Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Denali Therapeutics Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share amounts)
June 30, 2024 December 31, 2023
Assets
Current assets:
Cash and cash equivalents $ 74,679 $ 127,106
Short-term marketable securities 821,365 907,405
Prepaid expenses and other current assets 32,339 29,626
Total current assets 928,383 1,064,137
Long-term marketable securities 450,994 —
Property and equipment, net 48,077 45,589
Operating lease right-of-use asset 24,533 26,048
Other non-current assets 50,578 18,143
Total assets $ 1,502,565 $ 1,153,917
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 13,936 $ 9,483
Accrued clinical and other research & development costs 19,915 19,035
Accrued manufacturing costs 7,111 15,462
Other accrued costs and current liabilities 6,013 5,152
Accrued compensation 9,555 21,590
Operating lease liability, current 7,771 7,260
Deferred research funding liability 10,232 —
Total current liabilities 74,533 77,982
Operating lease liability, less current portion 40,981 44,981
Total liabilities 115,514 122,963
Commitments and contingencies (Note 6)
Stockholders' equity:
Convertible preferred stock, $ 0.01 par value; 40,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023
— —
Common stock, $ 0.01 par value; 400,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 143,123,582 shares and 138,385,498 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively
1,757 1,711
Additional paid-in capital 2,704,992 2,144,811
Accumulated other comprehensive income (loss) ( 2,659 ) 643
Accumulated deficit ( 1,317,039 ) ( 1,116,211 )
Total stockholders' equity 1,387,051 1,030,954
Total liabilities and stockholders’ equity $ 1,502,565 $ 1,153,917
See accompanying notes to unaudited condensed consolidated financial statements.
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Denali Therapeutics Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2024 2023 2024 2023
Collaboration revenue:
Collaboration revenue from customers (1)
$ — $ 294,123 $ — $ 329,264
Total collaboration revenue — 294,123 — 329,264
Operating expenses:
Research and development (2)
91,399 97,520 198,415 226,336
General and administrative 25,194 26,120 50,430 53,260
Total operating expenses 116,593 123,640 248,845 279,596
Gain from divestiture of small molecule programs — — 14,537 —
Income (loss) from operations ( 116,593 ) 170,483 ( 234,308 ) 49,668
Interest and other income, net 17,567 12,900 33,480 23,934
Net income (loss) ( 99,026 ) 183,383 ( 200,828 ) 73,602
Other comprehensive income (loss):
Net unrealized gain (loss) on marketable securities, net of tax ( 1,363 ) 1,076 ( 3,302 ) 5,445
Comprehensive income (loss) $ ( 100,389 ) $ 184,459 $ ( 204,130 ) $ 79,047
Net income (loss) per share:
Net income (loss) per share, basic $ ( 0.59 ) $ 1.34 $ ( 1.26 ) $ 0.54
Net income (loss) per share, diluted $ ( 0.59 ) $ 1.30 $ ( 1.26 ) $ 0.52
Weighted-average shares used in calculating:
Weighted average number of shares outstanding, basic 168,831,329 137,047,227 159,117,759 136,787,321
Weighted average number of shares outstanding, diluted 168,831,329 140,930,625 159,117,759 140,550,226
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(1) Includes related-party collaboration revenue from customers of $ 294.1 million and $ 294.3 million for the three and six months ended June 30, 2023, respectively.
(2) Includes expenses for cost sharing payments due to a related party of $ 7.0 million and $ 11.1 million for the three and six months ended June 30, 2023, respectively.
See accompanying notes to unaudited condensed consolidated financial statements.
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Denali Therapeutics Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
(In thousands, except share amounts)
Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss
Accumulated Deficit Total Stockholders' Equity
Shares Amount
Balance at December 31, 2023 138,385,498 $ 1,711 $ 2,144,811 $ 643 $ ( 1,116,211 ) $ 1,030,954
Issuance of common stock and pre-funded warrants, net of issuance costs of $ 480 K
3,244,689 32 499,221 — — 499,253
Issuances under equity incentive plans 657,522 7 7,771 — — 7,778
Vesting of restricted stock units 835,873 7 ( 7 ) — — —
Stock-based compensation — — 53,196 — — 53,196
Net loss — — — — ( 200,828 ) ( 200,828 )
Other comprehensive loss — — — ( 3,302 ) — ( 3,302 )
Balance at June 30, 2024 143,123,582 $ 1,757 $ 2,704,992 $ ( 2,659 ) $ ( 1,317,039 ) $ 1,387,051
Balance at March 31, 2024 142,512,856 $ 1,751 $ 2,673,033 $ ( 1,296 ) $ ( 1,218,013 ) $ 1,455,475
Issuances under equity incentive plans 527,308 5 6,750 — — 6,755
Vesting of restricted stock units 83,418 1 ( 1 ) — — —
Stock-based compensation — — 25,210 — — 25,210
Net loss — — — — ( 99,026 ) ( 99,026 )
Other comprehensive loss — — — ( 1,363 ) — ( 1,363 )
Balance at June 30, 2024 143,123,582 $ 1,757 $ 2,704,992 $ ( 2,659 ) $ ( 1,317,039 ) $ 1,387,051
Balance at December 31, 2022 135,965,918 $ 1,686 $ 2,018,617 $ ( 6,886 ) $ ( 970,987 ) $ 1,042,430
Issuances under equity incentive plans 730,887 7 10,616 — — 10,623
Vesting of restricted stock units 665,883 7 ( 7 ) — — —
Stock-based compensation — — 54,725 — — 54,725
Net income — — — — 73,602 73,602
Other comprehensive income
— — — 5,445 — 5,445
Balance at June 30, 2023 137,362,688 $ 1,700 $ 2,083,951 $ ( 1,441 ) $ ( 897,385 ) $ 1,186,825
Balance at March 31, 2023 136,741,627 $ 1,694 $ 2,048,297 $ ( 2,517 ) $ ( 1,080,768 ) $ 966,706
Issuances under equity incentive plans
526,579 5 9,014 — — 9,019
Vesting of restricted stock units 94,482 1 ( 1 ) — — —
Stock-based compensation
— — 26,641 — — 26,641
Net income — — — — 183,383 183,383
Other comprehensive income — — — 1,076 — 1,076
Balance at June 30, 2023 137,362,688 $ 1,700 $ 2,083,951 $ ( 1,441 ) $ ( 897,385 ) $ 1,186,825
See accompanying notes to unaudited condensed consolidated financial statements.
