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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2023

OR

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

For the transition period from            to           

Commission file number 0-17999

ImmunoGen, Inc.

Massachusetts

04-2726691

(State or other jurisdiction of incorporation or
organization)

(I.R.S. Employer Identification No.)

830 Winter Street, Waltham, MA 02451

(Address of principal executive offices) (Zip code)

(781) 895-0600

(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

Common Stock, $.01 par value

IMGN

Nasdaq Global Select Market

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

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

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

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: 266,264,274 shares outstanding as of October 25, 2023.

Table of Contents

IMMUNOGEN, INC.

FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2023

TABLE OF CONTENTS

Item

    

  

Page Number

Part I

Financial Information

1.

Financial Statements (Unaudited)

2

1a.

Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022

2

1b.

Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2023 and 2022

3

1c.

Consolidated Statements of Shareholders’ Equity for the three months ended September 30, June 30, and March 31, 2023 and the three months ended March 31, June 30, September 30, and December 31, 2022

4

1d.

Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022

5

1e.

Notes to Consolidated Financial Statements

6

2.

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

21

3.

Quantitative and Qualitative Disclosures about Market Risk

29

4.

Controls and Procedures

29

Part II

Other Information

1A.

Risk Factors

29

5.

Other Information

29

6.

Exhibits

30

Signatures

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 Reports on Form 10-Q for the quarters ended March 31, 2023 and June 30, 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

Table of Contents

ITEM 1. Financial Statements

IMMUNOGEN, INC.

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

In thousands, except per share amounts

    

September 30,

    

December 31,

2023

2022

ASSETS

Cash and cash equivalents

$

605,535

$

275,138

Accounts receivable

 

130,694

 

12,596

Unbilled receivable

 

3,026

 

1,531

Non-cash royalty receivable

3,438

3,851

Inventory

5,495

Prepaid and other current assets

 

18,712

 

11,005

Total current assets

 

766,900

 

304,121

Property and equipment, net of accumulated depreciation

 

4,431

 

4,377

Operating lease right-of-use assets

8,338

10,231

Inventory, net of current portion

28,273

16,196

Other assets

 

14,159

 

14,011

Total assets

$

822,101

$

348,936

LIABILITIES AND SHAREHOLDERS’ EQUITY

Accounts payable

$

24,853

$

45,353

Accrued compensation

 

15,155

 

11,111

Other accrued liabilities

 

43,571

 

38,783

Current portion of liability related to the sale of future royalties, net of deferred financing costs of $128 and $162, respectively

9,437

8,659

Current portion of operating lease liability

4,458

4,096

Current portion of deferred revenue

 

37,186

 

13,856

Total current liabilities

 

134,660

 

121,858

Senior secured term loan, net

72,113

Deferred revenue, net of current portion

 

26,718

 

36,355

Operating lease liability, net of current portion

7,759

11,148

Liability related to the sale of future royalties, net of current portion and deferred financing costs of $111 and $205, respectively

16,455

23,449

Other long-term liabilities

 

2,800

 

300

Total liabilities

 

260,505

 

193,110

Commitments and contingencies (Note K)

Shareholders’ equity:

Preferred stock, $.01 par value; authorized 5,000 shares; 22 and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

 

Common stock, $.01 par value; authorized 600,000 shares; 265,842 and 226,046 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

2,435

 

2,260

Additional paid-in capital

 

2,267,747

 

1,847,638

Accumulated deficit

 

(1,708,586)

 

(1,694,072)

Total shareholders’ equity

 

561,596

 

155,826

Total liabilities and shareholders’ equity

$

822,101

$

348,936

The accompanying notes are an integral part of the consolidated financial statements.

