ANAPTYSBIO INC
For the period ended Dec 31, 2024. Filed Feb 27, 2025.
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FY2024 · Filed Feb 27, 2025
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Notes to Consolidated Financial Statements
- Description of the Business
AnaptysBio, Inc. (“we,” “us,” “our,” or the “Company”) was incorporated in the state of Delaware in November 2005. We are a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Our pipeline includes our lead program, rosnilimab, a depleter and agonist targeting PD-1+ T cells, in a Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis (“RA”) and a Phase 2 trial for the treatment of moderate-to-severe ulcerative colitis (“UC”). We also have other antibodies in our portfolio, including ANB033, a CD122 antagonist in a Phase 1 trial and ANB101, a BDCA2 modulator, entering a Phase 1 trial. We have also discovered multiple therapeutic antibodies licensed to GlaxoSmithKline, Inc. (“GSK”) in a financial collaboration for immuno-oncology, including a PD-1 antagonist (Jemperli (dostarlimab-gxly) or “Jemperli”) and a TIM-3 antagonist (cobolimab, GSK4069889). We currently recognize revenue from milestones and royalties achieved under our immuno-oncology collaboration with GSK.
Since our inception, we have devoted our primary effort to research and development activities. Our financial support has been provided primarily from the sale of our common stock, royalty monetizations, as well as through funds received under our collaborative research and development agreements. Going forward, as we continue our expansion, we 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 us on acceptable terms, if at all. If events or circumstances occur such that we do not obtain additional funding, we will most likely be required to reduce our plans and/or certain discretionary spending, which could have a material adverse effect on our ability to achieve our intended business objectives. Our management believes our currently available resources will provide sufficient funds to enable us to meet our operating plans for at least the next 12 months from the issuance of our consolidated financial statements. The accompanying consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Public Offerings
On August 15, 2024, we completed an underwritten public offering selling 2,750,498 shares of common stock, at an offering price of $36.50 per share. The aggregate net proceeds received by us from the offering were $93.9 million, net of underwriting discounts and commissions and offering expenses of $6.5 million, in the aggregate.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Basis of Consolidation
The accompanying consolidated financial statements include us and our wholly owned Australian subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. We operate inone reportable segment, and our functional and reporting currency is the U.S. dollar.
Use of Estimates
The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires our management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. Significant estimates relied upon in preparing these financial statements include estimates related to revenue recognition, accrued research and development expenses, stock-based compensation, and the liability related to the sale of future royalties. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions.
Cash and Cash Equivalents
We consider all highly liquid investments with a maturity at date of purchase of three months or less to be cash equivalents. Cash equivalents consist primarily of money market and mutual funds with original maturities of 90 days or less.
Short-Term and Long-Term Investments
All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Those investments with contractual maturities 12 months or greater at the balance sheet date are considered long-term investments. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold. Unrealized gains and losses are reported as a component of accumulated other comprehensive income (loss). We review our portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss). No credit impairment losses have been recorded during the years ended December 31, 2024, 2023, or 2022.
Concentration of Credit Risk
Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents and certain investments in money market funds, certificates of deposit, agency securities, commercial obligations and U.S. Treasury securities. Bank deposits are diversified between three financial institutions and these deposits may exceed insured limits. We are exposed to credit risk in the event of default by the financial institutions holding our cash and cash equivalents and issuers of investments that are recorded on our consolidated balance sheets. We mitigate our risk by investing in high-grade instruments and limiting the concentration in any one issuer, which limits our exposure.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Expenditures for major additions and betterments are capitalized. Maintenance and repairs are charged to operations as incurred. Depreciation and amortization are calculated using the straight-line method over the estimated useful lives of the assets, which range from three toseven years. Leasehold improvements are amortized using the straight-line method over the term of the lease. Upon sale or retirement of property and equipment, the related cost and accumulated depreciation are removed from the accounts and any gain or loss is reflected in operations.
Long Lived Assets
Long-lived assets, consisting of property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If circumstances require a long-lived asset or asset group to be tested for possible impairment, we first compare undiscounted cash flows expected to be generated by the asset or asset group to its carrying amount. If the carrying amount of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment loss is recognized and is measured as the amount by which the carrying value exceeds the estimated fair value of the assets. No impairment charges were recorded during the years ended December 31, 2024, 2023, or 2022.
Leases
Our leases consist of a lease for office and lab space that is classified as an operating lease. We determine if an arrangement is a lease at inception. Rent expense is recognized on a straight-line basis. When an operating lease includes rent abatements or requires fixed escalations of the minimum lease payments, the aggregate rental expense is recognized on a straight-line basis over the term of the lease. When an operating lease includes lease incentives such as leasehold improvement allowances, the lease incentive is included in ROU asset. For leases that have greater than a 12-month lease term, the ROU assets and lease liabilities are recognized based on the present value of the future minimum unpaid lease payments over the lease term. For this purpose, we consider only payments that are fixed and determinable at the time of commencement.
As our lease does not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. We account for fixed lease components separately from non-lease components.
We elected the practical expedient to not record leases with an initial term of 12 months or less on the balance sheet and recognize the associated lease payments in the consolidated statements of operations on a straight-line basis over the lease term.
Liability Related to the Sale of Future Royalties
We treat the liability related to the sale of future royalties as debt, amortized under the effective interest rate method over the estimated life of the Jemperli Royalty Monetization Agreement and the Zejula Royalty Monetization Agreement. See
Note 5. The amortization of the liability related to the sale of future revenue is based on our current estimates of future royalty payments. Royalty and milestone revenue will be recognized as earned and the payments made will be recorded as a reduction of the liability when paid.
Debt Issuance Costs
Debt issuance costs related to a recognized debt liability are deferred and amortized over the term of the debt using the effective interest method. These costs are recorded as a direct reduction to the carrying value of the debt on the balance sheet and the amortization expense is included in non-cash interest expense in the statement of operations.
Non-Cash Interest Expense on the Liability Related to the Sale of Future Royalties
The total threshold of royalties to be paid, less the net proceeds received will be recorded as non-cash interest expense over the life of the liability. We impute interest on the unamortized portion of the liability using the effective interest method and record expense based on the timing of payments received over the term of the Jemperli Royalty Monetization Agreement and the Zejula Royalty Monetization Agreement. Over the course of the agreement, the actual interest rate will be affected by the timing of royalty and milestone payments made and changes in the forecasted revenue.
Revenue Recognition
Revenue is recognized in accordance with revenue recognition accounting guidance, which utilizes five basic steps to determine whether revenue can be recognized and to what extent: (i) identify the contract with a customer; (ii) identify the performance obligation; (iii) determine the transaction price; (iv) allocate the transaction price; and (v) determine the recognition period.
Performance Obligations. We evaluate deliverables on a contract-by-contract basis to determine whether each deliverable represents a good or service that is distinct or has the same pattern of transfer as other deliverables. A deliverable is considered distinct if the customer can benefit from the good or service independently of other goods/services either in the contract or that can be obtained elsewhere, without regard to contract exclusivity, and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contact. If the deliverable is not considered distinct, we combine such deliverables and account for them as a single performance obligation. We allocate the consideration to each deliverable at the inception of the arrangement based on the stand alone selling price.
Our performance obligations may include the following:
License Arrangements. The performance obligations under our collaboration and license agreements generally include exclusive or nonexclusive licenses to one or more products generated using our technologies. Licenses for multiple antibodies within a single contract are generally combined as they have substantially the same pattern of transfer to the customer. Historically, our licenses have held no value to the customer, as the antibodies were in the discovery phase and required our expertise for further development. Accordingly, licenses are not considered distinct.
Research and Development Services. The performance obligations under our collaboration and license agreements generally include research and development services we perform on behalf of or with our collaborators. As discussed within license arrangements above, our licenses have historically held no value without the research and development services we provide. As we generally only provide research and development services for internally generated antibodies that require a license to be utilized by a third party, our research and development services are not considered distinct.