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Denali Therapeutics Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
Six Months Ended
June 30,
2024 2023
Operating activities
Net income (loss) $ ( 200,828 ) $ 73,602
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 4,104 12,332
Stock–based compensation expense 52,940 54,654
Net accretion of discounts on marketable securities ( 20,574 ) ( 19,386 )
Non-cash adjustment to operating lease expense ( 1,976 ) ( 1,805 )
Non-cash gain from divestiture of small molecule programs ( 14,537 ) —
Changes in operating assets and liabilities:
Prepaid expenses and other assets ( 20,336 ) 1,823
Accounts payable 4,523 8,472
Accruals and other current liabilities ( 8,156 ) ( 12,399 )
Related-party contract liability — ( 289,264 )
Net cash used in operating activities ( 204,840 ) ( 171,971 )
Investing activities
Purchases of marketable securities ( 955,802 ) ( 901,841 )
Purchases of property and equipment ( 6,936 ) ( 8,636 )
Maturities and sales of marketable securities 608,120 985,829
Net cash (used in) provided by investing activities ( 354,618 ) 75,352
Financing activities
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs of $ 480 K
499,253 —
Proceeds from exercise of awards under equity incentive plans 7,778 10,623
Net cash provided by financing activities 507,031 10,623
Net decrease in cash, cash equivalents and restricted cash ( 52,427 ) ( 85,996 )
Cash, cash equivalents and restricted cash at beginning of period 128,681 219,544
Cash, cash equivalents and restricted cash at end of period $ 76,254 $ 133,548
Supplemental disclosures of cash flow information
Cash paid during the period for income taxes $ — $ 4
Equity consideration received in the divestiture of small molecule programs (Note 10) $ 15,000 $ —
Property and equipment purchases accrued but not yet paid $ 228 $ 575
See accompanying notes to unaudited condensed consolidated financial statements.
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Denali Therapeutics Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Significant Accounting Policies
Organization and Description of Business
Denali Therapeutics Inc. ("Denali" or the “Company”) is a biopharmaceutical company, incorporated in Delaware, that discovers and develops therapeutics to defeat neurodegenerative diseases and lysosomal storage diseases. The Company is headquartered in South San Francisco, California.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission ("SEC") Regulation S-X for interim financial information.
These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 28, 2024 (the "2023 Annual Report on Form 10-K"). The Condensed Consolidated Balance Sheet as of December 31, 2023 was derived from the audited annual consolidated financial statements as of and for the period then ended. Certain information and footnote disclosures typically included in the Company's annual consolidated financial statements have been condensed or omitted. The accompanying unaudited condensed consolidated financial statements reflect all adjustments that, in the opinion of management, are necessary for a fair statement of the results of the interim periods presented. All such adjustments are of a normal recurring nature except for the impacts of adopting new accounting standards, if any, discussed below. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.
During the six months ended June 30, 2024 there were no material changes to the Company's significant accounting and financial reporting policies from those reflected in the 2023 Annual Report on Form 10-K. For further information with regard to the Company’s Significant Accounting Policies, please refer to Note 1, "Significant Accounting Policies," to the Company’s Consolidated Financial Statements included in the 2023 Annual Report on Form 10-K.
Principles of Consolidation
These unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiaries, the functional currency has been determined to be U.S. dollars. Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates, non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates, and transactions in foreign currencies are remeasured at average exchange rates. Foreign currency gains and losses resulting from remeasurement are recognized in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss).
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Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates, and such differences could be material to the Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Operations and Comprehensive Income (Loss).
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and marketable securities. Substantially all of the Company’s cash and cash equivalents are deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits have and will continue to exceed federally insured limits. The Company maintains its cash with accredited financial institutions and accordingly, such funds are subject to minimal credit risk.