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IMMUNOGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(UNAUDITED)

In thousands, except per share amounts

Three Months Ended

Nine Months Ended

September 30,

September 30,

    

2023

    

2022

    

2023

    

2022

Revenues:

Product revenue, net

$

105,164

$

$

212,079

$

License and milestone fees

51

7,382

15,122

45,247

Non-cash royalty revenue related to the sale of future royalties

7,355

7,993

17,936

21,537

Research and development support

 

855

 

 

1,310

 

831

Total revenues

 

113,425

 

15,375

 

246,447

 

67,615

Cost and operating expenses:

Cost of sales

2,155

3,690

Research and development

 

47,570

 

59,181

 

149,267

 

154,885

Selling, general and administrative

 

37,744

 

33,623

 

114,116

 

74,064

Total cost and operating expenses

 

87,469

 

92,804

 

267,073

 

228,949

Income (loss) from operations

 

25,956

 

(77,429)

 

(20,626)

 

(161,334)

Interest income

 

7,383

 

1,539

 

14,775

 

2,183

Interest expense on term loan

(2,539)

(5,857)

 

Non-cash interest expense on liability related to the sale of future royalties and term loan

(1,054)

(867)

(2,986)

(3,194)

Other expense, net

 

(164)

 

(998)

 

(109)

 

(1,576)

Net income (loss) before income taxes

29,582

(77,755)

(14,803)

(163,921)

Income tax benefit

1,166

289

Net income (loss)

$

30,748

$

(77,755)

$

(14,514)

$

(163,921)

Net income (loss) per common share - basic (Note B)

$

0.10

$

(0.31)

$

(0.05)

$

(0.65)

Net income (loss) per common share - diluted (Note B)

$

0.10

(0.31)

$

(0.05)

$

(0.65)

Weighted-average common shares outstanding - basic

273,341

253,511

265,265

253,371

Weighted-average common shares outstanding - diluted

287,590

253,511

265,265

253,371

The accompanying notes are an integral part of the consolidated financial statements.

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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

$

220,361

$

2,204

$

1,794,525

$

(1,471,143)

$

325,586

Net loss

(24,145)

(24,145)

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

173

1

619

620

Issuance of common stock, net of issuance costs

Restricted stock units vested

2

Stock option and restricted stock compensation expense

4,196

4,196

Directors’ deferred share unit compensation

211

211

Balance at March 31, 2022

$

220,536

$

2,205

$

1,799,551

$

(1,495,288)

$

306,468

Net loss

(62,021)

(62,021)

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

108

1

410

411

Stock option and restricted stock compensation expense

4,760

4,760

Directors’ deferred share unit compensation

213

213

Balance at June 30, 2022

$

220,644

$

2,206

$

1,804,934

$

(1,557,309)

$

249,831

Net loss

(77,755)

(77,755)

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

107

2

447

449

Stock option and restricted stock compensation expense

5,336

5,336

Directors’ deferred share unit compensation

146

146

Balance at September 30, 2022

$

220,751

$

2,208

$

1,810,863

$

(1,635,064)

$

178,007

Net loss

(59,008)

(59,008)

Issuance of common stock, net of issuance costs

5,167

51

25,596

25,647

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

103

1

423

424

Stock option and restricted stock compensation expense

10,610

10,610

Restricted stock units vested

25

Directors’ deferred share unit compensation

146

146

Balance at December 31, 2022

$

226,046

$

2,260

$

1,847,638

$

(1,694,072)

$

155,826

Net loss

(41,014)

(41,014)

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

16

1

38

39

Stock option and restricted stock compensation expense

6,916

6,916

Directors’ deferred share unit and common stock compensation

8

151

151

Balance at March 31, 2023

$

226,070

$

2,261

$

1,854,743

$

(1,735,086)

$

121,918

Net loss

(4,248)

(4,248)

Issuance of common stock, net of issuance costs

29,900

299

350,534

350,833

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

3,234

32

14,874

14,906

Issuance of common stock pursuant to pre-funded warrant exchange

11,357

Issuance of Series A Preferred Stock in exchange for common stock

22

(21,853)

(218)

