UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
OR
For the transition period from to
Commission file number
(State or other jurisdiction of incorporation or | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip code)
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | ||||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ⌧
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ⌧
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12-b2 of the Exchange Act.
Accelerated filer ◻ | |
Non-accelerated filer ◻ | Smaller reporting company |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
Shares of common stock, par value $.01 per share:
IMMUNOGEN, INC.
FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2023
TABLE OF CONTENTS
Item |
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| Page Number | ||
Financial Information | |||||
2 | |||||
Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022 | 2 | ||||
3 | |||||
4 | |||||
Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022 | 5 | ||||
6 | |||||
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 20 | ||||
27 | |||||
27 | |||||
Part II | |||||
Other Information | |||||
28 | |||||
28 | |||||
30 | |||||
31 |
Forward-looking statements
This Form 10-Q includes forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, these forward-looking statements relate to analyses and other information that are based on beliefs, expectations, assumptions, and forecasts of future results and estimates of amounts that are not yet determinable. These statements also relate to our prospects, future clinical, regulatory, and other developments and data releases, commercialization efforts, product candidates, and business strategies.
These forward-looking statements are identified by their use of terms and phrases, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms and phrases, including references to assumptions. These statements are contained in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections, as well as the notes to our financial statements and other sections of this report.
We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and investors should not place undue reliance on our forward-looking statements. Additionally, these forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from those contemplated by our forward-looking statements. These known and unknown risks, uncertainties, and other factors are described in detail in the “Risk Factors” section and in other sections of this report and our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC) on March 1, 2023, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, and as updated and/or supplemented in subsequent filings with the SEC. The forward-looking statements contained herein represent our views as of the date of this Form 10-Q. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
1
ITEM 1. Financial Statements
IMMUNOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
In thousands, except per share amounts
| June 30, |
| December 31, | |||
2023 | 2022 | |||||
ASSETS | ||||||
Cash and cash equivalents | $ | | $ | | ||
Accounts receivable |
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Unbilled receivable |
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Non-cash royalty receivable | | | ||||
Inventory | | — | ||||
Prepaid and other current assets |
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Total current assets |
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Property and equipment, net of accumulated depreciation |
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Operating lease right-of-use assets | | | ||||
Inventory, net of current portion | | | ||||
Other assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||
Accounts payable | $ | | $ | | ||
Accrued compensation |
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Other accrued liabilities |
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Current portion of liability related to the sale of future royalties, net of deferred financing costs of $ | | | ||||
Current portion of operating lease liability | | | ||||
Current portion of deferred revenue |
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Total current liabilities |
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Senior secured term loan, net | | — | ||||
Deferred revenue, net of current portion |
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Operating lease liability, net of current portion | | | ||||
Liability related to the sale of future royalties, net of current portion and deferred financing costs of $ | | | ||||
Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies (Note K) | ||||||
Shareholders’ equity: | ||||||
Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
| ( |
| ( | ||
Total shareholders’ equity |
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Total liabilities and shareholders’ equity | $ | | $ | |
The accompanying notes are an integral part of the consolidated financial statements.
2
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
In thousands, except per share amounts
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | ||||||
Revenues: | |||||||||||||
Product revenue, net | $ | | $ | — | $ | | $ | — | |||||
License and milestone fees | | | | | |||||||||
Non-cash royalty revenue related to the sale of future royalties | | | | | |||||||||
Research and development support |
| — |
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Total revenues |
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Cost and operating expenses: | |||||||||||||
Cost of sales | | — | | — | |||||||||
Research and development |
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Selling, general and administrative |
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Total cost and operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
| ( | |||||
Interest income |
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Interest expense on term loan | ( | — | ( |
| — | ||||||||
Non-cash interest expense on liability related to the sale of future royalties and term loan | ( | ( | ( | ( | |||||||||
Other (expense) income, net |
| ( |
| ( |
| |
| ( | |||||
Net loss before income taxes | ( | ( | ( | ( | |||||||||
Income tax expense | | — | | — | |||||||||
Net loss | ( | ( | ( | ( | |||||||||
Basic and diluted net loss per common share | $ | ( | $ | ( | ( | ( | |||||||
Basic and diluted weighted-average common shares outstanding |
| |
| |
| |
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The accompanying notes are an integral part of the consolidated financial statements.
3
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(UNAUDITED)
In thousands
Series A Convertible | Additional | Total | |||||||||||||||||
Preferred Stock | Common Stock | Paid-In | Accumulated | Shareholders’ | |||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Equity | |||||||||||||
Balance at December 31, 2021 | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | — | — | | | | — | | ||||||||||||
Issuance of common stock, net of issuance costs | — | — | — | — | — | — | — | ||||||||||||
Restricted stock units vested | — | — | | — | — | — | — | ||||||||||||
Stock option and restricted stock compensation expense | — | — | — | — | | — | | ||||||||||||
Directors’ deferred share unit compensation | — | — | — | — | | — | | ||||||||||||
Balance at March 31, 2022 | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | — | — | | | | — | | ||||||||||||
Stock option and restricted stock compensation expense | — | — | — | — | | — | | ||||||||||||
Directors’ deferred share unit compensation | — | — | — | — | | — | | ||||||||||||
Balance at June 30, 2022 | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | — | — | | | | — | | ||||||||||||
Stock option and restricted stock compensation expense | — | — | — | — | | — | | ||||||||||||
Directors’ deferred share unit compensation | — | — | — | — | | — | | ||||||||||||
Balance at September 30, 2022 | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock, net of issuance costs | — | — | | | | — | | ||||||||||||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | — | — | | | | — | | ||||||||||||
Stock option and restricted stock compensation expense | — | — | — | — | | — | | ||||||||||||
Restricted stock units vested | — | — | | — | — | — | — | ||||||||||||
Directors’ deferred share unit compensation | — | — | — | — | | — | | ||||||||||||
Balance at December 31, 2022 | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | — | — | | | | — | | ||||||||||||
Stock option and restricted stock compensation expense | — | — | — | — | | — | | ||||||||||||
Directors’ deferred share unit and common stock compensation | — | — | | | — | | |||||||||||||
Balance at March 31, 2023 | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Issuance of common stock, net of issuance costs | — | — | | | | — | | ||||||||||||
Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan | — | — | | | | — | | ||||||||||||
Issuance of common stock pursuant to pre-funded warrant exchange | — | — | | — | — | — | — | ||||||||||||
Issuance of Series A Preferred Stock in exchange for common stock | — | ( | ( | | — | — | |||||||||||||
Stock option and restricted stock compensation expense | — | — | — | — | | — | | ||||||||||||
Directors’ deferred share unit and common stock compensation | — | — | | — | | — | | ||||||||||||
Balance at June 30, 2023 | | $ | — | | $ | | $ | | $ | ( | $ | |
The accompanying notes are an integral part of the consolidated financial statements.
4
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
In thousands
Six Months Ended | ||||||
June 30, | ||||||
| 2023 |
| 2022 | |||
Cash flows from operating activities: | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used for operating activities: | ||||||
Non-cash royalty revenue related to sale of future royalties | ( | ( | ||||
Non-cash interest expense on liability related to sale of future royalties | | | ||||
Non-cash interest expense on amortization of debt discount and issuance costs | | — | ||||
Depreciation and amortization |
| |
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Stock and deferred share unit compensation |
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Change in operating assets and liabilities: | ||||||
Accounts receivable |
| ( |
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Unbilled receivable |
| ( |
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Inventory |
| ( |
| — | ||
Contract asset | — |
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Prepaid and other current assets |
| ( |
| ( | ||
Operating lease right-of-use assets | | | ||||
Other assets |
| ( |
| ( | ||
Accounts payable |
| ( |
| ( | ||
Accrued compensation |
| ( |
| ( | ||
Other accrued liabilities |
| ( |
| | ||
Deferred revenue |
| ( |
| ( | ||
Operating lease liability | ( | ( | ||||
Net cash used for operating activities |
| ( |
| ( | ||
Cash flows from investing activities: | ||||||
Purchases of property and equipment | ( | ( | ||||
Net cash used for investing activities |
| ( |
| ( | ||
Cash flows from financing activities: | ||||||
Proceeds from issuance of common stock under stock plans |
| |
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Proceeds from term loan, net of $ | | — | ||||
Proceeds from common stock issuance, net of $ | | — | ||||
Net cash provided by financing activities |
| |
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Net change in cash and cash equivalents |
| |
| ( | ||
Cash and cash equivalents, beginning of period |
| | | |||
Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental cash flow information: | ||||||
Cash paid during the year for interest | $ | | $ | — | ||
Cash paid during the year for taxes | $ | | $ | — |
The accompanying notes are an integral part of the consolidated financial statements.
5
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2023
A. | Nature of Business and Plan of Operations |
ImmunoGen, Inc. (the Company) was incorporated in Massachusetts in 1981 and is focused on the development and commercialization of antibody-drug conjugates (ADCs). On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. ELAHERE was approved under the FDA's accelerated approval program based on objective response rate (ORR), duration of response (DOR), and safety data from the pivotal SORAYA trial. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The Company has generally incurred operating losses and negative cash flows from operations since inception, incurred a net loss of $
At June 30, 2023, the Company had $
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, the development by its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, manufacturing and marketing limitations, challenges entering into new collaborations, complexities associated with managing collaboration arrangements, third-party reimbursements, and compliance with governmental regulations.
B. | Basis of Presentation and Significant Accounting Policies |
Basis of Presentation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated. The consolidated financial statements include all of the adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the Company’s financial position in accordance with accounting principles generally accepted in the U.S. for interim financial information. The December 31, 2022 consolidated balance sheet presented for comparative purposes was derived from the Company’s audited financial statements, and certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported periods. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in
6
conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023.