The Company’s investment policy limits investments to certain types of securities issued by the U.S. government and its agencies, as well as institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of marketable securities to the extent recorded on the Condensed Consolidated Balance Sheets. As of June 30, 2024 and December 31, 2023, the Company had no off-balance sheet concentrations of credit risk.
The Company is subject to a number of risks similar to other clinical-stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements with third parties. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Further, the company is also subject to broad market risks and uncertainties resulting from recent events, such as bank failures or instability in the financial services sector, global pandemics, war and armed conflicts, inflation, rising interest rates, and recession risks as well as supply chain and labor shortages.
Segments
The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources.
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Investments
Investments in equity securities may be accounted for using (i) the fair value option, if elected, (ii) fair value through earnings if fair value is readily determinable or (iii) for equity investments without readily determinable fair values, the measurement alternative to measure at cost adjusted for any impairment and observable price changes, as applicable. The election to use the measurement alternative is made for each eligible investment.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents are reported at fair value.
Cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Statements of Cash Flows is composed of cash and cash equivalents reported in the Condensed Consolidated Balance Sheets and $ 1.6 million of restricted cash for the letter of credit for the Company’s headquarters building lease which is included within other non-current assets in the Condensed Consolidated Balance Sheets.
Marketable Securities
The Company generally invests its excess cash in money market funds and investment grade short to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents, or short-term marketable securities on the Condensed Consolidated Balance Sheets, are considered available-for-sale, and are reported at fair value with net unrealized gains and losses included as a component of stockholders’ equity.
The Company classifies investments in securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. The Company classifies investments in securities with remaining maturities of over one year as long-term investments, unless intended to fund current operations. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss). Realized gains and losses and declines in value determined to be due to credit losses on marketable securities, if any, are included in interest and other income, net.
The Company periodically evaluates the need for an allowance for credit losses. This evaluation includes consideration of several qualitative and quantitative factors, including whether it has plans to sell the security, whether it is more likely than not it will be required to sell any marketable securities before recovery of its amortized cost basis, and if the entity has the ability and intent to hold the security to maturity, and the portion of any unrealized loss that is the result of a credit loss. Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company's strategy and intentions for holding the marketable security.
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Accounts Receivable
Accounts receivable are included within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets. The accounts receivable balance represents amounts receivable from the Company's collaboration partners net of an allowance for credit losses, if required.
Leases
The Company leases real estate and certain equipment for use in its operations. A determination is made as to whether an arrangement is a lease at inception. Right-of-use (“ROU”) assets and operating lease liabilities are recognized for identified operating leases in the Condensed Consolidated Balance Sheets. The changes in operating lease ROU assets and operating lease liabilities are presented net within non-cash adjustment to operating lease expense in the Condensed Consolidated Statements of Cash Flows.
ROU assets represent the Company’s right to use the underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments due over the lease term, with the ROU assets adjusted for lease incentives received. When determining the present value of lease payments, the Company uses its incremental borrowing rate on the date of lease commencement, or the rate implicit in the lease, if known. The Company does not assume renewals in its determination of the lease term unless the renewals are deemed by management to be reasonably certain at lease inception.
Leases with an initial term of twelve months or less are not recorded on the balance sheet, unless they include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes lease expenses on a straight-line basis over the lease term. The Company has leases with lease and non-lease components, which the Company has elected to account for as a single lease component.
Revenue Recognition
License, Option and Collaboration Revenue
The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606. The accounting treatment pursuant to Topic 606 is outlined below.
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The terms of license, option and collaboration agreements entered into typically include payment of one or more of the following: non-refundable, up-front license fees; option exercise fees; development, regulatory and commercial milestone payments; payments for manufacturing supply and research and development services and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenue. The core principle of Topic 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. The Company may also receive reimbursement or make payments to a collaboration partner to satisfy cost sharing requirements. These payments are accounted for pursuant to ASC 808 and are recorded as an offset or increase to research and development expenses, respectively.
In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s Condensed Consolidated Balance Sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to the Company having an unconditional right (other than a right that is conditioned only on the passage of time) to receipt are recorded as contract assets in the Company's Condensed Consolidated Balance Sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer.
At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the promised good or service does not provide the customer with a material right.
The Company considers the terms of the contract to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices ("SSP"). The relative SSP for each deliverable is estimated using external sourced evidence if it is available. If external sourced evidence is not available, the Company uses its best estimate of the SSP for the deliverable.
Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer.
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After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception, or to a single performance obligation as applicable. The Company accounts for the exercise of a material right as either a contract modification or as a continuation of the existing contract, as is most appropriate based on the facts and circumstances.
Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the SSP of identified performance obligations, which may include forecasted revenue, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations.
Comprehensive Income (Loss)
Comprehensive income (loss) is composed of net income (loss) and certain changes in stockholders’ equity that are excluded from net income (loss), primarily unrealized gains or losses on the Company’s marketable securities.
Net Income (Loss) Per Share
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents.
