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Annual Report: 2011 (Form 10-K)
ImmunoGen, Inc. - Annual Report: 2011 (Form 10-K)
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ImmunoGen, Inc. Form 10-K TABLE OF CONTENTS
Item 8. Financial Statements and Supplementary Data
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended June 30, 2011 |
OR |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period
from to
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Commission file number 0-17999
ImmunoGen, Inc.
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Massachusetts
(State or other jurisdiction
of incorporation or organization) |
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04-2726691
(I.R.S. Employer
Identification No.) |
830 Winter Street, Waltham, MA 02451
(Address of principal executive offices, including zip code) |
(781) 895-0600
(Registrant's telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class |
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Name of Each Exchange on Which Registered |
Common Stock, $.01 par value |
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NASDAQ Global Select Market |
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities
Act. ý Yes o No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the
Act. o Yes ý No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. ý Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). o Yes o No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter)
is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. ý
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting
company. See definitions of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer ý |
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Non-accelerated filer o (Do not check if a smaller
reporting company) |
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Smaller reporting company o |
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). o Yes ý No
Aggregate market value, based upon the closing sale price of the shares as reported by the NASDAQ Global Market, of voting stock held by non-affiliates
at December 31, 2010: $623,655,861 (excludes shares held by executive officers and directors). Exclusion of shares held by any person should not be construed to indicate that such person
possesses the power, direct or indirect, to direct or cause the direction of management or policies of the registrant, or that such person is controlled by or under common control with the registrant.
Common Stock outstanding at August 24, 2011: 76,378,525 shares.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive Proxy Statement to be delivered to shareholders in connection with the Annual Meeting of Shareholders to be held on November 8,
2011 are incorporated by reference into Part III.
Table of Contents
ImmunoGen, Inc.
Form 10-K
TABLE OF CONTENTS
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Table of Contents
Item 1. Business
In this Annual Report on Form 10-K, ImmunoGen, Inc. (ImmunoGen, Inc., together with its subsidiaries,
is referred to in this document as "we", "us", "ImmunoGen", or the "Company"), incorporates by reference certain information from parts of other documents filed with the Securities and Exchange
Commission. The Securities and Exchange Commission allows us to disclose important information by referring to it in that manner. Please refer to all such information when reading this Annual Report
on Form 10-K. All information is as of June 30, 2011 unless otherwise indicated. For a description of the risk factors affecting or applicable to our business, see "Risk
Factors," below.
The Company
We develop novel, targeted therapeutics for the treatment of cancer using our expertise in cancer biology, monoclonal antibodies,
highly potent cytotoxic, or cell-killing, agents, and the design of linkers that enable these agents to be stably attached to the antibodies while in the blood stream and released in their
fully active form after delivery to a cancer cell.
Most
of the product candidates being developed by us and through our collaborations with others utilize our Targeted Antibody Payload, or TAP, technology. Our TAP technology is designed
to enable the creation of highly effective, well-tolerated anticancer products. A TAP compound consists of a monoclonal antibody that binds specifically to an antigen target found on
cancer cells with one of our proprietary cell-killing agents attached using one of our engineered linkers. Its antibody component enables a TAP compound to bind specifically to cancer
cells that express its target antigen, the highly potent cytotoxic agent serves to kill the cancer cell, and the engineered linker controls the release and activation of the cytotoxic agent inside the
cancer cell. Six TAP compounds and one therapeutic antibody are in clinical testing through our own programs and those of our partners, with more expected to enter the clinic going forward.
We
develop antibody-based anticancer compounds. Our most advanced wholly owned product candidate is lorvotuzumab mertansine, or IMGN901. This TAP compound is a potential treatment for
small-cell lung cancer (SCLC) and other cancers that express CD56. We expect to begin Phase II clinical testing with IMGN901 for SCLC in late 2011/early 2012. Our next most advanced
compound, IMGN388, is a potential treatment for solid tumors and is currently in an early stage clinical trial. We have a number of preclinical product candidates advancing towards clinical testing,
and we expect to submit investigational new drug, or IND, applications for two of theseIMGN529 and IMGN853to the US Food and Drug Administration, or FDA, in our current
fiscal year ending June 30, 2012. In addition to our product programs, we continue to invest in our TAP technology, including the development of additional cytotoxic agents and engineered
linkers, to maintain a leadership position in our field.
Part
of our business model is to establish collaborations with other companies in order to provide us with cash and revenue short term and potential significant value long term.
Collaborations also help expand the utilization of our TAP technology. Amgen, Bayer HealthCare, Biotest, Novartis, Roche and Sanofi have certain rights to use our TAP technology to development
anticancer therapies and have product candidates in clinical or preclinical testing. The most advanced TAP compound, trastuzumab emtansine or T-DM1, is in Phase III clinical testing
by Roche.
We
were organized as a Massachusetts corporation in 1981. Our principal offices are located at 830 Winter Street, Waltham, Massachusetts (MA) 02451, and our telephone number is
(781) 895-0600. We maintain a website at www.immunogen.com, where certain information about us is available. Please note that
information contained on the website is not a part of this document. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K, and any amendments to those reports are available free of charge through the "Investor Information" section of our website as soon as reasonably practicable after those
materials have been electronically filed with, or furnished to,
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the
Securities and Exchange Commission. We have adopted a Code of Corporate Conduct that applies to all our directors, officers and employees and a Senior Officer and Financial Personnel Code of
Ethics that applies to our senior officers and financial personnel. Our Code of Corporate Conduct and Senior Officer and Financial Personnel Code of Ethics are available free of charge through the
"Investor Information" section of our website.
Product Candidates
The following table summarizes the status for compounds in development by us and our collaborators. All of these compounds employ our
TAP technology except for SAR650984, which is a therapeutic antibody. The results in early clinical trials may not be predictive of results obtained in subsequent clinical trials and there can be no
assurance that each of our or our collaborators' product candidates will advance or will demonstrate the level of safety and efficacy necessary to obtain regulatory approval.