Significant Accounting Policies
There were no changes to significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2023 from those discussed in Note B to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
Revenue Recognition
Transaction Price Allocated to Future Performance Obligations
Deferred revenue under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC), Revenue from Contracts with Customers (ASC 606), represents the portion of the transaction price received under various contracts attributed to performance obligations that have not been satisfied (or have been partially satisfied) and includes the portion of the transaction price for certain arrangements attributed to unexercised contract options that are considered material rights. As of June 30, 2023, the aggregate amount of the transaction price allocated to remaining performance obligations comprising deferred revenue was $
Contract Balances from Contracts with Customers
The following tables present changes in the Company’s contract assets and contract liabilities during the six months ended June 30, 2023 and 2022 (in thousands):
Balance at | Balance at | ||||||||||||||
December 31, 2022 |
| Additions | Deductions | Impact of Netting | June 30, 2023 | ||||||||||
Contract liabilities (deferred revenue) | $ | | $ | — | $ | ( | $ | — | $ | |
Balance at | Balance at | ||||||||||||||
December 31, 2021 | Additions | Deductions | Impact of Netting | June 30, 2022 | |||||||||||
Contract asset | $ | | $ | | $ | ( | $ | — | $ | — | |||||
Contract liabilities (deferred revenue) | $ | | $ | | $ | ( | $ | — | $ | |
The Company recognized the following revenues as a result of changes in contract asset and contract liability balances in the respective periods (in thousands):
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
Revenue recognized in the period from: | ||||||||||||
Amounts included in contract liabilities at the beginning of the period | $ | | $ | | $ | | $ | |
The timing of revenue recognition, billings, and cash collections results in billed receivables, unbilled receivables, contract assets, and contract liabilities on the consolidated balance sheets. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded (under the caption deferred revenue). Contract liabilities are recognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met.
7
During the six months ended June 30, 2023, the Company received an upfront payment of $
During the six months ended June 30, 2022, pursuant to the Company’s license agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong), upon delivery of clinical materials in the six months ended June 30, 2022, the Company recognized as license and milestone fee revenue the remaining $
Financial Instruments and Concentration of Credit Risk
Cash and cash equivalents are primarily maintained with
Cash and Cash Equivalents
The Company considers all highly liquid financial instruments with maturities of three months or less when purchased to be cash equivalents. As of June 30, 2023 and December 31, 2022, the Company held $
Non-cash Investing and Financing Activities
The Company had $
Fair Value of Financial Instruments
Fair value is defined under ASC 820, Fair Value Measurements and Disclosures, 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. The standard describes a hierarchy to measure fair value, which is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:
● | Level 1 - Quoted prices in active markets for identical assets or liabilities. |
● | Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
● | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
8
As of June 30, 2023 and December 31, 2022, the Company held certain assets that are required to be measured at fair value on a recurring basis. The fair value of the Company’s cash equivalents is based on quoted prices from active markets (Level 1 inputs). The carrying amounts reflected in the consolidated balance sheets for accounts receivable, unbilled receivables, non-cash royalty receivable, prepaid and other current assets, accounts payable, accrued compensation, and other accrued liabilities approximate fair value due to their short-term nature.
As of June 30, 2023, the estimated fair value and gross carrying amount of the term loan was $
Accounts Receivable
Accounts receivable arise from product sales and amounts due from the Company’s collaboration partners. The amount from product sales represents amounts due from specialty distributors and specialty pharmacy providers in the U.S. The Company monitors economic conditions and the financial performance and credit worthiness of its counterparties to identify facts or circumstances that may indicate that its receivables are at risk of collection. The Company provides reserves against accounts receivable for estimated losses that may result from a customer’s inability to pay based on the composition of its accounts receivable, considering past events, current economic conditions, and reasonable and supportable forecasts about the future economic conditions. The contractual life of accounts receivable is generally short-term. Amounts determined to be uncollectible are charged or written off against the reserve. For the three and six months ended June 30, 2023 and 2022, the Company did not record any expected credit losses related to outstanding accounts receivable.
Inventory
Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. The Company classifies its inventory costs as long-term when it expects to utilize the inventory beyond its normal operating cycle based on forecasted levels of sales.
Prior to the regulatory approval of its drug candidates, the Company incurs expenses for the manufacture of drug product to support clinical development that could potentially be available to support the commercial launch of those drugs. Until the date at which regulatory approval has been received or is otherwise considered probable, the Company records all such costs as research and development expenses.
The Company performs an assessment of the recoverability of capitalized inventories during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of sales in the consolidated statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. There were
Debt issuance costs and debt discount
Debt issuance costs and debt discounts are presented on the accompanying consolidated balance sheets as a direct reduction from the carrying value of the debt and are amortized to interest expense over the term of the related debt using the effective interest method. See Note G, “Senior Secured Term Loan” for further discussion related to long-term debt.
Computation of Net Loss per Common Share
Basic and diluted net loss per share is calculated based upon the weighted average number of shares of common stock outstanding during the period. Shares of the Company’s common stock, par value $
9
securities are allocated a proportional share of income determined by dividing total weighted-average participating securities by the sum of the total weighted average common shares and participating securities (the two-class method). During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. Diluted loss per share is computed after giving consideration to the dilutive effect of stock options and restricted stock units that are outstanding during the period, except where such non-participating securities would be antidilutive. Diluted net loss per common share is calculated by increasing the denominator by the weighted-average number of additional shares that could have been outstanding from securities convertible into common stock, such as stock options and restricted stock units (using the “treasury stock” method), and Series A Convertible Preferred Stock (using the “if-converted” method), unless their effect on net loss per share is antidilutive. The effect of computing diluted net loss per common share was antidilutive for any potentially issuable shares of common stock from the conversion of stock options, restricted stock units, and Series A Convertible Preferred Stock and, as such, have been excluded from the calculation.
The Company’s common stock equivalents, as calculated in accordance with the treasury-stock method for options and unvested restricted stock units and the if-converted method for the Series A Convertible Preferred Stock, are shown in the following table (in thousands):
Three Months Ended | Six Months Ended | |||||||
June 30, | June 30, | |||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | |
Options outstanding to purchase common stock, shares issuable under the employee stock purchase plan, and unvested restricted stock units at end of period | ||||||||
Common stock equivalents under treasury stock method for options, shares issuable under the employee stock purchase plan, and unvested restricted stock units |
| |||||||
Common stock equivalents under if-converted method for Series A Convertible Preferred Stock | — | — |
Stock-Based Compensation
As of June 30, 2023, the Company was authorized to grant future awards under
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The stock-based awards are accounted for under ASC 718, Compensation—Stock Compensation (ASC 718). Pursuant to ASC 718, the estimated grant date fair value of awards is charged to the statement of operations over the requisite service period, which is the vesting period. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model with the weighted-average assumptions noted in the following table. As the Company has not paid dividends since inception, nor does it expect to pay any dividends for the foreseeable future, the expected dividend yield assumption is
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | ||||
Dividend | ||||||||
Volatility | ||||||||
Risk-free interest rate | ||||||||
Expected life (years) |
Using the Black-Scholes option-pricing model, the weighted-average grant date fair values of options granted during the three months ended June 30, 2023 and 2022 were $
A summary of option activity under the Company’s equity plans for the six months ended June 30, 2023 is presented below (in thousands, except weighted-average data):
|
| Weighted- | |||
Number | Average | ||||
of Stock | Exercise | ||||
Options | Price | ||||
Outstanding at December 31, 2022 | $ | ||||
Granted | |||||
Exercised | ( | ||||
Forfeited/Canceled | ( | | |||
Outstanding at June 30, 2023 | $ |
In 2020, the Company issued
A summary of restricted stock unit activity under the Company’s equity plans for the six months ended June 30, 2023 is presented below (in thousands, except weighted-average data):
Number of | Weighted- | ||||
Restricted | Average Grant | ||||
Stock Shares | Date Fair Value | ||||
Unvested at December 31, 2022 | $ | ||||
Granted | |||||
Forfeited | ( | ||||
Unvested at June 30, 2023 | $ |
In June 2018, the Company's Board of Directors, with shareholder approval, adopted the Employee Stock Purchase Plan (ESPP). Following the automatic share increase on January 1, 2021, pursuant to the ESPP’s “evergreen” provision, an aggregate of
11
purchase periods are six months and begin on January 1 and July 1 of each year, with purchase dates occurring on the final business day of the given purchase period. The fair value of each ESPP award is estimated on the first day of the offering period using the Black-Scholes option-pricing model. The Company recognizes share-based compensation expense equal to the fair value of the ESPP awards on a straight-line basis over the offering period.
Stock compensation expense related to stock options and restricted stock unit awards granted under the stock plans and the ESPP was $
Segment Information
During all periods presented, the Company continued to operate in
During the three months ended June 30, 2023,
Recently Adopted Accounting Pronouncements
There were no recently issued or effective FASB Accounting Standards Updates (ASUs) that had, or are expected to have, a material effect on the Company's results of operations, financial condition, or liquidity.
C.Collaboration and License Agreements
The Company has numerous collaboration and license agreements with third parties. These agreements typically provide the licensee with rights to use the Company’s ADC platform technology with the licensee’s antibodies or related targeting vehicles to a defined target to develop products. The licensee is generally responsible for the development, clinical testing, manufacturing, registration, and commercialization of any resulting product candidate. As part of these agreements, the Company is generally entitled to receive upfront fees, potential milestone payments, royalties on the sales of any resulting products, and research and development funding based on activities performed at our collaborative partner’s request. See below for details regarding the Company’s collaboration and license agreements with activity in the financial statement periods presented.