Diluted net income (loss) per share is computed based on the treasury stock method by dividing net income by the combined weighted-average number of common shares outstanding during the period and potentially dilutive common equivalent shares outstanding. However, where there is a net loss per share, no adjustment is made for potentially issuable shares since their effect would be anti-dilutive. In this case, diluted net loss per share is equal to basic net loss per share. The weighted-average common shares outstanding as of June 30, 2024 includes pre-funded warrants to purchase shares of common stock that were issued in connection with the February 2024 private placement, as discussed further in Note 7 - " Common Stock ".
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which is intended to improve reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments in this Update are effective for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The guidance is to be applied retrospectively to all prior periods presented in the financial statements. The Company has not early adopted this update, and is currently evaluating the impact of the new standard on its consolidated financial statements and related disclosures.
In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires that an entity, on an annual basis, disclose additional income tax information, primarily related to the rate reconciliation and income taxes paid. The amendments in this Update are effective to be applied prospectively for annual periods beginning after December 15, 2024, with early adoption permitted. The Company has not early adopted this update, and is currently evaluating the impact of the new standard on its income tax disclosures.
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2. Fair Value Measurements
Assets and liabilities measured at fair value at each balance sheet date are as follows (in thousands):
June 30, 2024
Level 1 Level 2 Level 3 Total
Assets:
Cash equivalents:
Money market funds $ 53,306 $ — $ — $ 53,306
Short-term marketable securities:
U.S. government treasuries 775,814 — — 775,814
Corporate debt securities — 10,172 — 10,172
Commercial paper — 35,379 — 35,379
Long-term marketable securities:
U.S. government treasuries 421,941 — — 421,941
Corporate debt securities — 29,053 — 29,053
Total $ 1,251,061 $ 74,604 $ — $ 1,325,665
December 31, 2023
Level 1 Level 2 Level 3 Total
Assets:
Cash equivalents:
Money market funds $ 121,034 $ — $ — $ 121,034
Short-term marketable securities:
U.S. government treasuries 869,172 — — 869,172
U.S. government agency securities — 7,086 — 7,086
Commercial paper — 31,147 — 31,147
Total $ 990,206 $ 38,233 $ — $ 1,028,439
The Company’s Level 2 securities are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly.
The Company has not transferred any assets or liabilities between the fair value measurement levels for the six months ended June 30, 2024 or 2023.
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3. Marketable Securities
All marketable securities were considered available-for-sale at June 30, 2024 and December 31, 2023. On a recurring basis, the Company records its marketable securities at fair value using Level 1 or Level 2 inputs as discussed in Note 2, "Fair Value Measurements". The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):
June 30, 2024
Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value
Short-term marketable securities:
U.S. government treasuries (1)
$ 776,793 $ — $ ( 979 ) $ 775,814
Corporate debt securities (2)
10,184 — ( 12 ) 10,172
Commercial paper
35,379 — — 35,379
Total short-term marketable securities
822,356 — ( 991 ) 821,365
Long-term marketable securities:
U.S. government treasuries (3)
423,194 7 ( 1,260 ) 421,941
Corporate debt securities (4)
29,117 — ( 64 ) 29,053
Total long-term marketable securities
452,311 7 ( 1,324 ) 450,994
Total
$ 1,274,667 $ 7 $ ( 2,315 ) $ 1,272,359
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(1) Unrealized holding losses on 26 securities with an aggregate fair value of $ 755.9 million.
(2) Unrealized holding losses on 2 securities with an aggregate fair value of $ 10.2 million.
(3) Unrealized holding losses on 11 securities with an aggregate fair value of $ 387.0 million.
(4) Unrealized holding losses on 5 securities with an aggregate fair value of $ 29.1 million.
December 31, 2023
Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value
Short-term marketable securities:
U.S. government treasuries
$ 868,174 $ 998 $ — $ 869,172
U.S. government agency securities (1)
7,089 — ( 3 ) 7,086
Commercial paper
31,147 — — 31,147
Total
$ 906,410 $ 998 $ ( 3 ) $ 907,405
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(1) Unrealized holding losses on 2 securities with an aggregate fair value of $ 7.1 million.
As of June 30, 2024 and December 31, 2023, some of the Company's marketable securities were in an unrealized loss position. The Company has no t recognized an allowance for credit losses as of June 30, 2024 or December 31, 2023. The Company determined that it had the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery. Further, a majority of these marketable securities are held in U.S. government securities, and the remainder were initially, and continue to be, held with investment grade, high credit quality institutions. All marketable securities with unrealized losses as of each balance sheet date have been in a loss position for less than twelve months or the loss is not material.
As of June 30, 2024, all of the Company’s marketable securities have an effective maturity of less than two years .
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4. Acquisition and Research Funding Collaboration Agreement
Acquisition of F-star Gamma
In August 2016, the Company entered into a License and Collaboration Agreement (“F-star Collaboration Agreement”) with F-star Gamma Limited (“F-star Gamma”), F-star Biotechnologische Forschungs-und Entwicklungsges M.B.H ("F-star GmbH") and F-star Biotechnology Limited ("F-star Ltd") (collectively, “F-star”) to leverage F-star’s modular antibody technology and the Company’s expertise in the development of therapies for neurodegenerative diseases. In May 2018, the Company exercised the pre-negotiated option agreement (the "Option Agreement") under the F-star Collaboration Agreement and entered into a Share Purchase Agreement (the “Purchase Agreement”) with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which the Company acquired all of the outstanding shares of F-star Gamma (the “Acquisition”). The details of the Acquisition are further described in Note 4, "Acquisition", to the consolidated financial statements in the Company's 2023 Annual Report on Form 10-K.
