0001558370-23-012499.txt : 20230731 0001558370-23-012499.hdr.sgml : 20230731 20230731064032 ACCESSION NUMBER: 0001558370-23-012499 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20230731 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230731 DATE AS OF CHANGE: 20230731 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ImmunoGen, Inc. CENTRAL INDEX KEY: 0000855654 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042726691 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-17999 FILM NUMBER: 231124999 BUSINESS ADDRESS: STREET 1: 830 WINTER ST CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: (781)895-0600 MAIL ADDRESS: STREET 1: 830 WINTER ST CITY: WALTHAM STATE: MA ZIP: 02451 FORMER COMPANY: FORMER CONFORMED NAME: IMMUNOGEN INC DATE OF NAME CHANGE: 19920703 8-K 1 imgn-20230731x8k.htm 8-K
0000855654false00008556542023-07-312023-07-31

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): July 31, 2023

ImmunoGen, Inc.

(Exact name of registrant as specified in its charter)

Massachusetts

0-17999

04-2726691

(State or other jurisdiction of
incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

830 Winter Street, Waltham, MA 02451

(Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code: (781) 895-0600

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter.

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.

ITEM 2.02 – RESULTS OF OPERATION AND FINANCIAL CONDITION

On July 31, 2023, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to announce the Company’s financial results for the quarter and six months ended June 30, 2023. The press release announcing financial results for the quarter and six months ended June 30, 2023 is included as Exhibit 99.1 and incorporated herein by reference.

ITEM 9.01 Financial Statements and Exhibits.

(d): Exhibits

Exhibit No.

    

Exhibit

99.1

Press Release of ImmunoGen, Inc. dated July 31, 2023

104

Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ImmunoGen, Inc.

(Registrant)

Date: July 31, 2023

/s/ Renee Lentini

Renee Lentini

Vice President - Finance, Chief Accounting Officer and Interim Chief Financial Officer

EX-99.1 2 imgn-20230731xex99d1.htm EX-99.1

Graphic

Exhibit 99.1

ImmunoGen Reports Recent Progress and Second Quarter 2023 Financial Results

Continued Strong Momentum with ELAHERE Launch in US; Net Sales of $77.4 Million in Q2

Presented Positive Results for ELAHERE from Phase 3 MIRASOL Trial During Late-Breaking Oral Presentation at ASCO; First Therapy to Demonstrate an Overall Survival Benefit Compared to Chemotherapy in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer

Submission of ELAHERE MAA to Support Expansion into Europe and sBLA for Potential Full Approval in US on Track for Q4 2023

Presented Interim Analysis from Phase 2 CADENZA Trial at EHA Congress Showing Encouraging Anti-Tumor Activity and Durable Responses for Pivekimab Sunirine in BPDCN; Pivotal Frontline Cohort Now Fully Enrolled

Generated $350.8 Million in Net Proceeds from Public Equity Offering, Further Strengthening Balance Sheet

Conference Call to be Held at 8:00 a.m. ET Today

Waltham, MA – July 31, 2023 – ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.

“This quarter we achieved a significant milestone for patients and our organization. With positive data from our confirmatory MIRASOL trial, ELAHERE is the first therapy to demonstrate an overall survival benefit versus chemotherapy in a Phase 3 trial in platinum-resistant ovarian cancer. These data further support the potential of ELAHERE to become the new standard of care for FRα-positive platinum-resistant disease,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “In parallel, through strong execution by our commercial team supported by robust engagement from medical affairs, we have accelerated the ELAHERE launch, more than doubling our Q1 results with increasing breadth and depth of adoption driven by recognition of the benefits this novel treatment brings to patients with advanced ovarian cancer.”

Enyedy continued, “We also progressed our broader development program to move ELAHERE into platinum-sensitive disease and position it as the combination agent of choice in ovarian cancer. Turning to our second pivotal program, PVEK, we presented an interim analysis from our CADENZA trial showing encouraging anti-tumor activity and durable responses in BPDCN and are pleased to share that we enrolled our last patient in the pivotal de novo frontline cohort at the end of the second quarter. We also advanced development with IMGC936 and IMGN151, our second-generation ADC targeting FRα. Looking ahead, we see continued momentum through the second half of the year with multiple data readouts and regulatory milestones, including efficacy results from PICCOLO with ELAHERE monotherapy in platinum-sensitive ovarian cancer and from the expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML as well as the submissions of the MAA and sBLA for ELAHERE.”


