Item 9A. Controls and Procedures
Item 9A. Controls and procedures
Evaluation of disclosure controls and procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of March 31, 2024. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2024.
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In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Management’s report on internal control over financial reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
(i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management of the Company has assessed the effectiveness of the Company’s internal control over financial reporting as of March 31, 2024. In making its assessment of internal control over financial reporting, management used the criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, management concluded that our internal control over financial reporting was effective as of March 31, 2024.
This annual report does not include an audit report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to audit by the Company’s registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit the Company to provide only management’s report in this Annual Report on Form 10-K.
Changes in internal control over financial reporting
There have been no changes in our internal control over financial reporting during the fourth quarter of the fiscal year ended March 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
Rule 10b5-1 Plan Trading Arrangements
During the three months ended March 31, 2024, each of the following officers adopted a “Rule 10b5-1 trading arrangement” (as defined in Item 408 of Regulation S-K) that is intended to satisfy the affirmative defense of Rule 10b5-1(c)
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under the Exchange Act and our policies on insider trading:
Name & Title Date Adopted (1)
Aggregate Number of Shares of Common Stock to be Purchased or Sold Pursuant to Trading Arrangement Expiration Date (3)
Pamela Esposito
Chief Business Officer
2/21/2024 (2)
Indeterminable (4)
November 14, 2024
Konstantinos Xynos
Chief Medical Officer
2/13/2024 (2)
Indeterminable (4)
February 18, 2025
(1) Date of adoption of Rule 10b5-1 trading arrangements is in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations.
(2) The first trade pursuant to the Rule 10b5-1 trading arrangement will be, in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations, on a date after the date of adoption of the Rule 10b5-1 trading arrangement.
(3) The Rule 10b5-1 trading arrangement permits transactions through and including the earlier to occur of (a) the completion of all sales or (b) the date listed in the table. The arrangement also provides for automatic expiration in the event of liquidation, dissolution, bankruptcy, insolvency, or death of the adopting person.
(4) The Rule 10b5-1 trading arrangement includes the sale of shares to be received upon future vesting of certain outstanding equity awards, net of any shares withheld by us to satisfy applicable taxes. The number of shares to be withheld, and thus the exact number of shares to be sold pursuant to the Rule 10b5-1 trading arrangement, can only be determined upon the occurrence of the future vesting events. For purposes of this disclosure, we have reported the gross number of shares to be received upon the future vesting of such equity awards, before subtracting any shares to be withheld by us to satisfy applicable taxes in connection with such future vesting events.
Other than those disclosed above, none of our directors or officers adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” in each case as defined in Item 408 of Regulation S-K.
Item 9C. Disclosure Regarding Jurisdictions That Prevent Inspections
Not Applicable.
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PART III
Item 10. Directors, executive officers and corporate governance
The text of our Code of Business Conduct and Ethics, which applies to our directors and employees (including our principal executive officer, principal financial officer, and principal accounting officer or controller, and persons performing similar functions), is posted in the “Corporate Governance” section of our website, www.replimune.com. A copy of the Code of Business Conduct and Ethics can be obtained free of charge on our website. We intend to disclose on our website any amendments to, or waivers from, our Code of Business Conduct and Ethics that are required to be disclosed pursuant to the rules of the Securities and Exchange Commission and Nasdaq. The information contained on our website is not considered part of, or incorporated by reference into, this Annual Report on Form 10-K or any other filing that we make with the Securities and Exchange Commission.
The remaining information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended March 31, 2024.
Item 11. Executive compensation
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2024.
Item 12. Security ownership of certain beneficial owners and management and related stockholder matters
Securities authorized for issuance under equity compensation plans
The following table provides information as of March 31, 2024, regarding our common stock that may be issued under (1) the 2017 Equity Compensation Plan, or the 2017 Plan; (2) the 2018 Omnibus Incentive Compensation Plan, or the 2018 Plan; or (3) the Employee Stock Purchase Plan, or the ESPP.
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights
(a)
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights
(b)
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (excluding securities reflected in column (a))
(c)
Plan Category:
Equity compensation plans approved by stockholders
2017 Plan 1,136,195 3.12 —
2018 Plan (1)
7,183,561 18.64 2,284,141
ESPP 2,738,208
Total 8,319,756 5,022,349
_________________
(1) Includes 2,229,143 shares of common stock subject to outstanding restricted and performance stock units.
The remaining information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2024.
Item 13. Certain relationships and related transactions, and director independence
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2024.
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Item 14. Principal accountant fees and services
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2024.
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PART IV
Item 15. Exhibits and financial statement schedules
(a) 1. Consolidated financial statements.
For a list of the consolidated financial statements included herein, see Index on page F-1 of this report.
2. Financial statement schedules.
All required information is included in the financial statements or notes thereto.
3. List of exhibits.
The documents listed in the exhibit index immediately preceding the signature page of this Annual Report on Form 10-K are incorporated by reference or are filed or furnished with this Annual Report on Form 10-K, in each case as indicated therein.
Item 16. 10-K summary
None.
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REPLIMUNE GROUP, INC.
Index to Consolidated Financial Statements
For the Years Ended March 31, 2024 and 2023
Page
Report of independent registered public accounting firm (PCAOB ID 238 )
F- 2
Consolidated balance sheets
F- 4
Consolidated statements of operations
F- 5
Consolidated statements of comprehensive loss
F- 6
Consolidated statements of stockholders’ equity
F- 7
Consolidated statements of cash flows
F- 8
Notes to consolidated financial statements
F- 9
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Replimune Group, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Replimune Group, Inc. and its subsidiaries (the “Company”) as of March 31, 2024 and 2023, and the related consolidated statements of operations, of comprehensive loss, of stockholders’ equity and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accrued Research and Development Costs
As described in Notes 2 and 6 to the consolidated financial statements, the Company has entered into various research and development-related contracts with companies both inside and outside of the United States. When billing terms under these contracts do not coincide with the timing of when the work is performed, management is required to make estimates of outstanding obligations to those third parties as of the end of the reporting period. The Company records accruals for estimated ongoing research costs. Within accrued expenses and other current liabilities, total accrued research and development costs amounted to $16.4 million as of March 31, 2024. Accrual estimates are based on a number of factors, including management’s assessment of progress towards completion of the research and development activities, invoicing to date under the contracts, communication from the research organization or other companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant judgments and estimates are made by management in determining the accrued balances at the end of any reporting period.
The principal considerations for our determination that performing procedures relating to accrued research and development costs is a critical audit matter are (i) the significant judgment by management in developing the estimate of the accrued research and development costs and (ii) a high degree of auditor judgment and effort in performing procedures related to the accrued research and development costs.
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Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others, (i) testing management’s process for developing the estimate of accrued research and development costs; (ii) evaluating the appropriateness of the methodology used by management to develop the estimate; (iii) evaluating the reasonableness of management’s estimate of accrued external research and development costs by (a) testing the completeness and accuracy of costs incurred, on a sample basis, by tracing information to the underlying contracts, purchase orders, invoices and information received from the research organization or other companies, as applicable, and (b) evaluating the reasonableness of the estimated costs incurred for the services that have not been invoiced, on a sample basis, by tracing to underlying supporting documentation, such as underlying contracts, purchase orders and information received from research organizations or other companies, as applicable.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
May 16, 2024
We have served as the Company’s auditor since 2018.
