IMMUNOGEN, INC. Overview
We are a clinical-stage biotechnology company focused on developing the next generation of 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 patients more good days. We call this our commitment to ''target a better now.''
An ADC with our proprietary technology comprises an antibody that binds to a target found on tumor cells and is conjugated to one of our potent anti-cancer agents as a ''payload'' to kill the tumor cell once the ADC has bound to its target. ADCs are an expanding approach to the treatment of cancer, with nine approved products and the number of agents in development growing significantly in recent years.
We have established a leadership position in ADCs with a portfolio of differentiated product candidates to address both solid tumors and hematological malignancies.
Managing the Impact of the COVID-19 Pandemic
Since the first quarter of 2020, we have continued to move our clinical studies
forward while adapting to meet the evolving challenges of the COVID-19 pandemic.
We implemented business continuity plans in
We have maintained a high level of productivity since
Our Business
Our lead program is mirvetuximab, a first-in-class investigational ADC targeting FR?, a cell-surface protein overexpressed in a number of epithelial tumors, including ovarian, endometrial, and non-small-cell lung cancers. In 2019, FORWARD I, our Phase 3 clinical trial of mirvetuximab in patients with FR?-positive, platinum-resistant ovarian cancer, did not meet its primary endpoint. In post hoc exploratory analyses in the FR?-high population scored by the PS2+ method, however, mirvetuximab was associated with longer progression free survival, a higher overall response rate, and longer overall survival.
Following consultation with the FDA, we moved forward with two new trials of mirvetuximab in FR?-high, platinum-resistant ovarian cancer: SORAYA, a single-arm clinical trial that, if successful, could lead to accelerated approval in this setting; and MIRASOL, a randomized Phase 3 clinical trial that, if successful, could lead to full approval in this setting. We are actively enrolling both studies and expect to report top-line data from SORAYA in the third quarter of 2021 and top-line data from MIRASOL in the first half of 2022. If SORAYA is successful, we expect to submit an application for accelerated approval of mirvetuximab in the applicable patient population to the FDA by the end of 2021 and, thereafter, seek full approval on the basis of the confirmatory Phase 3 MIRASOL trial.
Beyond our anticipated monotherapy indications, we are generating data for mirvetuximab in combination with other agents to expand into earlier lines of ovarian cancer therapy. In addition, we plan to support the initiation in 2021 of two investigator-sponsored trials of mirvetuximab plus carboplatin, including a randomized Phase 2 study in recurrent
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platinum-sensitive ovarian cancer and a neo-adjuvant study. With the benefit of these data, we believe there is potential for compendia listings for combination use of mirvetuximab and are also working to define the best path forward to label expansion.
IMGN632 is an ADC comprised of a high-affinity antibody designed to target CD123
with site-specific conjugation to our most potent IGN payload. We are advancing
IMGN632 in clinical trials for patients with BPDCN and AML. In
Our 802 study, which is a Phase 1b/2 study designed to determine the safety, tolerability, and preliminary antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax to patients with relapsed and frontline CD123-positive AML, is in the dose-escalation phase, enrolling relapsed and refractory patients to determine the recommended Phase 2 dose of IMGN632 for combination regimens. We anticipate sharing data from this study in 2021.
We continue to advance additional pipeline programs. IMGC936 is an ADC in co-development with MacroGenics designed to target ADAM9, an enzyme overexpressed in a range of solid tumors and implicated in tumor progression and metastasis. IMGC936 incorporates a number of innovations, including antibody engineering to extend the half-life, site-specific conjugation with a fixed drug-antibody ratio to enable higher dosing, and a next-generation linker and payload for improved stability and bystander activity. The IND for IMGC936 was accepted by the FDA in the second quarter of 2020 and we began enrollment in the Phase 1 study in the fourth quarter of 2020.
IMGN151 is our next generation anti-FR? candidate in preclinical development.
This ADC integrates innovation in each of its components, which may enable
IMGN151 to address patient populations with lower levels of FR? expression,
including tumor types outside of ovarian cancer. We presented encouraging data
for IMGN151 at the
We have selectively licensed restricted access to our ADC platform technology to other companies to expand the use of our technology and to provide us with cash to fund our own product programs. These agreements typically provide the licensee with rights to use our ADC platform technology with its antibodies or related targeting vehicles to a defined target to develop products. The licensee is generally responsible for the development, clinical testing, manufacturing, registration, and commercialization of any resulting product candidate. As part of these agreements, we are generally entitled to receive upfront fees, potential milestone payments, and royalties on the sales of any resulting products.
