Mind Medicine MindMed Inc
For the period ended Dec 31, 2023. Filed Feb 28, 2024.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Feb 28, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
(In USD thousands, except share and per share amounts)
DESCRIPTION OF THE BUSINESS
Mind Medicine (MindMed) Inc. (the “Company” or “MindMed”) is incorporated under the laws of the Province of British Columbia. Its wholly owned subsidiaries, Mind Medicine, Inc. (“MindMed US”), HealthMode, Inc., MindMed Pty Ltd., and MindMed GmbH are incorporated in Delaware, Delaware, Australia and Switzerland respectively. MindMed US was incorporated on May 30, 2019.
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The Company’s mission is to be the global leader in the development and delivery of treatments for brain health disorders that unlock new opportunities to improve patient outcomes. The Company is developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes, including MM120 and MM402, the Company’s lead product candidates.
As of December 31, 2023, the Company had an accumulated deficit of $290.2 million. Through December 31, 2023, all the Company’s financial support has primarily been provided by proceeds from the issuance of its common shares, no par value per share (“Common Shares”) and warrants to purchase Common Shares and the Company’s credit facility.
As the Company continues its expansion, it may seek additional financing and/or strategic investments; however, there can be no assurance that any additional financing or strategic investments will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain additional funding, it will most likely be required to reduce its plans and/or certain discretionary spending, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. The accompanying consolidated financial statements do not include any adjustments that might be necessary if it were unable to continue as a going concern. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date of the issuance of these financial statements.
Emerging Growth Company Status
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, the consolidated financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of the first sale of common equity securities of the issuer under an effective Securities Act of 1933 registration statement or such earlier time that it is no longer an emerging growth company.
BASIS OF pRESENTATION AND Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Updates of the Financial Accounting Standards Board (“FASB”).
Intercompany balances and transactions, and any unrealized income and expenses arising from intercompany transactions, are eliminated in preparing the consolidated financial statements. Unrealized losses are eliminated in the same way as unrealized gains, but only to the extent that there is no evidence of impairment.
Foreign Currency
The Company’s reporting currency is U.S. dollars. In 2019, the Company only operated MindMed US, a single US-based entity, which had a functional currency of the U.S. dollar. After the reverse takeover transaction in February 2020, the Company determined the functional currency of the Company to be the U.S. dollar. During the fourth quarter of 2020, the Company determined that the there was a significant change in circumstances relating to the primary economic environment of the Company, which required a change in the entity’s functional currency from the U.S. dollar to the Canadian dollar (“CAD”). This change in functional currency for the Company, was applied prospectively.
The local currency of the Company’s foreign affiliates is generally their functional currency. Accordingly, the assets and liabilities of the foreign affiliates and the parent entity, are translated from their respective functional currency to U.S. dollars using fiscal year-end exchange rates, income and expense accounts are translated at the average rates in effect during the fiscal year and equity accounts are translated at historical rates. Transactions denominated in currencies other than the functional currency are remeasured to the functional currency at the exchange rate on the transaction date. Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured at period-end using the period-end exchange rate.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgements 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. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the intangible assets, accrual for research and development costs, and share-based awards and valuation of warrants. Actual results could differ from those estimates, and such differences could be material to the consolidated balance sheets and statements of operations and comprehensive loss.
Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision maker, the Company’s Chief Executive Officer, views the Company’s operations and manages its business as a single operating segment, which is the research and development of the Company’s neuro-pharmaceutical drug development platform. All long-lived assets are located in the United States. The Company does not currently generate any revenue.
Concentration of Credit Risk
Financial instruments that potentially expose the Company to concentration of credit risk primarily consist of cash and cash equivalents. As of December 31, 2023, the Company’s cash equivalents primarily includes a U.S. government money market fund at a high-quality financial institution which invests in highly liquid securities that are issued or guaranteed by the U.S. government or by U.S. government agencies and instrumentalities. The Company's cash is deposited in checking accounts at high-quality financial institutions, which at times, may exceed federally insured limits. Management believes that these financial institutions are financially sound, and, accordingly, minimal credit risk exists with respect to these financial institutions. As of December 31, 2023, the Company has not experienced any losses on its cash or cash equivalents.
Business Combinations
The Company evaluates acquisitions to determine whether it is a business combination or an asset acquisition. The Company accounts for business combinations under the acquisition method of accounting. The Company includes the results of operations of acquired businesses in its consolidated financial statements as of the respective dates of acquisition. The purchase price is allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date, with the excess recorded to goodwill.
The determination of fair value requires considerable judgment and is sensitive to changes in the underlying assumptions. The Company’s estimates are preliminary and subject to adjustment, which may result in material changes to the final valuation. During the measurement period, which will not exceedone year from closing, the Company may continue to obtain information to assist in finalizing the acquisition date fair values. Any qualifying changes to the preliminary estimates will be recorded as adjustments to the respective assets and liabilities, with any residual amounts allocated to goodwill. Acquisition costs are expensed as incurred, unless they qualify to be treated as debt issue costs, or as cost of issuing equity securities.
Asset acquisitions are accounted for using a cost accumulation model, with the cost of the acquisition allocated to the acquired assets based on their relative fair values. Goodwill is not recognized in an asset acquisition.
Goodwill
Goodwill represents the excess of the purchase price over the estimated fair value of net tangible and identifiable intangible assets acquired in business combinations. The recognition of goodwill represents the strategic and synergistic benefits the Company expects to realize from acquisitions.
Goodwill is not amortized to earnings, rather, assessed for impairment annually during the fourth quarter for its single reporting unit. The Company also performs an assessment at other times if events or changes in circumstances indicate the carrying value of the assets may not be recoverable. When impairment indicators are identified, the Company compares the reporting unit’s fair value to its carrying amount, including goodwill. An impairment loss is recognized as the difference, if any, between the reporting unit’s carrying amount and its fair value, to the extent the difference does not exceed the total amount of goodwill allocated to the reporting unit.