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Product Candidate
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Development Stage |
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Collaborative
Partner, if any |
Late-Stage Compound in Development by ImmmunoGen Collaborator |
Trastuzumab emtansine (T-DM1) |
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For HER2+ breast cancer: 2nd-line use for metastatic diseasePhase III 1st-line use for metastatic diseasePhase III Adjuvant/neoadjuvant usePhase II |
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Roche |
Earlier-Stage Compounds in Development by ImmunoGen |
Lorvotuzumab mertansine (IMGN901) |
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For CD56+ cancers: Small-cell lung cancerPhase I/II Merkel cell carcinomaPhase I Multiple myelomaPhase I |
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IMGN388 |
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For solid tumorsPhase I |
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Johnson & Johnson
has opt-in rights |
IMGN529 |
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For CD37+ B-cell malignancies including
non-Hodgkin's lymphomaPre-IND |
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IMGN853 |
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For cancers that overexpress folate receptor 1 including ovarian cancerPreclinical |
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Other |
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Other TAP compounds for solid and/or liquid tumorsPreclinical/research |
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Earlier-Stage Compounds in Development by ImmunoGen Collaborators
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SAR3419 |
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For CD19+ B-cell malignancies including non-Hodgkin's lymphomaPhase I |
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Sanofi |
SAR650984 |
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For CD38+ hematological malignanciesPhase I |
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Sanofi |
SAR566658 |
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For DS6+ solid tumorsPhase I |
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Sanofi |
BT-062 |
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For multiple myelomaPhase I |
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Biotest; ImmunoGen has opt-in rights |
BAY 94-9343 |
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For mesothelin-expressing cancersIND submitted |
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Bayer HealthCare |
Other |
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Other TAP compounds for solid and/or liquid tumorsPre-IND/preclinical/research |
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Multiple |
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Trastuzumab Emtansine (T-DM1)
The most advanced compound in development using our TAP technology is trastuzumab emtansine, which is also known as T-DM1.
T-DM1 consists of trastuzumab, which is the active component of Roche's marketed anticancer compound Herceptin®, with one of our cell-killing agents attached using
one of our engineered linkers. T-DM1 is in global development by Roche under a license established in 2000 between us and Genentech, a member of the Roche Group.
Second-line useIn February 2009, Roche began a Phase III trial, EMILIA, to assess T-DM1 for second-line
treatment of HER2+ metastatic breast cancer, or MBC. EMILIA compares T-DM1 used alone to Tykerb® (lapatinib) used together with Xeloda® (capecitabine), which is
standard second-line treatment for this cancer. EMILIA has two co-primary endpoints: progression-free survival, or PFS, and overall survival. Roche expects to have
mature PFS data from EMILIA in 2012. If these data are favorable, it intends to apply in 2012 for accelerated marketing approval in the United States and for full approval in Europe of
T-DM1 for second-line treatment of HER2+ MBC. Roche expects to have mature overall survival data from EMILIA approximately eighteen months after it has mature PFS data and to
use these data to convert accelerated marketing approval in the United States to full approval.
First-line useIn July 2010, Roche began a Phase III trial, MARIANNE, to assess T-DM1 for first-line
treatment of HER2+ MBC. MARIANNE compares T-DM1 used alone to T-DM1 used together with Roche's pertuzumab antibody and to Herceptin used together with a taxane. If results from
MARIANNE are favorable, Roche expects to apply in 2014 for marketing approval of T-DM1 for first-line use in the United States and Europe.
For early stage breast cancerIn October 2010, Roche began a
135-patient Phase II trial to assess the safety of T-DM1 when used after anthracycline-based chemotherapy as adjuvant or neoadjuvant therapy for patients with early
stage HER2+ breast cancer.
Preclinical
studies have been conducted and published which explore the effectiveness of T-DM1 for the treatment of HER2+ gastric cancer.
We
believe that T-DM1 has the potential to be a valuable new therapeutic for the treatment of patients with HER2+ cancer. Under our agreement with Roche, through its
Genentech unit, we are entitled to receive royalties on T-DM1 sales, if any, as well as certain progress-related milestone payments.
Lorvotuzumab mertansine (IMGN901)
Our most advanced wholly owned compound is lorvotuzumab mertansine, which we also call IMGN901. IMGN901 targets CD56, which is found on
small-cell lung cancer, or SCLC, Merkel cell carcinoma, or MCC, multiple myeloma, ovarian cancers, carcinoid tumors, and other cancers of neuroendocrine origin. In early clinical testing,
IMGN901 has demonstrated evidence of activity when used alone to treat CD56+ cancersincluding SCLC, MCC, and multiple myelomathat had recurred after treatment with approved
anticancer drugs.
We
believe the best development path for IMGN901 is as a treatment for newly diagnosed SCLC. As we gain additional data, we also intend to continue to assess MCC as a registration
pathway for IMGN901. SCLC and MCC have a number of similarities in morphology, clinical course, and methods of treatment. For example, both newly diagnosed metastatic SCLC and newly diagnosed
metastatic MCC are typically treated with etoposide plus carboplatin (E/C), enabling information we obtain assessing IMGN901 with E/C in order to advance IMGN901 for SCLC to also enable us to advance
it for MCC if appropriate. We believe the clinical experience we have obtained with IMGN901 in the treatment of multiple myeloma contributes to the value of IMGN901, but do not view multiple myeloma
to currently be a registration pathway for the compound.
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In
late 2010 we initiated a clinical trial, Study 007, to assess IMGN901 used in combination with E/C to treat newly diagnosed metastatic SCLC. This trial has Phase I and
Phase II sections:
Phase IThis part is designed to establish the dose of IMGN901 to be used with E/C in the Phase II part. Patients with any
type of solid tumor normally treated with E/C are eligible for enrollment, and alternative doses of IMGN901 used with E/C are assessed.
Phase IIOnce the Phase II dose is established, the trial will be expanded. We intend to have approximately 20 clinical
centers across four countries enrolling patients into the Phase II leg of Study 007. Patient enrollment will be limited to individuals with newly diagnosed metastatic SCLC. Patients enrolled
will be randomized to receive either E/Ccurrent standard care for this canceror E/C plus IMGN901, with two patients randomized to the E/C plus IMGN901 group for every one
patient randomized to the E/C alone group. The trial is designed to assess whether the addition of IMGN901 to E/C meaningfully improves patient outcomes. An interim analysis focused on
progression-free survival is planned after enrollment of the first 60 patients. The full Phase II trial is designed to include 120 patients.
IMGN388
IMGN388 is a potential new treatment for solid tumors currently in Phase I clinical testing. This TAP compound was originally
created by a division of Johnson & Johnson, which has retained certain opt-in rights on the compound. IMGN388 targets a protein, av integrin,
found on many types of solid tumors. This protein also occurs on vascular endothelial cells in the process of forming new blood vessels, a process that needs to occur for a solid tumor to grow. We
began Phase I testing assessing IMGN388 dosed every three weeks and reported those findings. Based on the pharmacokinetic information obtained with that dosing schedule, we are now evaluating a
more frequent dosing schedule for IMGN388.
IMGN529
We created IMGN529 as a next generation therapy for non-Hodgkin's lymphoma, or NHL, and for chronic lymphocytic lymphoma,
or CLL. We expect to submit the IND for this product candidate in September 2011.
