Significant Operational and Financial Progress
in 2017 with a Robust Set of Data and Events Expected in 2018
Mirvetuximab Soravtansine Phase 3 FORWARD I
Trial to Complete Enrollment by Mid-Year; FORWARD II Combination
Data to be Presented Throughout 2018
Novel ADC Pipeline Continues to Advance with
Patients Enrolling in Phase 1 Study of IMGN632 and Phase 1 Data
Presented at ASH for IMGN779
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 highlights and operating results for the
quarter and year ended December 31, 2017.
“We made significant progress with the business in 2017, with
four consecutive quarters of strong execution across the Company.
Operationally, we advanced our monotherapy registration study and
published compelling combination data with mirvetuximab, expanded
our clinical pipeline, and established a high-value partnership
with Jazz Pharmaceuticals supporting our earlier-stage programs.
Financially, we added over $235 million in cash and eliminated
roughly $100 million in debt on the balance sheet through business
development and financing transactions,” said Mark Enyedy,
ImmunoGen’s president and chief executive officer. “With the
momentum we generated in the last twelve months, we enter 2018 from
a position of strength with a number of important catalysts
expected during the year. We anticipate completing patient
enrollment in our FORWARD I Phase 3 registration trial by mid-year,
multiple data readouts from our FORWARD II trial assessing
combinations with mirvetuximab beginning next month at the Society
of Gynecologic Oncology annual meeting, and clinical data from our
Phase 1 trials of both IMGN779 and IMGN632 later in the year. With
these anticipated events, we look forward to another productive
year in 2018 as we advance our pipeline to bring new therapies to
patients and create value for our shareholders.”
Recent Pipeline Highlights
- Activated more than 100 sites in North
America and Europe in the Company’s ongoing Phase 3 FORWARD I trial
of mirvetuximab soravtansine as single-agent therapy for
platinum-resistant ovarian cancer enabling rapid patient
enrollment;
- Advanced the Company’s Phase 1b/2
FORWARD II trial in North America and Europe evaluating
mirvetuximab soravtansine combination regimens in separate
expansion cohorts with Keytruda® (pembrolizumab) and Avastin®
(bevacizumab) for platinum-resistant disease, and initiated patient
dosing in a new cohort to evaluate the triplet combination of
mirvetuximab plus carboplatin and Avastin in patients with
platinum-sensitive disease;
- Reported updated safety data and
preliminary anti-leukemia activity from the dose-escalation phase
of the Phase 1 clinical trial of IMGN779 in patients with acute
myeloid leukemia (AML) at the 2017 American Society of Hematology
(ASH) Annual Meeting;
- Began dosing patients in the Company’s
Phase 1 clinical trial of IMGN632, a CD123-targeting ADC
integrating a potent DNA-alkylating payload intended to treat a
range of hematological malignancies, including AML and blastic
plasmacytoid dendritic cell neoplasm (BPDCN); and
- Received notice that partner Takeda has
filed an IND for TAK-164, an ADC directed to GCC-positive tumors
using ImmunoGen’s IGN platform.
Facilities Update
- Following an in-depth review of the
Company’s manufacturing strategy, ImmunoGen will move to an
operating model that will rely on external manufacturing and
quality testing for drug substance and drug product for its
development programs. The implementation of this new operating
model will lead to the ramp-down of manufacturing and quality
activities at the Company’s Norwood, Massachusetts facility by the
end of 2018, with a full exit of the site by early 2019.
Decommissioning the Norwood facility will result in anticipated
cost savings of over $20 million during the next five years.
- The Norwood facility has been a
long-standing staple of ImmunoGen’s business, delivering
high-quality products to patients and partners without interruption
for more than 25 years. The Company is grateful for the
contributions that its Norwood-based employees have made and will
support these employees through the transition.
Anticipated 2018 Events
- Conduct interim analysis from FORWARD
I, for futility only, in 1Q 2018;
- Report updated dose-escalation findings
from the FORWARD II mirvetuximab plus Keytruda combination cohort
at the Society of Gynecologic Oncology annual meeting (March
2018);
- Present highlights from ImmunoGen's
technology and innovation in ADCs at the American Association
for Cancer Research (AACR) annual meeting (April 2018);
- Anticipate partner Takeda to begin
clinical development of TAK-164 in the first half of 2018;
- Report updated data from the FORWARD II
mirvetuximab plus Avastin combination expansion cohort in over 50
patients in the first half of 2018;
- Complete patient enrollment in FORWARD
I by mid-year;
- Report findings from the FORWARD II
mirvetuximab plus Keytruda combination expansion cohort in over 30
patients the second half of the year;
- Report additional data from IMGN779
Phase 1 study in 4Q 2018;
- Report initial data from IMGN632 Phase
1 study in 4Q 2018; and
- Advance our ADAM9 program into
IND-enabling activities before year-end.
