Recent regulatory update
On May 15, Immunogen (IMGN) issued a press release announcing the FDA’s recommendation to conduct a new Phase 3 trial evaluating mirvetuximab soravtansine monotherapy in high folate receptor alpha platinum-resistant ovarian cancer indications. This recommendation was announced in a Type C meeting, which the company requested to discuss the potential path to registration for mirvetuximab monotherapy in this indication.
On March 1, Immunogen issued a press release announcing its top line results from the FORWARD I trial, which compared mirvetuximab soravtansine monotherapy with chemotherapy in folate receptor alpha platinum-resistant ovarian cancer indications. The trial failed to meet its primary endpoint of a statistically significant improvement in progression-free survival in the high folate receptor alpha expressing patient population as well as the overall patient population. However, according to its first-quarter earnings conference call, a consistent efficacy signal was seen in high folate receptor alpha expressing patients.
Since the FDA requires Immunogen to conduct a new Phase 3 trial, it implies more research and development spending for the company. It also implies that there will be a delay in the commercial launch of the drug if it gets approved by the FDA. The company had cash worth $270 million on its balance sheet at the end of the first quarter. However, in the absence of a steady revenue stream, increasing expenses may require Immunogen to take on more debt or dilute its equity. These concerns may have pushed the company’s stock down by more than 30% yesterday.
In the first quarter, Immunogen reported revenue of $8.58 million, a YoY (year-over-year) fall of 56.68% and $2.01 million lower than the consensus estimate. The company reported non-GAAP (generally accepted accounting principles) EPS of -$0.30, $0.04 higher than the consensus estimate.
Analysts expect Immunogen’s revenues to see YoY changes of 10.89% to $10.30 million in the second quarter, -12.24% to $9.59 million in the third quarter, and -24.09% to $10.47 million in the fourth quarter of 2019. Analysts also expect Immunogen’s non-GAAP EPS to see YoY rises of 17.74% to -$0.26 in the second quarter, 21.60% to -$0.25 in the third quarter, and 10.75% to -$0.25 in the fourth quarter of 2019.