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ImmunoGen, Inc. reported earnings of 10 cents per share for third-quarter 2023 against the Zacks Consensus Estimate of a loss of 2 cents. In the year-ago quarter, IMGN had incurred a loss of 31 cents per share.
Revenues totaled $113.4 million, which also beat the Zacks Consensus Estimate of $107 million. The top line was up a whopping 636% year over year, driven by the strong revenue growth 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 2022. The drug is yet to receive approval in Europe.
Quarter in Detail
Net product revenues from Elahere were $105.2 million, which comprehensively beat our model estimate of $20 million. No product revenues were recorded in the year-ago quarter. The drug’s sales increased 35.9% sequentially.
The top line included $7.4 million in non-cash royalty revenues, down almost 8% year over year. The figure, however, beat the Zacks Consensus Estimate of $6.2 million.
License and milestone fee revenues were significantly down year over year, totaling $0.05 million. The sharp decline was primarily due to license fees of $7.4 million received in the year-ago quarter from its license agreements with Eli Lilly and Novartis Institutes for BioMedical Research, Inc.
Research and development expenses declined almost 19.6% from the year-ago quarter’s level to $47.6 million as IMGN had expensed the costs of producing Elahere in the year-ago period, while it capitalized these costs in the reported quarter as well as reduced hiring costs.
Selling, general and administrative expenses were up almost 12.2% year over year to $37.7 million. This rise was due to an increase in expenses to support Elahere’s U.S. launch.
ImmunoGen’s cash and cash equivalents were $605.5 million as of Sep 30, 2023, compared with $572 million as of Jun 30, 2023.
Shares of ImmunoGen have skyrocketed 212.5% year to date against the industry’s decline of 18.9%.
Image Source: Zacks Investment Research
2023 Guidance
The company reiterated its financial guidance for full-year 2023 that it had provided earlier this year.
The company continues to expect full-year revenues in the range of $45-$50 million (excluding Elahere product revenues).
Operating expenses are expected in the range of $350-$365 million, unchanged from the previous expectation.
IMGN believes that its current cash balance, along with expected future product and collaboration revenues, will be sufficient to fund operations for more than two years.
Pipeline and Regulatory Updates
We note that ImmunoGen evaluated Elahere in the confirmatory phase III MIRASOL study as monotherapy in patients with FRα-high PROC.
Based on positive data from this study, the company filed a supplemental biologics license application with the FDA during the quarter, seeking to convert the accelerated approval for Elahere to full approval. A potential approval is expected in the first half of 2024.
Last month, the European Medicines Agency (EMA) accepted the marketing authorization application (“MAA”) for Elahere for the treatment of patients with FRα-high PROC. The MAA was based on positive data from the MIRASOL study. Upon successful review by the EMA, a potential approval is expected in late 2024.
IMGN is also evaluating Elahere as a monotherapy in a single-arm phase II study — PICCOLO — for treating FRα-high recurrent platinum-sensitive ovarian cancer (PSOC). In the interim analysis, the study met its primary endpoint of objective response rate with no new safety issues observed. Full data from the study is expected in mid-2024.
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 studies are currently enrolling patients.
This apart, ImmunoGen has another promising candidate, pivekimab sunirine (formerly IMGN632), in its pipeline. The company is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. Data from the same is expected in 2024.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 22 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 8 cents. Year to date, shares of DVAX have rallied 32.2%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 25.78%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 41.6%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with a four-quarter earnings surprise of 53.58%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 22.4%.
Earnings of Ligand Pharmaceuticals beat estimates in three of the trailing four quarters and missed the same on the other occasion. On average, LGND came up with a four-quarter earnings surprise of 52.47%.
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ImmunoGen (IMGN) Q3 Earnings Beat, Elahere Drives Revenues
ImmunoGen, Inc. reported earnings of 10 cents per share for third-quarter 2023 against the Zacks Consensus Estimate of a loss of 2 cents. In the year-ago quarter, IMGN had incurred a loss of 31 cents per share.
