Continued Strong Momentum with ELAHERE Launch in US; Net Sales
of $77.4 Million in Q2
Presented Positive Results for ELAHERE from Phase 3 MIRASOL
Trial During Late-Breaking Oral Presentation at ASCO; First Therapy
to Demonstrate an Overall Survival Benefit Compared to Chemotherapy
in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer
Submission of ELAHERE MAA to Support Expansion into Europe and
sBLA for Potential Full Approval in US on Track for Q4 2023
Presented Interim Analysis from Phase 2 CADENZA Trial at EHA
Congress Showing Encouraging Anti-Tumor Activity and Durable
Responses for Pivekimab Sunirine in BPDCN; Pivotal Frontline Cohort
Now Fully Enrolled
Generated $350.8 Million in Net Proceeds from Public Equity
Offering, Further Strengthening Balance Sheet
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 ended June 30, 2023.
“This quarter we achieved a significant milestone for patients
and our organization. With positive data from our confirmatory
MIRASOL trial, ELAHERE is the first therapy to demonstrate an
overall survival benefit versus chemotherapy in a Phase 3 trial in
platinum-resistant ovarian cancer. These data further support the
potential of ELAHERE to become the new standard of care for
FRα-positive platinum-resistant disease,” said Mark Enyedy,
ImmunoGen’s President and Chief Executive Officer. “In parallel,
through strong execution by our commercial team supported by robust
engagement from medical affairs, we have accelerated the ELAHERE
launch, more than doubling our Q1 results with increasing breadth
and depth of adoption driven by recognition of the benefits this
novel treatment brings to patients with advanced ovarian
cancer.”
Enyedy continued, “We also progressed our broader development
program to move ELAHERE into platinum-sensitive disease and
position it as the combination agent of choice in ovarian cancer.
Turning to our second pivotal program, PVEK, we presented an
interim analysis from our CADENZA trial showing encouraging
anti-tumor activity and durable responses in BPDCN and are pleased
to share that we enrolled our last patient in the pivotal de novo
frontline cohort at the end of the second quarter. We also advanced
development with IMGC936 and IMGN151, our second-generation ADC
targeting FRα. Looking ahead, we see continued momentum through the
second half of the year with multiple data readouts and regulatory
milestones, including efficacy results from PICCOLO with ELAHERE
monotherapy in platinum-sensitive ovarian cancer and from the
expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML as
well as the submissions of the MAA and sBLA for ELAHERE.”
RECENT PROGRESS
- Generated $77.4 million in ELAHERE® (mirvetuximab
soravtansine-gynx) net sales for the quarter ended June 30,
2023.
- Announced positive data from the confirmatory Phase 3 MIRASOL
trial in patients with folate receptor alpha (FRα)-positive
platinum-resistant ovarian cancer (PROC) and presented the results
in a late-breaking oral session at the American Society of Clinical
Oncology (ASCO) 2023 Annual Meeting.
- Presented an interim analysis from the Phase 2 CADENZA trial of
pivekimab sunirine (pivekimab) in patients with frontline and
relapsed/refractory (R/R) blastic plasmacytoid dendritic cell
neoplasm (BPDCN) at the European Hematology Association (EHA) 2023
Congress.
- Completed enrollment in the pivotal frontline de novo BPDCN
cohort in the Phase 2 CADENZA trial.
- Our partner, Neopharm Israel, submitted the Marketing
Authorization Application (MAA) to the Israeli Ministry of Health
(MoH) for ELAHERE in FRα-positive PROC to support potential
approval in mid-2024.
ANTICIPATED UPCOMING EVENTS
- Submit MAA to the European Medicines Agency (EMA) for ELAHERE
in FRα-positive PROC in the fourth quarter of 2023 to support
approval and launch in Europe.
- Submit supplemental Biologics License Application (sBLA) to the
Food & Drug Administration (FDA) in the fourth quarter of 2023
to support the conversion of the accelerated approval of ELAHERE to
full approval.
- Our partner, Huadong Medicine, expects to submit the MAA to the
National Medical Products Administration (NMPA) of China for
ELAHERE in FRα-positive PROC by the end of 2023 to support
potential approval and launch.
- Present additional subset analyses from the Phase 3 MIRASOL
trial in an oral session at the European Society of Gynaecological
Oncology (ESGO) Congress in September.
- Report on the primary endpoint of objective response rate (ORR)
for PICCOLO, a single-arm Phase 2 trial of mirvetuximab in FRα-high
platinum-sensitive ovarian cancer (PSOC), before the end of
2023.
- Report data from two cohorts evaluating the pivekimab triplet
with Venclexta® (venetoclax) and Vidaza® (azacitidine) in frontline
acute myeloid leukemia (AML) at the American Society of Hematology
(ASH) Annual Meeting in December.
- Provide an update on the IMGC936 non-small cell lung cancer
(NSCLC) cohort following a prespecified interim analysis.
