Kodiak Sciences Inc
For the period ended Dec 31, 2023. Filed Mar 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 Mar 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
- The Company
Kodiak Sciences Inc. (the “Company”) is a clinical stage biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. The Company devotes substantially all of its resources to the research and development of its product platforms and product candidates including activities to conduct clinical studies of its product candidates, manufacture product candidates and provide general and administrative support for these operations.
Liquidity
As of December 31, 2023, the Company had cash and cash equivalents of$285.5 million. Although the Company has incurred significant operating losses since inception and expects to continue to incur operating losses and negative operating cash flows for the foreseeable future, the Company believes that the cash and cash equivalents will be sufficient to meet the anticipated operating and capital expenditure requirements for the 12 months following the date of this Annual Report on Form 10-K.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).
Reclassification
Certain prior period amounts in the consolidated financial statements have been reclassified to conform to the current period presentation.
Principles of Consolidation
The consolidated financial statements include the Company’s accounts and the accounts of Kodiak Sciences Financing Corporation and Kodiak Sciences China, the Company’s direct wholly owned subsidiaries, incorporated in the United States and Cayman Islands, respectively, and Kodiak Sciences GmbH and Kodiak Sciences Valais GmbH, the Company’s indirect wholly owned subsidiaries, both incorporated in Switzerland. All intercompany accounts and transactions have been eliminated. The functional and reporting currency of the Company and its subsidiaries is the U.S. dollar. The aggregate foreign currency transaction gain (loss) included in determining net loss was$(0.1) million,$0.3 million, and$(0.3) million for the years ended December 31, 2023, 2022 and 2021, respectively.
Segments
The Company operates and manages its business asone reportable and operating segment, which is the business of research and development of drugs for retinal diseases. The chief operating decision maker reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance.
Use of Estimates
The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and expenses during the reporting period. Such estimates include, but are not limited to, accrued research and development, stock-based compensation, and impairment of long-lived assets. Actual results could differ from those estimates.
Risk and Uncertainties
Global economic and business activities continue to face widespread macroeconomic uncertainties, including health epidemics, labor shortages, bank failures, inflation and monetary supply shifts, recession risks and potential disruptions from the geopolitical conflicts. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations, and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business.
The Company’s future results of operations involve a number of risks and uncertainties common to clinical stage companies in the biotechnology industry. The Company’s product candidates are in development and the Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of any of the Company’s product candidates that receive regulatory approval, competition from new technological innovations, substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals, contract manufacturer and research organizations, and other suppliers.
Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that any of the Company’s product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approvals, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales.
The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical trials, launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be on terms acceptable by the Company.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents as of December 31, 2023. As of December 31, 2022, the Company also had marketable securities. As of December 31, 2023 and 2022, cash, cash equivalents and marketable securities were invested primarily in money market funds and U.S. treasury securities through highly rated financial institutions. Investments are restricted, in accordance with the Company’s investment policy, to a concentration limit per issuer or sector.
Cash and Cash Equivalents
The Company considers all highly liquid investments with stated maturities of three months or less at the date of purchase to be cash equivalents.
Marketable Securities
The Company may invest excess cash balances in marketable securities. The investments in marketable securities are classified as either held-to-maturity or available-for-sale based on facts and circumstances present at the time of purchase. Marketable securities with a remaining maturity date greater than one year are classified as non-current. The Company’s marketable securities can consist of U.S. treasury securities, commercial paper, and corporate bonds. Marketable debt securities that are available for sale, are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase of marketable debt securities is amortized and/or accreted to interest income or expense over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense), net. Refer to the Credit Losses – Available-for-Sale Debt Securities section below.
Restricted Cash
As of December 31, 2023, and 2022, the Company had$6.3 million of long-term restricted cash deposited with financial institutions. The entire amount is held in separate bank accounts to support letter of credit agreements related to the Company’s U.S. corporate offices.
Derivatives and Hedging
Derivative instruments that do not qualify for hedge accounting are recognized on the consolidated balance sheet at fair value, with changes in the fair value recognized on the consolidated statement of operations and comprehensive loss as a component of other income (expense), net. The cash flows associated with these derivatives are reflected as cash flows from investing activities in the consolidated statement of cash flows.
Fair Value of Financial Instruments
Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company's own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.
Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following:
Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and inputs to the model.
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. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The carrying amounts of the Company’s financial instruments consisting of cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities and other current liabilities, approximate fair value due to their relatively short maturities.
Leases
The Company determines if an arrangement is, or contains, a lease at inception and then classifies the lease as operating or financing based on the underlying terms and conditions of the contract. Leases with terms greater than one year are initially recognized on the consolidated balance sheet as right-of-use assets and lease liabilities based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the incremental borrowing rate, which is the rate incurred to borrow, on a collateralized basis, an amount equal to the lease payments over a similar term and in a similar economic environment of the applicable country or region. Variable lease payments are excluded from the right of use assets and operating lease liabilities and are recognized in the period in which the obligation for those payments is incurred.
Property and Equipment, Net
Property and equipment are stated at cost, net of accumulated depreciation. Construction in progress reflects amounts incurred for construction or improvements of property or equipment that have not been placed in service. Construction in progress is transferred to specific property and equipment and depreciated when these assets are ready for their intended use. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which generally follows:
| Asset Category | Useful Lives |
|---|---|
| Furniture and Fixtures | 5 years |
| Machinery and Equipment | 3 to 10 years |
| Computer Software and Hardware | 3 to 5 years |
| Leasehold improvements | Lesser of the useful life or the term of the respective lease |
Upon sale or retirement of assets, the costs and related accumulated depreciation are removed from the consolidated balance sheet and the resulting gain or loss is reflected in operations. Maintenance and repairs are charged to operations as incurred.
