 31, 2023 and December 31, 2022 was $494,000 and $538,000, respectively. Changes in the value of these licensed devices in Other Assets is captured on the Statement of Cash Flows with inventories.
(m) Impairment of Long-Lived Assets
Long lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying amount. If the carrying amount of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying amount exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary.
(n) Stock-based Compensation
The Company accounts for stock-based compensation in accordance with the ASC Topic 718, Compensation – Stock Compensation. The Company estimates the fair value of stock option awards using the Black-Scholes option pricing model on the date of the grant. Restricted stock unit awards and restricted stock awards without a market condition are valued based on the closing price of the Company’s common stock on the date of the grant. Compensation expense reflects actual forfeitures and is primarily recognized on a straight-line basis over the requisite service period of the individual grants, which typically equals the vesting period.
(o) Income Taxes
The Company follows the asset and liability method of accounting for income taxes under ASC 740, "Income Taxes." Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income 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 included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax provisions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company is currently not aware of any issues under review that could result in significant payments, accruals or deviation from its position during the next twelve months.
(p) Research and Development
Research and development costs are expensed as incurred. These costs include, but are not limited to, costs related to clinical trials, and compensation and related overhead for employees and consultants involved in research and development activities.
(q) Foreign Currency Translation and Transactions
The functional currency of the Company’s international operations has been determined to be the respective local currency. The Company translates functional currency assets and liabilities to their U.S. dollar equivalents at exchange rates in effect at the balance sheet date and translates functional currency income and expense amounts to their U.S. dollar equivalents at average exchange rates for the period. The U.S. dollar affects that arise from changing translation rates are recorded in other comprehensive loss. Foreign currency transaction gains and losses related to assets and liabilities that are denominated in a currency other than the functional currency are reported in the Consolidated Statements of Operations in the period they occur.
(r) Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business asone operating segment.
(s) Recently Adopted Accounting Standards
In November 2023, the FASB issued Accounting Standards Update (ASU) No.2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures which will require companies to disclose significant segment expenses that are regularly provided to the chief operating decision maker ("CODM"). The pronouncement is effective for annual filings for the year ended December 31, 2024. The Company is still assessing the impact of the adoption of this standard but does not expect it to have a material impact on its results of operations, financial position or cash flows.
In December 2023, the FASB issued Accounting Standards Update (ASU) No.2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures which will require companies to make additional income tax disclosures. The pronouncement is effective for annual filings for the year ended December 31, 2025. The*** ***Companyis still assessing the impact of the adoption of this standard but does not expect it to have a material impact on its results of operations, financial position or cash flows.
Note 3. Going Concern, Significant Risks and Uncertainties
Going Concern
The Company has experienced significant net losses and cash used in operations, and it expects to continue to incur net losses and cash used in operations for the near future as it works to increase market acceptance of its medical devices and wellness products. The Company has never been profitable and has incurred net losses and cash used in operations in each year since its inception.
Sales to the United States Department of Veteran Affairs comprised 60.1% of the Company's revenue during the year ended December 31, 2023. The majority of the Company's 2023 sales were made pursuant to our qualifying contract under the Federal Supply Schedule or FSS, which was secured by us in December 2018, as well as open market sales to individual facilities within the government channels. The initial term of our FSS contract was scheduled to expire on January 15, 2024. On January 5, 2024, we obtained a modification to the initial contract, temporarily extending the term from January 15, 2024, to March 14, 2024, and subsequently extending the term to June 14, 2024, while the U.S. Department of Veteran Affairs VA Federal Supply Schedule Service reviews our follow-on offer application for a replacement FSS contract.
The Company has historically funded its operations from the sale of its common stock. On July 31, 2023, the Company entered into a registered direct offering with certain institutional and accredited investors, and concurrent private placements with such investors and certain of the Company’s officers and directors, resulting in net proceeds to the Company of approximately $7.5 million after deducting the placement agent fees and expenses, and other offering expenses payable by the Company. SeeNote 8,Shareholders' Equity, Securities Purchase Agreements.