In conducting the annual impairment test, the Company first reviews qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If factors indicate that the fair value of the reporting unit is less than its carrying amount, a quantitative assessment is performed and the fair value of the reporting unit is determined by analyzing the total fair value of equity compared to the carrying value of the reporting unit. If the carrying value of the reporting unit continues to exceed its fair value, the implied fair value of the reporting unit’s goodwill is calculated and an impairment loss equal to the excess is recorded. No impairment charges have been recorded during the years ended December 31, 2023 and 2022.
Intangible Assets
The Company’s finite-lived intangible assets consist of acquired developed technology and are amortized on a straight-line basis, which is aligned to the economic benefit of the asset, over their estimated useful life ofthree years.
Intangible assets or asset groups are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset or asset group may not be fully recoverable. Upon occurrence, recoverability is measured by comparing the sum of the undiscounted expected future cash flows the asset or asset group is expected to generate to its carrying amount. If the carrying amount of the asset exceeds its undiscounted expected future cash flows, an impairment loss is recognized in the amount of the excess of the carrying amount over the fair value of the asset. Any write-downs are treated as permanent reductions in the carrying amount of the respective asset. There wasno impairment of intangible assets recorded during the years ended December 31, 2023 and 2022.
Warrants
CAD Financing Warrants and CAD Compensation Warrants
Between 2020 through 2021, in conjunction with equity offerings, the Company issued units at varying prices per unit in Canadian dollars (“CAD$”), with each unit comprised of one Common Share and one-half of one Common Share financing warrant (each whole warrant, a “CAD Financing Warrant”), and with each CAD Financing Warrant entitling the holder thereof to purchase a Common Share at a specified CAD$ exercise price. In connection with these equity offerings, the Company also issued compensation warrants to its underwriters (the “CAD Compensation Warrants”), with each Compensation Warrant entitling the holder thereof to purchase one unit at a specified CAD$ price per CAD Compensation Warrant, and with each unit purchased thereunder entitling the holder thereof to one Common Share and one-half CAD Financing Warrant. CAD Financing Warrants and CAD Compensation Warrants are classified as equity and recorded at fair value at the time of issuance.
2022 USD Financing Warrants
The 2022 USD Financing Warrants (as defined below in Note 7) are liability classified due to being denominated in USD and not the Company's functional currency. Accordingly, the 2022 USD Financing Warrants were recognized at fair value upon issuance and are remeasured to fair value at the end of each reporting period. Any change in fair value is recognized in general and administrative expense on the consolidated statements of operations. Issuance costs related to warrants were expensed within general and administrative expense on the consolidated statements of operations during the year ended December 31, 2022.
Cash and Cash Equivalents
The Company considers all investments with an original maturity date at the time of purchase of three months or less to be cash and cash equivalents. As of December 31, 2023, the Company’s cash equivalents consisted of U.S. government money market funds at a high-credit quality and federally insured financial institution. The Company’s accounts, at times, may exceed federally insured limits. The Company had cash equivalents of $96.7 million as of December 31, 2023, and $131.7 million as of December 31, 2022.
Fair Value Measurements
Certain assets and liabilities of the Company are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3 – Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
Cash and cash equivalents, other current assets, accounts payable and accrued expenses are all short-term in nature and, as such, their carrying values approximate fair values.
The Company's credit facility bears variable interest rates, and the carrying amount of the Company's credit facility approximates fair value because interest rates approximate the current rates available to the Company.
Research and Development
Research and development expenses include all direct and indirect operating expenses supporting the products and processes in development, including payroll and benefits, which includes stock-based compensation, for research and development employees, consulting expenses, licensing fees, manufacturing costs to produce clinical trial materials, clinical research costs, and data and study acquisition costs. The Company recognizes the benefit of refundable research and development tax credits as a reduction of research and development costs when received or there is reasonable assurance that the amount claimed will be recovered. The costs incurred in establishing and maintaining patents are expensed as incurred.
Substantial portions of the Company’s pre-clinical studies and clinical trials are performed by third-party laboratories, medical centers, contract research organizations (“CROs”) and other vendors. These vendors generally bill monthly for services performed, or bill based upon milestone achievement. The Company accrues expenses based upon estimated percentage of work completed and the remaining contract milestones. At times, the Company is obligated to make upfront payments upon execution of research and development agreements. Upfront payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are capitalized as prepaid expenses until such goods are delivered or the related services are performed. The Company estimates the period over which such services will be performed based on the terms of the agreements as well as the level of effort to be expended in each period. Sometimes the actual timing of performance or the level of effort varies from the estimate, and if that does occur, the Company will adjust the amounts recorded accordingly.
Intellectual property acquired separately for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) are expensed in research and development costs at the time the costs are incurred.
Generaland administrative expenses consist primarily of compensation costs, including stock-based compensation, for executive management and administrative employees, including finance and accounting, legal, human resources and other administrative functions, professional services fees, advisory and professional service fees in connection with financing transactions, insurance expenses and allocated expenses. We also incurred additional costs related to public relations, printing and professional services fees in connection with the proxy contest in connection with our 2023 annual general meeting of shareholders.
Income Taxes
The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the consolidated statements of operations in the period that includes the enactment date.
The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. To date, there have beenno interest charges or penalties related to unrecognized tax benefits.
As a result of incurring scientific research and development expenditures, management anticipates that there will be non-refundable tax credits receivable following the completion of normal audit processes by tax authorities. Investment tax credits are recorded at the earlier of when received or when there is reasonable assurance that the amounts claimed will be recovered. Upon recognition, amounts will be recorded as a reduction of research and development expenditures.
Net Loss Per Share
Basic net loss per common share is computed by dividing net loss by the weighted-average number of Common Shares outstanding during each period. Diluted net loss per share of Common Shares includes the effect, if any, from the potential exercise or conversion of securities such as share options and warrants, which would result in the issuance of incremental shares of common shares. For diluted net loss per share, the weighted-average number of common shares is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. For all periods presented, basic and diluted net loss per share are the same, as any additional share equivalents would be anti-dilutive.
