On February 8, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the recent progress and operating results for the quarter and year ended December 31, 2018 (Press release, ImmunoGen, FEB 8, 2019, View Source [SID1234533177]).
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"We generated significant momentum in the business during 2018, led by the completion of enrollment in FORWARD I, our registration study for mirvetuximab soravtansine in platinum-resistant ovarian cancer; the publication of combination data in over 100 patients to support label expansion; and the advancement of our earlier-stage portfolio," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "On the strength of this performance, we enter 2019 poised to deliver on a number of important catalysts for the company, including top-line results from FORWARD I in the first half of the year, the potential BLA and MAA submissions for mirvetuximab monotherapy in the second half of the year, and additional combination data from our triplet in platinum-sensitive disease. Beyond our lead program, we expect to report data from expansion studies in AML and BPDCN with our programs targeting hematological malignancies and to file an IND before year-end for IMGC936, an ADAM9-targeting ADC being developed in collaboration with MacroGenics. Finally, with the benefit of the sale of the Kadcyla royalty tail, we start the year with roughly $325 million on the balance sheet to support our development and pre-commercial activities as we transition to a fully-integrated company."
RECENT PROGRESS
Mirvetuximab Soravtansine
· Validation runs were successfully completed and commercial drug product is now in inventory.
· The Premarket Approval (PMA) submission for the folate receptor alpha companion diagnostic was initiated.
·Patient enrollment completed ahead of schedule in the FORWARD II triplet combination cohort evaluating mirvetuximab plus carboplatin and Avastin (bevacizumab) in patients with recurrent platinum-sensitive ovarian cancer.
·Initial safety and preliminary anti-tumor activity from the FORWARD II expansion cohort assessing mirvetuximab in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October. Data from this cohort confirm the activity of mirvetuximab in heavily pretreated platinum-resistant ovarian cancer, with a trend toward longer duration of response with the combination than would be expected for mirvetuximab monotherapy. Maturing data from this cohort will guide further development of this novel combination.
IGN Programs and Early-Stage Pipeline
· Both IGN programs received Orphan Drug Designation in acute myeloid leukemia (AML).
·Encouraging initial data from the Phase 1 study of IMGN632 in patients with relapsed or refractory adult AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December. IMGN632 displayed anti-leukemia activity across all dose levels tested and a tolerable safety profile at doses up to 0.3 mg/kg. Enrollment in expansion cohorts is ongoing to identify the recommended Phase 2 dose and schedule for both AML and BPDCN.
· Updated data from the IMGN779 Phase 1 dose finding study in AML patients were also presented at ASH (Free ASH Whitepaper). These data show that IMGN779 continues to display a tolerable safety profile with repeat dosing across a wide range of doses on the two schedules explored in patients with relapsed AML, with anti-leukemia activity seen in both schedules. Enrollment is ongoing to identify the recommended Phase 2 dose and schedule.
·IND-enabling activities were initiated during the quarter for IMGC936, a novel ADAM9-targeting ADC being developed in collaboration with MacroGenics.
·Multiple abstracts highlighting platform innovations were submitted for presentation at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
Operational Updates
·Commercial planning and launch readiness activities for mirvetuximab have been initiated to support a potential launch in 2020.
·Earlier this month, ImmunoGen announced the sale of residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to the Ontario Municipal Employees Retirement System (OMERS), the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, for $65 million.
ANTICIPATED 2019 EVENTS
·Report top-line results from Phase 3 FORWARD I trial of mirvetuximab in platinum-resistant ovarian cancer in the first half of 2019, followed by full FORWARD I data presentation at a medical meeting;
·Assuming a positive readout of FORWARD I, submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) for mirvetuximab for the treatment of women with platinum-resistant ovarian cancer in 2H 2019;
·Enroll FORWARD II Avastin cohort in platinum-agnostic ovarian cancer;
·Present initial FORWARD II triplet and mature doublet expansion cohort data;
·Present updated IMGN632 data with additional AML and BPDCN patients, and establish the recommended Phase 2 dose and schedule;
·Initiate IMGN632 combination studies;
· Establish IMGN779 recommended Phase 2 dose and schedule for combination studies in AML; and
·Submit an IND for IMGC936 before the end of 2019.
FINANCIAL RESULTS
Revenues for the year ended December 31, 2018 were $53.8 million, compared with $115.4 million for the year ended December 31, 2017. License and milestone fees of $15.3 million for 2018 included $13.8 million of recognized upfront fees previously received from partners and $1.5 million in partner milestone payments. This was compared to license and milestone fees of $79.5 million for 2017, which included a $30 million paid-up license fee related to an amendment to the Company’s collaboration and license agreement with Sanofi, $29.5 million related to the sale and transfer of the Company’s IMGN529 asset to Debiopharm, $7 million in partner milestone payments, and $12.7 million in amortization of a non-cash fee related to the Company’s license agreement with CytomX. Revenues for 2018 included $32.5 million in non-cash royalty revenues, compared with $28.1 million for 2017. Revenues for 2018 also included $1.4 million of research and development (R&D) support fees and $4.6 million of clinical materials revenue, compared with $3.5 million and $4.4 million, respectively, for 2017.
Operating expenses for 2018 were $214.3 million, compared with $174.4 million for 2017. The increase was driven by R&D expenses, which were $173.9 million for 2018, compared with $139.7 million for 2017. This increase was primarily due to higher external manufacturing costs and third-party service fees in support of commercial validation for mirvetuximab soravtansine, along with higher clinical trial costs related to the FORWARD I, FORWARD II, and IMGN632 studies and, to a lesser extent, an increase in stock-based compensation. General and administrative expenses for 2018 increased to $36.7 million, compared to $33.9 million for 2017, primarily due to increased third-party service fees and stock-based compensation. Operating expenses for 2018 also included a $3.7 million restructuring charge due to the previously announced decommissioning of the Company’s Norwood facility, compared to a $0.8 million charge in 2017 related to a loss recorded on leased office space.
ImmunoGen reported a net loss of $167.9 million, or $1.20 per basic and diluted share, for 2018, compared with a net loss of $96.0 million, or $0.98 per basic and diluted share, for 2017. Weighted average shares outstanding increased to 139.9 million in 2018 from 98.1 million in 2017.
ImmunoGen had $262.3 million in cash and cash equivalents as of December 31, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $166.4 million for 2018, compared with cash provided from operations of $7.6 million for 2017. The prior period benefited from a $75 million upfront payment received from Jazz Pharmaceuticals, and $59.5 million of fees received from Sanofi and Debiopharm. Capital expenditures were $5.2 million and $1.1 million for 2018 and 2017, respectively.
FINANCIAL GUIDANCE
For 2019, ImmunoGen expects:
·cash and cash equivalents at December 31, 2019 to be between $135 million and $140 million;
· revenues between $40 million and $45 million; and
·operating expenses between $265 and $270 million.
ImmunoGen expects that its current cash combined with the expected cash receipts from partners and collaborators will enable the Company to fund its operations at least a year beyond the release of top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.
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 323-794-2093; the conference ID is 6271602. 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 February 22, 2019.