The Company’s expected cash requirements for the next 12 months from the date these financial statements are issued and beyond are largely based on the commercial success of its products. The Company believes its cash and cash equivalents and anticipated revenue will enable it to fund its operating expenses, working capital, and capital expenditure requirements, as currently planned, through 12 months from the date of the accompanying financial statements. There are significant risks and uncertainties as to its ability to achieve these operating results. Due to the risks and uncertainties, there can be no assurance that the Company will have sufficient cash flow and liquidity to fund its planned activities, which could force it to significantly reduce or curtail its activities and potentially cease operations. These conditions raise substantial doubt about the Company's ability to continue as a going concern within one year of the date of these accompanying financial statements are issued. The accompanying financial statements do not include any adjustment that might result from the outcome of this uncertainty.
Concentration of Revenue Risks
The Company earns a significant amount of its revenue (i) in the United States from the Department of Veterans Affairs and Department of Defense ("VA/DoD") pursuant to its qualifying contract under the Federal Supply Schedule and open market sales to individual Department of Veterans Affairs facilities, (ii) in the United States from sales of its TAC-STIM products to several units of the DoD, and (iii) in the United Kingdom from the National Health Service.
The following table reflects the respective concentration as a percentage of the Company's net sales:
| Years ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Revenue channel: | ||
| VA/DoD | 60.1% | 60.8% |
| TAC-STIM | 10.9% | 1.5% |
| National Health Service | 8.8% | 15.1% |
During the years ended December 31, 2023 and 2022, two andone facilities accounted for more than 10% of total VA/DOD net sales, respectively. During the years ended December 31, 2023 and 2022, one facility accounted for more than 10% of net sales from the National Health Service.
Foreign Currency Exchange Risks
The Company has foreign currency exchange risk related to revenue and operating expenses in currencies other than the local currencies in which it operates. The Company is exposed to currency risk from the potential changes in functional currency values of its assets, liabilities, and cash flows denominated in foreign currencies.
Note 4. Revenue Recognition
Product Net Sales
| (in thousands) | Years ended December 31, | |
|---|---|---|
| Channel | 2023 | 2022 |
| Rx gammaCore - Department of Veteran Affairs and Department of Defense | $9,636 | $5,099 |
| Rx gammaCore - U.S. Commercial | 1,797 | 1,735 |
| Outside the United States | 1,821 | 1,618 |
| Truvaga | 1,027 | 15 |
| TAC-STIM | 1,749 | 125 |
| $16,030 | $8,592 | |
Geographical Net Sales
| Years ended December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Product revenue | ||
| United States | $14,209 | $6,974 |
| United Kingdom | 1,571 | 1,296 |
| Other | 148 | 183 |
| License revenue | ||
| Japan | 102 | 139 |
| Total Net Sales | $16,030 | $8,592 |
The Company generally invoices the customer and recognizes revenue once its performance obligations are satisfied, at which point payment is unconditional. Agreed upon payment terms with customers are within 30 days of shipment. Accordingly, contracts with customers do not include a significant financing component.
Note 5. Inventory
As of December 31, 2023 and 2022, inventories consisted of the following:
| December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Raw materials | $832 | $944 |
| Work in process | 1,538 | 2,879 |
| Finished Goods | 397 | 353 |
| Total Inventory | 2,767 | 4,176 |
| Less: noncurrent inventory | 607 | 2,194 |
| Total current inventory | $2,160 | $1,982 |
The reserve for obsolete inventory was $0.7 million as of December 31, 2023 and 2022, respectively. The Company records charges for obsolete inventory in Cost of goods sold. These charges to Cost of goods sold totaled $0.7 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 and 2022, noncurrent inventory was comprised of approximately $0.5 million and $0.1 million of raw materials, respectively, and $0.1 million and $2.1 million of work in process, respectively. Inventory classified under the category “Work in process” consists of prefabricated assembled product.
Note 6. Leases
The Company accounts for leases in accordance with ASU 842, and its operating leases consist of manufacturing/warehouse space in Rockaway, New Jersey and office equipment. The Company elected not to recognize right of use assets and lease liabilities for short term leases, i.e., leases with a noncancelable period of 12 months or less. The Company recognized the option to renew itsmanufacturing/warehouse space ("Rockaway space") as part of the right of use asset and the lease liability as the Company deemed that the renewal option was reasonably certain to be exercised.
For the years ended December 31, 2023 and 2022, the Company recognized lease expense of $153,000, respectively. This expense does not include non-lease components associated with the lease agreements as the Company elected not to include such charges as part of the lease expense.
