1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: Our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, are designed to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
+Added: Our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, are designed to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our co-Chief Executive Officers and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our principal executive officers and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024.
−Removed: Based on the evaluation of
−Removed: our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officers and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
+Added: Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our co-Chief Executive Officers and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
8 unchanged sentences
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
−Removed: Under the supervision and with the participation of the Company’s Chief Executive Officers and the Company’s Chief Financial Officer, we assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting under the 2013 “Internal Control—Integrated Framework”, issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO.
+Added: Under the supervision and with the participation of the Company’s Chief Executive Officers and the Company’s Chief Financial Officer, we assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting under the 2013 “Internal Control—Integrated Framework”, issued by the
+Added: Committee of Sponsoring Organizations of the Treadway Commission, or COSO.
Based on such assessment, our management concluded that we maintained effective internal control over financial reporting as of December 31, 2024.
Changes in Internal Control over Financial Reporting
−Removed: There were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
+Added: There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
4 unchanged sentences
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
−Removed: We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2023, of the Company and our report dated February 22, 2024, expressed an unqualified opinion on those financial statements.
+Added: We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2024, of the Company and our report dated March 4, 2025, expressed an unqualified opinion on those financial statements.
Basis for Opinion
16 unchanged sentences
Boston, Massachusetts
−Removed: February 22, 2024
+Added: March 4, 2025
Other Information.
−Removed: During the three months ended December 31, 2023, the following officers or directors of the Company (as defined in Rule 16a-1(f)) adopted the following trading plans for the sale of our common stock pursuant to the terms of the applicable plan;
−Removed: such plans are intended to satisfy the affirmative defense conditions of Rule 10b5–1(c)(1) of the Exchange Act:
−Removed: • Joshua Cohen , our Co-Chief Executive Officer and a member of our board of directors, adopted a new Rule 10b5-1 trading plan on December 15, 2023 , which is scheduled to expire on November 30, 2024 .
−Removed: The aggregate number of shares of our common stock authorized to be sold under this new arrangement is 60,000 ;
−Removed: • Justin Klee , our Co-Chief Executive Officer and a member of our board of directors, adopted a new Rule 10b5-1 trading plan on December 15, 2023 , which is scheduled to expire on November 30, 2024 .
−Removed: The aggregate number of shares of our common stock authorized to be sold under this new arrangement is 60,000 .
−Removed: • James Frates , our Chief Financial Officer , adopted a new Rule 10b5-1 trading plan on December 14, 2023 , which is scheduled to expire on December 1, 2024 .
−Removed: The aggregate number of shares of our common stock authorized to be sold under this new arrangement is 90,000 .
−Removed: Mazzariello , our Chief Legal Officer and General Counsel , adopted a new Rule 10b5-1 trading plan on December 14, 2023 , which is scheduled to expire on March 8, 2025 .
−Removed: The aggregate number of shares of our common stock authorized to be sold under this new arrangement is 76,290 , which includes shares that may be withheld or sold to cover withholding taxes at the time of vesting.
−Removed: No other director or officer has adopted or terminated any non-Rule 10b5-1 trading arrangements during the quarter ended December 31, 2023 .
+Added: Rule 10b5-1 Trading Arrangements
+Added: During the three months ended December 31, 2024 , no officers or directors of the Company (as defined in Rule 16a-1(f)) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(c) of Regulation S-K of the Exchange Act, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
16 unchanged sentences
For a list of the consolidated financial statements included herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report, which is incorporated into this Item by reference.
+Added: Asset Purchase Agreement by and between the Company and Eiger Biopharmaceuticals, Inc., dated June 21, 2024 (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 21, 2024).
Fourth Amended and Restated Certificate of Incorporation of Amylyx Pharmaceuticals, Inc.
11 unchanged sentences
333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
−Removed: Non-Employee Director Compensation Policy (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 21, 2023).
+Added: Amended and Restated Non-Employee Director Compensation Policy (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2024).
Executive Cash Incentive Bonus Plan (Incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1/A (File No.
10 unchanged sentences
333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
−Removed: Form of Employment Agreement, between the Registrant and Margaret Olinger (Incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1/A (File No.
−Removed: 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
−Removed: Form of Employment Agreement, between the Registrant and Patrick D.
−Removed: Yeramian, M.D.
−Removed: (Incorporated by reference to Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1/A (File No.
−Removed: 333-261703) filed with the Securities and Exchange Commission on January 3, 2022).
−Removed: Amendment to Employment Agreement, effective as of December 1, 2022, by and between the Company and Patrick Yeramian (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 6, 2022).
−Removed: Amendment to Employment Agreement, effective as of November 27, 2023, by and between the Company and Patrick Yeramian.
Form of Employment Agreement, between the Registrant and Gina Mazzariello (Incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2023).
2 unchanged sentences
333-261703) filed with the Securities and Exchange Commission on December 16, 2021).
−Removed: Separation Agreement between Registrant and Margaret Olinger dated December 31, 2023.
Master Manufacturing Services Agreement, dated as of November 12, 2019, by and between the Registrant and Patheon Inc.
14 unchanged sentences
(formerly Prodotti Chimici e Alimentari S.p.A.) (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on form 10-Q filed with the Securities and Exchange Commission on August 10, 2023).
+Added: Amylyx Pharmaceuticals, Inc.
+Added: Insider Trading Policy.
List of Subsidiaries of Registrant.
24 unchanged sentences
AMYLYX PHARMACEUTICALS, INC.
−Removed: February 22, 2024
+Added: March 4, 2025
/s/ Joshua B.
Co-Chief Executive Officer
−Removed: February 22, 2024
+Added: March 4, 2025
/s/ Justin B.
3 unchanged sentences
Co-Chief Executive Officer and Director (Principal Executive Officer)
−Removed: February 22, 2024
+Added: March 4, 2025
/s/ Justin B.
Co-Chief Executive Officer and Director (Principal Executive Officer)
−Removed: February 22, 2024
+Added: March 4, 2025
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
−Removed: February 22, 2024
+Added: March 4, 2025
/s/ George Mclean Milne Jr.
−Removed: February 22, 2024
+Added: March 4, 2025
George Mclean Milne Jr.
/s/ Paul Fonteyne
−Removed: February 22, 2024
+Added: March 4, 2025
Paul Fonteyne, M.S., M.B.A.
/s/ Daphne Quimi
−Removed: February 22, 2024
+Added: March 4, 2025
/s/ Karen Firestone
−Removed: February 22, 2024
+Added: March 4, 2025
Karen Firestone
+Added: /s/ Bernhardt Zeiher
+Added: March 4, 2025
+Added: Bernhardt Zeiher, MD.
Amylyx Pharmaceuticals, Inc.
4 unchanged sentences
Consolidated Statements of Comprehensive Income (Loss )
−Removed: Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit )
+Added: Consolidated Statements of Stockholders’ Equity (Deficit )
Consolidated Statements of Cash Flows
4 unchanged sentences
We have audited the accompanying consolidated balance sheets of Amylyx Pharmaceuticals, Inc.
−Removed: and subsidiaries (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive income (loss), redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows, for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
−Removed: We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 22, 2024, expressed an unqualified opinion on the Company's internal control over financial reporting.
+Added: and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows, for each of the years then ended, and the related notes (collectively referred to as the "financial statements").
+Added: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 4, 2025 , expressed an unqualified opinion on the Company's internal control over financial reporting.
Basis for Opinion
9 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Variable consideration related to gross-to-net (“GTN”) adjustments - Refer to Notes 2 and 3 to the financial statements
−Removed: Critical Audit Matter Description
−Removed: Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration related to certain GTN adjustments.
−Removed: Components of GTN adjustments include trade discounts and allowances, product returns, third-party payor rebates, and other allowances that are offered within contracts between the Company, its customers and payors relating to the sale of products.
−Removed: These GTN adjustments are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer).
−Removed: Trade discounts and allowances, provider chargebacks and returns are recorded as reductions of accounts receivables, net on the consolidated balance sheets.
−Removed: Government and other rebates are recorded as a component of accrued expenses on the consolidated balance sheets.
−Removed: Certain of the GTN adjustments involve the use of significant management assumptions and judgments.
−Removed: These significant assumptions and judgments include consideration of historical experience, payer channel mix (e.g., Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel.
−Removed: Given the complexity involved, we identified management’s estimation of significant assumptions as a critical audit matter.
−Removed: Auditing these significant assumptions involved especially subjective judgment and audit effort.
−Removed: How the Critical Audit Matter Was Addressed in the Audit
−Removed: Our audit procedures related to the GTN adjustments included the following, among others:
−Removed: • We tested the effectiveness of internal controls over the development of the Company’s significant assumptions utilized within the Company’s GTN model.
−Removed: • We evaluated the appropriateness and consistency of the Company’s methods and significant assumptions used to calculate the GTN adjustments.
−Removed: • We tested significant assumptions used to calculate the GTN adjustments by:
−Removed: o Performing sensitivity analyses addressing significant assumptions and subjective inputs utilized in the calculation.
−Removed: o Reviewing customer and third-party payor contracts and modifications.
−Removed: o Reviewing the terms of the discounts and rebates associated with the governmental programs the Company participates in.
−Removed: o Developing a range of independent expectations of the significant assumptions, including a comparison of contract prices under applicable programs to those used in management’s calculations.
−Removed: o Performing lookback analyses by comparing amounts actually invoiced to and paid by the Company to the corresponding GTN adjustment recorded by the Company.
−Removed: • We tested the mathematical accuracy of the GTN model.
+Added: Critical Audit Matters
+Added: Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: We determined that there are no critical audit matters.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
−Removed: February 22, 2024
+Added: March 4, 2025
We have served as the Company’s auditor since 2020.
4 unchanged sentences
Cash and cash equivalents
−Removed: Short-term investments
+Added: Marketable securities
Accounts receivable, net
15 unchanged sentences
Stockholders’ equity:
−Removed: Preferred stock, $ 0.0001 par value;
−Removed: 10,000,000 shares authorized
Common stock, $ 0.0001 par value;
3 unchanged sentences
Accumulated deficit
−Removed: Accumulated other comprehensive income (loss)
+Added: Accumulated other comprehensive (loss) income
Total stockholders’ equity
−Removed: Total liabilities, redeemable convertible preferred stock and stockholders' equity
+Added: Total liabilities and stockholders' equity
The accompanying notes are an integral part of these consolidated financial statements.
