Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
As of December 31, 2023, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed by, or under the supervision and with the participation of, our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.
73
As of December 31, 2023, our management assessed the effectiveness of our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act of 1934, as amended, using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013). Based on this assessment, management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, concluded that, as of December 31, 2023, our internal control over financial reporting was effective based on those criteria.
The effectiveness of our internal control over financial reporting as of December 31, 2023 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its report, which is included herein.
Changes in Internal Control Over Financial Reporting
An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), of any changes in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
74
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of
Acadia Pharmaceuticals Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Acadia Pharmaceuticals Inc.’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Acadia Pharmaceuticals Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, cash flows and stockholders’ equity for each of the three years in the period ended December 31, 2023, and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 and our report dated February 27, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. 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.
/s/ Ernst & Young LLP
San Diego, California
February 27, 2024
75
Item 9B. Other Information.
Insider Trading Arrangements
During the Company’s last fiscal quarter, the following officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) adopted or terminated a “Rule 10b5-1 trading arrangement” as defined in Item 408 of Regulation S-K, as follows:
• On December 15, 2023 , Stephen R. Davis , President and Chief Executive Officer , adopted a Rule 10b5-1 trading arrangement providing for the sale of up to 370,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is from March 14, 2024 until July 15, 2024, or earlier if and when all transactions under the trading arrangement are completed.
• On December 15, 2023 , Austin D. Kim , our former Executive Vice President, General Counsel and Secretary , adopted a Rule 10b5-1 trading arrangement providing for the sale of up to 10,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is from March 14, 2024 until June 14, 2024, or earlier if and when all transactions under the trading arrangement are completed.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections .
Not applicable.
76
PART III
Item 10. Directors, Executive Off icers and Corporate Governance .
The information required by this Item and not set forth below will be set forth under the proposal captioned “Election of Directors” and the sections captioned “Information Regarding the Board of Directors and Corporate Governance,” “Executive Officers” and “Delinquent Section 16(a) Reports,” if any, in our definitive Proxy Statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC by April 29, 2024 (our “Proxy Statement”) and is incorporated in this report by reference.
We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting officer or controller) and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on our website at http://www.acadia.com under the Corporate Governance section of our Investors page. Information contained in our website does not constitute a part of this report or our other filings with the SEC. We will promptly disclose on our website (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals, the name of such person who is granted the waiver and the date of the waiver. Stockholders may request a free copy of the Code of Business Conduct and Ethics from our compliance department c/o Acadia Pharmaceuticals Inc., 12830 El Camino Real, Suite 400, San Diego, CA 92130.
Item 11. Executi ve Compensation .
The information required by this Item will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated in this report by reference.
Item 12. Security Ownership of Certain Beneficial Ow ners and Management and Related Stockholder Matters .
The information required by this Item will be set forth in the section headed “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement and is incorporated in this report by reference.
Information regarding our equity compensation plans will be set forth in the section headed “Equity Compensation Plan Information” in our Proxy Statement and is incorporated in this report by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence .
The information required by this Item will be set forth in the section headed “Transactions With Related Persons” in our Proxy Statement and is incorporated in this report by reference.
Item 14. Principal Accou ntant Fees and Services .
The information required by this Item will be set forth under the proposal captioned “Ratification of Selection of Independent Registered Public Accounting Firm” in our Proxy Statement and is incorporated in this report by reference.
77
PART IV
Item 15. Exhibits and Fina ncial Statement Schedules.
(a) Documents filed as part of this report.
1. The following financial statements of Acadia Pharmaceuticals Inc. and Report of Ernst & Young LLP, Independent Registered Public Accounting Firm, are included in this report:
Page Number
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
F- 1
Consolidated Balance Sheets
F- 3
Consolidated Statements of Operations
F- 4
Consolidated Statements of Comprehensive Loss
F- 5
Consolidated Statements of Cash Flows
F- 6
Consolidated Statements of Stockholders’ Equity
F- 7
Notes to Consolidated Financial Statements
F- 8
2. List of financial statement schedules:
Schedule II – Valuation and Qualifying Accounts
Schedules not listed above have been omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.
3. List of Exhibits required by Item 601 of Regulation S-K. See part (b) below.
(b) Exhibits .
Exhibit
Number
Description
3.1
Amended and Restated Certificate of Incorporation, as Amended (incorporated by reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q, filed August 6, 2015).
3.2
Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K, filed February 25, 2021).
3.3
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed September 12, 2013).
4.1
Form of common stock certificate of the Registrant (incorporated by reference to Exhibit 4.1 to Registration Statement No. 333-52492) .
4.2
Form of Amended and Restated Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 10-K, filed February 26, 2019).
4.3
Description of the Registrant’s Common Stock (incorporated by reference to Exhibit 4.3 to the Registrant’s Annual Report on Form 10-K, filed February 27, 2020).
10.1 a
Form of Indemnity Agreement for directors and officers (incorporated by reference to Exhibit 10.1 to Registration Statement No. 333-113137).
10.2 a
2004 Equity Incentive Plan and forms of agreement thereunder (incorporated by reference to Exhibit 10.3 to Registration Statement No. 333-113137).
10.3 a
2010 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-K, filed August 9, 2022).
10.4 a
Forms of agreement under the 2010 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K, filed February 29, 2016).
78
10.5 a
Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under Acadia Pharmaceuticals Inc. 2010 Equity Incentive Plan.
10.6 a
2004 Employee Stock Purchase Plan, as amended (incorporated by reference to Exhibit 99.1 to the Registrant’s Current Report on Form 8-K, filed June 29, 2020).
10.7 a
Offerings under the 2004 Employee Stock Purchase Plan, as amended (incorporated by reference to Exhibit 10.6 to the Registrant’s Annual Report on Form 10-K, filed February 28, 2017).
10.8 a
Employment Agreement, dated September 1, 2015, between the Registrant and Stephen Davis (incorporated by reference to Exhibit 99.1 to the Registrant’s Current Report on Form 8-K, filed September 3, 2015).
10.9 a
Employment Offer Letter, dated June 26, 2018, between the Registrant and Brendan Teehan (incorporated by reference to Exhibit 10.9 to the Registrant’s Annual Report on Form 10-K, filed March 1, 2022).
10.10 a
Employment Offer Letter, dated July 2, 2018, between the Registrant and Austin D. Kim (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed November 6, 2018).
10.11 a
Employment Offer Letter, dated April 28, 2020, between the Registrant and Mark Schneyer (incorporated by reference to Exhibit 10.11 to the Registrant’s Annual Report on Form 10-K, filed March 1, 2022).
10.12 a
Employment Offer Letter, dated December 19, 2022, between the Registrant and Doug Williamson (incorporated by reference to Exhibit 10.12 to the Registrant’s Annual Report on Form 10-K, filed February 28, 2023).
10.13 a
Employment Offer Letter, dated January 12, 2024, between the Registrant and Jennifer Rhodes.
10.14 a
Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 99.2 to the Registrant’s Current Report on Form 8-K, filed June 29, 2020).
10.15 a
Management Severance Benefit Plan (incorporated by reference to Exhibit 99.1 to the Registrant’s Current Report on Form 8-K, filed December 15, 2015).
10.16 a
Amended and Restated Change in Control Severance Benefit Plan (incorporated by reference to Exhibit 99.2 to the Registrant’s Current Report on Form 8-K, filed December 15, 2015).
10.17 c
Master Manufacturing Services Agreement and Product Agreement, dated August 3, 2015, by and between the Registrant and Patheon Pharmaceuticals Inc.
10.18 c
First Amendment to Product Agreement, dated April 25, 2016, by and between the Registrant and Patheon Pharmaceuticals Inc.
10.19 c
Second Amendment to Product Agreement, dated October 6, 2016, by and between the Registrant and Patheon Pharmaceuticals Inc.
10.20 c
Third Amendment to Product Agreement, dated December 11, 2017, by and between the Registrant and Patheon Pharmaceuticals Inc.
10.21 c
Master Services Agreement, dated December 15, 2016, by and between Acadia Pharmaceuticals GmbH and Siegfried AG and its affiliates, and Attachment #1, Attachment #2 and Attachment #3 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed November 3, 2022).
10.22 c
Change Order #1 to Master Services Agreement Attachment #1, dated January 3, 2017, by and between Acadia Pharmaceuticals GmbH and Siegfried AG (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed November 3, 2022).
10.23 c
Attachment #4, Attachment #5 and Attachment #6, each dated May 12, 2017, to the Master Services Agreement, dated December 15, 2016, by and between Acadia Pharmaceuticals GmbH and Siegfried AG and its affiliates (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed November 3, 2022).
10.24 c
Attachment #7, dated September 30, 2020, to the Master Services Agreement, dated December 15, 2016, by and between Acadia Pharmaceuticals GmbH and Siegfried AG and its affiliates (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly report on Form 10-Q, filed November 4, 2020).
79
10.25
Registration Rights Agreement, dated January 6, 2016, between the Registrant and the investors listed on Schedule A thereto (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed January 7, 2016).
10.26
Assignment of Brann Intellectual Property Rights, dated January 29, 1997, by Mark R. Brann in favor of the Registrant (incorporated by reference to Exhibit 10.17 to Registration Statement No. 333-52492).
10.27 b
License Agreement, dated August 6, 2018, by and between the Registrant and Neuren Pharmaceuticals Ltd. (incorporated by reference to Exhibit 10.26 to the Registrant’s Annual Report on Form 10-K, filed February 27, 2019).
10.28 b
Lease Agreement, effective October 4, 2018, by and between the Registrant and Kilroy Realty, L.P. (incorporated by reference to Exhibit 10.27 to the Registrant’s Annual Report on Form 10-K, filed February 27, 2019).
10.29 c
First Amendment to Office Lease, dated December 23, 2019, between the Registrant and Kilroy Realty, L.P. (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly report on Form 10-Q, filed May 8, 2020).
10.30 c
Second Amendment to Office Lease, dated March 12, 2020, between the Registrant and Kilroy Realty, L.P. (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly report on Form 10-Q, filed May 8, 2020).
10.31 a
Acadia Pharmaceuticals Inc. 2023 Inducement Plan (incorporated by reference to Exhibit 99.1 to Registration Statement No. 333-269611).
10.32 a
Forms of Stock Option Grant Notice and Stock Option Agreement under Acadia Pharmaceuticals Inc. 2023 Inducement Plan (incorporated by reference to Exhibit 99.2 to Registration Statement No. 333-269611).
10.33 a
Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under Acadia Pharmaceuticals Inc. 2023 Inducement Plan (incorporated by reference to Exhibit 99.3 to Registration Statement No. 333-269611).
10.34 c
Lease Agreement, effective May 15, 2018, by and between the Registrant and Boston Properties Limited Partnership (incorporated by reference to Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K, filed February 28, 2023).
10.35 c
Master Commercial Supply Agreement, dated November 16, 2022, by and between the Registrant and Corden Pharma Bergamo S.p.A.
10.36 c
Commercial Supply Agreement, dated December 15, 2021, by and between the Registrant and F.I.S. Fabbrica Italiana Sintetici S.p.A.
10.37 c
Product Agreement, effective May 1, 2022, by and between the Registrant and Patheon Pharmaceuticals Inc.
