ReShape Lifesciences Inc
For the period ended Dec 31, 2023. Filed Apr 1, 2024.
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FY2023 · Filed Apr 1, 2024
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Notes to Consolidated Financial Statements
| (1) | Description of the Business and Risks and Uncertainties |
Description of Business
We were incorporated under the laws of Delaware on January 2, 2008. On June 15, 2021, we completed a merger with ReShape Lifesciences Inc. Pursuant to the Merger Agreement, a wholly owned subsidiary of Obalon merged with and into ReShape, with ReShape surviving the merger as a wholly owned subsidiary of Obalon. As a result of the merger, Obalon, the parent company, was renamed “ReShape Lifesciences Inc.” and ReShape was named ReShape Weightloss Inc. ReShape Lifesciences’ shares of common stock trade on the Nasdaq under the symbol RSLS.
ReShape Medical (formerly ReShape Lifesciences Inc.) was incorporated in the state of Minnesota in December 2002 and reincorporated in the state of Delaware in July 2004. In 2017, the Company changed its name from EnteroMedics Inc. to ReShape Lifesciences Inc.
The Company is headquartered in Irvine, California. The Company is a developer of minimally invasive medical devices that advance bariatric surgery to treat obesity and metabolic diseases. The Company’s current portfolio consists of the Lap-Band® Adjustable Gastric Banding System, the Obalon Balloon System, the first and only swallowable gas filled balloon system, and the Diabetes Bloc-Stim Neuromodulation, a technology under development as a new treatment for type 2 diabetes mellitus. The Company sells the Lap-Band worldwide and is managed in the following geographical regions: United States, Australia, Europe and the rest of world. Refer to Note 11 for additional information about operating segments.
Risks and Uncertainties
The Company continues to devote significant resources to developing its product technology, commercialization activities and raising capital. These activities are subject to significant risks and uncertainties, including the ability to obtain additional financing, and there can be no assurance that the Company will be successful in obtaining additional financing on favorable terms, or at all. If adequate funds are not available, the Company may have to further reduce its cost structure until financing is obtained and/or delay development, or commercialization of products, or license to third parties the rights to commercialize products, or technologies that the Company would otherwise seek to commercialize. Refer to Note 3 for additional information about the Company’s liquidity, going concern and management’s plans.
The medical device industry is characterized by frequent and extensive litigation and administrative proceedings over patent and other intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often difficult to predict, and the outcome may be uncertain until the court has entered final judgment and all appeals are exhausted. The Company’s competitors may assert that its products or the use of the Company’s products are covered by U.S. or foreign patents held by them. Refer to Note 14 for additional information about contingencies and litigation matters.
| (2) | Summary of Significant Accounting Policies |
Basis of Presentation
The Company has prepared the accompanying consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
Reverse Stock Splits
On December 23, 2022, at the commencement of trading, the Company effected a 1-for-50 reverse stock split. Accordingly, all share and per share amounts for the periods presented in the accompanying consolidated financial
statements and notes thereto have been adjusted retroactively, where applicable, to reflect the reverse stock split. No fractional shares were issued in connection with the reverse stock split.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and accounts have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers highly liquid investments generally with maturities of 90 days or less when purchased to be cash equivalents. Cash equivalents are stated at cost, which approximates market value. The Company’s cash equivalents are primarily in money market funds and certificates of deposit. The Company deposits its cash and cash equivalents in high-quality credit institutions.
Restricted Cash
Restricted cash represents $100 thousands at both December 31, 2023 and 2022, related to a collateral money market account maintained by the Company as collateral in connection with corporate credit cards with Silicon Valley Bank.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets to the same total reported in the consolidated statements of cash flows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2023 · 2022 | ||||||
| Cash and cash equivalents | | $4,459 | | $3,855 | ||
| Restricted cash | | | 100 | | | 100 |
| Total cash, cash equivalents, and restricted cash in the consolidated statement of cash flows | | $4,559 | | $3,955 | ||
Accounts Receivable
The majority of the Company’s accounts receivable arise from direct product sales and sales of products under consignment arrangements, and have payment terms that generally require payment within 30 to 90 days. The Company provides reserves against accounts receivable for estimated losses that may result from a customer’s inability to pay based on customer-specific analysis and general matters such as current assessments of past due balances, economic conditions and forecasts, and historical credit loss activity. Amounts determined to be uncollectible are charged or written-off against the reserve. Additionally, under the current expected credit loss model, we utilize historical loss rates based on number of days past due, adjusted to reflect current economic conditions and forecasts of future economic conditions.
Inventory
The Company accounts for inventory at the lower of cost or net realizable value, where net realizable value is based on market prices less costs to sell. The Company establishes inventory reserves for obsolescence based upon specific identification of expired or unusable units with a corresponding provision included in cost of revenue. The allowance for excess and slow-moving inventory was $1.0 million at both December 31, 2023 and 2022.
Property and Equipment, Net
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives offive toseven years for furniture and equipment andthree tofive years for computer hardware and software. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Upon retirement or sale, the cost and related accumulated depreciation or amortization are removed from the Consolidated Balance Sheets and the resulting gain or loss is reflected in the Consolidated Statements of Operations. Repairs and maintenance are expensed as incurred.
Goodwill and Other Long-Lived Assets
Goodwill represents the excess of the cost of an acquired business over the fair value of the identifiable tangible and intangible assets acquired and liabilities assumed in a business combination.
Indefinite-lived intangible assets relate to in-process research and development ("IPR&D") acquired in business combinations. The estimated fair values of IPR&D projects acquired in a business combination which have not reached technological feasibility are capitalized and accounted for as indefinite-lived intangible assets until completion or abandonment of the projects. In accordance with guidance within FASB ASC 350 “Intangibles - Goodwill and Other,” goodwill and identifiable intangible assets with indefinite lives are not subject to amortization but must be evaluated for impairment.
Finite-lived intangible assets primarily consist of developed technology and trademarks/tradenames and were being amortized on a straight-line basis over their estimated useful lives. During 2023, the Company fully impaired the finite-lived intangible assets, see Note 6 and Note 7, for further details.
We evaluate long-lived assets, including finite-lived intangible assets, for impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset group may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or estimates of future discounted cash flows. The Company recorded an impairment to developed technology and IPR&D intangible assets for both the years ended December 31, 2023 and 2022, for further details see Note 6 and Note 7.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. 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 includes the enactment date. A valuation allowance for deferred income tax assets is recorded when it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The Company’s policy is to classify interest and penalties related to income taxes as income tax expense in the consolidated statements of operations.
Foreign Currency
When the local currency of the Company's foreign subsidiaries is the functional currency, all assets and liabilities are translated into United States dollars at the rate of exchange in effect at the balance sheet date. Income and expense items are translated at the weighted-average exchange rate prevailing during the period. The effects of foreign currency translation adjustments for these subsidiaries are deferred and reported in stockholders’ equity as a component of Accumulated Other Comprehensive Loss. The effects of foreign currency transactions denominated in a currency other than an entity's functional currency are included in Gain on foreign currency exchange in the Consolidated Statements of Operations. The Company does not hedge foreign currency translation risk in the net assets and income it reports from these sources.