4 unchanged sentences
Product revenue, net
−Removed: Grant revenue
−Removed: Total revenues
Operating expenses:
Cost of sales
+Added: Cost of sales - inventory impairment and loss on firm purchase commitments
+Added: Acquired in-process research and development
Research and development
Selling, general and administrative
+Added: Restructuring expenses
Total operating expenses
−Removed: Income (loss) from operations
−Removed: Other income (expense), net:
+Added: (Loss) income from operations
+Added: Other income, net:
Interest income
−Removed: Change in fair value of convertible notes
Other expense, net
−Removed: Total other income (expense), net
−Removed: Income (loss) before income taxes
−Removed: Provision for income taxes
−Removed: Net income (loss)
−Removed: Net income (loss) per share
−Removed: Weighted-average shares used in computing net income (loss) per share
+Added: Total other income, net
+Added: (Loss) income before income taxes
+Added: (Benefit) provision for income taxes
+Added: Net (loss) income
+Added: Net (loss) income per share
+Added: Weighted-average shares used in computing net (loss) income per share
The accompanying notes are an integral part of these consolidated financial statements.
3 unchanged sentences
Year Ended December 31,
−Removed: Net income (loss)
−Removed: Other comprehensive income (loss):
−Removed: Foreign currency translation gain (loss)
−Removed: Net unrealized gain (loss) on investments held
−Removed: Other comprehensive income (loss)
−Removed: Comprehensive income (loss)
+Added: Net (loss) income
+Added: Other comprehensive (loss) income:
+Added: Foreign currency translation (loss) gain
+Added: Net unrealized gain on marketable securities
+Added: Other comprehensive (loss) income
+Added: Comprehensive (loss) income
The accompanying notes are an integral part of these consolidated financial statements.
AMYLYX PHARMACEUTICALS, INC.
−Removed: CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
−Removed: Preferred Stock
Comprehensive
1 unchanged sentence
Income (Loss)
−Removed: Equity (Deficit)
Balance as of January 1, 2023
−Removed: Issuance of Series C-1 redeemable convertible preferred stock, net of issuance costs of $ 209
−Removed: Conversion of convertible notes and accrued interest into Series C-2 redeemable convertible preferred stock, net of issuance cost of $ 50
Issuance of common stock upon exercise of stock options
−Removed: Stock-based compensation expense
−Removed: Other comprehensive loss
−Removed: Balance as of December 31, 2021
−Removed: Conversion of preferred stock into common stock upon initial public offering
−Removed: Issuance of common stock upon initial public offering, net of issuance costs of $ 19,639
−Removed: Issuance of common stock upon follow-on offering, net of issuance costs of $ 15,719
−Removed: Issuance of common stock upon exercise of stock options
+Added: Issuance of common stock upon vesting of RSUs
Stock-based compensation expense
−Removed: Other comprehensive loss
+Added: Other comprehensive income
Balance as of December 31, 2023
2 unchanged sentences
Stock-based compensation expense
−Removed: Other comprehensive income
+Added: Other comprehensive loss
Balance as of December 31, 2024
4 unchanged sentences
Year Ended December 31,
−Removed: Cash flows provided by (used in) operating activities:
−Removed: Net income (loss)
−Removed: Adjustments to reconcile net income (loss) to net cash used in operating activities:
+Added: Cash flows (used in) provided by operating activities:
+Added: Net (loss) income
+Added: Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
Stock-based compensation expense
Depreciation expense
−Removed: (Accretion) amortization of investment (discounts) premiums
−Removed: Change in fair value of convertible notes
+Added: Accretion of investment discounts, net
+Added: Inventory impairment and loss on firm purchase commitments
+Added: Property and equipment impairment
+Added: Charge for purchase of IPR&D assets
Changes in operating assets and liabilities:
Accounts receivable, net
−Removed: Interest receivable
−Removed: Prepaid expenses and other current assets
−Removed: Operating lease right-of-use assets
+Added: Prepaid expenses and other assets
Accounts payable
−Removed: Accrued expenses and deferred rent
+Added: Accrued expenses
Operating lease liabilities
−Removed: Accrued interest and accrued interest—related parties
−Removed: Net cash provided by (used in) operating activities
−Removed: Cash flows provided by (used in) investing activities:
+Added: Net cash (used in) provided by operating activities
+Added: Cash flows provided by investing activities:
Purchases of property and equipment
−Removed: Purchases of short-term investments
−Removed: Proceeds from maturities of short-term investments
−Removed: Net cash provided by (used in) investing activities
+Added: Purchases of IPR&D assets, including transaction costs
+Added: Purchases of investments
+Added: Proceeds from maturities of marketable securities
+Added: Net cash provided by investing activities
Cash flows provided by financing activities:
−Removed: Repayment and proceeds from PPP loan
−Removed: Proceeds from initial public offering
−Removed: Proceeds from follow-on offering
−Removed: Initial public offering costs paid
Follow-on offering costs paid
−Removed: Proceeds from issuance of convertible notes—related parties
−Removed: Proceeds from issuance of convertible notes, net of issuance costs
−Removed: Issuance costs related to conversion of convertible notes
−Removed: Proceeds from issuance of Series C-1 redeemable convertible preferred stock
−Removed: Issuance costs related to issuance of Series C-1 redeemable convertible preferred stock
−Removed: Proceeds from exercise of stock options
+Added: Proceeds from exercise of stock options and RSUs vesting
Withholding taxes paid on stock-based awards
−Removed: Payment of deferred offering costs
Net cash provided by financing activities
Effect of exchange rate changes on cash, cash equivalents and restricted cash equivalents
−Removed: Net increase in cash, cash equivalents and restricted cash equivalents
−Removed: Cash, cash equivalents and restricted cash equivalents, beginning of period
−Removed: Cash, cash equivalents and restricted cash equivalents, end of period
+Added: Net (decrease) increase in cash, cash equivalents and restricted cash equivalents
+Added: Cash, cash equivalents and restricted cash equivalents, beginning of year
+Added: Cash, cash equivalents and restricted cash equivalents, end of year
+Added: Reconciliation of cash, cash equivalents and restricted cash equivalents:
+Added: Cash and cash equivalents
+Added: Restricted cash equivalents
+Added: Total cash, cash equivalents and restricted cash equivalents:
Supplemental disclosure of cash flow information:
−Removed: Conversion of convertible notes and accrued interest into Series C-2 redeemable convertible preferred stock
−Removed: Unrealized gain (loss) on short-term investments
Taxes withheld on stock-based awards included in accrued expenses
Purchases of property and equipment included in accounts payable
−Removed: Deferred offering costs included in accounts payable and accrued expenses
−Removed: Right-of-use assets and liabilities upon ASC 842 adoption
−Removed: Right-of-use assets obtained in exchange for lease liabilities
−Removed: Movement of deferred offering costs to equity
−Removed: Follow-on offering costs included in accounts payable and accrued expenses
−Removed: Conversion of preferred stock to common stock upon initial public offering
Income taxes paid
3 unchanged sentences
Nature of Business
−Removed: Amylyx Pharmaceuticals, Inc., together with its wholly owned subsidiaries, known as Amylyx or the Company, is a commercial-stage biotechnology company with a mission to end the suffering caused by neurodegenerative diseases.
−Removed: The Company is pursuing amyotrophic lateral sclerosis, or ALS, as its first indication and is focused on the development and potential commercialization of AMX0035 for ALS globally.
−Removed: AMX0035 is approved by the U.S.
−Removed: Food and Drug Administration, or the FDA, and marketed as RELYVRIO ® (sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine) for the treatment of ALS in adults in the U.S.
−Removed: AMX0035 is also approved with conditions by Health Canada and marketed as ALBRIOZA for the treatment of ALS in Canada.
−Removed: The Company continues to focus on the completion of its global PHOENIX Phase 3 clinical trial, which will provide additional data on the efficacy and safety profile of AMX0035 in people living with ALS, and is also developing AMX0035 in other neurodegenerative diseases.
−Removed: AMX0035 was designed to target endoplasmic reticulum, or ER, stress and mitochondrial dysfunction, two connected central pathways that can lead to neurodegeneration.
−Removed: The Company is further investigating AMX0035 in diseases where ER and mitochondrial stress are implicated, including progressive supranuclear palsy, or PSP, and Wolfram syndrome, or WS.
−Removed: The Company dosed the first participant in the HELIOS trial, a Phase 2 trial of AMX0035 for the treatment of WS, in April 2023.
−Removed: The Company dosed the first participant in the ORION trial, a global, pivotal Phase 3 trial of AMX0035 for the treatment of PSP, in December 2023.
−Removed: The Company is also advancing additional drug candidates for neurodegenerative diseases including AMX0114, an antisense oligonucleotide, targeting Calpain-2, a key protein in axonal degeneration, among others.
+Added: Amylyx Pharmaceuticals, Inc., together with its wholly-owned subsidiaries, known as Amylyx or the Company, is a biotechnology company that is committed to the discovery and development of new treatment options for communities with high unmet needs, including people living with serious and fatal neurodegenerative diseases and endocrine conditions.
Risks and Uncertainties
−Removed: The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, the outcome of preclinical studies and clinical trials, market acceptance and the successful commercialization of its approved products ALBRIOZA, which received marketing authorization with conditions in Canada in June 2022, and RELYVRIO, which was approved by the FDA in the U.S.
−Removed: in September 2022, potential difficulties with or delays in timing with respect to regulatory approval processes, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, ability to secure additional capital to fund operations, and risks associated with the economic challenges caused by global health crises such as the COVID-19 pandemic and economic uncertainty in various global markets caused by geopolitical instability and conflict.
−Removed: The Company and its contractors may experience disruptions in supply of items that are essential for its research and development and commercial activities, including, for example, raw materials and bulk drug substances that the Company imports from Europe and Canada used in the manufacturing of AMX0035, and any additional or future product candidates.
+Added: The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, the outcome of preclinical studies and clinical trials, potential difficulties with or delays in timing with respect to regulatory approval processes, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, ability to secure additional capital to fund operations, and risks associated with the economic challenges caused by economic uncertainty in various global markets caused by geopolitical instability and conflict.
+Added: The Company and its contractors may experience disruptions in supply of items that are essential for its research and development activities, including, for example, raw materials and bulk drug substances that the Company imports from Europe and Canada used in the manufacturing of avexitide, AMX0035 and any additional or future product candidates.
+Added: The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.
+Added: The Company expects to continue to generate operating losses for the foreseeable future.
+Added: In January 2025, the Company received gross proceeds of $ 69 million in a public offering of the Company's common stock (see Note 18 Subsequent events ).
+Added: The Company expects that its cash, cash equivalents, marketable securities and the proceeds from the January 2025 Offering will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance of these consolidated financial statements.
+Added: To continue its development efforts, the Company will need to obtain substantial additional funding through public or private equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements in order to fund its research and development and ongoing operating expenses.
+Added: The Company may not be able to obtain financing on acceptable terms, when needed or at all, and the Company may not be able to enter into collaborations, strategic alliances or licensing arrangements.
+Added: The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders.