Supplemental Balance Sheet Information for Operating Leases:
| December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Operating leases: | ||
| Operating lease right of use assets | $502 | $565 |
| Operating lease liabilities: | ||
| Current portion of operating lease liabilities | 89 | 74 |
| Noncurrent operating lease liabilities | 537 | 625 |
| Total operating lease liabilities | $626 | $699 |
| Weighted average remaining lease term (in years) | 5.2 | 6.1 |
| Weighted average discount rate | 13.8% | 13.8% |
Future minimum lease payments under non-cancellable operating leases as of December 31, 2023:
| Financial year (in thousands) | |
|---|---|
| 2024 | $168 |
| 2025 | 171 |
| 2026 | 161 |
| 2027 | 157 |
| 2028 and thereafter | 216 |
| Total future minimum lease payments | 873 |
| Less: Amounts representing interest | (247) |
| Total | $626 |
On February 6, 2024, the Company entered into The First Amendment to Lease Agreement ("the Agreement") to extend the Rockaway, New Jersey lease for an additional 10 years and includes the expansion of leased property. The Amendment is effective May 1, 2024, and expires on July 31, 2034, with a tenant option to renew for an additional five years. The Amendment includes the expansion of leased property from 13,643 square feet to 22,557 square feet. The initial base rent under the Amendment is $15.00 per square foot and increases by 4% per annum on each anniversary of the effective date. The first three months of rent is abated for the additional 8,914 square feet leased under the Amendment.
Note 7. Accrued Expenses and Other Current Liabilities
Accrued expenses as of December 31, 2023 and 2022 consisted of the following:
| December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Accrued professional fees | $282 | $524 |
| Accrued bonuses and incentive compensation | 2,352 | 2,042 |
| Accrued legal fees | 1,041 | 1,001 |
| Accrued insurance expense | 247 | 264 |
| Accrued research and development expenses | 655 | — |
| Accrued vacation and other employee related expenses | 628 | 534 |
| Accrued tax expenses | 272 | 133 |
| Deferred revenue | 245 | 152 |
| Other | 149 | 192 |
| $5,871 | $4,842 | |
Finance and Security Agreements
On July 5, 2023, the Company entered into a Commercial Insurance Premium Finance and Security Agreement (the "2023 Agreement"). The 2023 Agreement provides for a single borrowing by the Company of approximately $618,000 with aten-month term and an annual interest rate of 6.03%. The proceeds from this transaction were used to partially fund the premiums due under certain of the Company's insurance policies. The amounts payable are secured by the Company's right under such policies. The Company began paying monthly installments of approximately $61,800 in July 2023. As of December 31, 2023 the remaining balance under the Agreement was approximately $247,000.
On July 5, 2022, the Company entered into a Commercial Insurance Premium Finance and Security Agreement (“the 2022 Agreement”). The 2022 Agreement provided for a single borrowing by the Company of approximately $783,000 with anine-month term and an annual interest rate of 2.49%. The proceeds from this transaction were used to partially fund the premiums due under certain of the Company’s insurance policies. The Company began to pay monthly installments of approximately $87,900 beginning in July 2022. All borrowings under the 2022 Agreement were repaid as of December 31, 2023.
During the years ended December 31, 2023 and 2022, the Company recognized $12,200 and $4,300 in aggregate interest expense related to the 2023 Agreement and 2022 Agreement, respectively.
Note 8. Shareholders’ Equity
Securities Purchase Agreements
On July 31, 2023, the Company entered into a securities purchase agreement (“First SPA”) in connection with a registered direct offering and concurrent private placement with certain institutional and accredited investors pursuant to which the Company issued and sold an aggregate of 1,062,600 shares of common stock,613,314 pre-funded common stock purchase warrants that are exercisable upon issuance, and warrants to purchase up to an aggregate of 837,955 shares of common stock. On July 31, 2023, the Company also entered into a securities purchase agreement (“Second SPA”) in connection with a concurrent private placement withsix of the Company’s officers and directors pursuant to which the Company issued and sold 169,968 shares of common stock and warrants to purchase up to an aggregate of 84,982 shares of common stock. The combined effective offering price of the securities sold pursuant to the First SPA and the Second SPA was $4.4125 per share of common stock and related common stock purchase warrant. The common stock purchase warrants will be exercisable commencingsix months after the date of issuance at a price of $4.35 per share and will expire five years after they first become exercisable. The net proceeds to the Company resulting from the First SPA and Second SPA was approximately $7.5 million, after deducting the placement agent fees and expenses, and other offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the common stock purchase warrants sold in the concurrent private placements.