Financial Results
As previously disclosed, effective January 1, 2017, ImmunoGen
transitioned to a fiscal year ending December 31. The years ended
December 31, 2017 and 2016 reflect the twelve-month results of the
respective calendar years.
Revenues for the year ended December 31, 2017 were $115.4
million, compared to $48.6 million for the year ended December 31,
2016. License and milestone fees of $79.5 million for 2017 included
a $30 million paid-up license fee related to an amendment to the
Company’s collaboration and license agreement with Sanofi, $29.5
million related to the sale and transfer of the Company’s IMGN529
asset to Debiopharm, $7 million in partner milestone payments and
$12.7 million in amortization of a non-cash fee related to the
Company’s license agreement with CytomX, compared to $15 million in
partner milestone payments received in 2016. Revenues for 2017
included $28.1 million in non-cash royalty revenues, compared with
$26.2 million in non-cash royalty revenues for 2016. Revenues for
2017 also included $3.5 million of research and development
(R&D) support fees and $4.4 million of clinical materials
revenue, compared with $5.2 million and $1.9 million, respectively,
for 2016.
Operating expenses, including R&D and G&A expenses, for
2017 were $174.4 million, compared to $184.3 million for 2016.
R&D expenses for 2017 decreased to $139.7 million, compared to
$141.3 million for 2016, primarily due to a workforce reduction
resulting from the strategic review in September 2016 and lower
third-party service fees, partially offset by increased clinical
trial and drug supply costs driven largely by the advancement of
the FORWARD I Phase 3 clinical trial. General and administrative
expenses decreased in 2017 to $33.9 million, compared to $38.5
million in 2016, primarily due to lower personnel expenses.
Operating expenses for 2016 also included a $4.4 million
restructuring charge related to the workforce reduction and a loss
on leased office space, compared to a $0.8 million charge in 2017
related to additional loss recorded on leased office space.
In September and November 2017, a total of $97.9 million of
convertible debt outstanding was converted into 26.2 million shares
of the Company’s common stock, resulting in a $22.9 million
non-cash debt conversion charge recorded in 2017. With this
conversion, the Company’s outstanding debt is reduced to $2.1
million. In October 2017, pursuant to a public offering, the
Company sold an aggregate of 16.7 million shares of its common
stock, with net proceeds to the Company of $101.7 million, after
deducting underwriting discounts and offering expenses.
ImmunoGen reported a net loss of $96.0 million, or $0.98 per
basic and diluted share, for 2017, which included a loss of $0.23
per basic and diluted share relating to the non-cash debt
conversion charge, compared to a net loss of $156.7 million, or
$1.80 per basic and diluted share, for 2016.
ImmunoGen had $267.1 million in cash and cash equivalents as of
December 31, 2017, compared with $160.0 million as of December 31,
2016, and had $2.1 million and $100.0 million of convertible debt
outstanding as of December 31, 2017 and December 31, 2016,
respectively. Cash provided by operations was $7.6 million for
2017, compared with cash used in operations of $(142.6) million for
2016. The current year benefited from $59.5 million of fees
received from Sanofi and Debiopharm, which were included in revenue
for 2017, and a $75 million upfront payment received from Jazz,
which is included in deferred revenue as of December 31, 2017.
Capital expenditures were $1.1 million and $6.7 million for 2017
and 2016, respectively.
Financial Guidance
For 2018, ImmunoGen expects:
- revenues between $60 million and
$65 million;
- operating expenses between
$185 million and $190 million; and
- cash and cash equivalents at December
31, 2018 between $115 million and $120 million.
ImmunoGen expects that its current cash combined with the
expected cash revenues from partners and collaborators will enable
the Company to fund its operations into the fourth quarter of
2019.
Conference Call InformationImmunoGen will hold a
conference call today at 8:00 am ET to discuss these results. To
access the live call by phone, dial 719-325-4917; the conference ID
is 5734226. The call may also be accessed through the Investors
section of the Company’s website, www.immunogen.com. Following the
webcast, a replay of the call will be available at the same
location through February 23, 2018.
