10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2024

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________________ to _________________

Commission File Number: 001-39311

 

CEREVEL THERAPEUTICS HOLDINGS, INC.

(Exact name of Registrant as specified in its Charter)

 

 

Delaware

85-3911080

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

222 Jacobs Street, Suite 200

Cambridge, MA

02141

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (844) 304-2048

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

CERE

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of April 26, 2024, the registrant had 182,194,722 shares of common stock, par value $0.0001 per share, outstanding.

 

 

 

 

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

5

Notes to Condensed Consolidated Financial Statements

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

PART II.

OTHER INFORMATION

36

Item 1.

Legal Proceedings

36

Item 1A.

Risk Factors

36

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

91

Item 3.

Defaults Upon Senior Securities

91

Item 4.

Mine Safety Disclosures

91

Item 5.

Other Information

91

Item 6.

Exhibits

91

Signatures

93

 

 

 

 

 

i


 

INTRODUCTORY NOTE

On December 6, 2023, we entered into an Agreement and Plan of Merger, or the Merger Agreement, with AbbVie Inc., a Delaware corporation, or AbbVie, Symphony Harlan LLC, a Delaware limited liability company and a wholly owned subsidiary of AbbVie, or Intermediate Holdco, and Symphony Harlan Merger Sub Inc., a Delaware corporation and a direct wholly owned subsidiary of Intermediate Holdco, or Merger Sub, pursuant to which, and on the terms and subject to the conditions thereof, at the effective time of the Merger, or the Effective Time, Merger Sub will merge with and into Cerevel, with Cerevel surviving as a wholly owned subsidiary of AbbVie, which we refer to as the Merger.

Under the terms of the proposed transaction, among other things, AbbVie will acquire all outstanding shares of Cerevel for $45.00 per share in cash. The transaction values Cerevel at a total equity value of approximately $8.8 billion. The boards of directors of both companies have approved the transaction, and Cerevel’s stockholders approved the transaction at a special meeting held on February 16, 2024. This transaction is expected to close in the middle of 2024, subject to regulatory approvals and other customary closing conditions.

The foregoing description of the Merger Agreement and the transactions contemplated thereunder is not complete and is qualified in its entirety by reference to the Merger Agreement, a copy of which is filed as an exhibit to the Current Report on Form 8-K, filed with the SEC on December 7, 2023, and incorporated herein by reference.

ii


 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements in this Quarterly Report on Form 10-Q, or this Quarterly Report, may constitute “forward-looking statements” for purposes of the federal securities laws, including the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” “can,” “target,” “future” or the negative of these terms or similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Quarterly Report may include, for example, statements about:

the structure, timing and ability to consummate the Merger;
any anticipated effects of the Merger’s announcement, pendency or completion on the value of our common stock;
our or AbbVie’s ability to obtain any required regulatory approvals in connection with the Merger;
any potential future costs or benefits of the Merger, including relating to expenses, restrictions on the conduct of our business, diversion of our management’s attention, ability to retain or hire employees, maintenance of relationships with collaborators, vendors and other business partners and payment of termination fees;
the outcome of any legal proceedings that have been or may be instituted against us and others relating to the Merger;
the format, objectives, likelihood of success, cost and timing of our clinical trials and other product development activities, including the design of clinical trials and preclinical studies, the timing of initiation and completion of clinical trials and related preparatory work, our ability to collect and interpret clinical trial data and the timing and outcome of regulatory interactions, including whether trials meet the criteria to serve as registrational;
our ability to recruit and enroll suitable patients in our clinical trials;
the potential attributes and benefits of our product candidates;
our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings on the label of an approved product candidate;
our ability to obtain funding for our operations, including funding necessary to complete further development, approval and, if approved, commercialization of our product candidates;
the period over which we anticipate our available financial resources will enable us to fund our operating expense and capital expenditure requirements;
the potential for our business development efforts to maximize the potential value of our portfolio;
our ability to identify, in-license or acquire additional product candidates;
our ability to maintain our license agreement with Pfizer;
our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for our product candidates;
our ability to obtain and maintain intellectual property protection for our product candidates and the duration of such protection;
our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing our product candidates;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
the rate and degree of market acceptance of our product candidates, if approved;
the pricing and reimbursement of our product candidates, if approved;
regulatory developments in the United States and foreign countries;
the impact of laws, regulations, accounting standards, regulatory requirements, judicial decisions and guidance issued by authoritative bodies;
our ability to attract and retain key scientific, medical, commercial or management personnel;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our future financial performance;

iii


 

our ability to recognize the anticipated benefits of the tavapadon financing transaction and other financing and business development transactions;
our ability to satisfy our payment obligations, remain in compliance with covenants under the 2027 Notes (as defined below), to service the interest on or to refinance the 2027 Notes or to make cash payments in connection with any conversion of the 2027 Notes, to the extent required;
the effect of adverse market or macroeconomic conditions, including, among others, inflation, interest rates and economic uncertainty, market volatility resulting from global political or economic developments, war, international hostilities and terrorism, any future public health epidemics or outbreaks of infectious disease, the residual post-COVID environment and other factors on any of the foregoing or other aspects of our business operations, including but not limited to our clinical trials and other product development activities, healthcare systems and the global economy as a whole; and
other risks and uncertainties, including those listed under the section titled “Risk Factors.