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REPLIMUNE GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
March 31,
2024 March 31,
2023
Assets
Current assets:
Cash and cash equivalents $ 74,457 $ 146,590
Short-term investments 346,211 436,796
Research and development incentives receivable 4,922 2,939
Prepaid expenses and other current assets 8,077 6,278
Total current assets 433,667 592,603
Property, plant and equipment, net 10,483 7,479
Restricted cash 1,700 1,636
Right-to-use asset – operating leases 4,635 5,208
Right-to-use asset – financing leases 37,237 39,665
Total assets $ 487,722 $ 646,591
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 2,578 $ 5,364
Accrued expenses and other current liabilities 33,981 24,704
Operating lease liabilities, current 1,161 1,118
Financing lease liabilities, current 2,718 2,639
Total current liabilities 40,438 33,825
Operating lease liabilities, non-current 3,771 4,389
Financing lease liabilities, non-current 23,410 23,965
Long term debt, net of discount 44,809 28,648
Other liabilities, non-current 786 472
Total liabilities $ 113,214 $ 91,299
Commitments and contingencies (Note 13)
Stockholders’ equity:
Common stock, $ 0.001 par value; 150,000,000 shares authorized as of March 31, 2024 and March 31, 2023; 61,415,105 and 56,676,313 shares issued and outstanding as of March 31, 2024 and March 31, 2023, respectively
61 57
Additional paid-in capital 1,070,874 1,034,994
Accumulated deficit ( 701,282 ) ( 485,488 )
Accumulated other comprehensive income (loss) 4,855 5,729
Total stockholders’ equity 374,508 555,292
Total liabilities and stockholders’ equity $ 487,722 $ 646,591
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
Year Ended March 31,
2024 2023
Operating expenses:
Research and development
$ 174,963 $ 126,527
Selling, general and administrative 59,810 50,553
Total operating expenses
234,773 177,080
Loss from operations
( 234,773 ) ( 177,080 )
Other income (expense):
Research and development incentives
1,920 2,914
Investment income
23,356 10,006
Interest expense on finance lease liability
( 2,163 ) ( 2,197 )
Interest expense on debt obligations
( 4,497 ) ( 1,963 )
Other income (expense)
771 ( 5,676 )
Total other income, net 19,387 3,084
Loss before income taxes $ ( 215,386 ) $ ( 173,996 )
Income tax provision 408 288
Net loss $ ( 215,794 ) $ ( 174,284 )
Net loss per common share, basic and diluted $ ( 3.24 ) $ ( 2.99 )
Weighted average common shares outstanding, basic and diluted
66,569,894 58,213,010
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands)
Year Ended March 31,
2024 2023
Net loss $ ( 215,794 ) $ ( 174,284 )
Other comprehensive loss:
Foreign currency translation (loss) gain
( 826 ) 5,483
Net unrealized (loss) gain on short-term investments, net of tax of $ 0
( 48 ) 1,219
Comprehensive loss $ ( 216,668 ) $ ( 167,582 )
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share amounts)
Common stock Additional paid-in capital Accumulated deficit Accumulated other comprehensive income (loss) Total stockholders’ equity
Shares Amount
Balances as of March 31, 2022 47,338,660 $ 47 $ 723,359 $ ( 311,204 ) $ ( 973 ) $ 411,229
Issuance of common stock through ATM sales, net of offering costs 2,026,438 2 37,436 — — 37,438
Issuance of prefunded warrants to purchase common stock — — 92,778 — — 92,778
Issuance of common stock, net of issuance costs and underwriter fees 6,810,658 7 149,847 — — 149,854
Foreign currency translation adjustment — — — — 5,483 5,483
Unrealized gain on short-term investments — — — — 1,219 1,219
Exercise of stock options 296,876 1 3,443 — — 3,444
Vesting of RSUs 203,681 — — — — —
Stock-based compensation expense — — 28,131 — — 28,131
Net loss — — — ( 174,284 ) — ( 174,284 )
Balances as of March 31, 2023 56,676,313 $ 57 $ 1,034,994 $ ( 485,488 ) $ 5,729 $ 555,292
Foreign currency translation adjustment — — — — ( 826 ) ( 826 )
Unrealized loss on short-term investments
— — — — ( 48 ) ( 48 )
Exercise of pre-funded warrants
4,202,622 4 ( 4 ) — — —
Exercise of stock options 164,221 — 1,759 — — 1,759
Vesting of RSUs 371,949 — — — — —
Stock-based compensation expense — — 34,125 — — 34,125
Net loss — — — ( 215,794 ) — ( 215,794 )
Balances as of March 31, 2024 61,415,105 $ 61 $ 1,070,874 $ ( 701,282 ) $ 4,855 $ 374,508
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Year Ended March 31,
2024 2023
Cash flows from operating activities:
Net loss $ ( 215,794 ) $ ( 174,284 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense 34,125 28,131
Depreciation and amortization 2,655 2,447
Net amortization of premiums and discounts on short-term investments ( 12,326 ) ( 5,638 )
Noncash interest expense 1,161 494
Unrealized foreign currency transaction losses ( 771 ) 5,676
Changes in operating assets and liabilities:
Research and development incentives receivable ( 1,916 ) ( 61 )
Prepaid expenses and other current assets ( 1,778 ) ( 1,059 )
Operating lease, right-of-use-asset 615 225
Finance lease, right-of-use-asset 2,428 2,428
Accounts payable ( 2,794 ) 1,981
Accrued expenses and other current liabilities 9,234 11,376
Operating lease liabilities ( 620 ) ( 238 )
Other non-current liabilities 314 472
Net cash used in operating activities ( 185,467 ) ( 128,050 )
Cash flows from investing activities:
Purchases of property, plant and equipment ( 5,662 ) ( 2,270 )
Purchase of short-term investments ( 489,516 ) ( 583,412 )
Proceeds from sales and maturities of short-term investments 592,379 443,180
Net cash provided by (used in) investing activities
97,201 ( 142,502 )
Cash flows from financing activities:
Proceeds from issuance of common stock, net of underwriting fees and discounts — 149,854
Proceeds from issuance of prefunded warrants to purchase common stock, net of underwriting fees and discounts
— 92,778
Proceeds from issuance of common stock through ATM sales, net of offering costs — 37,438
Proceeds from long-term debt, net of debt issuance costs 15,000 28,154
Principal payment of finance lease obligation ( 476 ) ( 365 )
Proceeds from exercise of stock options 1,759 3,444
Net cash provided by financing activities 16,283 311,303
Effect of exchange rate changes on cash, cash equivalents and restricted cash ( 86 ) ( 109 )
Net (decrease) increase in cash, cash equivalents and restricted cash ( 72,069 ) 40,642
Cash, cash equivalents and restricted cash at beginning of period 148,226 107,584
Cash, cash equivalents and restricted cash at end of period $ 76,157 $ 148,226
Supplemental disclosure of cash flow information:
Cash paid during the period for interest 3,044 $ 1,066
Cash paid for income taxes 300 —
Supplemental disclosure of non-cash investing and financing activities:
Purchases of property and equipment included in accounts payable $ 101 $ 103
Lease assets obtained in exchange for new operating lease liabilities $ — $ 290
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
1. Nature of the business
Replimune Group, Inc. (the “Company”) is a clinical-stage biotechnology company focused on the development of oncolytic immunotherapies to treat cancer. Replimune Group, Inc., whose predecessor was founded in 2015, is the parent company of its wholly owned, direct and indirect subsidiaries: Replimune Limited (“Replimune UK”); Replimune, Inc. (“Replimune US”); Replimune Securities Corporation; and Replimune (Ireland) Limited.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance and reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Basis of presentation
The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since its inception, including net losses of $ 215.8 million and $ 174.3 million for the years ended March 31, 2024 and 2023, respectively. In addition, as of March 31, 2024, the Company had an accumulated deficit of $ 701.3 million. The Company expects to continue to generate operating losses for the foreseeable future. As of the issuance date of these consolidated financial statements, the Company expects that its cash and cash equivalents and short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance of the consolidated financial statements.
2. Summary of significant accounting policies
Principles of consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune US, Replimune Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.
Use of estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances.
Foreign currency and currency translation
The functional currency for the Company’s wholly owned foreign subsidiary, Replimune UK, is the British pound. Assets and liabilities of Replimune UK are translated into United States dollars at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment, which is included in the consolidated statements of stockholders’ equity as a component of accumulated other comprehensive income (loss). Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other income (expense), net in the consolidated statements of operations as incurred.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
Concentrations of credit risk and of significant suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents as well as short-term investments. The Company deposits its cash in financial institutions in amounts that may exceed federally insured limits. We limit our exposure to credit risk by placing investments with high credit quality financial institutions, diversifying our investment portfolio and placing investments with maturities that maintain safety and liquidity. To date, the Company has not experienced any losses on such accounts.
The Company relies, and expects to continue to rely, on a small number of vendors to manufacture and supply raw materials and supply services for its development programs. These programs could be adversely affected by a significant interruption in these services or the availability of raw materials.
Cash and cash equivalents
The Company considers all highly liquid investments with original maturities of three months or less at date of purchase to be cash equivalents. Cash equivalents consisted of money market funds as of March 31, 2024 and 2023, respectively. As of March 31, 2024 and 2023, the amount of cash equivalents included in cash and cash equivalents totaled $ 41.1 million and $ 121.5 million, respectively.
Restricted cash
The Company holds restricted cash in segregated bank accounts in connection with a letter of credit. As of March 31, 2024 and 2023, restricted cash consisted of $ 1.7 million, held for the benefit of the landlords in connection with our leases and for the Company's credit card program in the United Kingdom. These amounts have been classified as non-current assets on the Company’s consolidated balance sheets.
Short-term investments
The Company’s short-term debt security investments are classified as available-for-sale and are carried at fair value, with the unrealized gains and non-credit related losses reported as a component of accumulated other comprehensive income (loss) and included in stockholders’ equity. Realized gains and losses and declines in value determined to be other than temporary are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations.
For available-for-sale debt securities in an unrealized loss position, we first assess whether we intend to sell, or if it is more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through a charge to interest income. For available-for-sale debt securities that do not meet the aforementioned criteria, we evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers such factors as, among other things, the severity of the impairment, any changes in interest rates, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the short-term debt security investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest income through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive loss on the statements of comprehensive loss.
No credit-related losses or impairments have been recognized on the Company's investments in available-for-sale debt securities during the years ended March 31, 2024 or 2023.
The Company’s short-term investments as of March 31, 2024 and 2023 had maturities of less than two years. The Company has classified its investments with maturities beyond one year as short term, based on their highly liquid nature and because they represent the investment of cash that is available for current operations.
Property, plant and equipment
Property, plant and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful lives of the respective assets as follows:
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
Estimated Useful life
Office equipment 5 years
Computer equipment and software 3 years
Plant, manufacturing and laboratory equipment 5 years
Capitalized software
3 to 5 years
Leasehold improvements Lesser of lease term or 10 years
Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred.
Capitalized software as a service costs represent implementation costs incurred during the application development stage and are included in "property, plant and equipment, net" on the Company's consolidated balance sheet. Such costs are amortized on a straight-line basis over the term of the associated arrangement plus any reasonably certain renewal period. Costs incurred during the preliminary project stage and the post-implementation-operation stage are expensed as incurred.
Impairment of long-lived assets
Long-lived assets consist of property, plant and equipment, right-to-use-asset - operating leases, and right-to-use-asset - financing leases. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. To date, the Company has not recorded any impairment losses on long-lived assets.
Fair value measurements
Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
• Level 1 — Quoted prices in active markets for identical assets or liabilities.
• Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
• Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The Company’s short-term investments and cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of research and development incentives receivable, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these assets and liabilities. Furthermore, the carrying value of the Company’s long-term
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
debt approximates its fair value at each balance sheet date due to its variable interest rate, which approximates a market interest rate.
Debt issuance costs
Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is canceled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability.
Segment information
The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Company’s current focus is on developing oncolytic immunotherapies for the treatment of cancer.
Research and development costs
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs and laboratory supplies, depreciation and external costs of outside vendors engaged to conduct preclinical development, clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. Upfront payments for materials and supplies acquired for particular research and development activities that have no alternative future use in other research and development projects or otherwise, and therefore have no separate economic value, are expensed as research and development costs at the time the costs are incurred.
Research contract costs and accruals
The Company has entered into various research and development-related contracts with companies both inside and outside of the United States. These agreements are generally cancellable, and related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. Accrual estimates are based on a number of factors, including management’s assessment of progress towards completion of the research and development activities, invoicing to date under the contracts, communication from the research organization or other companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. When billing terms under these contracts do not coincide with the timing of when the work is performed, management is required to make estimates of outstanding obligations to those third parties as of the end of the reporting period. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Patent costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as selling, general and administrative expenses.
