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ImmunoGen, Inc. incurred a loss of 16 cents per share in first-quarter 2023, narrower than the Zacks Consensus Estimate and our estimate of 25 cents and 26 cents, respectively. In the year-ago quarter, it reported a loss of 10 cents per share.
Revenues came in at $49.9 million, beating the Zacks Consensus Estimate and our estimate of $22.0 million and $20.1 million, respectively. Revenues were up 31.0% year over year, driven by the accelerated adoption of 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) last November.
Quarter in Detail
Net product revenues from the company’s first marketed product, Elahere, were $29.5 million. The reported sales figure beat our model estimates of $4.0 million. No product revenues were recorded in the year-ago quarter.
Following the earnings announcement, shares increased 24.8% on Apr 28. Investors cheered the results as the company posted strong Elahere sales in its first full quarter of launch, outperforming Wall Street estimates. This better-than-expected results also provides an encouraging outlook for the drug’s performance in future quarters.
In the year so far, shares of ImmunoGen have increased 8.7% against the industry’s 1.3% decline.
Image Source: Zacks Investment Research
Revenues also included $4.8 million in non-cash royalty revenues, down 24.7% year over year.
License and milestone fee revenues were down 51.3% year over year, totaling $15.0 million. During the quarter, ImmunoGen received a $15-million upfront fee received pursuant to a multi-target license and option agreement executed in the first quarter with Vertex Pharmaceuticals (VRTX - Free Report) .
Earlier this March, ImmunoGen granted licensing rights to Vertex Pharmaceuticals for its antibody-drug conjugate (ADC) 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 year-ago quarter, ImmunoGen received license fees of $30.8 million from its license agreements with Huadong Medicine and Eli Lilly and Company (LLY - Free Report) .
ImmunoGen entered into a global multi-year licensing agreement with Lilly in February 2022. Per the deal, ImmunoGen granted Lilly exclusive rights to research, develop and commercialize ADCs combining targets selected by the latter based on the former’s novel camptothecin technology.
During the quarter, research and development (R&D) expenses increased 16.6% from the year-ago quarter’s level to $51.6 million, driven by increased expenses in clinical studies.
Selling, general and administrative expenses were up 140.4% year over year to $40.0 million in first-quarter 2023. This surge was due to increase in expenses to support Elahere’s U.S. launch.
ImmunoGen’s cash and cash equivalents were $201.2 million as of Mar 31, 2023 compared with $275.1 million as of Dec 31, 2022.
2023 Guidance
The company updated its finanicial guidance for full year 2023.
It now expects full-year revenues, excluding Elahere product revenues, in the range of $45.0-$50.0 million, up from the previous guidance of $30-$35 million. This rise is a result of the $15.0-million upfront payment received from Vertex Pharmaceuticals in first-quarter 2023.
Management expects operating expenses in the range of $320.0-335.0 million, up from the earlier projected levels of $310.0-$320.0 million.
ImmunoGen expects to provide Elahere product revenue guidance later this year.
Last month, ImmunoGen received $75.0 million, the first tranche of the $175.0-million term loan facility with Pharmakon. Management expects that the current cash balance, combined with the anticipated product and collaboration revenues, will be sufficient to fund operations into 2025.
Pipeline Updates
Currently, ImmunoGen is evaluating Elahere in the confirmatory phase III MIRASOL study in patients as monotherapy in patients with FRα-high PROC. Management is expected to report top-line data from the MIRASOL study later this month.
Based on this data, the company will file supplemental Biologics License Application (sBLA) with the FDA in second-half 2023 seeking to convert the accelerated approval for Elahere to full approval. Management will also file a marketing authorization application (MAA) to the European Medicines Agency (EMA) in second-half 2023 seeking for 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.
Other than Elahere, ImmunoGen has another promising candidate, pivekimab sunirine (formerly IMGN632). Management is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The study is expected to complete enrolment by the end of this year.
The company is also evaluating another ADC candidate, IMGC936, in a phase I study to target solid tumors. IMGC936 is being co-developed with MacroGenics. ImmunoGen is developing a next-generation anti-FRα product candidate, IMGN151 to treat patients with lower levels of FRα expression, including tumour types other than ovarian cancer. The company enrolled its first patient in the phase I study of the candidate this January.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $3.30 to $4.16. During the same period, the earnings estimates per share for 2024 have risen from $3.10 to $4.58. Shares of Ligand Pharmaceuticals have gained 14.3% in the year-to-date period.
Earnings of Ligand beat estimates in one of the last four quarters while missing the mark on the other three occasions. On average, the company’s earnings witnessed a negative surprise of 10.07%. In the last reported quarter, Ligand’s earnings beat estimates by 10.57%.
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ImmunoGen (IMGN) Q1 Earnings Beat, Elahere Uptake Encouraging
ImmunoGen, Inc. incurred a loss of 16 cents per share in first-quarter 2023, narrower than the Zacks Consensus Estimate and our estimate of 25 cents and 26 cents, respectively. In the year-ago quarter, it reported a loss of 10 cents per share.