Steering Committee Meetings. The performance obligations under our collaboration and license agreements may also include our participation on steering committees, which allows us to direct the progression of our discovery programs. As these steering committees would not occur or benefit the customer without the use of our licenses, these are not considered distinct.
We recognize consideration allocated to a performance obligation as the performance obligation is satisfied, and the determination as to whether consideration is recognized over time or at a point in time is made upon contract inception. For our collaboration agreements, this is generally over the period in which research and development services have been performed. There were no new agreements with performance obligations entered into during the year ended December 31, 2024.
Transaction Price. Our collaboration and license agreements generally include both fixed and variable consideration. Fixed payments, such as those for upfront fees are included in the transaction price at contract value, while variable consideration such as reimbursement for research and development services, milestone and royalty payments are estimated and then evaluated for constraints upon inception of the contract and evaluated on a quarterly basis thereafter. Research and development services are updated for actual invoices. Given the nature of our agreements, milestones are estimated using the most likely amount and are evaluated on a quarterly basis. Upon commercialization, royalty payments will be recognized in the period incurred.
Royalty Revenue
We receive royalty revenue on sales by our partners of products covered by patents or contract rights that we own and net sales of their approved drugs, where we have concluded the license is the predominant item to which the royalties relate. We do not have future performance obligations under these license arrangements. We generally satisfy our obligation to grant intellectual property rights on the effective date of the contract. However, we apply the royalty recognition constraint required under the guidance for sales-based royalties, which requires a sales-based royalty to be recorded when the underlying sale occurs. Therefore, royalties on sales of products commercialized by our partners are recognized in the quarter the product is sold. Our partners generally report sales information to us on a quarter lag. Thus, we estimate the expected royalty proceeds based on an analysis of our partners’ historical experience including their publicly announced sales. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. As of December 31, 2024, there have not been material differences between actual and estimated royalty revenues.
Research and development costs primarily include third party clinical and preclinical research and development services such as manufacturing, laboratory and related supplies, salaries and personnel-related costs, in-licensing fees, outside services, and an allocation of information technology, and facility overhead costs.
Costs associated with research and development activities are expensed as incurred. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expense when the service has been performed or when the goods have been received. We estimate research and development costs incurred during the period, which impacts the amount of accrued expenses and prepaid balances related to such costs as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel and service providers to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. The significant estimates in our accrued research and development expenses include the costs incurred for services performed by our vendors in connection with research and development activities for which we have not yet been invoiced.
Upfront and milestone payments incurred under our in-licensing agreements are expensed as research and development in the period in which they are incurred, provided that the technology or method has no alternative future use.
Acquired In-process Research and Development
Acquired in-process research and development costs consist of upfront payments incurred in connection with the acquisition of licensing of products or technologies that do not meet the definition of a business under the Accounting Standards of Codification Topic 805, Business Combinations.
Stock-Based Compensation
We recognize stock-based compensation expense using a fair-value-based method for costs related to all share-based payments, including stock options. Stock-based compensation cost for stock options granted to our employees and directors is measured at the grant date based on the fair-value of the award which is estimated using the Black-Scholes option-pricing model, and is recognized as expense over the requisite service period on a straight-line basis. We recognize forfeitures in the period in which forfeitures occur and record stock-based compensation expense as though all awards are expected to vest.
We record the expense for stock-based compensation awards subject to performance-based milestone vesting over the requisite service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions at each reporting date.
Each Restricted Stock Unit (“RSU”) representsone equivalent share of our common stock to be issued after satisfying the applicable continued service-based vesting criteria over a specified period. The fair value of these RSUs is based on the closing price of our common stock on the date of the grant. We measure compensation expense over the expected vesting period on a straight-line basis.
Each Performance Stock Unit (“PSU”) representsone equivalent share of our common stock to be issued after achievement of the performance metrics specified in the grant. The fair value of our PSUs is estimated as of the grant date, based upon the expected achievement of the performance metrics specified in the grant and the closing market price of our common stock on the date of grant. The grant date fair value is estimated using a Monte Carlo simulation. The compensation expense for the awards is recognized over the requisite service period regardless of whether the market conditions are achieved and will only be adjusted for pre-vesting forfeitures due to the termination of the recipient’s employment with the Company prior to the expiration of the requisite service period.
No tax benefits for stock-based compensation have been recognized in the statements of changes in stockholders’ equity or cash flows. We have not recognized, and do not expect to recognize in the near future, any tax benefit related to stock-based compensation cost as a result of our full valuation allowance on net deferred tax assets and net operating loss carryforwards.
Segment Reporting
ASC Topic 280, Segment Reporting, establishes standards for companies to report financial statement information about operating segments. Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available that is regularly evaluated by the company’s chief operating decision-makers in deciding how to allocate resources and assess performance. Our chief operating decision maker (“CODM”) has been identified as the Chief Executive Officer, who reviews results at a consolidated level only. Therefore, we determined we operate asone reportable segment focused on research and development activities to deliver immunology therapeutics for autoimmune and inflammatory diseases.
Income Taxes
We account for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax basis of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings.
We recognize an uncertain tax position in our consolidated financial statements when we conclude that a tax position is more likely than not to be sustained upon examination based solely on technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. We have elected to accrue any interest or penalties related to income taxes as part of our income tax expense.
Functional Currency of Foreign Operations
Our Australian subsidiary operates in a U.S. dollar functional currency environment. Assets and liabilities of our foreign subsidiary that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets and capital accounts, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Expenses are generally remeasured at monthly foreign currency exchange rates which approximate average rates in effect during each period. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), net, in the consolidated statements of operations.
Comprehensive Income (Loss)
Comprehensive income (loss) represents all changes in stockholders’ equity except those resulting from distributions to stockholders. Our unrealized gain and losses on available for sale investments represent the only component of other comprehensive income (loss) that is excluded from the reported net income (loss).
Net Loss Per Common Share
Basic net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common equivalent shares outstanding for the period, as well as any dilutive effect from outstanding stock options and warrants using the treasury stock method. For each period presented, there is no difference in the number of shares used to calculate basic and diluted net loss per share.
The following table sets forth theweighted-average outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because to do so would be anti-dilutive (in common stock equivalent shares):
| Year EndedDecember 31, | |||
|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2022 |
| Options to purchase common stock | 6,076 | 4,279 | 3,602 |
| Stock awards | 840 | 521 | 375 |
| Total | 6,916 | 4,800 | 3,977 |
Accounting Pronouncements
We have implemented all new accounting pronouncements that are in effect and may have an impact on our consolidated financial statements. Unless otherwise discussed, we believe the impact of any recently issued pronouncements, not yet effective will not have a material impact on our consolidated financial statements.
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit or loss on an annual and interim basis and should be applied retrospectively to all prior periods presented in the financial statements. We adopted this standard retrospectively on December 31, 2024. For the purpose of the adoption of ASU 2023-07, we performed an evaluation of financial information regularly reviewed by the CODM for purposes of evaluating performance and allocating resources. Financial information provided to and used by the CODM is consistent with our consolidated GAAP financial statements including our Consolidated Statements of Operations, see Note 11.
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures Income Taxes, which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning after December 15, 2024. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. We are currently assessing the impact that this standard will have on our consolidated financial statements.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. The new disclosure requirements are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the provisions of this guidance and assessing the potential impact on our financial statement disclosures.