The forward-looking statements contained in this Quarterly Report are based on current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions or important factors that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the sections titled “Summary of Material Risks Associated with Our Business,” “Risk Factors” and “Managements Discussion and Analysis of Financial Condition and Results of Operations” of this Quarterly Report. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. There may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

You should read this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

This Quarterly Report contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed as exhibits to this Quarterly Report. Unless the context otherwise requires, reference in this Quarterly Report to the terms “Cerevel,” “the Company,” “we,” “us,” “our,” and similar designations refer to Cerevel Therapeutics Holdings, Inc. and, where appropriate, our consolidated subsidiaries.

We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Quarterly Report. Unless otherwise expressly stated, we obtained the industry, market and competitive position data from our internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies and publicly available information in addition to research, surveys and studies conducted by third parties that have not been independently verified which may, in the future, prove not to have been accurate.

SUMMARY OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including those highlighted in the section entitled “Risk Factors.” These risks include, but are not limited to, the following:

The conditions under the Merger Agreement to our and AbbVie’s consummation of the Merger may not be satisfied at all or in the anticipated timeframe.
The announcement of, or a failure to consummate, the Merger could negatively impact our business, financial condition, results of operations or our stock price.
The successful development of pharmaceutical products is highly uncertain.
We are a clinical-stage biopharmaceutical company with a limited operating history. We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future.

iv


 

We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our product discovery and development programs or commercialization efforts.
Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. Moreover, we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success.
Our business is highly dependent on the success of our product candidates. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed.
The regulatory approval processes of the U.S. Food and Drug Administration, or the FDA, and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates.
We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
Even if any of our product candidates receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
Competitive products may reduce or eliminate the commercial opportunity for our product candidates, if approved. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective or safer than ours, our ability to develop and successfully commercialize our product candidates may be adversely affected.
We depend heavily on our executive officers, third-party consultants and others and our ability to compete in the biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. The loss of their services or our inability to hire and retain such personnel would materially harm our business.
BC Perception Holdings, LP, or Bain Investor, and Pfizer Inc., or Pfizer, have significant influence over us, and may have interests different from yours.
We rely on third parties to assist in conducting our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
We depend and expect in the future to continue to depend on in-licensed intellectual property. Such licenses impose obligations on our business, and if we fail to comply with those obligations, we could lose license rights, which would substantially harm our business.

The risks described above should be read together with the text of the full risk factors discussed in the section entitled “Risk Factors” and the other information set forth in this Quarterly Report, including our unaudited condensed consolidated financial statements and the related notes, as well as in other documents that we file with the Securities and Exchange Commission, or the SEC. The risks summarized above or described in full elsewhere in this Quarterly Report are not the only risks that we face. Additional risks and uncertainties not presently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects.

 

v


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

CEREVEL THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts and per share data)

(Unaudited)

 

 

 

As of

 

 

 

March 31,
2024

 

 

December 31,
2023

 

ASSETS

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

320,436

 

 

$

416,465

 

Marketable securities

 

 

525,858

 

 

 

574,500

 

Prepaid expenses and other current assets

 

 

13,283

 

 

 

15,973

 

Total current assets

 

 

859,577

 

 

 

1,006,938

 

Marketable securities

 

 

218,591

 

 

 

185,199

 

Property and equipment, net

 

 

24,929

 

 

 

25,647

 

Operating lease assets

 

 

19,667

 

 

 

20,125

 

Restricted cash

 

 

1,960

 

 

 

1,960

 

Other long-term assets

 

 

2,619

 

 

 

3,429

 

Total assets

 

$

1,127,343

 

 

$

1,243,298

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

10,839

 

 

$

11,863

 

Accrued expenses and other current liabilities

 

 

69,750

 

 

 

76,912

 

Operating lease liabilities, current portion

 

 

3,515

 

 

 

3,404

 

Total current liabilities

 

 

84,104

 

 

 

92,179

 

Operating lease liabilities, net of current portion

 

 

26,866

 

 

 

27,786

 

Financing liability, related party (Notes 5, 7 and 15)

 

 

56,999

 

 

 

56,082

 

Financing liability (Notes 5 and 7)

 

 

56,999

 

 

 

56,082

 

2027 convertible senior notes, net (Note 6)

 

 

337,920

 

 

 

337,424

 

Total liabilities

 

 

562,888

 

 

 

569,553

 

Commitments and contingencies (Notes 13 and 14)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value: 10,000,000 shares authorized;
    
no shares issued and outstanding as of March 31, 2024 and
    December 31, 2023

 

 

 

 

 

 

Common stock, $0.0001 par value: 500,000,000 shares authorized;
    
181,888,631 and 181,362,064 shares issued and outstanding
    as of March 31, 2024 and December 31, 2023, respectively

 

 

18

 

 

 

18

 

Additional paid-in capital

 

 

2,098,035

 

 

 

2,072,553

 

Accumulated other comprehensive income (loss)

 

 

(1,089

)

 

 

1,771

 

Accumulated deficit

 

 