In accordance with ASC 480 and ASC 815-40, the Company assessed the warrants associated with its First SPA and Second SPA and determined that the warrants qualify for equity classification.
Reverse Stock Split
On February 13,2023, the Company held aspecial meeting (the “Special Meeting”) of stockholders of the Company. At the Special Meeting, the Company’s shareholders voted to approve an amendment to the Company’s Certificate of Incorporation to effect a reverse stock split of the Company’s common stock (the “Reverse Stock Split”) at a ratio between 1-for-5 and 1-for-50.
Following the Special Meeting, the board of directors of the Company approved a 1-for-15 Reverse Stock Split. The Reverse Stock Split became effective on February 15,2023.
Upon the effectiveness of the Reverse Stock Split, every 15 shares of common stock were automatically combined and converted intoone share of common stock. Appropriate adjustments were also made to all outstanding derivative securities of the Company, including all outstanding equity awards and warrants.
No fractional shares were issued in connection with the Reverse Stock Split. Instead, all fractional shares received a cash payment based on the closing sales price on the Nasdaq Capital Market of the Company’s common stock on February 14,2023.
Redemption and Elimination of Series A Preferred Stock
All shares of Series A Preferred Stock that were not present in person or by proxy as of immediately prior to the opening of the polls at the Special Meeting were automatically redeemed by the Company (the “Initial Redemption”). Any outstanding shares of Series A Preferred Stock that had not been so redeemed were redeemed automatically upon the approval at the Special Meeting of the Reverse Stock Split (the “Subsequent Redemption”). Each share of Series A Preferred Stock redeemed was entitled to receive an amount equal to $0.01 in cash for each 10 whole shares of Series A Preferred Stock owned immediately prior to the Redemption.
On March 6,2023, the Company filed a certificate of elimination (the “Certificate of Elimination”), with the Secretary of State of the State of Delaware with respect to the Series A Preferred Stock. The Certificate of Elimination (i) eliminated the previous designation of 80,000 shares of Series A Preferred Stock from the Company’s Certificate of Incorporation, none of which were outstanding at the time of the filing of the Certificate of Elimination, and (ii) caused such shares of Series A Preferred Stock to resume their status as authorized but unissued and non-designated shares of preferred stock.
Dividend Preferred
On December 2, 2022, the Company’s board of directors declared a dividend ofone one-thousandth of a share of Series A Preferred Stock, par value $0.001 per share (“Series A Preferred Stock”), for each outstanding share of the Company’s common stock, to stockholders of record on December 19, 2022.
Each share of Series A Preferred Stock entitled the holder thereof to 1,000,000 votes per share, and each fraction of a share of Series A Preferred Stock had a ratable number of votes. Thus, eachone-thousandth of a share of Series A Preferred Stock was entitled to 1,000 votes. The outstanding shares of Series A Preferred Stock voted together with the outstanding shares of the Company’s common stock as a single class exclusively with respect to the proposal to adopt an amendment to the Company’s Certificate of Incorporation, as amended, to reclassify the outstanding shares of the Company's Common Stock into a smaller number of shares of common stock at a ratio specified in or determined in accordance with the terms of such amendment (the “Reverse Stock Split”).
The Company was not solely in control of the redemption of the shares of Series A Preferred Stock since the holders had the option of deciding whether to vote in respect of the above described Reverse Stock Split, which determined whether a given holder’s shares of Series A Preferred Stock were redeemed in the Initial Redemption or the Subsequent Redemption. Since the redemption of the Series A Preferred Stock was not solely in the control of the Company, the shares of Series A Preferred Stock were classified within mezzanine equity in the Company’s audited consolidated balance sheet. The shares of Series A Preferred Stock were measured at redemption value. The value of the shares of Series A Preferred Stock as of December 31, 2023 and 2022 was $0 and $71, respectively.