- Balance Sheet Accounts and Supplemental Disclosures
Property and Equipment
Property and equipment consist of the following:
| (in thousands) | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Laboratory equipment | $6,715 | $6,473 |
| Office furniture and equipment | 1,530 | 1,640 |
| Leasehold improvements | 203 | 203 |
| Property and equipment, gross | 8,448 | 8,316 |
| Less: accumulated depreciation and amortization | (6,599) | (6,218) |
| Total property and equipment, net | $1,849 | $2,098 |
Accrued Expenses
Accrued expenses consist of the following:
| (in thousands) | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Accrued compensation and related expenses | $8,449 | $7,201 |
| Accrued professional fees and other expenses | 839 | 1,412 |
| Accrued research, development and manufacturing expenses | 30,213 | 21,898 |
| Accrued for repurchase of common stock | — | 456 |
| Total accrued expenses | $39,501 | $30,967 |
- Collaborative Research and Development Agreements
In March 2014, we entered into a Collaboration and Exclusive License Agreement (the “GSK Agreement”) with TESARO, Inc. (“Tesaro”), an oncology-focused biopharmaceutical company now a part of GSK (Tesaro and GSK are hereinafter referred to, collectively, as “GSK”). Currently, under the GSK Agreement, GSK is developing Jemperli(dostarlimab) as a monotherapy for various solid tumor indications. In addition, GSK is developing dostarlimab in combination with additional therapies under the collaboration, including with another development program from the GSK Agreement: cobolimab, a TIM-3 antibody, in 2L NSCLC. In October 2023, Amendment No. 5 to the GSK Agreement (the “GSK Amendment No. 5”) was agreed by both parties to terminate the LAG-3 antagonist antibody development program under the GSK Agreement. In accordance with the GSK Agreement and the GSK Amendment No. 5, we have regained full global rights to the LAG-3 antagonist antibody development program.
For each remaining development program under the GSK Agreement, we are eligible to receive milestone payments if certain clinical trial events are achieved by GSK, if certain U.S. and European regulatory submissions and approvals in multiple indications are achieved, and upon the achievement of specified levels of annual worldwide net sales. We will also be eligible to receive tiered 4-8% royalties related to worldwide net sales of products developed under the collaboration. On October 23, 2020, Amendment No. 3 to the GSK Agreement (the “GSK Amendment No. 3”) was agreed to by both parties to permit GSK to conduct development and commercialization in combination with any third party molecules of Zejula, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor (“Zejula”). Under GSK Amendment No. 3, we were granted increased royalties upon sales of Jemperli, equal to 8% of Net Sales (as defined in the GSK Agreement) below $1.0 billion,12% of Net Sales between $1.0 billion and $1.5 billion,20% of Net Sales between $1.5 billion and $2.5 billion and 25% of Net Sales above $2.5 billion. Unless earlier terminated by either party upon specified circumstances, the GSK Agreement will terminate, with respect to each specific developed product, upon the later of the 12 th anniversary of the first commercial sale of the product or the expiration of the last to expire of any patent.
We assessed these arrangements in accordance with Accounting Standards Codification 606 and concluded that the contract counterparty, GSK, is a customer. We identified the following material promises under the GSK Agreement: (1) the licenses under certain patent rights and transfer of certain development and regulatory information, (2) research and development (“R&D”) services, and (3) joint steering committee meetings. We considered the research and discovery capabilities of GSK for these specific programs and the fact that the discovery and optimization of these antibodies is proprietary and could not, at the time of contract inception, be provided by other vendors, to conclude that the license does not have stand-alone functionality and is therefore not distinct. Additionally, we determined that the joint steering committee participation would not have been provided without the R&D services and GSK Agreement. Based on these assessments, we identified all services to be interrelated and therefore concluded that the promises should be combined into a single performance obligation at the inception of the arrangement.
As of December 31, 2024, the transaction price for the GSK Agreement and its associated amendments includes the upfront payment, research reimbursement revenue and milestones and royalties earned to date, which are allocated in their entirety to the single performance obligation.
We recognized $51.3 million in royalty revenue during the year ended December 31, 2024 related to GSK’s net sales of Jemperli and Zejula during the period, which we estimate based on either GSK’s prior sales experience or actuals. Of the royalty revenue recognized during the year ended December 31, 2024, $47.4 million is Jemperli non-cash revenue related to the Jemperli Royalty Monetization Agreement (as amended), and $3.9 million is Zejula non-cash revenue related to the Zejula Monetization Agreement, each of such agreements as described in Note 5. We recognized $17.2 million in royalty revenue during the year ended December 31, 2023, related to GSK’s net sales of Jemperli and Zejula during the period based on GSK’s prior sales experience or actuals. Of the royalty revenue recognized during the year ended December 31, 2023, $13.8 million is Jemperli non-cash revenue related to the Jemperli Royalty Monetization Agreement (as amended) and $3.4 million is Zejula non-cash revenue related to the Zejula Royalty Monetization Agreement. We recognized $5.3 million in royalty revenue during the year ended December 31, 2022. Of the royalty revenue recognized during the year ended December 31, 2022, $2.3 million is Jemperli non-cash revenue related to the Jemperli Royalty Monetization Agreement (as amended), $1.6 million is Zejula revenue prior to the to the Zejula Royalty Monetization Agreement and $1.4 million is Zejula non-cash revenue related to the Zejula Royalty Monetization Agreement. GSK reports sales information to us on a one quarter lag and differences between actual and estimated royalty revenues will be adjusted in the following quarter.
Two sales milestones, for a total of $40.0 million, were recognized during the year ended December 31, 2024 when Jemperli annual sales exceeded both the $250.0 million and $500.0 million sales thresholds. These sales milestones are Jemperli non-cash revenue related to the Jemperli Royalty Monetization Agreement (as amended). No milestones were recognized during the year ended December 31, 2023, and we recognizedone clinical milestone for $5.0 million during the year ended December 31, 2022. No other future clinical or regulatory milestones have been included in the transaction price, as all milestone amounts were subject to the revenue constraint. As part of the constraint evaluation, we considered numerous factors including the fact that the receipt of milestones is outside of our control and contingent upon success in future clinical trials, an outcome that is difficult to predict, and GSK’s efforts. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur as they were determined to relate predominantly to the intellectual property license granted to GSK and therefore have also been excluded from the transaction price. We will re-evaluate the variable transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
Milestones under the GSK Agreement are as follows:
| PD-1(Jemperli/Dostarlimab) | TIM-3(GSK4069889/Cobolimab) | |||
|---|---|---|---|---|
| Milestone Event | Amount | Quarter Recognized | Amount | Quarter Recognized |
| Initiated in vivo toxicology studies using good laboratory practices (GLPs) | $1.0M | Q2'15 | $1.0M | Q4'15 |
| IND clearance from the FDA | $4.0M | Q1'16 | $4.0M | Q2'16 |
| Phase 2 clinical trial initiation | $3.0M | Q2'17 | $3.0M | Q4'17 |
| Phase 3 clinical trial initiation - first indication | $5.0M | Q3'18 | $5.0M | Q4'22 |
| Phase 3 clinical trial initiation - second indication | $5.0M | Q2'19 | $5.0M | — |
| Filing of the first BLA(1) - first indication | $10.0M | Q1'20 | $10.0M | — |
| Filing of the first MAA(2) - first indication | $5.0M | Q1'20 | $5.0M | — |
| Filing of the first BLA - second indication | $10.0M | Q1'21 | $10.0M | — |
| First BLA approval - first indication | $20.0M | Q2'21 | $20.0M | — |
| First MAA approval - first indication | $10.0M | Q2'21 | $10.0M | — |
| First BLA approval - second indication | $20.0M | Q3'21 | $20.0M | — |
| Filing of the first MAA - second indication(3) | $5.0M | — | $5.0M | — |
| First MAA approval - second indication(3) | $10.0M | — | $10.0M | — |
| First commercial sales milestone(3) | $15.0M | Q3'24 | $15.0M | — |
| Second commercial sales milestone(3) | $25.0M | Q4'24 | $25.0M | — |
| Third commercial sales milestone(3) | $50.0M | — | $50.0M | — |
| Fourth commercial sales milestone(4) | $75.0M | — | $75.0M | — |
| Milestones recognized through December 31, 2024 | $133.0M | — | $13.0M | — |
| Milestones that may be recognized in the future | $140.0M | — | $260.0M | — |
(1)Biologics License Application (“BLA”)
(2)Marketing Authorization Application (“MAA”)
(3)For Jemperli, the filing and approval of the first MAA for a second indication and first three commercial sales milestones are included as part of the royalty monetization agreement with Sagard (as defined below), see Note 5. Cash is generally received within 30 days of milestone achievement.