FINANCIAL RESULTS
Total revenues were $83.2 million for the quarter ended June 30,
2023, including $77.4 million of net product revenues from sales of
ELAHERE, compared to $14.2 million in total revenues for the
quarter ended June 30, 2022. The increase was primarily driven by
ELAHERE net sales, partially offset by $6.9 million of license fees
recorded as revenue in the prior year period pursuant to the
Company’s collaboration agreement with Huadong Medicine Co., Ltd
(Huadong Medicine).
Research and development expenses were $50.1 million for the
quarter ended June 30, 2023 compared to $51.4 million for the
quarter ended June 30, 2022. The decrease was primarily driven by a
$7.5 million one-time upfront fee recorded in the prior period
related to our research collaboration with Oxford Biotherapeutics
Ltd. and ELAHERE supply costs expensed in the prior quarter versus
capitalized in the current period. Partially offsetting these
decreases, third-party service fees and personnel costs increased
driven largely by the expansion of our medical affairs
organization, as well as an increase in clinical trial expenses in
the current quarter.
Selling, general and administrative expenses were $36.4 million
for the quarter ended June 30, 2023 compared to $23.8 million for
the quarter ended June 30, 2022. The increase was due primarily to
greater expenses in support of the US launch of ELAHERE, including
costs related to the addition of our commercial organization and
sales and marketing activities.
Net loss for the second quarter of 2023 was $4.2 million, or
$0.02 per share, compared to a net loss of $62.0 million, or $0.24
per share, for the second quarter of 2022.
In May 2023, pursuant to a public equity offering, the Company
sold an aggregate of 29,900,000 shares of its common stock, with
net proceeds of $350.8 million.
ImmunoGen had $572.0 million in cash and cash equivalents and
$75.4 million in accounts receivable as of June 30, 2023, compared
with $275.1 million in cash and cash equivalents and $12.6 million
in accounts receivable as of December 31, 2022. Cash used in
operations was $140.5 million for the first six months of 2023
compared with cash used in operations of $105.4 million for the
same period in 2022. Capital expenditures were $0.3 million and
$0.5 million for the first six months of 2023 and 2022,
respectively.
FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2023 and now
expects operating expenses of between $350 million and $365
million; this increase reflects greater spending in support of
ELAHERE, including preparations for a launch in Europe, and to
expand the Company’s research capabilities and pipeline. Revenue
guidance, excluding ELAHERE sales, remains unchanged at between $45
million and $50 million.
The Company expects 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 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
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 ImmunoGen,
Inc.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These
statements include, but are not limited to, the Company’s
expectations related to its revenues, operating expenses, and cash
forecast; the potential of ELAHERE to become the standard of care
and combination agent of choice in FRα-positive ovarian cancer; the
potential full approval of ELAHERE in the US and regulatory
approval of ELAHERE in Europe and China; the timing and
presentation of clinical data on the Company’s product candidates,
including data from the MIRASOL trial, and data from the PICCOLO
trial; the potential clinical benefits of pivekimab in BPDCN and
AML and the potential for regulatory approval of pivekimab; 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; top-line data may change as more patient
data become available and are subject to audit and verification
procedures; 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 the Company
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, the Company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on April 28, 2023 and July 31, 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. ImmunoGen undertakes 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. SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) June 30, December
31,
2023
2022
ASSETS Cash and cash equivalents $
571,987
$
275,138
Other assets
142,340
73,798
Total assets $
714,327
$
348,936
LIABILITIES AND SHAREHOLDERS' EQUITY Current portion
of deferred revenue $
14,389
$
13,856
Other current liabilities
79,313
108,002
Term loan, net
71,957
-
Long-term portion of deferred revenue
30,217
36,355
Other long-term liabilities
27,609
34,897
Shareholders' equity
490,842
155,826
Total liabilities and shareholders' equity $
714,327
$
348,936
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) Three Months Ended Six Months
Ended June 30, June 30,
2023
2022
2023
2022
Revenues: Product revenue, net $
77,371
$
-
$
106,915
$
-
License and milestone fees
40
6,973
15,071
37,865
Non-cash royalty revenue
5,742
7,116
10,581
13,544
Research and development support
-
73
455
831
Total revenues
83,153
14,162
133,022
52,240
Cost and operating expenses: Cost of sales
909
-
1,535
-
Research and development
50,077
51,422
101,697
95,704
Selling, general and administrative
36,356
23,793
76,372
40,441
Total cost and operating expenses
87,342
75,215
179,604
136,145
Loss from operations
(4,189)
(61,053)
(46,582)
(83,905)
Interest income (expense), net
1,905
590
4,074
644
Non-cash interest expense on liability related to sale of future
royalty & term loan
(1,079)
(1,078)
(1,932)
(2,327)
Other (loss) income, net
(8)
(480)
55
(578)
Loss before income taxes $
(3,371)
$
(62,021)
$
(44,385)
$
(86,166)
Income tax expense
877
-
877
-
Net loss
(4,248)
(62,021)
(45,262)
(86,166)
Basic and diluted net loss per common share $
(0.02)
$
(0.24)
$
(0.17)
$
(0.34)
Basic and diluted weighted average common shares
outstanding
263,446
253,336
261,160
253,263
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230731119395/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
ImmunoGen (NASDAQ:IMGN)
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