Biotechnology company ImmunoGen Inc. (IMGN:NASDAQ), which concentrates its efforts on generating targeted antibody-drug conjugates (ADCs) therapies for the treatment of cancer, today provided a report detailing its recent business activities and announced financial results for the fourth quarter and year ended December 31, 2020.
The company's President and CEO Mark Enyedy commented, "Despite the challenges of the pandemic, 2020 was a transformative year for ImmunoGen...Within our portfolio, we advanced accrual in the pivotal SORAYA and confirmatory MIRASOL trials for mirvetuximab soravtansine in patients with ovarian cancer to support our projected timelines for top-line data and regulatory submissions. In addition, we established a second registration program with our CD123-targeting ADC, IMGN632, for which we received Breakthrough Therapy designation and aligned with FDA on a path to full approval in BPDCN. Furthermore, we began dosing patients in the Phase 1 study of IMGC936, our first-in-class ADAM9-targeting ADC for solid tumors, and transitioned IMGN151, our next-generation FRα-targeting ADC, into preclinical development. Finally, through a combination of business development and activity under our ATM facility, we added over $140 million to our balance sheet in the fourth quarter."
"Taken together, our pivotal programs, experienced management team, and strong balance sheet position us well to execute on our strategy and transition ImmunoGen to a fully-integrated oncology company with two products on the market in 2022," Enyedy added.
The company discussed many of the highlights and its achievements during 2020. The company noted that it had continued patient enrollment in the pivotal SORAYA and confirmatory MIRASOL trials. The firm noted also that it was successful in advancing its partnership with Huadong Medicine and had received acceptance of the investigational new drug (IND) application for mirvetuximab in China from the National Medical Products Administration (NMPA).
The company indicated that it also worked closely with the U.S. Food and Drug Administration (FDA) to formulate "a clear path to full approval for IMGN632 by amending its ongoing 801 Phase 1/2 study with a new pivotal cohort of up to 20 frontline blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients."
The company stated that with enrollment complete in the SORAYA trial the first top-line pivotal data is expected to be available in Q3/21. The firm estimated that it will be a position to submit the biologics license application (BLA) before the end of December 2021 that will support potential accelerated approval in 2022. The firm further noted that the top-line data from the MIRASOL study should become available in H2/22.
The company reported that total revenues in Q4/20 increased to $85.8 million, compared to $44.9 million in Q4/19 and that for FY/20 total revenues were $132.3 million, versus $82.3 million for FY/19.
The firm stated that these revenues consisted of revenues from license and milestone fees and non-cash royalty revenue. A major component of these revenues totaling $62.4 million was recorded in Q4/20 as the company recognized $60.5 million of the upfront fee previously received under it collaboration agreement with Jazz Pharmaceuticals and $3.2 million in upfront fees received previously from other collaborative partners.
The firm indicated that in Q4/20, net income was $31.4 million, or $0.16 per diluted share, compared $4.8 million, or $0.03 per diluted share in Q4/19. The company additionally reported that for FY/20, it posted a net loss of $44.4 million, or $0.25 per diluted share, compared to a net loss of $104.1 million, or $0.70 per diluted share for FY/19.
ImmunoGen pointed out that in Q4/20, through its At-the-Market (ATM) facility, it sold approximately 20 million shares of its common stock, which generated around $100 million in gross proceeds. Similarly, the firm advised that it sold 4.5 million additional shares generating gross proceeds of around $35 million in January 2021.
ImmunoGen provided some forward guidance and stated that for FY/21 it expects total revenues in the range of $65-75 million with operating expenses in the range of $200-210 million and projects that at year-end 2021 it will have cash and cash equivalents on its balance sheet in the amount of $140-150 million.
ImmunoGen, Inc., based in Waltham, Mass., advised that it is "developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients." The firm endeavors to generate targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles in order to disrupt the progression of cancer giving patients many more good days.
ImmunoGen started the day with a market cap of around $1.6 billion with approximately 194.7 million shares outstanding and a short interest of about 14.0%. IMGN shares opened nearly 6% higher today at $8.54 (+$0.46, +32.67%) over yesterday's $8.08 closing price and reached a new 52-week high price this morning of $10.88. The stock has traded today between $8.43 and $10.88 per share and closed at $10.53 (+$2.45, +30.32%).[NLINSERT]
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