Revenue Recognition
The Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. Product sales consist of a single performance obligation that the Company satisfies at a point in time. The Company recognizes product revenue when the following events have occurred: (a) the Company has transferred physical possession of the products, (b) the Company has a present right to payment, (c) the customer has legal title to the products, and (d) the customer bears significant risks and rewards of ownership of the products.
For the Company’s Lap-Band product, these criteria are met under the agreements with most customers upon product shipment. This includes sales to distributors, who sell the products to their customers, take title to the products and assume all risks of ownership at the time of shipment. Distributors are obligated to pay within specified terms regardless of when, if ever, they sell the products.
Taxes collected from customers and remitted to governmental authorities are accounted for on a net basis. Accordingly, such amounts are excluded from revenues. Amounts billed to customers related to shipping and handling are included in revenues. Shipping and handling costs related to revenue producing activities are included in cost of sales.
Variable Consideration
The Company records revenue from customers in an amount that reflects the transaction price it expects to be entitled to after transferring control of the goods. Customers and distributors of the Lap-Band product generally have the right to return or exchange products purchased for up tothirty days from the date of product shipment contingent upon a 10% restocking fee. Any such return or exchange of Lap-Band products will be recorded as a reduction of revenue in the period incurred.
Certain Lap-Band customers may receive volume rebates or discounts. Discounts are treated as a reduction in sales price and therefore corresponding revenue at the point of sale. Any volume rebates offered would be estimated and reserved as a reduction in revenue.
Warranty
The Company generally provides warranties against defects in materials and workmanship, and provides replacements at no charge to the customer, as long as the customer has notified the Company within 30 days of delivery and returns such products in accordance with the Company’s instructions. As they are considered assurance-type warranties, the Company does not account for them as separate performance obligations. Warranty reserve requirements are based on a specific assessment of the products sold with warranties where a customer asserts a claim for warranty or a product defect.
For the vBloc product line, the Company has a 5-year warranty on all implantable parts. vBloc sales began in 2015 and ended in 2018, so this warranty period went through 2023.
Cost of Goods Sold
The Company expenses to cost of goods sold, direct and indirect inventory costs as sold. Additionally, the Company expenses to costs of goods sold, various indirect costs such as warehousing finished goods, shipping costs of sales to customers, non-production salaries and consulting costs relating to inventory, and portions of salaries that are not allocatable to operating expenses.
Advertising Cost
Advertising costs are expensed as incurred and totaled $2.2 million and $6.8 million for the years ended December 31, 2023 and 2022, respectively.
Stock-Based Compensation
The Company applies ASC 718 Compensation — Stock Compensation and accordingly records compensation expense for stock options over the vesting or service period using the fair value on the date of grant, as calculated by the Company using the Black-Scholes model. The Company’s stock-based compensation plans are more fully described in Note 12.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period, including the pre-funded warrants, see Note 10, that were reclassified from warrant liability to equity as a result of the reverse stock split. Diluted net loss per share is based on the weighted-average common shares outstanding during the period plus dilutive potential common shares calculated using the treasury stock method. Such potentially dilutive shares are excluded when the effect would be to reduce a net loss per share. For purposes of basic and diluted per share computations, loss from continuing operations and net loss are reduced by the down round adjustments for convertible preferred stock and warrants.
The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented:
| | | | | |
|---|---|---|---|---|
| · · December 31, | ||||
| · 2023 · 2022 | ||||
| Stock options | 12,497 | 21,416 | ||
| Unvested restricted stock units | | 1,417 | | 4,530 |
| Convertible preferred stock | | 10 | | 10 |
| Warrants | 15,598,392 | 193,476 | ||
Concentration of Credit Risk, Interest Rate Risk and Foreign Currency Exchange Rate
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents, restricted cash and trade accounts receivable. Cash and cash equivalents are primarily deposited in demand and money market accounts. At times, such deposits may be in excess of insured limits. Investments in money market funds are not considered to be bank deposits and are not insured or guaranteed by the federal deposit insurance company or other government agency. These money market funds seek to preserve the value of the investment at $1.00 per share; however, it is possible to lose money investing in these funds. The Company has not experienced any losses on its deposits of cash and cash equivalents. To minimize the risk associated with trade accounts receivable, management maintains relationships with the Company’s customers that allow management to monitor current changes in business operations so the Company can respond as needed.
Substantially all of the Company’s revenue is denominated in U.S. dollars. Only a small portion of revenue and expenses are denominated in foreign currencies, principally the Australian dollar and Euro for 2023 and 2022. The Company has not entered into any hedging contracts. Future fluctuations in the value of the U.S. dollar may affect the price competitiveness of the Company’s products outside the U.S.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (referred to as an “exit price”). Fair value of an asset or liability considers assumptions that market participants would use in pricing the asset or liability, including consideration of non-performance risk.
Assets and liabilities are categorized into a three-level fair value hierarchy based on valuation inputs used to determine fair value.
Level 1 inputs are quoted prices in active markets for identical assets or liabilities.
Level 2 inputs are observable, either directly or indirectly.
Level 3 inputs are unobservable due to little or no corroborating market data.
The carrying amounts of the Company’s financial instruments, including cash equivalents, accounts receivable, accounts payable and certain accrued and other liabilities approximate fair value due to their short-term maturities. Refer to Note 7 regarding the impairment of developed technology and IPR&D and Note 10 regarding fair value measurements and inputs of warrants.
Recent Accounting Pronouncements
New accounting standards adopted by the Company in 2023 are discussed below or in the related notes, where appropriate.
In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which is intended to provide financial statement users with more useful information about expected credit losses on financial assets held by a reporting entity at each reporting date. In May 2019, the FASB issued ASU No. 2019-05, which amended the new standard by providing targeted transition relief. The new guidance replaces the existing incurred loss impairment methodology with a methodology that requires consideration of a broader range of reasonable and supportable forward-looking information to estimate all expected credit losses. In November 2019, the FASB issued 2019-11, which amended the new standard by providing additional clarification. This guidance is effective for the fiscal years and interim periods within those years beginning after December 15, 2022. This guidance became effective on January 1, 2023 and did not have a material impact to the consolidated financial statements.
New accounting standards not yet adopted are discussed below.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires entities to provide additional information in the rate reconciliation and additional disaggregated disclosures about income taxes paid. This guidance requires public entities to disclose in their rate reconciliation table additional categories of information about federal, state, and foreign income taxes and to provide more details about the reconciling items in some categories if the items meet a quantitative threshold. The guidance is effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of this guidance to impact its financial statements, but the guidance will impact its income tax disclosures.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The amendments require disclosure of significant segment expenses and other segment items and requires entities to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. The amendment also requires disclosure of the title and position of the chief operating decision maker (“CODM”) and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. This guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application is required, and early adoption is permitted. The Company is currently evaluating the impact the guidance will have on its consolidated financial statements.
| (3) | Liquidity and Management’s Plans |
The Company currently does not generate revenue sufficient to offset operating costs and anticipates such shortfalls to continue, primarily due to the introduction of GLP-1 pharmaceuticals, which has taken a significant market share of the medical treatments for obesity. As of December 31, 2023, the Company had net working capital of approximately $6.5 million, primarily due to cash and cash equivalents and restricted cash of $4.6 million. The Company’s principal source of liquidity as of December 31, 2023, consisted of approximately $4.5 million of cash and cash equivalents, and $1.7 million of accounts receivable. The Company completed multiple public offerings during 2023, which the Company raised over $17.6 million in cash and cash equivalents after deducting underwriting expenses, commissions and offering expenses. Based on our available cash resources, we may not have sufficient cash on hand to fund our current operations for more than 12 months from the date of filing this Form 10-K. This condition raises substantial doubt about our ability to continue as a going concern.