Stock Purchase Warrants
The following table presents a summary of stock purchase warrants outstanding as of December 31, 2023:
| Number of Warrants (in thousands) | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Outstanding, January 1, 2023 | 1 | $229.50 | 3.0 | $— |
| Stock Purchase Warrants (a) | 923 | |||
| Exercised | — | |||
| Expired | — | |||
| Outstanding, December 31, 2023 | 924 | $4.54 | 5.1 | $1,477 |
| Exercisable, December 31, 2023 | 1 | $229.50 | 2.0 | $— |
*(a)*613 pre-funded warrants were excluded from the aforementioned table. Such pre-funded warrants became exercisable on August 2, 2023.
Note 9. Net Loss Per Share
All common stock share data reflects the reverse stock split effective February 15, 2023.
Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding adjusted to give effect to potentially dilutive securities. Due to their nominal exercise price of $0.001 per share,613,314 pre-funded warrants are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying consolidated statement of operations as of the closing date of the Company's July 2023 Securities Purchase Agreements. Restricted stock and unit awards, stock options, and warrants (other than the pre-funded warrants) have not been included in the diluted loss per share calculation as their inclusion would have had an anti-dilutive effect.
The potential common stock equivalents that have been excluded from the computation of diluted loss per share consist of the following:
| December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Outstanding stock options | 516 | 440 |
| Restricted and deferred stock units | 316 | 191 |
| Stock purchase warrants | 924 | 1 |
| 1,756 | 632 | |
Note 10. Income Taxes
The benefit for income taxes for the years ended December 31, 2023 and 2022 consisted of foreign taxes, state minimum tax and a benefit from the sale of state net operating losses.
Domestic and foreign components of the loss before provision forincome taxes isas follows:
| (in thousands) | December 31, 2023 | December 31, 2022 |
|---|---|---|
| Domestic | $(18,713) | $(21,518) |
| Foreign | (307) | (1,075) |
| Total | $(19,020) | $(22,593) |
The income tax (benefit)/expense from continuing operations contains the following components:
| (in thousands) | December 31, 2023 | December 31, 2022 |
|---|---|---|
| Federal | $— | $— |
| State | (208) | (449) |
| Foreign | 22 | 18 |
| Total current benefit | (186) | (431) |
| Total deferred | — | — |
| Total income tax benefit | $(186) | $(431) |
The Company has evaluated the available evidence supporting the realization of its deferred tax assets, including the amount and timing of future taxable income, and has determined that it is more likely than not that its net deferred tax assets will not be realized in the United States and certain foreign jurisdictions. Due to uncertainties surrounding the realization of the deferred tax assets, the Company maintains a full valuation allowance against all of its net deferred tax assets. When the Company determines that it will be able to realize some portion or all of its deferred tax assets, an adjustment to its valuation allowance on its deferred tax assets would have the effect of increasing net income in the period such determination is made. The net change in the valuation allowance was an increase of $3.5 million.
The significant components of the Company’s deferred income tax assets and liabilities after applying enacted corporate tax rates are as follows:
| Year ended December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Deferred tax assets | ||
| Net operating loss carryforwards | $33,580 | $29,854 |
| Accrued expenses | 197 | 257 |
| Intangibles | 2,547 | 1,720 |
| Fixed assets | — | 5 |
| Inventory | 172 | 165 |
| Allowance for bad debt | 9 | 3 |
| Charitable contributions | 10 | 10 |
| R&D credit | 1,257 | 422 |
| Lease liabilities | 152 | 172 |
| Stock compensation | 2,925 | 4,744 |
| Deferred tax assets | 40,849 | 37,352 |
| Less valuation allowance | (40,564) | (37,046) |
| Total deferred tax assets | 285 | 306 |
| Prepaid expenses | (163) | (167) |
| Right of use asset | (122) | (139) |
| Total deferred tax liabilities | (285) | (306) |
| Deferred tax assets, net | $— | $— |
A reconciliation of the income tax benefit computed at the U.S. federal statutory income tax rate of 21% and the reported income tax benefit for the years ended December 31, 2023 and 2022 isas follows:
| Year ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Statutory rate | (21.0)% | (21.0)% |
| State tax recovery, net of federal benefit | (5.1)% | (7.3)% |
| State tax rate change | 2.8% | 9.5% |
| Stock compensation | 10.7% | (0.2)% |
| State tax NOL sale | (0.9)% | (1.6)% |
| Nondeductible expenses | (2.2)% | 0.2% |
| Change in valuation allowance for deferred tax assets | 14.7% | 18.5% |
| Income tax benefit | (1.0)% | (1.9)% |
As of December 31, 2023 and 2022, the Company had accumulated Federal net operating losses totaling $134.1 million and $119.7 million, respectively. Also, as of December 31, 2023 and 2022, the Company had state post-apportioned net operating losses totaling $54.6 million and $47.0 million, respectively. The net operating losses may be available to carry forward and offset future years' taxable income. U.S. federal losses can be carried forward indefinitely, and state losses expire in various amounts beginning in 2026. The Company also had accumulated losses totaling $3.4 millionfor each of the years ended December 31, 2023 and 2022, respectively, in Germany which can be carried forward indefinitely.