Graphic

RECENT PROGRESS

Generated $77.4 million in ELAHERE® (mirvetuximab soravtansine-gynx) net sales for the quarter ended June 30, 2023.
Announced positive data from the confirmatory Phase 3 MIRASOL trial in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) and presented the results in a late-breaking oral session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting.
Presented an interim analysis from the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) at the European Hematology Association (EHA) 2023 Congress.
Completed enrollment in the pivotal frontline de novo BPDCN cohort in the Phase 2 CADENZA trial.
Our partner, Neopharm Israel, submitted the Marketing Authorization Application (MAA) to the Israeli Ministry of Health (MoH) for ELAHERE in FRα-positive PROC to support potential approval in mid-2024.

ANTICIPATED UPCOMING EVENTS

Submit MAA to the European Medicines Agency (EMA) for ELAHERE in FRα-positive PROC in the fourth quarter of 2023 to support approval and launch in Europe.
Submit supplemental Biologics License Application (sBLA) to the Food & Drug Administration (FDA) in the fourth quarter of 2023 to support the conversion of the accelerated approval of ELAHERE to full approval.
Our partner, Huadong Medicine, expects to submit the MAA to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-positive PROC by the end of 2023 to support potential approval and launch.
Present additional subset analyses from the Phase 3 MIRASOL trial in an oral session at the European Society of Gynaecological Oncology (ESGO) Congress in September.
Report on the primary endpoint of objective response rate (ORR) for PICCOLO, a single-arm Phase 2 trial of mirvetuximab in FRα-high platinum-sensitive ovarian cancer (PSOC), before the end of 2023.
Report data from two cohorts evaluating the pivekimab triplet with Venclexta® (venetoclax) and Vidaza® (azacitidine) in frontline acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting in December.
Provide an update on the IMGC936 non-small cell lung cancer (NSCLC) cohort following a prespecified interim analysis.

FINANCIAL RESULTS

Total revenues were $83.2 million for the quarter ended June 30, 2023, including $77.4 million of net product revenues from sales of ELAHERE, compared to $14.2 million in total revenues for the quarter ended June 30, 2022. The increase was primarily driven by ELAHERE net sales, partially offset by $6.9 million of license fees recorded as revenue in the prior year period pursuant to the Company’s collaboration agreement with Huadong Medicine Co., Ltd (Huadong Medicine).

Research and development expenses were $50.1 million for the quarter ended June 30, 2023 compared to $51.4 million for the quarter ended June 30, 2022. The decrease was primarily driven by a $7.5 million one-time upfront fee recorded in the prior period related to our research collaboration with Oxford Biotherapeutics Ltd. and ELAHERE supply costs expensed in the prior quarter versus capitalized in the current period. Partially offsetting these decreases, third-party service fees and personnel costs increased driven largely by the expansion of our medical affairs organization, as well as an increase in clinical trial expenses in the current quarter.

Selling, general and administrative expenses were $36.4 million for the quarter ended June 30, 2023 compared to $23.8 million for the quarter ended June 30, 2022. The increase was due primarily to greater expenses in support of the US launch of ELAHERE, including costs related to the addition of our commercial organization and sales and marketing activities.

Net loss for the second quarter of 2023 was $4.2 million, or $0.02 per share, compared to a net loss of $62.0 million, or $0.24 per share, for the second quarter of 2022.

In May 2023, pursuant to a public equity offering, the Company sold an aggregate of 29,900,000 shares of its common stock, with net proceeds of $350.8 million.


Graphic

ImmunoGen had $572.0 million in cash and cash equivalents and $75.4 million in accounts receivable as of June 30, 2023, compared with $275.1 million in cash and cash equivalents and $12.6 million in accounts receivable as of December 31, 2022. Cash used in operations was $140.5 million for the first six months of 2023 compared with cash used in operations of $105.4 million for the same period in 2022. Capital expenditures were $0.3 million and $0.5 million for the first six months of 2023 and 2022, respectively.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2023 and now expects operating expenses of between $350 million and $365 million; this increase reflects greater spending in support of ELAHERE, including preparations for a launch in Europe, and to expand the Company’s research capabilities and pipeline. Revenue guidance, excluding ELAHERE sales, remains unchanged at between $45 million and $50 million.

The Company expects that its existing cash and cash equivalents, together with anticipated future product and collaboration revenues, will fund operations for more than two years.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT ELAHERE
ELAHERE® (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated 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. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE.

ABOUT IMMUNOGEN

ImmunoGen is developing 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 our patients more good days. We call this our commitment to TARGET A BETTER NOW™.

Learn more about who we are, what we do, and how we do it at www.immunogen.com.

