Celldex Therapeutics Inc
For the period ended Mar 31, 2024. Filed May 6, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 6, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
March 31, 2024
(1) Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared by Celldex Therapeutics, Inc. (the “Company” or “Celldex”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect the operations of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.
These interim financial statements do not include all the information and footnotes required by U.S. GAAP for annual financial statements and should be read in conjunction with the audited financial statements for the year ended December 31, 2023, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 26, 2024. In the opinion of management, the interim financial statements reflect all normal recurring adjustments necessary to fairly state the Company’s financial position and results of operations for the interim periods presented. The year-end condensed balance sheet data presented for comparative purposes was derived from audited financial statements but does not include all disclosures required by U.S. GAAP.
The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for any future interim period or the fiscal year ending December 31, 2024.
At March 31, 2024, the Company had cash, cash equivalents and marketable securities of $823.8 million. The Company has had recurring losses and incurred a loss of $32.8 million for the three months ended March 31, 2024. Net cash used in operations for the three months ended March 31, 2024 was $40.6 million. The Company believes that the cash, cash equivalents and marketable securities at the filing date of this Quarterly Report on Form 10-Q will be sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months from the date of issuance of these financial statements.
During the next twelve months and beyond, the Company may take further steps to raise additional capital to meet its long-term liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although the Company has been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and the Company’s negotiating position in capital-raising efforts may worsen as existing resources are used. There is also no assurance that the Company will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to the Company’s stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce the Company’s economic potential from products under development. The Company’s ability to continue funding its planned operations beyond twelve months from the issuance date is also dependent on the timing and manner of payment of the future milestone under the Settlement Agreement (defined below) with Shareholder Representative Services LLC (“SRS”) (refer to Note 13), in the event that the Company achieves the milestone related to that payment. The Company, at its option, may decide to pay that milestone payment in cash, shares of its common stock or a combination thereof. If the Company is unable to raise the funds necessary to meet its long-term liquidity needs, it may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company.
(2) Significant Accounting Policies
The significant accounting policies used in preparation of these condensed consolidated financial statements on this Quarterly Report on Form 10-Q for the three months ended March 31, 2024 are consistent with those discussed in Note 2 to the financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption.
In November 2023, the FASB issued ASU 2023-07Segment Reporting - Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosure of significant segment expenses. The amendments in ASU 2023-07 apply to public entities, including those with a single reportable segment, and are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that ASU 2023-07 will have on its consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities to disclose specific categories in the effective tax rate reconciliation, as well as additional information for reconciling items that exceed a quantitative threshold. ASU 2023-09 also requires all entities to disclose income taxes paid disaggregated by federal, state and foreign taxes, and further disaggregated for specific jurisdictions that exceed 5% of total income taxes paid, among other expanded disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements and related disclosures.
In March 2024, the SEC adopted final rules requiring public entities to provide certain climate-related information in their registration statements and annual reports. The rules require disclosure of, among other things: material climate-related risks; activities to mitigate or adapt to such risks; governance and management of such risks; and material greenhouse gas (GHG) emissions from operations owned or controlled (Scope 1) and/or indirect emissions from purchased energy consumed in operations (Scope 2). Additionally, the rules require disclosure in the notes to the financial statements of the effects of severe weather events and other natural conditions, subject to certain materiality thresholds. In April 2024, the SEC voluntarily stayed the new rules as a result of pending legal challenges. Absent the result of pending legal challenges, and the removal of the stay, the rules were to become effective on a phased-in timeline, with the first requirements to be adopted for the Company’s fiscal year beginning in 2025. The Company is assessing the effect of the new rules on its consolidated financial statements and related disclosures.
(3) Fair Value Measurements
The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · As of · · · · · · · · · | ||||||||||||
| · March 31, 2024 · Level 1 · Level 2 · Level 3 | ||||||||||||
| | | (In thousands) | ||||||||||
| Assets: | | | | | | | | | | | | |
| Money market funds and cash equivalents | | $97,624 | | | — | | $97,624 | | | — | ||
| Marketable securities | | | 708,769 | | | — | | | 708,769 | | | — |
| | | $806,393 | | | — | | $806,393 | | | — | ||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · As of · · · · · · · · · | ||||||||||||
| · December 31, 2023 · Level 1 · Level 2 · Level 3 | ||||||||||||
| | | (In thousands) | ||||||||||
| Assets: | | | | | | | | | | | | |
| Money market funds and cash equivalents | | $19,803 | | | — | | $19,803 | | | — | ||
| Marketable securities | | | 388,784 | | | — | | | 388,784 | | | — |
| | | $408,587 | | | — | | $408,587 | | | — | ||
The Company’s financial assets consist mainly of money market funds, cash equivalents and marketable securities and are classified as Level 2 within the valuation hierarchy. The Company values its marketable securities utilizing independent pricing services which normally derive security prices from recently reported trades for identical or similar securities, making adjustments
based on significant observable transactions. At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a combination of these data sources.