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable. Recoverability is measured by comparison of the carrying amount of the assets to the estimated undiscounted net cash flows which the assets are expected to generate. If such assets are deemed not recoverable, an impairment loss is recognized in the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. The Company applied significant judgment in determining it has one asset group and that there is no lower level to group assets for impairment testing. The determination of the asset group primarily considers the interdependencies of its assets, shared cost structure, and the interrelated future cash flow generation. The Company assessed the recoverability of its asset group in 2023 based on the Company’s decision to wind-down the tarcocimab program following the topline results from the Phase 3 GLEAM and GLIMMER studies. The Company determined that the estimated undiscounted net cash flows which the asset group was forecasted to generate exceeded the carrying amount of the asset group. Therefore, no impairment loss was recognized in 2023. There was alsono such impairment of long-lived assets in the year ended December 31,2022.
Costs related to research, design and development of products are charged to research and development expense as incurred. Research and development costs include, but are not limited to, payroll and personnel expenses, including stock-based compensation, laboratory supplies, outside services and allocated overhead, including rent, depreciation and utilities.
Accrued Research and Development
The Company has entered into various agreements with various third parties, including clinical investigator sites, contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), to provide research and development activities. The Company’s accrued research and development costs are estimated based on the level of services performed, including the phase or completion of events, and contracted costs. Accrued clinical trial and related costs are estimated using data such as patient enrollment, clinical site activations or information provided by outside service providers regarding their actual costs incurred. Management determines accrual estimates through reports from and discussions with clinical personnel and outside service providers as to the progress of trials, or the services completed. The estimated costs of research and development provided, but not yet invoiced, are included in accrued and other current liabilities on the consolidated balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the performance of the related services are recorded as prepaid expenses or other assets until the services are rendered.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation-Stock Compensation. The Company measures stock-based compensation expense for stock options and restricted stock units granted to its employees, directors and non-employees based on the estimated fair value of the awards on the grant date. The fair value of options is calculated using the Black-Scholes valuation model or the Monte Carlo simulation model, which requires the input of subjective assumptions, including (i) the calculation of expected term of the award, (ii) the expected stock price volatility, (iii) the risk-free interest rate, and (iv) expected dividends.
The expected term is determined based on hypothetical exercise data for unexercised stock options.
The expected volatility is estimated based on the Company's historical information for its common stock and supplemented by the historical stock price volatility of a representative peer group over a period equivalent to the expected term of the equity award.
The risk-free interest rate is estimated based on the U.S. Treasury securities with maturity dates commensurate with the expected term of the equity award.
The Company has never paid, and does not expect to pay, dividends in the foreseeable future.
The expense is recorded on a straight-line basis over the requisite service period, which is generally the vesting period, for the entire award. The Company accounts for forfeitures as they occur.
The Company has certain stock options and restricted stock units that vest in conjunction with certain performance conditions. At each reporting date, the Company is required to evaluate whether achievement of the performance conditions is probable. Compensation expense is recorded over the appropriate service period based upon the Company's assessment of accomplishing each performance provision. Refer to Note 12.
Income Taxes
The Company accounts for income taxes under the asset and liability method, which requires, among other things, that deferred income taxes be provided for temporary differences between the tax basis of the Company’s assets and liabilities and their financial statement reported amounts. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses (“NOLs”) and research and development credit carryforwards and are measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse. A valuation allowance is provided against deferred tax assets unless it is more likely than not that they will be realized.
The Company accounts for uncertain tax positions by assessing all material positions taken in any assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have beenno interest or penalties charged in relation to the unrecognized tax benefits.
Comprehensive Loss
Comprehensive loss is composed of net loss and other comprehensive income (loss). Other comprehensive income (loss) consists primarily of unrealized gains and losses on debt securities.
Liability related to Sale of Future Royalties
On December 1, 2019, the Company and its subsidiary Kodiak Sciences GmbH entered into a funding agreement with Baker Bros. Advisors, LP ("BBA"), which holds more than 5% of the Company’s stock, pursuant to which BBA purchased the right to receive a capped 4.5% royalty on future net sales of tarcocimab, the Company’s anti-VEGF antibody biopolymer conjugate therapy, in exchange for $225.0 million. Under the terms of the funding agreement, there is no obligation to repay any funding amount received, other than through the capped royalty payments on future product revenues. The Company recorded the funding amount paid by BBA as aliability on the consolidated balance sheet net of issuance costs, in accordance with ASC 730, Research and Development. Under ASC 730, the significant related party relationship between the Company and BBA creates an implicit obligation to repay the funding amount paid to the Company. Once royalty payments to BBA are determined to be probable and estimable, and if such amounts exceed the liability balance, the Company will impute interest to accrete the liability on a prospective basis based on such estimates. If and when the Company makes royalty payments under the funding agreement, it would reduce the liability balance at such time. In July 2021, the funding agreement was amended, at the Company’s request, that the remaining funding amount of $125.0 million wouldnot be paid. Refer to Note 15.
Credit Losses – Available-for-Sale Debt Securities
For available-for-sale debt securities in an unrealized loss position, the Company will periodically assess its portfolio for impairment. The assessment first considers the intent or requirement to sell the security. If either of these criteria are met, the amortized cost basis will be written down to fair value through earnings.