Stock-based compensation
The Company accounts for share-based payment awards granted to employees, consultants, and non-employees and directors using the fair value of the Company’s common stock on the grant date and compensation expense is recognized for those awards over the requisite service period, which is generally the vesting period of the respective award. The grant date fair value is utilized for restricted stock units, or RSUs and performance stock units, or PSUs and is based on the closing price of the Company's common stock on the date of grant. For PSUs, the cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the Company’s expected dividend yield (see Note 10). Forfeitures are accounted for as they occur. To date, the Company has issued stock-based awards with service-based vesting conditions and records the related expense for these awards using the straight-line method. The Company has also issued PSUs with performance-based vesting conditions and records the expense for these awards using the graded vesting method.
The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Research and development incentives and receivable
The Company, through its subsidiary in the United Kingdom, receives reimbursements of certain research and development expenditures as part of a United Kingdom government’s research and development tax reliefs program. Under the program, a percentage of qualifying research and development expenses incurred by the Company’s subsidiary in the United Kingdom are reimbursed up to 14.5 %.
Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive program described above. At each period end, management estimates the reimbursement available to the Company based on available information at the time.
The Company recognizes income from the research and development incentives when the relevant expenditure has been incurred, the associated conditions have been satisfied and there is reasonable assurance that the reimbursement will be received. The Company records these research and development incentives as other income. The research and development incentives receivable represents an amount due in connection with the above program. The Company recorded other income from research and development incentives of $ 1.9 million and $ 2.9 million during the years ended March 31, 2024 and 2023, respectively, in the consolidated statements of operations and a research and development incentives receivable of $ 4.9 million and $ 2.9 million as of March 31, 2024 and 2023, respectively, on the consolidated balance sheets.
Comprehensive loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the year ended March 31, 2024, comprehensive loss included $ 0.8 million of foreign currency translation losses. For the year ended March 31, 2023, comprehensive loss included $ 5.5 million of foreign currency translation gains and $ 1.2 million of unrealized gains on short-term investments, net of tax.
Income taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax provision. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
50 % likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
Net income (loss) per share
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing the diluted net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents.
In periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
Recently Issued Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board issued Accounting Standards Update ("ASU") No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This ASU updates income tax disclosure requirements primarily by requiring specific categories and greater disaggregation within the rate reconciliation and disaggregation of income taxes paid by jurisdiction. This ASU is effective for annual periods beginning after December 15, 2024 and is applicable to the Company’s fiscal year beginning April 1, 2025, with early application permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures". The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the potential impact of this adoption on the consolidated financial statements and related disclosures.
3. Fair value of financial assets and liabilities
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis:
Fair Value Measurements as of March 31, 2024 Using:
Level 1 Level 2 Level 3 Total
Cash equivalents:
Money market funds $ — $ 41,077 $ — $ 41,077
Short-term investments:
US Government Agency bonds — 199,821 — 199,821
US Treasury bonds — 146,390 — 146,390
$ — $ 387,288 $ — $ 387,288
Fair Value Measurements as of March 31, 2023 Using:
Level 1 Level 2 Level 3 Total
Cash equivalents:
Money market funds $ — $ 121,455 $ — $ 121,455
Short-term investments:
US Government Agency bonds — 240,355 — 240,355
US Treasury bonds — 196,441 — 196,441
$ — $ 558,251 $ — $ 558,251
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
3. Fair value of financial assets and liabilities (Continued)
The underlying securities held in the money market funds held by the Company are all government backed securities. During the years ended March 31, 2024 and 2023, there were no transfers between levels.
Valuation of cash equivalents and short-term investments
Money market funds, U.S. Treasury bonds and U.S. Government Agency bonds were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. Cash equivalents consisted of money market funds at March 31, 2024 and March 31, 2023.
4. Short-term investments
As of March 31, 2024 and 2023, the Company's available-for-sale investments by type, consisted of the following:
March 31, 2024
Amortized cost Gross unrealized gains Gross unrealized losses Credit Losses Fair value
US Government agency bonds $ 199,905 $ 33 $ ( 117 ) $ — $ 199,821
US Treasury bonds 146,417 11 ( 38 ) $ — 146,390
$ 346,322 $ 44 $ ( 155 ) $ — $ 346,211
March 31, 2023
Amortized cost Gross unrealized gains Gross unrealized losses Credit Losses Fair value
US Government agency bonds $ 240,371 $ 187 $ ( 203 ) $ — $ 240,355
US Treasury bonds 196,488 77 ( 124 ) — 196,441
$ 436,859 $ 264 $ ( 327 ) $ — $ 436,796
As of March 31, 2024, available-for-sale securities consisted of investments that mature within one year. As of March 31, 2023, available-for-sale securities consisted of investments that mature within one year, with the exception of certain U.S. Government agency bonds and U.S. Treasury bonds which had maturities between one and two years and an aggregate fair value of $ 15.1 million.
5. Property, plant and equipment, net
Property, plant and equipment, net consisted of the following:
March 31,
2024 March 31,
2023
Office equipment $ 1,464 $ 1,240
Computer equipment 1,975 1,806
Plant and laboratory equipment 10,423 9,186
Leasehold improvements 1,886 1,706
Capitalized software
3,515 —
Construction in progress 1,117 783
20,380 14,721
Less: Accumulated depreciation and amortization ( 9,897 ) ( 7,242 )
$ 10,483 $ 7,479
Depreciation and amortization expense was $ 2.7 million and $ 2.4 million for the years ended March 31, 2024 and 2023, respectively, and recorded within research and development and selling, general and administrative expenses in the consolidated statement of operations.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
6. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following:
March 31,
2024 March 31,
2023
Accrued research and development costs $ 16,376 $ 11,261
Accrued compensation and benefits costs 13,906 9,909
Accrued professional fees 369 540
Other 3,330 2,994
$ 33,981 $ 24,704
7. Long-term debt
Hercules Loan Agreement
On October 6, 2022, the Company entered into a Loan and Security Agreement (the “Loan Agreement”), with Hercules Capital, Inc., as administrative agent, collateral agent and as a lender (“Hercules”). Pursuant to the Loan Agreement, the Company can borrow term loans in an aggregate maximum principal amount of up to $ 200.0 million under multiple tranches (the “Term Loan Facility”). Under the Loan Agreement, the Company borrowed an initial amount of $ 30.0 million on the Closing Date, and at the Company's sole option, could have drawn, but did not draw, an additional $ 30.0 million on or prior to September 30, 2023. The Company can also draw as additional term loan advances in an aggregate principal amount of up to $ 115.0 million during the term of the Term Loan Facility subject to achievement of specified performance milestones, and two additional term loan advances up to an aggregate principal amount of $ 25.0 million subject to certain terms and conditions, on or prior to the end of the interest-only period. The Company intends to use the proceeds of the Term Loan Facility for working capital and general corporate purposes.
The Loan Agreement was subsequently amended (the "Amendment") on June 28, 2023 pursuant to which the Company agreed to draw an initial term loan advance in an aggregate principal amount not less than $ 30.0 million, provided that the aggregate amount of the term loan advances made under tranche 1 do not exceed $ 30.0 million, which reflects a decrease of $ 30.0 million from the $ 60.0 million in the original Loan Agreement for tranche 1. The total amount of the Loan Agreement, as well as the outstanding balance of the loan, is unchanged, but the option to borrow additional funds were redistributed from tranche 1 to tranche 2. The impact of this amendment is not a modification, as it does not relate to outstanding debt, but is rather an amendment that provides for a future potential benefit. There was no material impact to the financial statements as a result of the Amendment.
A second amendment was made to the Loan Agreement (the "Second Amendment") on December 22, 2023 pursuant to which the Company agreed to draw a term loan advance in an aggregate principal amount not less than $ 15.0 million, provided that the aggregate amount of the term loan advances made under tranche 2 do not exceed $ 15.0 million on or prior to December 31, 2023. The Second Amendment re-allocated the total future consideration of the Loan Agreement to the future tranches extending through September 2026, subject to the terms and conditions of the Loan Agreement. The Second Amendment did not change the total aggregate maximum principal amount to be drawn under the Loan Agreement, which remains as up to $ 200.0 million. The Company evaluated the Second Amendment as a modification under relevant accounting guidance, and based on that analysis and the immaterial change in cash flows on current outstanding debt, it was determined that there was no material accounting impact. Upon closing of the Second Amendment, the Company drew down the tranche 2 amount of $ 15.0 million.
The Term Loan Facility will mature on October 1, 2027 (the “Maturity Date”). The outstanding principal balance of the Term Loan Facility bears interest payable in cash at a floating rate per annum equal to the greater of (i) 7.25 % and (ii) the sum of the Prime Rate (which is capped at 7.25 %) and 1.75 %. Accrued interest is payable monthly following the funding of each term loan advance. In addition, the principal balance of the Term Loan Facility will bear “payment-in-kind” interest at the rate of 1.50 % (“PIK Interest”), which PIK Interest will be added to the outstanding principal balance of the Term Loan Facility on each interest payment date.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
7. Long-term debt (Continued)
Borrowings under the Loan Agreement are repayable in monthly interest-only payments through September 2026. After the interest-only payment period, borrowings under the Loan Agreement are repayable in equal monthly payments of principal and accrued interest until October 2027. At the Company's option, the Company may prepay all or a portion of the outstanding borrowings, subject to a prepayment fee of 3.0 % of the principal amount if prepayment occurs during the 12 months following the Closing Date, 2.0 % after 12 months following the Closing Date but prior to 36 months following the Closing Date, and 1.0 % thereafter.