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Vertex
In February 2023, the Company entered into a multi-target license and option agreement with Vertex, pursuant to which the Company granted Vertex rights to the Company’s ADC technology to research and evaluate ADCs directed to specified targets, with an option to obtain worldwide exclusive development and commercialization licenses to a specified number of targets (each, an Option and, collectively, the Options) before the end of the research term. Under the terms of the agreement, the Company received a non-refundable upfront payment of $
The Company evaluated the agreement and determined it was within the scope of ASC 606. The Company determined the promised goods and services included a license to use the Company’s intellectual property and know-how to research, manufacture, and evaluate products related to each of the initial research targets selected by Vertex during the research term. The Company determined that the agreement has a single performance obligation for these promised goods and services.
The Options to obtain exclusive development and commercialization licenses and the right to select additional research targets during the research term do not represent a material right as the fees associated with each option are at or above the standalone selling price. Accordingly, upon exercise, these Options will be accounted for as a separate arrangement.
The transaction price related to the single performance obligation was determined to consist of the upfront payment of $
Lilly
In February 2022, the Company entered into a license agreement with Lilly, pursuant to which the Company granted Lilly worldwide exclusive rights to research, develop, and commercialize antibody-drug conjugates based on the Company’s novel camptothecin technology. Under the terms of the license agreement, the Company received a non-refundable upfront payment of $
The transfer of intellectual property and know-how to Lilly to allow for Lilly to derive benefit from the initial and additional target licenses was completed during the three months ended March 31, 2022. As such, during 2022 the Company recognized $
Huadong
In October 2020, the Company entered into a collaboration and license agreement with Huadong. The collaboration and license agreement grants Huadong an exclusive, royalty-bearing, and sublicensable right to develop and
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commercialize ELAHERE (the Licensed Product) in the People’s Republic of China, Hong Kong, Macau, and Taiwan (collectively, Greater China). The Company retains exclusive rights to the Licensed Product outside of Greater China. Under the terms of the collaboration and license agreement, the Company received a non-refundable upfront payment of $
The Company determined that revenue related to the agreement would be recognized as the clinical supply of the Licensed Product is delivered to Huadong, estimated to be completed over approximately
Roche
In 2000, the Company granted Genentech, now a unit of Roche, an exclusive development and commercialization license to use the Company’s maytansinoid ADC technology. Pursuant to this agreement, Roche developed and received marketing approval for its HER2-targeting ADC, KADCYLA, in the U.S., Japan, the European Union, and numerous other countries. In accordance with the Company’s revenue recognition policy, $
For additional information related to these agreements, as well as the Company’s other collaboration and license agreements, please read Note C, “Collaboration and License Agreements,” to the audited financial statements included within the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023.
D.Product Revenue Reserves and Allowances
In November 2022, the FDA granted accelerated approval for ELAHERE for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The Company recorded net product revenue of $
The following table summarizes activity in each of the product revenue reserve and allowance categories as of June 30, 2023 and 2022, respectively. (in thousands):
June 30, | June 30, | |||||
| 2023 |
| 2022 | |||
Beginning balance at January 1 | $ | | $ | — | ||
Provision related to sales in the current period | | — | ||||
Credits and payments made | ( | — | ||||
Ending balance at June 30 | $ | | $ | — |
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E.Inventory
Capitalized inventory consists of the following at June 30, 2023 and December 31, 2022 (in thousands):
June 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Raw materials | $ | | $ | | ||
Work in process | | — | ||||
Finished goods | | | ||||
Total inventory | $ | | $ | |
F. | Liability Related to Sale of Future Royalties |
In 2015, Immunity Royalty Holdings, L.P. (IRH) purchased the right to receive
In January 2019, the Company sold its residual rights to receive royalty payments on commercial sales of KADCYLA to OMERS for a payment of $
The following table shows the activity within the liability account during the six-month period ended June 30, 2023 (in thousands):
Six Months Ended | |||
| June 30, 2023 | ||
Liability related to sale of future royalties, net — beginning balance | $ | | |
Proceeds from sale of future royalties, net |
| — | |
KADCYLA royalty payments received and paid |
| ( | |
Non-cash interest expense recognized | | ||
Liability related to sale of future royalties, net — ending balance | $ | |
The Company receives royalty reports and royalty payments related to sales of KADCYLA from Roche
quarter in arrears. As royalties are remitted to OMERS, the balance of the Royalty Obligation will be effectively repaid over the life of the agreement. In order to determine the amortization of the Royalty Obligation, the Company is required to estimate the total amount of future royalty payments to be received and remitted as noted above over the life of the15
agreement. The sum of these amounts less the $
G. | Senior Secured Term Loan |
On April 6, 2023, the Company entered into a loan agreement with BioPharma Credit PLC as collateral agent, BPCR Limited Partnership, and BioPharma Credit Investments V (Master) LP, which are funds managed by Pharmakon Advisors, LP (collectively, Pharmakon), as lenders and the guarantors party to the agreement. The loan agreement provides for up to a $
The loan agreement permits voluntary prepayment at any time, subject to a prepayment premium. The loan agreement also includes a make-whole premium in the event of a voluntary prepayment, a prepayment due to a change in control or acceleration following an Event of Default (as defined in the loan agreement) on or prior to the three-year anniversary of the closing date, in each case in an amount equal to foregone interest from the date of prepayment through the three-year anniversary of the closing date. A change of control also triggers a mandatory prepayment of the term loan.
The loan agreement contains affirmative and negative covenants customary for transactions of this type and includes certain customary events of default. The Company was in compliance with all such covenants at June 30, 2023.
The term loan is secured by a perfected security interest on substantially all of the Company’s assets, excluding certain products and related intellectual property and contracts that are not related to ELAHERE.
The Company assessed all terms and features of the loan agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the loan agreement, including put and call features. The Company determined that all features of the loan agreement were either clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting.
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The following table presents the carrying value of the Company’s term loan balance as of June 30, 2023 (in thousands):
| June 30, 2023 | ||
Principal loan balance | $ | | |
Debt discount and issuance costs, unamortized | ( | ||
Term loan, net | $ | |
During the three and six months ended June 30, 2023, the Company recognized interest expense related to the term loan of $
H. | Income Taxes |
The liability method is used in the Company’s accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance when it is more likely than not that deferred tax assets will not be realized.
The realization of deferred income tax assets is dependent on the generation of sufficient taxable income during future periods in which temporary differences are expected to reverse. Where the realization of such assets does not meet the more likely than not criterion, the Company applies a valuation allowance against the deferred income tax asset under consideration. The valuation allowance is reviewed periodically and if the assessment of the more likely than not criterion changes, the valuation allowance is adjusted accordingly. As of June 30, 2023, the Company has a full valuation allowance applied against its deferred tax assets.
As part of the Tax Cuts and Jobs Act of 2017 (2017 Tax Act), beginning with the 2022 tax year, the Company is required to capitalize research and development expenses, as defined under Internal Revenue Code Section 174. For expenses that are incurred for research and development in the U.S., the amounts will be amortized over
As of June 30, 2023, although the Company expects to be in a taxable loss position for the calendar year ended December 31, 2023, the Company determined a provision for income tax was required due largely to the impact of research and development expense capitalization pursuant to Section 174 of the 2017 Tax Act, and as such, recorded income tax expense of $
I. | Capital Stock |
Pre-Funded Warrants
Pursuant to transactions completed in 2021, the Company issued pre-funded warrants to purchase up to an aggregate of
The pre-funded warrants’ fundamental transaction provision does not provide the warrant holders with the option to settle any unexercised warrants for cash in the event of any fundamental transactions; rather, in all fundamental transaction scenarios, the warrant holder will only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the shareholders of the Company in connection with the fundamental transaction, whether that consideration be in the form of cash, stock, or any combination thereof. The pre-funded warrants also include a separate provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than
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decrease such percentage to any other percentage not in excess of
The Company assessed the pre-funded warrants for appropriate equity or liability classification pursuant to the Company’s accounting policy described in Note B, “Summary of Significant Accounting Policies.” During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The pre-funded warrants are indexed to the Company’s common stock and meet all other conditions for equity classification under ASC 480 and ASC 815. Based on the results of this assessment, the Company concluded that the pre-funded warrants are freestanding equity-linked financial instruments that meet the criteria for equity classification under ASC 480 and ASC 815. Accordingly, the pre-funded warrants were classified as equity and accounted for as a component of additional paid-in capital at the time of issuance and at each subsequent balance sheet date. The Company also determined that the pre-funded warrants should be included in the determination of basic and diluted earnings per share in accordance with ASC 260, Earnings per Share.
In June 2023, Redmile completed a cashless exercise in full of its outstanding pre-funded warrant to purchase
Series A Convertible Preferred Stock
On May 1, 2023, the Company entered into an exchange agreement with RA Capital pursuant to which RA Capital exchanged
Each share of the Series A Preferred Stock is convertible into
Shares of Series A Preferred Stock will have no voting rights, except as required by law and except that the affirmative vote of the holders of the then outstanding Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock, increase the number of authorized shares of Series A Preferred Stock, or enter into an agreement with respect to any of the foregoing. The holders of the Series A Preferred Stock are entitled to receive a nominal preference of $
The Company evaluated the Series A Preferred Stock for liability or equity classification under ASC 480, “Distinguishing Liabilities from Equity,” and determined that equity treatment was appropriate because the Preferred Stock did not meet the definition of a liability under ASC 480. The Series A Preferred Stock is not redeemable for cash or other assets on a fixed or determinable date or at the option of the holder. Additionally, as noted above, upon the
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liquidation of the Company or in the event of a fundamental transaction, such as a merger or acquisition, the holders of the Series A Preferred Stock will receive the same assets that are distributed to the holders of the Company’s common stock. As such, the Company recorded the Series A Preferred Stock as permanent equity.
