Skip to main content

Annexon Inc

For the period ended Mar 31, 2024. Filed May 13, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 13, 2024

ANNX$4.20+4.9%Stored close · as of Nov 6, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Notes to Condensed Consolidated Financial Statements

  1. Organization

Annexon, Inc., or the Company, is a clinical-stage biopharmaceutical company pioneering a new class of complement medicines for people living with devasting inflammatory-related diseases. The Company is located in Brisbane, California and was incorporated in Delaware in March 2011.

The Company’s wholly-owned subsidiary, Annexon Biosciences Australia Pty Ltd, or the Subsidiary, is a proprietary limited company incorporated in 2016 and domiciled in Australia.

Liquidity

Since inception, the Company has been involved primarily in performing research and development activities, conducting clinical trials, hiring personnel, and raising capital to support and expand these activities. The Company has experienced losses and negative cash flows from operations since its inception and, as of March 31, 2024, had an accumulated deficit of$597.7 million and cash and cash equivalents and short-term investments of$264.9 million.

The Company has historically funded its operations through the issuance of shares of its common stock and warrants. Based on projected activities, management projects that existing cash and cash equivalents and short-term investments will enable the Company to fund its operating expenses and capital expenditure requirements for at least twelve months from the date of issuance of these financial statements. The Company’s future viability beyond that point is dependent on its ability to achieve development milestones and obtain additional funding. Management expects to continue to incur losses and negative cash flows from operations for at least the next several years. There are uncertainties associated with the Company’s ability to (1) obtain additional equity or debt financing on terms that are favorable to the Company, (2) enter into collaborative agreements with strategic partners, and (3) succeed in its future operations. If the Company is not able to obtain the required funding for its operations or is not able to obtain funding on terms that are favorable to the Company, it could be forced to delay, reduce or eliminate its research and development programs and its business could be materially harmed.

  1. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and applicable rules and regulations of the SEC regarding interim financial reporting.

The condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations, comprehensive loss, stockholders’ equity for the three months ended March 31, 2024 and 2023 and the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 are unaudited. These unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position, results of operations and cash flows for the interim period presented. The financial data and the other financial information contained in these notes to the condensed consolidated financial statements related to the three-month periods are also unaudited. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2023 included herein was derived from the audited financial statements as of that date. These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 26, 2024.

Use of Estimates

Thepreparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses during the reporting period. Management evaluates its estimates, including but not limited to the fair value of investments, operating lease right-of-use assets and liabilities, valuation of deferred tax assets and uncertain tax positions (including valuation allowance), clinical trial accruals and stock-based compensation. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates.

Principles of Consolidation

The condensed consolidated financial statements include the operations of Annexon, Inc. and its wholly-owned subsidiary and include the results of operations and cash flows of these entities. All intercompany balances and transactions have been eliminated in consolidation.

Summary of Significant Accounting Policies

Reference is made to Note 2, Summary of Significant Accounting Policies, in the Company’s 2023 Form 10-K filed on March 26, 2024 for a detailed description of significant accounting policies. There have been no significant changes to the Company’s accounting policies as disclosed in its 2023 Form 10-K.

Recently Issued Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an interim and annual basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company adopted annual requirements under ASU 2023-07 on January 1, 2024 and plans to adopt interim requirements under ASU 2023-07 on January 1, 2025. The Company will begin including financial statement disclosures in accordance with ASU 2023-07 in its Annual Report on Form 10-K for the year ended December 31, 2024. The Company is evaluating the impact of this guidance on its financial statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes: Improvements to Income Tax Disclosures, which requires enhanced annual disclosures regarding the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 and may be adopted on a prospective or retrospective basis. Early adoption is permitted. The Company is evaluating the impact of this guidance on its financial statements and related disclosures.

  1. Fair Value Measurements

The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:

Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.

Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.

Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date.