In
We expect that substantially all of our revenue for at least the next year will result from payments under our collaborative arrangements. For more information concerning these relationships, including their ongoing financial and accounting impact on our business, please read Note C, "Significant Collaborative Agreements," to our consolidated financial statements included in this report.
To date, we have not generated revenues from commercial sales of internal
products, and we expect to incur significant operating losses for the
foreseeable future. As of
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Critical Accounting Policies and Estimates
We prepare our consolidated financial statements in accordance with accounting
principles generally accepted in the
During 2019, we adopted Accounting Standards Codification (ASC) 842, Leases,
using the transition method provided by Accounting Standards Update (ASU) No.
2018-11, Leases (Topic 842): Targeted Improvements. Under this method, we
initially applied the new leasing rules on
Refer to Note B to the consolidated financial statements for further discussion regarding our critical accounting policies, including revenue recognition, clinical trial accruals, and stock-based compensation.
Results of Operations
For a discussion related to the results of operations for 2019 compared to 2018,
refer to Part II, Item 7, "Management's Discussion and Analysis of Financial
Condition and Results of Operations - Results of Operations" in our Annual
Report on Form 10-K for the year ended
Revenues
For 2020, our total revenues increased to
License and milestone fees
The amount of license and milestone fees we earn is directly related to the
number of our collaborators, the collaborators' advancement of the product
candidates, and the overall success in clinical trials of the product
candidates. As such, the amount of license and milestone fees may vary widely
from quarter to quarter and year to year. Total revenue recognized from license
and milestone fees for the years ended 2020 and 2019 was
Deferred revenue of
Non-cash royalty revenue related to the sale of future royalties
In
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Research and Development Expenses
Our research and development expenses relate to (i) research to evaluate new targets and to develop and evaluate new antibodies, linkers, and cytotoxic agents, (ii) preclinical testing of our own and, in certain instances, our collaborators' product candidates, and the cost of our own clinical trials, (iii) development related to clinical and commercial manufacturing processes, and (iv) external manufacturing operations, and prior to 2019, internal manufacturing operations, which also included raw materials.
We restructured our business in 2019, the details of which are included under
Restructuring Charges below. Research and development expense was
Clinical trial and regulatory approval processes for our product candidates that have advanced or that we intend to advance to clinical testing are lengthy, expensive, and uncertain in both timing and outcome. As a result, the pace and timing of the clinical development of our product candidates is highly uncertain and may never result in approved products. Completion dates and development costs will vary significantly for each product candidate and are difficult to predict. A variety of factors, many of which are outside our control, could cause or contribute to the prevention or delay of the successful completion of our clinical trials, or delay or prevent our obtaining necessary regulatory approvals. The costs to take a product through clinical trials are dependent upon, among other factors, the clinical indications, the timing, size, and design of each clinical trial, the number of patients enrolled in each trial, and the speed at which patients are enrolled and treated. Product candidates may be found to be ineffective or to cause unacceptable side effects during clinical trials, may take longer to progress through clinical trials than anticipated, may fail to receive necessary regulatory approvals, or may prove impractical to manufacture in commercial quantities at reasonable cost or with acceptable quality.
The lengthy process of securing FDA approvals for new drugs requires the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals, would materially adversely affect our product development efforts and our business overall. Accordingly, we cannot currently estimate, with any degree of certainty, the amount of time or money that we will be required to expend in the future on our product candidates prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding the timing and outcome of our clinical trials, we are currently unable to estimate when, if ever, our product candidates that have advanced into clinical testing will generate revenues and cash flows.
We do not track our research and development costs by project. Since we use our research and development resources across multiple research and development projects, we manage our research and development expenses within each of the categories listed in the following table and described in more detail below (in thousands):
Years Ended
December 31 ,
Research and Development Expense Category 2020 2019 Research
$ - $ 12,272
Preclinical and clinical testing 75,430 71,193
Process and product development 5,430 7,807
Manufacturing operations 33,732 23,250
Total research and development expense
Research
Research includes expenses associated with activities to evaluate new targets and to develop and evaluate new antibodies, linkers, and cytotoxic agents for our products and in support of our collaborators. Such expenses primarily include personnel, contract services, facility expenses, and laboratory supplies. There were no research expenses for 2020 as a result of the restructuring of the business at the end of the second quarter of 2019.