10.38 c
Commercial Supply Agreement, dated March 1, 2023, by and between the Registrant and CoreRx Inc., as amended by Amendment No. 1, dated August 1, 2023.
10.39 c
Joint Venture and License Agreement, dated July 13, 2023, by and between the Registrant and Neuren Pharmaceuticals Ltd. (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed August 3, 2023).
21.1
List of subsidiaries of the Registrant.
23.1
Consent of Independent Registered Public Accounting Firm.
24.1
Power of Attorney (see signature page hereto).
31.1
Certification of Stephen Davis, Chief Executive Officer, pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Mark Schneyer, Executive Vice President and Chief Financial Officer, pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1 d
Certification of Stephen Davis, Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
80
32.2 d
Certification of Mark Schneyer, Executive Vice President and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1
Acadia Pharmaceuticals Inc. Dodd-Frank Clawback Policy.
101
The following financial statements from this Annual Report, formatted in iXBRL (Inline Extensible Business Reporting Language), are filed herewith: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Comprehensive Loss, (iv) Consolidated Statements of Cash Flows, (v) Consolidated Statements of Stockholders’ Equity, and (vi) Notes to Consolidated Financial Statements.
104
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
a Indicates management contract or compensatory plan or arrangement.
b We have requested or received confidential treatment of certain portions of this agreement, which have been omitted and filed separately with the SEC pursuant to Rule 406 under the Securities Act of 1933, as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
c Pursuant to Item 601(b)(10) of Regulation S-K, certain portions of this exhibit have been omitted (indicated by “[***]” or “[
***
]”) because the Company has determined that the information is both not material and is the type that the Company treats as private or confidential.
d The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act (including this Annual Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference.
Item 16. Form 10-K Summary
None.
81
SIGNAT URES
Pursuant to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
A cadia Pharmaceuticals Inc.
Date: February 27, 2024
/s/ Stephen R. D avis
Stephen R. Davis
Chief Executive Officer
(on behalf of the registrant and as the registrant’s
Principal Executive Officer)
82
KNOW ALL PERSO NS BY THESE PRESENTS, that each individual whose signature appears below constitutes and appoints Stephen R. Davis his true and lawful attorney-in-fact and agent, with full power of substitution, for him and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities and Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/ S / S TEPHEN R. D AVIS
Stephen R. Davis
Chief Executive Officer and Director
(Principal Executive Officer)
February 27, 2024
/ S / M ARK C. S CHNEYER
Mark C. Schneyer
Executive Vice President and Chief Financial Officer (Principal Financial Officer)
February 27, 2024
/ S / J AMES K. K IHARA
James K. Kihara
Vice President, Chief Accounting Officer and Controller (Principal Accounting Officer)
February 27, 2024
/ S / S TEPHEN R. B IGGAR
Stephen R. Biggar
Chairman of the Board
February 27, 2024
/ S / J ULIAN C. B AKER
Julian C. Baker
Director
February 27, 2024
/ S / L AURA A. B REGE
Laura A. Brege
Director
February 27, 2024
/ S / J AMES M. D ALY
James M. Daly
Director
February 27, 2024
/ S / E LIZABETH A. G AROFALO
Elizabeth A. Garofalo
Director
February 27, 2024
/ S / E DMUND P. H ARRIGAN
Edmund P. Harrigan
Director
February 27, 2024
/ S / A DORA N DU
Adora Ndu
Director
February 27, 2024
/ S / D ANIEL B. S OLAND
Daniel B. Soland
Director
February 27, 2024
83
Report of Independent Regist ered Public Accounting Firm
To the Stockholders and the Board of Directors of
Acadia Pharmaceuticals Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Acadia Pharmaceuticals Inc. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, cash flows and stockholders’ equity for each of the three years in the period ended December 31, 2023, and the related notes and financial statement schedule listed in the Index at Item 15(a)2 (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at 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 U.S. generally accepted accounting principles.
We also have 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 issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 27, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
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. The communication of the critical audit matter does not alter in any way our opinion on the consolidated 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.
F- 1
Medicare Part D sales rebate accruals
Description of the Matter
As described in Note 2 to the consolidated financial statements under the caption “Revenue Recognition” the Company establishes provisions for sales rebates and discounts in the same period as the related sales occur. Estimated sales rebates for the purchase of the product covered by Medicare Part D are included within accrued liabilities on the consolidated balance sheet. In order to establish these sales rebate accruals, the Company estimated its rebates based upon the identification of the product subject to a rebate, the historical and expected payor mix, the applicable price, rebate terms and the estimated lag time between the sale and payment of the rebate.
Auditing the Medicare Part D sales rebate is complex because of the subjectivity of certain assumptions required to estimate the rebate liabilities and the amounts involved are material to the financial statements taken as a whole. In calculating the appropriate accrual amount, the Company considered historical Medicare Part D rebate payments as well as any significant changes in sales trends, the lag in payment timing, an evaluation of the current Medicare Part D laws and interpretations, the percentage of products that are sold via Medicare Part D, and product pricing. In deriving these estimates and assumptions, the Company used both internal and external sources of information to estimate product in the distribution channels, payor mix, prescription volumes and historical experience. Management supplemented its historical data analysis with qualitative adjustments based upon changes in rebate trends, rebate programs and contract terms, legislative changes, or other significant events which indicate a change in the reserve is appropriate.
How We Addressed the Matter in Our Audit
We obtained an understanding evaluated the design and tested the operating effectiveness of controls over the Company’s sales rebate accruals for Medicare Part D rebates. This included testing controls over management’s review of the significant assumptions described above and inputs into the rebate calculations. For example, we tested controls over actual sales and the accuracy of forecasting expected utilization and payor mix. The testing was inclusive of management’s controls to evaluate the accuracy of its reserve judgments to actual rebates paid, rebate validation and processing, and controls to ensure that the data used to evaluate and support the significant assumptions was complete, accurate and, where applicable, verified to external data sources.
To test the sales rebate accruals for Medicare Part D, our audit procedures included, among others, understanding and evaluating the significant assumptions and underlying data used in management’s calculations. Our testing of significant assumptions included a lookback analysis to evaluate the historical accuracy of management’s estimates by comparing actual rebates to previous estimates and performed sensitivity analyses over the subjective assumptions to evaluate the completeness of the reserves. As a part of our procedures, we evaluated the reasonableness of the Company’s assumptions considering recent sales trends and regulatory factors.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2015.
San Diego, California
February 27, 2024
F- 2
ACADIA PHARMACEUTICALS INC.
CONSOLIDATED B ALANCE SHEETS
(in thousands, except share and per share amounts)
December 31,
2023
2022
Assets
Cash and cash equivalents
$
188,657
$
114,846
Investment securities, available-for-sale
250,208
301,977
Accounts receivable, net
98,267
62,195
Interest and other receivables
4,083
885
Inventory
35,819
6,636
Prepaid expenses
39,091
21,398
Total current assets
616,125
507,937
Property and equipment, net
4,612
6,021
Operating lease right-of-use assets
51,855
55,573
Intangible assets, net
65,490
—
Restricted cash
5,770
5,770
Long-term inventory
4,628
4,924
Other assets
476
7,587
Total assets
$
748,956
$
587,812
Liabilities and stockholders’ equity
Accounts payable
$
17,543
$
12,746
Accrued liabilities
236,711
112,884
Total current liabilities
254,254
125,630
Operating lease liabilities
47,800
52,695
Other long-term liabilities
15,147
9,074
Total liabilities
317,201
187,399
Commitments and contingencies (Note 9)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized at December 31, 2023
and 2022; no shares issued and outstanding at December 31, 2023 and 2022
—
—
Common stock, $ 0.0001 par value; 225,000,000 shares authorized at December 31, 2023
and 2022; 164,650,219 shares and 162,064,872 shares issued and outstanding at
December 31, 2023 and 2022, respectively
16
16
Additional paid-in capital
2,862,552
2,770,923
Accumulated deficit
( 2,430,837
)
( 2,369,551
)
Accumulated other comprehensive income (loss)
24
( 975
)
Total stockholders’ equity
431,755
400,413
Total liabilities and stockholders’ equity
$
748,956
$
587,812
The accompanying notes are an integral part of these consolidated financial statements.
F- 3
ACADIA PHARMACEUTICALS INC.
CONSOLIDATED STATEM ENTS OF OPERATIONS
(in thousands, except per share amounts)
Years Ended December 31,
2023
2022
2021
Revenues
Product sales, net
$
726,437
$
517,235
$
484,145
Total revenues
726,437
517,235
484,145
Operating expenses
Cost of product sales
41,638
10,166
19,141
Research and development
351,619
361,575
239,415
Selling, general and administrative
406,559
369,090
396,028
Total operating expenses
799,816
740,831
654,584
Loss from operations
( 73,379
)
( 223,596
)
( 170,439
)
Interest income, net
17,234
6,610
591
Other income
5,109
3,542
2,329
Loss before income taxes
( 51,036
)
( 213,444
)
( 167,519
)
Income tax expense
10,250
2,531
351
Net loss
$
( 61,286
)
$
( 215,975
)
$
( 167,870
)
Net loss per common share, basic and diluted
$
( 0.37
)
$
( 1.34
)
$
( 1.05
)
Weighted average common shares outstanding, basic and diluted
163,819
161,683
160,493
The accompanying notes are an integral part of these consolidated financial statements.
F- 4
ACADIA PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Years Ended December 31,
2023
2022
2021
Net loss
$
( 61,286
)
$
( 215,975
)
$
( 167,870
)
Other comprehensive income (loss):
Unrealized income (loss) on investment securities
1,017
( 789
)
( 235
)
Foreign currency translation adjustments
( 18
)
6
7
Comprehensive loss
$
( 60,287
)
$
( 216,758
)
$
( 168,098
)
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
ACADIA PHARMACEUTICALS INC.