On a recurring basis, the Company measures certain financial assets and liabilities at fair value. The following tables summarize the fair value of the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):

ValuationHierarchyAmortizedCostGrossUnrealizedHoldingGainsGrossUnrealizedHoldingLossesAggregateFair Value
Assets:
Cash equivalents:
Money market fundsLevel 1$40,150$—$—$40,150
Commercial paperLevel 213,980——13,980
Government bondsLevel 286,3601(1)86,360
Total cash equivalents140,4901(1)140,490
Short-term investments:
Government bondsLevel 2113,0251(19)113,007
Total short-term investments113,0251(19)113,007
$253,515$2$(20)$253,497
ValuationHierarchyAmortizedCostGrossUnrealizedHoldingGainsGrossUnrealizedHoldingLossesAggregateFair Value
Assets:
Cash equivalents:
Money market fundsLevel 1$143,933$—$—$143,933
Government bondsLevel 272,689——72,689
Total cash equivalents216,622——216,622
Short-term investments:
Government bondsLevel 234,59610—34,606
Total short-term investments34,59610—34,606
$251,218$10$—$251,228

For the three months ended March 31, 2024 and 2023, the Company recognized no material realized gains or losses on financial instruments.

  1. Balance Sheet Components

Cash, Cash Equivalents and Restricted Cash

The Company considers all highly liquid instruments with an original maturity of three months or less at time of purchase to be cash equivalents. Cash equivalents, which include amounts invested in money market funds, are stated at fair value.

Restricted cash as of March 31, 2024 relates to the letters of credit established for the Company’s office leases.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows (in thousands):

March 31,2024December 31,2023
Cash$11,451$8,488
Cash equivalents140,490216,622
Cash and cash equivalents151,941225,110
Restricted cash1,0321,032
Cash, cash equivalents and restricted cash$152,973$226,142

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

March 31,2024December 31,2023
Prepaid research and development costs$4,643$2,617
Prepaid insurance418704
Other prepaid expenses708760
Other current assets2363
Total prepaid expenses and other current assets$5,792$4,144

Property and Equipment, Net

Property and equipment, net, consisted of the following (in thousands):

March 31,2024December 31,2023
Leasehold improvements$17,246$17,245
Laboratory equipment1,8321,832
Furniture and fixtures692692
Computer equipment and software3333
Total property and equipment, gross19,80319,802
Less: accumulated depreciation(5,568)(5,029)
Total property and equipment, net$14,235$14,773

The Company recognized depreciation for property and equipment of$0.5 million for each of the three months ended March 31, 2024 and 2023.

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

March 31,2024December 31,2023
Accrued research and development expenses$4,527$4,027
Accrued compensation1,6435,607
Accrued professional services570501
Other accrued expenses117100
Total accrued liabilities$6,857$10,235
  1. Commitments and Contingencies

Leases

The Company leases its offices and laboratory in Brisbane, California, or the Brisbane Lease, under aten-year noncancelable lease agreement that ends in October 2031 with aten-year renewable option. In November 2021, the Company subleased unoccupied space from December 2021 through November 2023, for aggregate sublease payments of $3.4 million. The sublease income, while it reduces the rent expense, is not considered in the value of the right-of-use assets or lease liabilities. The Company’s sublease income waszero and $0.4 million for the three months ended March 31, 2024 and 2023, respectively.

As of March 31, 2024, the operating lease right-of-use assets were$17.7 million and lease liabilities were$30.8 million on the condensed consolidated balance sheet. The weighted-average remaining lease term is 7.6 years.

The weighted-average incremental borrowing rate used to measure the operating lease liability is 8.4%.

Operating lease costs were$1.0 million and $0.5 million for the three months ended March 31, 2024 and 2023, respectively. Variable lease payments were$0.5 million and $0.4 million for the three months ended March 31, 2024 and 2023, respectively.

Future minimum lease payments and related lease liabilities as of March 31, 2024, were as follows:

(in thousands)
2024 (remaining nine months)$3,677
20255,065
20265,242
20275,425
2028 and thereafter22,600
Total undiscounted lease payments42,009
Less: Imputed interest(11,224)
Total$30,785

Guarantees and Indemnifications

In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company hasnot paid any claims or been required to defend any action related to its indemnification obligations. As of March 31, 2024, the Company didnot have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.

