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ImmunoGen (IMGN) Q1 Earnings Top, Pivotal Studies Delayed

ImmunoGen, Inc. IMGN incurred loss of 17 cents per share for the first quarter of 2021, narrower than the Zacks Consensus Estimate of a loss of 19 cents per share and in line with the loss in the year-ago quarter

Revenues came in at $15.7 million, which missed the Zacks Consensus Estimate of $16.92 million. Revenues were up 18.2% year over year.

Quarter in Details

First-quarter revenues included $15.6 million in non-cash royalty revenues, up 19.6% year over year. Then company records a key portion of these revenues from royalties on global sales of its partner Roche’s RHHBY Kadcyla.

ImmunoGen recorded license and milestone fees of $0.2 million in the first quarter, compared with $0.3 million in the year-ago quarter.

During the quarter, research and development expenses increased 25.6% from the year-ago level to $34.4 million. The significant increase was due to higher clinical activity related to its lead pipeline candidate, mirvetuximab soravtansine.

General and administrative expenses increased 15.2% to $10.2 million in the first quarter of 2021.

ImmunoGen’s cash and cash equivalents increased to $283.1 million at the end of March 2021 compared with $293.9 million at the end of December 2020.

Pipeline Update

ImmunoGen is evaluating its lead pipeline candidate, mirvetuximab soravtansine, in a pivotal study — SORAYA — in platinum-resistant ovarian cancer patients. The company expects the data from this study to form the basis of the candidate’s regulatory filing under accelerated pathway for ovarian cancer.

The company is 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 the MIRASOL study will support its continued approval of the candidate in the indication.

Delay in patient enrollment in the SORAYA study and COVID related impact on MIRASOL study have delayed top-line data readout from these studies almost by a quarter. The company now expects top-line data from the SORAYA study in the fourth quarter of 2021, which was previously anticipated in the third quarter. The delay in SORAYA study data readout will also delay the filing of a biologics license application to the first quarter of 2022. Top-line data from the MIRASOL study is now expected in the third quarter of 2022, which was previously expected in the second quarter of 2022.

ImmunoGen’s shares were down 1.8% in pre-market trading on May 10, following the mixed first quarter results. Moreover, delay in pivotal studies on the lead candidate is likely to have impacted share price as well. However, shares of the company have gained 13.7% so far this year against the industry’s decrease of 11.6%.

Meanwhile, an investigator-sponsored phase II study is expected to be initiated in the latter half of 2021 to evaluate mirvetuximab plus carboplatin in the neoadjuvant setting for treating ovarian cancer. ImmunoGen also plans to initiate a single-arm study to evaluate mirvetuximab monotherapy for treating recurrent platinum-sensitive ovarian cancer in the second half of 2021.

The company has another promising candidate, IMGN632, in its pipeline. It is being developed in clinical studies as monotherapy or in combination with Bristol-MyersBMY Vidaza or AbbVie ABBV/Roche’s Venclexta for treating acute myeloid leukemia. It is also developing IMGN632 monotherapy in a phase I/II in patients with blastic plasmacytoid dendritic cell neoplasm and acute lymphocytic leukemia.

The company initiated a phase I study on IMGC936 to evaluate it in solid tumors recently. The company will co-develop the candidate with MacroGenics. Initial data from the study is expected later this year or early 2022. The company plans to file an IND application with the FDA for a new candidate, IMGN151, by year-end.

Maintains 2021 Guidance

ImmunoGen reiterated its previous guidance for revenues, operating expenses and cash resources in 2021. The company expects revenues for the full year to be between $65 million and $75 million. The Zacks Consensus Estimates for 2021 revenues stands at $68.65 million.

The company expects operating expense to be in the range of $200-$210 million. It expects to end 2021 with cash and cash equivalents in the range of $140 million to $150 million.

It expects cash resources to be enough to fund its operations through the second half of 2022.

ImmunoGen, Inc. Price, Consensus and EPS Surprise

ImmunoGen, Inc. price-consensus-eps-surprise-chart | ImmunoGen, Inc. Quote

Zacks Rank

Currently, Immunogen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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