CONSOLIDATED STATEM ENTS OF CASH FLOWS
(in thousands)
Years Ended December 31,
2023
2022
2021
Cash flows from operating activities
Net loss
$
( 61,286
)
$
( 215,975
)
$
( 167,870
)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Stock-based compensation
66,421
68,201
63,615
Amortization of premiums and accretion of discounts on investment securities
( 7,533
)
( 2,736
)
2,404
Amortization of intangible assets
4,093
—
1,108
Gain on strategic investment
( 5,109
)
( 3,542
)
( 2,329
)
Depreciation
1,459
2,026
2,236
Loss on sale of investment securities
524
—
—
Changes in operating assets and liabilities:
Accounts receivable, net
( 36,072
)
2,171
( 16,119
)
Interest and other receivables
( 3,198
)
93
1,057
Inventory
( 28,808
)
2,415
( 4,210
)
Prepaid expenses and other current assets
( 17,693
)
2,494
1,802
Operating lease right-of-use assets
5,769
6,566
6,287
Other assets
( 33
)
( 48
)
10
Accounts payable
4,797
5,870
( 1,617
)
Accrued liabilities
93,170
24,306
( 8,455
)
Operating lease liabilities
( 5,872
)
( 7,916
)
( 5,433
)
Long-term liabilities
6,073
2,040
1,854
Net cash provided by (used in) operating activities
16,702
( 114,035
)
( 125,660
)
Cash flows from investing activities
Purchases of investment securities
( 369,985
)
( 363,174
)
( 492,797
)
Sale and maturity of investment securities
429,780
436,415
422,817
Proceeds from sales of strategic investment
12,253
—
—
Net purchases of property and equipment
( 50
)
—
( 1,122
)
Intangible assets
( 40,000
)
—
—
Net cash provided by (used in) investing activities
31,998
73,241
( 71,102
)
Cash flows from financing activities
Proceeds from issuance of common stock, net of issuance costs
25,129
8,199
18,162
Net cash provided by financing activities
25,129
8,199
18,162
Effect of exchange rate changes on cash
( 18
)
6
7
Net increase (decrease) in cash, cash equivalents and restricted cash
73,811
( 32,589
)
( 178,593
)
Cash, cash equivalents and restricted cash
Beginning of year
120,616
153,205
331,798
End of year
$
194,427
$
120,616
$
153,205
Supplemental disclosure of cash flow information:
Cash paid for income taxes
$
5,850
$
2,190
$
1,038
Supplemental disclosure of noncash information:
Accrued milestone and contingent payments in connection with asset acquisition
$
29,583
$
—
$
—
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
ACADIA PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Accumulated
Comprehensive
Stockholders’
Shares
Amount
Capital
Deficit
Income (Loss)
Equity
Balances at December 31, 2020
159,637,771
$
16
$
2,612,663
$
( 1,985,706
)
$
36
$
627,009
Issuance of common stock from
exercise of stock options and
units
1,078,074
—
12,850
—
—
12,850
Issuance of common stock
pursuant to employee stock
purchase plan
296,850
—
5,312
—
—
5,312
Net loss
—
—
—
( 167,870
)
—
( 167,870
)
Stock-based compensation
—
—
63,821
—
—
63,821
Other comprehensive loss
—
—
—
—
( 228
)
( 228
)
Balances at December 31, 2021
161,012,695
16
2,694,646
( 2,153,576
)
( 192
)
540,894
Issuance of common stock from
exercise of stock options and
units
721,652
—
3,705
—
—
3,705
Issuance of common stock
pursuant to employee
stock purchase plan
330,525
—
4,494
—
—
4,494
Net loss
—
( 215,975
)
( 215,975
)
Stock-based compensation
—
—
68,078
—
—
68,078
Other comprehensive loss
—
—
( 783
)
( 783
)
Balances at December 31, 2022
162,064,872
16
2,770,923
( 2,369,551
)
( 975
)
400,413
Issuance of common stock from
exercise of stock options and
units
2,236,849
—
20,309
—
—
20,309
Issuance of common stock
pursuant to employee
stock purchase plan
348,498
—
4,820
—
—
4,820
Net loss
—
—
—
( 61,286
)
—
( 61,286
)
Stock-based compensation
—
—
66,500
—
—
66,500
Other comprehensive income
—
—
—
—
999
999
Balances at December 31, 2023
164,650,219
$
16
$
2,862,552
$
( 2,430,837
)
$
24
$
431,755
The accompanying notes are an integral part of these consolidated financial statements.
F- 7
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Business
Acadia Pharmaceuticals Inc. (the Company), based in San Diego, California, is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders and rare diseases.
In April 2016, the U.S. Food and Drug Administration (FDA) approved the Company’s first drug, NUPLAZID ® (pimavanserin), for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). NUPLAZID became available for prescription in the United States in May 2016.
In March 2023, the FDA approved the Company’s second drug, DAYBUE (trofinetide), for the treatment of Rett syndrome. DAYBUE became available for prescription in the United States in April 2023.
2. Summary of Significant Accounting Policies
Significant accounting policies followed in the preparation of these financial statements are as follows:
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity date at the date of purchase of three months or less to be cash equivalents.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows (in thousands).
Twelve Months Ended
December 31, 2023
Twelve Months Ended
December 31, 2022
Beginning of period
End of period
Beginning of period
End of period
Cash and cash equivalents
$
114,846
$
188,657
$
147,435
$
114,846
Restricted cash
5,770
5,770
5,770
5,770
Total cash, cash equivalents and restricted
cash shown in the statements of cash flows
$
120,616
$
194,427
$
153,205
$
120,616
Investment Securities
Currently, all of the Company’s investment securities are debt securities. The Company has classified all of its investment securities as available-for-sale as the sale of such securities may be required prior to maturity to implement management strategies, and accordingly, carries these investments at fair value. Unrealized gains and losses, if any, are reported as a separate component of stockholders’ equity. The cost of investment securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses, if any, are also included in interest income. The cost of securities sold is based on the specific identification method.
F- 8
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Fair Value of Financial Instruments
The carrying values of the Company’s financial instruments, consisting of cash and cash equivalents, trade receivables, interest and other receivables, restricted cash, and accounts payable and accrued liabilities, approximate fair value due to the relative short-term nature of these instruments.
As disclosed in Note 4, the Company classifies its cash equivalents and available-for-sale investment securities within the fair value hierarchy as defined by authoritative guidance:
Level 1 Inputs — Quoted prices for identical instruments in active markets.
Level 2 Inputs — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable.
Level 3 Inputs — Valuation derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
Accounts Receivable
Accounts receivable are recorded net of customer allowances for distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company adopted FASB Accounting Standards Codification 326-20, Financial Instruments – Credit Losses (ASC 326-20) as of January 1, 2020. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about the collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. Based on its assessment, as of December 31, 2023 , the Company determined that an allowance for credit loss was not required.
Inventory
Inventory is stated at the lower of cost or net realizable value under the first-in, first-out method (FIFO). The Company uses a combination of standard and actual costing methodologies to determine the cost basis for its inventories which approximates actual costs. Inventory consists of raw material, work in process, and finished goods, including third-party manufacturing costs, freight, and indirect overhead costs. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Prior to FDA approval of NUPLAZID in April 2016 and DAYBUE and March 2023, all costs related to the manufacturing of NUPLAZID and DAYBUE were charged to research and development expense in the period incurred.
The Company periodically reviews inventory and reduces the carrying value of items to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life. During the years ended December 31, 2023, 2022 and 2021, the Company recorded charges of $ 0.9 million, $ 0.6 million and $ 1.3 million, respectively, to reduce certain finished goods and work in process inventory to its net realizable value.
F- 9
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Property and Equipment
Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Leasehold improvements are amortized over the shorter of their estimated useful lives or the term of the lease by use of the straight-line method. Construction-in-process reflects amounts incurred for property, equipment or improvements that have not been placed in service. Maintenance and repair costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are removed from the respective accounts and any gain or loss is recognized. Estimated useful lives by major asset category are as follows:
Useful Lives
Machinery and equipment
5 to 7 years
Computers and software
3 years
Furniture and fixtures
10 years
Impairment of Long-Lived Assets
The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Through December 31, 2023 , no such impairment losses have been recorded by the Company.
License Fees and Royalties
The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale.
In connection with the FDA approval of NUPLAZID in April 2016, the Company made a one-time milestone payment of $ 8.0 million pursuant to its 2006 license agreement with the Ipsen Group in which the Company licensed certain intellectual property rights that complement its patent portfolio for its serotonin platform, including NUPLAZID. The Company capitalized the $ 8.0 million payment as an intangible asset and is amortizing the asset on a straight-line basis over the estimated useful life which ended during the year ended December 31, 2021. The Company recorded no amortization expense related to its intangible asset for the years ended December 31, 2023 and 2022 and recorded amortization expense of $ 1.1 million for the year ended December 31, 2021. As of December 31, 2021, the intangible asset was fully amortized.
In connection with the first commercial sale of DAYBUE in April 2023, the Company made a milestone payment of $ 40.0 million pursuant to its 2018 license agreement with Neuren, as disclosed in Note 9. The Company capitalized the $ 40.0 million payment as an intangible asset and began amortizing the asset in April 2023 on a straight-line basis over the estimated useful life of the licensed patents through early 2036. The Company recorded amortization expense related to this inta ngible asset of $ 2.4 million f or the year ended December 31, 2023. As of December 31, 2023 , estimated future amortization expense related to the Company’s intangible asset was $ 3.1 million for each subsequent year.
Following the FDA approval of DAYBUE, the Company was granted a Rare Pediatric Disease Priority Review Voucher (PRV). Pursuant to the license agreement, the Company is required to pay Neuren one third of the value of the PRV at the time of sale or use of the PRV. If the PRV is sold, the amount to be paid will be the sale value net of applicable fees. If the PRV is not sold but used by the Company, the amount to be paid will be the average price of the three most recent publicly announced sales of Rare Pediatric Disease PRVs immediately preceding the issuance of the PRV to the Company. The Company capitalized the $ 29.6 million for the estimated PRV value owed to Neuren as an intangible asset and began amortizing it in April 2023 on a straight-line basis over the estimated useful life of the licensed patents through early 2036. The Company recorded amortization expense related to this intangible asset of $ 1.7 million for the year ended December 31, 2023. As of December 31, 2023 , estimated future amortization expense related to the Company’s intangible asset was $ 2.3 million for each subsequent year.
F- 10
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Royalties incurred in connection with the Company’s license agreement with Neuren, as disclosed in Note 9, are expensed to cost of product sales as revenue from product sales is recognized .
Intangible Assets
Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. A mortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. We review our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such intangible assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of intangible the assets exceeds the estimated fair value of the intangible assets. No impairment loss was recorded on intangible assets during the years ended December 31, 2023 or 2022 .
Acquisitions
The Company accounts for acquisitions of an asset or group of similar identifiable assets that do not meet the definition of a business as asset acquisition using the cost accumulation method, whereby the cost of the acquisition, including certain transaction costs, is allocated to the assets acquired on the basis of their relative fair values. No goodwill is recognized in an asset acquisition. Intangible assets acquired in an asset acquisition for use in research and development activities which have no alternative future use are expensed as in-process research and development on the acquisition date. Intangible assets acquired for use in research and development activities which have an alternative future use are capitalized as in-process research and development. Future costs to develop these assets are recorded to research and development expense as they are incurred. Contingent milestone payments associated with asset acquisitions are recognized when probable and estimable. These amounts are expensed to research and development if there is no alternative future use associated with the asset, or capitalized as an intangible asset if alternative future use of the asset exists.
Advertising Expense
Advertising costs are expensed when services are performed or goods are delivered. The Company incurred $ 9.4 million, $ 5.5 mil lion and $ 41.8 million in advertising costs during the years ended December 31, 2023, 2022 and 2021 , respectively. No advertising costs were capitalized as prepaid expenses at December 31, 2023 or 2022 .
Revenue Recognition
The Company operates in one business segment. Results of its operations are reported on a consolidated basis for purposes of s egment reporting, consistent with internal management reporting. Revenues consist of net product sales to customers, all of which are sales in the U.S. Revenues by product are as follows (in thousands):
Years Ended December 31,
2023
2022
2021
NUPLAZID
$
549,248
$
517,235
$
484,145
DAYBUE
177,189
—
—
Product sales, net
$
726,437
$
517,235
$
484,145
F- 11
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Product Sales, Net
The Company accounts for contracts with its customers in accordance with Revenue from Contracts with Customers (Topic 606) . The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (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. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. 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, 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. Payment terms differ by customer, but typically range from 31 to 35 days from the date of shipment. Revenue for the Company’s product sales has not been adjusted for the effects of a financing component as the Company expects, at contract inception, that the period between when the Company transfers control of the product and when the Company receives payment will be one year or less.