  1. Stockholders’ Equity

2023 Financing

In December 2023, the Company raised net proceeds of approximately $117.0 million after deducting underwriting discounts and offering expenses through the sale of 25,035,000 shares of the Company’s common stock, par value $0.001 per share at a price of $2.880 per share and pre-funded warrants to purchase an aggregate of 18,379,861 shares of common stock at a price of $2.879 per share, which equals the per share offering price for the shares of common stock less the $0.001 exercise price for each pre-funded warrant. An entity related to one of the Company’s directors participated in the public offering and purchased 350,000 shares of common stock for an aggregate price of approximately $1.0 million. The pre-funded warrants are immediately exercisable, subject to certain beneficial ownership limitations. The warrants meet the criteria for equity classification and were therefore recorded at fair value as of the grant date as a component of stockholders’ equity within additional paid-in capital in the amount of $52.9 million.

In February 2024, the Company issued an aggregate of 5,243,400 shares of common stock upon the cashless exercise of pre-funded warrants to purchase 5,244,444 shares of common stock. In April 2024, the Company issued an aggregate of 965,427 shares of common stock upon the exercise of pre-funded warrants. As of March 31, 2024, and as of the date of issuance of these interim condensed financial statements, pre-funded warrants to purchase up to 13,135,417 shares and 12,169,990 shares of common stock remained outstanding from the 2023 financing, respectively.

2022 Financing

In July 2022, the Company raised net proceeds of approximately $122.5 million after deducting fees and expenses through the sale of an aggregate of 9,013,834 shares of common stock, pre-funded warrants to purchase up to 24,696,206 shares of its common stock and accompanying common warrants to purchase up to 8,427,508 shares of its common stock. The offering price per share and accompanying common warrant was $3.87125 per share and the offering price per pre-funded warrant and accompanying common warrant was $3.87025 per share, which equals the per share offering price for the shares of common stock less the $0.001 exercise price for each such pre-funded warrant. The pre-funded warrants remain exercisable until exercised in full. The common warrants have an exercise price of $5.806875 per share and expire on June 30, 2025. Both the pre-funded and common warrants are immediately exercisable, subject to beneficial ownership limitations. The warrants meet the criteria for equity classification and were therefore recorded at fair value as of the grant date as a component of stockholders’ equity within additional paid-in capital.

In March 2023, the Company issued an aggregate of 2,582,557 shares of common stock upon the cashless exercise of pre-funded warrants to purchase 2,583,144 shares of common stock. As of March 31, 2024, pre-funded warrants to purchase up to 22,113,062 shares of common stock and common warrants to purchase up to 8,427,508 shares of common stock remained outstanding from the 2022 financing.

2021 At-the-Market (ATM) Program

In August 2021, the Company entered into a sales agreement with Cowen and Company LLC, or TD Cowen, as sales agent, pursuant to which the Company may issue and sell shares of its common stock for an aggregate maximum offering of $100.0 million under an at-the-market offering program, or 2021 ATM program. TD Cowen is entitled to compensation up to 3% of the aggregate gross proceeds for the common stock sold through the 2021 ATM program. During 2023, the Company sold 2,646,458 shares of common stock at a price of $6.80 per share under the 2021 ATM program for net proceeds of approximately $17.5 million after deducting commissions paid to TD Cowen. During the three months ended March 31, 2024, the Company sold 6,639,348 shares of common stock under the 2021 ATM program for net proceeds of approximately$32.2 million. As of March 31, 2024, approximately$48.9 million remained available for the offer and sale of shares of common stock under the 2021 ATM program. Subsequent to March 31, 2024 and through the date of issuance of these interim condensed financial statements, net proceeds of approximately $6.4 million were raised as a result of the sale of shares of the Company’s common stock through the 2021 ATM program.

2024 ATM Program

In March 2024, the Company entered into a sales agreement with TD Cowen, as sales agent, or 2024 ATM program, pursuant to which the Company may issue and sell shares of its common stock for an aggregate maximum offering of $100.0 million. TD Cowen is entitled to compensation up to 3% of the aggregate gross proceeds for the common stock sold through the 2024 ATM program. As of March 31, 2024, the Company has not made any sales under the 2024 ATM program.

