On April 28, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent progress in the business and announced financial results for the quarter ended March 31, 2023 (Press release, ImmunoGen, APR 28, 2023, View Source [SID1234630667]).
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"With a strong first full quarter of sales and continued momentum in FRα testing and market access, we have started the year making great strides towards establishing ELAHERE as the standard of care for FRα-positive ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Our commercial and medical teams have delivered exemplary performances in the first stages of the ELAHERE launch and we look forward to continued success with the appointment of Isabel Kalofonos as our new Chief Commercial Officer."
Enyedy continued, "With our goal of obtaining full approval for ELAHERE in the US and expanding into Europe, we expect to announce top-line data from our confirmatory MIRASOL trial in early May. In parallel, we advanced our broader development program to move into platinum-sensitive disease and position ELAHERE as the combination agent of choice in ovarian cancer. Turning to our second pivotal program, PVEK, we expect to complete enrollment in our pivotal CADENZA trial in frontline BPDCN by the end of the year. In addition, we anticipate reporting data from our expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML at ASH (Free ASH Whitepaper) in December. We also advanced dose escalation with IMGN151, our second-generation ADC targeting FRα, and expect to report data for IMGC936 following an interim analysis. With meaningful clinical milestones coming, strong commercial uptake of ELAHERE, and a strengthened balance sheet following our recent non-dilutive term loan financing with Pharmakon, we are well positioned to create significant value for both patients and shareholders throughout the year."
RECENT PROGRESS
Generated $29.5 million in ELAHERE (mirvetuximab soravtansine-gynx) net sales for the quarter ended March 31, 2023, the first full quarter of launch following approval in November of 2022.
Reached requisite number of progression-free survival (PFS) events in the confirmatory MIRASOL trial.
Presented final overall survival and additional efficacy data from the SORAYA trial at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting.
Advanced dose escalation with IMGN151 and enrollment in the non-small cell lung cancer (NSCLC) expansion cohort for IMGC936.
Announced non-dilutive credit facility with Pharmakon Advisors, LP for up to $175 million; $75 million received upon execution.
Appointed Isabel Kalofonos as Senior Vice President and Chief Commercial Officer.
ANTICIPATED UPCOMING EVENTS
Report top-line data for MIRASOL trial in early May 2023.
Submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for ELAHERE in FRα-high platinum-resistant ovarian cancer (PROC) in the second half of 2023 to support approval and launch in Europe.
Submit supplemental Biologics License Application (sBLA) to the FDA in the second half of 2023 to support the conversion of the accelerated approval of ELAHERE to full approval.
Our partner, Huadong Medicine, to submit Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-high PROC in the second half of 2023 to support potential approval and launch.
Report on primary endpoint for PICCOLO, a single-arm Phase 2 trial of mirvetuximab in FRα-high platinum-sensitive ovarian cancer (PSOC), before the end of 2023.
Complete enrollment in the pivotal Phase 2 CADENZA trial this year.
Initiate combination cohort of pivekimab with magrolimab in relapsed/refractory (R/R) acute myeloid leukemia (AML) in collaboration with Gilead in the second half of 2023.
Report data from two cohorts evaluating the pivekimab triplet with Venclexta (venetoclax) and Vidaza (azacitidine) in frontline AML at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Report data from the IMGC936 NSCLC cohort following an interim analysis.
FINANCIAL RESULTS
Total revenues were $49.9 million for the quarter ended March 31, 2023, including $29.5 million of net product revenues from sales of ELAHERE for the first full quarter of launch following approval in November 2022, compared to $38.1 million in total revenue for the quarter ended March 31, 2022. The increase was primarily driven by ELAHERE net sales and recognition of a $15 million upfront fee received pursuant to a multi-target license and option agreement executed in the first quarter with Vertex Pharmaceuticals, partially offset by $30.8 million of license fees recorded as revenue in the prior year period pursuant to the Company’s collaboration and license agreements with Huadong Medicine and Eli Lilly.
Research and development expenses rose to $51.6 million for the quarter ended March 31, 2023 compared to $44.3 million for the quarter ended March 31, 2022. The increase was primarily driven by costs related to the addition of our medical affairs organization and clinical trial expenses.
Selling, general and administrative expenses were $40.0 million for the quarter ended March 31, 2023 compared to $16.6 million for the quarter ended March 31, 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 first quarter of 2023 was $41.0 million, or $0.16 per diluted share, compared to net loss of $24.1 million, or $0.10 per diluted share, for the first quarter of 2022.
ImmunoGen had $201.2 million in cash and cash equivalents as of March 31, 2023, compared with $275.1 million as of December 31, 2022. Cash used in operations was $73.7 million for the first three months of 2023 compared with cash used in operations of $41.4 million for the same period in 2022. Capital expenditures were $0.2 million and $0.3 for the first three months of 2023 and 2022, respectively. Earlier this month, the Company entered into a term loan credit facility for up to $175 million with entities managed by Pharmakon and drew the initial tranche of $75 million upon execution of the facility.
FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2023 and now expects:
revenues, excluding product revenue from ELAHERE, between $45 million and $50 million; and
operating expenses between $320 million and $335 million.
ImmunoGen expects to provide ELAHERE product revenue guidance later this year. The increase in revenue guidance is a result of recognizing a $15 million upfront fee from Vertex in the first quarter as no deferral was required. Additionally, the Company increased its operating expense guidance to reflect greater spend in support of ELAHERE’s launch and expected growth trajectory.
ImmunoGen expects that its current cash, inclusive of the $75 million received pursuant to the term loan facility with Pharmakon, and combined with anticipated product and collaboration revenues, will fund operations into 2025.
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.