(1,532,509

)

 

 

(1,400,597

)

Total stockholders’ equity

 

 

564,455

 

 

 

673,745

 

Total liabilities and stockholders’ equity

 

$

1,127,343

 

 

$

1,243,298

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

1


 

CEREVEL THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share amounts and per share data)

(Unaudited)

 

 

 

 

For the Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

106,425

 

 

$

78,181

 

General and administrative

 

 

36,231

 

 

 

21,370

 

Total operating expenses

 

 

142,656

 

 

 

99,551

 

Loss from operations

 

 

(142,656

)

 

 

(99,551

)

Interest income, net

 

 

14,455

 

 

 

9,076

 

Interest expense

 

 

(2,652

)

 

 

(2,636

)

Other income (expense), net (including related party amounts), (Notes 5, 7 and 15)

 

 

(921

)

 

 

(11,090

)

Loss before income taxes

 

 

(131,774

)

 

 

(104,201

)

Income tax benefit (provision), net

 

 

(138

)

 

 

(85

)

Net loss

 

$

(131,912

)

 

$

(104,286

)

Net loss per share, basic and diluted

 

$

(0.73

)

 

$

(0.67

)

Weighted-average shares used in calculating net loss per share, basic and diluted

 

 

181,610,675

 

 

 

156,648,365

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(131,912

)

 

$

(104,286

)

Other comprehensive income (loss):

 

 

 

 

 

 

Changes in fair value attributable to instrument-specific credit risk (including related party amounts), (Notes 5, 7 and 15)

 

 

(920

)

 

 

(906

)

Unrealized gains (losses) on securities available-for-sale

 

 

(1,940

)

 

 

1,497

 

Total other comprehensive income (loss)

 

 

(2,860

)

 

 

591

 

Comprehensive loss

 

$

(134,772

)

 

$

(103,695

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

2


 

CEREVEL THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

(Unaudited)

 

 

Common stock

 

 

Additional
paid-in

 

 

Accumulated other
comprehensive

 

 

Accumulated

 

 

Total
stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

equity

 

Balance at December 31, 2023

 

 

181,362,064

 

 

$

18

 

 

$

2,072,553

 

 

$

1,771

 

 

$

(1,400,597

)

 

$

673,745

 

Issuance of common stock under equity incentive plans related to vesting of restricted stock units (RSUs)

 

 

105,384

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock under equity incentive plans related to exercise of options

 

 

421,183

 

 

 

 

 

 

4,550

 

 

 

 

 

 

 

 

 

4,550

 

Equity-based compensation expense

 

 

 

 

 

 

 

 

20,932

 

 

 

 

 

 

 

 

 

20,932

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(2,860

)

 

 

 

 

 

(2,860

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(131,912

)

 

 

(131,912

)

Balance at March 31, 2024

 

 

181,888,631

 

 

$

18

 

 

$

2,098,035

 

 

$

(1,089

)

 

$

(1,532,509

)

 

$

564,455

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

3


 

CEREVEL THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

(Unaudited)

 

 

 

Common stock

 

 

Additional
paid-in

 

 

Accumulated other
comprehensive

 

 

Accumulated

 

 

Total
stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

equity

 

Balance at December 31, 2022

 

 

156,502,285

 

 

$

16

 

 

$

1,485,880

 

 

$

3,097

 

 

$

(967,755

)

 

$

521,238

 

Issuance of common stock under equity incentive plans related to exercise of options

 

 

257,824

 

 

 

 

 

 

1,574

 

 

 

 

 

 

 

 

 

1,574

 

Equity-based compensation expense

 

 

 

 

 

 

 

 

12,592

 

 

 

 

 

 

 

 

 

12,592

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

591

 

 

 

 

 

 

591

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(104,286

)

 

 

(104,286

)

Balance at March 31, 2023

 

 

156,760,109

 

 

$

16

 

 

$

1,500,046

 

 

$

3,688

 

 

$

(1,072,041

)

 

$

431,709

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

CEREVEL THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

For the Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(131,912

)

 

$

(104,286

)

Adjustments to reconcile net loss to net cash flows used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

1,541

 

 

 

1,321

 

Adjustments to operating lease expense

 

 

(335

)

 

 

(280

)

Equity-based compensation

 

 

20,932

 

 

 

12,592

 

Change in fair value of financing liabilities (including related party amounts), (Notes 5, 7 and 15)

 

 

914

 

 

 

11,082

 

Non-cash interest expense

 

 

496

 

 

 

480

 

Amortization of premiums and accretion of discounts on marketable securities

 

 

(6,126

)

 

 

(5,206

)

Other non-cash items

 

 

 

 

 

(8

)

Changes in operating assets and liabilities, net:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

3,674

 

 

 

(147

)

Other assets

 

 

(413

)

 

 

(440

)

Accounts payable

 

 

(1,194

)

 

 

(2,768

)

Accrued expenses and other liabilities

 

 

(7,246

)

 

 

(7,263

)

Net cash flows used in operating activities

 

 

(119,669

)

 

 

(94,923

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of marketable securities

 

 

(122,649

)

 

 

(187,631

)

Maturities and redemptions of marketable securities

 

 

142,085

 

