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ImmunoGen (IMGN) Q2 Earnings and Revenues Miss Estimates
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ImmunoGen, Inc. incurred a loss of 24 cents per share for second-quarter 2022, wider than the Zacks Consensus Estimate of 22 cents. In the year-ago quarter, it had reported a loss of 15 cents per share.
Revenues came in at $14.2 million, missing the Zacks Consensus Estimate of $17 million. Revenues were down 16.4% year over year, which was due to lower non-cash royalty revenues. However, the downside was partially offset by the recognition fees of $6.9 million previously received from its agreement with Huadong Medicine.
Shares of the company have plunged 36.1% so far this year compared with with the industry’s 18.7% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Second-quarter revenues included $7.1 million in non-cash royalty revenues, down 57.4% year over year. The substantial decline in non-cash royalty revenues was on account of the completion of the first tranche of payments from Roche Holding AG’s (RHHBY - Free Report) marketed drug Kadcyla, recorded in the prior-year quarter.
We note that the Immunogen’s antibody-drug conjugates (ADC) technology is used in Roche's Kadcyla. The drug is one of the key drivers of RHHBY’s top line.
ImmunoGen recorded license and milestone fees of $7 million in the second quarter compared with $0.3 million in the year-ago period. This significant increase was on account of the recognition of fees of $6.9 million previously received and deferred related to the company’s collaboration agreement with Huadong Medicine, executed in October 2020.
Durig the quarter, research and development expenses increased 48.7% from the year-ago quarter’s level to $51.4 million, driven by increased expenses of clinical studies and expenses related to advancement of ImmunoGen’s ADC pipeline, which includes an upfront payment of $7.5 million to Oxford BioTherapeutics.
General and administrative expenses were up 144.6% year over year to $23.8 million in second-quarter 2022 due to costs related to building commercial capabilities for the anticipated U.S launch of mirvetuximab in fourth-quarter 2022.
ImmunoGen’s cash and cash equivalents were $373.9 million as of Jun 30, 2022 compared with $437.7 million as of Mar 31, 2022.
2022 Guidance
Immunogen reaffirmed the guidance it had provided in the first quarter of 2022.
The company 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.
Pipeline Updates
In March 2022, IMGN submitted a biologics license application (BLA) to the FDA, seeking accelerated approval of mirvetuximab in platinum-resistant ovarian cancer. The filing was based on data from the pivotal phase III SORAYA study, which evaluated the candidate as monotherapy in the given indication. In May, the FDA accepted its BLA for mirvetuximab and granted priority preview. With the FDA granting priority review to the BLA, a decision is expected in November 2022.
ImmunoGen completed patient enrollment in the confirmatory phase III MIRASOL study, which is evaluating mirvetuximab soravtansine as a monotherapy in patients with platinum-resistant ovarian cancer with FR alpha-high. It anticipates top-line data in early 2023. The company previously expected the top-line data readout from the MIRASOL study in the third quarter of 2022. The delay in the readout is due to the recent reforecast of projected progression-free-survival events, which are anticipated to accrue in the fourth quarter of 2022. Data from this study will support continued approval of mirvetuximab in the given indication. The company will seek full approval for mirvetuximab soravtansine in the given indication based on MIRASOL study data.
ImmunoGen is also evaluating mirvetuximab soravtansine monotherapy in a single-arm study — PICCOLO — for treating FRα-high recurrent platinum-sensitive ovarian cancer.
It intends to start enrolling first patients in two clinical studies in 2022, evaluating combination regimens of mirvetuximab in platinum-sensitive ovarian cancer — a phase III GLORIOSA study to evaluate the combination of mirvetuximab soravtansine and Avastin (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 (formerly IMGN632), in its pipeline. IMGN is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. Preliminary efficacy data from the CADZENA study is expected by the end of 2022.
ImmunoGen is also evaluating its phase I candidate, namely, IMGC936 an ADC in co-development with MacroGenics, Inc. in multiple solid tumor types, and IMGN151, in patients with recurrent endometrial cancer and recurrent, high-grade serous epithelial ovarian, primary peritoneal or fallopian tube cancers. The preliminary efficacy data for the IMGC936 study is expected by the end of 2022.
Verrica’s loss estimates for 2022 have narrowed down from $1.26 to $1.13 in the past 30 days. Shares of Verrica have declined 65.6% year to date. Earnings of VRCA beat earnings estimates in all the last four quarters, witnessing a surprise of 28.45%, on average.
Ionis Pharmaceuticals’ loss estimates for 2022 have widened from $2.40 to $2.44 in the past 30 days. Shares of IONS have returned 23.4% year to date. Earnings of IONS beat earnings estimates in two of the trailing four quarters and missed the same in the remaining two occasions, witnessing a surprise of 24.35%, on average.
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ImmunoGen (IMGN) Q2 Earnings and Revenues Miss Estimates
ImmunoGen, Inc. incurred a loss of 24 cents per share for second-quarter 2022, wider than the Zacks Consensus Estimate of 22 cents. In the year-ago quarter, it had reported a loss of 15 cents per share.