If not met, the Company will evaluate whether the decline resulted from credit losses or other factors by considering the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss exists, the present value of cash flows expected to be collected from the security is compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses will be recorded, limited by the amount that the fair value is less than the amortized cost basis. Any impairment that has not been recorded through an allowance for credit losses is recognized in other comprehensive income or loss, as applicable.
Net Loss per Share
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. Since the Company has reported net loss for all periods presented, diluted net loss per share is the same as basic net loss per common share for those periods.
Recenta ccountingp ronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”), under its ASC or other standard setting bodies, and adopted by the Company as of the specified date.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280), which requires disclosure of incremental segment information on an annual and interim basis, including enhanced disclosures for companies that have a single reportable segment. The amendment is effective for fiscal years beginning after December 15, 2023 and interim periods beginning after December 15, 2024, and early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740), which enhances the disclosures required for income taxes in annual consolidated financial statements. The amendment is effective for fiscal years beginning after December 15, 2024, and early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements and related disclosures.
- Property and Equipment, net
Property and equipment, net consists of the following (in thousands):
| December 31, 2023 | December 31,2022 | |
|---|---|---|
| Furniture and Fixtures | $2,042 | $1,969 |
| Machinery and Equipment | 39,709 | 12,763 |
| Computer Software and Hardware | 378 | 374 |
| Leasehold Improvement | 96,534 | 43,483 |
| Construction in Progress | 4,371 | 4,519 |
| Total property and equipment | 143,034 | 63,108 |
| Less: Accumulated depreciation | (22,552) | (6,724) |
| Property and equipment, net | $120,482 | $56,384 |
The Company's property and equipment are maintained in the United States and Switzerland with net book values of $40.2 million and $80.3 million, respectively, as of December 31, 2023 compared to $45.3 million and $11.1 million, respectively, as of December 31, 2022. Depreciation expense was$18.3 million,$3.8 million and$1.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
- Accrued and Other Current Liabilities
Accrued and other current liabilities consist of the following (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Accrued manufacturing and research & development costs | $8,662 | $5,978 |
| Accrued salaries and benefits | 6,078 | 6,033 |
| Accrued clinical trial and related costs | 2,701 | 18,334 |
| Accrued legal fees and professional fees | 196 | 283 |
| Accrued property and equipment | — | 1,893 |
| Accrued other liabilities | 714 | 919 |
| Total accrued and other current liabilities | $18,351 | $33,440 |
- Fair Value Measurements
The following tables present the Company’s fair value hierarchy for assets measured at fair value on a recurring basis (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $274,466 | $— | $— | $274,466 |
| Marketable securities: | ||||
| U.S. treasury securities | — | — | — | — |
| Total | $274,466 | $— | $— | $274,466 |
| Level 1 | Level 2 | Level 3 | Total | |
| Cash equivalents: | ||||
| Money market funds | $173,617 | $— | $— | $173,617 |
| Marketable securities: | ||||
| U.S. treasury securities | — | 288,500 | — | 288,500 |
| Total | $173,617 | $288,500 | $— | $462,117 |
As of December 31, 2023 and 2022, the fair value of the liability related to sale of future royalties is based on the Company's current estimates of future royalties expected to be paid to BBA, which are considered Level 3 inputs. Refer to
Note 15. There wereno transfers of assets or liabilities between the fair value measurement levels during the years ended December 31, 2023 and 2022.
- Marketable Securities
Marketable securities are classified as available-for-sale. The Company obtains fair value measurement data from third party pricing services and understands the valuation methods and data sources to validate this information.
The following table presents the Company's marketable securities by major security type (in thousands):
| As of December 31, 2022 | AmortizedCost | UnrealizedGains | UnrealizedLosses | FairValue |
|---|---|---|---|---|
| U.S. treasury securities | $289,807 | $— | $(1,307) | $288,500 |
| Total | $289,807 | $— | $(1,307) | $288,500 |
As of December 31, 2023, there were no marketable securities. All marketable securities held as of December 31, 2022 had effective maturities of less than one year. The unrealized losses for marketable securities related to changes in interest rates. There were no reclassifications out of accumulated other comprehensive income (loss), impairment charges or recoveries and no allowance for credit losses recorded during the twelve months ended December 31, 2023 and 2022.
- Derivatives
The Company uses certain derivative instruments, that are not designated as hedges for accounting purposes, which include foreign currency forward contracts. As of December 31, 2023 and 2022, the Company did not have any outstanding derivative instruments.
- Commitments and Contingencies
Leases
Palo Alto, California Leases
In June 2020, the Company entered into lease agreements fortwo buildings at 1200 and 1250 Page Mill Road in Palo Alto, California, which are now the Company’s U.S. corporate offices. The facilities are approximately 82,662 square feet and 72,812 square feet, respectively and include office and laboratory space. For 1200 Page Mill Road, the monthly rent during the initial 6.5-year term will be approximately $0.6 million, with annual year-over-year increases of 3% plus certain operating expenses and taxes and total rent abatement of approximately $7.2 million. The Company has an option to extend the lease term for a period of 6.5 years. For 1250 Page Mill Road, the monthly rent during the initial 13-year term will be approximately $0.5 million, with annual year-over-year increases of 3% plus certain operating expenses and taxes and total rent abatement of approximately $6.3 million. The Company hastwo options to extend the lease term for a period of 5 years each. The Company determined that the renewal options were not reasonably certain at lease inception for thetwo buildings. The Company executed a $10.9 million cash-collateralized letter of credit, which was subsequently reduced to $6.2 million as a result of meeting certain reduction requirements specified therein in 2020. The cash collateralizing the letter of credit is classified as restricted cash on the Company’s consolidated balance sheet. The Landlord will provide a tenant improvement allowance of approximately $1.2 million for 1200 Page Mill Road and $10.6 million for 1250 Page Mill Road. As of December 31,2023, the Company utilized $10.6 million of the tenant improvement allowance for 1250 Page Mill Road. Under ASC 842, the Company classified these leases as operating leases and recorded right-of-use assets and lease liabilities on the lease commencement date.