Compensation Policy for Non-Employee Directors
Pursuant to the Compensation Policy for Non-Employee Directors, as amended, non-employee directors are granted restricted stock units (RSUs) upon initial election to the Board of Directors and annually thereafter. Initial and annual RSUs vest annually over approximately three years and one year from the date of grant, respectively, contingent upon the individual remaining a director of ImmunoGen as of each vesting date. The number of RSUs awarded is fixed per the policy on the date of the award. All unvested RSUs will automatically vest immediately prior to the occurrence of a change of control or in the event a director ceases to serve as a member of the Board due to death or disability. Directors can elect to defer or re-defer RSU and/or deferred share unit (DSU) awards under the Company’s 2004 Non-Employee Director Compensation and Deferred Share Unit Plan, as amended. The directors received a total of approximately
Pursuant to the Compensation Policy for Non-Employee Directors, as amended, non-employee directors also receive stock option awards upon initial election to the Board of Directors and annually thereafter. The directors received a total of approximately
In addition, pursuant to the Compensation Policy for Non-Employee Directors, as amended, the Company may issue the Company’s common stock in lieu of cash to pay fees earned by the Company’s directors at each director’s election. The directors received a total of
J. | Leases |
The Company currently has
There have been no material changes in lease obligations from those disclosed in Note K, “Leases,” to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023.
K. Commitments and Contingencies
Manufacturing Commitments
As of June 30, 2023, the Company had noncancelable obligations under several agreements related to in-process and future manufacturing of antibody, drug substance, and cytotoxic agents required for supply of the Company’s product candidates totaling $
Litigation
The Company is not a party to any material litigation.
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L.Related Party Transactions
In May 2023, the Company entered into an exchange agreement with RA Capital pursuant to which RA Capital agreed to exchange
Stuart A. Arbuckle serves as the chief operating officer at Vertex and has served as a member of the Company’s board of directors since 2018. In February 2023, the Company entered into a multi-target license and option agreement with Vertex, pursuant to which the Company granted Vertex rights to the Company’s ADC technology to research and evaluate ADCs to specified targets, further details of which can be found in Note C, “Collaboration and License Agreements.”
The Company’s chief executive officer has served as a director on the board of directors of Ergomed PLC since June 2021. During the six months ended June 30, 2022, the Company executed agreements with Ergomed Clinical Research, Inc. and PrimeVigilance USA, Inc., subsidiaries of Ergomed PLC, for clinical trial and pharmacovigilance-related services. Ergomed Clinical Research, Inc. and PrimeVigilance USA, Inc. are each considered related parties pursuant to ASC 850, Related Party Disclosures. During the six months ended June 30, 2023 and 2022, the Company made payments totaling $
M.Subsequent Events
The Company has evaluated all events or transactions that occurred after June 30, 2023, up through the date the Company issued these financial statements. The Company did not have any material subsequent events.
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following information should be read in conjunction with the unaudited financial statements and the notes thereto included elsewhere in this report, and the consolidated financial statements and notes thereto for the year ended December 31, 2022, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023.
OVERVIEW
We are a commercial-stage biotechnology company focused on developing and commercializing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer patients more good days. We call this our commitment to “target a better now.”
An ADC with our proprietary technology comprises an antibody that binds to a target found on tumor cells and is conjugated to one of our potent anti-cancer agents as a “payload” to kill the tumor cell once the ADC has bound to its target. ADCs are an expanding class of anticancer therapeutics, with twelve approved products and the number of agents in development growing significantly in recent years.
We have established a leadership position in ADCs with a portfolio of differentiated product candidates to address both solid tumors and hematologic malignancies. We have set four strategic priorities for the business:
● | execute the commercial launch for ELAHERE; |
● | expand the ELAHERE label by moving into platinum-sensitive ovarian cancer; |
● | advance our clinical pipeline of novel ADCs for hematologic and solid tumors; and |
● | strengthen and expand our pipeline through both internal discovery and external partnerships. |
We believe that sound execution of these prioritized activities has the potential to create substantial short-and long-term value for shareholders, employees, patients, and other stakeholders in the Company.
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ELAHERE (Mirvetuximab Soravtansine)
Approval and Launch
ELAHERE is a first-in-class ADC targeting folate receptor alpha (FRα), a cell-surface protein over-expressed in a number of epithelial tumors, including ovarian, endometrial, and non-small-cell lung cancers. On November 14, 2022, the FDA granted accelerated approval for ELAHERE for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The accelerated approval of ELAHERE was based on efficacy and safety outcomes from SORAYA, a single-arm trial of ELAHERE in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. Patients eligible for treatment with ELAHERE are selected by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay developed by Roche Tissue Diagnostics, which was also approved by the FDA on November 14, 2022. We completed the build-out of our U.S. commercial infrastructure in 2022 and initiated sales in the U.S. in November 2022.
Ongoing Development
In May 2023, we reported positive top-line data from MIRASOL, a randomized Phase 3 clinical trial designed to support full approval of ELAHERE. MIRASOL demonstrated:
● | A statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment compared to investigators’ choice (IC) chemotherapy, with a hazard ratio of 0.65 (p<0.0001), which represents a 35% reduction in the risk of tumor progression or death in the mirvetuximab arm compared to the IC chemotherapy arm. The median PFS in the mirvetuximab arm was 5.62 months, compared to 3.98 months in the IC chemotherapy arm. |
● | A statistically significant and clinically meaningful improvement in overall survival (OS) compared to IC chemotherapy. With 204 OS events reported as of March 6, 2023, the median OS was 16.46 months in the mirvetuximab arm, compared to 12.75 months in the IC chemotherapy arm, with a hazard ratio (HR) of 0.67, p=0.0046. This represents a 33% reduction in the risk of death in the ELAHERE arm in comparison to the IC chemotherapy arm. |
● | The objective response rate (ORR) by investigator assessment in the ELAHERE arm was 42.3%, including 12 complete responses (CRs), compared to 15.9%, with no CRs, in the IC chemotherapy arm. |
In the fourth quarter of 2023, we plan to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) to support approval of ELAHERE in Europe for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. In the fourth quarter of 2023, we also plan to submit a supplemental Biologics License Application (sBLA) to the FDA to support the conversion of the accelerated approval of ELAHERE to full approval. Additionally, our partner, Huadong, expects to submit an MAA to the National Medical Products Administration (NMPA) of China for ELAHERE in the same indication by the end of 2023 to support potential approval and launch of ELAHERE in Greater China.
Beyond platinum-resistant ovarian cancer, our strategy is to move ELAHERE into platinum-sensitive disease, and to position the product as the combination agent of choice in ovarian cancer. To this end, in January 2023, we completed patient enrollment in PICCOLO, a single-arm trial of ELAHERE monotherapy in later-line FRα positive platinum-sensitive patients, and plan to report on the primary endpoint before the end of 2023. We have also generated encouraging data in recurrent platinum-sensitive disease with the combination of ELAHERE plus carboplatin and are supporting investigator sponsored trials (ISTs) with this combination in a single-arm trial in the neoadjuvant setting and in a randomized trial comparing ELAHERE combined with carboplatin to standard of care in patients with recurrent platinum-sensitive disease. We continued enrollment in our single-arm Phase 2 trial (0420) of this combination followed by ELAHERE continuation in FRα-low, medium, and high patients with platinum-sensitive disease. Results from this trial and our ongoing ISTs will inform a path to the potential registration for ELAHERE plus carboplatin and, in parallel, could support compendia listing for this combination. Lastly, in the second quarter of 2023, we enrolled the first patient in GLORIOSA, a randomized Phase 3 trial of ELAHERE plus bevacizumab maintenance in FRα-high recurrent platinum-sensitive disease that we believe could support label expansion.
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Pivekimab Sunirine
Pivekimab sunirine (PVEK), formerly known as IMGN632, is an ADC comprised of a high-affinity antibody designed to target CD123 with site-specific conjugation to a DNA-alkylating payload of the novel IGN (indolinobenzodiazepine pseudodimer) class. Our IGNs are designed to alkylate DNA without cross-linking, which has provided a broad therapeutic index in preclinical models. We are advancing PVEK in clinical trials for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML).
BPDCN is a rare form of blood cancer, with an annual incidence of between 500 and 1,000 patients in the US. In October 2020, the FDA granted Breakthrough Therapy designation for PVEK for the treatment of patients with relapsed or refractory BPDCN. Based on feedback from the FDA, we amended our ongoing 801 Phase 2 trial, known as CADENZA, to include a new cohort of up to 20 frontline BPDCN patients.
Initial enrollment in CADENZA did not distinguish between de novo BPDCN patients and those who presented with a prior or concomitant hematologic malignancy (PCHM). Although complete responses have been observed in BPDCN patients who present with PCHM, most will not achieve full hematologic recovery due to the impact of their prior or concomitant malignancy. For these patients, we believe that achieving a complete response with partial hematological recovery (CRh) is a potentially important measure of clinical benefit.
A Type B meeting was held in August 2022 regarding the initial data from the CADENZA trial. Based on FDA feedback on trial design provided in this meeting, the efficacy analysis will be conducted in de novo BPDCN patients with CR (complete response)/CRc (clinical complete response) as the primary endpoint and the key secondary endpoint of duration of CR/CRc. We will enroll up to 20 de novo patients for purposes of the efficacy analysis and continue to enroll PCHM patients in CADENZA to further evaluate PVEK in this population. In the second quarter of 2023, we completed enrollment of the efficacy evaluable cohort of de novo patients, and we expect to report top-line data on the primary and key secondary endpoints in 2024.