(4)For Jemperli, we retained the rights to a $75.0 million sales milestone when Jemperli annual Net Sales exceed $1 billion.
We recognized $91.3 million in revenue under the GSK Agreement during the year ended December 31, 2024, of which $51.3 million was related to royalty revenue and $40.0 million was related to milestone revenue, as there weretwo milestones earned during the year. We recognized $17.2 million in revenue during the year ended December 31, 2023, of which $17.2 million was related to royalty revenue andnone was related to milestone revenue, as there wereno milestones earned during the year. We recognized $10.3 million in revenue during the year ended December 31, 2022, of which $5.3 million was related to royalty revenue and $5.0 million was related toone milestone.
Centessa
On November 24, 2023, we entered into an exclusive license agreement (as amended, the “Centessa Agreement”) with Centessa Pharmaceuticals (UK) Limited (“Centessa”), pursuant to which we acquired the exclusive global development and commercialization rights to a blood dendritic cell antigen 2 (BDCA2) modulator antibody portfolio, including lead asset CBS004 (renamed ANB101), CBS008 (renamed ANB102) and the related family of backup antibodies, for the treatment of autoimmune and inflammatory diseases.
In connection with the Centessa Agreement, we paid Centessa an upfront cash payment of $4.0 million and an additional cash payment of $3.0 million as reimbursement to Centessa for manufacturing costs incurred. There were $0.3 million in transaction costs incurred. The total transaction amount of $7.3 million was expensed as in-process research and development and classified as an operating activity in the statement of cash flows. We accounted for the transaction as an asset acquisition as the set of acquired assets did not constitute a business.
Under the terms of the agreement, Centessa may be entitled to receive potential future payments of up to $10.0 million upon the achievement of a certain event-based milestone and would be entitled to receive on a product-by-product and country-by-country basis, a royalty of low single digits on annual net sales of any product in the territory in each calendar year. As of
December 31, 2024, achievement of the milestone is not probable and, therefore, we have not recognized a liability for the associated $10.0 million contingent consideration.
- Sale of Future Royalties
Jemperli Royalty Monetization Agreement
In October 2021, we signed a royalty monetization agreement (“Jemperli Royalty Monetization Agreement”) with Sagard Healthcare Royalty Partners, LP (“Sagard”). Under the terms of the Jemperli Royalty Monetization Agreement, we received $250.0 million in exchange for royalties and milestones payable to us under our GSK collaboration on annual global net sales of Jemperli.
In May 2024, we entered into an amendment to the Jemperli Royalty Monetization Agreement, Amendment No. 1 (the “Jemperli Amendment”) under which we sold additional receivables to Sagard in exchange for $50.0 million. The Jemperli Amendment includes all Jemperli sales, including any product containing Jemperli, whether or not such product constitutes a combination product, and the threshold amounts of aggregate Jemperli royalties and milestones to be received by Sagard under the Jemperli Amendment is either $600.0 million if received by the end of March 31, 2031, or $675.0 million if received thereafter. Once either of these thresholds are met, the Jemperli Royalty Monetization Agreement and the Jemperli Amendment will expire, resulting in us regaining all subsequent Jemperli royalties and milestones. As of December 31, 2024, Sagard has received a total of $63.8 million in royalties and milestones.
We retained the rights to a $75.0 million sales milestone when Jemperli annual Net Sales exceed $1 billion.
The proceeds received from Sagard of $250.0 million and $50.0 million were recorded as a liability, net of transaction costs of $0.4 million and $0.1 million, which will be amortized over the estimated life of the arrangement using the effective interest rate method. The aggregate future estimated payments, less the $299.5 million, net of proceeds, will be recognized as non-cash interest expense over the life of the agreement. Royalty and milestone revenue will be recognized as earned on net sales of Jemperli, and these payments to Sagard will be recorded as a reduction of the liability when paid. As such payments are made to Sagard, the balance of the liability will be effectively repaid over the life of the Jemperli Royalty Monetization Agreement.
We estimate the effective interest rate used to record non-cash interest expense under the Jemperli Royalty Monetization Agreement based on the estimate of future royalty payments to be received by Sagard. As of December 31, 2024, the estimated effective rate under the agreement was 22.7%. Over the life of the arrangement, the actual effective interest rate will be affected by the amount and the timing of the royalty payments received by Sagard and changes in our forecasted royalties. At each reporting date, we will reassess our estimate of total future royalty payments to be received and if such payments are materially different than our prior estimates, we will prospectively adjust the imputed interest rate and the related amortization of the royalty obligation.
We recognizedtwo sales milestones for a total of $40.0 million during the year ended December 31, 2024, when Jemperli annual sales exceeded both the $250.0 million and $500.0 million thresholds. No milestones were recognized during the years ended December 31, 2023 and 2022.
We recognized Jemperli non-cash royalty revenue of approximately $47.4 million, $13.8 million and $2.3 million during the years ended December 31, 2024, 2023 and 2022, respectively and non-cash interest expense of approximately $49.1 million, $17.1 million and $20.4 million during the years ended December 31, 2024, 2023 and 2022, respectively. The interest and amortization of issuance costs is reflected as non-cash interest expense for the sale of future royalties in the Consolidated Statements of Operations.
The following table shows the activity within the liability account for the year ended December 31, 2024:
| (in thousands) | December 31, 2024 |
|---|---|
| Liability related to sale of future Jemperli royalties and milestones - balance at 12/31/2023 | $278,090 |
| Proceeds from sale of future royalties | 50,000 |
| Issuance costs related to the sale of future royalties | (103) |
| Amortization of issuance costs | 60 |
| Royalty and milestone payments to Sagard | (53,465) |
| Non-cash interest expense recognized(1) | 49,076 |
| Liability related to sale of future royalties and milestones - ending balance | $323,658 |
(1)Of the non-cash interest expense recognized, $3.7 million was capitalized interest for the year ended December 31, 2024.
Zejula Royalty Monetization Agreement
In October 2020, in connection with GSK Amendment No. 3, GSK agreed, under the terms of a settlement agreement (the “GSK Settlement Agreement”), to pay us a royalty of 0.5% on all GSK net sales of Zejula starting January 1, 2021.
In September 2022, we signed a purchase and sale agreement (the “Zejula Royalty Monetization Agreement”) with a wholly owned subsidiary of DRI to monetize all of our future royalties on global net sales of Zejula under the GSK Settlement Agreement. Under the terms of the Zejula Royalty Monetization Agreement, we received $35.0 million in exchange for all royalties payable by GSK to us under the GSK Settlement Agreement on global net sales of Zejula starting in July 2022. In addition, under the Zejula Royalty Monetization Agreement, we are entitled to receive an additional $10.0 million payment from DRI if Zejula is approved by the U.S. Food and Drug Administration for the treatment of endometrial cancer on or prior to December 31, 2025.
The proceeds received from DRI of $35.0 million were recorded as a liability, net of transaction costs of $0.2 million, which will be amortized over the estimated life of the arrangement using the effective interest rate method. Royalty revenue will be recognized as earned on net sales of Zejula, and these royalty payments to DRI will be recorded as a reduction of the liability when paid. The aggregate future estimated payments, less the $34.8 million, of net proceeds, will be recorded as non-cash interest expense over the life of the agreement. As such payments are made to DRI, the balance of the liability will be effectively repaid over the life of the Zejula Royalty Monetization Agreement.