 

 

298,750

 

Purchases of property and equipment

 

 

(271

)

 

 

(336

)

Net cash flows provided by investing activities

 

 

19,165

 

 

 

110,783

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock related to follow-on offering, net of offering costs

 

 

(75

)

 

 

 

Proceeds from the exercise of stock options

 

 

4,550

 

 

 

1,574

 

Deferred costs related to financing activities

 

 

 

 

 

(139

)

Net cash flows provided by financing activities

 

 

4,475

 

 

 

1,435

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

(96,029

)

 

 

17,295

 

Cash, cash equivalents and restricted cash, beginning of the period

 

 

418,425

 

 

 

138,388

 

Cash, cash equivalents and restricted cash, end of the period

 

$

322,396

 

 

$

155,683

 

Reconciliation of cash, cash equivalents and restricted cash:

 

 

 

 

 

 

Cash and cash equivalents

 

$

320,436

 

 

$

153,816

 

Restricted cash

 

 

1,960

 

 

 

1,867

 

Total cash, cash equivalents and restricted cash

 

$

322,396

 

 

$

155,683

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

4,313

 

 

$

4,289

 

Cash paid for income taxes

 

$

207

 

 

$

 

Supplemental cash flow disclosures from non-cash investing and financing activities:

 

 

 

 

 

 

Fixed asset additions included in accounts payable and other current liabilities

 

$

441

 

 

$

779

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5


 

CEREVEL THERAPEUTICS HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Nature of Operations

Unless the context otherwise requires, references in these notes to “Cerevel,” “the company,” “we,” “us” and “our” and any related terms are intended to mean Cerevel Therapeutics Holdings, Inc. and its consolidated subsidiaries.

We are a clinical-stage biopharmaceutical company pursuing a targeted approach to neuroscience that combines a deep understanding of disease-related biology and neurocircuitry of the brain with advanced chemistry and central nervous system target receptor selective pharmacology to discover and design new therapies. We seek to transform the lives of patients through the development of new therapies for neuroscience diseases, including schizophrenia, Alzheimer’s disease psychosis, epilepsy, panic disorder and Parkinson’s disease. We are advancing our extensive and diverse pipeline with numerous clinical trials underway or planned, including one completed and two ongoing Phase 3 trials and an open-label extension trial for tavapadon in Parkinson’s, two ongoing Phase 2 trials and an open-label extension trial for emraclidine in schizophrenia, an ongoing Phase 2 proof-of-concept trial and an open-label extension trial for darigabat in focal epilepsy and an ongoing Phase 2 proof-of-concept trial for darigabat in panic disorder.

On December 6, 2023, we entered into an Agreement and Plan of Merger (the Merger Agreement) with AbbVie Inc., a Delaware corporation (AbbVie), Symphony Harlan LLC, a Delaware limited liability company and a wholly owned subsidiary of AbbVie (Intermediate Holdco), and Symphony Harlan Merger Sub Inc., a Delaware corporation and a direct wholly owned subsidiary of Intermediate Holdco (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, at the effective time of the Merger (the Effective Time), Merger Sub will merge with and into Cerevel, with Cerevel surviving as a wholly owned subsidiary of AbbVie, which we refer to as the Merger.

Under the terms of the proposed transaction, among other things, AbbVie will acquire all outstanding shares of Cerevel for $45.00 per share in cash. The transaction values Cerevel at a total equity value of approximately $8.8 billion. The boards of directors of both companies have approved the transaction, and Cerevels stockholders approved the transaction at a special meeting held on February 16, 2024. This transaction is expected to close in the middle of 2024, subject to regulatory approvals and other customary closing conditions.

For additional information on our formation, please read Note 1, Nature of Operations, to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 (our Annual Report).

2. Risks and Liquidity

We are subject to risks and uncertainties common to clinical-stage companies in the biopharmaceutical industry. These risks include, but are not limited to, the introduction of new products, therapies, standards of care or new technological innovations, our ability to obtain and maintain adequate protection for our in-licensed technology, data or other intellectual property and proprietary rights and compliance with extensive government regulation and oversight. In addition, we are dependent upon the services of our employees, including key personnel, consultants, third-party contract research organizations (CROs), third-party contract manufacturing organizations (CMOs) and other third-party organizations.

Our product candidates, currently under development or that we may develop, will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities. There can be no assurance that our research and development activities will be successfully completed, that adequate protection for our licensed or developed technology will be obtained and maintained, that products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable.

Our unaudited condensed consolidated financial statements have been prepared on the basis of continuity of operations, the realization of assets and the satisfaction of liabilities in the ordinary course of business. We have incurred significant operating losses since our inception and, as of March 31, 2024, we have not yet generated revenues. In addition, we anticipate that our expenses will increase significantly in connection with our ongoing activities to support our research, discovery and clinical development efforts and we expect to continue to incur significant expenses and operating losses for the foreseeable future.

6


 

We have funded our operations primarily with the net proceeds received from the issuance of preferred stock, common stock and convertible senior notes, net proceeds from the consummation of our Business Combination (as defined in Note 15, Related Party Transactions, to these unaudited condensed consolidated financial statements), and our Funding Agreements (as defined in Note 5, Financing Liabilities, to these unaudited condensed consolidated financial statements). We believe that our available cash, cash equivalents and marketable securities as of March 31, 2024, will enable us to fund our operating expense and capital expenditure requirements through at least 12 months from the issuance date of these financial statements.

3. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements include those of the company and its subsidiaries, Cerevel Therapeutics, Inc., Cerevel Therapeutics, LLC and Cerevel MA Securities Corp., after elimination of all intercompany accounts and transactions. The accompanying unaudited condensed consolidated financial statements and notes hereto have been prepared in conformity with the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting and, therefore, omit or condense certain footnotes and other information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) as set forth in the Financial Accounting Standards Board’s (FASB) accounting standards codification. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the FASB.

In the opinion of management, all adjustments necessary for a fair statement of the financial information, which are of a normal and recurring nature, have been made for the interim periods reported. Results of operations for the three months ended March 31, 2024 and 2023, are not necessarily indicative of the results for the entire fiscal year or any other period. Our unaudited condensed consolidated financial statements for the three months ended March 31, 2024 and 2023, have been prepared on the same basis as and should be read in conjunction with our audited consolidated financial statements and notes included in our Annual Report.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions made in the accompanying unaudited condensed consolidated financial statements include, but are not limited to, the fair value of our financing liabilities, the fair value of equity-based awards and the accrual for research and development expense. We evaluate our estimates and assumptions on an ongoing basis using historical experience and other factors and adjust those estimates and assumptions when facts and circumstances change. Actual results could differ materially from those estimates.

Restricted Cash

In connection with our entering into the lease agreement for our headquarters in Cambridge, MA, in July 2019, we were required to provide a security deposit in the form of a letter of credit. We have classified this amount as restricted cash in our condensed consolidated balance sheets as of March 31, 2024 and December 31, 2023. Restricted cash was classified as a non-current asset as the associated lease term expires more than 12 months from March 31, 2024.

For additional information related to our other significant accounting policies, please read Note 4, Summary of Significant Accounting Policies, to our audited consolidated financial statements included in our Annual Report.

Recent Accounting Guidance

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, we do not believe that the impact of recently issued standards that are not yet effective will have a material impact on our consolidated financial statements or related disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and by extending the disclosure requirements to entities with a single reportable segment. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. ASU 2023-07 is to be applied retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. We are currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.

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In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which modifies the rules on income tax disclosures to require entities to disclose (1) specific categories in the rate reconciliation, (2) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (3) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state and local jurisdictions, among other changes. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. We are currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.

4. Pfizer License Agreement

In August 2018, we entered into a license agreement with Pfizer (the Pfizer License Agreement) pursuant to which we were granted an exclusive, sublicensable, worldwide license under certain Pfizer patent rights, and a non-exclusive, sublicensable, worldwide license under certain Pfizer know-how to develop, manufacture and commercialize certain compounds and products, which currently constitute substantially all of our asset portfolio, in the field of treatment, prevention, diagnosis, control and maintenance of all diseases and disorders in humans, subject to the terms and conditions of the Pfizer License Agreement.

Under the Pfizer License Agreement, we are solely responsible for the development, manufacture, regulatory approval and commercialization of compounds and products in the field and we will pay Pfizer tiered royalties on the aggregate net sales during each calendar year, determined on a product-by-product basis, with respect to products under the Pfizer License Agreement, and we may pay potential milestone payments to Pfizer based on the successful achievement of certain regulatory and commercial milestones. To date, no regulatory or commercial approval milestone payments or royalty payments have been made or become due under this agreement.

For additional information related to our Pfizer License Agreement, please read Note 6, Pfizer License Agreement, to our audited consolidated financial statements included in our Annual Report.

5. Financing Liabilities

Funding Agreements

In April 2021, we entered into a funding agreement with NovaQuest Co-Investment Fund XVI, L.P. (NovaQuest and the NovaQuest Funding Agreement) and a funding agreement with BC Pinnacle Holdings, LP (Bain, the Bain Funding Agreement and, together with the NovaQuest Funding Agreement, the Funding Agreements), pursuant to which NovaQuest and Bain (the Funding Investors) committed to provide funding to support our development of tavapadon for the treatment of Parkinson’s disease.

Under the terms of the Funding Agreements, we received $62.5 million in funding from each of NovaQuest and Bain, for a combined total of $125.0 million in funding (the Total Funding Commitment), of which approximately $31.1 million (25% of the Total Funding Commitment, net of $0.2 million of fees incurred by Bain and NovaQuest) was received in April 2021, $37.5 million (30% of the Total Funding Commitment) was received in April 2022, $31.3 million (25% of the Total Funding Commitment) was received in April 2023 and $25.0 million (20% of the Total Funding Commitment) was received in April 2024.

In return, we agreed to pay to NovaQuest and Bain significant regulatory milestone, sales milestone and royalty payments upon approval of tavapadon by the FDA that collectively will not exceed $531.3 million. In addition, we have the option to satisfy our payment obligations to NovaQuest and Bain upon the earlier of FDA approval or May 1, 2025, by paying an amount equal to the Total Funding Commitment multiplied by an initial factor of 3.00x. This factor will increase ratably over time up to a maximum of 4.25x, less amounts previously paid to NovaQuest and Bain.