IMGN529
targets CD37, which has an expression profile similar to that of CD20, the target of Rituxan®, on NHL subtypes. In preclinical testing, the antibody component of
IMGN529 demonstrates pronounced anticancer activity and was found to be at least as effective as Rituxan at killing B-cell cancer cells. In preclinical testing, the antibody retained its
anticancer properties after attachment of our potent cell-killing agent and was found to be even more effective at killing cancer cells. We believe IMGN529 is a highly differentiated
product candidate for NHL and CLL because it combines the actions of our potent cell-killing agent with the anticancer activity of its antibody component.
IMGN853
We expect to submit an IND to the FDA for this TAP compound in early 2012. IMGN853 targets folate receptor 1, or FOLR1, which is over
expressed on many cases of ovarian cancer and also on other types of solid tumors including non-small cell lung cancer. IMGN853 consists of a FOLR1-targeting antibody with one
of our potent cell-killing agents attached using one of the new engineered linkers we developed for cancers with multi-drug resistance.
Other
We have additional TAP compounds in various stages of preclinical development. We also continue to conduct research and engage in
discussions with various third parties to identify new targeting
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antibodies
and other agents and to further expand our portfolio of potent cell-killing agents and our portfolio of engineered linkers.
Compounds in Development by Our Partners
In addition to T-DM1, a number of other compounds are in clinical testing through our collaborations with other companies.
SAR3419
We created the SAR3419 TAP compound, including its antibody component, and licensed it to Sanofi from our preclinical pipeline as part
of a broader collaboration. SAR3419 targets CD19 and is a potential new treatment for B-cell malignancies including NHL. SAR3419 has demonstrated encouraging activity and tolerability in
Phase I clinical testing, and Sanofi expects to begin Phase II clinical testing with the compound in the second half of 2011 in Diffuse Large B-cell Lymphoma, a type of NHL,
and in Acute Lymphoblastic Leukemia. Sanofi also retained us to develop a commercial-scale manufacturing process for SAR3419. We have completed and transferred this process.
SAR650984 and SAR566658
These compounds also were licensed to Sanofi as part of a broader collaboration. SAR650984 is a CD38-targeting therapeutic
antibody for hematological malignancies. SAR566658 is a TAP compound for DS6-expressing solid tumors, including ovarian cancers. Sanofi advanced both of these product candidates into
Phase I testing in 2010.
BT-062 and BAY 94-9343
These two TAP compounds are in development by Biotest and Bayer HealthCare Pharmaceuticals, respectively. Encouraging early stage
clinical data have been reported for BT-062. Bayer submitted the IND for BAY 94-9343 to the FDA in June 2011.
We
expect two additional TAP compounds to advance into clinical testing during our current fiscal year ending June 30, 2012 through our collaborative partners.
Incidence of Relevant Cancers
Cancer remains a leading cause of death worldwide, and is the second leading cause of death in the U.S. The American Cancer Society
estimates that approximately 1.6 million new cases of cancer will be diagnosed in the U.S. in 2011 and that approximately 572,000 people will die from cancer. The total number of people living
with cancer significantly exceeds the number of patients diagnosed with cancer in a given year as patients can live with cancer for a year or longer. Additionally, the potential market for anticancer
drugs exceeds the number of patients treated as many types of cancer typically are treated with multiple compounds at the same time and because patients often receive a number of drug regimens
sequentially.
Trastuzumab
emtansineBased on American Cancer Society and Roche estimates, we believe approximately 47,000-56,000 new cases of HER2+
breast cancer will be diagnosed in 2011. These include diagnoses for both localized disease and advanced, or metastatic, disease. The first approvals of T-DM1 are expected to be for
advanced disease. Roche has estimated the 2nd-line and later patient population in the U.S. to be approximately 13,700 patients.
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IMGN901We are assessing this compound for the treatment of CD56+ solid tumors, including small-cell lung
cancer and Merkel cell carcinoma, as well as the liquid tumor, multiple myeloma. Based on our own studies and scientific literature, we believe that CD56 is expressed on approximately 100% of
small-cell lung cancer and Merkel cell carcinoma cases and 70% of multiple myeloma cases. Based on American Cancer Society estimates and other sources, we believe that approximately 31,000
new cases of small-cell lung cancer will be diagnosed in the U.S. in 2011. Based on American Cancer Society estimates, we also believe that approximately 21,000 new cases of multiple
myeloma will be diagnosed in the U.S. in 2011. Based on other published data, we believe approximately 1,5001,900 new cases of Merkel cell carcinoma will be diagnosed in the U.S.
in 2011.
We
are assessing our IMGN388 compound for the treatment of solid tumors. Cancers of particular interest include melanoma, lung, breast, and ovarian cancers. Based on American Cancer
Society estimates, we believe approximately 546,000 new cases of these cancers will be diagnosed in the U.S. in 2011.
Out-licenses and Collaborations
We selectively out-license restricted access to our TAP technology to other companies to provide us with cash to fund our
own product programs and to expand the utilization of our technology. These agreements typically provide the licensee with rights to use our TAP technology with any of its antibodies and apply them 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, royalties on the sales of any resulting products and research and development funding
based on activities performed at our collaborative partner's request. We are also reimbursed for our direct and a portion of overhead costs to manufacture preclinical and clinical materials and, under
certain collaborative agreements, the reimbursement includes a profit margin. Our principal out-licenses and collaborative agreements are described below.
Roche
In May 2000, we granted Roche, through its Genentech unit, an exclusive license to our maytansinoid TAP technology for use with
antibodies that target HER2, such as trastuzumab. Under the terms of this agreement, Roche has exclusive worldwide rights to develop and commercialize maytansinoid TAP compounds with antibodies or
other proteins that target HER2. Roche is responsible for the manufacturing, product development and marketing of any products resulting from the agreement. We are reimbursed for any preclinical and
clinical materials that we manufacture under the agreement. We received a $2 million non-refundable payment from Roche upon execution of the agreement. We also are entitled to
receive up to $44 million in milestone payments from Roche under this agreement, as amended in May 2006, in addition to royalties on the net sales of any resulting products. Roche began
Phase III evaluation of T-DM1 in February 2009, which triggered a $6.5 million milestone payment to us. Through June 30, 2011, we have received a total of
$13.5 million in milestone payments.