We recognized Zejula non-cash royalty revenue of approximately $3.9 million, $3.4 million and $1.4 million during the years ended December 31, 2024, 2023 and 2022, respectively and non-cash interest expense of approximately $1.0 million, $1.0 million and $0.7 million during the years ended December 31, 2024, 2023 and 2022, respectively. The interest and amortization of issuance costs is reflected as non-cash interest expense for the sale of future royalties in the Consolidated Statements of Operations.
The following table shows the activity within the liability account for the year ended December 31, 2024:
| (in thousands) | December 31, 2024 |
|---|---|
| Liability related to sale of future Zejula royalties and milestones - balance at 12/31/2023 | $32,717 |
| Amortization of issuance costs | 29 |
| Royalty and milestone payments to DRI | (3,900) |
| Non-cash interest expense recognized | 922 |
| Liability related to sale of future royalties and milestones - ending balance | $29,768 |
- Fair Value Measurements and Available for Sale Investments
Fair Value Measurements
Our financial instruments consist principally of cash, cash equivalents, short-term and long-term investments, receivables, and accounts payable. Certain of our financial assets and liabilities have been recorded at fair value in the consolidated balance sheet in accordance with the accounting standards for fair value measurements.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance also establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:
Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 - Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities 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 related assets or liabilities; and
Level 3 - Unobservable inputs that are supported by little or no market activities, therefore requiring an entity to develop its own assumptions.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following table summarizes our assets and liabilities that require fair value measurements on a recurring basis and their respective input levels based on the fair value hierarchy:
| Fair Value Measurements at End of Period Using: | ||||
|---|---|---|---|---|
| (in thousands) | FairValue | Quoted MarketPrices forIdentical Assets(Level 1) | SignificantOther ObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) |
| Money market funds(1) | $104,553 | $104,553 | $— | $— |
| Mutual funds(1) | 9,376 | 9,376 | — | — |
| U.S. Treasury securities(1)(2) | 284,495 | 284,495 | — | — |
| Agency securities(2) | 7,579 | — | 7,579 | — |
| Commercial and corporate obligations(2) | 10,652 | — | 10,652 | — |
| Money market funds(1) | $27,789 | $27,789 | $— | $— |
| Mutual funds(1) | 6,286 | 6,286 | — | — |
| U.S. Treasury securities(2) | 325,714 | 325,714 | — | — |
| Certificates of deposit(2) | 244 | — | 244 | — |
| Agency securities(2) | 20,253 | — | 20,253 | — |
| Commercial and corporate obligations(2) | 35,754 | — | 35,754 | — |
(1) Included in cash and cash equivalents in the accompanying consolidated balance sheets.
(2)Included in short-term or long-term investments in the accompanying consolidated balance sheets depending on the respective maturity date.
The following methods and assumptions were used to estimate the fair value of our financial instruments for which it is practicable to estimate that value:
Marketable Securities. For fair values determined by Level 1 inputs, which utilize quoted prices in active markets for identical assets, the level of judgment required to estimate fair value is relatively low. For fair values determined by Level 2 inputs, which utilize quoted prices in less active markets for similar assets, the level of judgment required to estimate fair value is also considered relatively low.
Fair Value of Other Financial Instruments
The carrying amounts of certain of our financial instruments, including cash and cash equivalents, accounts payable, and accrued expenses approximate fair value due to their short-term nature.
Available for Sale Investments
We invest our excess cash in agency securities, debt instruments of financial institutions and corporations, commercial obligations, and U.S. Treasury securities, which we classify as available-for-sale investments. These investments are carried at fair value and are included in the tables above. The aggregate market value, cost basis, and gross unrealized gains and losses of available-for-sale investments by security type, classified in short-term and long-term investments as of December 31, 2024 are as follows:
| (in thousands) | AmortizedCost | GrossUnrealized Gains | GrossUnrealized Losses | TotalFair Value |
|---|---|---|---|---|
| Agency securities(1) | $7,587 | $— | $(8) | $7,579 |
| Commercial and corporate obligations(2) | 10,642 | 10 | — | 10,652 |
| US Treasury securities(3) | 283,985 | 517 | (7) | 284,495 |
| Total available-for-sale investments | $302,214 | $527 | $(15) | $302,726 |
(1) Of our outstanding agency securities, $7.6 million have maturity dates of less than one year and $0.0 million have a maturity date of betweenone totwo years as of December 31, 2024.
(2) Of our outstanding commercial and corporate obligations, $10.7 million have maturity dates of less than one year and $0.0 million have a maturity date of betweenone totwo years as of December 31, 2024.
(3) Of our outstanding U.S. Treasury securities, $249.0 million have maturity dates of less than one year and $35.5 million have a maturity date of betweenone totwo years as of December 31, 2024.
The aggregate market value, cost basis, and gross unrealized gains and losses of available-for-sale investments by security type, classified in cash equivalents, short-term and long-term investments as of December 31, 2023 are as follows:
| (in thousands) | AmortizedCost | GrossUnrealized Gains | GrossUnrealized Losses | TotalFair Value |
|---|---|---|---|---|
| Agency securities(1) | $20,322 | $— | $(69) | $20,253 |
| Certificates of deposit(2) | 246 | — | (2) | 244 |
| Commercial and corporate obligations(3) | 35,760 | 77 | (83) | 35,754 |
| US Treasury securities(4) | 326,227 | 122 | (635) | 325,714 |
| Total available-for-sale investments | $382,555 | $199 | $(789) | $381,965 |
(1) Of our outstanding agency securities, $20.3 million have maturity dates of less than one year and $0.0 million have a maturity date of betweenone totwo years as of December 31, 2023.
(2) Of our outstanding certificates of deposit, $0.2 million have a maturity date of less than one year and $0.0 million have a maturity date of betweenone totwo years as of December 31, 2023.
(3) Of our outstanding commercial and corporate obligations, $25.8 million have maturity dates of less than one year and $10.0 million have a maturity date of betweenone totwo years as of December 31, 2023.
(4)Of our outstanding U.S. Treasury securities, $308.6 million have maturity dates of less than one year and $17.1 million have a maturity date of betweenone totwo years as of December 31, 2023.
The following tables present gross unrealized losses and fair values for those investments that were in an unrealized loss position as of December 31, 2024 and December 31, 2023, aggregated by investment category and the length of time that individual securities have been in a continuous loss position:
| December 31, 2024 | ||||||
|---|---|---|---|---|---|---|
| Less than 12 Months | 12 Months or Greater | Total | ||||
| (in thousands) | Fair Value | GrossUnrealized Losses | Fair Value | GrossUnrealized Losses | Fair Value | GrossUnrealized Losses |
| Agency securities | $7,579 | $(8) | $— | $— | $7,579 | $(8) |
| US Treasury Securities | 25,250 | (7) | — | — | 25,250 | (7) |
| Total | $32,829 | $(15) | $— | $— | $32,829 | $(15) |
| December 31, 2023 | ||||||
|---|---|---|---|---|---|---|
| Less than 12 Months | 12 Months or Greater | Total | ||||
| (in thousands) | Fair Value | GrossUnrealized Losses | Fair Value | GrossUnrealized Losses | Fair Value | GrossUnrealized Losses |
| Agency securities | $2,530 | $(1) | $17,723 | $(68) | $20,253 | $(69) |
| Certificates of Deposit | — | — | 244 | (2) | 244 | (2) |
| Commercial and corporate obligations | 5,160 | (9) | 15,200 | (74) | 20,360 | (83) |
| US Treasury Securities | 98,840 | (110) | 99,000 | (525) | 197,840 | (635) |
| Total | $106,530 | $(120) | $132,167 | $(669) | $238,697 | $(789) |
As of December 31, 2024 and 2023, unrealized losses on available-for-sale investments were less than $0.1 million and $0.8 million, respectively, withno unrealized losses, on available for sale investments that were in an unrealized loss position for greater than 12 months as of December 31, 2024. We do not intend to sell the investments and it is not more likely than not that we will be required to sell the investments before recovery of their amortized cost basis, accordingly, no allowance for credit losses was recorded.