The Company has not adjusted its weighted average number of Common Shares outstanding in the calculation of diluted loss per share, as the effect of warrants and options is anti-dilutive.
The following table sets forth the computation of basic and diluted net loss per share attributable to common shareholders:
| Years Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Numerator: | ||
| Net loss attributable to common shareholders | $(95,732) | $(56,796) |
| Denominator: | ||
| Weighted-average shares used in computing net loss per share attributable to common shareholders, basic and diluted | 39,157,420 | 30,857,463 |
| Net loss per share attributable to common shareholders, basic and diluted | $(2.44) | $(1.84) |
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
| Years Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Options issued and outstanding under stock option plan | 2,161,734 | 2,190,315 |
| Restricted Share Units | 2,294,056 | 1,570,382 |
| CAD Compensation Warrants | 107,720 | 125,890 |
| CAD Financing Warrants | 897,667 | 1,286,282 |
| 2022 USD Financing Warrants | 7,031,823 | 7,058,823 |
| Total | 12,493,000 | 12,231,692 |
Stock-based compensation
Stock-based compensation expense represents the cost of the grant date fair value of employee, officer, director and non-employee stock option grants or restricted share unit (“RSU”) grants, estimated in accordance with the applicable accounting guidance, recognized on a straight-line basis over the vesting period. The vesting period generally approximates the expected service period of the awards. The Company recognizes forfeitures as they occur.
The fair value of stock options is estimated using a Black-Scholes-Merton valuation model on the date of grant. The Black-Scholes-Merton option-pricing model requires inputs based on certain highly subjective assumptions. Changes to these assumptions can materially affect the fair value of stock options and ultimately the amount of stock-based compensation expense recognized in the Company’s consolidated financial statements. These assumptions include:
Fair Value of Common Shares— The fair value of the Company’s Common Shares is determined based upon the closing price of the Company’s stock one day prior to grant.
Risk-free interest rate—The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of the Company's stock options.
Expected volatility—Due to the Company's limited operating history and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of the Company's own share price becomes available.
Expected term—The expected term represents the period that the stock-based awards are expected to be outstanding. The Company has opted to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option, which is generally between 5 to 10 years.
Dividend Yield—The Company has never paid dividends on its Common Shares and has no plans to pay dividends on its Common Shares. Therefore, the Company has used an expected dividend yield of zero.
When the terms and conditions are modified before an award vests, any increase in the fair value of the shares, measured immediately before and after the modification, is also charged to the consolidated statements of operations and comprehensive loss.
The Company also grants-cash settled Directors’ Deferred Share Units (“DDSUs”) to non-executive directors for compensation. Historically, the fair market value of one DDSU was equal to the volume weighted average trading price of a Common Share on the Cboe Canada exchange (formerly "NEO Exchange") for the five business days immediately preceding the valuation date. Effective June 8, 2023, the Company amended the definition of “Fair Market Value” under the DDSU Plan to be based upon the volume weighted average trading price of a Common Share on the Nasdaq Stock Market. This change is only applicable for DDSUs granted subsequent to June 8, 2023. Accordingly, DDSUs granted after June 8, 2023 are denominated in USD. The Company revalues DDSUs on a quarterly basis. The Company recognizes expense on the revaluation of DDSU awards as they vest and records the expense to stock-based compensation expense under general and administrative expense in the consolidated statement of operations and comprehensive loss with a corresponding adjustment related to a DDSU liability recorded to accrued expenses in the consolidated balance sheets.
Recently Adopted Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position, results of operations, or cash flows upon adoption.
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842), which requires lessees to recognize the following for all leases (with the exception of short-term leases) at the commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. In July 2018, the FASB issued ASU 2018-11 to amend certain aspects of Topic 842. These amendments provide entities with an additional (and optional) transition method to adopt Topic 842. Under this transition method, an entity initially applies the transition requirements in Topic 842 at that Topic’s effective date with the effects of initially applying Topic 842 recognized as a cumulative effect adjustment to the opening balance of retained earnings (or other components of equity or net assets, as appropriate) in the period of adoption. On April 8, 2020, the FASB changed the effective date of this standard applicable to the Company as an emerging growth company to January 1, 2022. The Company adopted this standard effective January 1, 2022, the adoption hadno impact on the consolidated financial statements. The Company adopted the standard using the practical expedients allowing the Company to not reassess (i) whether any expired or existing contracts are or contain leases, (ii) the lease classification for any expired leases, and (iii) indirect costs for any existing leases. The Company has elected to not separate lease and non-lease components for any leases within its existing classes of assets, therefore the Company accounts for lease and non-lease components as a single lease component. The Company has also elected to not apply the recognition requirement to any leases within its existing classes of assets with a term of 12 months or less.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting(“ASU 2023-07”). ASU 2023-07 requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within the segment measure of profit or loss. This guidance will be applied retrospectively and is effective for annual reporting periods in fiscal years beginning after December 15, 2023, and interim reporting periods in fiscal years beginning after December 31, 2024. The Company does not expect implementation of the new guidance to have a material impact on its consolidated financial statements and disclosures.
CREDIT FACILITY
On August 11, 2023 (the “Closing Date”), the Company and certain of its subsidiaries party thereto, as co-borrowers (together with the Company, the “Borrowers”) entered into a Loan and Security Agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”), as administrative agent and Canadian collateral agent for lenders thereunder (K2HV, together with any other lender from time to time, the "Lenders"), and Ankura Trust Company, LLC, as collateral trustee for the Lenders. The Loan Agreement provides for up to an aggregate principal amount of $50.0 million in term loans (the “Term Loan”) consisting of a first tranche term loan of $15.0 million funded on the Closing Date, subsequent tranches of term loans totaling $20.0 million to be funded upon the achievement of certain time-based, clinical and regulatory milestones, and an additional tranche term loan of up to $15.0 million upon the Company’s request, subject to review by the Lenders of certain information from the Company and discretionary approval by the Lenders. On the Closing Date, the Company paid a facility fee of $0.3 million to K2HV.