About ImmunoGen, Inc.ImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary ADC technology. The Company’s lead product
candidate, mirvetuximab soravtansine, is in a Phase 3 trial for
FRα-positive platinum-resistant ovarian cancer, and is in a
Phase 1b/2 trial in combination regimens for earlier-stage
disease. ImmunoGen has three additional clinical-stage product
candidates, two of which are being developed in collaboration with
Jazz Pharmaceuticals. ImmunoGen's ADC technology is also used in
Roche's marketed product, Kadcyla®, and in programs in development
by Amgen, Bayer, Biotest, CytomX, Debiopharm, Lilly, Novartis,
Sanofi and Takeda. More information about the Company can be found
at www.immunogen.com.
Keytruda®, Avastin® and Kadcyla® are registered trademarks of
their respective owners.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but
are not limited to, ImmunoGen's expectations related to: the
Company's revenues and, operating expenses for the twelve months
ending December 31, 2018; its cash and marketable securities as of
December 31, 2018; availability of cash to fund operations into the
fourth quarter of 2019; the cost-savings resulting from the
decommissioning of the Company’s Norwood, MA facility; the
occurrence, timing and outcome of potential pre-clinical, clinical
and regulatory events related to the Company's and its
collaboration partners' product programs; and the presentation of
preclinical and clinical data on the Company’s and collaboration
partners’ product candidates. For these statements, ImmunoGen
claims the protection of the safe harbor for forward-looking
statements provided by the Private Securities Litigation Reform Act
of 1995. 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
ImmunoGen's and the Company's collaboration partners' research and
clinical development processes; 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; ImmunoGen’s ability to
successfully implement its new operating model for external
manufacturing and quality testing; ImmunoGen's ability to
financially support its product programs; ImmunoGen's dependence on
collaborative partners; industry merger and acquisition activity;
and other factors more fully described in ImmunoGen's Transition
Report on Form 10-KT for the six-month period ended
December 31, 2016 and other reports filed with the Securities
and Exchange Commission.
-Financials Follow-
IMMUNOGEN, INC. SELECTED FINANCIAL
INFORMATION (in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) December 31, December 31,
2017 2016 ASSETS Cash and cash equivalents $
267,107 $ 159,964 Other assets 27,569 38,900
Total assets $ 294,676 $ 198,864
LIABILITIES AND SHAREHOLDERS' DEFICIT Current portion of
deferred revenue $ 1,405 $ 14,531 Other current liabilities 54,365
41,245 Long-term portion of deferred revenue 93,752 19,086 Other
long-term liabilities 163,049 276,852 Shareholders' deficit
(17,895 ) (152,850 ) Total liabilities and
shareholders' deficit $ 294,676 $ 198,864
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Year
Ended December 31, December 31, 2017
2016 2017 2016
Revenues: License and milestone fees $ 29,580 $ 5,076 $
79,469 $ 15,305 Non-cash royalty revenue 7,587 6,710 28,142 26,218
Research and development support 452 1,427 3,482 5,175 Clinical
materials revenue 1,829 633 4,354
1,930 Total revenues 39,448
13,846 115,447 48,628 Expenses:
Research and development 39,843 33,657 139,739 141,312 General and
administrative 9,048 8,536 33,911 38,528 Restructuring charge
393 301 779 4,431
Total operating expenses 49,284
42,494 174,429 184,271 Loss from
operations (9,836 ) (28,648 ) (58,982 ) (135,643 ) Non-cash
interest expense on liability related to sale of future royalty
& convertible bonds (3,221 ) (3,647 ) (13,682 ) (18,593 )
Non-cash debt conversion expense (724 ) - (22,915 ) - Interest
expense on convertible bonds (28 ) (1,099 ) (3,040 ) (2,387 ) Other
income (expense), net 691 (758 ) 2,607
(110 ) Net loss $ (13,118 ) $ (34,152 ) $ (96,012 ) $
(156,733 )
Net loss per common share, basic and
diluted $ (0.11 ) $ (0.39
) $ (0.98 ) $ (1.80
) Weighted average common shares
outstanding, diluted 124,583
87,102 98,068
87,029
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version on businesswire.com: http://www.businesswire.com/news/home/20180209005068/en/
For InvestorsImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaImmunoGen,
Inc.Courtney O’Konek,
781-895-0158courtney.okonek@immunogen.comorFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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