Common Stock

The Company reserved the following shares of common stock for issuance as follows:

March 31,2024December 31,2023
Stock options issued and outstanding11,859,3629,208,970
Stock options reserved for 2020 Incentive Award Plan1,762,9921,988,340
Unvested restricted stock units outstanding915,861495,579
Common stock reserved for 2021 ATM program25,980,1232,619,471
Common stock reserved for 2024 ATM program25,000,000—
Common stock reserved for Employee Stock Purchase Plan2,122,0711,338,381
Common stock reserved for 2022 Employment Inducement Award Plan1,667,300758,084
Common stock reserved for pre-funded warrants35,248,47940,493,510
Common stock reserved for common warrants8,427,5088,427,508
Total common stock reserved112,983,69665,329,843
  1. Equity Incentive Plans

In July 2020, the Company’s board of directors and stockholders adopted and approved the 2020 Incentive Award Plan, or the 2020 Plan, and the Employee Stock Purchase Plan, or the ESPP, which became effective in connection with the Company’s initial public offering, or the IPO.

The Company may not grant any additional awards under the 2011 Equity Incentive Plan, or the 2011 Plan. The 2011 Plan will continue to govern outstanding equity awards granted thereunder.

2020 Equity Incentive Plan

The number of shares of common stock reserved for issuance under the 2020 Plan automatically increases on the first day of January, in an amount equal to 4% of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding year, or a lesser number of shares determined by the Company’s board of directors.

Awards granted under the 2020 Plan expire no later thanten years from the date of grant. For Incentive Stock Options, or ISOs, and Nonstatutory Stock Options, or NSOs, the option price shall not be less than 100% of the estimated fair value on the date of grant. Options granted typically vest over afour-year period but may be granted with different vesting terms. As of March 31, 2024, there were 1,762,992 shares available for issuance under the 2020 Plan.

2022 Employment Inducement Award Plan

In July 2022, the Company’s board of directors adopted the Annexon, Inc. 2022 Employment Inducement Award Plan, or the Inducement Plan, and together with the 2011 Plan and the 2020 Plan, the Plans. The Inducement Plan was adopted by the Company’s board of directors without stockholder approval pursuant to Nasdaq Marketplace Rule 5635(c)(4), or Rule 5635(c)(4). In accordance with Rule 5635(c)(4), awards made under the Inducement Plan may only be granted to newly hired employees as an inducement material to the employees entering into employment with the Company. Awards granted under the Inducement Plan expire no later than ten years from the date of grant. An aggregate of 2,850,000 shares of common stock were reserved for issuance under the Inducement Plan. As of March 31, 2024, there were 1,667,300 shares available for issuance under the Inducement Plan.

Stock Options

The following table presents stock option activity under the Plans for the period:

Number ofSharesWeighted-AverageExercisePrice PerShareWeighted-AverageRemainingContractualTerm(in years)AggregateIntrinsicValue(in thousands)
Balances as of December 31, 20239,208,970$10.317.53$2,930
Stock options granted3,121,592$5.13
Stock options exercised(105,526)$2.06
Stock options forfeited(365,674)$9.15
Balances as of March 31, 202411,859,362$9.057.91$18,184
Exercisable as of March 31, 20245,469,398$12.116.49$5,860

The total intrinsic value of options exercised was$0.3 million for each of the three months ended March 31, 2024 and 2023. The intrinsic value is the difference between the fair value of the Company’s common stock at the time of exercise and the exercise price of the stock option.

The weighted-average grant date fair value of options granted to employees during the three months ended March 31, 2024 and 2023 was$4.06 and $4.35 per share, respectively.

As of March 31, 2024, the total unrecognized stock-based compensation cost related to outstanding unvested stock options was$29.8 million, which the Company expects to recognize over an estimated weighted-average period of 2.6 years.

Restricted Stock Units

RSUs are share awards that entitle the holder to receive freely tradeable shares of the Company’s common stock upon vesting. The RSUs cannot be transferred and the awards are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. The RSUs generally vest over a three-year period in equal amounts on an annual basis, provided the employee remains continuously employed with the Company. The fair value of the RSUs is equal to the closing price of the Company’s common stock on the grant date.