We are also conducting our 802 trial for PVEK, which is a Phase 1b/2 trial designed to determine the safety, tolerability, and preliminary antileukemia activity of PVEK when administered in combination with azacytidine and venetoclax to patients with relapsed and frontline CD123-positive AML. In December 2022, safety and efficacy findings in relapsed refractory AML and initial data in frontline AML were presented at the American Society of Hematology Annual Meeting. In the first 10 frontline patients enrolled, 5/10 (50%) patients achieved a CR and 3/4 (75%) patients tested had a minimal residual disease (MRD)-negative CR. Based upon these results, the Company moved forward with two frontline AML expansion cohorts to optimize the duration of venetoclax therapy. We expect to share data from these cohorts at the American Society of Hematology (ASH) Annual Meeting in December 2023.
Other Pipeline Programs
We continue to advance our earlier-stage pipeline programs. IMGC936 is an ADC in co-development with MacroGenics, Inc. that is designed to target ADAM9, an enzyme over-expressed in a range of solid tumors and implicated in tumor progression and metastasis. IMGC936 incorporates a number of innovations, including antibody engineering to extend half-life, site-specific conjugation with a fixed drug-antibody ratio to enable higher dosing, and a next-generation linker and payload designed for improved stability and bystander activity. Phase 1 dose escalation was completed and expansion cohorts in non–small cell lung cancer (NSCLC) and triple-negative breast cancer initiated in the second half of 2022. Since then, we have prioritized the NSCLC cohort, and the Company expects to provide an update after an interim analysis.
IMGN151 is our next generation anti-FRα product candidate in development. This ADC integrates innovation in each of its components, which we believe may enable IMGN151 to address patient populations with lower levels of FRα expression, including tumor types outside of ovarian cancer. We continue to advance our Phase 1 clinical trial evaluating IMGN151 in patients with recurrent endometrial cancer and recurrent, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancers.
We have selectively licensed restricted access to our ADC platform technology to other companies to expand the use of our technology and to provide us with cash to fund our own product programs. These agreements typically provide the licensee with rights to use our ADC platform technology with its antibodies or related targeting vehicles to a defined target to develop products. The licensee is generally responsible for the development, clinical testing, manufacturing, registration, and commercialization of any resulting product candidate. As part of these agreements, we are generally entitled to receive upfront fees, potential milestone payments, and royalties on the sales of any resulting products. For
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more information concerning these relationships, including their ongoing financial and accounting impact on our business, please read Note C, “Collaboration and License Agreements,” to our consolidated financial statements included in this report.
We expect to continue to incur substantial operating losses for at least the near term as we incur significant operating expenses related to research and development and selling and marketing of ELAHERE. As of June 30, 2023, we had $572.0 million in cash and cash equivalents compared to $275.1 million as of December 31, 2022.
Critical accounting policies and estimates
We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make certain estimates and judgments 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 revenues and expenses during the reported periods. These items are monitored and analyzed by management for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are reflected in reported results for the period in which the change occurs. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.
We believe that our application of the following accounting policies, each of which requires significant judgments and estimates on the part of management, are the most critical to aid in fully understanding and evaluating our reported financial results:
● | inventory capitalization; |
● | revenue recognition; |
● | clinical trial accruals; and |
● | stock-based compensation. |
During the six months ended June 30, 2023, there were no material changes to our critical accounting policies and estimates as reported in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023.
RESULTS OF OPERATIONS
Revenues
For the three and six months ended June 30, 2023, our total revenues increased $69.0 million and $80.8 million, respectively, compared to the three and six months ended June 30, 2022, driven by net product sales of ELAHERE in the current periods, partially offset by decreases in license and milestone fees and non-cash royalty revenue. See further discussion below.
Product revenue, net
On November 14, 2022, the FDA granted accelerated approval for ELAHERE for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. For the three and six months ended June 30, 2023, we recorded $77.4 million and $106.9 million, respectively, of net product revenue related to U.S. sales of ELAHERE.
License and milestone fees
The amount of license and milestone fees we earn is directly related to the number of our collaborators, the advancement of product candidates covered by the agreements with our collaborators, and the overall success in the clinical trials of these product candidates. As such, the amount of license and milestone fees recognized may vary significantly from quarter to quarter and year to year. In the three and six months ended June 30, 2023, license and milestone fee revenue decreased $6.9 million and $22.8 million, respectively, compared to the three and six months ended June 30, 2022. Driving the decreases, in the three and six months ended June 30, 2022, we recorded as revenue $6.9 million and $28.5 million, respectively, of previously received and deferred payments pursuant to our license agreement with Huadong. Additionally, during the six months ended June 30, 2022, we recorded $9.2 million of a $13.0 million
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upfront payment received pursuant to a multi-target license agreement executed with Lilly in February 2022. During the six months ended June 30, 2023, we received and recorded as revenue a $15.0 million upfront payment pursuant to a multi-target license and option agreement executed with Vertex in February 2023.
Non-cash royalty revenue related to the sale of future royalties
KADCYLA® is a marketed ADC resulting from one of our development and commercialization licenses with Roche, through its Genentech unit. We receive royalty reports and payments related to sales of KADCYLA from Roche one quarter in arrears. We sold our rights to receive royalty payments on the net sales of KADCYLA through two separate transactions in 2015 and 2019. In accordance with our revenue recognition policy, $5.7 million and $10.6 million of non-cash royalties on net sales of KADCYLA were recorded and included in non-cash royalty revenue for the three and six months ended June 30, 2023, respectively, compared to $7.1 million and $13.5 million in non-cash royalty revenue recorded for the three and six months ended June 30, 2022, respectively. The decreases are primarily a result of lower current and projected net sales of KADCYLA and lower royalty rates applied to increased sales generated in countries without patent coverage. See further details regarding these agreements in Note F, “Liability Related to Sale of Future Royalties,” of the Consolidated Financial Statements.
Cost of Sales
Our cost of sales includes the cost of producing and distributing inventories that are related to product revenue, including freight. In addition, shipping and handling costs for product shipments are recorded as incurred. Finally, cost of sales may also include costs related to excess or obsolete inventory adjustment charges.
Prior to receiving FDA accelerated approval for ELAHERE in November 2022, we manufactured inventory to be sold upon commercialization and recorded the costs as research and development expense. As a result, the manufacturing costs related to the inventory manufactured prior to receiving FDA accelerated approval were expensed in a prior period and are therefore excluded from the cost of goods sold for the three and six months ended June 30, 2023. We estimate our cost of sales related to product revenue as a percentage of net product revenue will continue to be positively affected as we sell through certain inventory that was previously expensed prior to FDA approval. We expect to utilize low-cost inventory for an extended period of time.
Research and development expenses
Our research and development expenses relate to (i) research to evaluate new targets and to develop and evaluate new antibodies, linkers, and cytotoxic agents, (ii) preclinical testing of our own and, in certain instances, our collaborators’ product candidates, and the cost of our own clinical trials, (iii) development related to clinical and commercial manufacturing processes, (iv) regulatory activities, (v) medical affairs activities, and (vi) external manufacturing operations.
We do not track our research and development costs by project. Since we use our research and development resources across multiple research and development projects, we manage our research and development expenses within each of the categories listed in the following table and described in more detail below (in thousands). Certain reclassifications have been made to prior periods to conform with current year.
Three Months Ended |
| Six Months Ended |
| |||||||||||||||
June 30, | Increase/ | June 30, | Increase/ | |||||||||||||||
Research and Development Expenses | 2023 | 2022 | (Decrease) |
| 2023 |
| 2022 |
| (Decrease) | |||||||||
Research |
| $ | 1,152 | $ | 7,500 | $ | (6,348) |
| $ | 2,510 |
| $ | 7,500 |
| $ | (4,990) | ||
Preclinical and clinical testing | 38,836 | 31,775 | 7,061 | 77,156 | 63,270 | 13,886 | ||||||||||||
Process and product development | 3,793 | 2,609 | 1,184 | 6,712 | 5,240 | 1,472 | ||||||||||||
Manufacturing operations | 6,296 | 9,538 | (3,242) | 15,319 | 19,694 | (4,375) | ||||||||||||
Total research and development expenses | $ | 50,077 | $ | 51,422 | $ | (1,345) | $ | 101,697 | $ | 95,704 | $ | 5,993 |
Research
Research includes expenses to evaluate new targets and to develop and evaluate new antibodies, linkers, and cytotoxic agents. Such expenses include third-party license fees, research funding payments, and contract services. In the three and six months ended June 30, 2023, research expenses decreased by $6.3 million and $5.0 million, respectively. Pursuant to a research collaboration agreement executed with Oxford BioTherapeutics Ltd. (OBT) in June 2022, we recorded a $7.5 million upfront license fee as expense in the three and six months ended June 30, 2022. Partially offsetting
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this one-time expense, during the three and six months ended June 30, 2023, we recognized $1.2 million and $2.2 million, respectively, of committed research costs related to the agreement with OBT.
Preclinical and clinical testing
Preclinical and clinical testing includes expenses related to preclinical testing of our own, and, in certain instances, our collaborators’ product candidates, regulatory activities, the cost of clinical trials, and expenses related to medical affairs. Such expenses include the costs of personnel, third-party staffing, patient enrollment at our clinical testing sites, consultant fees, contract services, and facility expenses. In the three and six months ended June 30, 2023, preclinical and clinical testing expenses increased by $7.1 million and $13.9 million, respectively, compared to the three and six months ended June 30, 2022, due primarily to costs related to an expanded medical affairs team to support the advancement of ELAHERE and an increase in clinical trial costs driven by our ELAHERE, PVEK, and IMGN151 trials.
Process and product development
Process and product development expenses include costs for development of clinical and commercial manufacturing processes for our own and collaborator compounds. Such expenses include the costs of personnel, third-party staffing, contract services, and facility expenses. In the three and six months ended June 30, 2023, process and product development expenses increased by $1.2 million and $1.5 million, respectively, compared to the three and six months ended June 30, 2022, due primarily to increased personnel-related costs and third-party contract services related to advancing early-stage programs.
