Basis of Presentation and Significant Accounting Policies |
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 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 nine months ended September 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 September 30, 2023, the aggregate amount of the transaction price allocated to remaining performance obligations comprising deferred revenue was $63.9 million. The Company expects to recognize revenue on approximately 58%, 41%, and 1% of the remaining performance obligations over the next 12 months, 13 to 60 months, and 61 to 120 months, respectively; however, the timing of recognition may vary due to such factors as the amount and timing of future sales of KADCYLA®, the timing of exercise of contract options considered to be material rights, or termination of existing development and commercialization licenses. Contract Balances from Contracts with Customers The following tables present changes in the Company’s contract assets and contract liabilities during the nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | Balance at | | | | | | | | | | | Balance at | | | December 31, 2022 | | Additions | | Deductions | | Impact of Netting | | September 30, 2023 | Contract liabilities (deferred revenue) | | $ | 50,211 | | $ | 23,227 | | $ | (9,534) | | $ | — | | $ | 63,904 |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Balance at | | | | | | | | | | | Balance at | | | December 31, 2021 | | Additions | | Deductions | | Impact of Netting | | September 30, 2022 | Contract asset | | $ | 3,000 | | $ | — | | $ | (3,000) | | $ | — | | $ | — | Contract liabilities (deferred revenue) | | $ | 92,068 | | $ | 5,704 | | $ | (43,961) | | $ | — | | $ | 53,811 |
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 | | Nine Months Ended | | | September 30, | | September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Revenue recognized in the period from: | | | | | | | | | | | | | Amounts included in contract liabilities at the beginning of the period | | $ | 3,929 | | $ | 7,337 | | $ | 9,534 | | $ | 43,961 |
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. During the nine months ended September 30, 2023, a $23.2 million upfront payment received pursuant to a collaboration and license agreement with Takeda Pharmaceutical Company Limited (Takeda) was recorded as deferred revenue and none of this amount was recognized as revenue during the nine months ended September 30, 2023. Additionally, the Company received an upfront payment of $15.0 million pursuant to a multi-target license and option agreement executed with Vertex Pharmaceuticals Incorporated (Vertex) which was recorded as license and milestone fee revenue in the nine months ended September 30, 2023. Further details of these agreements can be found in Note C, “Collaboration and License Agreements.” During the nine months ended September 30, 2023, the Company also recognized $9.4 million of previously deferred non-cash royalty revenue related to the sale of rights to KADCYLA royalties, further details of which can be found in Note F, “Liability Related to Sale of Future Royalties,” and recognized $0.1 million of license and milestone fee revenue related to numerous collaborators’ rights to technological improvements that had been previously deferred. During the nine months ended September 30, 2022, pursuant to the Company’s license agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong), upon delivery of clinical materials in the nine months ended September 30, 2022, the Company recognized as license and milestone fee revenue the remaining $28.5 million of the deferred revenue balance as of December 31, 2021, related to the $45.0 million of upfront and development milestone payments previously received. Additionally, pursuant to a license agreement executed with Eli Lilly and Company (Lilly), during the nine months ended September 30, 2022, the Company received upfront payments of $19.5 million, of which $13.8 million was recognized as license and milestone fee revenue and the remainder deferred. The Company also recognized $12.5 million of previously deferred non-cash royalty revenue related to the sale of rights to KADCYLA royalties and $2.9 million of license and milestone fee revenue related to numerous collaborators’ rights to technological improvements that had been previously deferred, which includes $2.8 million related to Novartis Institutes for BioMedical Research, Inc.’s (Novartis) termination of certain of the license agreements between the Company and Novartis in August 2022. Financial Instruments and Concentration of Credit Risk Cash and cash equivalents are primarily maintained with three financial institutions in the U.S. Deposits with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, the Company does not believe it is exposed to significant risk. The Company’s cash equivalents consist of money market funds with underlying investments primarily being U.S. Government-issued securities and high quality, short-term commercial paper. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and marketable securities. The Company held no marketable securities as of September 30, 2023 and December 31, 2022. The Company’s investment policy, approved by the Board of Directors, limits the amount it may invest in any one type of investment, thereby reducing credit risk concentrations. 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 September 30, 2023 and December 31, 2022, the Company held $605.5 million and $275.1 million, respectively, in cash and money market funds, which were classified as cash and cash equivalents. Non-cash Investing and Financing Activities The Company had $0.3 million of accrued capital expenditures as of December 31, 2022, which has been treated as a non-cash investing activity and, accordingly, is not reflected in the consolidated statement of cash flows. There were no accrued capital expenditures as of September 30, 2023. 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. |
As of September 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 September 30, 2023, the estimated fair value and gross carrying amount of the term loan was $79.7 million and $75.0 million, respectively. The Company’s disclosed fair value of the term loan falls into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. 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 nine months ended September 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 no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2023. There was no inventory held by the Company during the three and nine months ended September 30, 2022. 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 $.01 per share, underlying pre-funded warrants are included in the calculation of basic and diluted earnings per share. Shares of the Company’s Series A Convertible Preferred Stock participate in any dividends that may be declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of income, participating 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. The dilutive effect of participating securities is calculated using the more dilutive of either (i) the treasury stock method (for stock options and restricted stock units) and “if-converted” method (for Series A Convertible Preferred Stock) or (ii) the two-class method assuming the Series A Convertible Preferred Stock is not converted and applying the treasury stock method (for stock options and restricted stock units). The following table sets forth the computation of basic and diluted earnings per share for the three months ended September 30, 2023. There was a net loss in all other periods presented, and as such, no loss was allocated to participating securities pursuant to the two class method for those periods. | | | | | | Three Months Ended | | | September 30, | | | 2023 | Numerator: | | | | Net income | | $ | 30,748 | Allocation of earnings to participating securities | | | (2,276) | Numerator for basic EPS — income available to common stockholders (A) | | $ | 28,472 | Effect of dilutive securities: | | | | Add back allocation of earnings to participating securities | | $ | 2,276 | Reallocation of earnings to participating securities considering potentially dilutive securities | | | (2,171) | Numerator for diluted EPS — income available to common stockholders (C) | | $ | 28,577 | Denominator: | | | | Denominator for basic EPS — weighted average shares (B) | | | 273,341 | Effect of dilutive securities: | | | | Common stock equivalents | | | 14,249 | Denominator for diluted EPS — adjusted weighted average shares (D) | | | 287,590 | | | | | Basic EPS (A / B) | | $ | 0.10 | Diluted EPS (C / D) | | $ | 0.10 |
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 | | Nine Months Ended | | | September 30, | | September 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 | | 29,927 | | 31,479 | | 29,927 | | 31,479 | Common stock equivalents under treasury stock method for options, shares issuable under the employee stock purchase plan, and unvested restricted stock units | | 14,249 | | 2,246 | | 10,671 | | 1,437 | Common stock equivalents under if-converted method for Series A Convertible Preferred Stock | | 21,853 | | — | | 21,853 | | — |
Stock-Based Compensation As of September 30, 2023, the Company was authorized to grant future awards under three employee share-based compensation plans, which are the ImmunoGen, Inc. Amended and Restated 2018 Employee, Director and Consultant Equity Incentive Plan (the 2018 Plan), the Employee Stock Purchase Plan (the ESPP), and the ImmunoGen Inducement Equity Incentive Plan (the Inducement Plan). At the annual meeting of shareholders on June 15, 2022, the 2018 Plan was amended to provide for the issuance of stock grants, the grant of options, and the grant of stock-based awards for up to an additional 13,000,000 shares of the Company’s common stock, as well as up to 28,742,013 shares of common stock, which represent the number of shares of common stock remaining under the 2018 Plan as of April 1, 2022, and awards previously granted under the 2018 Plan and the Company’s former stock-based plans, including the ImmunoGen, Inc. 2016 and 2006 Employee, Director and Consultant Equity Incentive Plans, that forfeit, expire, or cancel without delivery of shares of common stock or which resulted in the forfeiture of shares of common stock back to the Company subsequent to April 1, 2022. The Inducement Plan was approved by the Board of Directors in December 2019, and pursuant to subsequent amendments, provides for the issuance of non-qualified option grants for up to 13,500,000 shares of the Company’s common stock. Options awarded under the two plans are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Options vest at various periods of up to four years and may be exercised within ten years of the date of grant under each of these plans. 