The Company’s product sales, net consist of U.S. sales of NUPLAZID and DAYBUE. NUPLAZID was approved by the FDA in April 2016 and the Company commenced shipments of NUPLAZID to SPs and SDs in late May 2016. SPs dispense product to a patient based on the fulfillment of a prescription and SDs sell product to government facilities, long-term care pharmacies, or in-patient hospital pharmacies. DAYBUE was approved by the FDA in March 2023 and the Company commenced shipments of DAYBUE to a single wholesale distributor in April 2023. Product shipping and handling costs are included in cost of product sales.
The Company recognizes revenue from product sales at the net sales price (the “transaction price”) which includes estimates of variable consideration for which reserves for sales discounts and allowance are established and reflects each of these as either a reduction to the related account receivable or as an accrued liability, depending on how the amount payable is settled. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which the Company is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from estimates, the Company may need to adjust its estimates, which would affect net revenue in the period of adjustment. The following are the Company’s significant categories of sales discounts and allowances:
Distribution Fees : Distribution fees include distribution service fees paid to the SPs, SDs and wholesale distributor based on a contractually fixed percentage of the wholesale acquisition cost (WAC), fees for data, and prompt payment discounts. Distribution fees are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized.
Rebates : Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with, or statutory requirements pertaining to, Medicaid and Medicare benefit providers. The allowance for rebates is based on statutory discount rates, estimated payor mix, and expected utilization. The Company’s estimates for expected utilization of rebates are based on historical data received from the SPs, SDs and single wholesale distributor since product launch. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for prior quarters’ unpaid rebates still estimated to be incurred. Allowances for rebates also include amounts due under the Inflation Reduction act of 2022 for Medicare Part D unit sales with applicable period AMP increases that outpace inflation over the benchmark period. The applicable period will be twelve months on October 1 of each year, with the initial applicable period beginning on October 1, 2022. The benchmark period AMP price is January 1, 2021 through September 30, 2021. The Company’s estimates are based Medicare Part D sales as a percentage of gross sales and the rate AMP for the current period will be in excess the benchmark period.
F- 12
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Chargebacks : Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs at a discounted price. The SDs charge back to the Company the difference between the price initially paid by the SDs and the discounted price paid to the SDs by these entities. The Company also incurs group purchasing organization fees for transactions through certain purchasing organizations. The Company estimates sales with these entities and accrues for anticipated chargebacks and organization fees, based on the applicable contractual terms.
Co-Payment Assistance : The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. Co-payment assistance is accrued for based on actual program participation and estimates of program redemption using data provided by third-party administrators.
Product Returns : Consistent with industry practice, the Company offers the SPs and SDs limited product return rights for damages, shipment errors, and expiring product; provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SPs and SDs and has the ability to control the amount of product that is sold to the SPs and SDs, it is able to make a reasonable estimate of future potential product returns based on this on-hand channel inventory data and sell-through data obtained from the SPs and SDs. In arriving at its estimate for product returns, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry.
Research and Development Expenses
Research and development expenses are charged to operations as incurred. Research and development expenses include costs associated with services provided by contract organizations for preclinical development, pre-commercialization manufacturing expenses, and clinical trials, salaries and related personnel expenses including stock-based compensation expense, and facilities and equipment expenses. The upfront consideration and transaction costs associated with acquired in-process research and development are also included in the research and development expenses.
The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. When the Company makes payments in advance of services being provided, it records those amounts as prepaid expenses on its consolidated balance sheets and expense them as the services are rendered. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. Other indirect costs are generally recognized on a straight-line basis over the estimated period of the study. As actual costs become known, the Company adjusts its accruals accordingly.
Concentration Risk
Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, investment securities, accounts receivable, and restricted cash. The Company invests its excess cash primarily in money market funds, U.S. treasury notes, and high quality, marketable debt instruments of corporations and government sponsored enterprises in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least Aa3/AA- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s. Further, the Company specifies credit quality standards for its customers that are designed to limit the Company’s credit exposure to any single party.
The Company does not currently have any of its own manufacturing facilities, and therefore it depends on an outsourced manufacturing strategy for the production of NUPLAZID and DAYBUE for commercial use and for the production of its product candidates for clinical trials. For the production of NUPLAZID, the Company has contracts in place with two third-party manufacturers of commercial drug product and one third-party manufacturer of drug substance that is approved for the production of NUPLAZID API. For the production of DAYBUE, the Company has contracts in place with two third-party manufacturers of commercial drug product and two third-party manufacturers of drug substance that is approved for the production of DAYBUE API. Although there are potential sources of supply other than the Company’s existing suppliers, any new supplier would be required to qualify under applicable regulatory requirements.
F- 13
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The Company has entered into agreements for the distribution of NUPLAZID with a limited number of SPs and SDs, and all of the Company’s product sales of NUPLAZID are to these customers. The Company has also entered into agreements for the distribution of DAYBUE with a single wholesale distributor, and all of the Company’s product sales of DAYBUE and accounts receivable balance at December 31, 2023 are related to this customer.
For the year ended December 31, 2023 , the Company’s four largest customers, including the single wholesale distributor, represented approximately 69 % of the Company’s product revenue and 73 % of the Company’s accounts receivable balance at December 31, 2023. For the year ended December 31, 2022 , the Company’s four largest customers represented approximately 73 % of the Company’s product revenue and 74 % of the Company’s accounts receivable balance at December 31, 2022 .
Stock-Based Compensation
The fair value of each employee stock option and each employee stock purchase right granted is estimated on the grant date under the fair value method using the Black-Scholes valuation model. The estimated fair value of each stock option and purchase right is then expensed on a straight-line basis over the requisite service period, which is generally the vesting period. The following weighted-average assumptions were used during these periods:
Years Ended December 31,
2023
2022
2021
Stock Options:
Expected volatility
66
%
68
%
64
%
Risk-free interest rate
3.9
%
2.9
%
0.9
%
Expected dividend yield
0
%
0
%
0
%
Expected life of options in years
5.4
5.4
5.4
Years Ended December 31,
2023
2022
2021
Employee Stock Purchase Plan:
Expected volatility
40 %- 67 %
62 %- 82 %
49 %- 100 %
Risk-free interest rate
4.0 %- 5.3 %
1.5 %- 4.6 %
0.0 %- 0.5 %
Expected dividend yield
0
%
0
%
0
%
Expected life in years
0.5 - 2.0
0.5 - 2.0
0.5 - 2.0
Expected Volatility. The Company considers its historical volatility and implied volatility when determining the expected volatility.
Risk-Free Interest Rate. The Company determines its risk-free interest rate assumption based on the U.S. Treasury yield for obligations with contractual terms similar to the expected term of the stock option or purchase right being valued.
Expected Dividend Yield. The Company has never paid any dividends and currently has no plans to do so.
Expected Life. In determining the expected life for stock options, the Company considers, among other factors, its historical exercise experience to date as well as the mean time remaining to full vesting of all outstanding options and the mean time remaining to the end of the contractual term of all outstanding options. The estimated life for the Company’s employee stock purchase rights is based upon the terms of each offering period.
Forfeitures. The Company recognizes forfeitures as they occur.
F- 14
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The fair value of restricted stock units (RSUs) is estimated based on the closing market price of the Company’s common stock on the date of grant. RSUs generally vest over a four-year period. Certain RSUs also have an accelerated vesting clause based on specified market condition target and continued employment through a minimum vesting period. The fair value of RSUs expected to vest are recognized and amortized on a straight-line basis over the requisite service period, which is generally the vesting period. For those RSUs requiring satisfaction of both market and service conditions, the requisite service period is the longest of the explicit, implicit and derived service periods. The fair value of performance-based stock units (PSUs) is estimated based on the closing market price of the Company’s common stock on the date of grant. PSUs vest upon the achievement of certain pre-defined company-specific performance-based criteria. Expense related to these PSUs is recognized ratably over the expected performance period once the pre-defined performance-based criteria for vesting becomes probable. During the year ended December 31, 2021, the Company had a change in estimate related to the achievement of certain performance-based criteria for performance-based stock awards which resulted in a reduction in stock-based compensation expenses by approximatel y $ 6.8 m illion.
The table below summarizes the total stock-based compensation expense included in the Company’s consolidated statements of operations for the periods presented (in thousands):
Years Ended December 31,
2023
2022
2021
Cost of product sales
$
1,007
$
1,106
$
1,286
Research and development
17,408
22,580
21,969
Sales, general and administrative
48,006
44,515
40,360
$
66,421
$
68,201
$
63,615
Income Taxes
Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits and loss carryforwards. Deferred income tax expense or benefit represents the net change during the year in the deferred income tax asset or liability. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company recognizes the impact of a tax position in the financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected in income tax expense.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, employee stock purchase rights, RSUs, and PSUs are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. More specifically, at December 31, 2023, 2022 and 2021 , stock options, employee stock purchase plan rights, RSUs and PSUs covering a total of approximately 21,264,000 shares, 21,185,000 shares and 17,535,000 shares, respectively, were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive.
F- 15
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Segment Reporting
The Company uses “the management approach” in determining reportable operating segments. The management approach considers the internal organization and reporting used by the Company’s chief operating decision maker for making operating decisions and assessing performance as the source for determining the Company’s reportable segments. The Company’s chief operating decision maker is the chief executive officer who reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. Management has determined that the Company operates in one business segment which is the development and commercialization of innovative medicines. All revenues for the years ended December 31, 2023, 2022 and 2021 were generated from customers in the United States.
Recently Issued Accounting Standards
In November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures . The amendments require disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting . The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.
In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures . The amendments require (i) enhanced disclosures in connection with an entity’s effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.
3. Investments
The carrying value and amortized cost of the Company’s investments, summarized by major security type, consisted of the following (in thousands):
December 31, 2023
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury notes
$
75,315
$
47
$
( 28
)
$
75,334
Government sponsored enterprise securities
174,867
119
( 112
)
174,874
$
250,182
$
166
$
( 140
)
$
250,208
December 31, 2022
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury notes
$
15,956
$
—
$
( 11
)
$
15,945
Government sponsored enterprise securities
81,216
16
( 291
)
80,941
Municipal bonds
20,873
—
( 98
)
20,775
Commercial paper
184,923
30
( 637
)
184,316
$
302,968
$
46
$
( 1,037
)
$
301,977
The Company has classified all of its available-for-sale investment securities, including those with maturities beyond one year, as current assets on its consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of December 31, 2023 and 2022, all of the Company’s available-for-sale investment securities have contractual maturity dates of less than one year . The Company has classified all equity securities as other assets on its consolidated balance sheets.