Manufacturing operations
Manufacturing operations expense includes costs to have preclinical and clinical materials manufactured for our product candidates and quality control and quality assurance activities. Such expenses include personnel, third-party staffing, raw materials for our preclinical studies and clinical trials, non-pivotal and pivotal development costs with contract manufacturing organizations, and facility expenses. In the three and six months ended June 30, 2023, manufacturing operations expense decreased by $3.2 million and $4.4 million, respectively, compared to the three and six months ended June 30, 2022, due primarily to greater raw materials produced for use in the manufacture and sale of ELAHERE in the prior year periods, which were expensed where produced prior to FDA accelerated approval, partially offset by increases in personnel-related costs and external manufacturing activity across our other internal programs.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of personnel-related costs, including stock-based compensation, for commercial operations and for personnel in executive, finance, accounting, business development, information technology, legal, and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, commercial development activities, legal fees related to intellectual property and corporate matters, and fees for accounting and consulting services.
In the three and six months ended June 30, 2023, selling, general and administrative expenses increased by $12.6 million and $35.9 million, respectively compared to the three and six months ended June 30, 2022 due to greater expenses in support of advancing the U.S. launch of ELAHERE, including personnel-related costs and sales and marketing activities.
Interest income
Interest income on cash equivalents for the three and six months ended June 30, 2023 was $5.2 million and $7.4 million, respectively, compared to $0.6 million in each of the three and six months ended June 30, 2022. The increases over prior year periods were driven by a significant increase in interest rates and higher average cash balances.
Interest expense on term loan
During the three and six months ended June 30, 2023, we recorded interest expense of $2.3 million related to the term loan executed with Pharmakon in April 2023 as described in Note G, “Senior Secured Term Loan.” Additionally, given our current capital and expected sales of ELAHERE, we determined the likelihood of drawing the second tranche of $50.0 million under the agreement to be remote, and as such, recorded a $1.0 million facility fee that is owed to Pharmakon regardless of whether the additional funding is drawn as interest expense for the three and six months ended June 30, 2023.
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Non-cash interest expense on liability related to the sale of future royalties and term loan
In 2015, IRH purchased our right to receive 100% of the royalty payments on commercial sales of KADCYLA arising under our development and commercialization license with Genentech, subject to a residual cap. In January 2019, OMERS purchased IRH’s right to the royalties the Company previously sold in 2015. As described in Note F, “Liability Related to Sale of Future Royalties,” to our consolidated financial statements included in this report, this royalty sale transaction has been recorded as a liability that amortizes over the estimated royalty payment period as KADCYLA royalties are remitted directly to the purchaser. During the three and six months ended June 30, 2023, we recorded $0.9 million and $1.8 million, respectively, of non-cash interest expense which includes amortization of deferred financing costs, compared to $1.1 million and $2.3 million recorded in the three and six months ended June 30, 2022. The decrease was a result of a lower average royalty liability balance for the period.
Additionally, during the three and six months ended June 30, 2023, we recorded non-cash interest expense of $0.1 million in amortization of discount and issuance costs for the term loan executed with Pharmakon in April 2023.
LIQUIDITY AND CAPITAL RESOURCES
The tables below summarize our cash and cash equivalents, working capital, and shareholders’ equity as of June 30, 2023 and December 31, 2022, and cash flow activities for the six months ended June 30, 2023 and 2022 (in thousands):
As of | ||||||
June 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Cash and cash equivalents |
| $ | 571,987 |
| $ | 275,138 |
Working capital |
| 575,571 |
| 182,263 | ||
Shareholders’ equity |
| 490,842 |
| 155,826 |
Six Months Ended June 30, | ||||||
| 2023 |
| 2022 | |||
Cash used for operating activities |
| $ | (140,460) |
| $ | (105,393) |
Cash used for investing activities |
| (287) |
| (514) | ||
Cash provided by financing activities |
| 437,596 |
| 1,031 |
Cash flows
We require cash to fund our operating expenses, including the advancement of our clinical programs and to make capital expenditures. Historically, we have funded our cash requirements primarily through equity and debt financings in private and public markets, payments from our collaborators, including license fees, milestone payments, research funding, and royalties, and more recently, through commercial sales of ELAHERE. We have also monetized our rights to receive royalties on KADCYLA for upfront consideration. As of June 30, 2023, we had $572.0 million in cash and cash equivalents. Net cash used for operations was $140.5 million and $105.4 million for the six months ended June 30, 2023 and 2022, respectively. The principal use of cash for operating activities for both periods presented was to fund our net loss, adjusted for non-cash items.
Net cash used for investing activities was $0.3 million and $0.5 million for the six months ended June 30, 2023 and 2022, respectively, consisting of cash outflows for capital expenditures in both periods.
Net cash provided by financing activities was $437.6 million and $1.0 million for the six months ended June 30, 2023 and 2022, respectively. Net cash provided by financing activities for the six months ended June 30, 2023 and 2022 includes $14.9 million and $1.0 million, respectively, of proceeds from the exercise of stock options and sale of shares through our ESPP. In May 2023, pursuant to a public offering, we issued and sold 29.9 million shares of common stock resulting in net proceeds of $350.8 million.
Additionally, in April 2023, we entered into a loan agreement with funds managed by Pharmakon which provides for up to a $175.0 million senior secured term loan consisting of two tranches that each mature on April 6, 2028. The initial tranche of $75.0 million was drawn upon execution of the loan agreement, resulting in proceeds net of fees and expenses of $71.8 million. The second tranche of $50.0 million is available at our option and may be increased to $100.0 million upon mutual agreement of the parties. The term loan bears interest at a rate based upon the secured overnight financing rate (SOFR), subject to a SOFR floor of 2.75% per annum, plus 8.00% per annum. Payments will be interest-
26
only for the first 36 months with an extension of 12 months if certain conditions are met, after which ratable principal payments will commence for the remainder of the term.
Future Capital Requirements
We have significant future capital requirements including:
● | significant expected operating expenses to commercialize ELAHERE globally; |
● | significant expected operating expenses to conduct research and development activities and to potentially commercialize our portfolio; |
● | noncancelable in-process and future manufacturing obligations, including commercial supply of ELAHERE; and |
● | substantial facility lease obligations as described in Note K, “Leases,” included in our Annual Report on Form 10-K for the year ended December 31, 2022, and as described in Note J, “Leases,” included in this Quarterly Report on Form 10-Q. |
We anticipate that our current capital resources will enable us to meet our operating expenses and capital requirements for more than twelve months after the date of filing this Quarterly Report on Form 10-Q. We expect to generate additional funds through a combination of commercial sales of ELAHERE and revenues from collaborations, including upfront license payments, milestone payments, royalty payments, and research funding, to support our planned operating activities; however, such activities may not succeed. If such activities are not successful, we may be required to seek additional funding through equity or other financings. The failure to generate sufficient funds from commercial sales of ELAHERE and collaborations or obtain additional funding through equity or other financings on acceptable terms could have a material adverse effect on our business, results of operations, and financial condition and require us to defer or limit some or all of our research, development, clinical, and/or commercial projects.
Recent Accounting Pronouncements
The information set forth under Note B, “Basis of Presentation and Significant Accounting Policies,” to our consolidated financial statements included in this report under the caption “Recently Adopted Accounting Pronouncements” is incorporated herein by reference.
Third-Party Trademarks
KADCYLA® is a registered trademark of Genentech, Inc.
ITEM 3. Quantitative and Qualitative Disclosure about Market Risk
Our market risks, and the ways we manage them, are summarized in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 1, 2023. There have been no material changes to our market risks, or to our management of such risks, as set forth in such Annual Report on Form 10-K.
ITEM 4. Controls and Procedures
(a) | Disclosure Controls and Procedures |
Our management, with the participation of our principal executive and principal financial officers, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this report. Based on such evaluation, our principal executive and principal financial officers have concluded that, as of the end of such period, our disclosure controls and procedures were effective.
(b) | Changes in Internal Controls Over Financial Reporting |
During the six months ended June 30, 2023, we implemented certain internal controls in connection with product revenue. There were no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and
27
15(d)-15(f) under the Exchange Act) that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1A. Risk Factors
In addition to the other information set forth in this report, you should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition, or future results set forth under Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed with the SEC on April 28, 2023. There have been no material changes from the factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022 or Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. We may, however, disclose changes to such risk factors, or disclose additional risk factors, from time to time in our future filings with the SEC.
ITEM 5. | Other Information |
Departure of Officer
On July 26, 2023, Anna Berkenblit, M.D., the Chief Medical Officer of the Company tendered her letter of resignation. She will relinquish her responsibilities as Chief Medical Officer effective August 11, 2023, but will remain with the Company through August 31, 2023 to assist in an orderly transfer of her responsibilities.
Michael J. Vasconcelles, M.D., the Executive Vice President of Research, Development and Medical Affairs of the Company, will assume the responsibilities of the Company’s Chief Medical Officer on an interim basis while the Company engages in a search for a permanent replacement for Dr. Berkenblit.
Adoption of 10b5-1 Trading Plans by Our Officers and Directors
During our fiscal quarter ended June 30, 2023, certain of our officers (as defined in Rule 16a-1(f) under the Exchange Act) and directors entered into contracts, instructions, or written plans for the purchase or sale of our securities that are intended to satisfy the conditions specified in Rule 10b5-1(c) under the Exchange Act for an affirmative defense against liability for trading in securities on the basis of material nonpublic information. We refer to these contracts, instructions, and written plans as “Rule 10b5-1 trading plans” and each one as a “Rule 10b5-1 trading plan.” We describe the material terms of these Rule 10b5-1 trading plans below.