Contingent consideration liabilities measured at fair value using Level 3 inputs were $0.0 million as of March 31, 2024 and December 31, 2023. The valuation technique used to measure fair value of the Company’s Level 3 liabilities, which consist of contingent consideration related to the acquisition of Kolltan Pharmaceuticals, Inc. (“Kolltan”) in 2016, is primarily an income approach. The significant unobservable inputs used in the fair value measurement of the contingent consideration are estimates including probability of success, discount rates and amount of time until the conditions of the milestone payments are met.
There wasno gain or loss on fair value remeasurement of contingent consideration recorded during the three months ended March 31, 2024 or March 31, 2023. The assumptions related to determining the fair value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a material impact on the amount of contingent consideration adjustment recorded in any given period.
The Company did not have any transfers in or out of Level 3 assets orliabilities during the three months ended March 31, 2024.
(4) Marketable Securities
The following is a summary of marketable debt securities, classified as available-for-sale:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Amortized · · Gross Unrealized · · Gross Unrealized · · Fair | ||||||||||||
| · Cost · Gains · Losses · Value | ||||||||||||
| | | (In thousands) | ||||||||||
| March 31, 2024 | | | | | | | | | | | | |
| Marketable securities | | | | | | | | | | | | |
| U.S. government and municipal obligations | | | | | | | | | | | | |
| Maturing in one year or less | | $139,787 | | $14 | | $(62) | | $139,739 | ||||
| Maturing after one year through three years | | | 93,179 | | | — | | | (275) | | | 92,904 |
| Total U.S. government and municipal obligations | | $232,966 | | $14 | | $(337) | | $232,643 | ||||
| Corporate debt securities | | | | | | | | | | | | |
| Maturing in one year or less | | $371,025 | | $141 | | $(142) | | $371,024 | ||||
| Maturing after one year through three years | | | 105,130 | | | 65 | | | (93) | | | 105,102 |
| Total corporate debt securities | | $476,155 | | $206 | | $(235) | | $476,126 | ||||
| Total marketable securities | | $709,121 | | $220 | | $(572) | | $708,769 | ||||
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| | | Amortized | | Gross Unrealized | | Gross Unrealized | | Fair | ||||
| | Cost | Gains | Losses | Value | ||||||||
| | | (In thousands) | ||||||||||
| December 31, 2023 | | | | | | | | | | | | |
| Marketable securities | | | | | | | | | | | | |
| U.S. government and municipal obligations | | | | | | | | | | | | |
| Maturing in one year or less | | $132,459 | | $143 | | $(53) | | $132,549 | ||||
| Maturing after one year through three years | | | 26,009 | | | 77 | | | — | | | 26,086 |
| Total U.S. government and municipal obligations | | $158,468 | | $220 | | $(53) | | $158,635 | ||||
| Corporate debt securities | | | | | | | | | | | | |
| Maturing in one year or less | | $183,625 | | $300 | | $(10) | | $183,915 | ||||
| Maturing after one year through three years | | | 45,977 | | | 257 | | | — | | | 46,234 |
| Total corporate debt securities | | $229,602 | | $557 | | $(10) | | $230,149 | ||||
| Total marketable securities | | $388,070 | | $777 | | $(63) | | $388,784 | ||||
The Company holds investment-grade marketable securities. Unrealized losses are generally attributable to changes in interest rates. The aggregate fair value of marketable securities held by the Company in an unrealized loss position as of March 31, 2024 and December 31, 2023 was $458.1 million and $80.4 million, respectively. The Company has the intent and ability to hold its marketable securities until recovery and has determined that there has been no material change to their credit risk. As a result, the Company determined it did not hold any investments with a credit loss at March 31, 2024.
Marketable securities include $4.7 million and $1.9 million in accrued interest at March 31, 2024 and December 31, 2023, respectively.