The Term Loan matures on August 1, 2027, and the obligations of the Borrowers under the Loan Agreement are secured by substantially all of the assets of the Borrowers, excluding intellectual property.
The Term Loan bears a variable interest rate equal to the greater of (i)10.95% and (ii) the sum of (a) the prime rate as reported in The Wall Street Journal plus (b)2.95%. The Company may prepay, at its option, all, but not less than all, of the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being prepaid of the Term Loan, subject to certain prepayment notice requirements; provided that such prepayment notice may be conditioned upon the effectiveness of a refinancing or any other transaction, in which case such prepayment notice may be revoked by the Borrowers.
The Lenders may elect at any time following the Closing Date and prior to the full repayment of the Term Loan to convert any portion of the principal amount of the term loans then outstanding, up to an aggregate principal amount of $4.0 million, into the Company’s Common Shares (the “Conversion Shares”), at a conversion price equal to $4.01 per Conversion Share, subject to certain limitations. The embedded conversion option qualifies for a scope exception from derivative accounting because it is both indexed to the Company’s own shares and meets the conditions for equity classification.
The Loan Agreement contains customary representations and warranties and affirmative and negative covenants, including covenants that limit or restrict the Company's ability to, among other things: dispose of assets; make changes to the Company's business, management, ownership or business locations; merge or consolidate; incur additional indebtedness, encumbrances or liens; pay dividends or other distributions or repurchase equity; make investments; and enter into certain transactions with affiliates, in each case subject to certain exceptions. The Company is in compliance with the Loan Agreement as of December 31, 2023.
The Company recorded $0.7 million in interest expense for the year ended December 31, 2023.
Future expected repayments of principal amount due on the credit facility as of December 31, 2023 are as follows (in thousands):
| 2024 · $ · - | |
|---|---|
| 2025 | 4,522 |
| 2026 | 6,026 |
| 2027 | 4,452 |
| Total principal repayments | $15,000 |
| Unamortized debt issuance costs | (871) |
| Total credit facility, non-current, net | $14,129 |
FAIR VALUE OF FINANCIAL INSTRUMENTS
The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2023 and 2022 and the fair value hierarchy of the valuation techniques utilized. The Company classifies its assets and liabilities as either short- or long-term based on maturity and anticipated realization dates.
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets: | ||||
| Cash equivalents | $96,682 | $— | $— | $96,682 |
| Financial liabilities: | ||||
| Directors' Deferred Share Unit Liability | $387 | $— | $— | $387 |
| 2022 USD Financing Warrant Liability | $— | $— | $16,476 | $16,476 |
| Level 1 | Level 2 | Level 3 | Total | |
| Financial assets: | ||||
| Cash equivalents | $131,702 | $— | $— | $131,702 |
| Financial liabilities: | ||||
| Directors' Deferred Share Unit Liability | $124 | $— | $— | $124 |
| 2022 USD Financing Warrant Liability | $— | $— | $9,904 | $9,904 |
There wereno transfers into or out of Level 1, Level 2, or Level 3 during the years ended December 31, 2023 and 2022.
The Company's cash equivalents includes a U.S. government money market fund which invests in highly liquid securities that are issued or guaranteed by the U.S. government or by U.S. government agencies and instrumentalities, and are measured at fair value in accordance with the fair value hierarchy.
The fair value of the warrant liability is measured at fair value on a recurring basis. The 2022 USD Financing Warrants (as defined below in Note 7) are classified as Level 3 in the fair value hierarchy and are determined using the Black-Scholes-Merton option pricing model using the following assumptions:
| As of December 31, 2023 | As of December 31, 2022 | |
|---|---|---|
| Share price | $3.66 | $2.20 |
| Expected volatility | 94.72% | 97.08% |
| Risk-free rate | 3.87% | 3.94% |
| Expected life | 3.75 years | 4.75 years |
GOODWILL AND INTANGIBLE ASSETS, NET
Goodwill
During the year ended December 31, 2023, the Company has madeno additions to its outstanding goodwill. During the fourth quarter of 2023, the Company performed its annual goodwill impairment test and considered the decrease in its share price as well as other market factors as triggering events and determined a quantitative analysis was needed to be performed. As a result of the quantitative analysis, no impairment loss was recognized. No impairment charges have been recorded during the years ended December 31, 2023 and 2022.
Intangible assets, net
The following table summarizes the carrying value of the Company’s intangible assets (in thousands):
| Useful Lives(in years) | Gross CarryingValue | Accumulated Amortization | Net Carrying Value | |
|---|---|---|---|---|
| Developed technology | 3 | $9,485 | $(8,958) | $527 |
| Total intangible assets, net | $9,485 | $(8,958) | $527 | |
| Useful Lives(in years) | Gross CarryingValue | Accumulated Amortization | Net Carrying Value | |
| Developed technology | 3 | $9,485 | $(5,796) | $3,689 |
| Total intangible assets, net | $9,485 | $(5,796) | $3,689 |
As of December 31, 2023, developed technology has a remaining useful life of 0.2 years. Amortization expense included in research and development expense was $3.2 million for both the years ended December 31, 2023 and 2022.
As of December 31, 2023, the expected future amortization expense for finite-lived intangible assets was as follows (in thousands):
| Year Ending December 31, | Amount |
|---|---|
| 2024 | 527 |
| Total | $527 |
ACCRUED EXPENSES
At December 31, 2023 and 2022, accrued expenses consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued compensation | $4,526 | $3,198 |
| Contribution payable | 2,841 | 1,566 |
| Professional services | 2,022 | 436 |
| Accrued clinical and manufacturing costs | 1,884 | 605 |
| Other accruals | 361 | 72 |
| Total accrued expenses | $11,634 | $5,877 |
SHAREHOLDERS’ EQUITY
Common Shares
The Company is authorized to issue an unlimited number of Common Shares, which haveno par value. As of December 31, 2023, the Company had issued and outstanding 41,101,303 shares of Common Shares.