However, the NOL carryforwards may be, or become subject to, an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over athree year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to an ownership change. Subsequent ownership changes may further affect the limitation in future years. If and when the Company utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation rules on the NOL carryforward balances.
During the year ended December 31, 2023 in accordance with the State of New Jersey's Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell unused NOL carry forwards to other New Jersey based corporate taxpayers, the Company sold New Jersey NOL carry forwards, resulting in the recognition of $215,000 of income tax benefit, net of transaction costs. The Company recognized $445,000 of income tax benefit from the sale of New Jersey carry forwards in 2022. There can be no assurance as to the continuation or magnitude of this program in the future.
As of December 31, 2023, the Company had Federal and NJ research and development credits of $698,000 and $198,000 respectively. The Federal R&D credits can be carried forward 20 years and will begin to expire in 2038. The New Jersey R&D credits can be carried forward seven years and will begin to expire in 2025.
On August 16, 2022, the U.S. government enacted the Inflation Reduction Act of 2022 (the Inflation Reduction Act) into law. The Inflation Reduction Act includes a new corporate alternative minimum tax (the Corporate AMT) of 15% on the adjusted financial statement income (AFSI) of corporations with an average AFSI exceeding $1.0 billion over athree-year period. The Corporate AMT was effective for the Company beginning in 2023. Given the AFSI threshold, the Corporate AMT was not applicable to the Company in 2023, but the Corporate AMT may have potential impacts on our future U.S. tax expense, cash taxes and effective tax rate. Additionally, the Inflation Reduction Act imposes a 1% excise tax on the fair market value of net stock repurchases made after December 31, 2022. The impact of this provision was not material in 2023 and future impacts will be dependent on the extent of share repurchases made in future periods.
Uncertain Tax Positions
The Company has adopted certain provisions of ASC 740, “Income Taxes”, which prescribes a recognition threshold and measurement attribute for the recognition and measurement of tax positions taken or expected to be taken in income tax returns. The provisions also provide guidance on the de-recognition of income tax assets and liabilities, classification of current and deferred income tax assets and liabilities, and accounting for interest and penalties associated with tax positions.
The Company files income tax returns in the U.S. federal jurisdiction, and in various state and foreign jurisdictions. The Company’s tax returns are subject to tax examinations by U.S. federal and state tax authorities, or examinations by foreign tax authorities until the expiration of the respective statutes of limitation. The Company’s U.S. federal and state net operating losses have occurred since inception in 2018 and as such, tax years subject to potential tax examinations could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company currently has no tax years under examination.
As of December 31, 2023, the Company does not have an accrual relating to uncertain tax positions. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. It is not anticipated that unrecognized tax benefits would significantly increase or decrease within 12 months of the reporting date.
Note 11. Stock Based Compensation
All common stock share and per share data reflects the reverse stock split effective February 15, 2023.
On June 21, 2018, the Company adopted the 2018 Omnibus Equity Incentive Plan (“Plan”). This plan reserved 0.4 million shares with an increase to be added annually beginning in 2019 through 2028 up to 4% of the total number of shares of common stock issued and outstanding on a fully diluted basis as of the end of the immediately preceding fiscal year, provided that the aggregate number of additional shares shall not exceed a total of 3.0 million shares, and a maximum of 2.7 million shares pursuant to the exercise of stock options. Effective January 1, 2024, the number of shares reserved under the Plan was increased by 0.3 million to approximately 1.3 million. The Company’s policy is to issue new shares of its common stock upon the exercise of stock options, new grants of restricted stock awards, and settlement of restricted stock units. Stock options issued under the plan have a contractual life of 10 years and are generally forfeited upon separation from the Company.