The Loan Agreement contains customary facility fees, events of default and representations, warranties and affirmative and negative covenants, including a financial covenant requiring the Company to maintain certain levels of cash in accounts subject to a control agreement in favor of the Agent (the “Unrestricted Cash”) at all times commencing on January 1, 2024. In addition, the Loan Agreement also contains a financial covenant that beginning on the later of (i) July 1, 2024 and (ii) the date on which the aggregate outstanding principal amount of the Term Loan Facility is equal to or greater than $ 100.0 million, the Company is required to satisfy one of the following requirements: (1) achieve a minimum amount of trailing three-month net product revenue tested on a monthly basis, (2) maintain a market capitalization in excess of $ 1.2 billion and Unrestricted Cash in an amount no less than 50 % of the outstanding amount under the Term Loan Facility, or (3) maintain Unrestricted Cash in an amount no less than 85 % of the outstanding amount under the Term Loan Facility.
The Company paid a $ 0.5 million facility charge and incurred debt issuance costs of $ 1.5 million upon closing of the Loan Agreement. The Loan Agreement also provides for a final payment, payable upon maturity or the repayment of the obligations in full or in part (on a pro rata basis), equal to 4.95 % of the aggregate principal amount of Term Loans advanced to the Borrower and repaid on such date, which is being accrued on the Company's consolidated balance sheet. As of March 31, 2024 and 2023, the amount accrued for the final payment was $ 0.5 million and $ 0.2 million, respectively.
Unamortized debt issuance costs are recorded as a reduction of the carrying amount on the term loan and amortized as interest expense using the effective-interest method. In addition, unamortized deferred financing costs of $ 1.2 million and $ 1.4 million were recorded in other assets as of March 31, 2024 and 2023, respectively, related to the Company's right to borrow additional amounts from Hercules in the future and amortized to interest expense over the relevant draw period on a straight-line basis. Interest expense for the twelve months ended March 31, 2024 and 2023 was $ 4.5 million and $ 2.0 million, respectively.
The summary of obligations under the term loan as of March 31, 2024 and 2023 consisted of the following (in thousands):
March 31, 2024 March 31, 2023
Principal loan balance $ 45,749 $ 30,222
Facility charge and diligence fee ( 266 ) ( 315 )
Unamortized issuance costs ( 1,191 ) ( 1,410 )
Accumulated end of term fee 517 151
Long term debt, net $ 44,809 $ 28,648
The annual principal payments by fiscal year due under the Loan Agreement as of March 31, 2024 were as follows:
March 31, 2024
2025 —
2026 —
2027 20,145
Thereafter 27,769
Total $ 47,914
The table of future payments of long-term debt excludes the end of term charge of $ 2.2 million, which is due upon the maturity of the loan.
8. Stockholders’ Equity
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
8. Stockholders’ Equity (Continued)
Common stock
As of March 31, 2024 and 2023, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 150,000,000 shares of common stock, par value $ 0.001 per share.
The Company had reserved for common stock for the exercise of outstanding stock options and the vesting of restricted share units, the number of shares remaining available for grant under the Company’s 2018 Omnibus Incentive Compensation Plan and the Company’s Employee Stock Purchase Plan (see Note 10) and the exercise of the outstanding warrants to purchase shares of common stock as follows:
March 31, 2024 March 31, 2023
Stock options, issued and outstanding 8,652,256 7,454,828
Restricted and performance stock units
2,397,890 1,351,280
Stock options and restricted stock units, future issuance 2,284,141 2,209,597
Employee stock purchase plan, available for future grants 2,738,208 2,076,603
Pre-IPO warrants to purchase common stock 497,344 497,344
Pre-funded warrants 5,281,616 9,484,238
Total shares of common stock reserved for future issuance 21,851,455 23,073,890
Undesignated preferred stock
As of March 31, 2024 and 2023, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $ 0.001 per share. There were no undesignated preferred shares issued or outstanding as of March 31, 2024 and 2023.
ATM program
On August 11, 2020, the Company and SVB Leerink (the "Agent") entered into a sales agreement, which was subsequently amended on October 21, 2020 (as amended, the “2020 Sales Agreement”), pursuant to which the Company could sell, from time to time, at its option, up to an aggregate of $ 62.5 million of shares of the Company’s common stock through the Agent, as the Company’s sales agent.
During the fiscal year ended March 31, 2023, the Company settled transactions that occurred pursuant to the 2020 Sales Agreement, whereby the Company issued and sold an aggregate of 1,686,438 shares of its common stock, resulting in gross proceeds of $ 32.0 million, before deducting fees of $ 1.0 million.
On June 23, 2022, the 2020 Sales Agreement was terminated by the execution by the Company and the Agent of a new sales agreement (the “2022 Sales Agreement”). Under the 2022 Sales Agreement, the Company may sell, from time to time, at its option, up to an aggregate $ 100.0 million of shares of the Company's common stock through the Agent, as the Company's sales agent.
During the year ended March 31, 2023, pursuant to the 2022 Sales Agreement, the Company issued and sold an aggregate of 340,000 shares of its common stock, resulting in gross proceeds of $ 6.7 million, before deducting fees of $ 0.3 million.
On August 3, 2023, the 2022 Sales Agreement was terminated by the execution by the Company and Leerink Partners LLC (formerly known as SVB Securities LLC) (the "Current Agent") of a new sales agreement, which was subsequently amended on May 16, 2024 (as so amended, the "2023 Sales Agreement"). Under the 2023 Sales Agreement, the Company may sell, from time to time, at its option, up to an aggregate of $ 100.0 million of share of the Company's common stock, $ 0.001 par value shares (the "Shares"), through the Current Agent, as the Company's sales agent.
Any Shares to be offered and sold under the 2023 Sales Agreement will be issued and sold (i) by methods deemed to be an “at the market offering” (“ATM”) as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if authorized by the Company, in negotiated transactions or block trades, and (ii) pursuant to a registration statement on Form S-3 filed by the Company with the Securities and Exchange Commission on August 3, 2023, as amended for an offering of various
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
8. Stockholders’ Equity (Continued)
securities, including shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one or more public offerings.
Subject to the terms of the 2023 Sales Agreement, the Current Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Current Agent a commission of up to 3.0 % of the gross proceeds from the sale of the Shares. The Company has also agreed to provide the Current Agent with customary indemnification rights.
During the year ended March 31, 2024, the Company did not issue or sell any shares under the 2023 Sales Agreement. The Company cannot provide any assurances that it will issue any additional Shares pursuant to the 2023 Sales Agreement.
Equity offerings
In December 2022, the Company completed a public offering of (a) 6,810,658 shares of the Company’s common stock, inclusive of the underwriters 30-day option to purchase up to an additional 1,436,172 shares of the Company’s common stock, at a public offering price of $ 23.50 per share and (b) pre-funded warrants to purchase 4,200,000 shares of the Company’s common stock at a public offering price of $ 23.4999 per warrant. The Company received aggregate net proceeds of approximately $ 242.6 million after deducting underwriting discounts, commissions and other offering expenses payable by the Company of approximately $ 16.1 million.
9 . Pre-funded Warrants
Between November 2019 and December 2022, the Company completed public offerings including an option to purchase pre-funded warrants to purchase shares of the Company's common stock. As of March 31, 2024, the total amount of pre-funded warrants issued was 9,484,238 of which 4,202,622 have been exercised and 5,281,616 remained outstanding.
The remaining outstanding pre-funded warrants described above are exercisable at any time after the date of issuance. Unless otherwise modified by a holder of a pre-funded warrant, no holder may exercise a pre-funded warrant if such holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of a pre-funded warrant may increase or decrease this percentage up to 19.99 % by providing at least 61 days’ prior notice to the Company.
The 5,281,616 shares of the Company's common stock underlying the above described pre-funded warrants, are not included in the number of issued and outstanding shares of the Company’s common stock outstanding as reported on the consolidated balance sheet, though they are included in the Company's annual pool increase calculation as well as the weighted average outstanding common stock in the calculation of basic and diluted net loss per share, as noted below in Note 11.
During the year ended March 31, 2024, a holder of the Company's pre-funded warrants exercised 4,202,622 of its pre-funded warrants and the Company issued 4,202,622 shares of common stock in exchange thereof.
10. Stock-based compensation
Stock-based compensation expense
The following table summarizes the classification of stock-based compensation expense in the consolidated statements of operations for the years ended March 31, 2024 and 2023 as follows:
Year ended March 31,
2024 2023
Research and development $ 14,745 $ 10,074
Selling, general and administrative 19,380 18,057
$ 34,125 $ 28,131
The following table summarizes stock-based compensation expense by award type for the years ended March 31, 2024 and 2023 as follows:
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
10. Stock-based compensation (Continued)
Year ended March 31,
2024 2023
Stock options $ 21,594 $ 19,521
Restricted and performance stock units
12,531 8,610
$ 34,125 $ 28,131
2015 Enterprise Management Incentive Share Option Plan
The 2015 Enterprise Management Incentive Share Option Plan of Replimune UK (the “2015 Plan”) provided for Replimune UK to grant incentive stock options, non-statutory stock options, stock awards, stock units, stock appreciation rights and other stock-based awards. Incentive stock options are granted only to the Company’s employees, including officers and directors who are also employees. Non-statutory stock options are granted to employees, members of the board of directors, outside advisors and consultants of the Company.
2017 Equity Compensation Plan
In July 2017, in conjunction with reorganization by Replimune Limited, pursuant to which each shareholder thereof exchanged their outstanding shares in Replimune Limited for shares in Replimune Group, Inc., on a one -for-one basis (the "Reorganization"), the 2015 Plan was terminated, and all awards were cancelled with replacement awards issued under the 2017 Equity Compensation Plan (the “2017 Plan”). Subsequent to the Reorganization, no additional grants have been or will be made under the 2015 Plan and any outstanding awards under the 2015 Plan have continued, and will continue with their original terms. The Company concluded that the cancellation of the 2015 Plan and issuance of replacement awards under the 2017 Plan was a modification with no change in the material rights and preferences and therefore no recorded change in the fair value of each respective award.