Revenues totaled $113.4 million, which also beat the Zacks Consensus Estimate of $107 million. The top line was up a whopping 636% year over year, driven by the strong revenue growth 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 2022. The drug is yet to receive approval in Europe.
Quarter in Detail
Net product revenues from Elahere were $105.2 million, which comprehensively beat our model estimate of $20 million. No product revenues were recorded in the year-ago quarter. The drug’s sales increased 35.9% sequentially.
The top line included $7.4 million in non-cash royalty revenues, down almost 8% year over year. The figure, however, beat the Zacks Consensus Estimate of $6.2 million.
License and milestone fee revenues were significantly down year over year, totaling $0.05 million. The sharp decline was primarily due to license fees of $7.4 million received in the year-ago quarter from its license agreements with Eli Lilly and Novartis Institutes for BioMedical Research, Inc.
Research and development expenses declined almost 19.6% from the year-ago quarter’s level to $47.6 million as IMGN had expensed the costs of producing Elahere in the year-ago period, while it capitalized these costs in the reported quarter as well as reduced hiring costs.
Selling, general and administrative expenses were up almost 12.2% year over year to $37.7 million. This rise was due to an increase in expenses to support Elahere’s U.S. launch.
ImmunoGen’s cash and cash equivalents were $605.5 million as of Sep 30, 2023, compared with $572 million as of Jun 30, 2023.
Shares of ImmunoGen have skyrocketed 212.5% year to date against the industry’s decline of 18.9%.
2023 Guidance
The company reiterated its financial guidance for full-year 2023 that it had provided earlier this year.
The company continues to expect full-year revenues in the range of $45-$50 million (excluding Elahere product revenues).
Operating expenses are expected in the range of $350-$365 million, unchanged from the previous expectation.
IMGN believes that its current cash balance, along with expected future product and collaboration revenues, will be sufficient to fund operations for more than two years.
Pipeline and Regulatory Updates
We note that ImmunoGen evaluated Elahere in the confirmatory phase III MIRASOL study as monotherapy in patients with FRα-high PROC.
Based on positive data from this study, the company filed a supplemental biologics license application with the FDA during the quarter, seeking to convert the accelerated approval for Elahere to full approval. A potential approval is expected in the first half of 2024.
Last month, the European Medicines Agency (EMA) accepted the marketing authorization application (“MAA”) for Elahere for the treatment of patients with FRα-high PROC. The MAA was based on positive data from the MIRASOL study. Upon successful review by the EMA, a potential approval is expected in late 2024.
IMGN is also evaluating Elahere as a monotherapy in a single-arm phase II study — PICCOLO — for treating FRα-high recurrent platinum-sensitive ovarian cancer (PSOC). In the interim analysis, the study met its primary endpoint of objective response rate with no new safety issues observed. Full data from the study is expected in mid-2024.
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 studies are currently enrolling patients.
This apart, ImmunoGen has another promising candidate, pivekimab sunirine (formerly IMGN632), in its pipeline. The company is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm. Data from the same is expected in 2024.
ImmunoGen, Inc. Price, Consensus and EPS Surprise
ImmunoGen, Inc. price-consensus-eps-surprise-chart | ImmunoGen, Inc. Quote
Zacks Rank & Stocks to Consider
ImmunoGen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Dynavax Technologies Corporation (DVAX - Free Report) , MEI Pharma, Inc. (MEIP - Free Report) and Ligand Pharmaceuticals Incorporated , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 22 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 8 cents. Year to date, shares of DVAX have rallied 32.2%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 25.78%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 41.6%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with a four-quarter earnings surprise of 53.58%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 22.4%.
Earnings of Ligand Pharmaceuticals beat estimates in three of the trailing four quarters and missed the same on the other occasion. On average, LGND came up with a four-quarter earnings surprise of 52.47%.