(5) Intangible Assets
At March 31, 2024 and December 31, 2023, the carrying value of the Company’s indefinite-lived intangible assets was $27.2 million. Indefinite-lived intangible assets consist of acquired in-process research and development ("IPR&D") related to the development of the anti-KIT program (including barzolvolimab), which was recorded in connection with the Kolltan acquisition. Barzolvolimab is in Phase 2 development. As of March 31, 2024, the IPR&D asset related to the anti-KIT program had not reached technological feasibility nor did the asset have alternative future uses.
The Company performs an impairment test on IPR&D assets at least annually, or more frequently if events or changes in circumstances indicate that IPR&D assets may be impaired. Due to the nature of IPR&D projects, the Company may experience future delays or failures to obtain regulatory approvals to conduct clinical trials, failures of such clinical trials or other failures to achieve a commercially viable product, and as a result, may recognize further impairment losses in the future.
(6) Other Long-Term Liabilities
Other long-term liabilities include the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · March 31, · December 31, | ||||
| | | 2024 | | 2023 |
| · · (In thousands) | ||||
| Net deferred tax liabilities related to IPR&D (Note 11) | | $1,613 | | $1,613 |
| Deferred income from sale of tax benefits | | 2,790 | | 3,720 |
| Deferred revenue (Note 10) | | 2,947 | | 3,058 |
| Total | | 7,350 | | 8,391 |
| Less current portion | | (3,877) | | (3,988) |
| Long-term portion | | $3,473 | | $4,403 |
In March 2022, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits of $5.0 million to an independent third party for $4.7 million. Under the agreement, the Company must maintain a base of operations in New Jersey forfive years or the tax benefits must be paid back on a pro-rata basis based on the number of years completed. The Company recognized $0.9 million and $0.9 million in other income related to the sale of these tax benefits during the three months ended March 31, 2024 and the three months ended March 31, 2023, respectively.
(7) Stockholders’ Equity
In November 2023, the Company filed an automatic shelf registration statement with the SEC to register for sale any combination of the types of securities described in the shelf registration statement, including shares of its common stock. Also in November 2023, the Company issued 8,538,750 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of $216.2 million, after deducting underwriting fees and offering expenses.
On February 26, 2024, the Company entered into a controlled equity offering sales agreement (“ATM Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock from time to time through Cantor, acting as agent. Also on February 26, 2024, the Company terminated its pre-existing controlled equity offering sale agreement dated May 19, 2016 with Cantor. At March 31, 2024, the Company had registered $300.0 million of its common stock to be sold pursuant to the Company’s ATM Agreement, all of which remained unsold as of that date.
In March 2024, the Company issued 9,798,000 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of $432.3 million, after deducting underwriting fees and offering expenses.
The changes in Stockholders’ Equity during the three months ended March 31, 2024 and 2023 are summarized below:
| · · · · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | Accumulated | | | | |
| · · Common · · Common · · Additional · · Other · · · · · Total | ||||||||||
| · · Stock · · Stock Par · · Paid-In · · Comprehensive · · Accumulated · · Stockholders’ | ||||||||||
| · Shares · Value · Capital · Income · Deficit · Equity | ||||||||||
| · · (In thousands, except share amounts) | ||||||||||
| Consolidated balance at December 31, 2023 | 55,883,377 | $56 | $1,823,168 | $3,308 | $(1,397,361) | $429,171 | ||||
| Shares issued under stock option and employee stock purchase plans | 229,171 | — | 3,814 | | | — | — | 3,814 | ||
| Shares issued in underwritten offering, net | 9,798,000 | 10 | 432,288 | — | — | 432,298 | ||||
| Stock-based compensation | — | — | 7,202 | — | — | 7,202 | ||||
| Unrealized loss on marketable securities | — | — | — | (1,064) | — | (1,064) | ||||
| Net loss | — | — | — | — | (32,808) | | (32,808) | |||
| Consolidated balance at March 31, 2024 | 65,910,548 | $66 | $2,266,472 | $2,244 | | $(1,430,169) | $838,613 | |||
| · · · · · · · · · · · · · · · · · | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · Accumulated · · · · | |||||||||||
| · · Common · · Common · · Additional · · Other · · · · · Total | |||||||||||
| · · Stock · · Stock Par · · Paid-In · · Comprehensive · · Accumulated · · Stockholders’ | |||||||||||
| · · Shares · · Value · · Capital · · Income · · Deficit · · Equity | |||||||||||