The Company’s anticipated operations include plans to (i) grow sales and operations of the Company with the Lap-Band product line both domestically and internationally as well as to obtain cost savings synergies, (ii) introduce to the market Lap-Band 2.0 FLEX, (iii) continue development of the Diabetes Bloc-Stim Neuromodulation (“DBSN”) device, (vi) identifying strategic merger and acquisition alternatives, (v) seek opportunities to find strategic partners to leverage our intellectual property portfolio and custom development services to provide third-party sales and licensing opportunities, and (vi) explore and capitalize on synergistic opportunities to expand our portfolio and offer future minimally invasive treatments and therapies in the obesity continuum of care. The Company believes that it has the flexibility to manage the growth of its expenditures and operations depending on the amount of available cash flows, which could include reducing expenditures for marketing, and product development activities. If managements’ plans don’t develop, and the Company doesn’t get additional cash raises, at the current burn rate, management expects to run out of cash during the third quarter of 2024.
The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $635.6 million. The Company also expects to incur a net loss and negative cash flows from operations for 2024.
The Company will be required to raise additional capital, however, there can be no assurance as to whether additional financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, it would have a negative impact on the Company’s financial condition and could force the Company to delay, limit, reduce, or terminate product development or future commercialization efforts or grant rights to develop and market product candidates or testing products that the Company would otherwise plan to develop.
Therefore, the plans cannot be deemed probable of being implemented. As a result, the Company’s plans do not alleviate substantial doubt about our ability to continue as a going concern.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
COVID-19 and Supply Chain Disruptions Risk and Uncertainties
The impact of the COVID-19 outbreak has subsided substantially in the U.S. but continues to result in reduced activity levels outside of the U.S., such as continued restrictions on travel and business operations and advising or requiring individuals to limit or forego their time outside of their homes or places of business.
In response to the global supply chain instability and inflationary cost increases, we continue to take action to minimize, as much as possible, any potential adverse impacts by working closely with our suppliers to closely monitor the availability of raw materials, lead times, and freight carrier availability.
We continuously monitor domestic and global economic conditions, potential outbreaks in viruses that may impact the medical field, and introduction of alternative procedures, pharmaceuticals and weight loss trends that may impact our business. With this information, we develop new models and approaches to achieve the best outcomes.
| (4) | Supplemental Balance Sheet Information |
Inventory
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2023 · 2022 | ||||||
| Raw materials | | $1,020 | | $832 | ||
| Sub-assemblies | | | 1,379 | | | 864 |
| Finished goods | | 1,342 | | 1,915 | ||
| Total inventory | | $3,741 | | $3,611 | ||
Prepaid expenses and other current assets:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2023 · 2022 | ||||||
| Prepaid insurance | | $110 | | $78 | ||
| Patents | | | 13 | | | — |
| Prepaid advertising and marketing | | | 41 | | | 3 |
| Taxes | | | 47 | | | — |
| Other current assets | | | 126 | | | 84 |
| Total prepaid expenses and other current assets | | $337 | | $165 | ||
Accrued and other liabilities:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2023 · 2022 | ||||||
| Payroll and benefits | | $701 | | $1,829 | ||
| Accrued legal settlements | | | 200 | | | 1,775 |
| Customer deposits | | | 639 | | | 510 |
| Taxes | | | 61 | | | 119 |
| Accrued professional | | | 155 | | | 316 |
| Other liabilities | | 58 | | 491 | ||
| Total accrued and other liabilities | | $1,814 | | $5,040 | ||
| (5) | Property and Equipment |
Property and equipment consist of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Machinery and equipment | | $61 | | $582 | ||
| Furniture and equipment | | | 5 | | | 27 |
| Computer hardware and software | | 78 | | 136 | ||
| Tooling and molds | | | 6 | | | 199 |
| Leasehold improvements | | | — | | | 19 |
| Construction in progress | | — | | 66 | ||
| | | 150 | | 1,029 | ||
| Less accumulated depreciation and amortization | | (90) | | (331) | ||
| Property and equipment, net | | $60 | | $698 | ||
Depreciation expense for the years ended December 31, 2023 and 2022, was approximately $121 thousand and $330 thousand, respectively.
During the year ended December 31, 2023 the Company determined the carrying value of the property plant and equipment had been impaired due to the current financial condition of the Company and recognized a non-cash impairment charge of $0.5 million. The fair value was determined by estimating the amount the Company could receive if they were to sell the assets.
| (6) | Intangible Assets |
During the year ended December 31, 2023 the Company determined the carrying value of the developed technology and trademarks/tradenames had been impaired due to the financial condition of the Company and recognized a non-cash impairment charge of $0.2 million, which fully impaired the intangible assets.
The consolidated intangible assets at December 31, 2022 consist of the following:
| | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2022 | |||||||||||
| · Weighted Average Useful Life (years) · Gross Carrying Amount · Accumulated Amortization · Net Book Value | |||||||||||
| Finite-lived intangible assets: | | | | | | | | | | | |
| Developed technology | | 10.0 | | $5,989 | | $(5,805) | | $184 | |||
| Trademarks/Tradenames | | 10.0 | | | 462 | | | (386) | | | 76 |
| Total | | | | $6,451 | | $(6,191) | | $260 | |||
The gross amount and accumulated impairment loss of indefinite-lived intangible assets are as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · · 2023 · · 2022 | ||||||
| Indefinite-lived intangible assets | | | | | | |
| Gross amount | | $— | | $20,721 | ||
| Accumulated impairment loss | | | — | | | (20,721) |
| Total Indefinite-lived intangible assets | | $— | | $— | ||
Amortization expense for the years ended December 31, 2023 and 2022, was approximately $33 thousand and $1.8 million, respectively.
The Company had impaired all of its remaining intangible assets during 2023, therefore there is no future projection of amortization expense at December 31, 2023.
| (7) | Impairment of Intangible Assets and Goodwill |
During the year ended December 31, 2023, the Company determined a triggering event occurred due to the decline in the Company’s market capitalization, and as such, the Company performed an impairment analysis of the long-lived assets. It was determined that the carrying value of the developed technology and trademarks/tradenames had been fully impaired and recognized a non-cash impairment charge of $0.2 million on the consolidated statement of operations for the year ended December 31, 2023 and a consolidated balance sheet value as of December 31, 2023, of zero.