Roche,
through its Genentech unit, also has licenses for the exclusive right to use our maytansinoid TAP technology with antibodies to four undisclosed targets, which were granted under
the terms of a separate May 2000 right-to-test agreement with Genentech. For each of these licenses we received a $1 million license fee and are entitled to receive up
to $38 million in milestone payments and also royalties on the sales of any resulting products. Roche is responsible for the development, manufacturing, and marketing of any products resulting
from these licenses. Roche no longer has the right to take additional licenses under the right-to-test agreement. We received non-refundable technology access fees
totaling $5 million for the eight-year term of the agreement.
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Amgen
In September 2000, we entered into a ten-year right-to-test agreement with Abgenix, Inc.,
which was later acquired by Amgen. The agreement provides Amgen with the right to test our maytansinoid TAP technology with antibodies to a defined number of targets on either an exclusive and
non-exclusive basis for specified option periods and to take exclusive or non-exclusive licenses to use our maytansinoid TAP technology to develop products for individual
targets on agreed-upon terms. We received a $5 million technology access fee in September 2000. Under the agreement, in September 2009 and November 2009, we entered into two
development and license agreements with Amgen and received a $1 million upfront payment with each license taken. In addition to the $1 million upfront payment, we are entitled to earn
milestone payments potentially totaling $34 million per target for each compound developed under the right-to-test agreement, as well as royalties on the commercial
sales of any resulting products. In September 2010, we granted Amgen a combination of exclusive and non-exclusive options to test our TAP technology with antibodies to specific antigen
targets. For each option taken, Amgen paid us a nominal fee. These options provide Amgen with the right to take a license for each of these targets, during the time period allowed, on the license
terms established in the September 2000 agreement. Amgen no longer has the right to designate new targets under this agreement, although the option periods with respect to the designated targets for
the options granted will remain in effect for the remainder of the respective option periods.
Sanofi
In July 2003, we entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and commercialize
antibody-based anticancer therapeutics.
The
agreement provides Sanofi with worldwide commercialization rights to new anticancer therapeutics developed to targets that were included in the collaboration, including the right to
use our TAP technology and our humanization technology in the creation of therapeutics to these targets. The product candidates (targets) currently in the collaboration include SAR3419 (CD19),
SAR650984 (CD38), SAR566658 (DS6, also known as CA6) and other earlier-stage compounds that have yet to be disclosed.
The
collaboration agreement entitles us to receive milestone payments potentially totaling $21.5 million for each therapeutic now included in the collaboration agreement. Through
June 30, 2011, we have earned a total of $5 million in milestone payments related to the three product candidates noted above and a target not yet disclosed. We also earned an aggregate
of $8 million of milestone payments related to two product candidates previously in the collaboration that have been returned to us along with the rights to the respective targets.
The
agreement also entitles us to royalties on the commercial sales of any resulting products if and when such sales commence. Sanofi is responsible for the cost of the development,
manufacturing and marketing of any products created through the collaboration. We are reimbursed for any preclinical and clinical materials that we make under the agreement. The collaboration
agreement also provides us an option to certain co-promotion rights in the U.S. on a product-by-product basis. The terms of the collaboration agreement allow Sanofi
to terminate our co-promotion rights if there is a change of control of our company.
As
part of this agreement, Sanofi paid us an upfront fee of $12.0 million in August 2003. Inclusive of all of its allowed extensions, the agreement enabled us to receive committed
research funding totaling $79.3 million over the five years of the research collaboration. The two companies subsequently agreed to extend the date of research funding through
October 31, 2008 to enable completion of previously agreed-upon research. We recorded the research funding as it was earned based upon its actual resources utilized in the
collaboration. We earned $81.5 million of committed funding over the
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duration
of the research program and are now compensated for research performed for Sanofi on a mutually agreed-upon basis.
In
October 2006, Sanofi licensed non-exclusive rights to use our proprietary resurfacing technology to humanize antibodies to targets not included in the collaboration,
including antibodies for non-cancer applications. This license provides Sanofi with the non-exclusive right to use our proprietary humanization technology through
August 31, 2011 with the right to extend for one or more additional periods of three years each by providing us with written notice prior to expiration of the then-current license
term. Under the terms of the license, we received a $1 million license fee, half of which was paid upon contract signing and the second half was paid in August 2008, and in addition, we are
entitled to receive milestone payments potentially totaling $4.5 million for each antibody humanized under this agreement and also royalties on commercial sales, if any.
In
August 2008, Sanofi exercised its option under a separate 2006 agreement for expanded access to our TAP technology. The exercise of this option enables Sanofi to evaluate, with
certain restrictions, our maytansinoid TAP technology with antibodies to targets that were not included in the existing research collaboration between the companies and to license the exclusive right
to use the technology
to develop products to specific targets based on the terms in the 2006 agreement. We are entitled to earn upfront and milestone payments potentially totaling $32 million per target for each
compound developed under the 2006 agreement, as well as royalties on the commercial sales of any resulting products. We are also entitled to manufacturing payments for any materials made on behalf of
Sanofi. We received $500,000 in December 2006 with the signing of the option agreement and we received $3.5 million with the exercise of this option in August 2008. The agreement has a
three-year term from the date of the exercise of the option and can be renewed by Sanofi for one additional three-year term by payment of a $2 million fee by
August 31, 2011.
Biotest
In July 2006, we granted Biotest an exclusive license to use our maytansinoid TAP technology to develop and commercialize therapeutic
compounds directed to the target CD138. We received a $1 million upfront payment upon execution of the license. In September 2008, Biotest began Phase I evaluation of BT-062,
which was created under this license. This event triggered a $500,000 milestone payment to us. Assuming all benchmarks are met under this agreement, we could receive up to $35.5 million in
milestone payments. We are also entitled to receive royalties on net sales of any resulting products. We receive payments for manufacturing any preclinical and clinical materials made at the request
of Biotest.
The
license agreement also provides us with the right to elect, at specific stages during the clinical evaluation of any compound created under this agreement, to participate in the U.S.
development and commercialization of that compound in lieu of receiving royalties on U.S. sales and the milestone payments not yet earned. We can exercise this right by making a payment to Biotest of
an agreed-upon fee of $5 million or $15 million, depending on the stage of development. Upon exercise of this right, we would share equally with Biotest the associated costs
of product development and commercialization in the U.S. along with the profit, if any, from U.S. product sales.
Bayer HealthCare
In October 2008, we granted Bayer HealthCare an exclusive license to use our maytansinoid TAP technology to develop and commercialize
therapeutic compounds directed to mesothelin. Bayer HealthCare is responsible for the research, development, manufacturing and marketing of any products resulting from the license. We received a
$4 million upfront payment upon execution of the license, andfor each compound developed and marketed by Bayer HealthCare under this collaborationwe could potentially
receive up to $170.5 million in milestone payments; additionally, we are entitled to receive royalties on the net sales of any resulting products. In June 2011, Bayer HealthCare filed an
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IND
with the FDA which triggered a $2 million payment to us. Through June 30, 2011, we have received a total of $3 million in milestone payments. We also are entitled to receive
payments for manufacturing any preclinical and clinical materials at the request of Bayer HealthCare as well as for any related process development activities.