Vidaza® and Venclexta® are registered trademarks of their respective owners. ELAHERE® is a registered trademark of ImmunoGen, Inc.


Graphic

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. These statements include, but are not limited to, the Company’s expectations related to its revenues, operating expenses, and cash forecast; the potential of ELAHERE to become the standard of care and combination agent of choice in FRα-positive ovarian cancer; the potential full approval of ELAHERE in the US and regulatory approval of ELAHERE in Europe and China; the timing and presentation of clinical data on the Company’s product candidates, including data from the MIRASOL trial, and data from the PICCOLO trial; the potential clinical benefits of pivekimab in BPDCN and AML and the potential for regulatory approval of pivekimab; and the Company’s business and product development strategies. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company's preclinical and clinical development processes; top-line data may change as more patient data become available and are subject to audit and verification procedures; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of preclinical studies, clinical trials, and regulatory processes; the timing and outcome of the Company's anticipated interactions with regulatory authorities; the risk that the Company may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for ELAHERE in light of the FDA granting accelerated approval; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen's industry and business; and other factors as set forth in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023, the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on April 28, 2023 and July 31, 2023, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. ImmunoGen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law.

INVESTOR RELATIONS CONTACT

ImmunoGen

Anabel Chan

781-895-0600

anabel.chan@immunogen.com

MEDIA CONTACTS

ImmunoGen

Courtney O’Konek

781-895-0600

courtney.okonek@immunogen.com

OR

FTI Consulting

Robert Stanislaro

212-850-5657

robert.stanislaro@fticonsulting.com


Graphic

SELECTED FINANCIAL INFORMATION

(in thousands, except per share amounts)

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

June 30,

December 31,

2023

2022

ASSETS

Cash and cash equivalents

$

571,987

$

275,138

Other assets

142,340

73,798

Total assets

$

714,327

$

348,936

LIABILITIES AND SHAREHOLDERS' EQUITY

Current portion of deferred revenue

$

14,389

$

13,856

Other current liabilities

79,313

108,002

Term loan, net

71,957

-

Long-term portion of deferred revenue

30,217

36,355

Other long-term liabilities

27,609

34,897

Shareholders' equity

490,842

155,826

Total liabilities and shareholders' equity

$

714,327

$

348,936


Graphic

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended

Six Months Ended

June 30,

June 30,

2023

2022

2023

2022

Revenues:

Product revenue, net

$

77,371

$

-

$

106,915

$

-

License and milestone fees

40

6,973

15,071

37,865

Non-cash royalty revenue

5,742

7,116

10,581

13,544

Research and development support

-

73

455

831

Total revenues

83,153

14,162

133,022

52,240

Cost and operating expenses:

Cost of sales

909

-

1,535

-

Research and development

50,077

51,422

101,697

95,704

Selling, general and administrative

36,356

23,793

76,372

40,441

Total cost and operating expenses

87,342

75,215

179,604

136,145

Interest income (expense), net

1,905

590

4,074

644

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

(1,079)

(1,078)

(1,932)

(2,327)

Other (loss) income, net

(8)

(480)

55

(578)

Loss before income taxes

$

(3,371)

$

(62,021)

$

(44,385)

$

(86,166)

Income tax expense

877

-

877

-

Net Loss

$

(4,248)

$

(62,021)

$

(45,262)

$

(86,166)

Basic and diluted net loss per common share

$

(0.02)

$

(0.24)

$

(0.17)

$

(0.34)

Basic and diluted weighted average common shares outstanding

263,446

253,336

261,160

253,263


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Document and Entity Information
Jul. 31, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Jul. 31, 2023
Securities Act File Number 0-17999
Entity Registrant Name ImmunoGen, Inc.
Entity Incorporation, State or Country Code MA
Entity Tax Identification Number 04-2726691
Entity Address, Address Line One Massachusetts
Entity Address, State or Province MA
Entity Address, City or Town Waltham
Entity Address, Postal Zip Code 02451
City Area Code 781
Local Phone Number 895-0600
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $.01 par value
Trading Symbol IMGN
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0000855654
Amendment Flag false
XML 9 R2.htm IDEA: XBRL DOCUMENT v3.23.2
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Jul. 31, 2023
Cover [Abstract]  
Entity Central Index Key 0000855654
Amendment Flag false
Securities Act File Number 0-17999
Document Type 8-K
Entity Registrant Name ImmunoGen, Inc.
Entity Address, Address Line One Massachusetts
Entity Address, City or Town Waltham
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02451
City Area Code 781
Local Phone Number 895-0600
Entity Emerging Growth Company false
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