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): May 3, 2019

 

ImmunoGen, Inc.

(Exact name of registrant as specified in its charter)

 

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))

 

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. ☐

 

Securities registered pursuant to Section 12(b) of the Act:

 

ITEM 2.02 – RESULTS OF OPERATION AND FINANCIAL CONDITION

 

On May 3, 2019, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to announce the company’s financial results for the quarter ended March 31, 2019.  The press release announcing financial results for the quarter ended March 31, 2019 is included as Exhibit 99.1 and incorporated herein by reference.

 

 

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS

 

(d): The following exhibit is being furnished herewith:

 

 

 

 

 

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.

 

 

 

 

Exhibit 99.1

ImmunoGen Reports Recent Progress and First Quarter 2019 Financial Results

 

Encouraging Efficacy Signal Observed in Pre-Specified Subset of Patients in Phase 3 FORWARD I Study; Company to Meet with Regulators this Quarter to Discuss Potential Path Forward for Mirvetuximab Soravtansine Monotherapy

 

FORWARD II Trial with Mirvetuximab Combinations Continues to Enroll, with Mature Data from Avastin® Expansion Cohort to be Presented at ASCO

 

Operational Review Underway with Goal of Extending Cash Position

 

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

 

Waltham, Mass. – May 3, 2019 – 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 March 31, 2019.

 

“Following the readout of the top-line results from FORWARD I, we have undertaken a comprehensive analysis of the data and see a consistent efficacy signal across a range of parameters in the pre-specified subset of ovarian cancer patients with high folate receptor alpha (FRα) expression. Specifically, in comparison to chemotherapy, we have observed higher response rates, more durable responses, and longer progression-free and overall survival in patients with high FRα expression treated with mirvetuximab,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “With the benefit of this analysis and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss a potential path to registration for mirvetuximab as a monotherapy.”

 

Enyedy continued, “In parallel, our FORWARD II combination trial continues to enroll patients and we look forward to presenting mature data for mirvetuximab in combination with Avastin in platinum-resistant ovarian cancer patients at ASCO. In addition, we ended the quarter with $270 million on the balance sheet and are conducting an operational review to enable us to extend our cash runway and execute against our goal of delivering more good days to people with cancer.”

 

RECENT PROGRESS

 

Mirvetuximab Soravtansine    

IGN Programs, Early-Stage Pipeline, and Research

 

Operational Updates

 

ANTICIPATED UPCOMING EVENTS

 

FINANCIAL RESULTS

Revenues for the quarter ended March 31, 2019 were $8.6 million, compared with $19.8 million for the quarter ended March 31, 2018. Revenues in the first quarter of 2019 included $8.5 million in non-cash royalty revenues, compared with $7.2 million for the first quarter of 2018. Revenues for the prior year period also included $11.5 million of recognized upfront license and milestone fees previously received from partners, $0.4 million of research and development (R&D) support fees, and $0.7 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

Operating expenses for the first quarter of 2019 were $50.2 million, compared with $56.6 million for the same quarter in 2018. The decrease was driven by R&D expenses, which were $38.9 million in the first quarter of 2019, compared with $44.8 million for the first quarter of 2018. This decrease was primarily due to lower clinical trial costs in the current period, driven by patient enrollment in the FORWARD I Phase 3 clinical trial during the prior year period. General and administrative expenses in the first quarter of 2019 were $10.8 million, compared to $10.0 million in the first quarter of 2018, primarily due to increased personnel costs driven by greater stock-based compensation and severance expense, partially offset by decreased third-party service fees. Operating expenses for the first quarter of 2019 also included a $0.6 million restructuring charge related to a loss recorded on leased office space, compared to a $1.7 million charge recorded in the first quarter of 2018 related to the decommissioning of the Company’s Norwood facility.  

ImmunoGen reported a net loss of $43.8 million, or $0.30 per basic and diluted share, for the first quarter of 2019, compared with a net loss of $38.6 million, or $0.30 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.8 million from 130.6 million in those quarters.

ImmunoGen had $270.4 million in cash and cash equivalents as of March 31, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash provided by operations was $10.2 million for the first quarter of 2019, compared with cash used in operations of $(50.0) million for the first quarter of 2018. The current period benefited from $65.2 million of net proceeds

generated from the sale of the Company’s residual rights to Kadcyla royalties in January 2019. Capital expenditures were $2.1 million and $1.0 million for the first quarter of 2019 and 2018, respectively.

FINANCIAL GUIDANCE

ImmunoGen will provide an update on the Company’s 2019 financial guidance following the completion of the operational review.

 

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 323-994-2093; the conference ID is 8980567. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 17, 2019.

 

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.” The Company has built a productive platform generating a broad pipeline of ADCs targeting solid tumors and hematologic malignancies.

 

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

 

Kadcyla® and Avastin® are registered trademarks of Genentech, a member of the Roche Group.

 

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing and outcome of potential pre-clinical, clinical and regulatory events related to the Company's and its collaboration partners' product programs; and the presentation of preclinical and clinical data on the Company’s and collaboration partners’ product candidates. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. 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 ImmunoGen's and the Company's collaboration partners' research and clinical development processes; 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; ImmunoGen's ability to financially support its product programs; ImmunoGen's dependence on collaborative partners; industry merger and acquisition activity; and other factors more fully described in ImmunoGen’s Annual Report on Form 10-K for the year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

 

INVESTOR RELATIONS CONTACT

Sarah Kiely

781-895-0600

sarah.kiely@immunogen.com 

 

MEDIA CONTACT

Courtney O’Konek

781-895-0600

courtney.okonek@immunogen.com 

 

OR

 

FTI Consulting

Robert Stanislaro

212-850-5657

robert.stanislaro@fticonsulting.com