As of December 31, 2022, the Company determined a triggering event occurred due to the decline in the Company’s market capitalization, and as such, the Company performed an impairment analysis of the long-lived assets. It was determined the developed technology related to the Obalon Balloon was fully impaired, as the Company has not been able to start up production or find a partner to manufacture the Obalon Balloon system. Based on this the Company has no current projections for revenues related to the Obalon Balloon and has fully impaired the asset of approximately $2.4 million. Additionally, due to the continuance of COVID-19, the Company has revised the near-term projected
revenues related to the Lap-Band asset group and has recognized an impairment charge to both the developed technology and tradenames of approximately $8.4 million and $0.5 million, respectively. The fair value of the Lap-Band developed technology was estimated using an income approach using Level 3 assumptions which included discounting projected future net cash flows to their present value, with a discount rate of 17.9%.
The Company also determined a triggering event occurred, as the Company elected to stop the clinical trials for the ReShape Vest and was closing out the previous trial that occurred, as significant additional clinical work and cost would be required to achieve regulatory approval. Additionally, the Company currently does not plan to pursue the development of the ReShape Vest. As such, the Company determined the carrying value of the IPR&D asset and related trademarks were impaired and recognized non-cash impairment charge of approximately $6.9 million and $0.5 million, respectively, on the consolidated balance sheet as of December 31, 2022, which reduced the value of these assets tozero.
| (8) | Leases |
The Company had a noncancelable operating lease for office and warehouse space in San Clemente, which expired June 30, 2023. The Company also had an operating lease and warehouse space in Carlsbad, California, which expired June 30, 2022. On March 13, 2023, the Company entered into a lease for approximately 5,038 square feet of office and warehouse space at 18 Technology Drive, Suite 110, Irvine, California 92618 and relocated our principal executive offices from our former San Clemente, California location to the Irvine, California location. The Irvine, California lease has a term of 36 months commencing on May 1, 2023.
The Company does not have any short-term leases or financing lease arrangements and the effects of any lease modifications have not been material. Lease and non-lease components are accounted for separately.
The Company determines the lease term as the noncancelable period of the lease, and may include options to extend or terminated the lease when reasonably certain that the Company will exercise that option. Leases with a term of 12 months or less are not recognized on the balance sheet. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present value of unpaid lease payments. Right-of-use assets also include any lease payments made at or before lease commencement and any initial direct costs incurred, and exclude any lease incentives received.
Operating lease costs for the years ended December 31, 2023 and 2022, were $0.3 million and $0.7 million, respectively. Variable lease costs were not material.
Supplemental information related to operating leases is as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| Balance Sheet information · · 2023 · · 2022 | ||||||
| Operating lease ROU assets | | $250 | | $171 | ||
| | | | | | | |
| Operating lease liabilities, current portion | | $111 | | $171 | ||
| Operating lease liabilities, long-term portion | | | 151 | | | — |
| Total operating lease liabilities | | $262 | | $171 | ||
| | | | | | | |
| Cash flow information for the twelve months ended December 31, | | 2023 | | 2022 | ||
| Cash paid for amounts included in the measurement of operating leases liabilities | | $228 | | $560 | ||
Maturities of operating lease liabilities at December 31, 2023
were as follows:
| | | | | |
|---|---|---|---|---|
| 2024 | | | 111 | |
| 2025 | | | 115 | |
| 2026 | | | 59 | |
| Total lease payments | | | 285 | |
| Less: imputed interest | | | 23 | |
| Total lease liabilities | | $262 | | |
| | | | | |
| Weighted-average remaining lease term at end of period (in years) | | | 2.4 | |
| Weighted-average discount rate at end of period | | | 6.9% |
| (9) | Equity |
The Company may issue preferred stock, common stock, or both, in connection with underwritten public offerings, registered direct offerings, private placements or business acquisitions. Such issuances of equity typically include the issuance or sale of warrants to purchase common stock. Certain issuances of convertible preferred stock and warrants may contain anti-dilutive features apart from customary adjustments for splits and reverse splits of common stock (collectively, “down round features”). When a series of convertible preferred stock contains this non-standard down round feature, the Company is required to adjust the conversion price in the event of future stock sales at a lower unit price. When warrants issued in connection with an equity transaction contain, or are amended to contain, this non-standard down round feature, the Company is required to adjust the exercise price upon the issuance of any shares of common stock or securities convertible into shares of common stock below the then-existing exercise price and evaluate and account for the value attributable to the reduced warrant exercise price. In the event down round adjustments are triggered, the values attributable to the adjustment to the convertible preferred stock conversion price and warrant exercise price are recorded as an increase to additional paid-in capital and increase to accumulated deficit.
All series of the Company’s convertible preferred stock are classified in stockholders’ equity, including those with the down round feature, when applicable to the equity transaction.
Warrants to purchase common stock are classified in stockholders’ equity, including those issued with the down round feature, as they are both indexed to the Company’s own stock and meet the scope exception in ASC 815 “Derivatives and Hedging.”
The Company had the following equity transactions during the years ended December 31, 2023 and 2022:
November 2023 Exercise of Warrants for Common Stock
On November 21, 2023, the Company entered into a warrant exercise agreement with an existing accredited investor to exercise certain outstanding warrants to purchase up to an aggregate of 5,382,500 shares of the Company’s common stock (the “Existing Warrants”). In consideration for the immediate exercise of the Existing Warrants for cash, the exercising holders received new unregistered warrants to purchase up to an aggregate of 10,765,000 shares (equal to 200% of the shares of common stock issued in connection with the Exercise) of the Company’s common stock (the “New Warrants”) in a private placement. In connection with the Exercise, the Company also agreed to reduce the exercise price of the Existing Warrants from $0.2503 to $0.23 and to reduce the exercise price of the remaining unexercised warrants from either $0.33 or $0.2503 to $0.23 per share, which is equal to the most recent closing price of the Company’s common stock on The Nasdaq Capital Market prior to the execution of the warrant exercise agreement.
The New Warrants will become exercisablesix months after issuance at an exercise price of $0.23 per share and have a term of exercise equal tofive and one-half years. The Existing Warrants and the New Warrants each include a beneficial ownership limitation that prevents the investor from owning more than 9.99%, with respect to the Existing Warrants, and 4.99%, with respect to the New Warrants, of the Company’s outstanding common stock at any time.
The gross proceeds to the Company from the Exercise was approximately $1.2 million, prior to deducting warrant inducement agent fees and estimated offering expenses. The Company intends to use the remainder of the net proceeds for commercial growth, working capital and general corporate purposes.
Maxim Group LLC (“Maxim”) acted as the exclusive warrant inducement agent and financial advisor to the Company for the Exercise. The Company agreed to pay Maxim an aggregate cash fee equal to 6.5% of the gross proceeds received by the Company from the Exercise.