As of June 30, 2024, the Company had paid consideration of $ 49.8 million in the aggregate consisting of up-front, preclinical, and clinical contingent consideration, all of which was recorded as research and development expense as incurred. This amount includes a $ 30.0 million contingent consideration payment which was triggered and recorded as research and development expense in March 2023 upon the achievement of a specified clinical milestone in the ETV:IDS program. This contingent consideration payment fully satisfies the Company's clinical contingent consideration obligations under the Purchase Agreement. There was no contingent consideration expense recognized for the three and six months ended June 30, 2024 or the three months ended June 30, 2023.
Collaboration and Development Funding Agreement
On January 29, 2024, the Company entered into a Collaboration and Development Funding Agreement with an unrelated third party, pursuant to which this third party will provide up to $ 75.0 million of funding and collaborate with the Company to conduct a global Phase 2a study of BIIB122/DNL151 in patients with Parkinson’s disease and confirmed pathogenic variants of LRRK2.
Pursuant to this agreement, an upfront payment of $ 12.5 million was received in January 2024, and a further payment of $ 12.5 million was received in July 2024, with the remainder to be paid upon achievement of operational milestones in the study. After the full $ 75.0 million in consideration has been paid, the third party will be eligible to receive low single-digit royalties from the Company on annual worldwide net sales of LRRK2 inhibitors for the treatment of Parkinson’s disease.
The Company determined that this arrangement is an R&D funding arrangement under ASC 730. As the third party is sharing in the risk associated with research and development activities with the Company, the development funding is recognized as an obligation to perform contractual services. Accordingly, payments received will be recorded as a liability, and recognized by the Company as a reduction to research and development expenses over the estimated Phase 2a study period as the underlying research and development costs are incurred. R&D funding under this arrangement of $ 2.3 million offset research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and six months ended June 30, 2024. As of June 30, 2024, a liability of $ 10.2 million was recorded within deferred research funding liability on the Condensed Consolidated Balance Sheet.
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5. Collaboration Agreements
Biogen
In October 2020, the Company entered into a Definitive Collaboration and License Agreement (“LRRK2 Agreement”), pursuant to which it granted Biogen a license to co-develop and co-commercialize its small molecule LRRK2 inhibitor program (the “LRRK2 Program”), and a Right of First Negotiation, Option and License Agreement (the “ROFN and Option Agreement”), pursuant to which it granted an option and right of first negotiation to certain of the Company's programs utilizing our TV technology platform, including its amyloid beta program (collectively the "Biogen Collaboration Agreement"), with Biogen Inc.’s subsidiaries, Biogen MA Inc. (“BIMA”) and Biogen International GmbH (“BIG”) (BIMA and BIG, collectively, “Biogen”). The details of the Biogen Collaboration Agreement, the August 2023 amendment to the ROFN and Option Agreement, and the payments the Company has received, and is entitled to receive, are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the 2023 Annual Report on Form 10-K.
On July 26, 2024, Denali and Biogen executed a Side Letter to the ROFN and Option Agreement, pursuant to which, effective as of the date of the Side Letter, Biogen terminated its license to the ATV:Abeta program enabled by Denali’s TfR-targeting technology against amyloid beta for the potential treatment of Alzheimer's disease, and granted Denali rights to data generated during the collaboration. The side letter also effected the immediate termination of the ROFN and Option Agreement; as such, the Company expects to receive no future milestone or royalty payments from Biogen related to the ATV:Abeta program. There were no changes to the terms of the LRRK2 Agreement during the three and six months ended June 30, 2024 or 2023.
The Company has no remaining performance obligations under the Biogen Collaboration Agreement, and therefore no contract liability remained on the Condensed Consolidated Balance Sheets as of June 30, 2024 or December 31, 2023 . As of December 31, 2023, Biogen was no longer considered a related party as defined in ASC 850.
As of June 30, 2024, the Company had earned $ 5.0 million in option fee payments, but had not recorded milestone revenue or product sales under the Biogen Collaboration Agreement.
Sanofi
In October 2018, the Company entered into a Collaboration and License Agreement ("Sanofi Collaboration Agreement") with Genzyme Corporation, a wholly owned subsidiary of Sanofi S.A. ("Sanofi"). The details of the Sanofi Collaboration Agreement and the payments the Company has received, and is entitled to receive, are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2023 Annual Report on Form 10-K. The Company has no remaining performance obligations under the Sanofi Collaboration Agreement, and therefore no contract liability remains on the Condensed Consolidated Balance Sheets as of June 30, 2024 or December 31, 2023 . As of June 30, 2024, the Company had earned milestone payments of $ 100.0 million and had no t recorded any product sales under the Sanofi Collaboration Agreement.