F- 16
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
At December 31, 2023 and 2022 , the Company had 21 and 43 securities, respectively, in an unrealized loss position. The following table presents gross unrealized losses and fair value for those available-for-sale investments that were in an unrealized loss position as of December 31, 2023 and December 31, 2022, aggregated by investment category and length of time that individual securities have been in a continuous loss position (in thousands):
Less Than 12 Months
12 Months or Greater
Total
Estimated
Fair Value
Unrealized
Losses
Estimated
Fair Value
Unrealized
Losses
Estimated
Fair Value
Unrealized
Losses
December 31, 2023
U.S. Treasury notes
$
41,366
$
( 28
)
$
—
$
—
$
41,366
$
( 28
)
Government sponsored enterprise securities
108,587
( 112
)
—
—
108,587
( 112
)
Total
$
149,953
$
( 140
)
$
—
$
—
$
149,953
$
( 140
)
December 31, 2022
U.S. Treasury notes
$
15,945
$
( 11
)
$
—
$
—
$
15,945
$
( 11
)
Government sponsored enterprise securities
58,254
( 291
)
—
—
58,254
( 291
)
Municipal bonds
20,775
( 98
)
—
—
20,775
( 98
)
Commercial paper
135,200
( 637
)
—
—
135,200
( 637
)
Total
$
230,174
$
( 1,037
)
$
—
$
—
$
230,174
$
( 1,037
)
During the first quarter of 2023, the Company made a sale of all of its investments in commercial paper. The proceeds from sales of these securities were $ 183.0 million and net realized losses from the related sales were $ 0.5 million. There were no other sales of available-for-sale investment securities in prior periods.
At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are the result of credit losses. Impairment is assessed at the individual security level. Factors considered in determining whether a loss resulted from a credit loss or other factors include the Company’s intent and ability to hold the investment until the recovery of its amortized cost basis, the extent to which the fair value is less than the amortized cost basis, the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any changes to the rating of the security by a rating agency, any adverse legal or regulatory events affecting the issuer or issuer’s industry, any significant deterioration in economic conditions.
The Company does not intend to sell the investment in unrealized loss position and it is unlikely that the Company will be required to sell the investment before the recovery of its amortized cost basis. Based on its evaluation, the Company determined its year-to-date credit losses related to its available-for-sale securities were immaterial at December 31, 2023 .
4. Fair Value Measurements
The Company’s investments include cash equivalents, available-for-sale investment securities consisting of money market funds, U.S. treasury notes, and marketable debt instruments of corporations and government sponsored enterprises in accordance with the Company’s investment policy, and equity investments. The Company’s investment policy defines allowable investment securities and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least Aa3/AA- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s.
The Company’s cash equivalents, available-for-sale investment securities, and equity securities are classified within the fair value hierarchy as defined by authoritative guidance. The Company’s investment securities and equity securities classified as Level 1 are valued using quoted market prices. The Company obtains the fair value of its Level 2 financial instruments from third-party pricing services. The pricing services utilize industry standard valuation models whereby all significant inputs, including benchmark yields, reported trades, broker/dealer quotes, issuer spreads, bids, offers, or other market-related data, are observable. The Company validates the prices provided by the third-party pricing services by reviewing their pricing methods and matrices and obtaining market values from other pricing sources. After completing the validation procedures, the Company did not adjust or override any fair value measurements provided by these pricing services as of December 31, 2023 and 2022, respectively.
F- 17
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
In November 2021, the Company established a plan whereby substantially all full-time employees excluding executive management are eligible to receive a series of cash bonuses based on achievement of certain conditions as described in more detail in Note 6 to the consolidated financial statements. The Company estimated the fair value of the cash awards using a Monte Carlo simulation, which utilizes level 3 inputs such as volatility, probabilities of success, and other inputs that are not observable in active markets. The cash awards are required to be measured at fair value on a recurring basis each reporting period, with changes in the fair value recognized as compensation cost over the derived service period of the awards.
The Company has not transferred any investment securities between the classification levels.
The recurring fair value measurements of the Company’s cash equivalents, available-for-sale investment securities, and equity securities at December 31, 2023 and 2022 consisted of the following (in thousands):
Fair Value Measurements at
Reporting Date Using
December 31, 2023
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets
Money market fund
$
64,586
$
64,586
$
—
$
—
U.S. Treasury notes
75,334
75,334
—
—
Government sponsored enterprise securities
174,874
—
174,874
—
Total
$
314,794
$
139,920
$
174,874
$
—
Liabilities
Cash awards
$
4,506
$
—
$
—
$
4,506
Total
$
4,506
$
—
$
—
$
4,506
Fair Value Measurements at
Reporting Date Using
December 31, 2022
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets
Money market fund
$
72,578
$
72,578
$
—
$
—
U.S. Treasury notes
15,945
15,945
—
—
Equity securities
7,180
7,180
—
—
Government sponsored enterprise securities
94,803
—
94,803
—
Municipal bonds
20,775
—
20,775
—
Commercial paper
184,316
—
184,316
—
Total
$
395,597
$
95,703
$
299,894
$
—
Liabilities
Cash awards
$
898
$
—
$
—
$
898
Total
$
898
$
—
$
—
$
898
Changes in estimated fair value of contingent cash awards during the twelve months ended December 31, 2023 are as follows (in thousands):
Balance as of December 31, 2022
$
898
Vesting of awards
772
Expense forfeited
( 128
)
Change in fair value
2,964
Balance as of December 31, 2023
$
4,506
F- 18
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
5. Balance Sheet Details
Inventory consisted of the following (in thousands):
December 31,
2023
2022
Finished goods
$
5,001
$
1,926
Work in process
4,134
4,427
Raw material
31,312
5,207
$
40,447
$
11,560
Reported as:
Inventory
$
35,819
$
6,636
Long-term inventory
4,628
4,924
Total
$
40,447
$
11,560
Amount reported as long-term inventory consisted of raw materials as of December 31, 2023 and 2022. The Company has raw materials beyond its one-year production plan that prevent the Company from potential supply interruption. Those raw materials maintained beyond the one-year production plan are classified as long-term inventory.
Property and equipment, net, consisted of the following (in thousands):
December 31,
2023
2022
Computers and software
$
5,873
$
5,873
Leasehold improvements
3,746
3,696
Furniture and fixtures
4,549
4,549
14,168
14,118
Accumulated depreciation
( 9,556
)
( 8,097
)
$
4,612
$
6,021
Depreciation of property and equipment was $ 1.5 million, $ 2.0 million, and $ 2.2 million for the years ended December 31, 2023, 2022, and 2021, respectively. For the year ended December 31, 2023, the Compan y did no t retire any fully depreciated property and equipment. For the year ended December 31, 2022 , the Company retired $ 0.1 million of fully depreciated property and equipment. During 2021, the Company did not retire any fully depreciated property and equipment.
Accrued liabilities consisted of the following (in thousands):
December 31,
2023
2022
Accrued sales allowances
$
90,718
$
26,046
Accrued compensation and benefits
42,718
28,023
Accrued research and development services
32,883
35,048
Accrued contingent payments
29,583
—
Accrued consulting and professional fees
18,804
11,377
Current portion of lease liabilities
9,405
9,305
Accrued taxes
1,564
377
Other
11,036
2,708
$
236,711
$
112,884
F- 19
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
6. Stockholders’ Equity
Equity Awards
The Company’s 2010 Equity Incentive Plan, as amended to date (the 2010 Plan), permits the grant of options to employees, directors and consultants. In addition, the 2010 Plan permits the grant of stock bonuses, rights to purchase restricted stock, and other stock awards. The exercise price of options granted under the 2010 Plan cannot be less than 100 percent of the fair market value of the common stock on the date of grant and the maximum term of any option is 10 years. Options granted under the 2010 Plan generally vest over a four-year period. All shares that remained eligible for grant under the Company’s 2004 Equity Incentive Plan (the 2004 Plan) at the time of approval of the 2010 Plan were transferred to the 2010 Plan. The 2010 Plan share reserve also has been, and may be, increased by the number of shares that otherwise would have reverted to the 2004 Plan reserve after June 2010. In June 2015, June 2016, June 2017, June 2018, June 2019 and June 2022, the Company’s stockholders approved amendments to its 2010 Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 5,000,000 shares, 3,000,000 shares, 5,500,000 shares, 6,700,000 shares, 8,300,000 shares and 6,000,000 shares, respectively. At December 31, 2023, there wer e 30,490,486 shar es of common stock authorized for issuance, of wh ich 7,731,848 share s were available for new grants under the 2010 Plan.
Stock Options
The 2010 Plan provided for the grant of options to employees, directors and consultants. The exercise price of options granted under the 2010 Plan was at 100 percent of the fair market value of the common stock on the date of grant and the maximum term of any option was 10 years. Options granted under the 2010 Plan generally vested over a four-year period.
The following table summarizes the Company’s stock option activity during the year ended December 31, 2023:
Number of
Shares
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term
(years)
Aggregate
Intrinsic Value
(in thousands)
Outstanding at December 31, 2022
16,339,465
$
29.83
Granted
3,157,634
$
21.99
Exercised
( 1,046,035
)
$
19.42
Cancelled/forfeited
( 1,825,035
)
$
32.07
Outstanding at December 31, 2023
16,626,029
$
28.75
5.6
$
90,962
Vested and exercisable at December 31, 2023
11,152,607
$
31.12
4.2
$
44,951
Unvested at December 31, 2023
5,473,422
$
23.92
8.4
$
46,012
The aggregate intrinsic value of options exercisable as of December 31, 2023 is calculated as the difference between the exercise price of the underlying options and the closing market price of the Company’s common stock on that date, which was $ 31.31 per share. The aggregate intrinsic value of options exercised during the years ended December 31, 2023, 2022, and 2021 was approximately $ 7.9 million, $ 1.7 million, and $ 8.0 million, respectively, determined as of the date of exercise. The Company receive d approximately $ 20.3 million, $ 3.7 millio n and $ 12.9 million in cash from options exercised during the years ended December 31, 2023, 2022 and 2021, respectively.
The weighted average per share fair value of options granted during the years ended December 31, 2023, 2022, and 2021 was approximately $ 13.25 , $ 13.66 , and $ 24.07 , respectively. As of December 31, 2023, 2022 and 2021 , total unrecognized compensation cost related to stock options was approximately $ 62.1 million, $ 63.9 million and $ 66.0 million , and the weighted averag e period over which this cost is expected to be recognized is approximately 2.6 years, 2.7 years and 2.3 years, respectively.
F- 20
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Restricted Stock
The Company grants RSUs and PSUs, both of which are considered restricted stock, pursuant to the 2010 Plan and satisfies such grants through the issuance of new shares. RSUs are share awards that, upon vesting, will deliver to the holder shares of the Company’s common stock. RSUs generally vest over a four-year period. Certain RSUs also have an accelerated vesting clause based on a specified market condition target and continued employment through the vesting period. PSUs for which the number of shares issuable at the end of performance period can reach up to 200% of the shares approved in the award based on the achievement of certain pre-defined Acadia-specific performance criteria and continued employment through the vesting period .