+Added: Any collaborations, strategic alliances or licensing arrangements may require the Company to relinquish rights to certain of its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to the Company.
+Added: If the Company is unable to obtain funding, the Company could be forced to delay, limit, reduce or eliminate some or all of its research and development programs, pipeline expansion or future commercialization efforts or grant rights to develop and market product candidates, which could adversely affect its business prospects.
+Added: Although management will continue to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations when needed or at all.
Summary of Significant Accounting Policies
3 unchanged sentences
Use of Estimates— The preparation of the consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of expenses during the reporting period.
−Removed: Actual results could differ from those estimates.
+Added: Actual results could differ
+Added: from those estimates.
Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the financial statements.
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Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates.
−Removed: Estimates are used in the following areas, among others:
−Removed: gross-to-net, or GTN, adjustments;
−Removed: recoverability of inventories, including those produced in preparation for product launches;
−Removed: accrued expenses;
−Removed: stock option valuations;
−Removed: valuation allowance for deferred tax assets and research and development expenses.
Revenue recognition— In June 2022, AMX0035 received marketing authorization with conditions as ALBRIOZA by Health Canada for the treatment of ALS, and the Company launched ALBRIOZA in Canada in July 2022.
1 unchanged sentence
in October 2022.
−Removed: The Company enters into arrangements with wholesalers, specialty pharmacies and specialty distributors, or Customers, to distribute ALBRIOZA, RELYVRIO and future approved products.
+Added: In April 2024, the Company announced that it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO and ALBRIOZA (AMX0035) for ALS and remove the product from the market based on topline results from the global Phase 3 PHOENIX trial, which did not meet its prespecified primary and secondary endpoints.
+Added: Amylyx wound down the Open Label Extension as planned.
+Added: The Company entered into arrangements with wholesalers, specialty pharmacies and specialty distributors, or customers, to distribute ALBRIOZA, RELYVRIO, prior to voluntary discontinuation.
In accordance with ASC Topic 606 - Revenue from Contracts with Customers , or Topic 606, revenue is recognized when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.
−Removed: To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps:
−Removed: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the Company satisfies a performance obligation.
−Removed: The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration the Company expects to be entitled to in exchange for the goods or services the Company transfers to its customer.
−Removed: At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.
+Added: At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.
The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Product Revenue, Net
−Removed: The Company sells its approved products to its Customers.
−Removed: These Customers subsequently resell our products to specialty pharmacy providers, specialty distributors, health care providers, certain medical centers or hospitals, and patients.
−Removed: In addition to agreements with the Customers, the Company enters into arrangements with specialty pharmacies, health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of our products.
−Removed: The Company’s customer identification process considers a number of factors, including contractual and legal factors, and who controls the Company’s product and bears inventory risk.
−Removed: The Company evaluates these factors on a customer-by-customer basis to determine the appropriate customer for revenue recognition purposes.
−Removed: In some cases, the Company may use a third-party logistics providers to deliver the Company’s product to its customers, but the Company recognizes revenue upon delivery to the customer, as its determined that the third-party logistics provider is acting as our agent.
−Removed: Changes in these factors or our assumptions regarding these factors could impact our revenue recognition
+Added: The Company sold its approved products to its customers.
+Added: These customers subsequently resold our products to specialty pharmacy providers, specialty distributors, health care providers, certain medical centers or hospitals, and patients.
+Added: In addition to agreements with the customers, the Company entered into arrangements with specialty pharmacies, health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of our products.
+Added: The Company’s customer identification process considered a number of factors, including contractual and legal factors, and who controls the Company’s product and bears inventory risk.
+Added: The Company evaluated these factors on a customer-by-customer basis to determine the appropriate customer for revenue recognition purposes.
+Added: In some cases, the Company used a third-party logistics providers to deliver the Company’s product to its customers, but the Company recognized revenue upon delivery to the customer, as it was determined that the third-party logistics provider was acting as our agent.
The Company recognizes revenue on product sales when the customer obtains control of our product, which occurs at a point in time (upon delivery).
Product revenues are recorded net of applicable GTN adjustments, which are described below.
−Removed: If taxes should be collected from Customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue.
+Added: Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenue.
The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less.
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These GTN adjustments, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer).
−Removed: These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as historical experience, payer channel mix (e.g., Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel.
+Added: These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as historical experience, payer channel mix (e.g., Medicare or
+Added: Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel.
In certain circumstances, the Company applies the most likely method in Topic 606.
−Removed: determination to use the expected value method or the most likely method is based on the type of GTN adjustment and what method better predicts the amount of consideration we expect to be entitled to.
+Added: The determination to use the expected value method or the most likely method is based on the type of GTN adjustment and what method better predicts the amount of consideration we expect to be entitled to.
Overall, these GTN adjustments reflect in the transaction price the amount of consideration to which the Company expects to be entitled to in exchange for transferring promised goods or services to its customers.
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The Company estimates the amount of product sales that may be returned by our customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net on the consolidated balance sheets.
−Removed: The Company currently estimates returns using quantitative and qualitative information including, but not limited to, historical experience with returns, projected demand, levels of inventory in the distribution channel, product dating and expiration period, and whether products have been discontinued, among others.
−Removed: The Company has received an immaterial amount of returns to date and believes that returns of product in future periods will be minimal.
Provider Chargebacks and Discounts
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These GTN adjustments are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net.
−Removed: GTN adjustments for chargebacks consist of credits that Customers have not claimed, but for which we expect to issue for units that remain in the distribution channel inventories at each reporting period-end that we expect will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which we have not yet issued a credit.
+Added: GTN adjustments for chargebacks consist of credits that customers have not claimed, but for which we expect to issue a credit.
Payor Rebates
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For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe an additional liability under the Medicare Part D program.
−Removed: The Company's liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for
−Removed: the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
+Added: The Company's liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
Other Incentives
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The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the consolidated balance sheets.
−Removed: Comprehensive Loss— Comprehensive loss includes net loss, as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders.
−Removed: Comprehensive loss is composed of net loss and other comprehensive (loss) income.
+Added: Comprehensive Income (Loss)— Comprehensive income (loss) includes net loss, as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders.
+Added: Comprehensive income (loss) is composed of net income (loss) and other comprehensive (loss) income.
Other comprehensive (loss) income consists of unrealized gains and losses on marketable securities and foreign currency translation.
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Cash equivalents represent funds invested in readily available checking and money market funds.
−Removed: Restricted Cash Equivalents— Restricted cash equivalents consist of $ 0.2 million of cash serving as collateral for a letter of credit issued for the Company’s office space, and $ 0.5 million as collateral for a corporate credit card program.
−Removed: As of December 31, 2023 and 2022, the Company’s restricted cash equivalents balance was $ 0.7 million and $ 0.7 million , respectively.
+Added: Restricted Cash Equivalents— Restricted cash equivalents consist of cash serving as collateral for a letter of credit issued for the Company’s office spaces and collateral for a corporate credit card program.
Accounts receivable, net— The Company’s accounts receivable consists of amounts due from customers related to product sales and have standard payment terms.
1 unchanged sentence
Amounts determined to be uncollectible are written-off against the established reserve.
−Removed: As of December 31, 2023 and 2022 , the credit profiles for the Company’s customers were deemed to be in good standing and expected credit losses were not material.
−Removed: Short-Term Investments— Short-term investments are composed of U.S.
−Removed: treasury notes and bills, corporate debt securities, commercial paper and agency bonds with maturities of less than one year from the balance sheet date.
−Removed: The Company classifies all of its short-term investments as available-for-sale.
+Added: The credit losses were not material in the periods presented.
+Added: Marketable Securities— Marketable securities are composed of U.S.
+Added: treasury bills and U.S.
+Added: agency bonds.
+Added: The Company classifies all of its marketable securities as available-for-sale.
Accordingly, these investments are recorded at fair value, which is determined based on quoted market prices.
Unrealized gains and losses on available-for-sale securities are included as a separate component of other accumulated comprehensive loss.
−Removed: The cost of short-term investments is adjusted for amortization of premiums and accretion of discounts until maturity.
+Added: The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts.
Such amortization and accretion are included in interest income.
Realized gains and losses are included in other expense, net.
−Removed: The Company evaluates short-term investments for other-than-temporary impairment at the balance sheet date.
+Added: The Company evaluates marketable securities for other-than-temporary impairment at the balance sheet date.
Declines in fair value, if any, determined to be other than temporary-than-temporary are also included in other income, net.
−Removed: When assessing short-term investments for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, and the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general.
−Removed: As of December 31, 2023 and 2022 , there were no impairment charges on short-term investments.
−Removed: Concentrations of Credit Risk— Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and accounts receivable, net.
−Removed: The Company maintains its cash in financial institutions that it believes have high credit quality.
+Added: When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, and the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general.
+Added: There were no impairment charges on marketable securities in the periods presented.
+Added: Concentrations of Credit Risk— Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities and accounts receivable, net.
+Added: The Company maintains its cash in financial institutions that management believes have high credit quality.
The Company has not experienced any losses on such accounts, and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
1 unchanged sentence
Amylyx performs ongoing credit evaluations of its customers and generally does not require collateral.
−Removed: The Company monitors its exposure and
−Removed: records a reserve against uncollectible amounts as necessary.
−Removed: Three and four customers individually accounted for approximately 81 % and 97 % of total gross product revenue in 2023 and 2022 , respectively.
−Removed: No revenue was recognized in 2021.
−Removed: Three and three customers individually accounted for approximately 81 % and 98 % of total accounts receivable, net as of December 31, 2023 and 2022 , respectively.
−Removed: Fair Value Measurements— Assets and liabilities recorded at fair value on a recurring basis on the consolidated balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair values.
−Removed: Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
+Added: The Company monitors its exposure and records a reserve against uncollectible amounts as necessary.
+Added: Five and three customers individually accounted for approximately 89 % and 81 % in the aggregate of gross product revenue in 2024 and 2023, respectively.
+Added: One and three customers individually accounted for approximately 100 % and 81 % of total accounts receivable, net as of December 31, 2024 and 2023 , respectively.
+Added: Fair Value Measurements— Assets and liabilities recorded at fair value on a recurring basis on the consolidated balance sheet are categorized based upon the level of judgment associated with the inputs used to measure fair values.
+Added: value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
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A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
−Removed: The Company’s financial instruments consist of cash, cash equivalents, restricted cash equivalents, short-term investments, accounts receivable, net, accounts payable and accrued expenses.
−Removed: The Company’s short-term investments are carried at fair value, determined according to Level 1 and Level 2 inputs to the fair value hierarchy described above.
−Removed: The Company’s 2021 Notes (as defined in Note 8) were carried at fair value, determined according to Level 3 inputs in the fair value hierarchy described above.