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 zero. Expected volatility is based exclusively on historical volatility of the Company’s stock. The expected term of stock options granted is based exclusively on historical data and represents the period of time that stock options granted are expected to be outstanding. The expected term is calculated for and applied to one group of stock options as the Company does not expect substantially different exercise or post-vesting termination behavior among its option recipients. The risk-free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Dividend | | None | | None | | None | | None | Volatility | | 88.4% | | 83.3% | | 83.4% | | 83.2% | Risk-free interest rate | | 4.52% | | 3.44% | | 3.78% | | 2.48% | Expected life (years) | | 5.6 | | 5.6 | | 5.7 | | 5.9 |
Using the Black-Scholes option-pricing model, the weighted-average grant date fair values of options granted during the three months ended September 30, 2023 and 2022 were $11.52 and $3.62 per share, respectively, and $4.85 and $3.58 for options granted during the nine months ended September 30, 2023 and 2022, respectively. A summary of option activity under the Company’s equity plans for the nine months ended September 30, 2023 is presented below (in thousands, except weighted-average data): | | | | | | | | | | Weighted- | | | Number | | Average | | | of Stock | | Exercise | | | Options | | Price | Outstanding at December 31, 2022 | | 33,126 | | $ | 5.76 | Granted | | 6,316 | | | 6.71 | Exercised | | (9,121) | | | 5.05 | Forfeited/Canceled | | (2,653) | | | 6.30 | Outstanding at September 30, 2023 | | 27,668 | | $ | 6.15 |
In 2020, the Company issued 2.6 million performance-based stock options to certain employees with vesting conditioned upon the achievement of specified performance goals. In 2022, 75% of the 2.6 million performance-based stock options vested upon achievement of specified performance goals and 12.5% were forfeited. There was no stock-based compensation recorded during the three or nine months ended September 30, 2023 related to these stock options. The fair value of the remaining unvested performance-based stock options that could be expensed in future periods is $1.3 million. A summary of restricted stock unit activity under the Company’s equity plans for the nine months ended September 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 | | 138 | | $ | 5.45 | Granted | | 2,380 | | | 6.32 | Forfeited | | (259) | | | 4.66 | Unvested at September 30, 2023 | | 2,259 | | $ | 7.11 |
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 2,000,000 shares of common stock have been reserved for issuance under the ESPP. ESPP 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 $7.8 million and $22.0 million during the three and nine months ended September 30, 2023, respectively, compared to $5.3 million and $14.3 million for the three and nine months ended September 30, 2022, respectively. The increase in stock compensation expense is primarily due to significant growth in personnel in the second half of 2022. As of September 30, 2023, the estimated fair value of unvested employee awards was $72.0 million. The weighted-average remaining vesting period for these awards is approximately three years. Segment Information During all periods presented, the Company continued to operate in one reportable business segment under the management approach of ASC 280, Segment Reporting, which is the business of development and commercialization of ADCs for the treatment of cancer. During the three months ended September 30, 2023, 93% of revenues were generated from net U.S. sales of ELAHERE to four specialty distributors and specialty pharmacy providers, and 7% of revenues were generated from an agreement with Roche, compared to 52%, 30% and 18% of revenues from Roche, Lilly and Novartis, respectively, during the three months ended September 30, 2022. During the nine months ended September 30, 2023, 86% of revenues were generated from net U.S. sales of ELAHERE to four specialty distributors and specialty pharmacy providers, and 7% and 6% of revenues were generated from agreements with Roche and Vertex, respectively, compared to 43%, 32% and 20% from agreements with Huadong, Roche, and Lilly, respectively, during the nine months ended September 30, 2022. There were no other customers of the Company that generated significant revenues in the three and nine months ended September 30, 2023 and 2022. 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.
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