| · · (In thousands, except share amounts) | |||||||||||
| Consolidated balance at December 31, 2022 | 47,200,695 | | $47 | | $1,580,829 | | $1,260 | | $(1,255,932) | | $326,204 |
| Shares issued under stock option and employee stock purchase plans | 43,986 | | — | | 694 | | — | | — | | 694 |
| Stock-based compensation | — | | — | | 4,340 | | — | | — | | 4,340 |
| Unrealized gain on marketable securities | — | | — | | — | | 863 | | — | | 863 |
| Net loss | — | | — | | — | | — | | (29,361) | | (29,361) |
| Consolidated balance at March 31, 2023 | 47,244,681 | | $47 | | $1,585,863 | | $2,123 | | $(1,285,293) | | $302,740 |
(8) Stock-Based Compensation
A summary of stock option activity for the three months ended March 31, 2024 is as follows:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | | | | Weighted | | Weighted |
| | | | | Average | | Average |
| | | | | Exercise | | Remaining |
| | | | | Price | | Contractual |
| · Shares · Per Share · Term (In Years) | ||||||
| Options outstanding at December 31, 2023 | 6,378,924 | | $29.69 | | 7.5 | |
| Granted | 5,000 | | $37.08 | | | |
| Exercised | (222,619) | | $16.27 | | | |
| Canceled | (2,568) | | $83.21 | | | |
| Options outstanding at March 31, 2024 | 6,158,737 | | $30.16 | | 7.4 | |
| Options vested and expected to vest at March 31, 2024 | 6,065,176 | | $30.14 | | 7.3 | |
| Options exercisable at March 31, 2024 | 3,284,980 | | $29.45 | | 6.3 | |
| Shares available for grant under the 2021 Plan | 1,011,071 | | | | | |
The weighted average grant-date fair value of stock options granted during the three months ended March 31, 2024 was $28.64.
The aggregate intrinsic value of stock options vested and expected to vest at March 31, 2024 was $104.1 million. The aggregate intrinsic value of stock options exercisable at March 31, 2024 was $74.3 million. As of March 31, 2024, total compensation cost related to non-vested employee, consultant and non-employee director stock options not yet recognized was approximately $55.3 million, net of estimated forfeitures, which is expected to be recognized as expense over a weighted average period of 2.4 years.
Stock-based compensation expense for the three months ended March 31, 2024 and 2023 was recorded as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||
| · 2024 · 2023 | ||||
| · · (In thousands) | ||||
| Research and development | | $3,693 | | $2,162 |
| General and administrative | | 3,509 | | 2,178 |
| Total stock-based compensation expense | | $7,202 | | $4,340 |
The fair values of employee, consultant and non-employee director stock options granted during the three months ended March 31, 2024 and 2023 were valued using the Black-Scholes option pricing model with the following assumptions:
| · · · · | |||
|---|---|---|---|
| · · Three Months Ended March 31, | |||
| 2024 · 2023 | |||
| Expected stock price volatility | 92% | | 92% |
| Expected option term | 6.0 Years | | 6.0 Years |
| Risk-free interest rate | 4.0 – 4.3% | | 3.7 – 4.0% |
| Expected dividend yield | None | | None |
(9) Accumulated Other Comprehensive Income
The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the three months ended March 31, 2024 are summarized below:
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · Unrealized · · · · · · | ||||||
| · · Gain (Loss) on · · · · · · | ||||||
| · · Marketable · · Foreign · · · | ||||||
| · Securities · Currency Items · Total | ||||||
| · · (In thousands) | ||||||
| Balance at December 31, 2023 | | $712 | | $2,596 | | $3,308 |
| Other comprehensive loss | | (1,064) | | — | | (1,064) |
| Balance at March 31, 2024 | | $(352) | | $2,596 | | $2,244 |
No amounts were reclassified out of accumulated other comprehensive income during the three months ended March 31, 2024.
(10) Revenue
Contract and Grants Revenue
The Company has entered into agreements with Rockefeller University (“Rockefeller”) pursuant to which the Company performs manufacturing and research and development services on a time-and-materials basis or at a negotiated fixed-price. The Company recognized $0.2 million and $1.0 million in revenue under the agreements with Rockefeller during the three months ended March 31, 2024 and 2023, respectively.
Contract Assets and Liabilities
At March 31, 2024 and December 31, 2023, the Company’s right to consideration under all contracts was considered unconditional, and as such, there wereno recorded contract assets. At March 31, 2024, the Company had $2.9 million in contract liabilities recorded, which is expected to be recognized during the next 12 months as manufacturing and research and development services are performed. At December 31, 2023, the Company had $3.1 million in contract liabilities recorded. Revenue recognized from contract liabilities as of December 31, 2023 during the three months ended March 31, 2024 was $0.2 million.
