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ImmunoGen (IMGN) Stock Down Despite Q2 Earnings & Sales Beat
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ImmunoGen, Inc. incurred a loss of 2 cents per share in second-quarter 2023, narrower than the Zacks Consensus Estimate of a loss of 16 cents. In the year-ago quarter, IMGN reported a loss of 24 cents per share.
Revenues totaled $83.2 million, which beat the Zacks Consensus Estimate of $43 million. The top line was up 487% year over year, driven by the accelerated adoption of its sole marketed drug Elahere (mirvetuximab soravtansine). The drug was approved by the FDA under the accelerated pathway for FRα-positive platinum-resistant ovarian cancer (PROC) in November last year.
Quarter in Detail
Net product revenues from the company’s first marketed product, Elahere, were $77.4 million, which beat our model estimates of $11 million. No product revenues were recorded in the year-ago quarter.
The top line also included $5.7 million in non-cash royalty revenues, down 19.31% year over year. The figure beat the Zacks Consensus Estimate and our model estimate of $4.21 million and $1 million, respectively.
License and milestone fee revenues were down 99.43% year over year, totaling $0.04 million. The decline was primarily due to the license fees of $6.9 million received in the year-ago quarter from its license agreements with Huadong Medicine.
License and milestone fee revenues missed both the Zacks Consensus Estimate and our model estimate of $7.30 million and $10 million, respectively.
During the quarter, research and development expenses declined 2.5% from the year-ago quarter’s level to $50.1 million. This was due to a one-time upfront fee of $7.5 million expensed in the year-ago quarter for a research collaboration with Oxford Biotherapeutics. Additionally, the company had expensed the costs of producing Elahere in the year-ago period, while it capitalized these costs in the reported quarter, which also contributed to the decrease.
Selling, general and administrative expenses were up almost 53% year over year to $36.4 million. This surge was due to an increase in expenses to support Elahere’s U.S. launch.
ImmunoGen’s cash and cash equivalents were $572 million as of Jun 30, 2023, compared with $201.2 million as of Mar 31, 2023.
2023 Guidance
The company updated its financial guidance for full-year 2023.
The full-year revenues remain unchanged in the range of $45-$50 million (excluding Elahere product revenues).
Investors did not cheer at this better-than-expected results probably as the company did not issue any product sales guidance for Elahere despite the new drug’s strong performance in the second quarter. Shares of the company were down 8.71% on Jul 31.
Shares of ImmunoGen have rallied 259.3% year to date compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Management expects operating expenses in the band of $350-365 million, up from the earlier projected range of $320-$335 million.
Management expects that the current cash balance, combined with the anticipated product and collaboration revenues, will be sufficient to fund operations into 2025.
Pipeline and Regulatory Updates
Earlier yesterday, Dr. Anna Berkenblit stepped down from the chief medical officer’s (CMO) position. Dr. Berkenblit has served ImmunoGen for over eight years. She will remain with the company until the end of August to facilitate the smooth transition of her responsibilities. Michael Vasconcelles, MD, executive vice president for research, development and medical affairs will be taking over the position of CMO.
In May, ImmunoGen reported positive data evaluating Elahere in the confirmatory phase III MIRASOL study as monotherapy in patients with FRα-high PROC. The study not only met its primary endpoint but also objective response and overall survival.
Based on this data, the company will file supplemental biologics license application with the FDA in the fourth quarter of 2023, seeking to convert the accelerated approval for Elahere to full approval. Management will also file a marketing authorization application to the European Medicines Agency in the fourth quarter, seeking approval of Elahere in FRα-high PROC.
IMGN is also evaluating Elahere as monotherapy in a single-arm phase II study — PICCOLO — for treating FRα-high recurrent platinum-sensitive ovarian cancer (PSOC). Data from the study is expected before this year’s end.
ImmunoGen is also evaluating combination regimens of Elahere in PSOC in two ongoing clinical studies — a phase III GLORIOSA study on the combination of Elahere and Avastin maintenance in patients with high FRα and a phase II 0420 study evaluating the combination of Elahere and carboplatin in patients with low, medium and high FRα. Both the studies are currently enrolling patients.
Other than Elahere, the company has another promising candidate, pivekimab sunirine (formerly IMGN632), in its pipeline. Management is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. The study has completed enrollment and expects to report data in 2024.
In the previous quarter, ImmunoGen received a $15-million upfront fee, pursuant to a multi-target license and option agreement executed in the first quarter with Vertex Pharmaceuticals (VRTX - Free Report) .
Earlier in March, IMGN granted licensing rights to Vertex Pharmaceuticals for its antibody-drug conjugate technology to conduct research and discover novel targeted conditioning agents for gene editing. Per the agreement, Vertex will be responsible for all research, development, commercialization and related costs of targeted conditioning agents. ImmunoGen will be eligible to receive tiered royalties on commercial sales of therapies developed under the deal.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has widened from a loss of $2.60 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.75 per share to a loss of $2.45 for 2024 during the same time frame. Shares of the company have lost 61.4% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Akoya Biosciences has narrowed from a loss of $1.80 per share to a loss of $1.71 for 2023. The consensus estimate has narrowed from a loss of $1.57 per share to a loss of $1.33 for 2024 during the same time frame. Shares of the company have lost 27.9% year to date.
AKYA’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 21.05%.
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ImmunoGen (IMGN) Stock Down Despite Q2 Earnings & Sales Beat
ImmunoGen, Inc. incurred a loss of 2 cents per share in second-quarter 2023, narrower than the Zacks Consensus Estimate of a loss of 16 cents. In the year-ago quarter, IMGN reported a loss of 24 cents per share.