Switzerland Lease
In April 2020, the Company entered into a lease agreement for office and laboratory space at Rottenstrasse 5 in Visp, Switzerland. The space is approximately 1,000 square meters. The initial lease term is 5 years, with automatic renewals every 5 years for a maximum lease term of 15 years. The monthly rent during the initial 5-year term will be approximately 32.0 thousand Swiss Francs plus certain operating expenses and taxes. Under ASC 842, the Company classified this lease as an operating lease and recorded a right-of-use asset and lease liability on the lease commencement date.
Ursus Facility
In August 2020, the Company and its wholly owned subsidiary Kodiak Sciences GmbH entered into a manufacturing agreement with Lonza Ltd (“Lonza”) for the clinical and commercial supply of the Company’s antibody biopolymer conjugate drug substance which included a custom-built manufacturing facility. The manufacturing agreement has an initial term of 8 years, and the Company has the right to extend the term up to a total of 16 years. The Company and Lonza each have the ability to terminate this agreement upon the occurrence of certain events.
In April 2021, the agreement was amended to provide for greater manufacturing flexibility, to define a comprehensive mandate as an antibody biopolymer conjugates manufacturing facility to be used for the Company’s antibody biopolymer conjugates pipeline, at clinical as well as commercial scales, across a broad capacity range under the tight quality controls required for ophthalmology and retinal medicines, and to allow for future process and equipment changes as needed.
The Company concluded that this agreement contained an embedded lease as the custom-built manufacturing suite would be dedicated for the Company’s use. On January 31, 2023, the custom-built manufacturing suite was commissioned as a cGMP facility. The consideration was allocated to lease and non-lease components as this agreement contained a significant service component (manufacturing services). Under ASC 842, the Company classified the lease portion as an operating lease and recorded a right-of-use asset and lease liability on the lease commencement date. The Company determined that the renewal options were not reasonably certain at lease inception.
Fixed assets of $81.7 million, in leasehold improvements and machinery and equipment, were placed in service and capitalized as of January 31, 2023. In October 2023, payment was made for the remaining $26.8 million of these fixed assets.
The maturities of the operating lease liabilities, including the Ursus Facility lease, as of December 31,2023 were as follows (in thousands):
| Year ending December 31, | As of December 31, 2023 |
|---|---|
| 2024 | $14,788 |
| 2025 | 16,318 |
| 2026 | 16,567 |
| 2027 | 9,838 |
| 2028 | 8,636 |
| Thereafter | 38,807 |
| Total undiscounted lease payments | 104,954 |
| Less: imputed interest | (23,322) |
| Total operating lease liabilities | $81,632 |
The minimum lease payments above do not include any related common area maintenance charges or real estate taxes. The operating lease expenses for the years ended December 31, 2023, 2022 and 2021 were$13.2 million,$12.8 million and$12.8 million, respectively. Variable lease expenses, including common area maintenance charges and real estate taxes, for the years ended December 31, 2023, 2022 and 2021 were$3.6 million,$3.1 million and$1.7 million, respectively. The weighted-average remaining lease terms and weighted-average discount rates were as follows:
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Weighted-average remaining lease term (in years) | 7.5 | 8.4 |
| Weighted-average discount rate | 6.8% | 6.8% |
Manufacturing Agreements
The Company has entered into service and equipment purchase agreements in the normal course of business with various providers, pursuant to which such providers agreed to perform activities in connection with the manufacturing process of certain materials. These agreements, and any related amendments, state that planned activities and purchases that are included in the signed work orders are, in some cases, binding and, hence, obligate the Company to pay the full price of the work order upon satisfactory delivery of products and services or obligate the Company to the binding amount regardless of whether such planned activities are in fact performed. Per the terms of the agreements, the Company has the option to cancel signed orders at any time upon written notice, which may or may not be subject to payment of a cancellation fee. The level of cancellation fees may be dependent on the timing of the written notice in relation to the commencement date of the work, with the maximum cancellation amount dependent on the agreement or the work order.
As of December 31, 2023, future contractual obligations related to these manufacturing agreements that may be subject to cancellation fees, was$15.4 million. This amount represents our minimal contractual obligations, excluding the commitments under the Ursus Facility arrangement. Purchases under these manufacturing agreements for the years ended December 31, 2023, 2022 and 2021 were$59.7 million,$47.4 million and$31.8 million, respectively.
In addition, future manufacturing contractual obligations totaling approximately 123.0 million Swiss Francs may be incurred for the potential clinical and commercial supply of tarcocimab and other antibody biopolymer conjugates medicines based on the agreements with Lonza for production at the Ursus Facility.
Other Funding Commitments
In the normal course of business, the Company enters into agreements with third-parties for services to be provided to the Company. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The actual amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of services to be provided to the Company.