(11) Income Taxes
The Company has evaluated the positive and negative evidence bearing upon the realizability of its net deferred tax assets and considered its history of losses, ultimately concluding that it is “more likely than not” that the Company will not recognize the
benefits of federal, state and foreign deferred tax assets and, as such, has maintained a full valuation allowance on its deferred tax assets as of March 31, 2024 and December 31, 2023.
The net deferred tax liability of $1.6 million at March 31, 2024 and December 31, 2023 relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and is not deductible for tax purposes.
Massachusetts, New Jersey, New York and Connecticut are the jurisdictions in which the Company primarily operates or has operated and has income tax nexus. The Company is not currently under examination by these or any other jurisdictions for any tax year.
(12) Net Loss Per Share
Basic net loss per common share is based upon the weighted-average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common shares outstanding during the period when the effect is dilutive. In periods in which the Company reports a net loss, there is no difference between basic and diluted net loss per share because dilutive shares of common stock are not assumed to have been issued as their effect is anti-dilutive. The potentially dilutive common shares that have not been included in the net loss per common share calculations because the effect would have been anti-dilutive are as follows:
| · · · · | ||
|---|---|---|
| | | Three Months Ended March 31, |
| | 2024 | 2023 |
| Stock Options | 6,158,737 | 4,967,764 |
| Restricted Stock | — | — |
| | 6,158,737 | 4,967,764 |
(13) Kolltan Acquisition
On November 29, 2016, the Company acquired all of the share and debt interests of Kolltan, a clinical-stage biopharmaceutical company, in exchange for 1,217,200 shares of the Company’s common stock plus contingent consideration in the form of development, regulatory approval and sales-based milestones (“Kolltan Milestones”) of up to $172.5 million payable in cash, in shares of Celldex’s common stock or a combination of both, in the sole discretion of Celldex and subject to provisions of the Agreement and Plan of Merger, dated November 1, 2016 (the “Merger Agreement”).
In October 2019, the Company received a letter from SRS, the hired representative of the former stockholders of Kolltan, notifying the Company that it objected to the Company’s characterization of the development, regulatory approval and sales-based Kolltan Milestones relating to CDX-0158 as having been abandoned and contending instead that the related milestone payments are due from Celldex to the Kolltan stockholder.
On August 18, 2020, Celldex filed a Verified Complaint in the Court of Chancery of the State of Delaware against SRS (acting in its capacity as the representative of the former stockholders of Kolltan pursuant to the Merger Agreement) seeking declaratory relief with respect to the rights and obligations of the parties relating to certain contingent milestone payments under the Merger Agreement relating to the discontinued CDX-0158 program (the “Litigation”).
On July 15, 2022, the Company entered into a definitive settlement agreement between the Company and SRS (the “Settlement Agreement”) and the Company and SRS jointly filed a Stipulation of Dismissal with prejudice relating to the Litigation on July 19, 2022.
Pursuant to the terms of the Settlement Agreement, all milestone payments provided for by the Merger Agreement were replaced in their entirety with the following payments, each of which is payable only once:
| (i) | The Company paid $15.0 million upon execution of the Settlement Agreement (the “Initial Payment”). |
| (ii) | The Company paid $12.5 million upon the Successful Completion (as defined in the Settlement Agreement) of a Phase 2 Clinical Trial (as defined in the Merger Agreement) of barzolvolimab. |
| (iii) | The Company shall pay $52.5 million upon the first United States Food and Drug Administration or European Medicines Agency, or, in each case, any successor organization, regulatory approval of a Surviving Company Product (as defined in the Settlement Agreement). |
The above payment obligations replace, in their entirety, the contingent consideration in the form of development, regulatory approval and sales-based milestones of up to $172.5 million contained in the Merger Agreement.
Under the Settlement Agreement, each of the Company and SRS provided broad mutual releases of all claims relating to or arising out of the Merger Agreement, including without limitation, all claims brought in the Litigation or that could have been brought in the Litigation.
The Company paid the Initial Payment in cash in July 2022. The Company paid the second milestone for “successful completion” of a Phase 2 Clinical Trial of barzolvolimab in cash in November 2023.
A future milestone payment related to the barzolvolimab program, which was subject to the Litigation, will be recorded when and if payment becomes probable and reasonably estimable in accordance with the loss contingency model under ASC 450. A future milestone payment related to the remaining Surviving Company Products is measured at fair value (refer to Note 3). When and if the remaining payment described above becomes due, it shall be payable, at the Company’s sole election, in either cash or stock (as set forth in the Merger Agreement) or a combination thereof.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.