ImmunoGen, Inc. IMGN reported earnings of 3 cents per share for the fourth quarter of 2019 against the Zacks Consensus Estimate of a loss of 5 cents and the year-ago loss of 28 cents. The earnings figure includes a restructuring charge of $0.5 million.
Revenues came in at $44.9 million, comfortably beating the Zacks Consensus Estimate of $29 million. Revenues also increased from the year-ago quarter figure of $13.4 million.
ImmunoGen’s shares surged 26.9% on Feb 14, following the strong fourth-quarter results. The company’s stock has gained 20.4% in the past year against the
industry’s decrease of 3.9%. Quarter in Details
During the fourth quarter, Immunogen reported license and milestone fees of $29.6 million compared with $1.75 million in the year-ago period. The significant increase was due to inclusion of amortization of an upfront payment ($14.5 million) received from Jazz Pharmaceuticals
JAZZ, a fee ($7.3 million) related to license agreement executed with CytomX and other milestone payments ($12.7 million).
Fourth-quarter revenues included $15.3 million in non-cash royalty revenues, up 65% year over year.
During the quarter, research and development expenses decreased 40.4% from the year-ago level to $26.1 million due to certain factors including reduction in personnel expenses due to restructuring initiatives. General and administrative expenses increased 0.5% to $9.8 million in the fourth quarter of 2019.
ImmunoGen’s cash and cash equivalents decreased to $176.2 million at the end of December 2019 compared with $204.5 million at the end of September 2019.
failure of mirvetuximab soravtansine in late-stage, monotherapy study – FORWARD I – in March 2019, Immunogen had initiated several restructuring initiatives including prioritizing pipeline candidates to focus on most promising programs.
In December 2019, the FDA had
advised the company to conduct a new single-arm pivotal study, which can support accelerated approval for its lead candidate, mirvetuximab soravtansine. Concurrently, it had announced a new pivotal study — SORAYA — to evaluate its lead pipeline candidate, mirvetuximab soravtansine, in platinum-resistant ovarian cancer patients. Enrollment in the study is expected to start in the first quarter of 2020, with top-line data expected to be available by mid-2021.
The company has already started enrolling patients in the confirmatory phase III MIRASOL study, which compared mirvetuximab soravtansine head-to-head with single agent chemotherapy in platinum-resistant ovarian cancer patients with high folate receptor alpha expression. Data from this study will support continued approval for the candidate, following a potential accelerated approval based on data from SORAYA study.
On its fourth-quarter earnings call, the company also announced its plan to initiate an additional investigator-sponsored clinical study to evaluate a combination of mirvetuximab soravtansine and chemotherapy, carboplatin, in platinum-sensitive ovarian cancer.
The company is also evaluating multiple combination regimens of mirvetuximab soravtansine in a phase Ib FORWARD II study for treating platinum-resistant ovarian cancer. It plans to provide updated data from a triple combination cohort of the study, evaluating the candidate in combination with Roche’s
RHHBY Avastin (bevacizumab) and carboplatin in 2020.
The company also has another promising candidate, IMGN632, in its pipeline. It is being developed in clinical studies as monotherapy or in combination with Celgene’s (now a part of Bristol-Myers) Vidaza or AbbVie (
ABBV Quick Quote ABBV - Free Report) /Roche’s Venclexta for treating acute myeloid leukemia (“AML”). It is also developing IMGN632 monotherapy in early-stage studies in patients with blastic plasmacytoid dendritic cell neoplasm and acute lymphocytic leukemia. Full-Year Results
ImmunoGen reported loss of 70 cents per share for full-year 2019, 42.1% narrower year over year. Revenues came in at $82.3 million, up 53.9% from the year-ago period.
ImmunoGen provided its guidance for 2020. The company expects revenues for the full year to be between $60 million and $65 million. The mid-point of the guided range is 59.2% higher than the Zacks Consensus Estimates of $39.27 million. It expects operating expense to be in the range of $165-$170 million. The company expects cash and cash equivalents to be between $170 million and $175 million at 2020 end.
It expects cash resources to be enough to fund its operations through the second half of 2022.