| ● | Completed dose escalation in the Phase 1 study of img src='https://www.sec.gov/Archives/edgar/data/855654/000155837023002470/https://www.sec.gov/Archives/edgar/data/855654/000155837023002470/imgn-20230301xex99d1001.jpg' alt="Graphic" style="display:inline-block;height:30.6pt;left:0%;padding-bottom:0pt;position:relative;top:0pt;width:158.65pt;">FINANCIAL RESULTS Total revenues were $41.2 million for the quarter ended December 31, 2022 compared to $28.0 million for the quarter ended December 31, 2021, and $108.8 million for the year ended December 31, 2022 compared to $69.9 million for the year ended December 31, 2021. The increase in the quarter ended December 31, 2022 was primarily driven by one-time milestone payments achieved pursuant to the Company’s license and collaboration agreements with Huadong Medicine and Viridian Therapeutics. In addition to greater partner milestones achieved, the increase for the current year was driven by one-time license fees received pursuant to agreements executed with Eli Lilly and Magenta Therapeutics in 2022, as well as greater amortization in 2022 of the $40.0 million upfront fee previously received pursuant to the Company’s collaboration agreement with Huadong Medicine. The Company also recorded $2.6 million in net product revenue from sales of ELAHERE for the quarter and year ended December 31, 2022. Research and development expenses rose to $58.5 million for the quarter ended December 31, 2022 compared to $49.0 million for the quarter ended December 31, 2021, and $213.4 million for the year ended December 31, 2022 compared to $151.1 million for the year ended December 31, 2021. The increases in both periods were driven by greater personnel and temporary staffing costs, external manufacturing costs, and third-party service fees, including medical affairs’ activities in support of the US commercial launch of ELAHERE in the fourth quarter of 2022, as well as greater clinical trial expenses. Additionally, research and development expenses for the year ended December 31, 2022 included $8.9 million of research costs to expand our ADC pipeline, inclusive of a one-time $7.5 million upfront fee paid to Oxford BioTherapeutics. Selling, general and administrative expenses were $42.1 million for the quarter ended December 31, 2022 compared to $13.6 million for the quarter ended December 31, 2021, and $116.1 million for the year ended December 31, 2022 compared to $43.8 million for the year ended December 31, 2021. The increases in both periods were due primarily to building our commercial infrastructure and capabilities, including personnel-related costs and sales and marketing activities in support of the US launch of ELAHERE in the fourth quarter of 2022. Net loss for the fourth quarter of 2022 was $59.0 million, or $0.23 per diluted share, compared to net loss of $37.2 million, or $0.17 per diluted share, for the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $222.9 million, or $0.88 per diluted share, compared to a net loss of $139.3 million, or $0.68 per diluted share, for the year ended December 31, 2021. ImmunoGen had $275.1 million in cash and cash equivalents as of December 31, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $229.8 million for the year ended December 31, 2022 compared with $169.4 million for the year ended December 31, 2021. Capital expenditures were $1.4 million in each of the years ended December 31, 2022 and 2021. During the quarter ended December 31, 2022, the Company sold 5.2 million shares of its common stock through its At-the-Market facility, generating net proceeds to the Company of $25.6 million. FINANCIAL GUIDANCE For 2023, ImmunoGen expects: | ● | revenues, excluding product revenue from ELAHERE, between $30 million and $35 million; and |
| ● | operating expenses between $310 million and $320 million. |
ImmunoGen expects to provide ELAHERE product revenue guidance later this year. Excluding anticipated ELAHERE and collaboration revenue, our level of cash and cash equivalents as of December 31, 2022, alone is not sufficient to meet our current operating plans through March 1, 2024. With the addition of forecasted ELAHERE product revenue and milestone payments under existing collaboration agreements, we expect these amounts combined with existing cash and cash equivalents will fund operations for more than 12 months from the date of this release. The Company intends to raise additional funds through equity, debt, or other financings. CONFERENCE CALL INFORMATION ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be
accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location. ABOUT ELAHERE™ (MIRVETUXIMAB SORAVTANSINE-GYNX) ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE. ABOUT IMMUNOGEN ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™. Learn more about who we are, what we do, and how we do it at www.immunogen.com. Vidaza®, and Venclexta® are registered trademarks of their respective owners. ELAHERE™ is a trademark of ImmunoGen, Inc. FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. These statements include, but are not limited to, ImmunoGen’s expectations related to: the Company’s revenues and operating expenses for 2023; the Company’s anticipated cash runway; the Company’s expectations regarding future financing activities; the occurrence, timing, and outcome of potential preclinical, clinical, and regulatory events related to, and the potential benefits of, the Company’s product candidates, including, but not limited to: the commercialization of ELAHERE, the potential of ELAHERE to become the combination agent of choice, and the potential full approval of ELAHERE in the US and expansion to Europe; the timing and presentation of preclinical and clinical data on the Company’s product candidates, including data from the MIRASOL trial, data from the CADENZA trial, data from the SORAYA trial, and data from the Phase 1 trial of img src='https://www.sec.gov/Archives/edgar/data/855654/000155837023002470/https://www.sec.gov/Archives/edgar/data/855654/000155837023002470/imgn-20230301xex99d1001.jpg' alt="Graphic" style="display:inline-block;height:30.6pt;left:0%;padding-bottom:0pt;position:relative;top:0pt;width:158.65pt;"> INVESTOR RELATIONS CONTACT ImmunoGen Anabel Chan 781-895-0600 anabel.chan@immunogen.com MEDIA CONTACTS ImmunoGen Courtney O’Konek 781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting Robert Stanislaro 212-850-5657 robert.stanislaro@fticonsulting.com
| | | | | | SELECTED FINANCIAL INFORMATION | (in thousands, except per share amounts) | | | | | | | CONDENSED CONSOLIDATED BALANCE SHEETS | (Unaudited) | | | | | | | | December 31, | | December 31, | | 2022 | | 2021 | ASSETS | | | | | | | | | | Cash and cash equivalents | $ | 275,138 | | $ | 478,750 | Other assets | | 73,798 | | | 47,015 | | | | | | | Total assets | $ | 348,936 | | $ | 525,765 | | | | | | | LIABILITIES AND SHAREHOLDERS' EQUITY | | | | | | | | | | | | Current portion of deferred revenue | $ | 13,856 | | $ | 44,351 | Other current liabilities | | 108,002 | | | 56,594 | Long-term portion of deferred revenue | | 36,355 | | | 47,717 | Other long-term liabilities | | 34,897 | | | 51,517 | Shareholders' equity | | 155,826 | | | 325,586 | | | | | | | Total liabilities and shareholders' equity | $ | 348,936 | | $ | 525,765 |
| | | | | | | | | | | | | CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | (Unaudited) | | | | | | | | | | | | | | | Three Months Ended | | Year Ended | | December | | December | | 2022 | | 2021 | | | 2022 | | 2021 | | | | | | | | | | | | | | Revenues: | | | | | | | | | | | | | License and milestone fees | $ | 30,780 | | $ | 19,564 | | | $ | 76,027 | | $ | 22,650 | Non-cash royalty revenue | | 7,724 | | | 8,040 | | | | 29,261 | | | 46,808 | Product revenue, net | | 2,554 | | | - | | | | 2,554 | | | - | Research and development support | | 109 | | | 388 | | | | 940 | | | 398 | | | | | | | | | | | | | | Total revenues | | 41,167 | | | 27,992 | | | | 108,782 | | | 69,856 | | | | | | | | | | | | | | Cost and operating expenses: | | | | | | | | | | | | | Cost of sales | | 176 | | | - | | | | 176 | | | - | Research and development | | 58,485 | | | 48,968 | | | | 213,370 | | | 151,117 | Selling, general and administrative | | 42,065 | | | 13,578 | | | | 116,129 | | | 43,812 | | | | | | | | | | | | | | Total cost and operating expenses | | 100,726 | | | 62,546 | | | | 329,675 | | | 194,929 | | | | | | | | | | | | | | Loss from operations | | (59,559) | | | (34,554) | | | | (220,893) | | | (125,073) | | | | | | | | | | | | | | Non-cash interest expense on liability related to sale of future royalty & convertible bonds | | (971) | | | (2,151) | | | | (4,165) | | | (13,103) | Interest expense on convertible bonds | | - | | | - | | | | - | | | (47) | Other income (loss), net | | 2,740 | | | (467) | | | | 3,347 | | | (1,080) | | | | | | | | | | | | | | Loss before income taxes | $ | (57,790) | | $ | (37,172) | | | $ | (221,711) | | $ | (139,303) | Income tax expense | | 1,218 | | | - | | | | 1,218 | | | - | | | | | | | | | | | | | | Net Loss | $ | (59,008) | | $ | (37,172) | | | $ | (222,929) | | $ | (139,303) | Basic and diluted net loss per common share | $ | (0.23) | | $ | (0.17) | | | $ | (0.88) | | $ | (0.68) | | | | | | | | | | | | | | Basic and diluted weighted average common shares outstanding | | 254,405 | | | 215,830 | | | | 253,361 | | | 206,147 |
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