Revenues totaled $83.2 million, which beat the Zacks Consensus Estimate of $43 million. The top line was up 487% year over year, driven by the accelerated adoption of its sole marketed drug Elahere (mirvetuximab soravtansine). The drug was approved by the FDA under the accelerated pathway for FRα-positive platinum-resistant ovarian cancer (PROC) in November last year.
Quarter in Detail
Net product revenues from the company’s first marketed product, Elahere, were $77.4 million, which beat our model estimates of $11 million. No product revenues were recorded in the year-ago quarter.
The top line also included $5.7 million in non-cash royalty revenues, down 19.31% year over year. The figure beat the Zacks Consensus Estimate and our model estimate of $4.21 million and $1 million, respectively.
License and milestone fee revenues were down 99.43% year over year, totaling $0.04 million. The decline was primarily due to the license fees of $6.9 million received in the year-ago quarter from its license agreements with Huadong Medicine.
License and milestone fee revenues missed both the Zacks Consensus Estimate and our model estimate of $7.30 million and $10 million, respectively.
During the quarter, research and development expenses declined 2.5% from the year-ago quarter’s level to $50.1 million. This was due to a one-time upfront fee of $7.5 million expensed in the year-ago quarter for a research collaboration with Oxford Biotherapeutics. Additionally, the company had expensed the costs of producing Elahere in the year-ago period, while it capitalized these costs in the reported quarter, which also contributed to the decrease.
Selling, general and administrative expenses were up almost 53% year over year to $36.4 million. This surge was due to an increase in expenses to support Elahere’s U.S. launch.
ImmunoGen’s cash and cash equivalents were $572 million as of Jun 30, 2023, compared with $201.2 million as of Mar 31, 2023.
2023 Guidance
The company updated its financial guidance for full-year 2023.
The full-year revenues remain unchanged in the range of $45-$50 million (excluding Elahere product revenues).
Investors did not cheer at this better-than-expected results probably as the company did not issue any product sales guidance for Elahere despite the new drug’s strong performance in the second quarter. Shares of the company were down 8.71% on Jul 31.
Shares of ImmunoGen have rallied 259.3% year to date compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Management expects operating expenses in the band of $350-365 million, up from the earlier projected range of $320-$335 million.
Management expects that the current cash balance, combined with the anticipated product and collaboration revenues, will be sufficient to fund operations into 2025.
Pipeline and Regulatory Updates
Earlier yesterday, Dr. Anna Berkenblit stepped down from the chief medical officer’s (CMO) position. Dr. Berkenblit has served ImmunoGen for over eight years. She will remain with the company until the end of August to facilitate the smooth transition of her responsibilities. Michael Vasconcelles, MD, executive vice president for research, development and medical affairs will be taking over the position of CMO.
In May, ImmunoGen reported positive data evaluating Elahere in the confirmatory phase III MIRASOL study as monotherapy in patients with FRα-high PROC. The study not only met its primary endpoint but also objective response and overall survival.
Based on this data, the company will file supplemental biologics license application with the FDA in the fourth quarter of 2023, seeking to convert the accelerated approval for Elahere to full approval. Management will also file a marketing authorization application to the European Medicines Agency in the fourth quarter, seeking approval of Elahere in FRα-high PROC.
IMGN is also evaluating Elahere as monotherapy in a single-arm phase II study — PICCOLO — for treating FRα-high recurrent platinum-sensitive ovarian cancer (PSOC). Data from the study is expected before this year’s end.
ImmunoGen is also evaluating combination regimens of Elahere in PSOC in two ongoing clinical studies — a phase III GLORIOSA study on the combination of Elahere and Avastin maintenance in patients with high FRα and a phase II 0420 study evaluating the combination of Elahere and carboplatin in patients with low, medium and high FRα. Both the studies are currently enrolling patients.
Other than Elahere, the company has another promising candidate, pivekimab sunirine (formerly IMGN632), in its pipeline. Management is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. The study has completed enrollment and expects to report data in 2024.
In the previous quarter, ImmunoGen received a $15-million upfront fee, pursuant to a multi-target license and option agreement executed in the first quarter with Vertex Pharmaceuticals (VRTX - Free Report) .
Earlier in March, IMGN granted licensing rights to Vertex Pharmaceuticals for its antibody-drug conjugate technology to conduct research and discover novel targeted conditioning agents for gene editing. Per the agreement, Vertex will be responsible for all research, development, commercialization and related costs of targeted conditioning agents. ImmunoGen will be eligible to receive tiered royalties on commercial sales of therapies developed under the deal.
ImmunoGen, Inc. Price and Consensus
ImmunoGen, Inc. price-consensus-chart | ImmunoGen, Inc. Quote
Zacks Rank and Other Stocks to Consider
ImmunoGen currently sports a Zacks Rank #1 (Strong Buy).
A couple of other top-ranked stocks in the same industry are ADC Therapeutics (ADCT - Free Report) and Akoya Biosciences (AKYA - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has widened from a loss of $2.60 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.75 per share to a loss of $2.45 for 2024 during the same time frame. Shares of the company have lost 61.4% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Akoya Biosciences has narrowed from a loss of $1.80 per share to a loss of $1.71 for 2023. The consensus estimate has narrowed from a loss of $1.57 per share to a loss of $1.33 for 2024 during the same time frame. Shares of the company have lost 27.9% year to date.
AKYA’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 21.05%.