October 2023 Securities Offering
On October 3, 2023, the Company completed a Securities Purchase Agreement with certain investors pursuant to which the Company agreed to issue and sell to the investors (i)1,770,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), (ii) warrants to purchase up to 13,650,000 shares of Common Stock at an initial exercise price of $0.33 per share (the “Common Warrants”) and (iii) pre-funded warrants to purchase 7,330,000 shares of Common Stock at an exercise price of $0.001 per share. The securities were sold as part of units at a price of $0.33 per unit or, with respect to the units including pre-funded warrants, $0.329 per unit. In connection with the offering, the Company also agreed that certain existing warrants to purchase up to an aggregate of 965,351 shares of Common Stock at an exercise price of $3.07 per share and warrants to purchase up to an aggregate of 382,500 shares of Common Stock at an exercise price of $8.00 per share that were previously issued to one of the investors, were amended effective upon the closing of the Offering so that the amended warrants have an exercise price of $0.33 per share. The net proceeds from the offering were approximately $2.8 million, after deducting the placement agent fees and before deducting offering expenses.
April 2023 Securities Offering
On April 20, 2023, the Company entered into a Securities Purchase Agreement with a certain institutional investor, pursuant to which the Company agreed to issue and sell to the Investor in a registered direct offering (i)291,395 shares of the Company’s common stock, par value $0.001 per share, and (ii) pre-funded warrants to purchase an aggregate of 509,300 shares of Common Stock. Each share of common stock was sold at a price of $3.07 per share and each Pre-funded Warrant was sold at an offering price of $3.069 per share underlying such Pre-funded Warrants, for aggregate gross proceeds of approximately $2.5 million before deducting the placement agent’s fees and the offering expenses. The Company has been using the net proceeds of this offering to continue implementation of its growth strategies, for working capital and general corporate purposes. In addition, under the Purchase Agreement, the Company also agreed to issue and sell to the Investor in a concurrent private placement warrants to purchase an aggregate of 800,695 shares of common stock.
In connection with the Offering, the Company also agreed that certain existing warrants to purchase up to an aggregate of 164,656 shares of Common Stock that were issued to the Investor, at an exercise price of $15.00 per share, were amended effective upon the closing of the Offering so that the amended warrants have an exercise price of $3.07. The Company’s exclusive placement agent in connection with the Offering, Maxim Group LLC, received a cash fee equal to 7.0% of the gross proceeds received by the Company from the sale of the securities in Offering, as well as reimbursement for certain expenses, and warrants to purchase up to 40,035 shares of Common Stock, which is equal to 5.0% of the aggregate amount of shares of Common Stock issued in the Offering, at an exercise price of $3.38 per share.
February Public Offering of Common Stock and Warrants
On February 8, 2023, the Company closed a public offering of 1,275,000 units, with each consisting ofone share of its common stock, orone pre-funded warrant to purchaseone share of its common stock, andone warrant to purchaseone and one-half shares of its common stock. Each unit was sold at public offering price of $8.00. The warrants in the units are immediately exercisable at a price of $8.00 per share and expire five years from the date of issuance. Alternatively, each warrant can be exercised pursuant to the “alternative cashless exercise” provision, to which the holders would receive an aggregate number of shares of common stock equal the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y)0.50. For purposes of clarity, one common warrant to purchaseone and one-half shares would be exercisable for 0.75 shares under this alternative cashless exercise provision. The shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants were only purchasable together in this offering but were issued separately and immediately separable upon issuance. As of
December 31, 2023, warrants to purchase 1,674,376 shares of common stock have been exercised under the alternative cashless exercise for a total of 835,313 shares of common stock.
Gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, are approximately $10.2 million. The Company has been using the net proceeds of this offering to continue implementation of its growth strategies, for working capital and general corporate purposes.
The Company also granted the underwriters an option to purchase an additional 191,250 shares of common stock and/or additional warrants to purchase up to 286,875 shares of common stock, to cover over-allotments, of which Maxim Group LLC exercised its option to purchase additional warrants to purchase 286,875 shares of common stock.
November 2022 Sale of Common Stock
On November 8, 2022, the Company entered into a securities purchase agreement with an existing accredited investor, to issue and sell 47,851 shares of common stock,2,500 shares of Series D Mirroring Preferred stock for $0.001 per share, which automatically terminated subsequent to the shareholder meeting on December 14, 2022, and prefunded warrants to purchase an aggregate of 9,841 shares of common stock. Each share of common stock was sold at a price of $13.00 per share, and each pre-funded warrant was sold at an offering price of $12.95 per share underlying such pre-funded warrants, for aggregate gross proceeds of $750,000 before deducting the placement agent’s fees and offering expenses. Under the purchase agreement, the Company also agreed to issue and sell to the investor in a concurrent private placement warrants to purchase an aggregate of 57,693 shares of common stock. The Company intends to use the remainder of the net proceeds for commercial growth, working capital and general corporate purposes.
In connection with the offering, the Company also entered into a warrant amendment agreement with the investor. Under the warrant amendment agreement, the Company agreed to amend certain existing warrants to purchase up to 106,963 shares of common stock that were previously issued to the investor, with an exercise price of $33.33 per share and expiration dates of June 2026 and December 2029, in consideration of their purchase of securities in the offering as follows: (i) lower the exercise price of the existing warrants to $15.00 per share, (ii) provide the existing warrants as amended, will not be exercisable untilsix months following the closing date of the offering, and (iii) extend the expiration date of the existing warrants with an expiration date of June 2026 byfive and one-half years following the close of the offering.
June 2022 Exercises of Warrants for Common Stock
On June 16, 2022, the Company entered into a warrant exercise agreement with an existing accredited investor to exercise certain outstanding warrants to purchase up to an aggregate of 74,773 shares of common stock. In consideration for the immediate exercise of the existing warrants for cash, the exercising holders received new unregistered warrants to purchase up to an aggregate of 74,773 shares (equal to 100% of the shares of common shares exercised) of the Company’s common stock (the “New Warrants”) in a private placement pursuant to Section (4)(2) of the Securities Act. In connection with the exercise, the Company also agreed to reduce the exercise price of the existing warrants and 32,190 remaining unexercised warrants from $300.00 to $33.33 per share, which is equal to the most recent closing price of the Company’s common stock on the Nasdaq prior to the execution of the warrant exercise agreement. For further details see Note 10 below.
The gross proceeds to the Company from the exercise was approximately $2.5 million, prior to deducting warrant inducement agent fees and estimated offering expenses. The Company intends to use the remainder of the net proceeds for commercial growth, working capital and general corporate purposes.
Common Stock Issued Related to Stock Awards and Options
Restricted Stock Units
The Company issued restricted stock units (“RSUs”) to certain members of the management and Board of Directors. During the year ended December 31, 2023, the Company issued 2,546 shares of common stock subject to the vesting of the awards.
During the year ended December 31, 2022, the Company issued 50,131 shares of common stock subject to the vesting of the awards, of which 28,769 shares of common stock were related to bonus in-leu of cash. For further details see Note 12.
Exercise of Stock Options
There wereno exercises of stock options during the years ended December 31, 2023 and 2022.