Stephen C. McCluski, Chairman of the Board of Directors
On
Mark A. Goldberg, M.D., Director
On
Kristine Peterson, Director
28
On
Mark J. Enyedy, President and Chief Executive Officer, and Director
On
Anna Berkenblit, M.D., Senior Vice President, Chief Medical Officer
On
Also on
Stacy A. Coen, Senior Vice President, Chief Business Officer
On
Renee Lentini, Vice President, Finance, Chief Accounting Officer, and Interim Chief Financial Officer
On
Theresa G. Wingrove, Ph.D., Senior Vice President, Regulatory Affairs and Quality
On
29
Also on
ITEM 6. Exhibits
Exhibit No. |
| Description | |
3.1 | |||
3.1(a | ) | ||
3.1(b | ) | ||
3.1(c | ) | ||
3.1(d | ) | ||
3.1(e | ) | ||
3.2 | |||
10.1 | ± | Compensation Policy for Non-Employee Directors, as amended through June 14, 2023 | |
10.2 | |||
10.3 | * | ||
31.1 | |||
31.2 | |||
32 | † | ||
101 | Financial statements from the quarterly report on Form 10-Q of ImmunoGen, Inc. for the quarter ended June 30, 2023 formatted in inline XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets; (ii) the Consolidated Statements of Operations and Comprehensive Loss; (iii) the Consolidated Statements of Shareholder’s Equity (Deficit); (iv) the Consolidated Statements of Cash Flows; and (v) the Notes to Consolidated Financial Statements | ||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | ||
± Exhibit is a management contract or compensatory plan, contract, or arrangement required to be filed as an exhibit to this Quarterly Report on Form 10-Q.
* Certain confidential portions of this exhibit were omitted by means of marking such portions with brackets [***] because the identified confidential portions (i) are not material and (ii) is the type of information the Registrant treats as private or confidential.
† | Furnished, not filed. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ImmunoGen, Inc. | |||
Date: July 31, 2023 | By: | /s/ Mark J. Enyedy | |
Mark J. Enyedy | |||
President and Chief Executive Officer (Principal Executive Officer) | |||
Date: July 31, 2023 | By: | /s/ Renee Lentini | |
Renee Lentini | |||
Vice President - Finance, Chief Accounting Officer, and Interim Chief Financial Officer (Principal Accounting Officer and Principal Financial Officer) | |||
31
EXHIBIT 3.2
ImmunoGen, Inc.
BY-LAWS
AMENDED AND RESTATED AS OF JUNE 14, 2023
TABLE OF CONTENTS
BY-LAWS
The Chair of the Board of Directors or, in his or her absence, the Chief Executive Officer of the corporation or, in his or her absence, the President or, in his or her absence, such person as the Board of Directors may have designated, shall call to order any meeting of the shareholders and shall preside at and act as chair of the meeting. In the absence of the Secretary of the corporation, the secretary of the meeting shall be such person as the chair of the meeting appoints. The chair of any meeting of shareholders shall determine the order of business and the procedures at the meeting, including such regulation of the manner of voting and the conduct of discussion as he or she deems to be appropriate. The chair of any meeting of shareholders shall have the power to adjourn the meeting to another place and time. The date and time of the opening and closing of the polls for each matter upon which the shareholders will vote at the meeting shall be announced at the meeting.
If such annual meeting is not held on the date fixed, or by adjournment therefrom, a special meeting of the shareholders shall be held in place thereof, and any business transacted or elections held at such a special meeting shall have the same force and effect as if transacted or held at the annual meeting. Any such special meeting shall be called as provided in Section 1.3 of this Article I.
Every shareholder who is present at a meeting (whether in person or by proxy) shall be deemed to have waived notice thereof; provided, however, that in the absence of his or her waiver in writing, a shareholder may expressly reserve his or her objection to the transaction of any business as to which requisite notice was not given to him or her and on which he or she does not vote.
Nominations of persons for election to the Board of Directors and the proposal of business to be considered by the shareholders may be made at an annual meeting of shareholders (a) pursuant to the corporation’s notice of meeting, (b) by or at the direction of the Board of Directors or (c) by any shareholder of the corporation who is entitled to vote at the meeting and who complies with the notice procedures set forth in this Section and, to the extent that Rule 14a-19 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), applies, Rule 14a-19 of the Exchange Act.
Only such business shall be conducted at a special meeting of shareholders as shall have been brought before the meeting pursuant to the notice of meeting given pursuant to Section 1.4 above. Nominations of persons for election to the Board of Directors may be made at a special meeting of shareholders (a) by or at the direction of the Board of Directors or (b) provided that the Board of Directors has determined that directors shall be elected at such meeting, by any shareholder of the corporation who is a shareholder of record at the time of giving of notice provided for in this Section, who shall be entitled to vote at the meeting and who complies with the notice procedures set forth in this Section.
No officer or director need be a shareholder. The Chair of the Board of Directors shall be elected by and from the Board of Directors. Two or more offices may be held by any person.
Any Director or officer may resign by giving written notice of his or her resignation to the Chair of the Board of Directors, President, or Secretary, or to the Board of Directors at a meeting of the Board, and such resignation shall become effective at the time specified therein, or, if none is specified, upon receipt. Unless otherwise specified in the resignation, its acceptance shall not be necessary to make it effective. Any Director may at any time be removed with or without cause by the affirmative vote of the holders of a majority in interest of the capital stock issued and outstanding and entitled to vote; provided, that a Director of a class elected by a particular class of shareholders may be removed only by the affirmative vote of the holders of a majority in interest of the stock of such class. A Director may also be removed from office with cause by vote of a majority of the Directors then in office. Any officer may at any time be removed with or without cause by vote of a majority of the Directors then in office, or, if the officer was appointed by the Chief Executive Officer, by the Chief Executive Officer. A Director may be removed for cause only after a reasonable notice and opportunity to be heard before the body proposing to remove him or her.
In the case of the issuance and transfer of uncertificated stock, the corporation shall send to the registered owner thereof:
Except as otherwise expressly provided by law, the rights, and obligations of the holders of stock of the same class and series shall be identical.
If no record date is fixed by the Board of Directors and the transfer books are not closed:
Such indemnification shall include payment by the corporation of expenses incurred in defending a civil or criminal action or proceeding in advance of the final disposition of such action or proceeding, upon receipt of an undertaking by the person indemnified to repay such payment if he or she shall be adjudicated not to be entitled to indemnification under this section.
The corporation shall similarly indemnify and hold harmless persons who serve at its express written request as directors or executive officers of another organization in which the corporation owns shares or of which it is a creditor, if such entity fails, pursuant to an indemnity or advancement obligation or insurance, to cover such costs and expenses; notwithstanding the foregoing, if such person may be entitled to be indemnified by such other organization or is insured by an insurer providing insurance coverage under an insurance policy issued to such other organization for any liabilities, expenses or other losses as to which such person also would be entitled to be indemnified by the corporation pursuant to the foregoing provisions of this Section 6.6, then it is intended, as between the corporation and such other organization and/or its insurer, that such other organization and its insurer will be the full indemnitor or insurer of first resort for any such liabilities, expenses or other losses, and that only thereafter may the corporation be required to pay indemnification or advancement of any such liabilities, expenses, or other losses.
The right of indemnification herein provided shall be in addition to and not exclusive of any other rights to which any executive officer or Director of the corporation, or any such persons who serve at its request as aforesaid, may otherwise be lawfully entitled. As used in this Section, the terms “executive officer” and “Director” include their respective heirs, executors and administrators.
EXHIBIT 10.1
ImmunoGen, Inc.
Compensation Policy for Non-Employee Directors
(Effective June 14, 2023)
Objective
It is the objective of ImmunoGen, Inc. to compensate non-employee members (each, a “Director”) of the Board of Directors (the “Board”) in a manner that will enable the recruitment and retention of highly qualified Directors by fairly compensating them for their services as Directors.
Cash Compensation
Annual meeting fee for non-employee Directors:$45,000 per annum, paid quarterly
Additional annual fees:
(a) | Lead Director / Chairman of the Board:1$35,000 per annum, paid quarterly |
(b) | Chairman of the Audit Committee:$20,000 per annum, paid quarterly |
(c) | Chairman of the Compensation Committee:$15,000 per annum, paid quarterly |
(d) | Chairman of the G&N Committee:$15,000 per annum, paid quarterly |
(e) | Other members of the Audit Committee$10,000 per annum, paid quarterly |
(f) | Other members of the Compensation Committee$7,500 per annum, paid quarterly |
(g) | Other members of the G&N Committee$7,500 per annum, paid quarterly |
(h) | Members of the Clinical Committee$7,500 per annum, paid quarterly |
Quarterly payments shall be paid in arrears within 30 days following the end of each calendar quarter.2 A non-employee Director may elect to receive any or all of his or her cash compensation in the form of deferred stock units (“DSUs”) under the Company’s 2004 Non-Employee Director Compensation and Deferred Share Unit Plan, as amended and restated as of December 15, 2022 (the “Deferred Share Unit Plan”), with the value of such DSUs determined by dividing the quarterly payment amount by the closing price per share of the Company’s common stock, $0.01 par value (“Common Stock”) on the Nasdaq Global Select Market on the determination date, which shall be the last day of the calendar quarter for which the retainer is being paid, rounded down to the nearest whole share.
All deferral elections with respect to quarterly payments under the Deferred Share Unit Plan shall be made annually by December 31st of the year prior to the year of service to which the quarterly payment relates, with such election being effective for all payments to be made in the following calendar year. New non-employee Directors shall make their elections within 30 days of their initial appointment or election to the Board for all payments to be made in that calendar year. Any such election shall be prospective only for compensation attributable to services performed after the effective date of such election and any amounts covered by such election shall be prorated as necessary. Each non-employee Director shall be deemed to have elected to receive his or her quarterly payments in cash for periods prior to any such election or if no timely
1 Payable to non-employee Chairman of the Board only.
2 | Quarterly payments will be appropriately pro-rated for Directors who retire, resign, or are otherwise removed from the Board prior to the end of a calendar quarter. |
election shall have been made. Notwithstanding the foregoing, a previous deferral election made by a non-employee Director pursuant to the Deferred Share Unit Plan shall remain in effect for subsequent calendar years until it is changed by the timely and effective completion, signature and delivery to the Company of a new election form, in accordance with the terms of the Deferred Share Unit Plan.
