“Building on the momentum generated in the first half of 2023, we delivered a strong third quarter highlighted by significant ELAHERE revenue growth and the achievement of key operational milestones,” said
Enyedy continued, “In addition, we advanced the ELAHERE development program and are pleased to report that our PICCOLO trial in platinum-sensitive ovarian cancer has met the primary endpoint of objective response rate based on an interim efficacy assessment. With a number of patients remaining on treatment and longer follow-up required to establish mature response durability of ELAHERE in this patient population, we anticipate an ORR of at least 48% when we report full data in mid-2024. Turning to our second pivotal program, PVEK, we continue to advance our 802 study and look forward to reporting data from our PVEK/VEN/AZA triplet in frontline AML at ASH in December. We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα. We look forward to a strong finish to the year and a productive 2024 with the continued growth of ELAHERE, important new data for our programs, and geographic expansion in
RECENT PROGRESS
ELAHERE (mirvetuximab soravtansine-gynx)
Clinical Pipeline and Research
Corporate
ANTICIPATED UPCOMING EVENTS
FINANCIAL RESULTS
Total revenues were
Research and development expenses were
Selling, general and administrative expenses were
Net income for the third quarter of 2023 was
ImmunoGen had
FINANCIAL GUIDANCE
ImmunoGen’s full year financial guidance for 2023 remains unchanged; the Company continues to expect:
The Company continues to expect that its existing cash and cash equivalents, together with anticipated future product and collaboration revenues, will fund operations for more than two years.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at
ABOUT ELAHERE
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 registered trademark of
1 ¥3.4 billion (0.0068 exchange rate as of
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These statements include, but are not limited to, the timing and outcome of the submissions of a Marketing Authorization Application in
IMMUNOGEN, INC. | |||||||||||||||||
SELECTED FINANCIAL INFORMATION | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
2023 |
2022 |
||||||||||||||||
ASSETS | |||||||||||||||||
Cash and cash equivalents | $ |
605,535 |
$ |
275,138 |
|||||||||||||
Accounts receivable |
130,694 |
12,596 |
|||||||||||||||
Inventory |
33,768 |
16,196 |
|||||||||||||||
Other assets |
52,104 |
45,006 |
|||||||||||||||
Total assets | $ |
822,101 |
$ |
348,936 |
|||||||||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||||||||
Current portion of deferred revenue | $ |
37,186 |
$ |
13,856 |
|||||||||||||
Other current liabilities |
97,474 |
108,002 |
|||||||||||||||
Term loan, net |
72,113 |
- |
|||||||||||||||
Long-term portion of deferred revenue |
26,718 |
36,355 |
|||||||||||||||
Other long-term liabilities |
27,014 |
34,897 |
|||||||||||||||
Shareholders' equity |
561,596 |
155,826 |
|||||||||||||||
Total liabilities and shareholders' equity | $ |
822,101 |
$ |
348,936 |
|||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
2023 |
2022 |
2023 |
2022 |
||||||||||||||
Revenues: | |||||||||||||||||
Product revenue, net | $ |
105,164 |
$ |
- |
$ |
212,079 |
$ |
- |
|||||||||
License and milestone fees |
51 |
7,382 |
15,122 |
45,247 |
|||||||||||||
Non-cash royalty revenue |
7,355 |
7,993 |
17,936 |
21,537 |
|||||||||||||
Research and development support |
855 |
- |
1,310 |
831 |
|||||||||||||
Total revenues |
113,425 |
15,375 |
246,447 |
67,615 |
|||||||||||||
Cost and operating expenses: | |||||||||||||||||
Cost of sales |
2,155 |
- |
3,690 |
- |
|||||||||||||
Research and development |
47,570 |
59,181 |
149,267 |
154,885 |
|||||||||||||
Selling, general and administrative |
37,744 |
33,623 |
114,116 |
74,064 |
|||||||||||||
Total cost and operating expenses |
87,469 |
92,804 |
267,073 |
228,949 |
|||||||||||||
Income (loss) from operations |
25,956 |
(77,429) |
(20,626) |
(161,334) |
|||||||||||||
Interest income (expense), net |
4,844 |
1,539 |
8,918 |
2,183 |
|||||||||||||
Non-cash interest expense on liability related to sale of future royalty and term loan |
(1,054) |
(867) |
(2,986) |
(3,194) |
|||||||||||||
Other loss, net |
(164) |
(998) |
(109) |
(1,576) |
|||||||||||||
Income (loss) before income taxes | $ |
29,582 |
$ |
(77,755) |
$ |
(14,803) |
$ |
(163,921) |
|||||||||
Income tax benefit |
1,166 |
- |
289 |
- |
|||||||||||||
Net income (loss) |
30,748 |
(77,755) |
(14,514) |
(163,921) |
|||||||||||||
Net income (loss) per common share - basic | $ |
0.10 |
$ |
(0.31) |
$ |
(0.05) |
$ |
(0.65) |
|||||||||
Net income (loss) per common share - diluted | $ |
0.10 |
$ |
(0.31) |
$ |
(0.05) |
$ |
(0.65) |
|||||||||
Weighted-average common shares outstanding - basic |
273,341 |
253,511 |
265,265 |
253,371 |
|||||||||||||
Weighted-average common shares outstanding - diluted |
287,590 |
253,511 |
265,265 |
253,371 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20231102828508/en/
INVESTOR RELATIONS
ImmunoGen
781-895-0600
anabel.chan@immunogen.com
MEDIA
ImmunoGen
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com
Source:
YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE
Notice
The "Yes" link below will take you out of the AbbVie family of websites.
Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie.
The Internet site that you have requested may not be optimized to your screen size.
Do you wish to leave this site?