Voting Rights -The holders of Common Shares are entitled toone vote for each Common Share held. All holders of Common Shares are entitled to receive notice of any meeting of shareholders of the Company, and to attend, vote and participate at such meetings, except those meetings at which only holders of a specific class of shares are entitled to vote separately as a class under the Business Corporations Act (British Columbia) (the “BCBCA”). A quorum for the transaction of business at a meeting of shareholders is present if at least two shareholders who, in the aggregate, hold at least 33⅓% of the issued shares entitled to be voted at the meeting are present in person or represented by proxy, irrespective of the number of persons actually present at the meeting. If, within one half hour from the time set for the holding of a meeting of shareholders, a quorum is not present in the case of a shareholder meeting not requisitioned by shareholders, the meeting stands adjourned to the time and place determined by the chair of the meeting or the Board. If, at the adjourned meeting, a quorum is not present within one half hour from the time set for the holding of the meeting, the person or persons present and being, or representing by proxy, one or more shareholders entitled to attend and vote at the meeting constitute a quorum.
August 2022 Reverse Share Split
The Company’s Board of Directors (the “Board”) approved a reverse split of the Company’s Common Shares on a 15-for-1 basis (the “August Share Split”), which was effected on August 26, 2022, and which brought the bid price of the Company’s Common Shares above the minimum bid price requirement under the Listing Rules of The Nasdaq Stock Market LLC (“Nasdaq”). No fractional Common Shares were issued as a result of the August Share Split. Each fractional Common Share that was remaining upon the August Share Split that was less than ½ of a Common Share was cancelled and each fractional Common Share that was at least ½ of a Common Share was changed toone whole Common Share. The August Share Split affected all Common Shares outstanding immediately prior to the effective time of the August Share Split, as well as the number of Common Shares available under the Company’s stock option plan and equity incentive plan. In addition, the August Share Split effected a reduction in the number of Common Shares issuable upon exercise of stock options, vesting of Restricted Share Units and exercise of warrants outstanding immediately prior to the effectiveness of the August Share Split. All references to Common Shares, options to purchase Common Shares, share data, per share data, and related information contained in these financial statements have been retrospectively adjusted to reflect the effect of the August Share Split for all periods presented.
Common Shares Issued
On May 4, 2022, the Company filed a shelf registration statement on Form S-3 (the “Registration Statement”). Pursuant to the Registration Statement, the Company may offer and sell securities having an aggregate public offering price of up to $200.0 million. In connection with the filing of the Registration Statement, the Company also entered into a sales agreement with Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. as sales agents (together, the “Sales Agents”), pursuant to which the Company may issue and sell Common Shares for an aggregate offering price of up to $100.0 million under an at-the-market offering program (the “ATM”). Pursuant to the ATM, the Company will pay the Sales Agents a commission rate equal to 3.0% of the gross proceeds from the sale of any Common Shares. The Company is not obligated to make any sales of its Common Shares under the ATM. During the year ended December 31, 2023, the Company sold 2,232,113 common shares for net proceeds of $7.8 million under the ATM. As of December 31, 2023, the Company had raised an aggregate of $40.2 million under the ATM and may issue and sell common shares for an aggregate offering price of up to an additional $59.8 million.
On September 30, 2022, the Company closed an underwritten public offering of 7,058,823 Common Shares and accompanying warrants to purchase 7,058,823 Common Shares (the “2022 USD Financing Warrants”) at a combined offering price of $4.25 per Common Share, for net proceeds of $27.5 million after deducting underwriting discounts and commissions and offering costs. Each 2022 USD Financing Warrant is immediately exercisable for one Common Share at an exercise price of $4.25 per Common Share, subject to certain adjustments and will expire on September 30, 2027.
Common Shares Reserved for Issuance
A summary of shares reserved for issuance as of December 31, 2023 is summarized below:
| Options issued and outstanding under stock option plan | 2,161,734 |
|---|---|
| Restricted Share Units | 2,294,056 |
| CAD Compensation Warrants | 107,720 |
| CAD Financing Warrants | 897,667 |
| 2022 USD Financing Warrants | 7,031,823 |
| Shares available for grant under stock option plan | 1,709,405 |
| Total shares reserved for issuance | 14,202,405 |
WARRANTS
The following table summarizes warrant activity for the year ended December 31, 2023.
| Expiration Date · Exercise Price (CAD$) · Outstanding as ofDecember 31, 2022 · Exercised · Expired · Outstanding as ofDecember 31, 2023 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| December 11, 2020 CAD compensation warrants | December 2023 | $28.50 | 18,170 | — | (18,170) | — | ||||
| January 7, 2021 CAD compensation warrants | January 2024 | 66.00 | 83,720 | — | — | 83,720 | ||||
| March 9, 2021 CAD compensation warrants | March 2024 | 48.75 | 24,000 | — | — | 24,000 | ||||
| Total CAD compensation warrants | 125,890 | — | (18,170) | 107,720 | ||||||
| October 30, 2020 CAD financing warrants | October 2023 | 21.00 | 122,510 | — | (122,510) | — | ||||
| December 11, 2020 CAD financing warrants | December 2023 | 36.75 | 266,105 | — | (266,105) | — | ||||
| January 7, 2021 CAD financing warrants | January 2024 | 86.25 | 697,667 | — | — | 697,667 | ||||
| March 9, 2021 CAD financing warrants | March 2024 | 66.00 | 200,000 | — | — | 200,000 | ||||
| Total CAD financing warrants | 1,286,282 | — | (388,615) | 897,667 | ||||||
The following table summarizes warrant activity for the year ended December 31, 2022.