Novartis
In October 2010, we entered into an agreement with Novartis Institutes for BioMedical Research, Inc. (Novartis) that initially
provides Novartis with a research license to test our TAP technology with Novartis' antibodies and an option to take exclusive development and commercialization licenses to use our TAP technology to
develop therapeutic products for a specified number of individual antigen targets. The initial term of the research license is for three years and it may be extended by Novartis for up to two one year
periods by the payment of additional consideration. The terms of the agreement also require Novartis to exercise its option for the development and commercialization licenses by the end of the
research term. We received a $45 million upfront payment in connection with the execution of the agreement, and for each development and commercialization license for an antigen target, we are
entitled to receive milestone payments potentially totaling $200.5 million plus royalties on product sales, if any. We also are entitled to receive payments for manufacturing preclinical and
clinical materials at the request of Novartis as well as for research and development activities performed on behalf of Novartis. Novartis is responsible for the development, manufacturing and
marketing of any products resulting from this agreement.
In-Licenses
From time to time we may in-license certain rights to targets or technologies for use in conjunction with our internal
efforts to develop TAP compounds and related technologies. In exchange, we may be obligated to pay upfront fees, potential milestone payments and royalties on any product sales.
Janssen Biotech
In December 2004, we entered into a development and license agreement with a predecessor to Janssen Biotech (formerly known as Centocor
Ortho Biotech), a wholly owned subsidiary of Johnson & Johnson. Under the terms of this agreement, Janssen was granted exclusive worldwide rights to develop and commercialize anticancer
therapeutics that consist of our maytansinoid cell-killing agent attached to an av integrin-targeting antibody that was developed by Janssen. Under
the terms of the agreement, we received an upfront payment of $1 million upon execution of the agreement.
In
December 2007, we licensed from Janssen Biotech the exclusive, worldwide right to develop and commercialize a TAP compound, IMGN388, that consists of an
av integrin-targeting antibody developed by them and one of our maytansinoid cell-killing agents. This license reallocates the parties' respective
responsibilities and financial obligations from the license referenced above. Janssen Biotech has the right to opt-in on future development and commercialization of IMGN388 at an
agreed-upon stage in early clinical testing. Should Janssen Biotech not exercise this right, Janssen Biotech would be entitled to receive milestone payments potentially totaling
$30 million, with the first payment due upon the completion of a successful Phase III trial, and also royalties on IMGN388 sales, if any. In this event, ImmunoGen has the right to obtain
a new partner for IMGN388, with certain restrictions. Should Janssen Biotech exercise its opt-in right, ImmunoGen would receive an opt-in fee and be released from its
obligation to pay Janssen Biotech any milestone payments or royalties on sales. Both companies would contribute to the costs of developing the compound. The two companies would share equally any
profits on the sales of the compound in the U.S. and ImmunoGen would receive royalties on any international sales. The companies have agreed to share certain third-party payments. In June 2008, the
FDA approved the IND application for IMGN388. This event triggered a $1 million milestone payment to a third-party, half of which was paid by ImmunoGen. As of June 30, 2011, the
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maximum
amount that may be payable in the future to such third-parties under this agreement is $11 million.
Other Licenses
We also have licenses with third parties, including other companies and academic institutions, to gain access to techniques and
materials for drug discovery and product development and the rights to use those techniques and materials to make our product candidates. These licenses include rights to certain antibodies.
Patents, Trademarks and Trade Secrets
Our intellectual property strategy centers on obtaining patent protection for our proprietary technologies and product candidates. As
of June 30, 2011, our patent portfolio had a total of 415 issued patents worldwide and 420 pending patent applications worldwide that we own or license from third parties. We seek to protect
our TAP technology and our product candidates through a multi-pronged approach. In this regard, we have patents and patent applications covering antibodies and other cell-binding agents,
linkers, maytansinoid and other cell-killing agents, and complete antibody-drug conjugates, or immunoconjugates, comprising these components and methods of making and using
each of the above. Typically, multiple issued patents and pending patent applications cover various aspects of each product candidate.
We
consider our maytansinoid technology to be a key component of our overall corporate strategy. We currently own 26 issued U.S. patents covering various embodiments of our maytansinoid
technology including claims directed to certain maytansinoids, antibody-maytansinoid conjugates and other cell-binding agents used with maytansinoids, and methods of making and using the
same. In all cases, we have received or are applying for comparable patents in other jurisdictions including Europe and Japan. We have issued patents that cover numerous aspects of the manufacture of
both our DM1 and DM4 cell-killing agents. These issued patents remain in force until various times between 2020 and 2026. We also have several composition of matter patents covering
various aspects of our DM4 cell-killing agent and antibody-maytansinoid conjugates incorporating DM4 that are expected to remain in force until 2024-2025.
Our
intellectual property strategy also includes pursuing patents directed to linkers, antibodies, conjugation methods, immunoconjugate formulations and the use of specific antibodies
and immunoconjugates to treat certain diseases. In this regard, we have issued patents and pending patent applications related to many of our linker technologies. These issued patents, expiring in
2021-2023, and any patents which may issue from the patent applications, cover antibody-maytansinoid conjugates using these linkers. We also have issued U.S. patents and pending patent
applications covering methods of assembling immunoconjugates from their constituent antibody, linker and cell-killing agent moieties. These issued patents will expire in
2021-2026, while any patents that may issue from pending patent applications also covering various aspects of these technologies will, if issued, expire between 2021 and 2032. We also have
issued patents and pending patent applications related to monoclonal antibodies that may be a component of a TAP compound or may be developed as a therapeutic, or "naked," antibody anticancer
compound. Among these patents is an issued U.S. patent claiming a method of humanizing murine antibodies to avoid their detection by the human immune system. We have received patents in other
jurisdictions, including Europe and Japan, that correspond to our antibody humanization U.S. patent. These patents will expire between 2013 and 2014.
We
expect our continued work in each of these areas will lead to other patent applications. In all such cases, we will either be the assignee or owner of such patents or have an
exclusive license to the technology covered by the patents. For example, we also own issued patents covering proprietary derivatives of non-maytansinoid cell-killing molecules.
However, we do not currently consider these additional patent families to be material to our business.