Series C Convertible Preferred Stock
The Series C convertible stock has a liquidation preference of $274.88 per share. Holders of the Series C convertible preferred stock have the right to convert their shares into shares of common stock instead of receiving the liquidation preference. The Series C convertible preferred stock is entitled to dividends on an as-if-converted-to-common stock basis if such dividends are paid on shares of common stock. In general, the holders of the Series C convertible preferred stock do not have voting rights, except in connection with director elections.
| (10) | Warrants |
The Company’s grants of warrants to purchase common stock are primarily in connection with equity and debt financings. See Note 9 for additional information about equity financings and the related issuance of warrants. Warrant activity was as follows:
| | | | | |
|---|---|---|---|---|
| · · | ||||
| · · · | ||||
| · · · | ||||
| · · Shares · | ||||
| Balance December 31, 2021 | 139,047 | | | |
| Issued | 145,192 | (1) | ||
| Exercised | (84,614) | (2) | ||
| Cancelled | (6,149) | | ||
| Balance December 31, 2022 | | 193,476 | | |
| Issued | | 35,912,718 | | (3) |
| Exercised | | (20,507,676) | (4) | |
| Cancelled | | (126) | | |
| Balance December 31, 2023 | | 15,598,392 | | |
| (1) | Warrants issued in 2022 includes: 74,773 reload warrants, 57,693 common stock purchase warrants, 2,885 representative’s warrants, and 9,841 pre-funded warrants. |
| (2) | Warrants exercised in 2022 includes: 74,773 reload warrants at an exercise price of $33.33 per share, and 9,841 pre-funded warrants at an exercise price of $0.05 per share. |
| (3) | Warrants issued in 2023 includes: 27,415,070 common stock purchase warrants, of which 2,199,375 are classifies as liability warrants, 7,929,300 pre-funded warrants, and 568,348 representative’s warrants. |
| (4) | Warrants exercised in 2023 includes: 10,904,000 common stock purchase warrants at an exercise price range of $0.33 per share and $0.23 per share, 1,674,376 common stock purchase warrants (liability warrants) exercised with the alternative cash less option, 7,929,300 pre-funded warrants at an exercise price range of $0.001 and $0.0001 per share. |
Warrant Assumptions – 2023 Warrants Issued
The following table provides the assumptions used to calculate the fair value of the new warrants issued during 2023, using a Black-Scholes model:
| · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · Warrants · · · Strike Price · · Volatility · · · Expected Term · · Risk Free Rate · | ||||||||||
| Pre-funded warrants - February 2023 | | 90,000 | | $0.0001 | | 96.5% | | 5.0 | | 3.78% |
| Representative's warrants - February 2023 | | 73,313 | | $8.80 | | 96.5% | | 5.0 | | 3.79% |
| Common stock warrants - April 2023 | | 800,695 | | $3.07 | | 88.4% | | 5.5 | | 3.56% |
| Pre-funded warrants - April 2023 | | 509,300 | | $0.0001 | | 88.4% | | 5.5 | | 3.56% |
| Representative's warrants - April 2023 | | 40,035 | | $3.38 | | 96.3% | | 5.0 | | 3.57% |
| Common stock warrants - October 2023 | | 13,650,000 | | $0.33 | | 89.1% | | 5.0 | | 4.74% |
| Pre-funded warrants - October 2023 | | 7,330,000 | | $0.001 | | 89.1% | | 5.0 | | 4.74% |
| Representative's warrants - October 2023 | | 455,000 | | $0.363 | | 89.2% | | 5.0 | | 4.74% |
The following table provides the assumptions used to calculate the fair value of the new warrants issued during 2023, using a Monte Carlo model:
| · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · Warrants · · · Strike Price · · Volatility · · · Expected Term · · Risk Free Rate · | ||||||||||
| Common stock warrants - November 2023 | | 10,765,000 | | $0.23 | | 86.9% | | 5.5 | | 4.40% |
The following table provides the assumptions used in the bifurcated Black-Scholes option pricing model for the common stock purchase warrants classified as a liability:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Cash Exercise · · Cashless Exercise | ||||||
| Stock Price | | $5.905 | | $5.905 | ||
| Exercise Price | | $16.00 | | $0.00 | ||
| Term (years) | | | 5.00 | | | 5.00 |
| Volatility | | | 96.50% | | | 96.50% |
| Risk Free Rate | | | 3.784% | | | 3.784% |
| Dividend Yield | | | 0% | | | 0% |
The following table presents the changes in the fair value of the liability warrants:
| | | | |
|---|---|---|---|
| · · Common Stock | |||
| · · Purchase Warrants | |||
| Fair value as of February 8, 2023 (issuance date) | | $10,363 | |
| Fair value of liability warrants in excess of proceeds, at issuance | | | (164) |
| Exercises of liability warrants | | | (6,249) |
| Gain on changes in fair value of liability warrants | | | (3,878) |
| Fair value as of December 31, 2023 | | $72 | |
Warrant Assumptions – 2022 Warrants Issued
The following table provides the assumptions used to calculate the fair value of the Series G warrants issued during 2022, using a Black-Scholes model:
| · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · Warrants · · · Strike Price · · Volatility · · · Expected Term · · Risk Free Rate · | ||||||||||
| Reload warrants - June 2022 | | 74,773 | | $33.33 | | 64.8% | | 7.5 | | 3.32% |
| Reload warrants - November 2022 | | 57,693 | | $15.00 | | 84.3% | | 5.5 | | 4.21% |
| Representative's warrants | | 2,885 | | $15.00 | | 84.3% | | 5.0 | | 4.23% |
| Pre-funded warrants | | 9,841 | | $0.05 | | 84.3% | | 5.5 | | 4.21% |
| (11) | Revenue Disaggregation and Operating Segments |
The following table presents the Company’s revenue disaggregated by geography:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended | ||||||
| · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| United States | | $7,134 | | $9,230 | ||
| Australia | | | 526 | | | 688 |
| Europe | | | 956 | | | 1,252 |
| Rest of world | | | 62 | | | 70 |
| Total revenue | | $8,678 | | $11,240 | ||
Operating Segments
The Company conducts operations worldwide and is managed in the following geographical regions: United States, Australia, Europe and Rest of World (primarily in the Middle East). All regions sell the Lap-Band product line, which consisted of nearly all our revenue and gross profit for the years ended December 31, 2023 and 2022. During the second half of 2020 the Company launched ReShapeCare, which had minimal revenue for the years ended December 31, 2023 and 2022. During the fourth quarter of 2023, the Company placed the continued development of ReShapeCare on hold indefinitely. There wasno revenue or gross profit recorded for the DBSN device in 2023 or 2022 because this product is still in the development stage. During June 2021, the Company merged with Obalon, which hadno revenues for the years ended December 31, 2023 and 2022.
The Company hasone operating segment based on the financial information provided to the Chief Operating Decision Maker (the Chief Executive Officer, or “CODM”). The Company’s CODM evaluates segment performance based on revenue and gross profit at the consolidated level. The CODM does review revenue based on domestic and international. As such, the Company believes reporting revenue based on territory is useful to the user of the financial statements.
| (12) | Stock-based Compensation |
The ReShape Lifesciences Inc. 2022 Equity Incentive Plan (the “Plan”) became effective December 14, 2022, and provides for the grant of stock options or other stock-based awards to employees, officers, non-employee directors and outside consultants of the Company. The maximum number of shares of common stock that will be available for issuance under this Plan was originally 105,000 shares; provided however, that the aggregate number of shares that may be issued under all awards under the Plan will automatically increase on an annual basis on the first day of each year beginning in 2024 such that the aggregate number of shares that may be issued under all awards under this Plan equals 15% of the total number of shares of Common Stock, on a converted basis, on the last day of the immediately preceding fiscal year. Under the 2003 Stock Incentive Plan, as amended in 2018 (the “Prior Plan”), as of January 1, 2023, there were 110,798 shares available.