| Expiration Date · ExercisePrice (CAD$) · Outstanding as of December 31, 2021 · Exercised · Expired · Outstanding as of December 31, 2022 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| December 11, 2020 CAD compensation warrants | December 2023 | $28.50 | 18,170 | — | — | 18,170 | ||||
| January 7, 2021 CAD compensation warrants | January 2024 | 66.00 | 83,720 | — | — | 83,720 | ||||
| March 9, 2021 CAD compensation warrants | March 2024 | 48.75 | 24,000 | — | — | 24,000 | ||||
| Total CAD compensation warrants | 125,890 | — | — | 125,890 | ||||||
| May 26, 2020 CAD financing warrants | May 2022 | 11.85 | 90,490 | (76,021) | (14,469) | — | ||||
| October 30, 2020 CAD financing warrants | October 2023 | 21.00 | 122,510 | — | — | 122,510 | ||||
| December 11, 2020 CAD financing warrants | December 2023 | 36.75 | 266,105 | — | — | 266,105 | ||||
| January 7, 2021 CAD financing warrants | January 2024 | 86.25 | 697,667 | — | — | 697,667 | ||||
| March 9, 2021 CAD financing warrants | March 2024 | 66.00 | 200,000 | — | — | 200,000 | ||||
| Total CAD financing warrants | 1,376,772 | (76,021) | (14,469) | 1,286,282 | ||||||
The weighted average market fair value of shares purchased through warrant exercises during the year ended December 31, 2022 was CAD$11.85.
2022 USD Financing Warrants
On September 30, 2022, the Company closed an underwritten public offering of 7,058,823 Common Shares and accompanying warrants to purchase 7,058,823 Common Shares (see Note 7) at a combined offering price of $4.25 per Common Share, for net proceeds of $27.5 million after deducting underwriting discounts and commissions and offering costs. Each 2022 USD Financing Warrant is immediately exercisable for one Common Share at an exercise price of $4.25 per Common Share, subject to certain adjustments and will expire on September 30, 2027.
The below table represents the activity associated with the Company's outstanding liability classified 2022 USD Financing Warrants for the year ended December 31, 2023:
| 2022 USD FinancingWarrants | |
|---|---|
| Balance at December 31, 2022 | 7,058,823 |
| Issued | — |
| Exercised | (27,000) |
| Expired | — |
| Balance at December 31, 2023 | 7,031,823 |
The 2022 USD Financing Warrants are liability classified due to being denominated in USD and not the Company's functional currency. Accordingly, the 2022 USD Financing Warrants are recognized at fair value upon issuance and are adjusted to fair value at the end of each reporting period. Any change in fair value is recognized on the consolidated statements of operations. The Company recognized a loss relating to the change in fair value of the warrant liability of $6.6 million during the year ended December 31, 2023, and a gain of $7.8 million for the year ended December 31, 2022. Issuance costs of $1.5 million related to warrants were expensed within general and administrative expense on the consolidated statements of operations during the year ended December 31, 2022.
| Balance at December 31, 2022 | $9,904 |
|---|---|
| Warrant exercise | (64) |
| Change in fair value of the warrant liability | 6,636 |
| Balance at December 31, 2023 | $16,476 |
STOCK-BASED COMPENSATION
Stock Incentive Plans
Effective March 7, 2023, the Company amended the definition of "Market Value" under both the MindMed Stock Option Plan (the “Stock Option Plan”) and the Performance and Restricted Share Unit Plan (the “RSU Plan”) to be based upon the closing price of the Company's Common Shares as traded on the Nasdaq Stock Market on the last trading day on which Common Shares traded prior to the day on which an equity award is granted (the “Amendments”). This change is only applicable for equity compensation awards granted subsequent to the Amendments. Accordingly, stock options granted after March 7, 2023 ("USD options") are denominated in USD, and the grant date fair value of restricted share units granted after March 7, 2023 ("USD RSUs") is denominated in USD. The fair value of both USD options and USD RSUs is based upon the closing price of the Company's Common Shares as traded on the Nasdaq Stock Market.
Stock Options
On February 27, 2020, the Company adopted the Stock Option Plan to advance the interests of the Company by providing employees, contractors and directors of the Company a performance incentive for continued and improved service with the Company. The Stock Option Plan sets out the framework for determining eligibility as well as the terms of any stock-based compensation granted. The Stock Option Plan was approved by the shareholders as part of the terms of an arrangement agreement (the “Arrangement”) entered into by the Company on October 15, 2019 in connection with the completion of its reverse acquisition, which completed on February 27, 2020 (the “Transaction”). The Company is authorized to issue 15% of the Company’s outstanding Common Shares under the terms of the Stock Option Plan, together with Common Shares that are issuable pursuant to outstanding awards or grants under any other compensation or incentive mechanism involving the issuance or potential issuance of Common Shares, including the RSU Plan.
The fair value of options issued has been estimated using the Black-Scholes-Merton option pricing model with the following assumptions:
| Year Ended December 31, 2023 | Year Ended December 31, 2022 | |
|---|---|---|
| Share price | USD$2.98 - USD$3.61 | CAD$3.47 - CAD$25.65 |
| Expected volatility | 87.2% | 91.8% - 100.6% |
| Risk-free rate | 2.8% - 3.9% | 1.8% - 4.2% |
| Expected life | 5.3 - 6.1 years | 2.5 - 6.1 years |
| Expected dividend yield | 0% | 0% |
The following table summarizes the Company’s stock option activity (excluding 178,006 USD options granted with an average exercise price of $3.38):
| Number of Options | Weighted Average Exercise Price (CAD$) | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value(CAD$) | |
|---|---|---|---|---|
| Options outstanding at December 31, 2022 | 2,190,315 | $24.29 | 4.1 | $4,484 |
| Issued | — | — | — | — |
| Exercised | (13,333) | 4.95 | — | 7,333 |
| Forfeited | (43,800) | 17.29 | — | — |
| Expired | (149,454) | 15.29 | — | — |
| Options outstanding at December 31, 2023 | 1,983,728 | $25.26 | 3.3 | $41,523 |
| Options vested and exercisable at December 31, 2023 | 1,217,163 | $26.05 | 2.9 | $11,973 |
The weighted average grant date fair value of options granted during the year ended December 31, 2023 was $2.44. The aggregate fair value of options vested during the year ended December 31, 2023 was $7.3 million. The expense recognized related to options during the years ended December 31, 2023 and 2022 was $6.6 million and $6.7 million, respectively.