Takeda
In January 2018, the Company entered into a Collaboration and Option Agreement ("Takeda Collaboration Agreement") with Takeda Pharmaceutical Company Limited ("Takeda"). The details of the Takeda Collaboration Agreement are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2023 Annual Report on Form 10-K. There are no remaining performance obligations or potential payments remaining under the initial Takeda Collaboration Agreement.
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The opt-in by Takeda on the PTV:PGRN and ATV:TREM2 programs represented two new contracts with a customer for accounting purposes (the "PTV:PGRN Collaboration Agreement" and the "ATV:TREM2 Collaboration Agreement"), both of which became effective in December 2021. The details of the PTV:PGRN Collaboration Agreement and the ATV:TREM2 Collaboration Agreement are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2023 Annual Report on Form 10-K.
As of June 30, 2024, the Company had earned an aggregate of $ 10.0 million in option fee payments and $ 10.0 million in milestone payments from Takeda under the PTV:PGRN and ATV:TREM2 Collaboration Agreements, and had no t recorded any product sales under either agreement.
Collaboration Revenue
Revenue disaggregated by collaboration agreement and performance obligation is as follows (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2024 2023 2024 2023
Takeda Collaboration Agreement:
PTV:PGRN Collaboration Agreement (1)
$ — $ — — 10,000
Total Takeda Collaboration Revenue — — — 10,000
Sanofi Collaboration Agreement
CNS Program License (2)
— — — 25,000
Total Sanofi Collaboration Revenue — — — 25,000
Biogen Collaboration Agreement
ATV:Abeta Program License (3)
— 293,912 — 293,912
Option Research Services (4)
— 211 — 352
Total Biogen Collaboration Revenue — 294,123 — 294,264
Total Collaboration Revenue $ — $ 294,123 $ — $ 329,264
_________________________________________________
(1) Revenue for the six months ended June 30, 2023 from a specified clinical milestone in the Phase 1/2 study of DNL593 in patients with frontotemporal dementia-granulin (FTD-GRN).
(2) Revenue for the six months ended June 30, 2023 from a milestone payment triggered and received in January 2023 upon the commencement of dosing in a Phase 2 study of SAR443820/DNL788 in individuals with multiple sclerosis.
(3) Revenue for the three and six months ended June 30, 2023 was associated with Biogen exercising its option to license Denali’s ATV:Abeta program which was previously concluded to be a material right, $ 288.9 million of which was included in the contract liability balance at the beginning of the period and $ 5.0 million of which was an option exercise fee received in April 2023.
(4) Revenue for the three and six months ended June 30, 2023 was included in the contract liability balance at the beginning of the period.
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Cost Sharing Payments and Reimbursements
Cost sharing payments to collaboration partners recorded as expenses in research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss), and cost sharing reimbursements from collaboration partners recorded as an offset to expense in research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) are as follows (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2024 2023 2024 2023
Takeda Collaboration Agreement:
PTV:PGRN cost sharing (reimbursements)
$ ( 1,138 ) $ ( 1,864 ) $ ( 2,338 ) $ ( 3,342 )
ATV:TREM2 cost sharing (reimbursements)
( 215 ) ( 1,605 ) ( 728 ) ( 3,262 )
Total Takeda cost sharing (reimbursements) (1)
( 1,353 ) ( 3,469 ) ( 3,066 ) ( 6,604 )
Biogen Collaboration Agreement: LRRK2 cost sharing payments (2)
4,440 6,976 9,229 11,126
Net cost sharing payments (reimbursements)
$ 3,087 $ 3,507 $ 6,163 $ 4,522
_________________________________
(1) Cost sharing reimbursements of $ 1.4 million and $ 2.7 million were recorded as a receivable within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023, respectively.
(2) Cost sharing payments due to Biogen of $ 4.4 million and $ 3.2 million were recorded within accounts payable on the Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023, respectively.
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6. Commitments and Contingencies
Lease Obligations
In May 2018, the Company entered into an operating lease for its corporate headquarters in South San Francisco (the "Headquarters Lease"), as further described in Note 8, "Commitments and Contingencies," to the consolidated financial statements in the Company's 2023 Annual Report on Form 10-K. In August 2021, the Company entered into an operating lease for laboratory, office and warehouse premises in Salt Lake City, Utah (the “SLC Lease”) . In March 2023, the Company terminated the SLC Lease, which resulted in the recognition of $ 7.9 million of accelerated depreciation on leasehold improvements in the six months ended June 30, 2023 .
In April 2023, the Company entered into a new operating lease in Salt Lake City for a 59,336 square foot laboratory, office and warehouse premises with a contractual term of approximately 15 years upon commencement, and undiscounted lease payments of approximately $ 13.4 million, which was subsequently amended in October 2023. For accounting purposes, this new lease has not yet commenced, and as such, no lease liability or ROU asset is recorded on the Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023 , and no operating lease expense has been recorded on the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and six months ended June 30, 2024 . Payments of $ 26.5 million made by the company, primarily for assets that are deemed to be landlord owned, and which will form part of the ROU asset upon lease commencement, are included within other non-current assets on the Condensed Consolidated Balance Sheet as of June 30, 2024 .