We determined that each funding agreement represents a financial instrument that is considered to be a debt host containing embedded redemption features due to certain contingencies related to repayment. We elected to account for the Funding Agreements in accordance with the fair value option as permitted under ASC 825, Financial Instruments.

As of March 31, 2024 and December 31, 2023, the estimated fair value of the financing liability related to potential amounts payable to Bain under the Bain Funding Agreement, which is reflected in our condensed consolidated balance sheets as financing liability, related party, totaled approximately $57.0 million and $56.1 million, respectively. As of March 31, 2024 and December 31, 2023, the estimated fair value of the financing liability related to potential amounts payable to NovaQuest under the NovaQuest Funding Agreement, which is reflected in our condensed consolidated balance sheets as financing liability, totaled approximately $57.0 million and $56.1 million, respectively.

Changes in estimated fair value of the financing liabilities in our unaudited condensed consolidated statements of operations and comprehensive loss are summarized as follows:

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For the Three Months Ended
March 31,

 

(In thousands)

 

2024

 

 

2023

 

Financing liability, related party

 

 

 

 

 

 

Change in fair value recognized in other income (expense), net

 

$

(457

)

 

$

(5,541

)

Change in fair value attributable to instrument-specific credit risk recognized in other comprehensive income (loss)

 

 

(460

)

 

 

(453

)

Financing liability

 

 

 

 

 

 

Change in fair value recognized in other income (expense), net

 

$

(457

)

 

$

(5,541

)

Change in fair value attributable to instrument-specific credit risk recognized in other comprehensive income (loss)

 

 

(460

)

 

 

(453

)

Changes in fair value attributable to instrument-specific credit risk recognized in other comprehensive income (loss) were derived by benchmarking the current credit spread against the prior period credit spread to isolate the impact directly associated with the change in the credit spread utilized between periods. As of March 31, 2024, accumulated other comprehensive loss from changes in fair value attributable to instrument-specific credit risk was $0.1 million, and as of March 31, 2023, accumulated other comprehensive income from changes in fair value attributable to instrument-specific credit risk was $5.1 million.

For additional information related to our Funding Agreements, please read Note 8, Financing Liabilities, to our audited consolidated financial statements included in our Annual Report.

6. 2027 Convertible Senior Notes

In August 2022, we completed the offering of $345.0 million aggregate principal amount of 2.50% Convertible Senior Notes due 2027 (the 2027 Notes). The aggregate net proceeds from the 2027 Notes offering totaled approximately $334.8 million, after deducting the initial purchasers’ discounts of $9.5 million and other offering expenses of approximately $0.7 million. We accounted for the debt issuance costs as a debt discount for accounting purposes, which was recorded as a reduction in the carrying value of the debt in our condensed consolidated balance sheet and is being amortized to interest expense using the effective interest method over the expected life of the 2027 Notes, or approximately their five-year term.

The 2027 Notes accrue interest at a rate of 2.50% per annum, payable semi-annually in arrears on February 15 and August 15 of each year, beginning on February 15, 2023. As of March 31, 2024 and December 31, 2023, accrued interest on the 2027 Notes of $1.1 million and $3.2 million was included in accrued expenses and other current liabilities in our condensed consolidated balance sheets, respectively.

The 2027 Notes mature on August 15, 2027, unless earlier converted, redeemed or repurchased. We will settle conversions by paying or delivering, as applicable, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, subject to terms and conditions provided in the indenture between us and U.S. Bank Trust Company, National Association, as trustee (the Indenture).

Holders of 2027 Notes may convert all or any portion of their Notes at their option at any time prior to the close of business on the business day immediately preceding May 15, 2027, only in the following circumstances: (i) During any calendar quarter (and only during such calendar quarter) commencing after the calendar quarter ending on December 31, 2022, if the last reported sale price per share of our common stock exceeds 130% of the conversion price for each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter. (ii) During the five consecutive business days immediately after any 10 consecutive trading day period (the Measurement Period) in which the trading price per $1,000 principal amount of notes for each trading day of the Measurement Period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and the conversion rate on such trading day. (iii) Upon the occurrence of certain corporate events or distributions on our common stock, as defined in the Indenture. (iv) If we call the 2027 Notes for redemption.

From and after May 15, 2027, noteholders may convert their notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. The initial conversion rate is 21.5633 shares of common stock per $1,000 principal amount of the 2027 Notes, which represents an initial conversion price of approximately $46.38 per share of common stock, or a total of approximately 7,439,338 shares. The conversion rate and conversion price are subject to customary adjustments upon the occurrence of certain events outlined within the Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.

We may not redeem the 2027 Notes at any time before August 20, 2025, and no sinking fund is required to be provided for the 2027 Notes. The 2027 Notes will be redeemable, in whole or in part (subject to certain limitations), at our option at any time, on or

9


 

after August 20, 2025, and on or before the 50th scheduled trading day immediately before the maturity date, under certain circumstances defined within the Indenture.