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As
described elsewhere in this annual report on Form 10-K under the heading "In-LicensesJanssen
Biotech," we have in-licensed certain technology from Janssen Biotech in connection with the development of our IMGN388 product candidate. In addition, we have
in-licensed intellectual property relating to our IMGN901 product candidate from Dana-Farber Cancer Institute. We do not believe that the terms of this license are material to
our business or prospects.
We
cannot provide assurance that the patent applications will issue as patents or that any patents, if issued, will provide us with adequate protection against competitors with respect
to the covered products, technologies or processes. Defining the scope and term of patent protection involves complex legal and factual analyses and, at any given time, the result of such analyses may
be uncertain. In addition, other parties may challenge our patents in litigation or administrative proceedings resulting in a partial or complete loss of certain patent rights owned or controlled by
ImmunoGen, Inc. Furthermore, as a patent does not confer any specific freedom to operate, other parties may have patents that may block or otherwise hinder the development and commercialization
of our technology.
In
addition, many of the processes and much of the know-how that are important to us depend upon the skills, knowledge and experience of our key scientific and technical
personnel, which skills, knowledge and experience are not patentable. To protect our rights in these areas, we require that all employees, consultants, advisors and collaborators enter into
confidentiality agreements with us. Further, we require that all employees enter into assignment of invention agreements as a condition of employment. We cannot provide assurance, however, that these
agreements will provide adequate or any meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of such
trade secrets,
know-how or proprietary information. Further, in the absence of patent protection, we may be exposed to competitors who independently develop substantially equivalent technology or
otherwise gain access to our trade secrets, know-how or other proprietary information.
Competition
We focus on highly competitive areas of product development. Our competitors include major pharmaceutical companies and other
biotechnology firms. For example, Pfizer, Seattle Genetics, Roche and Bristol Myers Squibb have programs to attach a proprietary cell-killing small molecule to an antibody for targeted
delivery to cancer cells. Pharmaceutical and biotechnology companies, as well as other institutions, also compete with us for promising targets for antibody-based therapeutics and in recruiting highly
qualified scientific personnel. Many competitors and potential competitors have substantially greater scientific, research and product development capabilities, as well as greater financial, marketing
and human resources than we do. In addition, many specialized biotechnology firms have formed collaborations with large, established companies to support the research, development and
commercialization of products that may be competitive with ours.
In
particular, competitive factors within the antibody and cancer therapeutic market include:
-
- the safety and efficacy of products;
-
- the timing of regulatory approval and commercial introduction;
-
- special regulatory designation of products, such as Orphan Drug designation; and
-
- the effectiveness of marketing, sales, and reimbursement efforts.
Our
competitive position depends on our ability to develop effective proprietary products, implement clinical development programs, production plans and marketing plans, including
collaborations with other companies with greater marketing resources than ours, and to obtain patent protection and secure sufficient capital resources.
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Continuing
development of conventional and targeted chemotherapeutics by large pharmaceutical companies and biotechnology companies may result in new compounds that may compete with our
product candidates. In addition, antibodies developed by certain of these companies have been approved for use as cancer therapeutics. In the future, additional antibodies may compete with our product
candidates. In addition, other companies have created or have programs to create potent cell-killing agents for attachment to antibodies. These companies may compete with us for technology
out-license arrangements.
Because
of the acceptance of combination therapy for the treatment of cancer and the variety of genes and targets implicated in cancer incidence and progression, we believe that products
resulting from applications of new technologies may be complementary to our own.
Such
new technologies include, but are not limited to:
-
- the use of genomics technology to identify new gene-based targets for the development of anticancer drugs;
-
- the use of high-throughput screening to identify and optimize lead compounds;
-
- the use of gene therapy to deliver genes to regulate gene function; and
-
- the use of therapeutic vaccines.
Regulatory Matters
Government Regulation and Product Approval
Government authorities in the U.S., at the federal, state and local level, and other countries extensively regulate, among other
things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import
of products such as those we are developing. A new drug must be approved by the FDA through the new drug application, or NDA, process and a new biologic must be approved by the FDA through the
biologics license application, or BLA, process before it may be legally marketed in the U.S.
U.S. Drug Development Process
In the U.S., the FDA regulates drugs under the federal Food, Drug, and Cosmetic Act, or FDCA, and in the case of biologics, also under
the Public Health Service Act, or PHSA, and implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign
statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development
process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA's refusal to approve pending applications,
withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a
drug or biologic may be marketed in the U.S. generally involves the following:
-
- completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices
or other applicable regulations;
-
- submission to the FDA of an IND which must become effective before human clinical trials may begin;
-
- performance of adequate and well-controlled human clinical trials according to Good Clinical Practices to
establish the safety and efficacy of the proposed drug for its intended use;
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-
- submission to the FDA of an NDA or BLA;
-
- satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to
assess compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity; and
-
- FDA review and approval of the NDA or BLA.
Once
a pharmaceutical candidate is identified for development it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and
formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. The
sponsor will also include a protocol detailing, among other things, the objectives of the first phase of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness
criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. Some preclinical testing may continue even after the
IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical
hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during
studies due to safety concerns or non-compliance.
All
clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with good clinical practice regulations. They must be conducted under
protocols detailing the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted
to the FDA as part of the IND, and progress reports detailing the results of the clinical trials must be submitted at least annually. In addition, timely safety reports must be submitted to the FDA
and the investigators for serious and unexpected adverse events. An institutional review board, or IRB, at each institution participating in the clinical trial must review and approve each protocol
before a clinical trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal
representative, monitor the study until completed and otherwise comply with IRB regulations.
Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:
-
- Phase I: The product candidate is initially introduced into healthy human
subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, such as cancer,
especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
-
- Phase II: This phase involves studies in a limited patient population to
identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
-
- Phase III: Clinical trials are undertaken to further evaluate dosage, clinical
efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit ratio of the
product candidate and provide, if appropriate, an adequate basis for product labeling.
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The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed
to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's
requirements or if the drug has been associated with unexpected serious harm to patients. Phase I, Phase II, and Phase III testing may not be completed successfully within any
specified period, if at all.
Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the
drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality
batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate
packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
U.S. Review and Approval Processes
The results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process,
analytical tests conducted on the chemistry of the drug, proposed labeling, and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product.