Following an effective election as described above, DSUs shall be granted without any further action by the Compensation Committee of the Board (the “Compensation Committee”). These awards are fully vested as to all of the issued DSUs on the date of grant.
A non-employee Director may also elect to be issued, on each quarterly payment date, a number of shares of Common Stock under the Company’s Amended and Restated 2018 Employee, Director and Consultant Equity Incentive Plan (the “2018 Plan”) determined by dividing the quarterly payment amount by the closing price per share of Common Stock on the Nasdaq Global Select Market on the determination date, which shall be the last day of the calendar quarter for which the retainer is being paid, rounded down to the nearest whole share. Any such election to receive shares of Common Stock in lieu of all, or a portion, of a cash retainer must be delivered in writing (including electronic mail) on an annual basis by December 31st of the year prior to the year of service to which the quarterly payment relates.
Equity Compensation
1.Restricted Stock Units (RSUs).
(a) Initial RSU Awards. New non-employee Directors will automatically be awarded, without any further action by the Compensation Committee, 34,200 RSUs (each RSU relating to one (1) share of Common Stock) on the date of their initial election or appointment to the Board (the “date of grant”). This award will vest pro rata, on an annual basis as to one-third (1/3) of the RSUs on each of the first, second, and third anniversaries of the date of grant, with the number of RSUs that vests on any such date being rounded down to the nearest whole RSU, except for the third anniversary of the date of grant when one hundred percent (100%) of the RSUs shall be vested, provided, in each case, that the non-employee Director is then, and since the date of grant has continuously been, a member of the Board, except as expressly provided for below.
(b) Annual RSU Awards. Non-employee Directors will automatically be awarded, on an annual basis and without further action by the Compensation Committee, 17,100 RSUs on the earlier of the date of the Company’s annual meeting of shareholders or June 30 of the applicable year (the “date of grant”). These awards will vest on the one-year anniversary of the date of grant, or, if sooner, on the date of the Company’s next annual meeting of shareholders following the date of grant, provided in each case that the non-employee Director is then, and since the date of grant has continuously been, a member of the Board, except as expressly provided for below. If a non-employee Director is first elected to the Board other than at an annual meeting of shareholders, the number of RSUs subject to such non-employee Director’s first annual RSU award shall be pro-rated, based on the number of days between his or her date of election and the date of grant of his or her first annual RSU award. If a non-Employee Director is first elected to the Board at an annual meeting of shareholders, he or she is ineligible to receive his or her first annual RSU award until the following year.3
(c) Terms of Grant. All RSU awards granted to non-employee Directors under this policy are granted under the 2018 Plan and are subject to the terms and conditions set forth in the 2018 Plan and the form of Restricted Stock Unit Agreement approved by the Board on December 15, 2022. In the event a Director ceases to serve as a member of the Board due to the death or Disability (as defined in the 2018 Plan) of the Director, upon such cessation of service, any then-unvested RSUs will fully vest. In the event of a Change of Control (as defined in the 2018 Plan), any then-unvested RSUs will fully vest, provided that the Director is then, and since the date of grant has continuously been, a member of the Board. All capitalized terms that are not defined herein shall have the meanings set forth in the 2018 Plan.
(d) Deferral of RSUs. All RSU awards granted to non-employee Directors are eligible for deferral and/or re-deferral, as the case may be, in each case pursuant to the terms of the Deferred Share Unit Plan.
2.Stock Options.
(a) Initial Stock Option Awards. New non-employee Directors will automatically be granted, without any further action by the Compensation Committee, a stock option award covering 25,600 shares of Common Stock on the date of their initial election or appointment to the Board (the “date of grant”). This award (i) will be granted with an exercise price equal to the closing price per
3 | Any Director who transitions from an employee director to a non-employee Director without a break in service shall not be eligible to receive an award of RSUs under paragraphs 1(a), but shall be eligible to receive awards under paragraph 1(b), beginning with the first annual meeting of shareholders on or after the date on which such Director ceases to be an employee of the Company. |
share of the Common Stock on the Nasdaq Global Select Market on the date of grant, (ii) will vest pro rata, on a quarterly basis over a three-year period, as to eight and one-third percent (8-1/3%) of the number of shares covered by such award per quarter on each of September 1, December 1, March 1, and June 1 following the date of grant, beginning with the first such date to occur following the date of grant, with the number of underlying shares that vests on any such date being rounded down to the nearest whole share, except for the twelfth vesting date when one hundred percent (100%) of the underlying shares shall be vested, provided in each case that the non-employee Director is then, and since the date of grant has continuously been, a member of the Board, and (iii) will expire on the tenth (10th) anniversary of the date of grant.
(b) Annual Stock Option Grants. Non-employee Directors will automatically be granted, on an annual basis and without further action by the Compensation Committee, stock option awards covering 25,600 shares of Common Stock on the earlier of the date of the Company’s annual meeting of shareholders or June 30 of the applicable year. These awards (i) will be granted with an exercise price equal to the closing price per share of the Common Stock on the Nasdaq Global Select Market on the date of grant, (ii) will vest pro rata, on a quarterly basis over a one-year period, as to twenty-five percent (25%) of the number of shares covered by such awards per quarter on each of September 1, December 1, March 1, and June 1 following the date of grant, beginning with the first such date to occur following the date of grant, with the number of underlying shares that vests on any such date being rounded down to the nearest whole share, except for the fourth vesting date when one hundred percent (100%) of the underlying shares shall be vested, provided in each case that the non-employee Director is then, and since the date of grant has continuously been, a member of the Board, and (iii) will expire on the tenth (10th) anniversary of the date of grant. If a non-employee Director is first elected to the Board other than at an annual meeting of shareholders, the number of shares covered by such non-employee Director’s first annual stock option award shall be pro-rated, based on the number of days between his or her date of election and the date of grant of his or her first annual stock option award. If a non-employee Director is first elected to the Board at an annual meeting of shareholders, he or she is ineligible to receive his or her first annual stock option award until the following year.4
(c) Terms of Grant. All stock option awards to non-employee Directors under this policy are granted under the 2018 Plan and are subject to the terms and conditions set forth in the 2018 Plan and the form of Director Option Agreement approved by the Compensation Committee on December 15, 2022. In the event a Director ceases to serve as a member of the Board due to the death or Disability (as defined in the 2018 Plan) of the Director, upon such cessation of service, a pro rata portion of any then-unvested stock options will vest, with such pro rata portion determined based on the number of days accrued in the current vesting period prior to the date of the Director’s death or Disability. In the event of a Change of Control (as defined in the 2018 Plan), any then-unvested stock options will fully vest, provided that the Director is then, and since the date of grant has continuously been, a member of the Board. All capitalized terms that are not defined herein shall have the meanings set forth in the 2018 Plan. Notwithstanding anything in the 2018 Plan or any Director Option Agreement to the contrary, in the event of the director’s cessation of service on the Board (other than due to Cause, as defined in the 2018 Plan), each outstanding and vested stock option award shall remain exercisable until the earlier of (i) the end of the 18-month period measured from the non-employee Director’s date of retirement and (ii) the expiration date for such stock option specified in the Director Option Agreement.
Expense Reimbursements
Directors are entitled to be reimbursed for their reasonable expenses incurred in connection with attendance at Board and committee meetings during their tenure as Directors. Any reimbursement in one calendar year shall not affect the amount that may be reimbursed in any other calendar year and a reimbursement (or right thereto) may not be exchanged or liquidated for another benefit or payment. Any business expense reimbursements subject to Section 409A of the Internal Revenue Code of 1986, as amended, shall be made no later than the end of the calendar year following the calendar year in which such business expense is incurred by the Director.
Approved by the Board of Directors: June 14, 2023
4 | Any Director who transitions from an employee to a non-employee Director without a break in service shall not be eligible to receive a stock option award under paragraph 2(a), but shall be eligible to receive awards under paragraph 2(b), beginning with the first annual meeting of shareholders on or after the date on which such Director ceases to be an employee of the Company. |
EXHIBIT 31.1
CERTIFICATIONS
I, Mark Enyedy, certify that:
1. I have reviewed this quarterly report on Form 10-Q of ImmunoGen, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: July 31, 2023
/s/ Mark J. Enyedy | |
Mark J. Enyedy | |
President, Chief Executive Officer (Principal Executive Officer) | |
EXHIBIT 31.2
CERTIFICATIONS
I, Renee Lentini, certify that:
1. I have reviewed this quarterly report on Form 10-Q of ImmunoGen, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: July 31, 2023
/s/ Renee Lentini | |
Renee Lentini | |
Vice President - Finance, Chief Accounting Officer, and Interim Chief Financial Officer (Principal Accounting Officer and Principal Financial Officer) | |
EXHIBIT 32
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of ImmunoGen, Inc., a Massachusetts corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
The Quarterly Report for the period ended June 30, 2023 (the “Form 10-Q”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: July 31, 2023 | /s/ MARK J. ENYEDY |
| Mark J. Enyedy |
| President, Chief Executive Officer |
| (Principal Executive Officer) |
| |
Dated: July 31, 2023 | /s/ RENEE LENTINI |
| Renee Lentini |
| Vice President - Finance, Chief Accounting Officer, and Interim Chief Financial Officer |
| (Principal Accounting Officer and Principal Financial Officer) |
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