+Added: The Company’s financial instruments consist of cash, cash equivalents, restricted cash, marketable securities, accounts receivable, net, accounts payable and accrued expenses.
+Added: The Company’s marketable securities are carried at fair value, determined according to Level 1 and Level 2 inputs to the fair value hierarchy described above.
The remaining financial instruments are stated at their respective carrying amounts, which approximate fair value due to the short-term nature of these assets and liabilities.
3 unchanged sentences
The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified.
−Removed: Such impairment charges, should they occur, are recorded within cost of sales.
−Removed: The determination of whether inventory costs will be realizable requires estimates by management.
−Removed: If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as cost of sales in the consolidated statements of operations.
+Added: Such impairment charges are recorded within cost of sales.
The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized.
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Maintenance and repairs that do not improve or extend the life of the assets are expensed when incurred.
−Removed: Upon sale or retirement of assets, the cost and accumulated depreciation are removed from the consolidated balance sheets
−Removed: and any resulting gain or loss is reflected in the consolidated statements of operations in the period realized.
+Added: Upon sale or retirement of assets, the cost and accumulated depreciation are removed from the consolidated balance sheets and any resulting gain or loss is reflected in the consolidated statements of operations in the period realized.
The range of useful lives of property and equipment is as follows:
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Impairment of Long-Lived Assets— The Company evaluates assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable.
−Removed: Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate.
−Removed: If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book values of the assets exceed their fair value.
−Removed: The Company has no t recognized any impairment losses in the years ended December 31, 2023 and 2022 .
+Added: Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to
+Added: If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book values of the assets exceed fair value.
+Added: Business Combinations and Asset Acquisitions— The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.
+Added: If the screen test is met, the transaction is accounted for as an asset acquisition.
+Added: If the screen test is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the requirements of a business.
+Added: If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given.
+Added: Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values.
+Added: In-process research and development, or IPR&D, projects with no alternative future use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated.
Research and Development— Research and development expenses include costs directly attributable to the conduct of research and development activities.
2 unchanged sentences
In addition, research and development-related salaries and benefits, facility, and overhead costs, supplies and other related costs are included in research and development expense.
+Added: License and Collaboration Agreements — The Company analyzes license and collaboration arrangements pursuant to ASC Topic 808 - Collaborative Arrangement Guidance and Considerations , or ASC 808, to assess whether such arrangements, or transactions between arrangement participants, 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.
+Added: Collaboration arrangements often require upfront payments and may include additional milestone, research and development cost sharing, royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development and commercialization.
+Added: Upfront payments associated with collaborative arrangements and subsequent payments made to the partner for the achievement of development milestones prior to regulatory approval are expensed to acquired IPR&D expense as incurred.
+Added: Contingent consideration obligations are recorded when it is probable that they will occur and they can be reasonably estimated.
Sales and Marketing Costs— Sales and marketing expenses consist primarily of wages and benefits for sales and marketing personnel, professional and consulting fees, administrative travel expenses, and marketing and advertising costs such as marketing literature, promotional activities, conferences and seminars and branding.
2 unchanged sentences
For the years ended December 31, 2024 and 2023, advertising costs were $ 2.7 million and $ 9.5 million , respectively.
−Removed: The Company did not have commercial products in 2021.
Patent-Related Costs— Patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure.
Amounts incurred are classified as selling, general and administrative expenses in the accompanying consolidated statements of operations.
−Removed: Stock-Based Compensation Expense— Stock-based compensation is recognized in the consolidated statements of operations based on their fair values on the date of grant over the requisite service period, which is generally equal to the vesting period of the respective award.
−Removed: Forfeitures are accounted for as they occur.
−Removed: Generally, the Company issues stock option awards with only service-based vesting conditions and records the expense for these awards using the straight-line method.
−Removed: The Company classifies stock-based compensation expense in the same manner in which the awards recipient’s payroll or service provider’s costs are classified.
−Removed: The fair value of each restricted common stock award is estimated on the date of grant based on the fair value of the Company’s common stock on that same date.
+Added: Stock-Based Compensation Expense— Stock-based compensation is recognized in the consolidated statements of operations based on the fair value on the date of grant over the requisite service period, which is generally equal to the vesting period of the respective award.
+Added: Forfeitures are accounted for as incurred.
+Added: Generally, the Company issues stock awards with only service-based vesting conditions and records the expense for these awards using the straight-line method.
+Added: The Company classifies stock-based compensation expense in the same manner in which the award recipient’s payroll costs are classified.
+Added: The fair value of each restricted common stock award is measured based on the fair value of the Company’s common stock on the grant date.
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the award, the risk-free interest rate, and expected dividends.
5 unchanged sentences
The stock price of the Company is based on the closing price on the date of grant.
−Removed: Prior to the IPO, as there was no public market for the Company’s common stock, the estimated fair value of common stock was determined by the Company’s Board of Directors as of the date of each option grant, with input from management, considering third-party valuations of its common stock as well as the Company’s Board of Directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the
−Removed: These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately Held Company Equity Securities Issued as Compensation .
Contingencies— From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities.
1 unchanged sentence
If the reasonable estimate of the loss is a range and no amount within the range is a better estimate, the minimum amount of the range is recorded as a liability on the Company’s consolidated balance sheets.
−Removed: The Company does not accrue for contingent losses that, in its judgement, are considered to be reasonably possible, but not probable;
+Added: The Company does not accrue for contingent losses that, in its judgment, are considered to be reasonably possible, but not probable;
however, it discloses the range of reasonably possible losses.
−Removed: There were no loss or gain contingencies recorded in the Company’s consolidated financial statements as of and during the years ended December 31, 2023 and 2022 .
−Removed: Leases— The Company adopted the FASB, ASC 842, Leases, or ASC 842, on January 1, 2022.
−Removed: ASC 842 allows the Company to elect a package of practical expedients, which include:
−Removed: (i) an entity need not reassess whether any expired or existing contracts are or contain leases;
−Removed: (ii) an entity need not reassess the lease classification for any expired or existing leases;
−Removed: and (iii) an entity need not reassess any initial direct costs for any existing leases.
−Removed: Another practical expedient allows the Company to use hindsight in determining the lease term when considering lessee options to extend or terminate the lease and to purchase the underlying asset.
−Removed: The Company has elected to utilize this package of practical expedients and has not elected the hindsight methodology in its implementation of ASC 842.
−Removed: The Company leases its offices, and may from time to time, enter into other lease agreements in conducting its business.
+Added: Leases— The Company leases its offices, and may from time to time, enter into other lease agreements in conducting its business.
The Company determines if an arrangement includes a lease at the inception of the agreement.
1 unchanged sentence
Operating lease right-of-use assets and operating lease liabilities are recognized at the lease commencement date based on the net present value of the remaining future minimum lease payments over the lease term.
−Removed: If the interest rate implicit in the Company’s leases is not readily determinable, in determining the weighted-average discount rate used to calculate the net present value of lease payments, the Company utilizes an estimate of its incremental borrowing rate based on market sources including interest rates for companies with similar credit quality for agreements of similar duration, determined by class of underlying asset, to discount the lease payments.
+Added: If the interest rate implicit in the Company’s leases is not readily determinable, in determining the weighted-average discount rate used to calculate the net present value of lease payments, the Company utilizes an estimate of its incremental borrowing rate based on market sources including interest rates for companies with similar credit quality for agreements of similar duration to discount the lease payments.
Lease expense for the Company’s operating leases is recognized on a straight-line basis over the lease term and variable lease costs are expensed as incurred.
2 unchanged sentences
The lease may require the Company to pay additional amounts for maintenance and other expenses, which are generally referred to as non-lease components.
−Removed: The Company has elected the practical expedient to combine lease and non-lease components.
+Added: Non-lease components (e.g., common area maintenance) are paid separately from rent based on actual costs incurred and therefore are not included in the operating lease right-of-use assets and lease liabilities and are reflected as an expense in the period incurred.
If a lease includes options to extend the lease term, the Company does not assume the option will be exercised in its initial lease term assessment unless there is reasonable certainty that the Company will renew based on an assessment of economic factors present as of the lease commencement date.
−Removed: Prior to the adoption of ASC 842, at the inception of each lease, the Company evaluated the lease agreement to determine whether the lease was an operating or capital lease in accordance with ASC 840, Leases (ASC 840) .
−Removed: When any one of the four test criteria in ASC 840 was met, the lease then qualified as a capital lease.
−Removed: If the lease agreements contained renewal options, tenant improvement allowances, rent holidays or rent escalation clauses, the Company recorded a deferred rent asset or liability equal to the difference between the rent expense and future minimum lease payments due.
−Removed: The rent expense related to operating leases was recognized on a straight-line basis in the statements of operations over the term of each lease.
Income Taxes— The Company accounts for income taxes using the asset and liability approach.
5 unchanged sentences
Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
−Removed: As of December 31, 2023, we continued to maintain a full valuation allowance against all of our U.S.
−Removed: federal and state deferred tax assets based on management’s evaluation of all available evidence, including our history of incurring significant losses from operations.
−Removed: Our evaluation of all available evidence also includes consideration of regulatory approvals of ALBRIOZA and RELYVRIO, including revenue generated from the sale these products in 2023 .
−Removed: Given the early stage of our product launch, we are uncertain about the timing and amount of future sales.
−Removed: We may release all or a portion of the valuation allowance in the near-term;
−Removed: however, the release of the valuation allowance, as well as the exact timing and the amount of such release, continue to be subject to, among other things, our level of profitability, revenue growth, clinical program progression and expectations regarding future profitability.
−Removed: Segment Information— An operating segment is defined as a component of a business that engages in business activities for which it may earn revenues and incur expenses and for which discrete financial information is available that is evaluated regularly by the chief operating decision maker or makers in order to make decisions about resources to be allocated to the segment and assess its performance.
−Removed: The Company has determined that its CO-Chief Executive Officers are the chief operating decision makers, or CODM.
−Removed: The CODM reviews consolidated operating results to make decisions about allocating resources or capital to specific compounds or projects in line with the Company’s overall strategies and goals.
−Removed: The Company's entire business is managed by a single management team, which reports to the CO-Chief Executive Officers.
−Removed: The Company has one operating segment which is the business of researching and developing therapeutics for neurodegenerative disorders.
−Removed: For the years ended December 31, 2023 and 2022 , all of the Company's long-lived assets were held within the U.S.
−Removed: Net income (loss) per share— The Company follows the two-class method when computing net income (loss) per share as the Company has issued shares that meet the definition of participating securities.
−Removed: The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings.
−Removed: The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.
−Removed: Basic net income (loss) per share is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period.
−Removed: Diluted net income (loss) is computed by adjusting net income (loss) attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities.
−Removed: Diluted net income (loss) per share attributable to common stockholders is computed by dividing the diluted net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares.