The Plan is administered by the committee, which determines the types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. Options granted under the Plan expire no later thanten years from the date of grant. The exercise price of each option may not be less than 100% of the fair market value of the common stock at the date of grant, except if an incentive stock option is granted to a Plan participant possessing more than 10% of the Company’s common stock, as defined by the Plan, the exercise price may not be less than 110% of the fair value of the common stock at the date of grant. Employee stock options generally vest over four years.
Stock Options
A summary of the status of the Company’s stock options are as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · Weighted · · · | ||||||||||
| · · · · Weighted · · Average · · Aggregate | ||||||||||
| · · · · Average · · Remaining · · Intrinsic | ||||||||||
| · · · Exercise Price · · Contractual · · Value | ||||||||||
| · · Shares · · Per Share · · Life (years) · · (in thousands) | ||||||||||
| Outstanding at December 31, 2021 | | 17,702 | | $398.57 | | | | $— | ||
| Options granted | | 11,201 | | | 59.00 | | | | | |
| Options exercised | | — | | | — | | | | | |
| Options cancelled | | (7,487) | | | 139.16 | | | | | |
| Outstanding at December 31, 2022 | 21,416 | | | 311.65 | | | | $— | ||
| Options granted | — | | | — | | | | | | |
| Options exercised | — | | | — | | | | | | |
| Options cancelled | (6,198) | | | 149.34 | | | | | | |
| Outstanding at December 31, 2023 | 15,218 | | | 377.75 | | 6.4 | | $— | ||
| Exercisable at December 31, 2023 | | 12,366 | | | 445.51 | | 6.0 | | | — |
| Vested and expected to vest at December 31, 2023 | | 15,891 | | | 377.75 | | 6.4 | | | — |
As of December 31, 2023, stock options under the Plan that were outstanding, exercisable and vested, and expected to vest, hadno intrinsic value. The unrecognized share-based expense at December 31, 2023 was $0.1 million and will be recognized over a weighted average period of 1.8 years.
Stock option awards outstanding under the Company’s incentive plans have been granted at exercise prices that are equal to the market value of its common stock on the date of grant. Such options generally vest over a period offour years and expire atten years after the grant date. The Company recognizes compensation expense ratably over the vesting period. The Company uses a Black-Scholes option-pricing model to estimate the fair value of stock options granted, which requires the input of both subjective and objective assumptions as follows:
Expected Term – The estimate of expected term is based on the historical exercise behavior of grantees, as well as the contractual life of the options granted.
Expected Volatility – The expected volatility factor is based on the volatility of the Company’s common stock.
Risk-free Interest Rate – The risk-free interest rate is determined using the implied yield for a traded zero-coupon U.S. Treasury bond with a term equal to the expected term of the stock options.
Expected Dividend Yield – The expected dividend yield is based on the Company’s historical practice of paying dividends on its common stock.
The Company did not issue any stock options during the year ended December 31, 2023. The Company’s weighted average assumptions used to estimate fair value of stock options granted during the year ended December 31, 2022 were as follows:
| | | |
|---|---|---|
| Risk-free interest rate | | 2.67% |
| Expected term (in years) | | 6.25 |
| Expected dividend yield | | 0% |
| Expected volatility | | 80.40% |
Restricted Stock Units
A summary of the status of the Company’s unvested RSUs are as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · · · Weighted | |||||
| · · · · Average | |||||
| · · · Grant Date | |||||
| · · Shares · · Fair Value | |||||
| Unvested RSUs at December 31, 2021 | | 34,226 | | $218.00 | |
| Granted | | 32,777 | | | 16.92 |
| Vested (1) | | (50,131) | | | 97.44 |
| Cancelled/Forfeited | | (12,342) | | | (189.88) |
| Unvested RSUs at December 31, 2022 | 4,530 | | | 174.15 | |
| Granted | — | | | — | |
| Vested (1) | (3,113) | | | 194.81 | |
| Cancelled/Forfeited | — | | | — | |
| Non-vested RSUs at December 31, 2023 | 1,417 | | | 128.56 | |
| (1) | At December 31, 2023 and 2022, there were 113 and 278 shares of common stock, respectively, related to RSU awards that have vested and the shares were not released to the participants subsequently. Additionally, during the year ended December 31, 2023 due to a decline in our stock price 454 shares of common stock were not issued in order to cover employee taxes. |
The fair value of each RSU is the closing price on the Nasdaq of the Company’s common stock on the date of grant. Upon vesting, a portion of the RSU award may be withheld to satisfy the statutory income tax withholding obligation. The remaining RSUs will be settled in shares of the Company’s common stock after the vesting period. The unrecognized compensation cost related to RSUs at December 31, 2023 was $0.6 million and is expected to be recognized over a period of 1.2 years.
Compensation expense related to stock options was recognized as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended | ||||||
| · · December 31, | ||||||
| · · 2023 · · 2022 | ||||||
| Sales and marketing | | $107 | | $280 | ||
| General and administrative | | | 451 | | | 1,494 |
| Research and development | | | 209 | | | 313 |
| Total stock-based compensation expense | | $767 | | $2,087 | ||
| (13) | Income Taxes |
Income tax expense (benefit) consists of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year ended December 31, | ||||||
| · 2023 · 2022 | ||||||
| Deferred: · · · · · | ||||||
| Federal | | $— | | $(293) | ||
| State | | | — | | | (76) |
| Foreign | | | 28 | | | (54) |
| Deferred income tax benefit | | | 28 | | | (423) |
| Current: | | | | | | |
| Federal | | | — | | | 30 |
| State | | | 7 | | | 9 |
| Foreign | | | 17 | | | 4 |
| Total income tax expense (benefit), net | | $52 | | $(380) | ||
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · Year ended December 31, | |||||
| · 2023 · 2022 · | |||||
| Income tax benefit at U.S. federal statutory rate | | 21.0% | | 21.0% | |
| State income tax benefit, net of federal benefit | | | 5.9% | | 3.8% |
| Stock warrant valuation | | | 9.7% | | —% |
| Other permanent differences | | (2.2)% | | (1.9)% | |
| Change in state tax rate | | | 4.3% | | 0.3% |
| Foreign rate differential | | | 2.7% | | (0.2)% |
| Net operating loss true up | | | (6.3)% | | —% |
| Other adjustments | | | (0.8)% | | 2.8% |
| Change in valuation allowance | | (34.8)% | | (25.0)% | |
| Effective income tax rate | | (0.5)% | | 0.8% | |
A reconciliation of the beginning and ending amount of uncertain tax positions are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2023 · · 2022 | ||||||
| Uncertain gross tax positions, January 1 | | $1,052 | | $1,052 | ||
| Current year tax positions | | | — | | | — |
| Increase in prior year tax positions | | | — | | | — |
| Settlements | | | — | | | — |
| Lapse of statute of limitations | | | — | | | — |
| Uncertain gross tax positions, December 31 | | $1,052 | | $1,052 | ||
The components of deferred tax assets and liabilities are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| | December 31, | |||||
| · · 2023 · 2022 | ||||||
| Deferred tax assets: · · | ||||||
| Start-up costs | | $1,096 | | $1,137 | ||
| Capitalized research and development costs | | 170 | | 272 | ||
| Reserves and accruals | | 751 | | 1,157 | ||
| Property and equipment | | | 56 | | | — |
| Intangible assets | | | 4,420 | | | 4,597 |
| Research and development credit | | 2,492 | | 2,492 | ||
| Lease liability | | | 70 | | | 43 |
| Net operating loss carryforwards | | | 67,930 | | | 63,424 |
| State and local taxes | | | 2 | | | 2 |
| Total gross deferred tax assets | | 76,987 | | 73,124 | ||
| Valuation allowance | | (76,895) | | (72,945) | ||
| Deferred tax assets, net of valuation allowance | | | 92 | | | 179 |
| Property and equipment | | | — | | | (80) |
| Intangible assets | | | — | | | — |
| Operating lease right-of-use assets | | | (64) | | | (43) |
| Total gross deferred tax liabilities | | | (64) | | | (123) |
| Deferred income taxes, net | | $28 | | $56 | ||
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during periods in which those temporary differences become deductible. Based on the level of historical losses and projections of losses in future periods, the Company provided a valuation allowance at both December 31, 2023 and 2022. The remaining net deferred tax asset at December 31, 2023 is the remaining balance of the Netherlands net operating loss. A valuation allowance is not applicable to this entity, as they historically produce income and utilize their net operating loss carryforward. In 2022, the indefinite-lived intangible
asset became fully impaired. The Company has a policy that NOL’s are shown gross with valuation allowances with respect to IRC 382 limitations.