The net carrying amount of the 2027 Notes included in our condensed consolidated balance sheets consisted of the following:

 

 

As of

 

(In thousands)

 

March 31,
2024

 

 

December 31,
2023

 

Principal amount

 

$

345,000

 

 

$

345,000

 

Unamortized debt discount

 

 

(7,080

)

 

 

(7,576

)

Net carrying amount

 

$

337,920

 

 

$

337,424

 

The following table sets forth the total interest expense related to the 2027 Notes recognized in interest expense in our unaudited condensed consolidated statements of operations and comprehensive loss for the periods presented:

 

 

For the Three Months Ended
March 31,

 

(In thousands)

 

2024

 

 

2023

 

Contractual interest expense

 

$

2,156

 

 

$

2,156

 

Amortization of debt issuance costs

 

 

496

 

 

 

480

 

Total interest expense

 

$

2,652

 

 

$

2,636

 

Effective interest rate

 

 

3.1

%

 

 

3.1

%

Future minimum payments under the 2027 Notes as of March 31, 2024, are as follows (in thousands):

Fiscal year ended December 31, 2024(1)

 

$

4,312

 

Fiscal year ended December 31, 2025

 

 

8,625

 

Fiscal year ended December 31, 2026

 

 

8,625

 

Fiscal year ended December 31, 2027

 

 

353,625

 

Thereafter

 

 

 

Total future payments

 

$

375,187

 

Less: amounts representing interest

 

 

(30,187

)

Total principal amount

 

$

345,000

 

(1) For the nine months ended December 31, 2024.

For additional information related to our 2027 Convertible Senior Notes, please read Note 9, 2027 Convertible Senior Notes, to our audited consolidated financial statements included in our Annual Report.

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7. Fair Value Measurements

The tables below present information about our assets and liabilities that are measured and carried at fair value on a recurring basis and indicate the level within the fair value hierarchy of the inputs we utilized to determine such fair values:

As of March 31, 2024 (In thousands)

 

Quoted
Prices in
Active
Markets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

319,557

 

 

$

 

 

$

 

 

$

319,557

 

Marketable securities (current)

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

 

120,501

 

 

 

 

 

 

 

 

 

120,501

 

U.S. government agencies

 

 

 

 

 

136,397

 

 

 

 

 

 

136,397

 

Corporate debt securities

 

 

 

 

 

9,967

 

 

 

 

 

 

9,967

 

Commercial paper

 

 

 

 

 

258,993

 

 

 

 

 

 

258,993

 

Marketable securities (non-current)

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

 

166,313

 

 

 

 

 

 

 

 

 

166,313

 

U.S. government agencies

 

 

 

 

 

52,278

 

 

 

 

 

 

52,278

 

Restricted cash

 

 

 

 

 

 

 

 

 

 

 

 

Money market account

 

 

1,960

 

 

 

 

 

 

 

 

 

1,960

 

Total assets

 

$

608,331

 

 

$

457,635

 

 

$

 

 

$

1,065,966

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Financing liability, related party

 

$

 

 

$

 

 

$

56,999

 

 

$

56,999

 

Financing liability

 

 

 

 

 

 

 

 

56,999

 

 

 

56,999

 

Total liabilities

 

$

 

 

$

 

 

$

113,998

 

 

$

113,998

 

 

As of December 31, 2023 (In thousands)

 

Quoted
Prices in
Active
Markets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

415,681

 

 

$

 

 

$

 

 

$

415,681

 

Marketable securities (current)

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

 

43,538

 

 

 

 

 

 

 

 

 

43,538

 

U.S. government agencies

 

 

 

 

 

201,058

 

 

 

 

 

 

201,058

 

Corporate debt securities

 

 

 

 

 

9,982

 

 

 

 

 

 

9,982

 

Commercial paper

 

 

 

 

 

319,922

 

 

 

 

 

 

319,922

 

Marketable securities (non-current)

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

 

125,040

 

 

 

 

 

 

 

 

 

125,040

 

U.S. government agencies

 

 

 

 

 

60,159

 

 

 

 

 

 

60,159

 

Restricted cash

 

 

 

 

 

 

 

 

 

 

 

 

Money market account

 

 

1,960

 

 

 

 

 

 

 

 

 

1,960

 

Total assets

 

$

586,219

 

 

$

591,121

 

 

$

 

 

$

1,177,340

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Financing liability, related party

 

$

 

 

$

 

 

$

56,082

 

 

$

56,082

 

Financing liability

 

 

 

 

 

 

 

 

56,082

 

 

 

56,082

 

Total liabilities

 

$

 

 

$

 

 

$

112,164

 

 

$

112,164

 

We have not recognized any impairments of our assets measured and carried at fair value during the three months ended March 31, 2024.

There have been no changes in valuation techniques, inputs utilized or transfers between fair measurement levels in the periods presented. The fair value of our Level 2 instruments were determined using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly. We validate the prices provided by our third-party pricing services by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. After completing our

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validation procedures, we did not adjust or override any fair value measurements provided by our pricing services as of March 31, 2024 and December 31, 2023.