The Company has also entered into various cancellable license agreements for certain technology. The Company may be obligated to make payments on future sales of specified products associated with such license agreements. Such payments are dependent on future product sales and are not estimable.
From time to time, the Company may become involved in legal proceedings arising from the ordinary course of its business. Management is currently not aware of any matters that could have a material adverse effect on the Company’s financial position, results of operations or cash flows. The Company records a legal liability when it believes that it is both probable that a liability may be imputed, and the amount of the liability can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount.
Indemnification
To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s request in such capacity. The indemnification period covers all pertinent events and occurrences during the director’s or officer’s service. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is not specified in the agreements; however, the Company has director and officer insurance coverage that reduces its exposure and enables the Company to recover a portion of any future amounts paid. The Company believes the estimated fair value of these indemnification agreements in excess of applicable insurance coverage is minimal.
- Income Taxes
The components of loss before income taxes were as follows (in thousands):
| Year Ended December 31, 2023 | Year Ended December 31,2022 | Year Ended December 31,2021 | |
|---|---|---|---|
| United States | $(143,256) | $(163,240) | $(46,590) |
| Foreign | (117,176) | (170,550) | (220,326) |
| Total loss before income taxes | $(260,432) | $(333,790) | $(266,916) |
The provision (benefit) for income taxes consists of the following (in thousands):
| Year Ended December 31, 2023 | Year Ended December 31,2022 | Year Ended December 31,2021 | |
|---|---|---|---|
| Current: | |||
| Federal | $— | $— | $— |
| State | — | — | — |
| Foreign | 33 | 33 | 74 |
| Total current | 33 | 33 | 74 |
| Deferred: | |||
| Federal | — | — | — |
| State | — | — | — |
| Foreign | — | — | — |
| Total deferred | — | — | — |
| Provision (Benefit) for income taxes | $33 | $33 | $74 |
The tax effects of temporary differences that give rise to significant components of the net deferred tax assets are as follows (in thousands):
| December 31, 2023 | December 31,2022 | |
|---|---|---|
| Deferred tax assets: | ||
| Net operating loss carryforwards | $133,919 | $117,232 |
| Intangible assets | 163,841 | 166,259 |
| Research and development tax credits | 29,630 | 25,110 |
| Stock-based compensation | 24,344 | 23,576 |
| Accruals | 1,086 | 1,562 |
| Operating lease liability | 15,845 | 25,548 |
| Sec. 174 Capitalized R&D | 16,992 | 7,914 |
| Total deferred tax assets | 385,657 | 367,201 |
| Valuation allowance | (373,474) | (347,789) |
| Net deferred tax assets | 12,183 | 19,412 |
| Deferred tax liabilities: | ||
| Operating lease right-of-use asset | (10,362) | (17,073) |
| Property and equipment | (1,821) | (2,339) |
| Total deferred tax liabilities | (12,183) | (19,412) |
| Total net deferred tax assets | $— | $— |
The Company has recorded a full valuation allowance against its net deferred tax assets due to the uncertainty as to whether such assets will be realized. The net change in the total valuation allowance for the years ended December 31, 2023 and 2022, was an increase of approximately$25.7 million and$72.0 million, respectively.
The Tax Cuts and Jobs Act eliminated the option to deduct research and development expenditures currently and requires taxpayers to capitalize and amortize them pursuant to Internal Revenue Code Section 174 beginning in 2022. The capitalized expenses are amortized over a 5-year period for domestic expenses and a 15-year period for foreign expenses.
NOLs and tax credit carry-forwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50% as defined under Sections 382 and 383 in the Internal Revenue Code, which could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the Company’s value immediately prior to the ownership change. The Company periodically completes a Section 382 analysis. Subsequent ownership changes since the most recent study may further affect the limitation in future years.
As of December 31, 2023, the Company had$83.8 million of federal and$616.3 million of state net operating loss available to offset future taxable income. A portion of the federal net operating loss carryforwards begin to expire in 2035 and the state net operating loss carryforwards begin to expire in 2035, if not utilized.$65.6 million of the federal net operating loss are not subject to expiration.
As of December 31, 2023, the Company also had federal and state research and development credit carryforwards of approximately$28.9 million and$9.0 million, respectively. The federal research and development credit carryforwards expire beginning 2035. The California tax credit can be carried forward indefinitely.
California Senate Bill 113 (SB 113), was signed into law by Governor Newsom on February 9, 2022. The legislation contains important California tax law changes, including reinstatement of business tax credits and net NOL deductions limited by AB 85 mentioned above. Given the Company’s taxable loss position, this legislation did not impact the tax provision for the years ended December 31, 2023 or 2022.
A reconciliation of the Company’s effective tax rate to the statutory U.S. federal rate is as follows:
| December 31, 2023 | December 31,2022 | December 31,2021 | |
|---|---|---|---|
| Federal statutory income tax rate | 21.0% | 21.0% | 21.0% |
| State taxes | (2.6) | 5.8 | 6.7 |
| Foreign tax rate differential | (4.3) | (4.7) | (7.7) |
| Change in valuation allowance | (10.5) | (20.0) | (78.3) |
| Stock-based compensation | (4.1) | (3.9) | (1.2) |
| Research tax credit | 1.4 | 1.8 | 2.4 |
| Other | (0.1) | — | — |
| Sale of future royalties | — | — | 0.1 |
| Section 162(m) | — | — | (0.8) |
| Intangible valuation | (0.8) | — | 57.8 |
| Provision for income taxes | 0.0% | 0.0% | 0.0% |
The Company recognizes benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. As of December 31, 2023, 2022 and 2021, none of the unrecognized tax benefits would affect income tax expense with consideration of the valuation allowance. The Company does not anticipate the uncertain tax positions will materially change in the next 12 months. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have beenno interest or penalties charged in relation to the unrecognized tax benefits.