−Removed: For purpose of this calculation, stock options, convertible notes, and redeemable convertible preferred stock are considered potential dilutive common shares.
−Removed: The Company’s redeemable convertible preferred stock contractually entitles the holders of such shares to participate in dividends but does not contractually require the holders of such shares to participate in losses of the Company.
−Removed: Accordingly, in periods in which the Company reports a net loss attributable to common stockholders, such losses are not allocated to such participating securities.
−Removed: In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
+Added: As of December 31, 2024 , we continued to maintain a full valuation allowance against all of our deferred tax assets based on management’s evaluation of all available evidence, including our history of incurring significant losses from operations.
Recent Accounting Pronouncements
3 unchanged sentences
Improvement to Income Tax Disclosures , or ASU 2023-09, to enhance the transparency and decision usefulness of income tax disclosures.
−Removed: ASU 2023-09 is effective for annual periods beginning after December 15, 2024 on a prospective basis.
−Removed: Early adoption and retrospective application is permitted.
−Removed: The Company is currently evaluating the impact of this ASU on its consolidated financial statements and related disclosures.
+Added: ASU 2023-09 is effective for the Company beginning January 1, 2025 on a prospective basis.
+Added: The impact of this ASU on the tax disclosures is not expected to be material.
In November 2024, the FASB issued ASU No.
−Removed: 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures , or ASU 2023-09, which requires public entities to disclose information about their reportable segments’ significant expenses on an interim and annual basis.
−Removed: ASU 2023-07 is effective for the Company beginning the year ended May 31, 2025.
+Added: 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses, which requires new financial statement disclosures in tabular format, in the notes to financial statements, of specified information about certain costs and expenses.
+Added: The amendments in this update do not change or remove current expense disclosure requirements.
+Added: The amendments in this update are effective for the Company's annual financial statement disclosure beginning December 31, 2027, and interim periods within the years beginning January 1, 2028.
+Added: Early adoption is permitted.
The Company is currently evaluating the impact of this ASU on its consolidated financial statements and related disclosures.
−Removed: Recently Adopted Accounting Pronouncements
−Removed: In June 2016, the FASB issued ASU No.
−Removed: 2016-13, Financial Instruments—Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments , or ASU 2016-13.
−Removed: The provisions of ASU 2016-13 modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates.
−Removed: Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security.
−Removed: The Company adopted ASU 2016-13 effective January 1, 2023, with no material impact on its consolidated financial statements and related disclosures.
−Removed: Effective January 1, 2022, the Company adopted the requirements under the ASC 842 using the modified retrospective transition approach.
−Removed: Comparative periods have not been restated.
−Removed: This standard requires entities that lease assets to recognize the assets and liabilities for the rights and obligations created by those leases on the balance sheet.
−Removed: The Company elected the available package of practical expedients which allows it to not reassess previous accounting conclusions around whether arrangements are or contain leases, the classification of its leases, and the treatment of initial direct costs.
−Removed: The Company has made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet.
−Removed: ASC 842 was issued in order to increase transparency and comparability of financial reporting related to leasing arrangements.
−Removed: The main difference between previous GAAP, or ASC 840, and ASC 842 is the recognition of right-of-use lease assets and lease liabilities by lessees for those leases that were classified as operating leases under ASC 840.
−Removed: At January 1, 2022, the Company recorded right-of-use assets of $ 2.2 million and operating lease liabilities of $ 2.2 million.
−Removed: Adoption of the standard did not have a material impact on the consolidated statements of operations.
−Removed: For additional information regarding how the Company is accounting for leases under ASC 842, refer to Note 10.
PRODUCT REVENUE, NET
−Removed: To date, the Company’s only source of product revenue has been from the sales of RELYVRIO, known as ALBRIOZA in Canada.
−Removed: Significant judgment is required in estimating GTN adjustments considering historical experience, payer channel mix (e.g., Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel.
+Added: To date, the Company’s only source of product revenue had been from the sales of RELYVRIO, known as ALBRIOZA in Canada.
+Added: In April 2024, the Company announced it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA and remove the product from the market in the U.S.
+Added: and Canada based on topline results from the Phase 3 PHOENIX trial.
The following table reconciles gross product revenue to net product revenue:
9 unchanged sentences
(in thousands)
−Removed: Ending balance at December 31, 2021
+Added: Balance at January 1, 2022
Provision related to sales in the current year
1 unchanged sentence
Credits and payments made
−Removed: Ending balance at December 31, 2022
+Added: Balance at December 31, 2023
Provision related to sales in the current year
1 unchanged sentence
Credits and payments made
−Removed: Ending balance at December 31, 2023
−Removed: Included in the ending reserve balance for GTN adjustments are chargebacks resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company, discounts to customers for prompt payment and estimates for product returns.
−Removed: Chargebacks, discounts and returns are recorded as reductions of accounts receivable, net on the consolidated balance sheets.
−Removed: In addition, included in the ending reserve balance for GTN adjustments are Medicaid and Medicare rebates, other
−Removed: rebates for obligations under voluntary patient assistance programs, and accrued fees payable to customers.
−Removed: Medicaid and Medicare rebates, other rebates and fees are recorded as a component of accrued expenses on the consolidated balance sheets.
−Removed: SHORT-TERM INVESTMENTS
−Removed: The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date.
−Removed: The Company has classified all of its marketable securities at December 31, 2023 and 2022 as “available-for-sale” pursuant to ASC 320, Investments – Debt and Equity Securities .
+Added: Balance at December 31, 2024
+Added: Included in the ending reserve balance for GTN adjustments are chargebacks resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from the Company, rebates and estimates for product returns.
+Added: Chargebacks, discounts and returns are recorded as reductions of accounts receivable, net on the condensed consolidated balance sheets to the extent there are receivable balances to reduce.
+Added: If there are net balances owed to customers, they are recorded as a component of accrued expenses on the consolidated balance sheets.
+Added: MARKETABLE SECURITIES
+Added: The Company has classified all of its marketable securities as “available-for-sale”.
The Company records available-for-sale securities at fair value, with the unrealized gains and losses included as a separate component of other accumulated comprehensive income (loss).
−Removed: There were no realized gains or losses recognized during the years ended December 31, 2023 and 2022.
+Added: There were no realized gains or losses recognized in the periods presented.
The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity.
2 unchanged sentences
The Company includes interest and dividends on securities classified as available-for-sale in interest income.
−Removed: Accrued interest receivable relating to the Company's available-for-sale securities is presented within prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets, and amounted to $ 0.5 million and $ 0.5 million at December 31, 2023 and 2022, respectively.
−Removed: The following is a summary of available-for-sale securities with unrealized losses for less than 12 months as of December 31, 2023 and 2022 (in thousands):
−Removed: December 31, 2023
−Removed: December 31, 2022
−Removed: Unrealized Losses
−Removed: Unrealized Losses
−Removed: Treasury notes
−Removed: Treasury bills
−Removed: Corporate debt securities
−Removed: Total available-for-sale securities in an unrealized loss position
−Removed: At December 31, 2023, the Company's security portfolio consisted of 11 securities related to investments in debt securities available-for-sale, of which 1 security was in an unrealized loss position.
−Removed: There were no securities in an unrealized loss position for greater than 12 months as of December 31, 2023.
−Removed: The contractual terms of these investments do not permit the issuer to settle the securities at a price less than the amortized cost bases of the investments.
−Removed: The Company does not intend to sell the investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.
−Removed: The Company did not record an allowance for credit losses as of December 31, 2023.
−Removed: Prior to January 1, 2023, the Company evaluated short-term investments for other-than-temporary impairment at the balance sheet date.
−Removed: Declines in fair value, if any, determined to be other-than-temporary were also included in other income, net.
−Removed: When assessing short-term investments for other-than-temporary declines in value, the Company considered such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, and the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general.
−Removed: The Company determined it did not hold any investments with any other-than-temporary impairment as of December 31, 2022.
−Removed: Short-term investments, which are classified as available-for-sale, consisted of the following:
+Added: Accrued interest receivable relating to the Company's available-for-sale securities is presented within prepaid expenses and other current assets in the accompanying consolidated balance sheets, and amounted to $ 0.1 million and $ 0.5 million at December 31, 2024 and 2023, respectively.
+Added: Marketable securities, which are classified as available-for-sale, consisted of the following (in thousands):
December 31, 2024
1 unchanged sentence
Treasury bills
−Removed: Total short-term investments
+Added: Total marketable securities
December 31, 2023
(in thousands)
−Removed: Treasury notes
Treasury bills
−Removed: Commercial paper
−Removed: Corporate debt securities
−Removed: Total short-term investments
+Added: Total marketable securities
Inventories consisted of the following:
4 unchanged sentences
Total inventories
−Removed: The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized.
−Removed: As of December 31, 2023, the Company had $ 2.7 million of inventory on hand that was acquired prior to regulatory approvals.
−Removed: This inventory was expensed to research and development as the future economic benefit was not probable.
−Removed: The Company began to capitalize inventory costs upon receipt of regulatory approvals in 2022.
−Removed: Long-term inventory consists primarily of raw materials, which have a current usable period of approximately two to three years in its raw material form.
−Removed: Raw material has until its stated expiry date to be manufactured into finished goods, at which point the material has another twelve to eighteen months of useful life.
−Removed: The Company classifies inventory as long-term when consumption or sale of the inventory is expected beyond twelve months.
+Added: In April 2024, the Company announced it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO ® /ALBRIOZA and remove the product from the market in the U.S.
+Added: and Canada based on topline results from the global Phase 3 PHOENIX trial.
+Added: As a result, the Company recorded approximately $ 92.5 million of charges associated with the write-down of inventory for the year ended December 31, 2024.
+Added: For the year ended December 31, 2023, the Company recognized inventory write-downs of $ 3.3 million .
Inventory amounts written down as a result of obsolescence or other reasons are charged to cost of sales.
−Removed: For the years ended December 31, 2023, 2022, and 2021 the Company recognized write-downs of $ 3.3 million , $ 0.4 million and zero , respectively.
Property and equipment, net
15 unchanged sentences
Accrued consulting and other professional fees
−Removed: Accrued rebates and co-pay assistance
+Added: Accrued returns, rebates and co-pay assistance
Accrued royalties
+Added: Accrued loss on future purchase commitments
Other accrued expenses
Total accrued expenses
−Removed: CONVERTIBLE NOTES
−Removed: Issuance of the 2021 Notes
−Removed: In January 2021, the Company issued, in aggregate, $ 27.3 million in convertible notes, or 2021 Notes, to certain investors, including related parties, of which proceeds of $ 1.2 million were received in advance of issuance of the 2021 Notes in December 2020 and the remaining proceeds of $ 26.1 million were received in January and February 2021.