The Company’s 2017 Plan provides for the Company to grant incentive stock options or non-statutory stock options, stock awards, stock units, stock appreciation rights and other stock-based awards. Incentive stock options were granted under the 2017 Plan only to the Company’s employees, including officers and directors who were also employees. Restricted stock awards and non-statutory stock options were granted under the 2017 Plan to employees, officers, members of the board of directors, advisors and consultants of the Company. The maximum number of common shares that may be issued under the 2017 Plan was 2,659,885 , of which none remained available for future grants as of March 31, 2024. Shares with respect to which awards have expired, terminated, surrendered or cancelled under the 2017 Plan without having been fully exercised will be available for future awards under the 2018 Plan referenced below. In addition, shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of shares of common stock available for the grant of awards.
2018 Omnibus Incentive Compensation Plan
On July 9, 2018, the Company’s board of directors adopted, and the Company’s stockholders approved the 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s initial public offering. The 2018 Plan provides for the issuance of incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards. The number of shares initially reserved for issuance under the 2018 Plan is 3,617,968 shares. If any options or stock appreciation rights, including outstanding options and stock appreciation rights granted under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or are canceled, forfeited, exchanged, or surrendered without having been exercised, or if any stock awards, stock units or other stock-based awards, including outstanding awards granted under the 2017 Plan, are forfeited, terminated, or otherwise not paid in full in shares of common stock, the shares of the Company’s common stock subject to such grants will be available for purposes of our 2018 Plan. The number of shares reserved for issuance under the 2018 Plan will increase automatically on the first day of each April equal to 4.0 % of the total number of shares of Company stock outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the 5,281,616 shares issuable upon exercise of those pre-funded warrants described in Note 9 to these consolidated financial statements, or such lesser amount as determined by the Board. On April 1, 2023, the number of shares reserved for issuance under the 2018 Plan automatically increased by 2,646,422 shares pursuant to the terms of the 2018 Plan and based on total number of shares of Company stock
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
10. Stock-based compensation (Continued)
outstanding on March 31, 2023. As of March 31, 2024, 2,284,141 shares remained available for future grants under the 2018 Plan.
The 2015 Plan, the 2017 Plan and the 2018 Plan are administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. However, the board of directors shall administer and approve all grants made to non-employee directors. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, except that the exercise price per share of incentive stock options may not be less than 100 % of the fair market value of the common stock on the date of grant (or 110 % of fair value in the case of an award granted to employees who hold more than 10% of the total combined voting power of all classes of stock at the time of grant) and the term of stock options may not be greater than five years for an incentive stock option granted to a 10% stockholder and greater than ten years for all other options granted. Stock options awarded under both plans expire ten years after the grant date, unless the board of directors sets a shorter term. Vesting periods for both plans are determined at the discretion of the board of directors. Incentive stock options granted to employees and non-statutory options granted to employees, officers, members of the board of directors, advisors, and consultants of the Company typically vest over four years . In 2021 the board of directors initiated the award of RSUs, under the 2018 Plan in addition to stock option awards available as part of the Company’s equity incentive for employees, officers, advisors and consultants of the Company. The RSUs typically vest over four approximately equal annual installments with the first such installment occurring on a designated vesting date that is approximately on the one year anniversary date of the date of grant and the subsequent installments occurring on the subsequent three annual anniversaries of the designated vesting date. In 2024 the Board of Directors approved the award of PSUs, under the 2018 Plan in addition to the aforementioned stock option awards and RSUs available as part of the Company’s equity incentive for employees, officers, advisors and consultants of the Company. The PSUs will vest in connection with the timely achievement of a specified corporate milestone, and the expense recognized for these awards is based on the grant date fair value of the Company's common stock multiplied by the number of units granted. The timing of recognition of this stock-based compensation expense is subject to our judgment as to when the performance conditions are considered probable of being achieved. The Company granted 368,980 PSUs under the 2018 Plan during the year ended March 31, 2024.
Employee Stock Purchase Plan
On July 9, 2018, the Company’s board of directors adopted and the Company’s stockholders approved the Employee Stock Purchase Plan (the “ESPP”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s IPO. The total shares of common stock initially reserved for issuance under the ESPP is limited to 348,612 shares. In addition, as of the first trading day of each fiscal year during the term of the ESPP (excluding any extensions), an additional number of shares of the Company’s common stock equal to 1 % of the total number of shares outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the 5,281,616 shares issuable upon exercise of those pre-funded warrants described in Note 9 to these consolidated financial statements, or 697,224 shares, whichever is less (or such lesser amount as determined by the Company’s board of directors) will be added to the number of shares authorized under the ESPP. In accordance with the terms of the ESPP, on April 1, 2023, the number of shares reserved for issuance under the ESPP automatically increased by 661,605 , for a total of 2,738,208 shares reserved for the ESPP. If the total number of shares of common stock to be purchased pursuant to outstanding purchase rights on any particular date exceed the number of shares then available for issuance under the ESPP, then the plan administrator will allocate the available shares pro-rata and refund any excess payroll deductions or other contributions to participants. The Company’s ESPP is not currently active.
Out-of-Plan Inducement Grant
From time to time, the Company grants equity awards to newly hired executives as a material inducement to enter into employment with the Company. The grants constitute "employment inducement grants" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of the other stock incentive plans described above. The inducement grants typically include nonqualified stock options to purchase shares of the Company's common stock, as well as restricted stock unit grants representing shares of the Company's common stock. These stock option and restricted stock unit inducement grants have terms and conditions consistent with those set forth under the 2018 Plan and vest under the same respective vesting schedules as stock option and restricted stock unit awards granted under the 2018 Plan. The inducement grants are included in the stock option and RSU award tables below. During the years ended March 31, 2024 and 2023, the Company granted 125,000 and 82,500 nonqualified stock options to purchase shares of the Company's common stock, respectively, and 83,330 and 55,000 restricted stock units, respectively, under employment inducement grants.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
10. Stock-based compensation (Continued)
Stock option valuation
The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. As the Company has limited company-specific historical and implied volatility information, the expected stock volatility is based on a combination of Replimune volatility and the historical volatility of a publicly traded set of peer companies. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
The following table presents, on a weighted-average basis, the assumptions that the Company used to determine the grant-date fair value of stock options granted to employees and directors:
Year ended March 31,
2024 2023
Risk-free interest rate 3.75 % 2.83 %
Expected term (in years) 6.0 6.0
Expected volatility 74.2 % 75.2 %
Expected dividend yield 0 % 0 %
Stock options
A summary of stock option activity under the Company’s equity incentive plans for the year ended March 31, 2024 is as follows:
Number of Shares Weighted Average Exercise Price Weighted Average Contractual Term (Years) Aggregate Intrinsic Value
Outstanding as of March 31, 2023 7,454,828 $ 17.24 6.88 $ 31,244
Granted 2,394,124 16.90
Exercised ( 164,221 ) 10.71
Cancelled ( 1,032,475 ) 20.05
Outstanding as of March 31, 2024 8,652,256 16.94 6.61 $ 5,748
Options exercisable as of March 31, 2024 5,483,718 $ 15.65 5.40 $ 5,738
Options vested and expected to vest as of March 31, 2024 8,652,256 $ 16.94 6.61 $ 5,748
As of March 31, 2024, there was $ 33.0 million of unrecognized compensation cost related to unvested common stock options, which is expected to be recognized over a weighted average period of 2.5 years.
The weighted average grant-date fair value of stock options granted during the years ended March 31, 2024 and 2023 was $ 11.41 and $ 12.80 , respectively. The aggregate intrinsic value of stock options exercised during the years ended March 31, 2024 and 2023 was $ 1.4 million and $ 2.7 million, respectively.
Restricted and performance stock units
In January 2024, the Board approved a one-time PSU award under the 2018 Plan for all employees at the VP level and below as of January 31, 2024, subject to non-market performance and service conditions. The grants will become vested upon the achievement of the approval of the Company’s first Biologics License Application (“BLA”) for RP1 by the Food and Drug Administration (“FDA”) no later than June 30, 2026. The grant date fair value for the PSUs is determined based on the market price of the Company's common stock on the grant date and is recognized over the requisite service period if and when the achievement of such performance condition is determined to be probable by the Company. The Company reassesses the
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
10. Stock-based compensation (Continued)
probability of achieving the performance condition at each reporting period. As of March 31, 2024, the Company has not recognized any expense related to PSUs.
A summary of the changes in the Company’s RSUs and PSUs during the year ended March 31, 2024 is as follows:
Number of Shares
Weighted Average Grant Date Fair Value
Outstanding as of March 31, 2023 1,351,280 $ 24.38
Granted 1,771,872 15.07
Vested ( 371,949 ) 25.26
Cancelled ( 353,313 ) 20.25
Outstanding as of March 31, 2024 2,397,890 $ 17.97
At March 31, 2024, there was $ 29.9 million of total unrecognized compensation cost related to unvested awards, which will be recognized over a weighted-average period of 2.5 years. Of the $ 29.9 million of total unrecognized compensation cost, performance based awards tied to the achievement of a company milestone account for approximately $ 2.9 million. The performance based awards will vest upon achievement of the performance milestone. The remaining $ 27.0 million in unrecognized compensation cost is related to restricted stock units which vest over time.
11. Net loss per share
The following table sets forth the computation of the Company’s basic and diluted net loss per share attributable to common stockholders (in thousands, except per share amounts):
Year ended March 31,
2024 2023
Numerator:
Net loss $ ( 215,794 ) $ ( 174,284 )
Denominator:
Weighted average common shares outstanding, basic and diluted 66,569,894 58,213,010
Net loss per share, basic and diluted $ ( 3.24 ) $ ( 2.99 )
The 5,281,616 shares of the Company's common stock issuable upon exercise of Pre-Funded Warrants described in Note 9 to these consolidated financial statements are included as outstanding common stock in the calculation of basic and diluted net loss per share.