Revenues came in at $49.9 million, beating the Zacks Consensus Estimate and our estimate of $22.0 million and $20.1 million, respectively. Revenues were up 31.0% year over year, driven by the accelerated adoption of 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) last November.
Quarter in Detail
Net product revenues from the company’s first marketed product, Elahere, were $29.5 million. The reported sales figure beat our model estimates of $4.0 million. No product revenues were recorded in the year-ago quarter.
Following the earnings announcement, shares increased 24.8% on Apr 28. Investors cheered the results as the company posted strong Elahere sales in its first full quarter of launch, outperforming Wall Street estimates. This better-than-expected results also provides an encouraging outlook for the drug’s performance in future quarters.
In the year so far, shares of ImmunoGen have increased 8.7% against the industry’s 1.3% decline.
Image Source: Zacks Investment Research
Revenues also included $4.8 million in non-cash royalty revenues, down 24.7% year over year.
License and milestone fee revenues were down 51.3% year over year, totaling $15.0 million. During the quarter, ImmunoGen received a $15-million upfront fee received pursuant to a multi-target license and option agreement executed in the first quarter with Vertex Pharmaceuticals (VRTX - Free Report) .
Earlier this March, ImmunoGen granted licensing rights to Vertex Pharmaceuticals for its antibody-drug conjugate (ADC) 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 year-ago quarter, ImmunoGen received license fees of $30.8 million from its license agreements with Huadong Medicine and Eli Lilly and Company (LLY - Free Report) .
ImmunoGen entered into a global multi-year licensing agreement with Lilly in February 2022. Per the deal, ImmunoGen granted Lilly exclusive rights to research, develop and commercialize ADCs combining targets selected by the latter based on the former’s novel camptothecin technology.
During the quarter, research and development (R&D) expenses increased 16.6% from the year-ago quarter’s level to $51.6 million, driven by increased expenses in clinical studies.
Selling, general and administrative expenses were up 140.4% year over year to $40.0 million in first-quarter 2023. This surge was due to increase in expenses to support Elahere’s U.S. launch.
ImmunoGen’s cash and cash equivalents were $201.2 million as of Mar 31, 2023 compared with $275.1 million as of Dec 31, 2022.
2023 Guidance
The company updated its finanicial guidance for full year 2023.
It now expects full-year revenues, excluding Elahere product revenues, in the range of $45.0-$50.0 million, up from the previous guidance of $30-$35 million. This rise is a result of the $15.0-million upfront payment received from Vertex Pharmaceuticals in first-quarter 2023.
Management expects operating expenses in the range of $320.0-335.0 million, up from the earlier projected levels of $310.0-$320.0 million.
ImmunoGen expects to provide Elahere product revenue guidance later this year.
Last month, ImmunoGen received $75.0 million, the first tranche of the $175.0-million term loan facility with Pharmakon. Management expects that the current cash balance, combined with the anticipated product and collaboration revenues, will be sufficient to fund operations into 2025.
Pipeline Updates
Currently, ImmunoGen is evaluating Elahere in the confirmatory phase III MIRASOL study in patients as monotherapy in patients with FRα-high PROC. Management is expected to report top-line data from the MIRASOL study later this month.
Based on this data, the company will file supplemental Biologics License Application (sBLA) with the FDA in second-half 2023 seeking to convert the accelerated approval for Elahere to full approval. Management will also file a marketing authorization application (MAA) to the European Medicines Agency (EMA) in second-half 2023 seeking for 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.
Other than Elahere, ImmunoGen has another promising candidate, pivekimab sunirine (formerly IMGN632). Management is evaluating pivekimab sunirine as a monotherapy in the pivotal phase II CADZENA study in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The study is expected to complete enrolment by the end of this year.
The company is also evaluating another ADC candidate, IMGC936, in a phase I study to target solid tumors. IMGC936 is being co-developed with MacroGenics. ImmunoGen is developing a next-generation anti-FRα product candidate, IMGN151 to treat patients with lower levels of FRα expression, including tumour types other than ovarian cancer. The company enrolled its first patient in the phase I study of the candidate this January.
ImmunoGen, Inc. Price
ImmunoGen, Inc. price | ImmunoGen, Inc. Quote
Zacks Rank & Stocks to Consider
Immunogen has a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Ligand Pharmaceuticals (LGND - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $3.30 to $4.16. During the same period, the earnings estimates per share for 2024 have risen from $3.10 to $4.58. Shares of Ligand Pharmaceuticals have gained 14.3% in the year-to-date period.
Earnings of Ligand beat estimates in one of the last four quarters while missing the mark on the other three occasions. On average, the company’s earnings witnessed a negative surprise of 10.07%. In the last reported quarter, Ligand’s earnings beat estimates by 10.57%.