Restricted Share Units
The Company adopted the RSU Plan to advance the interests of the Company by providing employees, contractors and directors of the Company a performance incentive for continued and improved service with the Company. The RSU Plan sets out the framework for determining eligibility as well as the terms of any stock-based compensation granted. The RSU Plan was approved by the shareholders as part of the Arrangement. The fair value has been estimated based on the closing price of the Common Shares on the day prior to the grant.
| (CAD$) · (USD$) | |||||
|---|---|---|---|---|---|
| Number of RSUs | Number of RSUs | Weighted Average Grant Date Fair Value | Number of RSUs | Weighted Average Grant Date Fair Value | |
| Balance at December 31, 2022 | 1,522,793 | 1,522,793 | $17.75 | — | — |
| Granted | 1,676,638 | — | — | 1,676,638 | 3.24 |
| Vested, issued and unissued | (834,599) | (531,638) | 19.92 | (302,961) | 3.43 |
| Cancelled | (76,106) | (28,106) | 30.11 | (48,000) | 3.77 |
| Balance at December 31, 2023 | 2,288,726 | 963,049 | $16.19 | 1,325,677 | $3.18 |
The fair market value of RSUs vested during the year ended December 31, 2023 was $2.9 million. The expense recognized related to RSUs during the years ended December 31, 2023 and 2022 was $8.6 million and $6.9 million, respectively.
Modification of Stock Options and RSUs
The Company modified the option awards and RSUs of certain employees and non-employees to accelerate the vesting and continue the vesting of 603,125 unvested options and 26,042 RSUs during the year ended December 31, 2022, that were improbable of vesting as of the modification date. Under this type of modification, the original grant date fair value is remeasured, and compensation cost is recognized based on the fair value of the modified award, as measured on the modification date. For the year ended December 31, 2022, the Company recognized $0.7 million of incremental compensation cost resulting from the modification in general and administrative expense in the consolidated statements of operations and comprehensive loss. There were no modifications of option awards and RSUs during the year ended December 31, 2023.
Directors’ Deferred Share Unit Plan
On April 16, 2021 the Company adopted the MindMed Director's Deferred Share Unit Plan (the "DDSU Plan"). The DDSU Plan sets out a framework to grant non-executive directors DDSUs which are cash settled awards. Effective June 8, 2023, the Company amended the definition of “Fair Market Value” under the DDSU Plan to be based upon the closing price of the Company’s Common Shares as traded on the Nasdaq Stock Market. This change is only applicable for Directors Deferred Share Units (“DDSUs”) granted subsequent to June 8, 2023. Accordingly, DDSUs granted after June 8, 2023 are denominated in USD. The DDSU Plan states that the fair market value of one DDSU shall be equal to the volume weighted average trading price of a Common Share on the Nasdaq Stock Market for the five business days immediately preceding the valuation date. The DDSUs generally vest ratably over twelve months after grant and are settled within 90 days of the date the director ceases service to the Company.
| Number of DSUs | |
|---|---|
| Balance at December 31, 2022 | 213,799 |
| Issued | 13,131 |
| Settled | (26,629) |
| Cancelled | (1,275) |
| Balance at December 31, 2023 | 199,026 |
For the year ended December 31, 2023 stock-based compensation expense of a nominal amount was recognized relating to the revaluation of the vested DDSUs, recorded in general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. There were 103,455 DDSUs vested as of December 31, 2023. The liability associated with the outstanding vested DDSUs was $0.4 million as of December 31, 2023 and was recorded to accrued expenses in the accompanying consolidated balance sheets.
Stock-based Compensation Expense
Stock-based compensation expense for all equity arrangements for the years ended December 31, 2023 and 2022 was as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development | $7,087 | $5,597 |
| General and administrative | 8,407 | 8,110 |
| Total stock-based compensation expense | $15,494 | $13,707 |
As of December 31, 2023, there was approximately $9.1 million of total unrecognized stock-based compensation expense, related to unvested options granted to employees under the Stock Option Plan that is expected to be recognized over a weighted average period of 1.8 years for CAD options, and 2.0 years for USD options. As of December 31, 2023, there was approximately $15.0 million of total unrecognized stock-based compensation expense, related to restricted share units granted to employees under the RSU Plan that is expected to be recognized over a weighted average period of 1.8 years for CAD RSUs, and 3.2 years for USD RSUs.
INCOME TAXES
The Components of the loss before income taxes were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Domestic | $(89,536) | $(61,763) |
| Foreign | (6,196) | 4,967 |
| Total | $(95,732) | $(56,796) |
For purposes of reconciling the Company’s provision for income taxes at the statutory rate and the Company’s provision (benefit) for income taxes at the effective tax rate, a notional of 21% tax rate was applied as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Income tax at federal statutory rate | $(20,104) | $(11,926) |
| State income tax expense, net of federal tax effect | 331 | — |
| Nondeductible permanent items | 51 | 224 |
| Executive compensation | 423 | 383 |
| Warrant fair value adjustment | 2,477 | (3,240) |
| Foreign rate differential | (957) | 1,356 |
| Adjustment to deferred taxes | 783 | 10,742 |
| Nonqualified stock option and performance award windfall upon exercise | 2,002 | 1,732 |
| Change in valuation allowance | 14,994 | 729 |
| $— | $— | |
The difference between the statutory federal income tax rate and the Company’s effective tax rate in 2023 and 2022 is primarily attributable to the change in valuation allowance, foreign rate differential, executive compensation, and capitalized research expenses.