The following table presents stock compensation expense recognized by the Company for the years ended December 31, 2023 and 2022. Total unrecognized compensation cost related to equity awards as of December 31, 2023 was $1.7 million and is expected to be recognized over the next 1.5 years.
| Year ended December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Selling, general and administrative | $1,435 | $2,319 |
| Research and development | 237 | 335 |
| Cost of goods sold | 26 | 28 |
| Total expense | $1,698 | $2,682 |
The following table presents a summary of stock option award activity during the year ended December 31, 2023:
| Number of Options (in thousands) | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Outstanding, January 1, 2023 | 440 | $55.65 | 7.5 | $— |
| Granted | 206 | — | $— | |
| Exercised | — | — | $— | |
| Cancelled | (130) | — | $— | |
| Outstanding, December 31, 2023 | 516 | $37.46 | 7.7 | $307 |
| Exercisable, December 31, 2023 | 252 | $67.70 | 6.5 | $39 |
The intrinsic value is calculated as the difference between the fair market value at December 31, 2023 and the exercise price per share of the stock option. The options granted to employees generally vest over athree year period.
The following table provides additional information about stock options that are outstanding and exercisable at December 31, 2023:
| Exercise Price | Options Outstanding (in thousands) | Options Outstanding Weighted Average Remaining Contractual Life (Years) | Options Exercisable (in thousands) |
|---|---|---|---|
| $4.05 - $4.55 | 144 | 9.6 | — |
| $4.56 - $19.88 | 182 | 8.3 | 95 |
| $19.89 - $225.00 | 190 | 5.7 | 157 |
The following table presents a summary of restricted and deferred stock unit (“Unit” or "Units") activity during the year ended December 31, 2023:
| Number of Shares (in thousands) | Weighted Average Grant Date Fair Value | |
|---|---|---|
| Nonvested, January 1, 2023 | 127 | $11.85 |
| Granted | 137 | — |
| Vested | (28) | — |
| Cancelled | (9) | — |
| Nonvested, December 31, 2023 | 227 | $7.41 |
In general, Units granted to employees vest overtwo tofour-year periods.
Immediately following the Company’s annual meeting of stockholders, the Company generally grants each non-employee director an equity award that vests over a 12-month period. Upon a non-employee director’s initial appointment or election to the board of directors, the Company grants such non-employee director an equity award subject to vesting over a 36-month period.
Valuation Information for Stock-Based Compensation
The fair value of each stock option award during the years ended December 31, 2023 and 2022 was estimated on the date of grant using the Black-Scholes model. Effective July 1, 2023, expected volatility was based 100% on the Company's historical common stock volatility. For the 2022 period presented below, and prior to July 1, 2023, expected volatility was based on a composite comprising of (i)50% of the Company's historical common stock volatility and (ii) the remaining 50% was based on historical volatility of its peers. The risk-free interest rate was based on the average U.S. Treasury rate that most closely resembled the expected life of the related award. The expected term of the award was calculated using the simplified method. No dividend was assumed as the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.
The weighted average assumptions used in the Black-Scholes option pricing model in valuing stock options granted in the years ended December 31, 2023 and 2022 are summarized in the table below.
| 2023 | 2022 | |
|---|---|---|
| Fair value at grant date | $3.95 | $7.20 |
| Expected volatility | 122.4% | 90.6% |
| Risk-free interest rate | 4.1% | 2.1% |
| Expected holding period, in years | 5.8 | 5.8 |
| Dividend yield | — | — |
The fair value of the Units is the market close price of the Company’s common stock on the trading day immediately preceding the date of grant.
Note 12. Commitments and Contingencies
Stockholders Litigation
In the Turnofsky case, on November 25, 2019, several plaintiffs and their counsel moved to be selected as lead plaintiff and lead plaintiff’s counsel. On April 24, 2020, the Court granted the motion of Carole Tibbs and the firm Bragar, Eagel & Squire, P.C. On July 17, 2020, the plaintiffs filed an amended complaint in Turnofsky. In addition to the prior claims, the amended complaint added an additional director defendant andtwo investors as defendants and adds a claim against the Company and the underwriters for violating Section 12(a)(2) of the Securities Act.