−Removed: The 2021 Notes were to mature on June 30, 2022 and carried both automatic and optional conversion features.
−Removed: The 2021 Notes were secured and carried an interest rate of 3 %.
−Removed: The Company recorded the $1.2 million of proceeds received in December 2020 as proceeds received in advance of issuance of 2021 Notes in the consolidated balance sheet as of December 31, 2020, as the subscription agreement and commitment to issue the 2021 Notes was not effective until January 2021.
−Removed: The Company qualified for and elected to account for the 2021 Notes under the fair value option and, in doing so, bypassed the analysis of potential embedded derivative features.
−Removed: The Company believes that the fair value option better reflects the underlying economics of the 2021 Notes.
−Removed: As a result, the 2021 Notes were recorded at fair value upon issuance, which was determined to be equal to principal amounts of these notes of $ 27.3 million.
−Removed: At each financial reporting period, and immediately prior to conversion, the Company remeasured the fair value of the 2021 Notes.
−Removed: The change in fair value of the 2021 Notes from issuance date to the conversion date totaled $ 5.2 million, which is recorded as change in fair value of convertible notes in the consolidated statement of operations for the year ended December 31, 2021.
−Removed: Conversion of the 2021 Notes
−Removed: In July 2021, the Company consummated a financing transaction in which it issued shares of Series C-1 redeemable convertible preferred stock.
−Removed: The consummation of this financing transaction resulted in the automatic conversion of the 2021 Notes into shares of Series C-2 redeemable convertible preferred stock (together with the Series C-1 redeemable convertible preferred stock, the “Series C Preferred Stock”) pursuant to their original terms.
−Removed: The Series C Preferred Stock was determined to have a fair value of $ 10.265809 .
−Removed: Under the fair value option, the 2021 Notes were remeasured to fair value immediately prior to conversion at a price per share equal to the fair value of the Series C-1 redeemable convertible preferred stock.
−Removed: The Company recorded $ 5.2 million loss related to change in fair value of the 2021 Notes in its consolidated statement of operations for the year ended December 31, 2021.
−Removed: The 2021 Notes converted into 3,170,585 shares of Series C-2 redeemable convertible preferred stock at the effective conversion price of $ 8.725938 .
−Removed: Convertible Notes—Related Parties
−Removed: There were no convertible notes issued to related parties that were outstanding as of December 31, 2023 and 2022 .
−Removed: In connection with the issuance of the 2021 Notes, the Company issued, in aggregate, $ 14.3 million of convertible notes to certain related parties.
−Removed: These notes were issued under the same terms and conditions as the 2021 Notes.
FAIR VALUE MEASUREMENTS
3 unchanged sentences
Cash equivalents
−Removed: Short-term investments:
−Removed: Treasury bills
−Removed: Total short-term investments
Restricted cash equivalents
+Added: Treasury bills
Total financial assets
2 unchanged sentences
Cash equivalents
−Removed: Short-term investments:
−Removed: Treasury notes
+Added: Marketable securities:
Treasury bills
−Removed: Commercial paper
−Removed: Corporate debt securities
−Removed: Total short-term investments
+Added: Total marketable securities
Restricted cash equivalents
Total financial assets
−Removed: Valuation of Short-Term Investments
−Removed: The Company classifies its money market funds, treasury notes and treasury bills as Level 1 assets under the fair value hierarchy, as these assets have been valued using quoted market prices for identical assets in active markets without any valuation adjustment.
−Removed: The Company classifies its commercial paper, corporate debt securities, and agency bonds as Level 2 assets under the fair value hierarchy, as these assets have been valued using information obtained through a third-party pricing service at each balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.
−Removed: The Company does no t hold any short-term investments classified as Level 3, which are securities valued using unobservable inputs.
−Removed: The Company has not transferred any investment securities between the classification levels .
−Removed: There were no other assets or liabilities that were measured at fair value on a recurring basis as of December 31, 2023 and 2022 .
+Added: The Company classifies its money market funds and treasury bills as Level 1 assets under the fair value hierarchy, as these assets have been valued using quoted market prices for identical assets in active markets without any valuation adjustment.
+Added: The Company classifies its U.S.
+Added: agency bonds as Level 2 assets under the fair value hierarchy, as these assets have been valued using information obtained through a third-party pricing service at each balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.
The Company leases its office facilities under non-cancelable operating leases that expire at various dates through October 2026.
−Removed: The Company entered into an office space lease at 121 First Street in Cambridge, Massachusetts on January 10, 2022, for 36 months , with an option to extend the lease for 3 years .
−Removed: Because the Company was not reasonably certain to exercise the option to extend the lease at inception, the option to extend was not considered in determining the lease term.
−Removed: The Company initially recognized a right-of-use asset of $ 5.0 million and a lease liability of $ 5.0 million upon commencement of the lease.
+Added: On September 12, 2024, the Company entered into a new office lease in Cambridge, Massachusetts for office space for its headquarters facility.
+Added: The lease commencement date is expected to be June 1, 2025 when the premises are expected to be available for occupancy and, therefore, as the office lease has not commenced, the related operating lease right-of-use assets and liabilities are not recorded in the Company's consolidated balance sheet as of December 31, 2024.
Components of lease expense required by ASC 842 are presented below for the years ended December 31, 2024 and 2023:
10 unchanged sentences
Because the Company is not reasonably certain to exercise these renewal options, they are not considered in determining the lease terms, and associated potential additional payments are excluded from lease payments.
−Removed: The Company has elected to account for each lease component and its associated non-lease components as a single lease component and has allocated all of the contract consideration across lease components only.
The Company has existing net leases in which the non-lease components (e.g., common area maintenance) are paid separately from rent based on actual costs incurred and therefore are not included in the operating lease right-of-use assets and lease liabilities and are reflected as an expense in the period incurred.
+Added: Variable lease payments during the years ended December 31, 2024 and 2023 were not material.
The following table summarizes the presentation in the Company’s consolidated balance sheet of its operating leases:
11 unchanged sentences
As of December 31, 2024 and 2023, the weighted average remaining lease term was 1.2 years and 2 years , respectively.
−Removed: As of December 31, 2023 and 2022, the weighted average incremental borrowing rate used to determine the operating lease right-of-use assets was 7.3 % .
−Removed: Redeemable Convertible Preferred Stock
−Removed: On July 1, 2021, the Company amended its certificate of incorporation in which it authorized 13,150,430 shares of Series C-1 redeemable convertible preferred stock and 3,170,585 shares of Series C-2 redeemable convertible preferred stock.
−Removed: In July 2021, the Company consummated a financing transaction in which it issued 13,150,430 shares of Series C-1 redeemable convertible preferred stock.
−Removed: In connection with the issuance of these shares, the principal including accrued interest of the 2021 Notes totaling $ 27.7 million automatically converted into 3,170,585 shares of Series C-2 redeemable convertible preferred stock.
−Removed: The Company’s redeemable convertible preferred stock consisted of the following:
−Removed: December 31, 2021
−Removed: (dollars in thousands)
−Removed: Preferred Shares
−Removed: Issuable Upon
−Removed: Series A preferred stock
−Removed: Series B preferred stock
−Removed: Series C-1 preferred stock
−Removed: Series C-2 preferred stock
−Removed: In January 2022, upon the completion of the Company’s IPO, all of the Company's outstanding shares of preferred stock were converted into shares of its common stock.
−Removed: There were no redeemable convertible preferred stock outstanding as of December 31, 2023 or 2022 .
−Removed: Stockholders’ EQUITY (Deficit )
−Removed: Common Stock— Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders provided, however, that, except as otherwise required by law, holders of common stock shall not be entitled to vote on any amendment to the Company’s Certificate of Incorporation that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to the Certificate of Incorporation or pursuant to the Delaware General Corporation Law.
−Removed: Common stockholders are entitled to receive dividends, as may be declared by the Company’s Board of Directors, if any, subject to the preferential dividend rights of the Preferred Stock.
−Removed: No dividends were declared or paid during the years ended December 31, 2023 and 2022.
−Removed: The Company had reserved shares of common stock for issuance in connection with the following:
−Removed: Common stock authorized
−Removed: Common stock issued and outstanding
−Removed: Common stock authorized and reserved for future issuances:
−Removed: Common stock reserved for the exercise of stock options
−Removed: Common stock reserved for the unvested restricted stock units
−Removed: Common stock reserved for future issuance of share-based awards
−Removed: Total common stock authorized and reserved for future issuance
−Removed: Unreserved common stock available for future issuance
−Removed: In January 2022, the Company completed its IPO in which the Company issued and sold 11,369,369 shares of its common stock at a price of $ 19.00 per share.
−Removed: After deducting underwriting discounts and commissions and estimated offering expenses, the Company received net proceeds of approximately $ 196.4 million.
−Removed: Upon the completion of the IPO, all of the Company’s outstanding shares of preferred stock were converted into shares of its common stock.
−Removed: In October 2022, the Company completed a follow-on public offering in which the Company issued 7,697,812 shares of its common stock at a price of $ 32.00 per share.
−Removed: After deducting underwriting discounts and commissions and estimated offering expenses, the Company received net proceeds of approximately $ 230.6 million.
−Removed: Stock Option and Grant Plan
−Removed: Stock Incentive Plan— In January 2022, the Company’s board of directors adopted, and its stockholders approved the 2022 Stock Option and Incentive Plan, or 2022 Plan, which became effective on January 5, 2022, at which point no further grants would be made under the 2015 Stock Option and Restricted Stock Plan, or 2015 Plan.
+Added: As of December 31, 2024 and 2023, the weighted average incremental borrowing rate used to determine the operating lease right-of-use assets was 7.4 % and 7.3 % , respectively .
+Added: aSSET aCQUISITIONS AND COLLABORATION AGREEMENTS
+Added: Eiger Asset Acquisition
+Added: On July 9, 2024, the Company completed the acquisition of substantially all the assets and interests in the development, manufacture and commercialization of avexitide from Eiger BioPharmaceuticals, Inc., or Eiger, for $ 35.1 million, or the Eiger Acquisition.
+Added: The Eiger Acquisition includes the acquisition of all of Eiger’s owned and co-owned patents and applications directed to avexitide, as well as the assumption of Eiger’s licenses to patents and applications directed to avexitide and owned and co-owned by other entities, and the samples, retains, raw materials and active pharmaceutical ingredients in Eiger’s possession and control.
+Added: The transaction was accounted for as an asset acquisition as the acquired assets did not meet the definition of a business.
+Added: The Company did not acquire any outputs and there was not an acquired substantive process in place to create outputs.
+Added: The total purchase consideration of $ 36.2 million was composed of cash paid at closing of $ 35.1 million and direct transaction costs of $ 1.1 million.