- Stockholders’ Equity
Common Stock
Of the 500,000,000 shares of common stock authorized,30,473,443 shares were issued and outstanding as of December 31, 2024.
Stock Repurchase Program
In January 2023, our Board of Directors authorized a stock repurchase program (the “Repurchase Program”) to repurchase up to $50.0 million of our outstanding common stock. The Repurchase Program was completed in May 2023. The following table presents the repurchase activity from January 1, 2023 through May 5, 2023, the end date of the Repurchase Program:
| Total number of shares purchased · Average price paid per share · Approximate dollar value of shares purchased(in thousands) | ||||
|---|---|---|---|---|
| First Quarter 2023 | 1,589,424 | $24.19 | $38,456 | |
| Second Quarter 2023 | 534,790 | 21.59 | 11,544 | |
| Total | 2,124,214 | $50,000 | ||
The repurchased common stock was subsequently retired after the repurchase and the par value of the shares was charged to common stock. The excess of the repurchase price over the par value was applied against additional paid in capital.
Open Market Sales Agreement
In November 2024, we entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”), through which we may offer and sell shares of our common stock, having an aggregate offering of up to $100.0 million through TD Cowen as our sales agent. Our prior sales agreement with Cowen terminated upon effectiveness of the registration statement on the Form S-3 we filed in connection with our sales agreement with TD Cowen. As of December 31, 2024, we had soldno shares under this agreement.
Underwriting Agreement
In August 2024, we entered into an underwriting agreement with TD Securities (USA) LLC and Leerink Partners LLC as representatives to the several underwriters listed therein (the “Underwriters”), pursuant to which we issued and sold an aggregate of 2,750,498 shares of our common stock to the Underwriters, at an offering price of $36.50 per share. The net proceeds from these sales were approximately $93.9 million, net of underwriting discounts and commissions and offering expenses of $6.5 million, in the aggregate.
- Equity Incentive Plans
2017 Equity Incentive Plan
In January 2017, our Board of Directors and stockholders approved and adopted the 2017 Equity Incentive Plan (the “2017 Plan”). Under the 2017 Plan, we may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then our employees, officers, directors or consultants. In addition, the number of shares of stock available for issuance under the 2017 Plan were to be automatically increased each January 1, beginning on January 1, 2018, by 4% of the aggregate number of outstanding shares of our common stock as of the immediately preceding December 31 or such lesser number as determined by our Board of Directors. The 2017 Plan automatically increased by 1,063,871 shares as of January 1, 2024. At our annual stockholder meeting on June 12, 2024, the 2017 Plan was amended, eliminating the automatic annual share increase and the number of shares available for issuance was increased by 2,700,000 shares. All future share increases will require stockholder approval. As of December 31, 2024,2,882,340 shares were available for future issuance.
Employee Stock Purchase Plan
In January 2017, our Board of Directors and stockholders approved and adopted the 2017 Employee Stock Purchase Plan (“ESPP”). In addition, the number shares of stock available for issuance under the ESPP will be automatically increased each January 1, beginning on January 1, 2018, by 1% of the aggregate number of outstanding shares of our common stock as of the immediately preceding December 31 or such lesser number as determined by our Board of Directors. The ESPP automatically increased by 265,967 shares as of January 1, 2024. As of December 31, 2024,181,078 shares have been issued under the ESPP. As of December 31, 2024,1,917,729 shares were available for future issuance under the ESPP.
Stock Options
Stock options granted to employees and non-employees generally vest over afour-year period while stock options granted to directors generally vest over aone-year period. Each stock option award has a maximum term of 10 years from the date of grant, subject to earlier cancellation prior to vesting upon cessation of service to us. A summary of the activity related to stock option awards during the year ended December 31, 2024 is as follows:
| SharesSubject toOptions | Weighted-AverageExercisePrice perShare | Weighted-AverageRemainingContractualTerm (in years) | AggregateIntrinsicValue (inthousands) | |
|---|---|---|---|---|
| Outstanding at January 1, 2024 | 4,225,615 | $27.36 | 7.42 | $5,827 |
| Granted | 2,423,788 | $21.81 | ||
| Exercises | (282,210) | $18.96 | ||
| Forfeitures and cancellations | (280,904) | $34.74 | ||
| Outstanding at December 31, 2024 | 6,086,289 | $25.20 | 7.63 | $534 |
| Exercisable at December 31, 2024 | 2,829,196 | $28.60 | 6.32 | $534 |
Total cash received from the exercise of stock options was approximately $5.3 million during the year ended December 31, 2024.
Time-Based Restricted Stock Units
Each Restricted Stock Unit (“RSU”) representsone equivalent share of our common stock to be issued after satisfying the applicable continued service-based vesting criteria over a specified period. The fair value of these RSUs is based on the closing price of our common stock on the date of the grant. We measure compensation expense over the expected vesting period on a straight-line basis. The RSUs do not entitle the participants to the rights of holders of common stock, such as voting rights, until the shares are issued.
| Number of Restricted Stock Units | Weighted-Average Grant Date Fair Value | Weighted-AverageRemainingContractualTerm(in years) | AggregateIntrinsicValue (inthousands) | |
|---|---|---|---|---|
| Outstanding at January 1, 2024 | 1,481,572 | $24.80 | 0.73 | $31,735 |
| Granted | 882,385 | $21.81 | ||
| Released | (1,108,333) | $25.74 | ||
| Forfeitures and cancellations | (27,947) | $25.37 | ||
| Outstanding at December 31, 2024 | 1,227,677 | $21.79 | 1.46 | $16,254 |
| RSU expected to vest at December 31, 2024 | 1,227,677 | $21.79 | 1.46 | $16,254 |
Performance Stock Units
A Performance Stock Unit (“PSU”) representsone equivalent share of our common stock to be issued after achievement of the performance metrics specified in the grant. The fair value of our PSUs is estimated as of the grant date of July 22, 2024, based upon the expected achievement of the performance metrics specified in the grant and the closing market price of our common stock on the date of grant. The grant date fair value is estimated using a Monte Carlo simulation using the following assumptions:
| Twelve months endedDecember 31, | ||
|---|---|---|
| 2024 | ||
| Volatility of common stock | 59.0 | % |
| Risk-free interest rate | 4.1 | % |
| Contract term (in years) | 3.9 | |
The compensation expense for the awards is recognized over the requisite service period regardless of whether the market conditions are achieved and will only be adjusted for pre-vesting forfeitures due to the termination of the recipient’s employment with the Company prior to the expiration of the requisite service period. The requisite service period over which the compensation expense will be recognized is July 22, 2024 through July 1, 2028.
The following table presents a summary of activity with respect to our PSUs:
| Number of Performance Stock Units | Weighted-Average Grant Date Fair Value | Weighted-Average Remaining Contractual Term (in years) | |
|---|---|---|---|
| Outstanding at January 1, 2024 | — | $— | — |
| Granted | 511,000 | $24.69 | |
| Released | — | $— | |
| Forfeitures | (6,500) | $24.69 | |
| Outstanding at December 31, 2024 | 504,500 | $24.69 | 3.52 |
Stock-Based Compensation Expense
We recognize stock-based compensation expense for awards issued to employees and non-employees over the requisite service period based on the estimated grant-date fair value of such awards. We record the expense for stock-based compensation awards subject to performance-based milestone vesting over the requisite service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions at each reporting date. The estimated fair values of stock option awards granted were determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions:
| Year EndedDecember 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Risk-free interest rate | 4.0% | 3.8% | 2.5% |
| Expected volatility | 78.4% | 85.7% | 87.4% |
| Expected dividend yield | —% | —% | —% |
| Expected term (in years) | 6.28 | 5.82 | 6.09 |
| Weighted average grant date fair value per share | $15.54 | $16.06 | $21.58 |
We determine the appropriate risk-free interest rate, expected term for employee stock-based awards, contractual term for non-employee stock-based awards, and volatility assumptions. The weighted-average expected option term for employee and non-employee stock-based awards reflects the historical option term. Expected volatility incorporates the historical volatility of our stock price. The risk-free interest rate is based upon U.S. Treasury securities with remaining terms similar to the expected or contractual term of the stock-based payment awards. The assumed dividend yield is based on our expectation of not paying dividends in the foreseeable future.