The following table provides the effect of temporary differences that created deferred income taxes as of December 31, 2023 and 2022. Deferred tax assets and liabilities represent the future effects on income taxes resulting from temporary differences and carryforwards at the end of the respective periods (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Reserves | $730 | $555 |
| Stock-based compensation | 1,936 | 1,618 |
| Share issuance costs | 2,139 | 2,944 |
| Net operating loss carryforward | 31,560 | 25,312 |
| Other assets | 677 | 638 |
| Intangible assets | 945 | 442 |
| Capitalized R&D | 13,128 | 4,595 |
| Lease liability | 22 | 35 |
| Valuation allowance | (51,023) | (36,107) |
| Net deferred income tax assets | 114 | 32 |
| Deferred tax liabilities: | ||
| Right of use asset | (20) | (32) |
| Other | (94) | — |
| Total deferred tax liabilities | (114) | (32) |
| Net deferred income tax liability | $— | $— |
As of December 31, 2023 and 2022, management assessed the realizability of deferred tax assets and evaluated the need for a valuation allowance for deferred tax assets on a jurisdictional basis. This evaluation utilizes the framework contained in ASC 740, Income Taxes, wherein management analyzes all positive and negative evidence available at the balance sheet date to determine whether all or some portion of the Company’s deferred tax assets will not be realized. Under this guidance, a valuation allowance must be established for deferred tax assets when it is more-likely-than-not that the asset will not be realized. In assessing the realization of the Company’s deferred tax assets, management considers all available evidence, both positive and negative.
In concluding on the evaluation, management placed significant emphasis on guidance in ASC 740, which states that “a cumulative loss in recent years is a significant piece of negative evidence that is difficult to overcome.” Based upon available evidence, it was concluded on a more-likely-than-not basis that all deferred tax assets were not realizable as of December 31, 2023 and 2022. Accordingly, a valuation allowance of $51.0 million has been recorded to offset this deferred tax asset. The valuation allowance increased by $14.9 million for the year ended December 31, 2023.
As of December 31, 2023, the Company has accumulated federal and state net operating loss (“NOL”) carryforwards of $128.3 million and $17.0 million, respectively. The federal NOL carryforwards can be carried forward indefinitely, subject to 80%taxable income limitation. Of the $17.0 million of state NOL carryforwards, $0.2 million can be carried forward indefinitely and $16.8 million expire beginning December 31, 2028.
As of December 31, 2023 the Company had combined foreign net operating loss carryforwards available to reduce future taxable income of approximately $13.4 million, of which $0.8 million carryforward indefinitely, $9.1 million begin to expire in 2040, and $3.5 million begin to expire in 2028.
Utilization of the Company’s net operating loss and tax credit carryforwards may be subject to a substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended, and similar state provisions. Such an annual limitation could result in the expiration or elimination of the net operating loss and tax credit carryforwards before utilization. Management believes that the limitation will not limit utilization of the carryforwards prior to their expiration.
The Company is subject to taxation in the United States, various states, Canada, Australia and Switzerland. The Company has not been notified that it is under audit by the IRS or any state or foreign taxing authorities, however, due to the presence of NOL carryforwards, all of the income tax years remain open for examination in each of these jurisdictions.
Deferred income taxes have not been provided for undistributed earnings of the Company’s consolidated foreign subsidiaries because of the Company’s intent to reinvest such earnings indefinitely in active foreign operations.
As of December 31, 2023 and 2022 the Company didnot have a liability for unrecognized tax benefits.
The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the years ended December 31, 2023 and 2022, interest and penalties recognized were insignificant.
The Tax Cuts and Jobs Act subjects a U.S. shareholder to tax on GILTI earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740 No. 5. Accounting for Global Intangible Low-Taxed Income, states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI in the year the tax is incurred.
COMMITMENTS AND CONTINGENCIES
As of December 31, 2023 and 2022, the Company has obligations to make future payments, representing significant research and development contracts and other commitments that are known and committed in the amount of approximately $28.0 million and $31.6 million, respectively. Most of these agreements are cancelable by the Company with notice. These commitments include agreements related to the conduct of the clinical trials, sponsored research, manufacturing and preclinical studies.
The Company enters into research, development and license agreements in the ordinary course of business where the Company receives research services and rights to proprietary technologies. Milestone and royalty payments that may become due under various agreements are dependent on, among other factors, clinical trials, regulatory approvals and ultimately the successful development of a new drug, the outcome and timing of which are uncertain.
The Company periodically enters into research and license agreements with third parties that include indemnification provisions customary in the industry. These guarantees generally require the Company to compensate the other party for certain damages and costs incurred as a result of claims arising from research and development activities undertaken by or on behalf of the Company. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions could be unlimited. These indemnification provisions generally survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the consolidated financial statements with respect to these indemnification obligations.
Operating Lease Agreement
During April 2022, the Company entered into a 3-year operating lease for office space located in North Carolina. Total lease payments under the lease amount to approximately $0.2 million and the Company recorded a related right-of-use asset and related lease liability upon lease commencement of approximately $0.2 million. Upon the expiration of the initial term of the lease, the Company has the option to extend the term of the lease for an additional 5-year period. The right-of-use asset is recorded inother non-current assets in the accompanying consolidated balance sheet. The current portion of thelease liability isrecorded in accrued expenses and the noncurrent portion is recorded in other liabilities, long-term in the accompanying consolidated balance sheet. The incremental borrowing rate utilized in the determination of the lease liability was 8.0%.
EMPLOYEE BENEFIT PLANS
During the year ended December 31, 2023, the Company adopted a 401(k) savings plan for its employees. The Company is required to make matching contributions to the 401(k) plan equal to 100% of the first 3% of employee contributions, and 50% on the next 2% of employee contributions. The Company contributed $0.4 million during the year ended 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.