The following table summarizes the Company’s restricted stock activity during the year ended December 31, 2023:
Number of
Shares
Weighted
Average Grant
Date Fair Value
Aggregate
Intrinsic Value
(in thousands)
Outstanding at December 31, 2022
4,187,107
$
29.49
Granted
1,960,482
$
21.97
Vested
( 1,190,814
)
$
28.09
Cancelled/forfeited
( 571,030
)
$
28.23
Outstanding at December 31, 2023
4,385,745
$
26.67
$
134,440
There were 1,734,828 , 2,055,574 and 1,276,936 PSUs outstanding at December 31, 2023, 2022 and 2021, respectivel y, of which 484,757 , 1,057,741 and 639,700 were related to the RSUs with an accelerated vesting clause based on a specified market condition target and continued employment through the vesting period. During the years ended 2023, 2022 and 2021, 517,290 , 986,739 , and 918,434 PSUs were granted, respectively, of which 459,420 were vested during the year ended December 31, 2023. There was no vesting during the years ended December 31, 2022 and 2021. D uring the years ended December 31, 2023, 2022 and 2021, total intrinsic value of PSUs outstanding was $ 50.0 million, $ 32.7 million and $ 29.8 million, respectively. Total unrecognized compensation cost related to RSUs was approximately $ 46.7 million, $ 44.6 million and $ 39.8 million for the years ended December 31, 2023, 2022 and 2021 , respectively, and the weighted average period over which the cost is expected to be recognized is approximately 2.9 years, 2.7 years and 2.3 years, respectively. Total unrecognized compensation cost related to PSUs was approximately $ 5.7 million, $ 12.7 million and $ 11.5 million for the years ended December 31, 2023, 2022 and 2021, respectively, and the weighted average remaining contractual term related to outstanding PSUs was 3.2 years, 3.0 years and 3.3 years, respectively.
Employee Stock Purchase Plan
The Company’s 2004 Employee Stock Purchase Plan (the Purchase Plan) became effective upon the closing of the Company’s initial public offering in June 2004. In June 2016, June 2019 and June 2020, the Company’s stockholders approved an amendment to the Purchase Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the Purchase Plan by 400,000 shares, 600,000 shares and 3,000,000 shares, respectively. At December 31, 2023, a total o f 5,525,000 sha res of common stock had been reserved for issuance under the Purchase Plan. At December 31, 2023 , 2,131,122 shares of common stock remained available for issuance pursuant to the Purchase Plan. Eligible employees who elect to participate in an offering under the Purchase Plan may have up to 15 percent of their earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the Purchase Plan. The price of common stock purchased under the Purchase Plan is equal to 85 percent of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant purchase date.
During the years ended December 31, 2023, 2022, and 2021, a total of 348,498 , 330,525 and 296,850 shares of common stock were issued under the Purchase Plan at average per share prices of $ 13.83 , $ 13.60 , and $ 17.89 , respectively. The weighted ave rage per share fair value of purchase rights granted during the years ended December 31, 2023, 2022, and 2021 was $ 22.25 , $ 13.91 , and $ 23.97 , respectively. During the years ended December 31, 2023, 2022, and 2021, the Company recorded cash received from the exercise of purchase rights of $ 4.8 million, $ 4.5 million, and $ 5.3 million, respectively.
F- 21
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contingent Cash Awards
In November 2021, the Company established a plan whereby substantially all full-time employees excluding executive management are eligible to receive a series of cash bonuses over certain periods based on continued employment and the Company’s stock price reaching a pre-specified target. The maximum potential payout of the cash awards at the grant date was $ 15.1 million. The Company has determined that the cash awards were classified as liabilities pursuant to ASC Topic 718, Compensation – Stock Compensation . The Company estimates the fair value of the awards at each reporting period using the Monte Carlo simulation, which is recognized as compensation cost over the derived service period . Total fair value of the awards at the grant date was $ 4.4 million. The maximum potential payout at December 31, 2023 after adjusting for forfeitures was $ 10.1 million. The total fair value of the awards at December 31, 2023 was approximately $ 5.2 million, compared to $ 1.8 million at December 31, 2022. The estimated liability included on the December 31, 2023 and 2022 consolidated balance sheets was $ 4.5 mill ion and $ 0.9 million. During years ended December 31, 2023 and 2022 , the Company recorded a total of $ 3.6 million and $ 0.3 million compensation cost related to the awards.
2023 Inducement Plan
The Board adopted the Company’s 2023 Inducement Plan (the Inducement Plan) on February 1, 2023. The Inducement Plan p ermits the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards and other stock-related awards. Stock awards granted under the Inducement Plan may only be made to individuals who did not previously serve as employees or non-employee directors of the Company or an affiliate of the Company. In addition, stock awards must be approved by either a majority of the Company’s independent directors or the Compensation Committee. The terms of the Inducement Plan are otherwise substantially similar to the Company’s 2010 Equity Incentive Plan. The maximum number of shares of Company common stock that may be issued under the Inducement Plan is 1,750,000 shares. At December 31, 2023 , there were 599,864 shares available for new grants.
7. 401(k) Plan
Effective January 1997, the Company established a deferred compensation plan (the 401(k) Plan) pursuant to Section 401(k) of the Internal Revenue Code of 1986, as amended (the Code), whereby substantially all employees are eligible to contribute up to 60 percent of their pretax earnings, not to exceed amounts allowed under the Code. The Company makes discretionary contributions to the 401(k) Plan equal to 100 percent of each employee’s pretax contributions up to 5 percent of his or her eligible compensation, subject to limitations under the Code. The Company’s total contributions to the 401(k) Plan were $ 6.1 mil lion, $ 5.1 million, and $ 5.8 million for the years ended December 31, 2023, 2022, and 2021 , respectively.
8. Income Taxes
Domestic and foreign pre-tax income (loss) is as follows (in thousands):
Years Ended December 31,
2023
2022
2021
Domestic
$
( 100,215
)
$
( 233,216
)
$
( 138,913
)
Foreign
49,179
19,772
( 28,606
)
$
( 51,036
)
$
( 213,444
)
$
( 167,519
)
The income tax provision consists of the following (in thousands):
Years Ended December 31,
2023
2022
2021
Current provision:
Federal
$
5,440
$
—
$
—
State
4,805
2,531
351
Foreign
5
—
—
Total deferred tax assets
10,250
2,531
351
Total income tax provision
$
10,250
$
2,531
$
351
F- 22
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
At December 31, 2023, the Company had federal, state, and foreign net operating loss (NOL) carryforwards of approximately $ 196.8 million, $ 456.3 million, and $ 845.1 million, respectively. Utilization of the domestic NOL and research and development (R&D) credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred or that could occur in the future, as required by Section 382 of the Code, as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups.
The Company previously completed a study to assess whether an ownership change, as defined by Section 382 of the Code, had occurred from the Company’s formation through December 31, 2013. Based upon this study, the Company determined that several ownership changes had occurred. Accordingly, the Company reduced its deferred tax assets related to the federal NOL carryforwards and the federal R&D credit carryforwards that are anticipated to expire unused as a result of these ownership changes. These tax attributes were excluded from deferred tax assets with a corresponding reduction of the valuation allowance with no net effect on income tax expense or the effective tax rate. The Company completed a study through December 31, 2022 and concluded no additional ownership changes occurred. Future ownership changes may further limit the Company’s ability to utilize its remaining tax attributes.
The Company had federal and state carryforwards of $ 29.4 million and $ 454.4 million that will begin to expire in 2031 and 2024 respectively unless utilized. The remaining federal and state NOL carryforwards of $ 167.4 million and $ 1.9 million will carry forward indefinitely. At December 31, 2023, the Company had federal and state charitable contribution carryforwards of $ 174.8 million which will begin to expire in 2024. At December 31, 2023, the Company had $ 75.6 million of federal R&D credit carryforwards, of which $ 0.5 million will expire in 2024 unless utilized, and the remaining federal R&D credit carryforwards will begin to expire beginning in 2025. At December 31, 2023 , the Company had state R&D credit carryforwards of approximately $ 2.3 million that will begin to expire in 2025 and $ 20.3 million that have no expiration date. At December 31, 2023, the Company had foreign NOL carryforwards of $ 231.6 million that will expire in 2024 unless utilized and $ 6.5 million that have no expiration date. The Company continues to record the deferred tax assets related to these attributes, subject to valuation allowance, until expiration occurs.
The components of the deferred tax assets are as follows (in thousands):
December 31,
2023
2022
Deferred tax assets
NOL carryforwards
$
149,049
$
225,993
R&D credit carryforwards
70,906
83,074
Capitalized R&D
90,164
38,507
Stock-based compensation
51,028
51,661
Charitable contributions
40,956
42,677
Lease liabilities
13,671
14,730
Intangibles
43,220
24,030
Property and equipment
51
—
Accrued rebates
19,401
5,748
Other
16,036
8,022
Total deferred tax assets
494,482
494,442
Valuation allowance
( 482,089
)
( 481,210
)
Deferred tax liabilities
Property and equipment
—
( 29
)
Right-of-use assets
( 12,393
)
( 13,203
)
Total deferred tax liabilities
( 12,393
)
( 13,232
)
Total net deferred tax assets
$
—
$
—
F- 23
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by approximately $ 0.9 million in 2023 primarily due to an increase in deferred tax assets generated by capitalization of research and development expenses, acquired intangibles and accrued rebates, offset in part by the utilization of US and state net operating losses and research credits, the expiration of Switzerland NOLs, and the remeasurement of the Company’s deferred tax balance for future state tax rates.
An accounting policy may be selected to either (i) treat taxes due on future U.S. inclusions in taxable income related to global intangible low-taxed income (GILTI) as a current-period expense when incurred or (ii) factor such amounts into a company’s measurement of its deferred taxes. The Company has elected to account for GILTI as a period cost.
A reconciliation of income taxes to the amount computed by applying the statutory federal income tax rate to the pretax loss is summarized as follows (in thousands):
Years Ended December 31,
2023
2022
2021
Amounts computed at statutory federal rate
$
( 10,718
)
$
( 44,823
)
$
( 35,179
)
Stock-based compensation and other permanent differences
8,458
7,596
6,083
Branded pharmaceutical drug fee
1,848
1,454
613
Write-off of IP R&D
—
2,449
1,277
R&D credits
( 5,827
)
( 9,974
)
( 11,727
)
Change in valuation allowance
1,100
11,227
36,099
State taxes
( 977
)
( 2,232
)
( 2,617
)
Contingencies
( 2,071
)
6,993
3,879
Foreign rate differential
( 5,076
)
( 1,971
)
2,857
Deferred adjustments for limits on executive compensation
2,112
3,918
1,808
Deferred rate adjustment
( 192
)
922
( 2,424
)
Switzerland tax reform
( 246
)
—
( 923
)
Expiration of attributes
17,225
16,142
726
GILTI
7,665
10,804
—
Other
( 3,051
)
26
( 121
)
Income tax expense
$
10,250
$
2,531
$
351
The tax years 2003-2022 remain open to examination by the major taxing jurisdictions to which the Company is subject.
The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination. The Company recorded an uncertain tax position reserve of $ 18.0 million, $ 5.1 million and $ 4.1 million for the years ended December 31, 2023, 2022 and 2021 , respectively. Due to the valuation allowance recorded against the Company’s deferred tax assets, approximately $ 6.8 million and $ 1.2 million of the total unrecognized tax benefits as of December 31, 2023 and December 31, 2022, respectively, would reduce the annual effective tax rate if recognized. The Company does not anticipate that the amount of unrecognized tax benefits as of December 31, 2023 will significantly change within the next twelve months. The Company’s practice is to recognize interest and/or penalties related to uncertain income tax positions in income tax expense. The Company had immaterial interest and/or penalties accrued on the Company’s consolidated balance sheets at December 31, 2023 or 2022, respectively. Further, the Company recognized an insignificant amount of interest and/or penalties in the statement of operations for the years ended December 31, 2023, 2022 and 2021, respectively, related to uncertain tax positions.