Preclinical and clinical testing
Preclinical and clinical testing includes expenses related to preclinical
testing of our own, and, in certain instances, our collaborators' product
candidates, regulatory activities, and the cost of clinical trials. Such
expenses include personnel, patient enrollment at our clinical testing sites,
consultant fees, contract services, and facility expenses. Preclinical and
clinical testing expenses increased to
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increase is primarily the result of increased clinical trial costs driven by costs incurred related to advancing the MIRASOL, SORAYA, IMGN632, and IMGC936 studies and less reimbursement recorded in the current year pursuant to our cost-sharing agreement with Jazz. Partially offsetting these increases were lower personnel, administrative, laboratory, and allocated facility expenses resulting from the restructuring of the business, lower clinical trial costs related to the FORWARD I, FORWARD II, and IMGN779 studies, and a decrease in contract services driven by certain regulatory and pre-commercial activities related to mirvetuximab and preclinical development of IMGC936 in the prior year.
Process and product development
Process and product development expenses include costs for development of
clinical and commercial manufacturing processes for our own and collaborator
compounds. Such expenses include the costs of personnel, contract services,
laboratory supplies, and facility expenses. Process and product development
expenses decreased to
Manufacturing operations
Manufacturing operations expense includes costs to have preclinical and clinical
materials manufactured for our product candidates and quality control and
quality assurance activities. Such expenses include personnel, raw materials for
our preclinical studies and clinical trials, non-pivotal and pivotal development
costs with contract manufacturing organizations, and facility expenses.
Manufacturing operations expense increased
Antibody development and supply expense in support of commercial validation and
in anticipation of potential future clinical trials, as well as our ongoing
trials, was
General and Administrative Expenses
General and administrative expenses increased
Restructuring Charges
On
As a result of the workforce reduction, we recorded a charge of
In addition to the termination benefits and other related charges, we sub-leased
the majority of the laboratory and office space at
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Charge Related to Unoccupied Office Space
We have sought to sub-lease 10,281 square feet of unoccupied office space in
Investment Income, net
Investment income for 2020 and 2019 was
Non-Cash Interest Expense on Liability Related to Sale of Future Royalty
In 2015, IRH purchased our right to receive 100% of the royalty payments on
commercial sales of Kadcyla arising under our development and commercialization
license with
Interest Expense on Convertible Senior Notes
In
Other Income (Expense), net
Other income (expense), net for 2020 and 2019 was
Liquidity and Capital Resources
For a discussion related to our cash flows for 2019 compared to 2018, refer to
Part II, Item 7, "Management's Discussion and Analysis of Financial Condition
and Results of Operations - Liquidity and Capital Resources" in our Annual
Report on Form 10-K for the year ended
The following tables show certain balance sheet and cash flow information as of and for the periods indicated (in thousands):
As of December 31,
2020 2019
Cash and cash equivalents $ 293,856 $ 176,225
Working capital 201,931 131,488Shareholders' equity (deficit) 89,570 (76,121)
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Years Ended December 31
2020 2019
Cash used for operating activities $ (78,620) $ (88,367)
Cash provided by (used for) investing activities 509 (533)
Cash provided by financing activities 195,742 2,873
Cash Flows
We require cash to fund our operating expenses, including the advancement of our
clinical programs, and to make capital expenditures. Historically, we have
funded our cash requirements primarily through equity and convertible debt
financings in public markets and payments from our collaborators, including
license fees, milestones, research funding, and royalties. We have also
monetized our rights to receive royalties on Kadcyla for up-front consideration.
As of
Net cash provided by (used for) investing activities was
Net cash provided by financing activities was
Net cash provided by financing activities for 2020 and 2019 also include proceeds from the exercise of stock options and sale of shares through our ESPP.
On
We anticipate that our current capital resources will enable us to meet our operational expenses and capital expenditures for more than twelve months after the date of this report. We may raise additional funds through equity, debt, and other financings or generate revenues from collaborators through a combination of upfront license payments, milestone payments, royalty payments, and research funding. We cannot provide assurance that we will be able to obtain additional debt, equity, or other financing or generate revenues from collaborators on terms acceptable to us or at all. Should we or our partners not meet some or all of the terms and conditions of our various collaboration agreements or if we are not successful in securing future collaboration agreements, we may elect or be required to secure alternative financing arrangements, and/or defer or limit some or all of our research, development, and/or clinical projects.
Contractual Obligations
We lease approximately 120,000 square feet of laboratory and office space in a
building located at
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variable operating costs and real estate taxes approximating
As of
Recent Accounting Pronouncements
The information set forth under Note B to the consolidated financial statements under the caption "Summary of Significant Accounting Policies" is incorporated herein by reference.
Third-Party Trademarks
Kadcyla and Herceptin are registered trademarks of
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