The submission of an NDA or BLA is subject to the payment of user fees; a waiver of such fees may be obtained under certain limited circumstances. The FDA reviews all NDAs and BLAs submitted to ensure
that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept a NDA or BLA for filing. In this event, the
NDA or BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review. FDA may refer the NDA or BLA to an advisory committee for review, evaluation and recommendation as to whether the application should be
approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The approval process is lengthy and difficult
and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. Even if such data and
information is submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may
interpret data differently than we interpret the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that must be
met in order to secure final approval of the NDA or BLA, or an approved letter following satisfactory completion of all aspects of the review process. The FDA reviews an NDA to determine, among other
things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product's identity, strength, quality and
purity. The FDA reviews a BLA to determine, among other things whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards
designed to assure the product's continued safety, purity and potency. Before approving an NDA or BLA, the FDA will inspect the facility or facilities where the product is manufactured.
NDAs
or BLAs receive either standard or priority review. A drug representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review. In
addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may
receive accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the
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drug
product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible
morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical
trials. Priority review and accelerated approval do not change the standards for approval, but may expedite the approval process.
If
a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could
restrict the commercial value of the product. In addition, the FDA may require us to conduct Phase IV testing which involves clinical trials designed to further assess a drug's safety and
effectiveness after NDA or BLA approval, and may require testing and surveillance programs to monitor the safety of approved products which have been commercialized.
In
addition, under the Pediatric Research Equity Act of 2007, or PREA, an NDA, BLA and certain types of supplements to an NDA or BLA must contain data to assess the safety and
effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and
effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan
designation has been granted. PREA sunsets on October 1, 2012.
Patent Term Restoration and Marketing Exclusivity
Depending upon the timing, duration and specifics of FDA approval of the use of our drugs, some of our U.S. patents may be eligible for
limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent
restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining
term of a patent beyond a total of 14 years from the product's approval date. The patent term restoration period is generally one-half the time between the effective date of an IND,
and the submission date of an NDA or BLA, plus the time between the submission date of an NDA or BLA and the approval of that application. Only one patent applicable to an approved drug is eligible
for the extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves the
application for any patent term extension or restoration. In the future, we intend to apply for restorations of patent term for some of our currently owned or licensed patents to add patent life
beyond their current expiration date, depending on the expected length of clinical trials and other factors involved in the filing of the relevant NDA or BLA.
Market
exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a five-year period of
non-patent marketing exclusivity within the U.S. to the first applicant to gain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously
approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for
review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of
reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA
also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or
sponsored by the applicant are deemed by FDA to be essential to the approval of the application, for example, for new indications, dosages, or strengths of an existing drug. This
three-year exclusivity covers only the conditions associated with the new clinical
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investigations
and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent. Five-year and three-year exclusivity will not delay the
submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and
well-controlled clinical trials necessary to demonstrate safety and effectiveness.
Pediatric
exclusivity is another type of exclusivity in the U.S. Pediatric exclusivity, if granted, provides an additional six months to an existing exclusivity or statutory delay in
approval resulting from a patent certification. This six-month exclusivity, which runs from the end of other exclusivity protection or patent delay, may be granted based on the voluntary
completion of a pediatric study in accordance with an FDA-issued "Written Request" for such a study. The current pediatric exclusivity provision will sunset on October 1, 2012.
Biologics Price Competition and Innovation Act of 2009
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act which included the Biologics
Price Competition and Innovation Act of 2009, or BPCIA. The BPCIA amended the PHSA to create an abbreviated approval pathway for two types of "generic" biologicsbiosimilars and
interchangeable biologic products, and provides for a twelve-year exclusivity period for the first approved biological product, or reference product, against which a biosimilar or
interchangeable application is evaluated; however if pediatric studies are performed and accepted by the FDA, the twelve-year exclusivity period will be extended for an additional six
months A biosimilar product is defined as one that is highly similar to a reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically
meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product. An interchangeable
product is a biosimilar product that may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
The
biosimilar applicant must demonstrate that the product is biosimilar based on data from (1) analytical studies showing that the biosimilar product is highly similar to the
reference product; (2) animal studies (including toxicity); and (3) one or more clinical studies to demonstrate safety, purity and potency in one or more appropriate conditions of use
for which the reference product is approved. In addition, the applicant must show that the biosimilar and reference products have the same mechanism of action for the conditions of use on the label,
route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity and potency.
An
application for a biosimilar product may not be submitted until four years after the date on which the reference product was first approved. The first approved interchangeable
biologic product will be granted an exclusivity period of up to one year after it is first commercially marketed, but the exclusivity period may be shortened under certain circumstances.
In
November 2010, the FDA held a 2-day public hearing on the approval pathway for biosimilar and interchangeable biological products. It has not yet issued any guidance on
how the law will be implemented, but senior officials at FDA have indicated that the guidance will be available by the end of 2011.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is
generally a disease or condition that affects fewer than 200,000 individuals in the U.S., or more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of
developing and making available in the U.S. a drug for this type
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of
disease or condition will be recovered from sales in the U.S. for that drug. Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation,
the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory
review and approval process.
If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product
exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication, except in very limited circumstances, for seven years. Orphan drug
exclusivity, however, also could block the approval of one of our products for seven years if a competitor obtains approval of the same drug as defined by the FDA or if our product candidate is
determined to be contained within the competitor's product for the same indication or disease.
The
FDA also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials to support the approval of drugs, biologics, medical
devices, and medical foods for rare diseases and conditions. A product does not have to be designated as an orphan drug to be eligible for the grant program. An application for an orphan grant should
propose one discrete clinical study to facilitate FDA approval of the product for a rare disease or condition. The study may address an unapproved new product or an unapproved new use for a product
already on the market.
The
FDA granted Orphan Drug designation to our lorvotuzumab mertansine compound when used for the treatment of Merkel cell carcinoma (MCC), small-cell lung cancer (SCLC) and
multiple myeloma (MM). Orphan drug designation provides ImmunoGen with seven years of market exclusivity that begins once lorvotuzumab mertansine receives FDA marketing approval for the use for which
the orphan drug status was granted. Also, through a separate process, lorvotuzumab mertansine has been granted orphan medicinal product designation for the treatment of MCC, SCLC and MM in the
European Union. Orphan medicinal product designation provides ImmunoGen with ten years of market exclusivity that begins once lorvotuzumab mertansine receives European approval for the use for which
it was granted. We may pursue these designations for other indications for lorvotuzumab mertansine, and for other product candidates intended for qualifying patient populations.
New Drugs for Serious or Life Threatening Illnesses
The FDA Modernization Act allows the designation of "Fast Track" status to expedite development of new drugs, including review and
approvals, and is intended to speed the availability of new therapies to desperately ill patients. "Fast Track" procedures permit early consultation and commitment from the FDA regarding preclinical
studies and clinical trials necessary to gain marketing approval. We may seek "Fast Track" status for some, or all, of our product candidates.