The following table provides a reconciliation of changes in unrecognized tax benefits (in thousands):
Years Ended December 31,
2023
2022
2021
Balance at beginning of period
$
19,064
$
13,923
$
9,843
Additions related to current period tax positions
5,304
5,140
3,973
Additions related to prior period tax positions
12,956
38
140
Reductions related to prior period tax positions
( 212
)
( 37
)
( 33
)
Balance at end of period
$
37,112
$
19,064
$
13,923
F- 24
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
9. Commitments and Contingencies
License and Merger Agreements
The Company has entered into various collaboration, licensing and merger agreements which provide the Company with rights to certain know-how, technology and patent rights. The agreements generally include upfront license fees, development and commercial milestone payments upon achievement of certain clinical and commercial development and annual net sales milestones, as well as royalties calculated as a percentage of product revenues, with rates that vary by agreement. The Company incurred $ 102.5 million, $ 88.7 million and $ 11.0 million in upfront and license payments in the years ended December 31, 2023, 2022 and 2021, respectively. These upfront and license payments were included in the research and development expenses in the consolidated statements of operations as there was no alternative future use associated with the payments. As of December 31, 2023, the Company may be required to make milestone payments up to $ 3.4 billion in the aggregate for candidates in its pipeline.
In May 2018, the Company signed an Exclusivity Deed (the Deed) with Neuren that provided for exclusive negotiations for a period of three months from the date of the Deed. Under the terms of the Deed, the Company invested $ 3.1 million to subscribe for 1,330,000 shares of Neuren and paid $ 0.9 million for the exclusive right to negotiate a deal with Neuren, which was recorded in selling, general and administrative expenses in the consolidated statements of operations in the second quarter of 2018. In 2023 , the Company sold the 1,330,000 shares of Neuren for total proceeds of $ 12.3 million. Net gain on the strategic investments recognized in other income in the consolidated statements of operations for the year ended December 31, 2023, 2022 and 2021 was $ 5.1 million, $ 3.5 million and $ 2.3 million, respectively .
In August 2018, the Company entered into a license agreement with Neuren and obtained exclusive North American rights to develop and commercialize trofinetide for Rett syndrome and other indications. Under the terms of the agreement, the Company paid Neuren an upfront license fee of $ 10.0 million and it may be required to pay up to an additional $ 455.0 million in milestone payments based on the achievement of certain development and annual net sales milestones. In addition, the Company will be required to pay Neuren tiered, escalating, double-digit percentage royalties based on net sales. The license agreement was accounted for as an asset acquisition and the upfront cash payment of $ 10.0 million was expensed to research and development in the third quarter of 2018 as there is no alternative use for the asset. In connection with the FDA approval of DAYBUE, the Company paid a milestone payment of $ 40.0 million to Neuren following the first commercial sale of DAYBUE pursuant to the license agreement. The Company capitalized the $ 40.0 million milestone payment as an intangible asset as it was deemed probable of occurring as of March 31, 2023. In addition, the Company was granted a Rare Pediatric Disease PRV following the FDA approval of DAYBUE. Pursuant to the license agreement, the Company is required to pay Neuren one third of the value of the PRV at the time of sale or use of the PRV. The Company capitalized the $ 29.6 million for the estimated PRV value owed to Neuren as an intangible asset.
In July 2023, the Company expanded its licensing agreement for trofinetide with Neuren to acquire rights to the drug outside of North America as well as global rights in Rett syndrome and Fragile X syndrome to Neuren’s development candidate NNZ-2591. Under the terms of the expanded agreement, Neuren received an upfront payment of $ 100.0 million and is eligible to receive up to an additional $ 426.3 million in milestone payments based on the achievement of certain commercial and sales milestones for trofinetide outside of North America and up to $ 831.3 million in milestone payments based on the achievement of certain development and sales milestones for NNZ-2591. In addition, the Company will be required to pay Neuren tiered royalties from the mid-teens to low-twenties percent of trofinetide net sales outside of North America. Percentage royalties related to NNZ-2591 net sales are identical to the trofinetide in each of North America and outside North America. The expanded license agreement was accounted for as an asset acquisition and the upfront cash payment of $ 100.0 million was expensed to research and development in the third quarter of 2023 as there is no alternative use for the asset.
In January 2022, the Company entered into a license and collaboration agreement with Stoke to discover, develop and commercialize novel RNA-based medicines for the potential treatment of severe and rare genetic neurodevelopmental diseases of the CNS. The collaboration includes SYNGAP1 syndrome, Rett syndrome (MECP2), and an undisclosed neurodevelopmental target. For the SYNGAP1 program, the two companies will jointly share global research, development and commercialization responsibilities and share 50/50 in all worldwide costs and future profits. In addition, Stoke is eligible to receive potential development, regulatory, first commercial sales and sales milestones. For the MECP2 program and the undisclosed neurodevelopmental program, the Company acquired an exclusive worldwide license to develop and commercialize MECP2 program and the undisclosed neurodevelopmental program. Stoke will lead research and pre-clinical
F- 25
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
development activities, while the Company will lead clinical development and commercialization activities. The Company will fund research and pre-clinical development activities related to these two targets and Stoke is eligible to receive potential development, regulatory, first commercial sales and sales milestones as well as tiered royalty payments on worldwide sales starting in the mid-single digit range and escalating to the mid-teens based on revenue levels. Under the terms of the agreement, the Company paid Stoke a $ 60.0 million upfront payment which was accounted for as an asset acquisition and was expensed to research and development in the first quarter of 2022 as there is no alternative use for the asset. The Company may be required to pay up to an additional $ 907.5 million in milestones as well as royalties on future sales.
Corporate Credit Card Program
In connection with the Company’s credit card program, the Company established a letter of credit in 2016 for $ 2.0 million, which has automatic annual extensions and is fully secured by restricted cash.
Fleet Program
In connection with the Company’s fleet program, the Company established a letter of credit for $ 0.4 million, which has automatic annual extensions and is fully secured by restricted cash.
Legal Proceedings
Patent Infringement
On July 24, 2020, the Company filed complaints against (i) Aurobindo Pharma Limited and its affiliate Aurobindo Pharma USA, Inc. and (ii) Teva Pharmaceuticals USA, Inc. and its affiliate Teva Pharmaceutical Industries Ltd., and on July 30, 2020, the Company filed complaints against (i) Hetero Labs Limited and its affiliates Hetero Labs Limited Unit-V and Hetero USA Inc., (ii) MSN Laboratories Private Ltd. and its affiliate MSN Pharmaceuticals, Inc., and (iii) Zydus Pharmaceuticals (USA) Inc. and its affiliate Cadila Healthcare Limited. These complaints, which were filed in the United States District Court for the District of Delaware, allege infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID (Pimavanserin I Cases). The cases have been assigned to the Honorable Richard G. Andrews. On September 1, 2020, Aurobindo filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On September 22, 2020, the Company filed its answer to Aurobindo’s counterclaims. On August 31, 2020, Teva filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On September 21, 2020, the Company filed its answer to Teva’s counterclaims. On October 5, 2020, Hetero filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On October 26, 2020, the Company filed its answer to Hetero’s counterclaims. On September 30, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On November 5, 2020, the Company filed its first amended complaint against MSN in the United States District Court for the District of Delaware, alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On November 19, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On December 10, 2020, the Company filed its answer to MSN’s counterclaims. On November 2, 2020, Zydus filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On November 23, 2020, the Company filed its answer to Zydus’s counterclaims. On December 8, 2020, the parties’ joint proposed scheduling order was entered by Judge Andrews. On April 7, 2021, the Company filed its first amended complaints against Hetero and Teva and its second amended complaint against MSN, to include an additional Orange Book-listed patent covering NUPLAZID. On April 8, 2021, the Company filed its first amended complaint against Zydus and on April 9, 2021, the Company filed its first amended complaint against Aurobindo. On April 20, 2021, MSN filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On April 21, 2021, Teva filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On April 22, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity.
F- 26
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
On April 22, 2021, Aurobindo filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On May 11, 2021, the Company filed its answer to MSN’s counterclaims. On May 12, the Company filed its answer to Teva’s counterclaims. On May 13, the Company filed its answer to Zydus’s counterclaims and its answer to Aurobindo’s counterclaims. The Company entered into an agreement effective April 22, 2021 with Hetero settling all claims and counterclaims in the litigation. The agreement allows Hetero to launch its generic pimavanserin product on February 27, 2038, subject to certain triggers for earlier launch. The Hetero case was dismissed by joint agreement on May 3, 2021.
On August 27, 2021, the Company filed its second amended complaint against Zydus to include an additional Orange Book-listed patent covering NUPLAZID. On September 10, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity. Also on September 10, 2021, the parties filed their Joint Claim Construction Chart. On October 1, 2021, the Company filed its answer to Zydus’s counterclaims. On November 30, 2021, the Company filed a stipulation and proposed order to dismiss two of its Orange Book-listed patents covering NUPLAZID against Teva, which was ordered by the Court on December 1, 2021. On January 28, 2022, the parties filed their Joint Claim Construction Brief and Appendix. On February 23, 2022, the Court heard oral argument on claim construction. On April 6, 2022, the Court issued a Memorandum Opinion construing several terms at issue, adopting the Company’s construction on two terms, Defendants’ construction on two terms, and one agreed-upon construction. On February 28, 2022, the Company filed a stipulation and proposed order to dismiss one patent against MSN, which was ordered by the Court on March 1, 2022. On March 10, 2022, the Company filed a stipulation and proposed order to dismiss one patent against Teva, which was ordered by the Court on March 10, 2022. On March 22, 2022, the Company filed a stipulation and proposed order to dismiss seven patents against Aurobindo, which was ordered by the Court on March 22, 2022. On March 30, 2022, the Company filed a stipulation and proposed order to dismiss two patents against Zydus, which was ordered by the Court on March 31, 2022. On April 22, 2022, the Company filed a stipulation and proposed order of non-infringement against Aurobindo regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 22, 2022. On April 26, 2022, the Company filed a stipulation and proposed order of non-infringement against MSN regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 26, 2022. On April 26, 2022, the Company filed a stipulation and proposed order of non-infringement against Teva regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 27, 2022. On May 10, 2022, the Company filed its second amended complaint against Teva to include an additional Orange Book-listed patent covering NUPLAZID. On May 18, 2022, the Company filed a stipulation and proposed order of non-infringement against Zydus regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on May 19, 2022. On May 24, 2022, Teva filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 1, 2022, the Company filed its second amended complaint against Aurobindo alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 2, 2022, the Company filed its third amended complaint against Zydus alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 14, 2022, the Company filed its answer to Teva’s counterclaims. June 15, 2022, Aurobindo filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 16, 2022, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s third amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On July 6, 2022, the Company filed its answer to Aurobindo’s counterclaims.
On September 7, 2022, the consolidated cases were reassigned to the Honorable Judge Gregory B. Williams. On September 30, 2022, the Company filed a stipulation and proposed order to stay the claims currently asserted against Teva and for Teva to be bound by the result of the litigation rendered against the remaining Defendants, which was ordered by the Court on October 4, 2022. On October 21, 2022, the Company filed complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID (Pimavanserin II Cases).