Revenues came in at $14.2 million, missing the Zacks Consensus Estimate of $17 million. Revenues were down 16.4% year over year, which was due to lower non-cash royalty revenues. However, the downside was partially offset by the recognition fees of $6.9 million previously received from its agreement with Huadong Medicine.
Shares of the company have plunged 36.1% so far this year compared with with the industry’s 18.7% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Second-quarter revenues included $7.1 million in non-cash royalty revenues, down 57.4% year over year. The substantial decline in non-cash royalty revenues was on account of the completion of the first tranche of payments from Roche Holding AG’s (RHHBY - Free Report) marketed drug Kadcyla, recorded in the prior-year quarter.
We note that the Immunogen’s antibody-drug conjugates (ADC) technology is used in Roche's Kadcyla. The drug is one of the key drivers of RHHBY’s top line.
ImmunoGen recorded license and milestone fees of $7 million in the second quarter compared with $0.3 million in the year-ago period. This significant increase was on account of the recognition of fees of $6.9 million previously received and deferred related to the company’s collaboration agreement with Huadong Medicine, executed in October 2020.
Durig the quarter, research and development expenses increased 48.7% from the year-ago quarter’s level to $51.4 million, driven by increased expenses of clinical studies and expenses related to advancement of ImmunoGen’s ADC pipeline, which includes an upfront payment of $7.5 million to Oxford BioTherapeutics.
General and administrative expenses were up 144.6% year over year to $23.8 million in second-quarter 2022 due to costs related to building commercial capabilities for the anticipated U.S launch of mirvetuximab in fourth-quarter 2022.
ImmunoGen’s cash and cash equivalents were $373.9 million as of Jun 30, 2022 compared with $437.7 million as of Mar 31, 2022.
2022 Guidance
Immunogen reaffirmed the guidance it had provided in the first quarter of 2022.
The company 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.
Pipeline Updates
In March 2022, IMGN submitted a biologics license application (BLA) to the FDA, seeking accelerated approval of mirvetuximab in platinum-resistant ovarian cancer. The filing was based on data from the pivotal phase III SORAYA study, which evaluated the candidate as monotherapy in the given indication. In May, the FDA accepted its BLA for mirvetuximab and granted priority preview. With the FDA granting priority review to the BLA, a decision is expected in November 2022.
ImmunoGen completed patient enrollment in the confirmatory phase III MIRASOL study, which is evaluating mirvetuximab soravtansine as a monotherapy in patients with platinum-resistant ovarian cancer with FR alpha-high. It anticipates top-line data in early 2023. The company previously expected the top-line data readout from the MIRASOL study in the third quarter of 2022. The delay in the readout is due to the recent reforecast of projected progression-free-survival events, which are anticipated to accrue in the fourth quarter of 2022. Data from this study will support continued approval of mirvetuximab in the given indication. The company will seek full approval for mirvetuximab soravtansine in the given indication based on MIRASOL study data.
ImmunoGen is also evaluating mirvetuximab soravtansine monotherapy in a single-arm study — PICCOLO — for treating FRα-high recurrent platinum-sensitive ovarian cancer.
It intends to start enrolling first patients in two clinical studies in 2022, evaluating combination regimens of mirvetuximab in platinum-sensitive ovarian cancer — a phase III GLORIOSA study to evaluate the combination of mirvetuximab soravtansine and Avastin (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 (formerly IMGN632), in its pipeline. IMGN is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. Preliminary efficacy data from the CADZENA study is expected by the end of 2022.
ImmunoGen is also evaluating its phase I candidate, namely, IMGC936 an ADC in co-development with MacroGenics, Inc. in multiple solid tumor types, and IMGN151, in patients with recurrent endometrial cancer and recurrent, high-grade serous epithelial ovarian, primary peritoneal or fallopian tube cancers. The preliminary efficacy data for the IMGC936 study is expected by the end of 2022.
ImmunoGen, Inc. Price, Consensus and EPS Surprise
ImmunoGen, Inc. price-consensus-eps-surprise-chart | ImmunoGen, Inc. Quote
Zacks Rank and Stocks to Consider
Currently, Immunogen has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector are Verrica Pharmaceuticals (VRCA - Free Report) and Ionis Pharmaceuticals (IONS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Verrica’s loss estimates for 2022 have narrowed down from $1.26 to $1.13 in the past 30 days. Shares of Verrica have declined 65.6% year to date. Earnings of VRCA beat earnings estimates in all the last four quarters, witnessing a surprise of 28.45%, on average.
Ionis Pharmaceuticals’ loss estimates for 2022 have widened from $2.40 to $2.44 in the past 30 days. Shares of IONS have returned 23.4% year to date. Earnings of IONS beat earnings estimates in two of the trailing four quarters and missed the same in the remaining two occasions, witnessing a surprise of 24.35%, on average.