The beginning and ending unrecognized tax benefits amounts are as follows (in thousands):
| December 31, 2023 | December 31,2022 | December 31,2021 | |
|---|---|---|---|
| Unrecognized tax benefits at beginning of period | $7,578 | $6,729 | $4,650 |
| Increases related to current year tax positions | 667 | 849 | 2,079 |
| Unrecognized tax benefits at end of period | $8,245 | $7,578 | $6,729 |
The Company files income tax returns in the United States and Switzerland. The Swiss Federal Tax Administration is currently conducting examinations of the Company's tax returns for the years 2018 through 2022. All US tax returns remain open for examination by the federal and state authorities forthree andfour years, respectively, from the date of utilization of any net operating loss or credits.
- Preferred Stock
As of December 31, 2023 and 2022, the Company’s amended and restated certificate of incorporation authorized the Company to issue up to 10,000,000 shares of preferred stock at the par value of $0.0001 per share. As of December 31,2023, there areno shares of the Company’s preferred stock issued or outstanding.
- Common Stock
As of December 31, 2023 and 2022, the Company’s amended and restated certificate of incorporation authorized the Company to issue 490,000,000 shares of common stock at the par value of $0.0001 per share. Each share of common stock is entitled toone vote. The board of directors may declare and pay dividendsto holders of common stock. The Company has never declared or paid any dividends on common stock.
The Company had reserved common stock for future issuances as follows:
| December 31, 2023 | December 31,2022 | |
|---|---|---|
| Exercise of options outstanding and release of restricted shares | 17,766,283 | 16,822,629 |
| Issuance of common stock under the 2018 Equity Incentive Plan | 2,460,375 | 1,934,606 |
| Issuance of common stock under the 2018 Employee Share Purchase Plan | 374,358 | 425,179 |
| Total | 20,601,016 | 19,182,414 |
- Stock-Based Compensation
2018 Equity Incentive Plan
In August 2018, the Company adopted the 2018 Equity Incentive Plan (“2018 Plan”), which became effective on the business day prior to the effectiveness of the registration statement relating to the IPO. The 2018 Plan initially reserved 4,300,000 shares of common stock for the issuance of incentive stock options ("ISOs"), nonstatutory stock options ("NSOs"), restricted stock, restricted stock units (“RSUs”), stock appreciation rights, performance units and performance shares to employees, directors and consultants of the Company. The number of shares available for issuance increases annually on the first day of each fiscal year equal to the least of (1)4,300,000 shares, and (2)4% of outstanding shares of common stock as of the last day of the immediately preceding year, and (3) such other amount as determined by the board of directors. The exercise price of options must be equal to at least the fair market value of the common stock on the grant date. For ISOs, the term may not exceed ten years, except in respect to any participant with more than 10% of voting power of all classes of stock, then the term may not exceed five years and the exercise price must be equal to at least 110% of the fair market value of the common stock on the grant date. Optionsand RSUs granted generally vest over four years.
The number of shares available for issuance increased by 2,093,354 shares in 2023 and there were 2,460,375 shares available for grant under the 2018 Plan as of December 31, 2023.
2021 Long-Term Performance Incentive Plan
The 2021 Long-Term Performance Incentive Plan (“2021 LTPIP”) was designed to be a long-term, pay-for-performance, incentive plan that would further align the interests of management and other eligible employees with the creation of substantial long-term value for the Company's stockholders. During 2021, eligible employees were provided a one-time opportunity to "opt-in" and forgo a portion of their annual equity incentive awards in exchange for a one-time grant of performance-based stock options from the 2021 LTPIP and 2018 Plan, collectively referred to as the "LTPIP Program". There were no options granted under the LTPIP Program for the year ended December 31, 2023.
Shares underlying the options granted under the LTPIP Program may be earned based on the achievement of the performance-based requirement based on stock price goals and/or certain operational milestones based on approval by the U.S. Food and Drug Administration of a Biologics License Application in respect of a first, second, and third major indication and based on sales. The performance-based requirement and operational milestones were not achieved as of December 31, 2023.
The Company determined the exchange of the original award of annual equity incentive awards with the modified award of options granted under the LTPIP Program represented a change in the original terms and conditions. The modification resulted in additional compensation cost equal to the incremental value between the original and modified awards to be recognized. For the annual equity incentive awards, the Company continues to record the unrecognized compensation expense over the original vesting period. For the options granted under the LTPIP Program, the stock-based compensation expense recognized during the years ended December 31, 2023, 2022 and 2021 was$53.7 million,$65.1 million and$15.7 million, respectively.
As of December 31, 2023, there was$165.4 million of unrecognized stock-based compensation expense related to the 6,207,334 options granted under the LTPIP Program, but not yet earned or vested, to be recognized over a weighted-average period of 3.04 years.