The carrying amounts reflected in our condensed consolidated balance sheets for our cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate fair value due to the short-term nature of these assets and liabilities. As of March 31, 2024, our financing liabilities represented our only Level 3 assets or liabilities carried at fair market value. Changes in the fair value remeasurement of our financing liabilities can result from changes in one or multiple inputs, including adjustments to discount rates, changes in the expected achievement or timing of any sales-based, development or regulatory milestones, changes in the amount or timing of expected net cash flows, changes in the probability or timing of certain clinical events, or changes in the assumed probability or timing associated with regulatory approval. These fair value measurements represent Level 3 measurements as they are based on significant inputs not observable in the market.

Marketable Securities

The estimated fair value and amortized cost of our available-for-sale marketable debt securities, by contractual maturity and security type, are summarized as follows:

As of March 31, 2024 (In thousands)

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

Due in one year or less

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

$

120,543

 

 

$

43

 

 

$

(85

)

 

$

120,501

 

U.S. government agencies

 

 

136,511

 

 

 

14

 

 

 

(128

)

 

 

136,397

 

Corporate debt securities

 

 

9,966

 

 

 

1

 

 

 

 

 

 

9,967

 

Commercial paper

 

 

258,967

 

 

 

53

 

 

 

(27

)

 

 

258,993

 

Due after one year through two years

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

 

167,047

 

 

 

 

 

 

(734

)

 

 

166,313

 

U.S. government agencies

 

 

52,391

 

 

 

13

 

 

 

(126

)

 

 

52,278

 

Total marketable securities

 

$

745,425

 

 

$

124

 

 

$

(1,100

)

 

$

744,449

 

 

As of December 31, 2023 (In thousands)

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

Due in one year or less

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

$

43,487

 

 

$

71

 

 

$

(20

)

 

$

43,538

 

U.S. government agencies

 

 

201,217

 

 

 

74

 

 

 

(233

)

 

 

201,058

 

Corporate debt securities

 

 

9,954

 

 

 

28

 

 

 

 

 

 

9,982

 

Commercial paper

 

 

319,713

 

 

 

239

 

 

 

(30

)

 

 

319,922

 

Due after one year through two years

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasuries

 

 

124,581

 

 

 

459

 

 

 

 

 

 

125,040

 

U.S. government agencies

 

 

59,783

 

 

 

379

 

 

 

(3

)

 

 

60,159

 

Total marketable securities

 

$

758,735

 

 

$

1,250

 

 

$

(286

)

 

$

759,699

 

We had no realized gains or losses recognized on the sale or maturity of marketable securities during the three months ended March 31, 2024 and 2023. To date, we have not recognized any allowances for credit losses or impairments in relation to our available-for-sale marketable securities as these marketable securities are comprised of high credit quality, investment grade securities that we do not intend or expect to be required to sell prior to their anticipated recovery, and the decline in fair value of these securities is attributable to factors other than credit losses. All marketable securities with unrealized losses presented in the previous tables have been in a continuous unrealized loss position for less than 12 months or the loss is not material. Based on our evaluation, we determined credit losses related to marketable securities were immaterial for the three months ended March 31, 2024.

The weighted average maturity of our marketable securities as of March 31, 2024 and December 31, 2023 was approximately eight months.

Financing Liabilities

Upon execution of the Funding Agreements, we determined that the agreements qualified for election under the fair value option and initially measured the financial instruments at their issue-date estimated fair value. We revalue the related financial liabilities on a recurring basis at each reporting period.

As of March 31, 2024, the financing liability, related party and financing liability each totaled approximately $57.0 million. We determined their respective estimated fair values using a Monte Carlo simulation model under the income approach determined by using probability assessments of the expected future cash receipts and expected future cash payments and a discount rate of approximately 10.0% and 9.0% as of March 31, 2024 and December 31, 2023, respectively. The probability assessments of the

12


 

expected future cash receipts and expected future payments and the timing of expected future repayments are based on significant inputs that are not observable in the market and are subject to remeasurement at each reporting date.

The following table provides a rollforward of the estimated fair value associated with our total financing liabilities:

 

 

For the Three Months Ended
March 31,

 

(In thousands)

 

2024

 

Beginning balance, total financing liabilities

 

$

112,164

 

Funding commitment received

 

 

 

Change in fair value recognized in other (income) expense, net

 

 

914

 

Change in fair value attributable to instrument-specific credit risk recognized in other comprehensive (income) loss

 

 

920

 

Ending balance, total financing liabilities

 

$

113,998

 

For additional information related to the fair value of our financing liability and financing liability, related party, please read Note 5, Financing Liabilities, to these unaudited condensed consolidated financial statements.

2027 Convertible Senior Notes

The fair value of the 2027 Notes, which were issued in August 2022, may differ from the carrying value. The fair value is determined utilizing prices for the 2027 Notes observed in market trading. As the market for the trading of the 2027 Notes is not considered to be an active market, the estimate of fair value is considered a Level 2 measurement. As of March 31, 2024, the estimated fair value of the 2027 Notes, which have an aggregate carrying value of $337.9 million, was $386.6 million. As of December 31, 2023, the 2027 Notes had an aggregate carrying value and estimated fair value of $337.4 million and $382.0 million, respectively.

For additional information related to the 2027 Notes, please read Note 6, 2027 Convertible Senior Notes, to these unaudited condensed consolidated financial statements.

8