+Added: The fair value was allocated to in-process research and development (IPR&D) assets with no alternative future use for these assets at the closing of the acquisition.
+Added: As a result, the Company recorded a charge of $ 36.2 million related to acquired in-process research and development expense on the consolidated statements of operations in 2024.
+Added: As part of the transaction, the Company assumed certain contractual obligations from Eiger, including royalty obligations between 4 % and 7 % on future sales owed to certain academic institutions and individuals.
+Added: The Company will recognize these royalty payments related to avexitide in the period in which the achievement of the underlying milestones becomes probable.
+Added: Gubra A/S Collaboration and License Agreement
+Added: On December 23, 2024, the Company entered into a collaboration and license agreement, or the Gubra Agreement, with Gubra pursuant to which the parties will perform research and discovery activities for the development of a potential novel long-acting GLP-1 receptor antagonist, under the oversight of a joint research committee.
+Added: The collaboration provides the Company an exclusive license to develop, manufacture, commercialize and otherwise exploit any development candidate and product(s) arising in the performance of activities under the agreement.
+Added: The Company made an immaterial upfront payment in January 2025, which became due upon the effective date of the Gubra Agreement.
+Added: Since the payment was made for the use of Gubra’s intellectual property and research and development services and there is no alternative use, the Company recorded the upfront payment to research and development expense on the consolidated statements of operations in 2024.
+Added: Gubra is eligible to receive an additional $ 53.5 million upon the achievement of certain development, regulatory and commercial milestones, as well as tiered royalties on future sales from any products that result from the agreement.
+Added: None of these payments are deemed probable at December 31, 2024 and have not been recognized.
+Added: The Company has agreed to make quarterly payments to fund Gubra's ongoing research activities, which are not expected to be material.
+Added: Stock Option and Grant PlanS
+Added: Stock Incentive Plan— In January 2022, the Company’s board of directors adopted, and its stockholders approved the 2022 Stock Option and Incentive Plan, or 2022 Plan.
Under the 2022 Plan, the Company may grant incentive stock options, or ISOs, non-statutory stock options, stock appreciation rights, restricted stock units, restricted stock awards and other stock-based awards.
5 unchanged sentences
The number of shares of the Company’s common stock reserved for issuance under the 2022 Plan will automatically increase on January 1 of each year commencing January 1, 2023, by 5 % of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Company’s board of directors.
−Removed: The maximum current number of shares that may be issued pursuant to the exercise of ISOs under the 2022 Plan is 7,650,000 .
−Removed: The maximum number of shares of the Company’s common stock subject to awards granted under the 2022 Plan or otherwise during a single calendar year to any individual nonemployee director, taken together with any cash fees paid by the Company to such nonemployee director during the calendar year for serving on the Company’s board of directors, will not exceed $ 750,000 in total value, or, with respect to the calendar year in which a nonemployee director is first appointed or elected to the Company’s board of directors, $ 1,000,000 .
−Removed: All options and awards granted under the 2015 Plan consisted of the Company’s common stock.
−Removed: As of January 6, 2022, no additional stock awards have been or will be granted under the 2015 Plan.
−Removed: Although the 2015 Plan was terminated as to future awards in January 2022, it continues to govern the terms of options that remain outstanding under the 2015 Plan.
Inducement Plan— In July 2023, the Company’s board of directors adopted the Amylyx Pharmaceuticals, Inc.
7 unchanged sentences
As of December 31, 2024, there were 1,947,194 shares available for future issuance under the ESPP.
−Removed: General Option Information
The Company estimates the fair value of stock option awards on the grant date using the Black-Scholes option pricing model with the following weighted-average assumptions:
4 unchanged sentences
Dividend yield
−Removed: The per share weighted average grant date fair value of stock options granted during the year ended December 31, 2023, 2022 and 2021 was $ 19.56 , $ 15.10 and $ 5.25 , respectively.
+Added: The weighted average grant date fair value of stock options granted during the year ended December 31, 2024 and 2023 was $ 5.61 per share and $ 19.56 per share, respectively.
A summary of option activity for the year ended December 31, 2024, is as follows:
(in thousands)
−Removed: Outstanding at December 31, 2022
+Added: Outstanding at January 1, 2024
Cancelled or forfeited
2 unchanged sentences
Unvested at December 31, 2024
−Removed: The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s common stock.
−Removed: The aggregate intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 20.6 million , $ 14.2 million and $ 6.2 million respectively.
−Removed: The total fair value of stock options vested during the years ended December 31, 2023, 2022 and 2021 was $ 31.2 million , $ 8.8 million and $ 1.3 million , respectively.
+Added: The aggregate intrinsic value of options exercised during the years ended December 31, 2024 and 2023 was $ 1.0 million and $ 20.6 million , respectively.
+Added: The total fair value of stock options vested during the years ended December 31, 2024 and 2023 was $ 32.5 million and $ 31.2 million , respectively.
Restricted Stock Unit Activity
2 unchanged sentences
Weighted Average Grant Date Fair Value
−Removed: Nonvested as of December 31, 2022
+Added: Nonvested as of January 1, 2024
Nonvested as of December 31, 2024
5 unchanged sentences
Total stock-based compensation
−Removed: The Company capitalized stock-based compensation expense of $ 0.4 million , less than $ 0.1 million, and zero for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: Stock-based compensation recognized through cost of sales were $ 0.2 million , less than $ 0.1 million, and zero for years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: The following table summarizes stock-based compensation by type of award:
−Removed: Year Ended December 31,
−Removed: (in thousands)
−Removed: Stock options
−Removed: Restricted stock units
−Removed: Total stock-based compensation expense
The following table summarizes unrecognized stock-based compensation expense as of December 31, 2024, by type of awards, and the weighted-average period over which that expense is expected to be recognized.
6 unchanged sentences
Restricted stock units
−Removed: The components of net loss before the provision for income taxes are as follows:
+Added: The components of net (loss) income before the provision for income taxes are as follows:
(in thousands)
−Removed: Income (loss) before income taxes
−Removed: The provision for income taxes is as follows:
+Added: (Loss) income before income taxes
+Added: The (benefit) provision for income taxes is as follows:
(in thousands)
10 unchanged sentences
Valuation allowances
+Added: Stock Based Compensation
Effective income tax rate
14 unchanged sentences
On a periodic basis the Company reassess the valuation allowance that has been established, weighing all positive and negative evidence.
−Removed: In 2023, the Company reassessed the valuation allowance and considered negative evidence, including cumulative losses over the three years ended December 31, 2023, and positive evidence, including recent regulatory approvals of ALBRIOZA and RELYVRIO, 2023 profitability and positive cash flow, and realization of a portion of prior year U.S.
−Removed: federal and state NOL and research and development tax credit carryforwards.
−Removed: After assessing both the negative and positive evidence, the Company concluded that a full valuation should continue to be retained against the net deferred tax assets as of December 31, 2023.
−Removed: It is possible that all or a portion of the valuation allowance will be released in the near-term.
−Removed: The release of the valuation allowance, as well as the exact timing and the amount of such release, continue to be subject to, among other things, levels of profitability, revenue growth, clinical program progression and expectations regarding future profitability.
+Added: As of December 31, 2024, the Company maintained a full valuation against net deferred tax assets.
As of December 31, 2024 and 2023, the Company had federal NOL loss carryforwards of approximately $ 262.7 million and $ 69.8 million , respectively, and state NOL loss carryforwards of approximately $ 126.9 million and $ 124.6 million , respectively, which are available to reduce future taxable income.
9 unchanged sentences
Valuation allowance at beginning of year
−Removed: (Decreases) increases recorded to income tax provision
+Added: Increases (decreases) recorded to income tax provision
Valuation allowance at end of year
−Removed: The decrease in the valuation allowance recorded during the year primarily relates to taxable income resulting pre-tax profits earned in 2023 and increased as a result of required capitalization of research and development costs.
+Added: The increase in the valuation allowance recorded during the year was primarily due to the increase in net operating loss generated by the Company in 2024 and required capitalization of research and development costs.
The Company accounts for uncertainty in income taxes under the provisions of ASC 740 which defines the thresholds for recognizing the benefits of tax return positions in the consolidated financial statements as “more likely than not” to be sustained by the taxing authority.
−Removed: The tax benefit is measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlemen t.
+Added: The tax benefit is measured based on the largest benefit that has a greater than 50%
+Added: likelihood of being realized upon ultimate settlemen t.
A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows:
1 unchanged sentence
Balance at beginning of the period
−Removed: Increases (decreases) related to tax positions taken during prior years
+Added: Increases related to tax positions taken during prior years
Increases related to tax positions taken during the current year
4 unchanged sentences
The Company accrues interest and penalties related to unrecognized tax benefits as a component of its provision for income taxes.
−Removed: The Company did no t recognize any interest or penalties related to uncertain tax positions during the years ended December 31, 2023, 2022 and 2021.
+Added: The Company did no t recognize any material interest or penalties related to uncertain tax positions during the years ended December 31, 2024 and 2023.
The Company files U.S.
6 unchanged sentences
Plan participants are able to defer eligible compensation subject to applicable annual IRC limits.
−Removed: For the year ended December 31, 2022, the Company provided a safe-harbor contribution o f 3 % of employee compensation to employees who satisfy the minimum service requirements.
−Removed: Effective October 1, 2023, the safe-harbor contribution was increased to 5 %.
−Removed: The Company made $ 2.3 million and $ 1.2 million of safe-harbor contributions for the years ended December 31, 2023 and 2022 , respectively.
−Removed: NET INCOME (LOSS) PER SHARE
−Removed: Net Income (Loss) per Share
−Removed: Basic earnings per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period.
−Removed: Diluted earnings per share is calculated based on the combined weighted average
−Removed: number of common shares and potentially dilutive shares, which include the assumed exercise of employee stock options and unvested restricted stock units.
+Added: The Company made $ 2.8 million and $ 2.3 million of contributions for the years ended December 31, 2024 and 2023, respectively.
+Added: NET (LOSS) INCOME PER SHARE
+Added: Net (Loss) Income per Share
+Added: Basic earnings per share is computed by dividing net (loss) income by the weighted average number of common shares outstanding during the period.
+Added: Diluted earnings per share is calculated based on the combined weighted average number of common shares and potentially dilutive shares, which include the assumed exercise of employee stock options and unvested restricted stock units.
In computing diluted earnings per share, the Company utilizes the treasury stock method.
A summary of the numerator and denominators used in the computation of earnings per share follows (in thousands, except share and per share data:
−Removed: Net income (loss)
−Removed: Weighted-average shares used to compute basic net income (loss) per share
+Added: Net (loss) income
+Added: Weighted-average shares used to compute basic net (loss) income per share
Dilutive effect of employee stock options and restricted stock units
−Removed: Weighted-average shares used to compute diluted net income (loss) per share
−Removed: Net income (loss) per share
−Removed: Because the Company reported a net loss for the twelve months ended December 31, 2022 and 2021, basic and diluted net loss per share were the same.