Total non-cash stock-based compensation expense for all stock awards that was recognized in the consolidated statements of operations and comprehensive loss is as follows:
| Year EndedDecember 31, | ||||||
|---|---|---|---|---|---|---|
| (in thousands) · 2024 · 2023 · 2022 | ||||||
| Research and development | $14,823 | $10,159 | $6,775 | |||
| General and administrative | 19,225 | (1) | 23,046 | (2) | 20,581 | (3) |
| Total | $34,048 | $33,205 | $27,356 | |||
(1) Includes $2.6 million related totwo year RSU initially issued to our Chief Executive Officer in March 2022 and now fully recognized.
(2)Includes $11.7 million related totwo year RSU initially issued to our Chief Executive Officer in March 2022 and now fully recognized.
(3) Includes $9.2 million related totwo year RSU initially issued to our Chief Executive Officer in March 2022 and now fully recognized.
At December 31, 2024, there was $44.1 million of unrecognized compensation cost related to unvested stock option awards, which is expected to be recognized over a remaining weighted average vesting period of 2.75 years, $20.1 million of unrecognized cost related to unvested RSU awards, which is expected to be recognized over a period of 2.75 years, $11.0 million of unrecognized cost related to unvested PSU awards, which is expected to be recognized over a period of 3.52 years, and $0.4 million of unrecognized compensation cost related to the ESPP, which is expected to be recognized over a remaining weighted-average vesting period of 0.37 years.
- Employee Benefit Plan
We have a defined contribution 401(k) plan available to eligible employees. Employee contributions are voluntary and are determined on an individual basis, limited to the maximum amount allowable under U.S. federal tax regulations. We elected to match 100% of an employee’s contributions up to 10% of the employees’ eligible salary with a maximum limit of $23,000 in 2024,100% of an employee’s contribution up to 10% of the employees’ salary with a maximum limit of $22,500 in 2023, and 100% of an employee’s contribution up to 6% of the employee’s salary with a maximum limit of $11,000 in 2022. For the years ended December 31, 2024, 2023, and 2022, we incurred approximately $2.2 million, $1.6 million, and $1.0 million, respectively of costs related to the 401(k) plan.
- Commitments and Contingencies
Operating Leases
On May 4, 2020, we entered into a lease agreement with Wateridge Property Owner, LP, with respect to facilities in the building at 10770 Wateridge Circle, San Diego, California 92121 (the “Lease Agreement”). Under the Lease Agreement, we agreed to lease approximately 45,000 square feet of space for a term of 124 months, beginning on April 5, 2021. The terms of the Lease Agreement provide us with an option to extend the term of the lease for an additional five years, as well as a one-time option to terminate the lease after seven years with the payment of a termination fee. The exercise of the lease option is at our sole discretion, which we currently do not anticipate exercising and as such was not recognized as part of the right-of-use asset (the “ROU asset”) and lease liability. The monthly base rent was initially $4.20 per rentable square foot and is increased by 3% annually. Under the Lease Agreement, we are also responsible for our pro rata share of real estate taxes, building insurance, maintenance, direct expenses, and utilities. Upon lease commencement, on April 5, 2021, we recognized an ROU asset of $20.6 million, with a corresponding lease liability of $20.7 million on the consolidated balance sheets. The ROU asset includes adjustments for prepayments, initial direct costs, and lease incentives. As of December 31, 2024, we have recorded $0.3 million as a security deposit in accordance with the terms of the Lease Agreement.
Our lease payments are fixed, and we recognize lease expense for leases on a straight-line basis over the lease term. Operating lease ROU assets and lease liabilities are recorded based on the present value of the future minimum lease payments over the lease term at commencement date. As our lease does not provide an implicit rate, we used our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future payments. The weighted-average discount rate used was 4.0% and the weighted-average remaining lease term is approximately 6.7 years.
The following non-cancellable office lease costs are included in our consolidated statements of cash flow (in thousands):
| Year Ended December 31, | ||||
|---|---|---|---|---|
| Leases | Classification on the Cash Flow | 2024 | 2023 | 2022 |
| Operating lease cost | Operating | $2,478 | $2,478 | $2,478 |
| Cash paid for amounts included in the measurement of lease liabilities | Operating | 2,457 | 2,386 | 2,316 |
At December 31, 2024, the future minimum annual obligations for the Company’s operating lease liabilities are as follows:
| Years Ending December 31, (in thousands) | |
|---|---|
| 2025 | $2,531 |
| 2026 | 2,607 |
| 2027 | 2,685 |
| 2028 | 2,766 |
| 2029 | 2,849 |
| Thereafter | 4,939 |
| Total minimum payments required | $18,377 |
| Less: imputed interest | (2,340) |
| Total | $16,037 |
Other Commitments and Contingencies
We have entered into agreements with certain vendors for the provision of goods and services, which includes manufacturing services with contract manufacturing organizations and development services with contract research organizations. These agreements may include certain provisions for purchase obligations and termination obligations that could require payments for the cancellation of committed purchase obligations or for early termination of the agreements. The amount of the cancellation or termination payments vary and are based on the timing of the cancellation or termination and the specific terms of the agreement.
Guarantees and Indemnifications
We enter into standard indemnification arrangements in the ordinary course of business. Pursuant to certain of these arrangements, we indemnify, hold harmless, and agree to reimburse the indemnified parties for losses suffered or incurred by the indemnified party for third party claims in connection with our breach of the agreement, our negligence or willful misconduct in connection with the agreement, or any trade secret, copyright, patent or other intellectual property infringement claim with respect to our technology. The term of these indemnification arrangements is generally perpetual. The maximum potential amount of future payments we could be required to make under these agreements is not determinable because it involves claims that may be made against us in the future, but have not yet been made.
We indemnify our officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving in such capacity, as permitted under Delaware law, in accordance with our certificate of incorporation and bylaws, and pursuant to agreements providing for indemnification entered into with our officers and directors. The term of the indemnification period lasts as long as an officer or director may be subject to any proceeding arising out of acts or omissions of such officer or director in such capacity.
The maximum amount of potential future indemnification of directors and officers is unlimited; however, we currently hold director and officer liability insurance. This insurance allows the transfer of risk associated with our exposure and may enable us to recover a portion of any future amounts paid.
We believe that the fair value of these indemnification obligations is minimal. Accordingly, we have not recognized any liabilities relating to these obligations for any period presented.
- Segment Reporting
We operate asone reportable segment focused on research and development activities to deliver immunology therapeutics for autoimmune and inflammatory diseases. Segment profit or loss is measured as the net loss reported on our Consolidated Statements of Operations and Comprehensive Loss and net loss is used to monitor results. Our segment revenue consists of non-cash royalties and milestones, and is derived from collaboration agreements, see Note 4. The measure of segment assets is reported on our Consolidated Balance Sheets as total assets.
The CODM is our Chief Executive Officer. The CODM manages the business activities on a consolidated basis in making decisions regarding resource allocation and performance assessment.
