ImmunoGen, Inc. ( IMGN Quick Quote IMGN - Free Report) incurred a loss of 17 cents per share for fourth-quarter 2021, narrower than the Zacks Consensus Estimate of 18 cents. In the year-ago quarter, it reported earnings of 16 cents per share.
Revenues came in at $28 million, which beat the Zacks Consensus Estimate of $26 million. Revenues, however, declined 67.4% year over year.
Shares were up 7.4% on Feb 25 following the announcement. Shares of the company have plunged 38.7% so far this year in comparison with the
industry’s 31% decrease. Image Source: Zacks Investment Research Quarter in Detail
Fourth-quarter revenues included $8 million in non-cash royalty revenues, down 65.6% year over year. This substantial decline was on account of the absence of a significant amount of non-cash royalties from
Roche Holding AG’s ( RHHBY Quick Quote RHHBY - Free Report) marketed drug Kadcyla, recorded in the prior-year quarter.
We note that the company’s ADC technology is used in Roche's Kadcyla. The drug is one of the key drivers of RHHBY’s top line. For full-year 2021, Kadcyla sales were up 16% from 2020.
ImmunoGen recorded license and milestone fees of $19.6 million for the fourth quarter compared with $62.4 million in the year-ago period. This significant decline was on account of the recognition of an upfront payment of $60.5 million from
Jazz Pharmaceuticals ( JAZZ Quick Quote JAZZ - Free Report) in the year-ago period. This payment was triggered after JAZZ exercised its opt-out rights to the pivekimab sunirine (formerly IMGN632) development program. Resultantly, Jazz Pharmaceuticals has relinquished the rights to receive any royalty payments on the candidate’s sales, upon potential approval.
For the quarter, research and development expenses increased 23.7% from the year-ago level to $49 million, driven by higher clinical study expenses related to its pipeline candidates.
General and administrative expenses were up 39.4% year over year to $13.6 million for fourth-quarter 2021 due to higher personnel costs.
ImmunoGen’s cash and cash equivalents were $478.8 million at December 2021-end compared with $245.8 million at the end of September 2021.
For 2021, ImmunoGen generated revenues of $69.9 million, reflecting a significant year-over-year decline from the year-ago figure of $132.3 million.
For the same period, the company reported earnings of 68 cents per share versus the year-ago loss of 25 cents.
ImmunoGen expects revenues for the full year between $75 million and $85 million.
The company expects operating expenses in the range of $285-$295 million.
IMGN expects to end 2022 with cash and cash equivalents in the range of $245-$255 million. The company anticipates cash resources to be sufficient to fund operations into 2024.
The above figures do not take into consideration any anticipated revenues generated from product sales of mirvetuximab soravtansine, following a potential approval.
ImmunoGen is evaluating its lead pipeline candidate, mirvetuximab soravtansine, in a pivotal study — SORAYA — in platinum-resistant ovarian cancer patients. Last November, the company announced that the study met its primary endpoint of objective response rate. Based on this data, IMGN expects to file a biologics license application with the FDA, seeking accelerated approval of mirvetuximab in first-quarter 2022.
ImmunoGen is enrolling patients in the phase III MIRASOL study as a monotherapy in patients with platinum-resistant ovarian cancer with FR alpha-high. It anticipates top-line data in third-quarter 2022. Data from this study will support continued approval of mirvetuximab in the given indication.
ImmunoGen is also evaluating mirvetuximab soravtansine monotherapy in a single-arm study — PICCOLO — for treating recurrent platinum-sensitive ovarian cancer.
It intends to start two clinical studies in second-quarter 2022 evaluating combination with mirvetuximab in platinum-sensitive ovarian cancer — a phase III GLORIOSA study to evaluate the combination of mirvetuximab soravtansine and bevacizumab maintenance in patients with high FR alpha and a phase II 0420 study that will evaluate the combination of mirvetuximab soravtansine and carboplatin in patients with low, medium and high FR.
Other than mirvetuximab soravtansine, the company has another promising candidate, pivekimab sunirine, in its pipeline. IMGN is evaluating pivekimab sunirine as a monotherapy in the phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. Top-line data from the CADZENA study is expected in second-quarter 2022. It is also being evaluated in clinical studies for acute myeloid leukemia and acute lymphocytic leukemia indications.
Earlier this month, ImmunoGen
entered into a licensing agreement with Eli Lilly and Company ( LLY Quick Quote LLY - Free Report) . The agreement will provide Lilly exclusive rights to the company’s technology to develop and commercialize antibody-drug conjugates (ADCs) directed toward targets selected by LLY.
In return, Eli Lilly will pay an upfront payment of $13 million to IMGN for the initial targets. ImmunoGen is also eligible to receive an additional $32.5 million for any additional targets selected by Lilly. ImmunoGen is entitled to receive up to $1.7 billion in potential target program exercise fees and potential development, regulatory and commercial milestone payments.
Currently, Immunogen has a Zacks Rank #4 (Sell).
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