−Removed: All stock options and restricted stock units were excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact for the twelve months ended December 31, 2022 and 2021 .
−Removed: The following stock options and restricted stock units outstanding at each period end have been excluded from the calculation of diluted net income (loss) per share because their inclusion would have been antidilutive:
+Added: Weighted-average shares used to compute diluted net (loss) income per share
+Added: Net (loss) income per share
+Added: All stock options and restricted stock units were excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact for the year ended December 31, 2024 .
+Added: The following stock options and restricted stock units outstanding at each period end have been excluded from the calculation of diluted net (loss) income per share because their inclusion would have been antidilutive:
Options to purchase common stock
Restricted stock units
−Removed: Redeemable convertible preferred stock
Total excluded common stock equivalents
−Removed: Related party transactions
−Removed: Convertible Notes
−Removed: In connection with the issuance of the 2021 Notes, the Company issued, in aggregate, $ 14.3 million of convertible promissory notes to Morningside Ventures Investments Limited, and certain members of the board of directors of the Company.
−Removed: Morningside Ventures Investments Limited was a 5 % significant stockholder of the Company at the time of the transaction.
−Removed: These notes were issued under the same terms and conditions as the 2021 Notes (see Note 8).
−Removed: Supplier Agreements
−Removed: In the ordinary course of business, the Company may purchase materials or supplies or services from entities that are associated with a party that meets the criteria of a related party of the Company.
−Removed: These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements.
+Added: The Company has one operating segment which is the business of researching and developing therapeutics for neurodegenerative diseases and endocrine conditions.
+Added: Our operating segments are determined based on how our Co-Chief Executive Officers , Justin Klee and Joshua Cohen, who collectively serve as our chief operating decision makers ("CODM") manages our business, regularly accesses discrete financial information, and evaluates performance for operating decision-making purposes, including allocation of resources or capital to specific compounds or projects in line with the Company’s overall strategies and goals.
+Added: The Company's entire business is managed by a single management team, which reports to the CODM.
+Added: The accounting policies of the Company's segment are the same as those described in Note 2 Significant Accounting Policies .
+Added: The CODM assesses segment performance and decides how to allocate resources based on consolidated net (loss) income that also is reported on the consolidated statement of operations.
+Added: The CODM uses net income to monitor budget and forecast versus actual results in assessing segment performance and to evaluate income generated from segment assets in deciding how to allocate resources.
+Added: The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
+Added: For the years ended December 31, 2024 and 2023, all of the Company's long-lived assets were held within the U.S.
+Added: The following table reconciles segment revenue and expenses to consolidated net loss (income) for the year ended December 31, 2024 and 2023 (in thousands):
+Added: Year Ended December 31,
+Added: Product revenue, net
+Added: Cost of sales 2
+Added: Direct research and development expenses by program:
+Added: AMX0035 - ALS
+Added: AMX0035 - PSP
+Added: Other programs
+Added: Acquired in-process research and development
+Added: Personnel-related research and development 3
+Added: Selling, general and administrative
+Added: Restructuring expenses
+Added: (Benefit) provision for income taxes
+Added: Interest income
+Added: Other segment items 4
+Added: Net (loss) income
+Added: The significant expense categories and amounts align with the segment-level information that is regularly provided to the CODM.
+Added: As the Company has one reportable segment, there were no intersegment eliminations for the year ended December 31, 2024 and 2023.
+Added: Includes inventory impairment and loss on firm purchase commitments of $ 118.7 million and zero during year ended December 31, 2024 and 2023, respectively.
+Added: The Company does not allocate personnel and other similar costs to specific programs because these costs are deployed across multiple programs.
+Added: Other segment items primarily consists of net realized and unrealized losses on foreign exchange transactions
+Added: Depreciation and amortization expense of $ 0.9 million and $ 1.1 million durin g the years ended December 31, 2024 and 2023, respectively, are allocated across the significant expense captions.
Commitments and Contingencies
−Removed: Legal Proceedings— As of December 31, 2023, the Company is not a party to any material legal proceedings.
−Removed: At each reporting date, the Company evaluates whether or not a potential loss amount or potential range of loss is probable and reasonably estimated under the provisions of the authoritative guidance that addresses accounting for contingencies.
+Added: Legal Proceedings— As of December 31, 2024, the Company is not a party to any legal proceedings that are expected to have a material impact on the Company's consolidated financial statements.
The Company recognizes expenses for its costs related to its legal proceedings, as incurred.
−Removed: Royalty Payments— Between August 2016 and February 2019, the Company entered into grant agreements with the ALS Association, ALS Finding a Cure Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and
−Removed: Cure Alzheimer’s Fund, or Grantors.
−Removed: Under the terms of the agreements, the Company was granted, in aggregate, $ 4.3 million.
−Removed: These grants were provided to the Company for the purpose of furthering the research and development of AMX0035 as a therapeutic benefit for ALS and Alzheimer’s disease.
−Removed: Under the terms of the arrangements, the Company would receive a tranche of funds as it completed certain milestones.
+Added: Royalty Payments— Between August 2016 and February 2019, the Company entered into grant agreements with the ALS Association, ALS Finding a Cure Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and Cure Alzheimer’s Fund, or Grantors.
Pursuant to the terms of the grant agreements, the Company has certain payment obligations that are contingent upon future events such as the achievement of commercialization or the receipt of proceeds from a revenue generating transaction resulting from the projects for which the grants are used for.
−Removed: Pursuant to the terms of the respective grant agreements among the Company, ALS Association and ALS Finding a Cure, the Company will be required to make royalty payments to each Grantor in the total amount equal to 150 % of the grant received.
−Removed: The royalty payments will be achieved through a combination of the following payment methods:
−Removed: (i) an annual installment payment of 3 % of net sales of any products developed under the project for which the grant was used for and (ii) 3 % of cash proceeds resulting from revenue generating transaction under the project for which the grants are used for.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company recorded $ 3.1 million , $ 1.4 million and zero in royalty expense, respectively, which is included in cost of sales in the consolidated financial statements.
−Removed: As of December 31, 2023, no further royalties remain to be accrued under the grant agreements with the ALS Association and ALS Finding a Cure Foundation.
−Removed: Under the terms of the respective grant agreements among the Company, Alzheimer’s Drug Discovery Foundation, the Alzheimer’s Association, and Cure Alzheimer’s Fund, the Company will make royalty payments up to the maximum amount of $ 15.0 million to each Grantor (or $ 45.0 million in aggregate).
−Removed: The royalty payment will be made through a combination of the following payment methods:
−Removed: (i) 4 % of annual net sales of any product commercialized from the project for which the grant was used for and directly related to the treatment of the Alzheimer’s disease and (ii) 15 % of all royalties and cash proceeds resulting from revenue generating transactions associated with the projects for which the grants were used for under the grant agreements.
−Removed: As the conditions that would trigger royalty payments under the agreements have not occurred, no amounts have been recorded in the consolidated financial statements for the years ended December 31, 2023 and 2022.
+Added: The Company does not expect to incur any costs under the agreements given the discontinuation of sales of RELYVRIO®/ALBRIOZA.
+Added: As disclosed in Note 10 Asset Acquisitions and Collaboration Agreements, the Company assumed royalty obligations from Eiger related to the acquisition of avexitide and Gubra A/S related to a collaboration arrangement.
+Added: As the conditions that would trigger royalty payments under the agreements have not occurred, no amounts have been recorded in the consolidated financial statements.
Purchase Commitments— The Company enters into agreements in the normal course of business with contract manufacturing organizations for raw material purchases and manufacturing services.
−Removed: As of December 31, 2023, the Company had committed approximately $ 195.0 million under these agreements related to raw material purchases and manufacturing services, which are expected to be paid through 2028.
+Added: As of December 31, 2024, the amounts committed under these agreements are not material.
+Added: Following the discontinuation of the sales of RELYVRIO®/ALBRIOZA in 2024, the Company recognized a loss on purchase commitments of $ 26.1 million , which was recorded to cost of sales on the condensed consolidated statement of operations.
+Added: Restructuring
+Added: In April 2024, the Company announced a restructuring plan designed to focus the Company’s resources on key clinical and preclinical programs, or the Restructuring Plan.
+Added: The Restructuring Plan included a reduction in force which reduced the Company’s workforce by approximately 70 % and decreased external financial commitments outside of its priority areas.
+Added: The Company completed the Restructuring Plan in 2024.
+Added: Restructuring expenses consists primarily of employee severance and termination benefits, contract termination costs, impairment of long-lived assets and other costs.
+Added: Liabilities for costs associated with a restructuring activity are recognized when the liability is incurred and are measured at fair value.
+Added: One-time employee severance and termination benefits are expensed at the date the entity notifies the employee of the plan.
+Added: One-time termination benefits primarily include severance, continuation of health insurance coverage, and other benefits such as outplacement support services for a specified period of time.
+Added: In connection with the Restructuring Plan, the Company performed an impairment evaluation of its long-lived assets resulting in an impairment charge of $ 0.9 million during the year ended December 31, 2024 related to the impairment of capitalized internal-use software.
+Added: Restructuring expenses for the year ended December 31, 2024 included $ 21.8 million of severance and employee benefit costs and $ 1.0 million of other contract termination costs and impairment charges.
+Added: All costs related to this restructuring activity were paid as of December 31, 2024 , and the Company does not expect to incur costs in future periods for the Restructuring Plan.
Subsequent Events
−Removed: On February 9, 2024, a putative class action lawsuit was filed in the U.S.
−Removed: District Court for the Southern District of New York against the Company and certain of its current and former officers ( Shih v.
−Removed: Amylyx Pharmaceuticals, Inc., et al.
−Removed: , Case Number 1:24-CV-00988 (the “Shih Complaint”).
−Removed: The Shih Complaint asserts a claim against all defendants for alleged violations of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder and a claim under Section 20(a) against certain current and former officers as alleged controlling persons.
−Removed: The Shih Complaint alleges that defendants made materially false and misleading statements related to the commercial results and prospects for RELYVRIO.
−Removed: The Shih Complaint seeks unspecified damages, interest, costs and attorneys’ fees, and other unspecified relief that the court deems appropriate.
−Removed: The Company intends to defend against the Shih Complaint vigorously.
−Removed: At this time, an estimate of the impact, if any, of these claims cannot be made.
+Added: On January 13, 2025, the Company closed an underwritten public offering of 19,714,285 shares of its common stock at a public offering price of $ 3.50 per share.
+Added: The net proceeds from this offering were approximately $ 65.5 million, after deducting underwriting discounts and commissions and offering expenses.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.