On March 29, 2023, following Aurobindo’s conversion of various patent certifications from Paragraph IV certifications to Paragraph III certifications in connection with the Pimavanserin I Case, the Company filed a stipulation and proposed order in the Pimavanserin I Case to dismiss the remaining asserted patents against Aurobindo. This stipulation was ordered by the Court on March 30, 2023.
F- 27
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The Company entered into an agreement, effective March 31, 2023, with Zydus settling all claims and counterclaims in the Pimavanserin I Cases and Pimavanserin II Cases. The agreement allows Zydus to launch its generic pimavanserin 10 mg products on September 23, 2036 and 34 mg products on February 27, 2038, subject to certain triggers for earlier launch. On April 4, 2023, the Company filed a stipulation and proposed order to dismiss all claims and counterclaims between the Company and Zydus in the Pimavanserin I Cases and Pimavanserin II Cases, which was ordered by the Court on April 5, 2023.
As a result of the above, only MSN remained as an active defendant in the Pimavanserin I Cases. On April 6, 2023, the Company and MSN filed a stipulation and proposed order requesting adjournment of the final pre-trial conference and trial, and requesting resolution of the remaining issue – MSN’s validity challenge of the sole patent in suit – through summary judgment briefing by the parties, which was ordered by the Court on April 10, 2023. Briefing was completed on June 28, 2023 and oral argument took place on September 27, 2023. On December 13, 2023, the Court ruled in the Company’s favor on the summary judgment motions – denying MSN’s motion for summary judgment of invalidity and granting the Company’s cross-motion for no invalidity. MSN had previously stipulated to infringement of the patent-in-suit. On January 11, 2024, the District Court entered final judgment in the Company’s favor that MSN’s submission of ANDA No. 214925 was an act of infringement in the Pimavanserin I Case. On January 18, 2024, MSN filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit from the December 13, 2023 Memorandum Order of the United States District Court for the District of Delaware, and final judgment entered on January 11, 2024. On February 12, 2024, the Company filed an Entry of Appearance for the appeal to the United States Court of Appeals for the Federal Circuit. MSN’s Opening Appeal Brief is due on March 29, 2024.
In connection with the Pimavanserin II cases, MSN and Aurobindo are the remaining defendants. On December 13, 2023, the Court issued a claim construction order finding in favor of the Company on all disputed terms of the patent-in-suit. Fact discovery closes on March 21, 2024. Trial is scheduled in the matter for December 3, 2024 to December 5, 2024.
Securities Class Action
On April 19, 2021, a purported stockholder of the Company filed a putative securities class action complaint (captioned Marechal v. Acadia Pharmaceuticals, Inc., Case No. 21-cv-0762) in the U.S. District Court for the Southern District of California against the Company and certain of the Company’s current executive officers. On September 29, 2021, the Court issued an order designating lead plaintiff and lead counsel. On December 10, 2021, lead plaintiff filed an amended complaint. The amended complaint generally alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, by failing to disclose that the materials submitted in support of its sNDA seeking approval of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis contained statistical and design deficiencies and that the FDA was unlikely to approve the sNDA in its current form. The amended complaint seeks unspecified monetary damages and other relief. Defendants filed a motion to dismiss the amended complaint on February 15, 2022. On September 27, 2022, the Court issued an order denying Defendants’ motion to dismiss. Defendants filed their answer to the amended complaint on October 19, 2022, and filed a motion for reconsideration on October 25, 2022. On February 2, 2023, the Court issued an order denying the motion for reconsideration. On August 21, 2023, plaintiffs filed a motion for class certification. Briefing on that motion concluded on January 12, 2024, and the Court will hear oral argument on the motion on February 28, 2024. The parties are currently engaged in discovery. The cutoff for fact discovery is June 13, 2024.
Derivative Suit
On December 15, 2023, a purported stockholder of the Company filed a derivative action (captioned Kanner et al v. Biggar et al. , Case No. 23-cv-2293) in the U.S. District Court for the Southern District of California against certain of the Company’s current directors. The Company is named as a nominal defendant. The complaint is based on the same alleged misconduct as the Securities Class Action, and asserts state law claims, on behalf of the Company, against the individual defendants for breach of fiduciary duty, unjust enrichment, abuse of control, waste of corporate assets, and insider trading. The complaint also asserts federal claims under sections 10(b), 21D, and 14(a) of the Securities Exchange Act of 1934, as amended. On December 27, 2023, the action was reassigned to District Judge William Q. Hayes and Magistrate Judge Michael S. Berg due to its relation to the Securities Class Action. On January 30, 2024, the parties jointly requested a stay of the action. The Court granted that request and the action was stayed on February 20, 2024, pending the outcome of our Demand Review Committee’s investigation into the underlying claims.
F- 28
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Given the unpredictability inherent in litigation, the Company cannot predict the outcome of these matters. The Company is unable to estimate possible losses or ranges of losses that may result from these matters, and therefore it has not accrued any amounts in connection with these matters other than attorneys’ fees incurred to date .
10. Leases
The Company leases facilities and certain equipment under noncancelable operating leases that expire at various dates through February 2031 . Under the terms of the facilities leases, the Company is required to pay its proportionate share of property taxes, insurance and normal maintenance costs.
In 2015, the Company entered into a master lease agreement giving the Company the ability to lease vehicles under operating leases with initial terms of 36 months from the date of delivery. In 2018, the lease agreement was terminated and a new master lease agreement was entered into with a new vendor giving the Company the ability to lease vehicles under operating leases with initial terms ranging from 12 to 50 months from the date of delivery . In 2021, the Company entered into a new master lease agreement giving the Company the ability to lease vehicles under operating leases with initial terms of 60 months from the date of delivery.
The Company leases facilities and certain equipment under noncancelable operating leases with remaining lease terms of 0.9 year to 7.4 years, some of which include options to extend the lease for up to two five-year terms. These optional periods were not considered in the determination of the right-of-use asset or the lease liability as the Company did not consider it reasonably certain that it would exercise such options.
The operating lease costs were as follows (in thousands):
Years Ended December 31,
2023
2022
2021
Operating lease cost
$
10,343
$
8,095
$
8,874
Operating sublease income
( 93
)
—
—
Net operating lease costs
$
10,250
$
8,095
$
8,874
Supplemental cash flow information related to the Company’s leases were as follows (in thousands):
Years Ended December 31,
2023
2022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$
9,456
$
9,083
Right-of-use assets obtained in exchange for operating lease obligations:
2,051
3,871
The balance sheet classification of the Company’s lease liabilities was as follows (in thousands):
December 31, 2023
December 31, 2022
Operating lease liabilities
Current portion included in accrued liabilities
$
9,405
$
9,305
Operating lease liabilities
47,800
52,695
Total operating lease liabilities
$
57,205
$
62,000
F- 29
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Maturities of lease liabilities were as follows (in thousands):
Operating Leases
Years ending December 31,
2024
$
9,662
2025
9,744
2026
9,127
2027
8,831
2028
8,521
Thereafter
20,586
Total lease payments
66,471
Less:
Imputed interest
( 9,266
)
Total operating lease liabilities
$
57,205
Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. As of December 31, 2023 and 2022, the weighted average remaining lease term was 7.0 years and 7.9 years, respectively, and the weighted average discount rate used to determine the operating lease liability was 4.5 % and 4.4 %, respectively.
In the fourth quarter of 2018, the Company entered into an agreement to lease the 4 th and 5 th floors of corporate office space in San Diego, California with total minimum lease payments of $ 50.4 million over an initial term of 10 years and 9 months . In February 2020, the Company entered into the first amendment to the lease agreement to lease the 2 nd floor of corporate office space in San Diego, California with total minimum lease payments of $ 25.3 million over an initial term of approximately 10 years and 7 months . In March 2020, the Company entered into the second amendment to the lease agreement which increased the total minimum lease payments of the original corporate office space to $ 51.4 million. In the third quarter of 2020, the lease for the 4 th and 5 th floors of corporate office space commenced and the Company capitalized a right of use asset and related lease liability of $ 40.3 million. In the first quarter of 2021 , the lease for the 2 nd floor of corporate office space commenced and the Company capitalized a right of use asset and related lease liability of $ 19.2 million. In connection with this lease and the amendment, the Company established a letter of credit for $ 3.1 million, which has automatic annual extensions and is fully secured by restricted cash.
In May 2023, the Company entered into an agreement to sublease its 2 nd floor of corporate office space in San Diego to a s ublessee with a total minimum sublease income of $ 18.4 million over a term of approximately 7 years and 6 months . The Company delivered the full possession of its 2 nd floor of corporate office space to the sublessee in August 2023. Pursuant to the sublease agreement, the Company received the first sublease payment in December 2023.
11. Selected Quarterly Financial Data (Unaudited)
The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for the years ended December 31, 2023 and 2022 are as follows (in thousands, except per share data):
Fiscal Year 2023 Quarters
1st
2nd
3rd
4th
Total
Revenues
$
118,462
$
165,235
$
211,699
$
231,041
$
726,437
Gross profit (1)
$
116,795
$
157,776
$
197,077
$
213,151
$
684,799
Net income (loss)
$
( 43,021
)
$
1,114
$
( 65,176
)
$
45,797
$
( 61,286
)
Basic net income (loss) per share (2)
$
( 0.27
)
$
0.01
$
( 0.40
)
$
0.28
$
( 0.37
)
Diluted net income (loss) per share (2)
$
( 0.27
)
$
0.01
$
( 0.40
)
$
0.28
$
( 0.37
)
F- 30
ACADIA PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Fiscal Year 2022 Quarters
1st
2nd
3rd
4th
Total
Revenues
$
115,468
$
134,563
$
130,714
$
136,490
$
517,235
Gross profit (1)
$
112,518
$
131,896
$
128,578
$
134,076
$
507,068
Net loss
$
( 113,056
)
$
( 34,011
)
$
( 27,183
)
$
( 41,725
)
$
( 215,975
)
Basic and diluted net loss per share (2)
$
( 0.70
)
$
( 0.21
)
$
( 0.17
)
$
( 0.26
)
$
( 1.34
)
(1) Determined by subtracting cost of product sales from product sales, net.
(2) Basic and diluted net income ( loss) per common share are computed independently for each quarter and the full year based upon respective average shares outstanding. Therefore, the sum of the quarterly net income (loss) per common share amounts may not equal the annual amounts reported.
F- 31
SCHEDULE II – Valuation and Qualifying Accounts
(in thousands)
Additions
Deductions
Balance at
Beginning of
Period
Provision
Related to
Current
Period Sales
Actual
Distribution
Fees,
Discounts and
Chargebacks
Related to
Current Period
Sales
Actual
Distribution
Fees,
Discounts and
Chargebacks
Related to
Prior Period
Sales
Balance at
End of Period
Allowance for distribution fees, discounts and chargebacks:
For the year ended December 31, 2021
$
4,221
$
72,011
$
( 63,544
)
$
( 4,221
)
$
8,467
For the year ended December 31, 2022
$
8,467
$
80,836
$
( 69,913
)
$
( 8,467
)
$
10,923
For the year ended December 31, 2023
$
10,923
$
97,797
$
( 85,641
)
$
( 10,923
)
$
12,156