A summary of RSU activity under the Company’s equity incentive plan and related information is as follows:

Number of SharesWeighted-Average Grant Date Fair Value Per Share
Unvested as of December 31, 2023495,579$5.69
Granted602,6005.13
Vested(124,695)6.44
Cancelled(57,623)5.33
Unvested as of March 31, 2024915,861$5.24

As of March 31, 2024, unrecognized stock-based compensation expense related to outstanding unvested RSUs was$4.3 million, which is expected to be recognized over a weighted-average period of 2.4 years.

Employee Stock Purchase Plan

The ESPP enables eligible employees to purchase shares of the Company’s common stock at the end of each offering period at a price equal to 85% of the fair market value of the shares on the first business day or the last business day of the offering period, whichever is lower. Eligible employees generally include all employees. Share purchases are funded through payroll deductions of at least 1%, and up to 15% of an employee’s eligible compensation for each payroll period. The number of shares reserved for issuance under the ESPP increase automatically on the first day of each fiscal year, by a number equal to,1% of the shares of common stock outstanding on the last day of the immediately preceding fiscal year, or such number of shares determined by the Company’s board of directors. As of March 31, 2024,2,122,071 shares were available for future purchase. The ESPP generally provides for six-month consecutive offering periods beginning on May 16 th and November 16 th of each year. The ESPP is a compensatory plan as defined by the authoritative guidance for stock compensation. As such, stock-based compensation expense has been recorded for the three months ended March 31, 2024.

The stock-based compensation expense related to the ESPP was$0.1 million for each of the three months ended March 31, 2024 and 2023.

Stock-Based Compensation Expense

The total stock-based compensation expense recognized was as follows (in thousands):

Three Months EndedMarch 31,
20242023
Research and development$2,282$2,251
General and administrative2,3782,356
Total stock-based compensation expense$4,660$4,607

To determine the value of stock option awards for stock-based compensation purposes, the Company uses the Black-Scholes option pricing model and the assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment.

Fair Value of Common Stock—The fair value of each share of underlying common stock is based on the closing price of the Company’s common stock as reported on the date of grant on the Nasdaq Global Select Market.

Expected Term—The expected term represents the period that the stock-based awards are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). The Company continues using the simplified method as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited period of time its equity shares have been publicly traded.

Expected Volatility—Beginning in 2024, the expected volatility was estimated based on a weighted volatility using both the Company’s trading history for its common stock and the average volatility for comparable publicly traded life sciences companies over a period equal to the expected term of the stock option grants. Prior to 2024, the expected volatility was estimated based on the average volatility for comparable publicly traded life sciences companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on the similar size, stage in life cycle or area of specialty.

Risk-Free Interest Rate—The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the option.

Dividend Yield—The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero.

The fair value of each stock option issued was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions:

Three Months EndedMarch 31,
20242023
Expected term (in years)6.02 - 6.086.02 - 6.08
Expected volatility95.90% - 96.20%81.20% - 81.50%
Risk-free interest rate4.29% - 4.33%3.58% - 4.02%
Dividend yield——
  1. Net Loss Per Share

The Company calculates basic net loss per share by dividing net loss by the weighted-average number of shares of common stock outstanding, excluding restricted common stock. The weighted-average number of shares of common stock used in the basic and diluted net loss per share calculation include pre-funded warrants to purchase up to 35,248,479 shares of common stock, as the pre-funded warrants are exercisable at any time for nominal cash consideration. The Company has generated a net loss in all periods presented, so the basic and diluted net loss per share are the same, as the inclusion of the potentially dilutive securities would be anti-dilutive.

The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

Three Months EndedMarch 31,
20242023
Stock options to purchase common stock11,859,3629,389,106
Shares subject to Employee Stock Purchase Plan79,74887,983
Unvested restricted stock units915,861678,996
Common warrants8,427,5088,427,508
Total21,282,47918,583,593
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.