As of December 31, 2023 and 2022, the Company had U.S. federal net operating loss carryforwards of $218.9 million and $207.9 million, respectively. Of the total U.S. federal net operating loss carryforwards at December 31, 2023. Losses generated beginning in 2018 will carryover indefinitely. The Company had state net operating loss carryforwards of $348.7 million and $329.1 million at December 31, 2023 and 2022, respectively and had foreign net operating loss carryforwards of $0.2 million at both December 31, 2023 and 2022. Net operating loss carryforwards of the Company are subject to review and possible adjustment by the taxing authorities. With certain exceptions (e.g. the net operating loss carryforwards), the Company is no longer subject to U.S. federal, state or local examinations by tax authorities for years prior to 2016. There are no tax examinations currently in progress.
The Company’s ability to utilize its net operating loss carryforwards, tax credits, and built-in items of deduction, including capitalized start-up costs and research and development costs, has been, and may continue to be substantially limited due to ownership changes. These ownership changes limit the amount of net operating loss carryforwards, credits and built-in items of deduction that can be utilized annually to offset future taxable income. In general, an ownership change, as defined in IRC Section 382, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50% of the outstanding stock of a company by certain stockholders or public groups. Due to the valuation allowance against deferred tax assets at December 31, 2023, the net effect of any further limitation will have no impact on results of operations.
The Company is in the process of completing an IRC Section 382 analysis for the year ended December 31, 2023. The Company believes it experienced an ownership change during 2023 that will result in further limitations on the utilization of its net operating losses. The 2023 ownership change is expected to result in further net operating losses to expire unused. The Company reflected the estimated impact of the 2023 ownership change in the deferred tax table and gross net operating loss carryforwards within this footnote.
The Company has adopted accounting standards which prescribe a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in a company’s income tax return, and also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company hadno amounts of unrecognized tax benefits that, if recognized, would affect its effective income tax rate for the years ended December 31, 2023 and 2022. The Company’s policy is to classify interest and penalties related to income tax expense as tax expense. As of December 31, 2023, the Company hadno amount accrued for the payment of interest and penalties related to unrecognized tax benefits.
The Inflation Reduction Act (IRA) was enacted on August 16, 2022 and includes a new corporate alternative minimum tax based on book income, an excise tax on stock buybacks, and other items such as tax incentives for energy and climate initiatives. There is no impact to the Company at this time, however this may change depending on each year’s differing facts and activities. The Company will continue to monitor this over time.
| (14) | Commitments and Contingencies |
Employee Arrangements and Other Compensation
Certain members of management are entitled to severance benefits payable upon termination following a change in control, which would approximate $0.8 million at December 31, 2023. The Company also has agreements with certain employees to pay bonuses based on targeted performance criteria. As of December 31, 2023 and 2022, approximately $15 thousand and $0.3 million, respectively, was accrued for performance bonuses, which is included in accrued liabilities in the consolidated balance sheets.
Purchase Commitments
The Company generally purchases its products and accessories from a limited group of third-party suppliers through purchase orders. The Company had $0.9 million of inventory open purchase orders as of December 31, 2023, for orders being issued to supplies for which the Company has not received the goods or services and which are expected
to be fulfilled within one year. These purchase commitments were made to secure better pricing and to ensure the Company will have the necessary inventory to meet anticipated near term demand. Although open purchase orders are considered enforceable and legally binding, the Company may be able to cancel, reschedule, or adjust requirements prior to supplier fulfillment.
Litigation
On August 6, 2021, Cowen and Company, LLC filed a complaint against ReShape, as successor in interest to Obalon Therapeutics, in the Supreme Court of the State of New York based on an alleged breach of contract arising out of Cowen’s prior engagement as Obalon’s financial advisor. The complaint alleges that Cowen is entitled to be paid a $1.35 million fee in connection with ReShape’s merger with Obalon under the terms of Cowen’s engagement agreement with Obalon. The complaint also sought reimbursement of Cowen’s attorneys’ fees and interest in connection with its claim. On May 11, 2023, the Supreme Court of the State of New York issued the final judgement in favor of Cowen & Company in the amount of $1.35 million, plus interest at the statutory rate of 9% per annum from June 16, 2021 until judgement is paid in full, and reimbursement of $675,000 of Cowen’s attorneys’ fees, with $275,000 to be paid upfront, $200,000 paid after six months and $200,000 paid after 12 months. As of December 31 2023, the Company has paid the $1.35 million judgement, including related interest, and first $275,000 installment of Cowen’s attorneys’ fees. At December 31, 2023, $200 thousand of attorneys’ fees were included as accrued expenses.
The Company is not aware of any pending or threatened litigation against it that could have a material adverse effect on the Company’s business, operating results or financial condition, other than what was disclosed above. The medical device industry in which the Company operates is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result the Company may be involved in various legal proceedings from time to time.
Product Liability Claims
The Company is exposed to product liability claims that are inherent in the testing, production, marketing and sale of medical devices. Management believes any losses that may occur from these matters are adequately covered by insurance, and the ultimate outcome of these matters will not have a material effect on the Company’s financial position or results of operations. The Company is not currently a party to any product liability litigation and is not aware of any pending or threatened product liability litigation that could have a material adverse effect on the Company’s business, operating results or financial condition.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.