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WALTHAM, Mass.--(BUSINESS WIRE)--Mar 1, 2023--
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter and year ended December 31, 2022.
“We significantly advanced the business on multiple fronts over the last 12 months, most notably with the accelerated approval and launch of ELAHERE for patients with platinum-resistant ovarian cancer,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “We have seen broad and deep adoption of ELAHERE to date, with FRα testing, managed care coverage, and provider access all exceeding our expectations. Building upon this progress and in line with our goal of obtaining full approval for ELAHERE in the US and expanding into Europe, we will imminently reach the requisite number of PFS events in the confirmatory MIRASOL trial and expect to announce top-line data in the second quarter. In parallel, we are pursuing our broader development program in support of moving ELAHERE into platinum-sensitive disease and positioning ELAHERE as the combination agent of choice in ovarian cancer.”
Enyedy continued, “Turning to our second pivotal program, pivekimab sunirine, we presented promising findings from our triplet expansion cohorts in AML in an oral presentation at ASH in December, and continued enrollment in the pivotal CADENZA trial in frontline BPDCN with top-line data in de novo patients anticipated in 2024. We are also progressing our earlier-stage portfolio with the completion of dose escalation in the Phase 1 study of IMGC936, while also having dosed the first patient in our Phase 1 trial for IMGN151 in January. Combining our commitment to advance our pipeline of novel ADCs along with driving the commercial uptake of ELAHERE in the US, we are well positioned for another exciting and productive year.”
RECENT PROGRESS
ELAHERE (mirvetuximab soravtansine-gynx)
Clinical Pipeline
Corporate Development
ANTICIPATED UPCOMING EVENTS
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:
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 IMGC936; and the Company’s business and product development strategies. Various factors could cause ImmunoGen’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company’s preclinical and clinical development processes; the results of the ongoing MIRASOL trial may fail to support full approval of ELAHERE and, if not, additional studies may be required; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of preclinical studies, clinical trials, and regulatory processes; the timing and outcome of the Company’s anticipated interactions with regulatory authorities;the risk that we may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for ELAHERE in light of the FDA granting accelerated approval; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen’s industry and business; and other factors as set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023 and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law.
ImmunoGen, Inc. Reports Financial Results for the Quarter and Year Ended December 31, 2022 | |||||||
| IMMUNOGEN, INC. | |||||||
| 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 31, | December 31, | ||||||||||
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 |
View source version on businesswire.com:https://www.businesswire.com/news/home/20230301005398/en/
CONTACT: INVESTOR RELATIONS
ImmunoGen
Anabel Chan
781-895-0600
anabel.chan@immunogen.comMEDIA
ImmunoGen
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.comORFTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH ONCOLOGY
SOURCE: ImmunoGen, Inc.
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PUB: 03/01/2023 06:30 AM/DISC: 03/01/2023 06:33 AM
http://www.businesswire.com/news/home/20230301005398/en