The Company’s potentially dilutive securities, which include stock options, unvested restricted and performance stock units and warrants to purchase common stock have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
Year ended March 31,
2024 2023
Options to purchase common stock 8,652,256 7,454,828
Unvested restricted and performance stock units
2,397,890 1,351,280
Warrants to purchase common stock 497,344 497,344
12. Significant agreements
Agreement with Bristol-Myers Squibb Company
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
12. Significant agreements (Continued)
In February 2018, the Company entered into an agreement with Bristol-Myers Squibb Company (“BMS”). Pursuant to the agreement, BMS will provide to the Company, at no cost, nivolumab, its anti-PD-1 therapy, for use in the Company’s ongoing clinical trial of RP1. Under the agreement, the Company will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted the Company a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use nivolumab in the clinical trial and agreed to supply nivolumab, at no cost to the Company, for use in the clinical trial. Both parties will own the study data produced in the clinical trial, other than study data related solely to nivolumab, which will belong solely to BMS, or study data related solely to RP1, which will belong solely to us. In January 2020, this agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
Unless earlier terminated, the agreement will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data have been delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the clinical trial protocol or any analysis otherwise agreed upon by the parties. The agreement may be terminated by either party (x) in the event of an uncured material breach by the other party, (y) in the event the other party is insolvent or in bankruptcy proceedings or (z) for safety reasons. Upon termination, the licenses granted to the Company to use BMS’s nivolumab in the clinical trial will terminate.
In April 2019, the Company entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to which BMS will provide to the Company, at no cost, nivolumab for use in the Company’s Phase 1 clinical trial of RP2 in combination with nivolumab.
Agreement with Regeneron Pharmaceuticals, Inc.
In May 2018, the Company entered into a Master Clinical Trial Collaboration and Supply Agreement with Regeneron. Pursuant to the agreement the Company agreed to undertake one or more clinical trials with Regeneron for the administration of the Company's product candidates in combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types. The first of which, agreed in June 2018, is the Company's ongoing clinical trial testing RP1 in combination with cemiplimab versus cemiplimab alone in patients with CSCC. Each clinical trial will be conducted pursuant to an agreed study plan which, among other things, will identify the name of the sponsor and which party will manage the particular study, and include the protocol, the budget and a schedule of clinical obligations.
Pursuant to the terms of the agreement, each party granted the other party a non-exclusive license of their respective intellectual property and agreed to contribute the necessary resources needed to fulfill their respective obligations, in each case, under the terms of agreed study plans. The Company does not expect any further reimbursements from Regeneron related to the initial study plan of June 2018 and the CERPASS trial. The agreement contains representations, warranties, undertakings and indemnities customary for a transaction of this nature. The agreement also contains certain time-based covenants that restrict the Company from entering into a third-party arrangement with respect to the use of its product candidates in combination with an anti-PD-1 therapy and that restrict Regeneron from entering into a third-party arrangement with respect to the use of cemiplimab in combination with an HSV-1 virus, in each case, for the treatment of a tumor type that is the subject of a clinical trial to which the covenants apply. Unless otherwise mutually agreed in a future study plan, these covenants are only applicable to the Company's ongoing Phase 2 clinical trial in CSCC.
The agreement may be terminated by either party if (i) there is no active study plan for which a final study report has not been completed and the parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final study report or (ii) in the event of a material breach
The agreement with Regeneron is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and each party pays its own compound costs and share equally in development costs. The Company accounts for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations. The Company recognizes any amounts received from Regeneron in connection with this agreement as an offset to research and development expense within the consolidated statement of operations.
In July 2022, Regeneron informed the Company that the costs of the study have reached the initial budget for the initial study plan of June 2018 and that Regeneron's reimbursement of CERPASS study costs to the Company have completed in the period ending June 30, 2022 in relation to the initial study budget. As a result of this notice from, and the ongoing
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
12. Significant agreements (Continued)
communications with, Regeneron, the Company has not recorded any cost-sharing reimbursements from Regeneron in prepaid expenses and other current assets in the consolidated balance sheet or as an offset to research and development expense within the consolidated statement of operations since Regeneron informed it that Regeneron’s reimbursement of CERPASS study costs have completed. The Company does not expect any further reimbursements from Regeneron related to the initial study plan of June 2018.
The Company did not record any costs as an offset to research and development expenses during the year ended March 31, 2024 and recorded $ 1.1 million during the year ended March 31, 2023. During the years ended March 31, 2024 and 2023, the Company did not make any payments to Regeneron under the terms of the agreement. During the years ended March 31, 2024 and 2023, the Company received payments under the terms of the agreement from Regeneron of $ 0.0 million and $ 3.1 million, respectively. There were no outstanding receivables from Regeneron associated with this agreement at March 31, 2024 or 2023.
Roche
In December 2022, the Company entered into a Master Clinical Trial Collaboration and Supply Agreement with Roche in relation to the Company's RP2 and RP3 programs in colorectal cancer, or CRC, and hepatocellular carcinoma, or HCC. Under the agreement, the companies intended to collaborate in 30 patient cohort signal finding studies in third-line, or 3L, CRC and in first- and second-line, or 1L and 2L, respectively, HCC. Following the Company's re-prioritization of its product development portfolio in December 2023, the Company has agreed with Roche to terminate the CRC collaboration and pursue the 2L cohort in HCC with RP2 only. Roche has expressed its intent to continue to supply its currently approved drugs, atezolizumab and bevacizumab for the 2L cohort in HCC but is unlikely to share costs following the Company's re-prioritization. The Company is in discussions with Roche about revising these agreements following the Company's changes to its RP2 and RP3 development plans. Under the terms of the initial agreement the Company retained the responsibility of operating the clinical trials as well as retaining all the rights to the development and commercialization of its product candidates. The agreement may be terminated by either party upon sixty days prior written notice to the other party.
The agreement with Roche is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and each party pays its own compound costs and shares equally in development costs in accordance with and up to the amount in the agreed upon first study plan. The Company accounts for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations. The Company recognizes any amounts received from Roche in connection with this agreement as an offset to research and development expense within the consolidated statement of operations.
During the years ended March 31, 2024 and 2023, the Company did not make any payments to Roche under the terms of the agreement. The Company recorded $ 2.7 million and $ 0.9 million as an offset to research and development expenses during the years ended March 31, 2024 and 2023, respectively. During the years ended March 31, 2024 and 2023, the Company received payments under the terms of the agreement from Roche of $ 1.7 million and $ 0.0 million , respectively. As of March 31, 2024 and 2023, the Company recorded $ 1.8 million and $ 0.9 million as receivables from Roche in connection with this agreement, respectively.
Incyte
In July 2023, the Company entered into a Clinical Trial Collaboration and Supply Agreement with Incyte Corporation, or Incyte. Under the agreement, the companies will collaborate in a signal finding study in which Incyte will initiate and sponsor a clinical trial of INCB99280 (oral PD-L1 inhibitor) and RP1 in approximately 40 patients with unresectable, high risk CSCC in the neoadjuvant setting. Under the terms of the agreement, the Company will supply Incyte with RP1 for the study and share costs of the study equally with Incyte. The agreement may be terminated by either party upon (i) a material breach not reasonably cured within thirty days ; (ii) the discontinuation of development of its clinical drug candidate; (iii) the unethical or illegal business practices of the other party; or (iv) if the parties have not agreed on the protocol or budget within ninety days of the effective date of the agreement. In addition, the Company may terminate the agreement upon the inappropriate or unsafe use of the RP1 product candidate. As of March 31, 2024, the Company and Incyte had not yet agreed on the protocol or budget. However, the Company and Incyte continue to discuss a potential protocol and neither party has triggered termination of the agreement in accordance with the termination right described in clause (iv) above. The parties are evaluating potential collaboration efforts pending further CERPASS data readout of RP1 in combination with cemiplimab and additional data for Incyte's product candidate INCB99280. During the year ended March 31, 2024, the Company did not make any payments to, or
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
12. Significant agreements (Continued)
receive any payments from, Inctye under the terms of the agreement. Additionally, no costs were recorded to research and development expenses during the year ended March 31, 2024 related to this agreement.
Amgen
In August 2023 the Company entered into a Settlement Agreement with Amgen and mutually agreed to terminate the Company's challenges to Amgen's patents. In connection with the Settlement Agreement, the Company entered into a License and Covenant Agreement with Amgen in which the Company agreed to pay Amgen low single-digit royalty payments on net sales of its products that, but for the license, could be found to infringe a valid Amgen patent on a country-by-country and product-by-product basis.
13. Commitments and contingencies
Leases
The Company leases real estate assets and equipment, and determination if an arrangement is a lease occurs at inception. For leases with terms greater than 12 months, the Company records a related right-of-use (“ROU”) asset and lease liability at the present value of lease payments over the term. Many leases include fixed rental escalation clauses, renewal options and/or termination options that are factored into the determination of lease payments when appropriate. The Company’s leases do not provide an implicit rate, and thus the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has elected not to record a ROU asset and lease obligation for short-term leases (with terms less than 12 months) or separate non-lease components from associated lease components for its real estate lease assets. As a result, all contract consideration is allocated to the single lease component.