Management exercised judgment in applying the requirements of ASC 842, including the determination as to whether certain contracts contain a lease, the lease consideration, and the commencement date of the lease, and for leases identified under the standard, the discount rate used to determine the measurement of the lease liability. The discount rates of our operating leases are an approximation of the Company's incremental borrowing rate and are dependent upon the term and economics of the agreement. To estimate the incremental borrowing rate, management considers observable debt yields of comparable market instruments, as well as benchmarks within the lease agreement that may be indicative of the rate implicit in the lease. There were no changes to the terms of the leases recognized under ASC 842 during the three and six months ended June 30, 2024.
Operating lease costs, including variable costs recognized under ASC 842, was $ 3.1 million and $ 6.2 million for the three and six months ended June 30, 2024, respectively, and $ 3.3 million and $ 6.2 million for the three and six months ended June 30, 2023, respectively. The following table contains a summary of other information pertaining to the Company’s operating lease for the periods presented (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2024 2023 2024 2023
Cash paid for amounts included in measurement of lease liabilities $ 2,854 $ 2,763 $ 5,647 $ 5,759
As of June 30,
2024 2023
Weighted average remaining lease term 4.8 years 5.8 years
Weighted average discount rate 9.0 % 9.0 %
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The following table reconciles the undiscounted cash flows for the next five years and total of the remaining years to the operating lease liabilities recorded in the Condensed Consolidated Balance Sheet as of June 30, 2024 (in thousands):
Year Ended December 31:
2024 (six months)
$ 5,770
2025 11,793
2026 12,182
2027 12,584
2028
13,001
Thereafter 4,381
Total undiscounted lease payments 59,711
Present value adjustment ( 10,959 )
Net operating lease liability
$ 48,752
Indemnification
In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to vendors, lessors, business partners, board members, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by the Company, negligence or willful misconduct of the Company, violations of law by the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the Company’s Condensed Consolidated Balance Sheets , Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) , or Condensed Consolidated Statements of Cash Flows .
Commitments
Effective September 2017, the Company entered into a Development and Manufacturing Services Agreement as amended (“DMSA”) with Lonza Sales AG (“Lonza”) for the development and manufacture of biologic products. Under the DMSA, the Company will execute purchase orders based on project plans authorizing Lonza to provide development and manufacturing services with respect to certain of the Company's antibody and enzyme products, and will pay for the services provided and batches delivered in accordance with the DMSA and project plan. Unless earlier terminated, the DMSA will expire when all development and manufacturing services are completed, which is not expected to be before November 2029. As of June 30, 2024 and December 31, 2023, the Company had total non-cancellable purchase commitments under the DMSA of $ 24.0 million and $ 37.6 million, respectively.
During the three months ended June 30, 2024 and 2023, the Company incurred costs of $ 6.2 million and $ 10.9 million, respectively, and made payments of $ 16.8 million and $ 8.3 million, respectively, for the development and manufacturing services rendered under the DMSA. During the six months ended June 30, 2024 and 2023, the Company incurred costs of $ 22.6 million and $ 16.1 million, respectively, and made payments of $ 30.3 million and $ 12.1 million, respectively, for the development and manufacturing services rendered under the DMSA.
In the normal course of business, the Company enters into other firm purchase commitments primarily related to research and development activities. The Company had contractual obligations under certain clinical and manufacturing agreements other than the DMSA of $ 32.5 million and $ 34.8 million, as of June 30, 2024 and December 31, 2023, respectively, with certain amounts subject to cost sharing with Takeda.
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Contingencies
From time to time, the Company may be involved in lawsuits, arbitration, claims, investigations and proceedings consisting of intellectual property, employment and other matters which arise in the ordinary course of business. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated.
7. Common Stock
On February 27, 2024, the Company entered into a securities purchase agreement (the "Purchase Agreement") with certain investors for the private placement of (i) 3,244,689 shares of Denali's common stock at a price of $ 17.07 per share and (ii) pre-funded warrants to purchase an aggregate of 26,046,065 shares of Denali's common stock (the "Pre-Funded Warrants") at a purchase price of $ 17.06 per Pre-Funded Warrant, which represents the per share price for the common stock less the $ 0.01 exercise price. The private placement closed on February 29, 2024, at which time the Company received aggregate net proceeds of approximately $ 499.3 million, after deducting issuance costs of approximately $ 0.5 million.
The Pre-Funded Warrants were classified as a component of permanent equity in the Company’s consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its shares and permit the holders to receive a fixed number of shares of common stock upon exercise. As of June 30, 2024, all of the Pre-Funded Warrants issued in the private placement were outstanding.
8. Stock-Based Awards
The Company has issued stock-based awards from various equity incentive and stock purchase plans, as more fully described in Note 9, "Stock-Based Awards" to the consolidated financial statements in the Company's 2023 Annual Report on Form 10-K.