Stock Options
Stock option activity, including stock options and performance-based stock options under the 2021 LTPIP, 2018 Plan and 2015 Plan is summarized as follows:
| NumberofOptions | WeightedAverageExercisePrice | WeightedAverageRemainingContractualTerm (in years) | AggregateIntrinsicValue(in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2022 | 16,542,107 | $51.48 | 7.91 | $5,410 |
| Granted | 3,305,000 | $7.09 | ||
| Exercised | (7,528) | $7.96 | ||
| Forfeited or canceled | (2,238,113) | $45.99 | ||
| Outstanding at December 31, 2023 | 17,601,466 | $43.86 | 7.29 | $933 |
| Shares exercisable December 31, 2023 | 9,671,905 | $38.37 | 6.41 | $903 |
| Vested and expected to vest December 31, 2023 | 17,601,466 | $43.86 | 7.29 | $933 |
The weighted-average grant date fair value of the time-vested stock options granted for 2023, 2022 and 2021 was$4.51,$6.31 and$51.55 per share, respectively. The total intrinsic value of stock options exercised during 2023 was not significant. The total intrinsic value of stock options exercised during 2022 and 2021 was$6.1 million and$40.2 million, respectively. The intrinsic value represents the amount by which the market price of the underlying stock exceeds the exercise price of an option.
Employee Stock Options
The Company estimated the fair value of employee stock options using the Black-Scholes valuation model. The fair value of time-vested employee stock options was estimated using the following weighted-average assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Expected volatility | 86% | 83% | 61% |
| Risk-free interest rate | 3.55% | 2.86% | 1.03% |
| Dividend yield | 0% | 0% | 0% |
| Expected term | 4.00 | 5.98 | 6.25 |
The Company granted 3,282,500 options to employees in 2023. The total fair value of employee options vested during the years ended December 31, 2023, 2022 and 2021 was$25.6 million,$28.9 million and$26.9 million, respectively. Stock-based compensation expense recognized during the years ended December 31, 2023, 2022 and 2021 for options granted to employees, including the options granted under the LTPIP Program, was$80.8 million,$93.8 million and$44.1 million, respectively.
Restricted Shares
Restricted share activity, including restricted stock awards, restricted stock units, and performance-based restricted stock units, under the 2018 Plan is summarized as follows:
| Number ofRestrictedShares | WeightedAverageGrant DateFair Value | |
|---|---|---|
| Unvested at December 31, 2022 | 280,522 | $60.17 |
| Granted | 30,250 | $5.72 |
| Vested | (116,403) | $61.98 |
| Canceled | (29,552) | $54.77 |
| Unvested at December 31, 2023 | 164,817 | $49.87 |
Employee Restricted Stock Units
The Company granted 28,750 RSUs to employees in 2023. The total fair value of RSUs vested during the year ended December 31, 2023, 2022, and 2021 was$4.8 million,$4.9 million and$3.2 million, respectively. Stock-based compensation expense recognized during the years ended December 31, 2023, 2022 and 2021 for RSUs was$4.5 million,$4.6 million, and$4.4 million, respectively.
Non-Employee Awards
The Company granted 22,500 stock options and 1,500 RSUs to non-employees during the year ended December 31,2023. The fair value of non-employee stock options was estimated using the following weighted-average assumptions:
| Year Ended December 31, | Year Ended December 31, | Year Ended December 31, | |
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Expected volatility | 88% | — | 60% |
| Risk-free interest rate | 3.82% | — | 0.97% |
| Dividend yield | 0% | — | 0% |
| Expected term | 4.11 | — | 5.69 |
The Company granted no stock options or RSUs to non-employees during the year ended December 31, 2022. Stock-based compensation expense recognized during the years ended December 31, 2023, 2022 and 2021 for equity awards granted to non-employees was$0.9 million,$1.2 million and$1.2 million, respectively.
Performance-Based Awards
In December 2019, the Company granted 170,150 performance-based stock options and 128,900 performance-based RSUs (collectively "2019 PSA"). These equity awards would vest 25% upon the achievement of specific clinical development milestones. The remaining awards would then vest in three equal annual installments after that date. The performance criteria for 2019 PSA was achieved in June 2021.37,925 of the performance-based stock options and 25,907 of the performance-based restricted stock vested during 2023. The total fair value of the performance-based stock options and RSUs vested during the years ended December 31, 2023, 2022 and 2021 was$3.7 million,$3.9 million and$4.2 million, respectively.
The Company estimated the fair value of the 2019 PSA using the Black-Scholes valuation model and significant assumptions included an expected volatility of 72%, a risk-free rate of 1.67%, expected dividend yield of 0%, and expected term of 6.31 years.
In February 2021, the Company granted 190,831 performance-based stock options ("2021 Feb PSO"). These stock options will vest 25% upon the achievement of specific clinical development milestones. The remaining awards would then vest in 36 successive equal monthly installments after the performance criteria is achieved. The performance criteria for 2021 Feb PSOs was achieved in February 2022.40,509 of the performance-based stock options vested during 2023. The total fair value of the performance-based stock options vested during the year ended December 31, 2023 and 2022 was$3.1 million and$6.2 million, respectively.
The Company estimated the fair value of the 2021 Feb PSO using the Black-Scholes valuation model. Significant assumptions utilized in estimating the fair value of 2021 Feb PSO include an expected volatility of 66%, a risk-free rate of 0.66%, expected dividend yield of 0%, and expected term of 5.94 years.
In August 2021, the Company granted 478,750 performance-based stock options ("2021 Aug PSO"). These stock options will vest upon the achievement of specific clinical development milestones with the percentage of shares earned being dependent on the relative total stockholder return over the performance period. As of December 31, 2023, the requisite performance criteria for the 2021 Aug PSO was not achieved and the shares were cancelled and returned to the plan. No stock-based compensation expense was recognized related to these stock options.