218

Stock option and restricted stock compensation expense

7,281

7,281

Directors’ deferred share unit and common stock compensation

4

152

152

Balance at June 30, 2023

22

$

248,712

$

2,374

$

2,227,802

$

(1,739,334)

$

490,842

Net income (loss)

30,748

30,748

Issuance of common stock pursuant to the exercise of stock options and employee stock purchase plan

6,136

61

32,105

32,166

Issuance of common stock pursuant to pre-funded warrant exchange

10,992

Issuance of common stock, net of issuance costs

(34)

(34)

Stock option and restricted stock compensation expense

7,807

7,807

Directors’ deferred share unit and common stock compensation

2

67

67

Balance at September 30, 2023

22

$

265,842

$

2,435

$

2,267,747

$

(1,708,586)

$

561,596

The accompanying notes are an integral part of the consolidated financial statements.

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IMMUNOGEN, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

In thousands

Nine Months Ended

September 30,

    

2023

    

2022

Cash flows from operating activities:

Net loss

$

(14,514)

$

(163,921)

Adjustments to reconcile net loss to net cash used for operating activities:

Non-cash royalty revenue related to sale of future royalties

(8,494)

(9,027)

Non-cash interest expense on liability related to sale of future royalties

2,691

3,194

Non-cash interest expense on amortization of debt discount and issuance costs

295

Depreciation and amortization

 

1,298

 

1,355

Stock and deferred share unit compensation

 

22,374

 

14,862

Change in operating assets and liabilities:

Accounts receivable

 

(118,098)

 

4,425

Unbilled receivable

 

(1,495)

 

1,649

Inventory

 

(17,572)

 

Contract asset

 

3,000

Prepaid and other current assets

 

(7,707)

 

(9,392)

Operating lease right-of-use assets

1,893

1,583

Other assets

 

(148)

 

(4,389)

Accounts payable

 

(20,395)

 

1,689

Accrued compensation

 

4,044

 

3,152

Other accrued liabilities

 

7,472

 

23,057

Deferred revenue

 

13,693

 

(38,257)

Operating lease liability

(3,027)

(2,583)

Net cash used for operating activities

 

(137,690)

 

(169,603)

Cash flows from investing activities:

Purchases of property and equipment

(1,641)

(1,116)

Net cash used for investing activities

 

(1,641)

 

(1,116)

Cash flows from financing activities:

Proceeds from issuance of common stock under stock plans

 

47,111

 

1,480

Proceeds from term loan, net of $3,182 of issuance costs

71,818

Proceeds from common stock issuance, net of $526 of transaction costs

350,799

Net cash provided by financing activities

 

469,728

 

1,480

Net change in cash and cash equivalents

 

330,397

 

(169,239)

Cash and cash equivalents, beginning of period

 

275,138

478,750

Cash and cash equivalents, end of period

$

605,535

$

309,511

Supplemental cash flow information:

Cash paid during the year for interest

$

4,857

$

Cash paid during the year for taxes

$

1,361

$

The accompanying notes are an integral part of the consolidated financial statements.

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IMMUNOGEN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

September 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 $14.5 million during the nine months ended September 30, 2023, and had an accumulated deficit of approximately $1.7 billion as of September 30, 2023. To date, the Company has funded these losses through payments received from its collaborations, equity, convertible debt, and other financings, such as royalty financing transactions and a term loan facility, and, more recently, through commercial sales of ELAHERE.

At September 30, 2023, the Company had $605.5 million of cash and cash equivalents on hand. The Company currently believes that its existing capital resources will be sufficient to fund its operating expenses and capital expenditures for more than twelve months after the date these financial statements were issued. The Company expects 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 its planned operating activities; however, such activities may not succeed. If such activities do not raise sufficient funds, the Company may be required to seek additional funding through equity or other financings. The failure of the Company 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 the Company’s business, results of operations, and financial condition and require the Company to defer or limit some or all of its research, development, clinical, and/or commercial projects.

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 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.

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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.

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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.

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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

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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

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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

11

Table of Contents

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