Stock Option Activity
The following table summarizes stock option activity for the six months ended June 30, 2024:
Number of Options
Weighted-Average
Exercise Price
Balance at December 31, 2023 16,490,551 $ 27.34
Granted
4,370,561 20.25
Exercised
( 453,206 ) 10.09
Forfeited
( 1,435,314 ) 30.95
Balance at June 30, 2024 18,972,592 $ 25.84
Vested and expected to vest at June 30, 2024 18,162,721 $ 27.85
Exercisable at June 30, 2024 11,565,306 $ 27.31
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The estimated fair value of stock options granted to employees were calculated using the Black-Scholes option-pricing model using the following assumptions:
Six Months Ended June 30,
2024 2023
Expected term (in years)
5.50 - 6.08
5.50 - 6.08
Volatility
64.5 % - 66.0 %
68.7 % - 69.6 %
Risk-free interest rate
3.9 % - 4.5 %
3.4 % - 4.2 %
Dividend yield
— —
Restricted Stock Activity
The following table summarizes restricted stock unit ("RSU") activity for the six months ended June 30, 2024:
Number of RSU shares Weighted-Average Fair Value at Date of Grant per Share
Unvested at December 31, 2023 3,635,157 $ 35.60
Granted 1,989,571 20.18
Vested and released ( 835,873 ) 38.86
Forfeited ( 641,220 ) 29.10
Unvested and expected to vest at June 30, 2024 4,147,635 $ 28.55
Stock-Based Compensation Expense
The Company’s results of operations include expenses relating to stock-based compensation as follows (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2024 2023 2024 2023
Research and development
$ 14,364 $ 15,189 $ 30,706 $ 31,973
General and administrative
10,736 11,381 22,234 22,681
Total
$ 25,100 $ 26,570 $ 52,940 $ 54,654
9. Net Income (Loss) Per Share
The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share amounts):
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Three Months Ended June 30, Six Months Ended June 30,
2024 2023 2024 2023
Numerator:
Net income (loss)
$ ( 99,026 ) $ 183,383 $ ( 200,828 ) $ 73,602
Denominator:
Weighted average number of:
Common stock shares outstanding
142,785,264 137,047,227 141,515,199 136,787,321
Private placement pre-funded warrants
26,046,065 — 17,602,560 —
Weighted average number of shares outstanding, basic
168,831,329 137,047,227 159,117,759 136,787,321
Dilutive effect of outstanding common stock options, ESPP shares issuable, and restricted shares
— 3,883,398 — 3,762,905
Weighted average number of shares outstanding, diluted
168,831,329 140,930,625 159,117,759 140,550,226
Net income (loss) per share, basic
$ ( 0.59 ) $ 1.34 $ ( 1.26 ) $ 0.54
Net income (loss) per share, diluted
$ ( 0.59 ) $ 1.30 $ ( 1.26 ) $ 0.52
Potentially dilutive securities, including options issued and outstanding, ESPP shares issuable, and restricted shares subject to future vesting that were not included in the diluted per share calculations for the periods presented because they would be anti-dilutive totaled approximately 23.3 million and 11.8 million shares as of June 30, 2024 and June 30, 2023, respectively.
10. Divestiture of Preclinical Small Molecule Programs
On March 1, 2024, the Company divested certain assets, including specified intellectual property, tangible assets, and equipment used to conduct early stage small molecule drug discovery ("Divested Assets") through an Asset Purchase and License Agreement (the "Asset Purchase Agreement") executed with a venture-backed private company ("VBPC"). Additionally, certain of the Company’s employees terminated their employment with the Company and became employees of VBPC.
In exchange for the Divested Assets, the Company received equity consideration in the form of a simple agreement for future equity (“SAFE”), equal to $ 15.0 million of equity in VBPC’s next financing round or, if VBPC’s next equity financing does not occur prior to December 31, 2024, a number of shares of preferred stock issued in VBPC’s previous round of equity financing prior to this agreement equal to $ 15.0 million divided by the price per share paid by investors in that previous equity financing. The Company may also be eligible to receive certain market valuation, development and sales based milestone payments up to approximately $ 1.2 billion in the form of either cash or equity at the election of VBPC. The Company will also be entitled to receive future royalties on aggregate net sales of any products that bind to certain identified targets, on a product-by-product and country-by-country basis during the periods of time commencing at the time of the first commercial sale of such product in such country, until the later of (i) the expiration of certain related patents, (ii) the expiration of Regulatory Exclusivity, or (iii) ten years after such first commercial sale.
Concurrently, VBPC and the Company also entered into a sublease for 12,985 square feet of office and lab space within the Company's corporate headquarters, and transition and research services agreement ("Service Agreements"). The sublease commenced in May 2024 and will continue for a period of approximately ten months , with two optional six month extension periods. The Service Agreements allow Denali to provide access to equipment and provision of certain specified administrative and research services to VBPC for a period up to the end of the sublease term.
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This divestiture did not meet the criteria for reporting discontinued operations as the sale does not represent a strategic shift in the Company’s business. The Company recognized a gain on divestiture of approximately $ 14.5 million in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) during the six months ended June 30, 2024, representing the difference between the fair value of the consideration received and the carrying amount of the Divested Assets.
The Company recorded the SAFE at $ 15.0 million based on the expected value of the equity to be received within other non-current assets in the Condensed Consolidated Balance Sheet. The SAFE remains outstanding as of June 30, 2024.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.