Performance-based awards are recorded as expense beginning when vesting events are determined to be probable. Stock-based compensation expense recognized during the years ended December 31, 2023, 2022 and 2021 for the performance-based equity awards was$2.2 million,$6.3 million and$11.4 million, respectively.
2018 Employee Share Purchase Plan
In August 2018, the Company adopted the 2018 Employee Share Purchase Plan (“ESPP”), which became effective on the business day prior to the effectiveness of the registration statement relating to the IPO. A total of 460,000 shares of common stock were initially reserved for issuance under the ESPP. The initial offering period of the ESPP was authorized by the Company’s board of directors and commenced on January 4, 2021. Each offering period is twelve months long, with two purchase periods. ESPP participants will purchase shares of common stock at a price per share equal to 85% of the lesser of (1) the fair market value per share of the common stock on the enrollment date or (2) the fair market value of the common stock on the exercise date.
The Company issued 50,821 shares under the ESPP during the year ended December 31, 2023. Stock-based compensation expense recognized during the year ended December 31, 2023, 2022 and 2021 for the ESPP was$0.2 million,$0.2 million and$0.3 million, respectively.
Stock-Based Compensation Expense
Stock-based compensation is classified in the consolidated statements of operations and comprehensive loss as follows (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Research and development | $44,014 | $59,288 | $33,237 |
| General and administrative | 44,542 | 46,745 | 28,148 |
| Total stock-based compensation | $88,556 | $106,033 | $61,385 |
As of December 31, 2023, the Company had$200.9 million of unrecognized compensation expense related to unvested share-based awards including options granted under the LTPIP Program and ESPP, which is expected to be recognized over a weighted-average period of 2.87 years.
Shares Subject to Repurchase
The Company has a right of repurchase with respect to unvested shares issued upon early exercise of options at an amount equal to the lower of (1) the exercise price of each restricted share being repurchased and (2) the fair market value of such restricted share at the time the Company’s right of repurchase is exercised. The Company’s right to repurchase these shares lapses as those shares vest over the requisite service period.
Shares purchased by employees pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be issued until those shares vest according to their respective vesting schedules. Cash received for early exercised stock options is recorded as accrued liabilities and other current liabilities on the consolidated balance sheet and is reclassified to common stock and additional paid-in capital as such shares vest. At December 31, 2023, there were no early exercised stock options subject to the Company’s right of repurchase.
- Net Loss per Common Share
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders which excludes shares which are legally outstanding, but subject to repurchase by the Company (in thousands, except share and per share data):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Numerator: | |||
| Net loss attributable to common stockholders | $(260,491) | $(333,823) | $(266,990) |
| Denominator: | |||
| Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | 52,414,256 | 52,249,620 | 51,788,918 |
| Net loss per share attributable to common stockholders, basic and diluted | $(4.97) | $(6.39) | $(5.16) |
The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because their inclusion would have been antidilutive:
| As of December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Outstanding stock options | 17,601,466 | 16,542,107 | 14,523,917 |
| Unvested restricted shares | 164,817 | 280,522 | 363,930 |
| Total | 17,766,283 | 16,822,629 | 14,887,847 |
- 401(k) Plan
In 2011, the Company adopted a 401(k)retirement and savings plan covering all employees. The 401(k) plan allows employees to make pre- and post-tax contributions up to the maximum allowable amount set by the Internal Revenue Service. The 401(k) plan was amended to include an employer matching provision in 2019. The Company will make matching contributions of 100% of employee contributions up to a maximum of $10,250. For the years ended December 31,2023, 2022 and 2021, the expense related to the matching contributions was$0.9 million,$0.9 million and$0.7 million, respectively.
- Liability related to Sale of Future Royalties
On December 1, 2019, the Company and its subsidiary Kodiak Sciences GmbH entered into a funding agreement with BBA, which holds more than 5% of the Company’s capital stock, pursuant to which BBA purchased the right to receive a capped 4.5% royalty on future net sales of tarcocimab, the Company’s anti-VEGF antibody biopolymer conjugate therapy, in exchange for $225.0 million. The royalty terminates upon the date that BBA has received an aggregate amount equal to 4.5 times the funding amount paid to the Company, unless earlier terminated or repurchased by the Company. Under the terms of the funding agreement, there is no obligation to repay any funding amount received, other than through the capped royalty payments on future product revenues. The Company has the option, exercisable at any point during the term of the funding agreement, to repurchase 100% of the royalties due to BBA for a purchase price equal to 4.5 times the funding amount paid to the Company as of such time, less amounts paid by the Company to BBA.
The closing of the funding agreement was subject to certain conditions and occurred in February 2020. The Company received $100.0 million of the funding on February 4, 2020. The remaining $125.0 million, subject to delivery of notice by the Company, was payable upon enrollment of 50% of the patients in the RVO clinical program. In July 2021, the funding agreement was amended, at the Company’s request, that the remaining funding amount of $125.0 million would not be paid.
The Company recorded the initial $100.0 million payment as a liability on the consolidated balance sheet net of issuance costs. Once royalty payments to BBA are determined to be probable and estimable, and if such amounts exceed the liability balance, the Company will impute interest to accrete the liability on a prospective basis based on such estimates. If and when the Company makes royalty payments under the funding agreement, it would reduce the liability balance at such time. As of December 31, 2023, royalty payments are not probable and estimable.
For the years ended December 31, 2023, 2022, and 2021, no interest expense was recognized for the liability related to the sale of future royalties.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.