On September 15, 2020, the Company and the other defendants filed a motion to dismiss the amended complaint for failure to state a claim. On November 6, 2020, the plaintiffs filed their opposition to the motion to dismiss. The Company and the other defendants filed reply papers in support of the motion on December 7, 2020. Argument of the motion to dismiss occurred on June 18, 2021. On August 13, 2021, the Court dismissed the amended complaint with leave to re-plead. On October 4, 2021, the plaintiffs filed a second amended complaint in the Turnofsky case. The defendants moved to dismiss, and briefing on the motion was completed on January 7, 2022. On July 13, 2023, the court dismissed the second amended complaint with leave to re-plead. The plaintiffs did not file a third amended complaint. On August 23, 2023, the plaintiffs provided the court with an order of dismissal, and the court entered the order on August 24, 2023. On September 8, 2023, plaintiff Carole Tibbs filed a notice of appeal to the United States Court of Appeals for the Third Circuit. The appeal has been docketed as number 23-2655. The principal brief of appellant and appendix were filed on January 5, 2024. The appellees’ brief is due on or before February 15, 2024, and appellant’s reply brief is due on or before March 15, 2024. Argument of the motion has not yet been scheduled.
On March 4, 2021, purported stockholder Richard Maltz brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Richard Maltz, derivatively on behalf ofelectroCore, Inc., vs. Francis R. Amato, et al., Case 3:21-cv-04135. The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with the IPO and actions occurring between the IPO and September 25, 2019. The complaint alleges that demand on the board of directors is excused. The complaint purports to allege claims against the defendants for violating Section 14(a) of the Exchange Act, breaching fiduciary duties, unjust enrichment and waste of corporate assets. The complaint also purports to allege claims for contribution in connection with the Turnofsky case described above, pursuant to Section 11(f) of the Securities Act and Sections 10(b) and 21D of the Exchange Act. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to the Bylaws and Certificate of Incorporation.
On March 8, 2021, purported stockholder Erin Yuson brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Erin Yuson, derivatively on behalf ofelectroCore, Inc., vs. Francis R. Amato, et al., Case 3:21-cv-04481. The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with a 2019 proxy statement and actions occurring from the IPO through September 25, 2019. The complaint alleges that demand on the board of directors is excused. The complaint purports to allege claims against the defendants for violating Section 14(a) of the Exchange Act and breaching fiduciary duties. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to the Bylaws and Certificate of Incorporation.
The plaintiffs in the Maltz and Yuson derivative actions agreed to consolidate and stay those actions. The actions are stayed until and through the resolution of any motion for summary judgment in the Turnofsky federal securities class action. A stipulation to that effect was filed by the plaintiffs on April 14, 2021, and ordered by the court on April 30, 2021. On June 9, 2023, the cases were administratively dismissed without prejudice.
The Company intends to continue to vigorously defend itself in these matters. However, in light of, among other things, the preliminary stage of these litigation matters, the Company is unable to determine the reasonable probability of loss or a range of potential loss. Accordingly, the Company has not established an accrual for potential losses, if any, that could result from any unfavorable outcome, and there can be no assurance that these litigation matters will not result in substantial defense costs and/or judgments or settlements that could adversely affect the Company’s financial condition.
The Company is subject to various claims, complaints and legal actions in the normal course of business from time to time. The Company is not aware of any further currently pending litigation for which it believes the outcome could have a material adverse effect on its operations or financial position. The Company expenses associated legal fees including those relating to the stockholder litigation described in this Note 12 in the period they are incurred.
Purchase Commitments
The Company enters into contracts in the normal course of business with contract research organizations for its clinical trials, contract manufacturing organizations for the manufacture and supply of its clinical and commercial product needs and other vendors for other research and development and commercial activities, as well as services and products for operating purposes. The Company’s agreements generally provide for termination with notice. Such agreements that are cancelable contracts are not included as purchase commitments. The Company has included as purchase obligations its commitments under agreements to the extent they are quantifiable and are not cancelable. The Company hasno material purchase obligations as of December 31, 2023.
Note 13. Severance and Other Related Charges
During the year ended December 31, 2023, the Company entered into separation agreements with former employees of which agreements required aggregate payments totaling $464,000. The charge for these payments is included in Selling, general and administrative expense in the accompanying Statement of Operations for the year ended December 31, 2023. As of December 31, 2023, the Company has an outstanding payable of $21,000 in connection with these charges. This outstanding payable is included in Accrued expenses and other current liabilities in the accompanying Consolidated Balance Sheet as of December 31, 2023.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.