The Company’s leases have remaining lease terms of five years to fifteen years . Some of the Company's leases include one or more options to renew with renewal terms that can extend the lease for additional years, or options to terminate the leases, both at the Company’s discretion. The Company’s lease terms include options to extend or terminate leases when the Company concludes it is reasonably certain that it would exercise those options. Lease expense for minimum lease payments is recognized on a straight-line basis based on the fixed components of a lease arrangement. The Company amortizes this expense over the term of the lease beginning with the date of initial possession, which is the date the Company can enter the leased space and begin to make improvements in preparation for its intended use. Variable lease components represent amounts that are not fixed in nature and are not tied to an index or rate, and are recognized as incurred.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
13. Commitments and contingencies (Continued)
The table below presents the lease-related costs which are included in the consolidated statements of operations for the years ended as of March 31, 2024 and 2023:
Year ended March 31,
2024 2023
Lease cost
Finance lease costs:
Amortization of right-to-use asset $ 2,428 $ 2,428
Interest on lease liabilities 2,163 2,197
Operating lease costs 1,122 1,018
Total lease cost $ 5,713 $ 5,643
The following table summarizes the classification of lease costs in the consolidated statement of operations for the years ended March 31, 2024 and 2023 as follows:
Year ended March 31,
2024 2023
Finance Lease Costs
Research and development $ 2,428 $ 2,071
Selling, general and administrative — 358
Other income, net
2,163 2,197
Operating Lease Costs
Research and development 911 421
Selling, general and administrative 211 596
Total lease cost $ 5,713 $ 5,643
The following table summarizes the maturity of the Company’s lease liabilities on an undiscounted cash flow basis and a reconciliation to the operating and financing lease liabilities recognized on our balance sheet as of March 31, 2024:
March 31, 2024
Operating leases Financing lease Total
2025 $ 1,161 $ 2,718 $ 3,879
2026 1,170 2,799 3,969
2027 1,136 2,883 4,019
2028 1,085 2,969 4,054
2029 1,004 3,058 4,062
Thereafter 923 31,995 32,918
Total lease payments 6,479 46,422 52,901
Less: interest 1,547 20,294 21,841
Total lease liabilities $ 4,932 $ 26,128 $ 31,060
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
13. Commitments and contingencies (Continued)
The following table provides lease disclosure as of and for the year ended March 31, 2024:
March 31, 2024 March 31, 2023
Leases
Right-to-use operating lease asset $ 4,635 $ 5,208
Right-to-use finance lease asset 37,237 39,665
Total lease assets $ 41,872 $ 44,873
Operating lease liabilities, current $ 1,161 $ 1,118
Finance lease liabilities, current 2,718 2,639
Operating lease liabilities, non-current 3,771 4,389
Finance lease liabilities, non-current 23,410 23,965
Total lease liabilities $ 31,060 $ 32,111
Other information
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases $ 1,059 $ 1,014
Operating cash flows from finance leases $ 2,163 $ 2,197
Financing cash flows from finance leases $ 476 $ 365
Right-to-use asset obtained in exchange for new operating lease liabilities
$ — $ 290
Weighted-average remaining lease term – operating leases 5.6 years 6.6 years
Weighted-average remaining lease term – financing leases 15.3 years 16.3 years
Weighted-average discount rate – operating leases 10.3 % 10.3 %
Weighted-average discount rate – financing leases 8.3 % 8.3 %
The variable lease costs and short-term lease costs were insignificant for the years ended March 31, 2024 and 2023, respectively.
Manufacturing commitments
The Company has entered into an agreement with a contract manufacturing organization to provide clinical trial products. As of March 31, 2024 and 2023, the Company had committed to minimum payments under these arrangements totaling $ 0.9 million and $ 1.0 million.
Indemnification agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its executive management team and its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and therefore it has not accrued any liabilities related to such obligations in its consolidated financial statements as of March 31, 2024 or 2023.
Legal proceedings
The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities.
14. Benefit plans
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
The Company established a defined-contribution savings plan under Section 401(k) of the Code (the “401(k) Plan”). The 401(k) Plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Matching contributions to the 401(k) Plan may be made at the discretion of the Company’s board of directors. During the years ended March 31, 2024 and 2023, the Company made contributions totaling $ 2.1 million and $ 1.3 million, respectively, to the 401(k) Plan.
We provide a pension contribution plan for our employees in the United Kingdom, pursuant to which we match our employees’ contributions each year in amounts up to 8 % of their annual base salary.
15. Income taxes
Loss before income taxes for the years ended March 31, 2024 and 2023 were as follows:
Year Ended March 31,
2024 2023
United States $ ( 19,367 ) $ ( 18,367 )
United Kingdom ( 196,019 ) ( 155,629 )
Total $ ( 215,386 ) $ ( 173,996 )
During the year ended March 31, 2024 and 2023, the Company recorded an income tax provision of $ 0.4 million and $ 0.3 million, respectively, related to U.S. current taxes primarily due to the transfer pricing arrangement between the U.S. and the U.K., as well as unfavorable adjustments related to stock compensation, resulting in U.S. taxable income reduced by certain prior year available net operating losses.
Future realization of the tax benefits of existing temporary differences and net operating loss carryforwards ultimately depends on the existence of sufficient taxable income within the carryforward period. As of March 31, 2024 and 2023, the Company performed an evaluation to determine whether a valuation allowance was needed. The Company considered all available evidence, both positive and negative, which included the results of operations for the current and preceding years. It was determined that it was not possible to reasonably quantify future taxable income and determined that it is more likely than not that all of the deferred tax assets will not be realized. Accordingly, a full valuation allowance was maintained as of March 31, 2024 and 2023.
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective tax rate for the years ended March 31, 2024 and 2023 is as follows:
Year Ended March 31,
2024 2023
U.S. federal statutory income tax rate - 21.0 % - 21.0 %
State taxes, net of federal benefit - 0.3 % - 0.6 %
Research and development 0.7 % 1 %
Stock compensation 3.0 % - 0.1 %
Foreign tax rate differential - 3.6 % 1.8 %
Change in tax rates 0.0 % - 6.0 %
Change in valuation allowance 21.4 % 23.6 %
Other 0.0 % 1.5 %
0.2 % 0.2 %
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
15. Income taxes (Continued)
Components of the Company’s deferred tax assets as of March 31, 2024 and 2023 were as follows:
Year Ended March 31,
2024 2023
Deferred tax assets:
Net operating loss carryforwards $ 141,911 $ 93,788
Property, plant and equipment 4,706 4,535
Capitalized start-up costs 1,199 1,301
Stock compensation 13,798 14,757
Accrued expenses 3,221 2,906
Lease liability 7,938 7,964
Other 39 24
Total deferred tax assets 172,812 125,275
Valuation allowance ( 161,890 ) ( 113,889 )
Net deferred tax assets 10,922 11,386
Deferred tax liabilities:
Right of use asset ( 10,922 ) ( 11,386 )
Total deferred tax liabilities ( 10,922 ) ( 11,386 )
Net deferred tax assets (liabilities) $ — $ —
As of March 31, 2024, the Company had U.S. federal operating loss carryforwards of approximately $ 32.0 million, which can be carried forward indefinitely subject to 80% limitation of taxable income when utilized. As of March 31, 2024, the Company had U.S. state operating loss carryforwards of $ 60.1 million, which will begin to expire in 2039. As of March 31, 2024, the Company had U.K. operating loss carryforwards of approximately $ 528.7 million, which can be carried forward indefinitely. Such U.S. federal and state, as well as U.K., net operating loss carryforwards are based on tax returns filed and does not reflect uncertain tax positions in the U.S. and offsetting positions in the U.K. related to the transfer pricing arrangement.
Utilization of the U.S. federal and state net operating loss carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss carryforwards that can be utilized annually to offset future taxable income and tax liabilities, respectively. The Company has not completed a study to assess whether a change of ownership has occurred, or whether there have been multiple ownership changes since its formation, due to the significant cost and complexity associated with such a study. Any limitation may result in expiration of a portion of the net operating loss carryforwards before utilization.
Changes in the valuation allowance for deferred tax assets during the years ended March 31, 2024 and 2023 related primarily to the increase in net operating loss carryforwards were as follows:
Year Ended March 31,
2024 2023
Valuation allowance as of beginning of year $ 113,889 $ 74,892
Increases recorded to income tax provision 45,941 41,063
Increases (decreases) recorded to equity
2,060 ( 2,066 )
Valuation allowance as of end of year $ 161,890 $ 113,889
Changes in the Company's gross unrecognized tax benefits from uncertain tax positions consisted of the following:
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
15. Income taxes (Continued)
Year Ended March 31,
2024 2023
Unrecognized tax benefits as of beginning of year $ 8,757 $ —
(Decreases) increases for tax positions taken during prior years
( 90 ) 8,757
Unrecognized tax benefits as of end of year $ 8,667 $ 8,757
The Company's unrecognized tax benefits primarily relate to the Company's transfer pricing arrangements.
The Company's unrecognized tax benefits, if recognized, would not impact the effective tax rate and income tax provision due to the Company's valuation allowance.
As of March 31, 2024 and 2023, the Company had not accrued interest or penalties related to uncertain income tax positions.
The Company files income tax returns in the U.S., Massachusetts and the U.K. In the normal course of business, the Company is subject to examination by U.S. federal and state as well as U.K. jurisdictions, where applicable. There are currently no pending income tax examinations. The Company is open to future U.S. federal income tax examination from 2020 to the present and in the U.K. from 2022 to the present. Although, carryforward attributes may still be adjusted upon examination if they either have been or will be used in a future period.
As of March 31, 2024 and 2023, income taxes on outside basis differences, primarily related to undistributed earnings, of the Company’s subsidiary have not been provided for as the Company intends to indefinitely reinvest its outside basis differences, and the undistributed earnings were in a cumulative and overall deficit.
16. Geographic information
The Company operates in two geographic regions: the United States (Massachusetts) and the United Kingdom (Oxfordshire). Information about the Company’s long-lived assets held in different geographic regions is presented in the tables below:
March 31, 2024 March 31, 2023
United States $ 8,992 $ 5,836
United Kingdom 1,491 1,643
$ 10,483 $ 7,479
17. Subsequent events
In April 2024, the Company granted an equity award to a newly hired executive as a material inducement to enter into employment with the Company. The grant constitutes an "employment inducement grant" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of the other stock incentive plans described above. The inducement grant included a nonqualified stock option to purchase up to 75,000 shares of the Company's common stock, as well as a restricted stock unit grant representing 50,000 shares of the Company's common stock. These stock option and restricted stock unit inducement grants have terms and conditions consistent with those set forth under the 2018 Plan and vest under the same respective vesting schedules as stock option and restricted stock unit awards granted under the 2018 Plan.
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TABLE OF CONTENTS
Exhibit index
Exhibit Number Exhibit Description Incorporated by Reference
Form Date Number
3.1 Third Amended and Restated Certificate of Incorporation of the Registrant (conformed to include the Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation filed on September 9, 2019).
