Launched ELAHERE™ (mirvetuximab soravtansine-gynx), the First
and Only ADC Approved for Platinum-Resistant Ovarian Cancer in the
US; ELAHERE Monotherapy and in Combination with Bevacizumab
Included in NCCN Guidelines and Compendium
Top-Line Results from Confirmatory MIRASOL Trial Anticipated in
Q2 2023; Expected to Support Full Approval of ELAHERE in the US and
Expansion into Europe
Encouraging Safety and Efficacy Data from Pivekimab Sunirine
Triplet in AML Presented in Oral Session at ASH 2022; Clinical
Collaboration with Gilead Announced to Evaluate Pivekimab with
Magrolimab in Relapsed/Refractory AML
Announced a Global, Multi-Target License and Option Agreement of
ImmunoGen's ADC Technology to Vertex; ImmunoGen to Receive a $15
Million Upfront Payment and is Eligible to Receive Up to $337
Million in Potential Option Fees and Milestone Payments Plus Tiered
Royalties on a Per Target Basis
Appointments of Michael Vasconcelles as Executive Vice
President, Research, Development, and Medical Affairs, and Daniel
Char as Chief Legal Officer, Further Strengthen Management Team
Conference Call to be Held at 8:00 a.m. ET Today
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)
- Received US Food and Drug Administration (FDA) accelerated
approval of ELAHERE for folate receptor alpha (FRα)-positive
platinum-resistant ovarian cancer (PROC) on November 14, 2022.
- Generated $2.6 million in net sales for the fourth quarter of
2022.
- ELAHERE monotherapy and in combination with bevacizumab
included in the National Comprehensive Cancer Network (NCCN)
Clinical Practice Guidelines and compendium.
Clinical Pipeline
- Published manuscript on the safety and efficacy of mirvetuximab
in PROC in the SORAYA trial in the Journal of Clinical
Oncology.
- Published manuscript on the safety and efficacy of mirvetuximab
in combination with bevacizumab in PROC in Gynecologic
Oncology.
- Completed enrollment in PICCOLO, a single-arm study of
mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive
ovarian cancer (PSOC).
- Presented data from expansion cohorts in the Phase 1b/2 study
evaluating the pivekimab sunirine (pivekimab) triplet with Vidaza®
(azacitidine) and Venclexta® (venetoclax) in relapsed/refractory
(R/R) and initial data in frontline unfit acute myeloid leukemia
(AML) in an oral presentation at the 2022 American Society of
Hematology (ASH) Annual Meeting in December.
- Progressed the pivotal Phase 2 CADENZA study of pivekimab
sunirine (pivekimab) in frontline and relapsed/refractory (R/R)
blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- Completed dose escalation in the Phase 1 study of IMGC936 in
multiple solid tumor types and initiated expansion cohorts in
triple-negative breast cancer (TNBC) and non-small cell lung cancer
(NSCLC).
- Enrolled the first patient in the Phase 1 study of IMGN151 in
January 2023.
Corporate Development
- Announced a global, multi-target license and option agreement
granting Vertex Pharmaceuticals rights to conduct research using
ImmunoGen's ADC technology to discover novel targeted conditioning
agents for use with gene editing in exchange for a $15 million
upfront payment and up to $337 million in potential option exercise
fees, development and commercial milestones, and tiered royalties
on a per target basis.
- Announced a clinical collaboration with Gilead to evaluate the
safety and anti-leukemia activity of pivekimab in combination with
magrolimab, a potential first-in-class CD47 inhibitor, in patients
with R/R CD123-positive AML.
- Appointed Michael Vasconcelles, MD, as Executive Vice
President, Research, Development, and Medical Affairs, and Daniel
Char, JD, as Senior Vice President and Chief Legal Officer.
ANTICIPATED UPCOMING EVENTS
- Report top-line data for MIRASOL in the second quarter of
2023.
- Submit the Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for ELAHERE in FRα-high PROC in the
second half of 2023 to support potential approval and launch.
- Submit the supplemental Biologics License Application (sBLA) to
the FDA in the second half of 2023 to support the conversion of the
accelerated approval of ELAHERE to a full approval.
- Our partner, Huadong Medicine, to submit the biologics license
application (BLA) to the National Medical Products Administration
(NMPA) of China for ELAHERE in FRα-high PROC in the second half of
2023 to support potential approval and launch.
- Present efficacy data from the SORAYA trial by sequence of
treatment and final overall survival analysis at the Society of
Gynecologic Oncology (SGO) 2023 Annual Meeting in March.
- Report on the primary endpoint for PICCOLO before the end of
2023.
- Complete enrollment of the efficacy evaluable cohort of de novo
BPDCN patients in the pivotal phase 2 CADENZA study by the end of
2023.
- Initiate the combination cohort of pivekimab with magrolimab in
R/R AML in collaboration with Gilead in the second half of
2023.
- Report dose escalation data in Phase 1 trial of IMGC936 and
initial experience in expansion cohorts in the second quarter of
2023.
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 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/
INVESTOR RELATIONS ImmunoGen Anabel Chan 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
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