The following table is a summary of segment revenue, loss and our significant expenses (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Collaboration revenue | $91,280 | $17,157 | $10,287 |
| Operating expenses: | |||
| External R&D | |||
| Rosnilimab | 53,422 | 25,010 | 7,794 |
| ANB032 | 26,084 | 17,197 | 3,866 |
| ANB033 | 12,460 | 11,520 | 1,706 |
| ANB101 | 3,367 | — | — |
| Imsidolimab | 8,284 | 31,769 | 38,812 |
| Preclinical and other unallocated costs | 14,350 | 14,526 | 11,838 |
| Total External R&D(1) | 117,967 | 100,022 | 64,016 |
| Total Internal R&D(2) | 45,873 | 32,261 | 24,782 |
| Total R&D | 163,840 | 132,283 | 88,798 |
| Acquired in-process research and development | — | 7,339 | — |
| External G&A(3) | 10,033 | 8,294 | 7,285 |
| Internal G&A(1) | 32,356 | 33,652 | 29,358 |
| Total G&A | 42,389 | 41,946 | 36,643 |
| Total operating expenses | 206,229 | 181,568 | 125,441 |
| Loss from operations | (114,949) | (164,411) | (115,154) |
| Interest income | 19,794 | 18,873 | 7,550 |
| Non-cash interest expense | (50,087) | (18,083) | (21,108) |
| Other income (expense), net | 14 | (2) | 12 |
| Total other (expense) income, net | (30,279) | 788 | (13,546) |
| Loss before income taxes | (145,228) | (163,623) | (128,700) |
| (Provision) Benefit for income taxes | (3) | 4 | (24) |
| Segment net loss | (145,231) | (163,619) | (128,724) |
(1) External R&D consists of costs associated with our research and development activities, including drug discovery efforts, preclinical and clinical development of our programs, manufacturing, and allocated facility-related costs.
(2) Internal R&D and G&A consist of salaries and wages, stock-based compensation, recruiting and other employee benefits.
(3) External G&A consists of general and administrative expenses including legal services, insurance, professional fees for auditing, tax, and market research, and allocated facility-related costs not otherwise included in research and development expenses.
- Income Taxes
The components of loss before income tax provision consist of the following:
| Year Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2022 |
| U.S. | $(145,367) | $(163,580) | $(128,650) |
| Foreign | 139 | (43) | (50) |
| Consolidated net loss before income taxes | $(145,228) | $(163,623) | $(128,700) |
For the years ended December 31, 2024, 2023 and 2022, we recognized income tax provision of $3,000, income tax benefit of $4,000, and income tax provision of $24,000 respectively, related to state income taxes.
Significant components of our deferred tax assets and liabilities are as follows:
| December 31, | ||
|---|---|---|
| (in thousands) | 2024 | 2023 |
| Deferred Tax Assets: | ||
| Net operating loss carryforwards | $70,724 | $72,777 |
| Section 174 Capitalized R&D | 61,029 | 37,240 |
| Research and development credits | 26,102 | 19,058 |
| Equity compensation | 13,000 | 10,533 |
| Deferred Zejula royalty revenue | 6,363 | 6,978 |
| Lease liability | 3,540 | 3,912 |
| Other, net | 12,774 | 7,201 |
| Total deferred tax assets | 193,532 | 157,699 |
| Deferred Tax Liabilities: | ||
| ROU asset | (3,175) | (3,552) |
| Other, net | (3,009) | (2,658) |
| Fixed assets | (163) | (122) |
| Total deferred tax liabilities | (6,347) | (6,332) |
| Net deferred tax assets | 187,185 | 151,367 |
| Less: valuation allowance | (187,185) | (151,367) |
| Deferred tax assets, net of valuation allowance | $— | $— |
We have recorded a full valuation allowance against our net deferred tax assets due to the uncertainty surrounding the realization of such assets. Management has determined it more likely than not that the deferred tax assets are not realizable due to our historical loss position.
As of December 31, 2024, we had federal and state net operating loss carryforwards (“NOLs”), of $300.7 million and $73.0 million, respectively. The federal and state NOLs generated prior to 2018 will begin to expire in 2031 and 2028, respectively, unless previously utilized. The federal NOL includes $262.0 million of net operating losses generated in 2018 and after. Federal net operating losses generated in 2018 and after carryover indefinitely and may generally be used to offset up to 80% of future taxable income. As of December 31, 2024, we had federal and state research tax credit carryforwards of approximately $18.6 million and $17.4 million, respectively. The federal research tax credit carryforwards will begin to expire in 2041 and the state research tax credits carryforward indefinitely. We also have foreign tax losses of $2.8 million, which will carry forward indefinitely, subject to a continuity of ownership test.
The above NOL carryforward and the federal and state research credit carryforwards may be subject to limitation under section 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state provisions if we experience one or more ownership changes which would limit the amount of NOL and tax credit carryforwards that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change as defined by Section 382 and 383, results from transactions increasing ownership of certain stockholders or public groups in the stock of the corporation by more than 50 percentage points over a three-year period.
We experienced ownership changes as defined by Section 382 of the Code during 2007, 2017 and 2021. As a result, as of December 31, 2024, there are $114.6 million of federal NOLs available to offset taxable income in future years without
Section 382 limitation, while $186.1 million of federal NOLs are subject to annual limitations over future periods. State NOL and credit carryforwards may be similarly limited.
Our use of federal and state NOLs and research credits could be further limited if we experience one or more ownership changes subsequent to December 31, 2024. If a change in ownership occurs, NOLs and tax credit carryforwards could be eliminated or restricted. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by ownership changes, if any, will not impact our effective tax rate.
The following is a reconciliation of the expected statutory federal income tax provision to our actual income tax provision:
| Year Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2022 |
| Expected income tax benefit at federal statutory tax rate | $(30,498) | $(34,361) | $(27,026) |
| State income taxes, net of federal benefit | (1,699) | (1,912) | (800) |
| Permanent items | 82 | 56 | 27 |
| Equity compensation | 804 | 2,840 | (297) |
| Non-deductible compensation | 2,188 | 3,693 | 2,060 |
| Research credits | (7,057) | (6,213) | (3,319) |
| Other | 35 | 109 | (6) |
| Change in the valuation allowance | 36,148 | 35,784 | 29,385 |
| Income tax expense (benefit) | $3 | $(4) | $24 |
We recognize a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet a more likely than not recognition at the effective date to be recognized. As of December 31, 2024 and 2023, we hadno unrecognized tax benefits that, if recognized and realized, would affect the effective tax rate due to the valuation allowance against deferred tax assets. The following table summarizes the activity related to our unrecognized tax benefits:
| Year Ended December 31, | ||
|---|---|---|
| (in thousands) | 2024 | 2023 |
| Balance at the beginning of the year | $5,016 | $3,369 |
| (Decrease) increase related to prior year tax positions | (4) | 153 |
| Increase related to current year tax positions | 1,899 | 1,494 |
| Balance at the end of the year | $6,911 | $5,016 |
If recognized, these amounts would not affect our effective tax rate, since they would be offset by an equal corresponding adjustment in the deferred tax asset valuation allowance. We do not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months.
Our policy is to recognize interest and penalties related to income tax matters in the provision for income taxes. As of December 31, 2024 and 2023, there wereno interest or penalties on uncertain tax benefits.
We file income tax returns in the United States, California, various U.S. state jurisdictions and Australia. Due to our losses incurred, we are essentially subject to income tax examination by tax authorities from inception to date.
- Subsequent Event
Exclusive License Agreement
On January 31, 2025, we entered into an Exclusive License Agreement (the “License Agreement”) with Vanda Pharmaceuticals Inc. (“Vanda”) pursuant to which we granted to Vandaan exclusive, global license for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP).
Pursuant to the terms of the License Agreement, we received an upfront payment of $10.0 million and a $5.0 million payment for existing drug supply. Anaptys is also eligible to receive up to $35.0 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.