10-K June 3, 2020 3.1
3.2 Amended and Restated By-laws of the Registrant.
8-K July 24, 2018 3.2
4.1 Form of Common Stock Certificate of the Registrant.
S-1/A July 10, 2018 4.1
4.2 Amended and Restated Investors’ Rights Agreement, dated July 10, 2017, by and among the Registrant and the investors set forth therein.
S-1 June 22, 2018 4.2
4.3* Description of the Registrant’s Securities registered pursuant to Section 12 of the Securities Exchange Act of 1934.
4.4 Form of Pre-Funded Warrant (2019).
8-K November 18, 2019 4.1
4.5 Form of Pre-Funded Warrant (2020).
8-K June 10, 2020 4.1
4.6 Form of Pre-Funded Warrant (2022)
8-K December 12, 2022 4.1
4.7 Form of Indenture to be entered into between the Registrant and a trustee acceptable to the Registrant.
S-3 August 8, 2019 4.4
10.1† Form of Indemnification Agreement by and between the Registrant and its directors and officers.
S-1/A July 10, 2018 10.1
10.2† 2017 Equity Compensation Plan and Sub-Plan for U.K. Employees and forms of agreements thereunder.
S-1/A June 26, 2018 10.2
10.3†* 2018 Omnibus Incentive Compensation Plan and Sub-Plan for U.K. Employees and forms of agreements thereunder.
10-K May 19, 2022 10.3
10.4†* Form of Performance Stock Unit Award Agreement under 2018 Omnibus Incentive Compensation Plan for U. S . Employees.
10.5†*
Form of Performance Stock Unit Award Agreement under 2018 Omnibus Incentive Compensation Plan and Sub-Plan for U.K. Employees.
10.6†*
Form of Inducement Stock Option Grant Agreement.
10.7†*
Form of Inducement Restricted Stock Unit Grant Agreement.
10.8†
Employee Stock Purchase Plan.
S-1/A July 10, 2018 10.4
10.9†
Amended and Restated Employment Agreement, dated as of November 2, 2021, by and between Robert Coffin and Replimune, Inc.
10-Q November 4, 2021 10.2
10.10†
Employment Agreement, effective as of November 1, 2015, by and between Pamela Esposito and Replimune, Inc.
S-1 June 22, 2018 10.7
10.11†
Employment Agreement, dated as of September 16, 2015, by and between Colin Love and Replimune Limited.
S-1/A July 10, 2018 10.9
10.12†
Employment Agreement, dated as of November 27, 2019, by and between Jean Franchi and Replimune, Inc.
8-K December 9, 2019 10.1
10.13†*
Employment Agreement, dated as of May 10, 2021, by and between Tanya Lewis and Replimune, Inc.
10-K May 20, 2021 10.12
10.14†
Separation Agreement and Release, dated as of December 23, 2019, by and between Howard Kaufman and Replimune, Inc.
10-Q February 13, 2020 10.2
10.15†
Separation Agreement and Release, dated as of April 3, 2020, by and between Stephen Gorgol and Replimune, Inc.
10-K June 3, 2020 10.13
TABLE OF CONTENTS
Exhibit Number Exhibit Description Incorporated by Reference
Form Date Number
10.16
Lease, dated as of April 1, 2016, by and between Cummings Properties, LLC and the Registrant.
S-1 June 22, 2018 10.8
10.17
Lease, dated as of April 4, 2016, by and between MEPC Milton Park No. 1 Limited and MEPC Milton Park No. 2 Limited, and Replimune Limited.
S-1 June 22, 2018 10.9
10.18
Deed of Variation, dated June 29, 2020, by and among MEPC Milton Park No. 1 Limited and MEPC Milton Park No. 2 Limited, and Replimune Limited.
10-Q August 7, 2020 10.3
10.19‡
Clinical Trial Collaboration and Supply Agreement, dated as of February 26, 2018, by and between Bristol-Myers Squibb Company and the Registrant.
S-1/A July 10, 2018 10.12
10.20‡
Master Clinical Trial Collaboration and Supply Agreement, dated as of May 29, 2018, by and between Regeneron Pharmaceuticals, Inc. and the Registrant.
S-1/A July 17, 2018 10.13
10.21
Indenture of Lease, dated as of June 22, 2018, by and between CRP/King 33 NY Ave. Owner, L.L.C. and the Registrant.
S-1 June 22, 2018 10.12
10.22
Lease, dated as of June 7, 2019, by and between ND/CR Unicorn LLC and the Registrant.
8-K June 13, 2019 10.1
10.23 Payoff Letter to Loan and Security Agreement by and among the Registrant, Replimune, Inc., Replimune Limited and Hercules Capital, Inc., dated December 15, 2020.
10-Q February 4, 2021 10.1
10.24
Clinical Trial Collaboration and Supply Agreement (RP-2), dated as of April 12, 2019, by and between Bristol-Myers Squibb Company and Replimune, Inc.
10-K June 3, 2020 10.22
10.25
Lease Agreement, dated as of October 29, 2021, by and among Replimune Limited, MEPC Milton Park No. 1 Limited, and MEPC Milton Park No. 2 Limited.
10-Q February 3, 2022 10.3
10.26*
Lease Agreement, dated as of March 23, 2023, by and among Replimune Limited, MEPC Milton Park No. 1 Limited, and MEPC Milton Park No. 2 Limited.
10-K
May 18, 2023 10.34
10.27†*
Separation Agreement and Release, dated as of August 25, 2021, by and between Andrea Pirzkall and Replimune, Inc., as amended.
10-K May 19, 2022 10.27
10.28
S econd Amendment to Loan and Security Agreement, dated as of December 22, 2023, by and among Replimune Group Inc ., Replimune, Inc., Replimune L imited and Hercules
10-Q February 8, 2024 10.1
10.29†
Employment Agreement, dated as of December 1, 2022, by and between Konstantinos Xynos and Replimune, Inc.
10-Q February 9, 2023 10.2
10.30† Amendment to Amended and Restated Employment Agreement, dated as of December 30, 2022, by and between Sushil Patel and Replimune, Inc.
10-Q February 9, 2023 10.3
10.31† Employment Agreement, dated as of December 30, 2022, by and between Christopher Sarchi and Replimune, Inc.
10-Q February 9, 2023 10.4
10.32†*
E mployment Agreement, dated as of August 31, 2023, by and between Emily Hill and Replim une, Inc.
10-Q November 7, 2023 10.1
10.33†*
Second Amended and Restated Employment Agreement, dated as of March 25, 2024, by and between Replimune, Inc. and Sushil Patel.
10.34†*
Second Amended and Restated Employment Agreement, dated as of March 25, 2024, by and between Replimune, Inc. and Philip Astley-Sparke.
10.35†*
Separation and Transition Agreement, dated as of March 25, 2024, by and between Robert Coffin and Replimune, Inc.
TABLE OF CONTENTS
Exhibit Number Exhibit Description Incorporated by Reference
Form Date Number
10.36†*
Consulting Agreement, dated as of March 25, 2024, by and between Robert Coffin and Replimune, Inc.
10.37†
Separation Agreement and Release, dated as of May 18, 2023 by and between Jean Franchi and Replimune, Inc.
10-Q
August 3, 2023 10.2
10.38†
Consulting Agreement, dated as of May 18, 2023 by and between Jean Franchi and Replimune, Inc.
10-Q
August 3, 2023 10.3
10.39†*
Separation Agreement and Release, dated as of March 26, 2024, by and between Pamela Esposito and Replimune, Inc.
10.40†*
Consulting Agreement, dated as of March 26, 2024, by and between Pamela Esposito and Replimune, Inc.
10.41†*
Separation Agreement and Release, dated as of March 31, 2024, by and between Tanya Lewis and Replimune, Inc.
10.42†*
Consulting Agreement, dated as of March 31, 2024, by and between Tanya Lewis and Replimune, Inc.
10.43*
Replimune Group, Inc. Clawback Policy
21.1* Subsidiaries of the Registrant.
23.1* Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
31.1* Certification of the Chief Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
31.2* Certification of the Chief Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
32.1** Certification of the Chief Executive Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
32.2** Certification of the Chief Financial Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
101.INS* Inline XBRL Instance Document.
101.SCH* Inline XBRL Taxonomy Extension Schema Document.
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document.
___________________
* Filed herewith.
** Furnished and not filed herewith.
† Indicates management contract or compensatory plan.
‡ Indicates confidential treatment has been requested with respect to specific portions of this exhibit. Omitted portions have been filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
TABLE OF CONTENTS
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
REPLIMUNE GROUP, INC.
Date: May 16, 2024 By: /s/ SUSHIL PATEL
Sushil Patel
Chief Executive Officer and Director
Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
Name Title Date
/s/ SUSHIL PATEL
Chief Executive Officer and Director
(Principal Executive Officer)
May 16, 2024
Sushil Patel
/s/ EMILY HILL
Chief Financial Officer, (Principal Financial Officer)
May 16, 2024
Emily Hill
/s/ ANDREW SCHWENDENMAN Chief Accounting Officer,
(Principal Accounting Officer) May 16, 2024
Andrew Schwendenman
/s/ PHILIP ASTLEY-SPARKE
Director
May 16, 2024
Philip Astley-Sparke
/s/ ROBERT COFFIN
Director
May 16, 2024
Robert Coffin
/s/ KAPIL DHINGRA Director May 16, 2024
Kapil Dhingra
/s/ HYAM LEVITSKY Director May 16, 2024
Hyam Levitsky
/s/ CHRISTY OLIGER Director May 16, 2024
Christy Oliger
/s/ PAOLO PUCCI Director May 16, 2024
Paolo Pucci
/s/ JOSEPH SLATTERY Director May 16, 2024
Joseph Slattery
/s/ VELEKA PEEPLES-DYER
Director May 16, 2024
Veleka Peeples-Dyer
/s/ DIETER WEINAND
Director May 16, 2024
Dieter Weinand