 "Fast
Track" status also incorporates initiatives announced by the President of the U.S. and the FDA Commissioner in March 1996 intended to provide cancer patients with faster access to
new cancer therapies. One of these initiatives states that the initial basis for approval of anticancer agents to treat refractory, hard-to-treat cancer may be objective
evidence of response, rather than statistically improved disease-free and/or overall survival, as had been common practice. The sponsor of a product approved under this accelerated
mechanism is required to follow up with further studies on clinical safety and effectiveness in larger groups of patients.
Post-Approval Requirements
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory standards is not maintained or if problems
occur after the product reaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even
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complete
withdrawal of the product from the market. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims,
are subject to further FDA review and approval. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with
the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. We rely, and expect to continue
to rely, on third parties for the production of clinical and commercial quantities of our products. Future FDA and state inspections may identify compliance issues at the facilities of our contract
manufacturers that may disrupt production or distribution, or require substantial resources to correct.
Any
drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements,
reporting of adverse experiences with the drug, providing the FDA with updated safety and efficacy information, drug sampling and distribution requirements, complying with certain electronic records
and signature requirements, and complying with FDA promotion and advertising requirements. FDA strictly regulates labeling, advertising, promotion and other types of information on products that are
placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label.
From
time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing
of products regulated by the FDA. For example, the Food and Drug Administration Amendments Act of 2007, or FDAAA, gave the FDA enhanced postmarket authority, including the authority to require
postmarket studies and clinical trials, labeling changes based on new safety information, and compliance with a risk evaluation and mitigation strategy approved by the FDA. Failure to comply with any
requirements under FDAAA may result in significant penalties, and it authorizes significant civil money penalties for the dissemination of false or misleading
direct-to-consumer advertisements. In addition, it expands the clinical trial registry so that sponsors of all clinical trials, except for Phase I trials, are required
to submit certain clinical trial information for inclusion in the clinical trial registry data bank, including summary adverse effect information. FDA regulations and guidance are often revised or
reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether further legislative changes will be
enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any, may be.
Foreign Regulation
In addition to regulations in the U.S., we will be subject to a variety of foreign regulations governing clinical trials and commercial
sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before
we can commence clinical trials and approval of foreign countries or economic areas, such as the European Union, before we may market products in those countries or areas. The approval process and
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place and the time may be longer or shorter than that required for FDA
approval.
Under
European Union regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized procedure. The centralized procedure, which
is compulsory for medicines produced by certain biotechnological processes, orphan drugs and products containing a new active substance intended for treatment of specific conditions/illnesses
including cancer, provides for the grant of a single marketing authorization that is valid for all European Union member states. If a drug does not fall within a mandatory category, it may still be
submitted to the centralized procedure if it contains a new active substance and constitutes a significant therapeutic, scientific or technical innovation. Other new drugs without approval in any
Member State, will follow
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the
decentralized procedure which provides for approval by one or more other, or concerned, Member States of an assessment of an application performed by one Member State, known as the reference
Member State. Under this procedure, an applicant submits an application, or dossier, and related materials (draft summary of product characteristics, draft labeling and package leaflet) to the
reference Member State and concerned Member States. The reference Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid
application. Within 90 days of receiving the reference Member State's assessment report, each concerned Member State must decide whether to approve the assessment report and related materials.
If a Member State cannot approve the assessment report and related materials on the grounds of potential serious risk to public health, the disputed points may eventually be referred to the European
Commission, whose decision is binding on all Member States.
Reimbursement
Sales of pharmaceutical products depend in significant part on the availability of third-party reimbursement. Third-party payors
include government healthcare programs, managed care providers, private health insurers and other organizations. We anticipate third-party payors will provide reimbursement for our products. However,
these third-party payors are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the
reimbursement status of newly approved healthcare products. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of our products. Our
product candidates may not be considered cost-effective. It is time consuming and expensive for us to seek reimbursement from third-party payors. Reimbursement may not be available or
sufficient to allow us to sell our products on a competitive and profitable basis.
The
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, imposed new requirements for the distribution and pricing of prescription drugs for Medicare
beneficiaries, and included a major expansion of the prescription drug benefit under Medicare Part D. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered
by private entities which provide coverage of outpatient prescription drugs. Part D plans include both stand-alone prescription drug benefit plans and prescription drug coverage as a supplement
to Medicare Advantage plans. Unlike Medicare Part A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered
Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription drug formularies
must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D
prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee.
It
is not clear what effect the MMA has had on the prices paid for currently approved drugs and the pricing options for future approved drugs. Government payment for some of the costs of
prescription drugs may increase demand for products for which we receive marketing approval. However, any negotiated prices for our products covered by a Part D prescription drug plan will
likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and
payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental payors.
We
expect that there will continue to be a number of federal and state proposals to implement governmental pricing controls and limit the growth of healthcare costs, including the cost
of prescription drugs. For example, in March 2010, President Obama signed one of the most significant health care reform measures in decades, the Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Affordability Reconciliation Act, collectively referred to as the
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PPACA.
The PPACA will significantly impact the pharmaceutical industry. The PPACA will require discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid. In
addition, the PPACA imposes an annual fee, which will increase annually, on sales by branded pharmaceutical manufacturers starting in 2011. The financial impact of these discounts, increased rebates
and fees and the other provisions of the PPACA on our business is unclear.
In
addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from
country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide
reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or
indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for
pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products.
Research and Development Spending
During each of the three years ended June 30, 2011, 2010 and 2009, we spent approximately $63.5 million,
$50.3 million and $45.9 million, respectively, on research and development activities.
Raw Materials and Manufacturing
We procure certain raw material components of finished conjugate, including antibodies, DM1, DM4, and linker, for ourselves and on
behalf of our collaborators. In order to meet our commitments to our collaborators as well as our own needs, we are required to enter into agreements with third parties to produce these components
well in advance of our production needs. Our principal suppliers for these components include Cytovance Biologics LLC, SAFC, Inc. and Società Italiana
Corticosteroidi S.r.l.
In
addition, we operate a conjugate manufacturing facility. A portion of the cost of operating this facility, including the cost of manufacturing personnel, is reimbursed by our
collaborators based on the number of batches of preclinical and clinical materials produced on their behalf. Over the past few years, we have expanded and upgraded the capabilities of our
manufacturing facility.
Employees
As of June 30, 2011, we had 248 full-time employees, of whom 208 were engaged in research and development
activities. Ninety-seven research and development employees hold post-graduate degrees, of which 48 hold Ph.D. degrees and four hold M.D. degrees. We consider our relations with our
employees to be good. None of our employees is covered by a collective bargaining agreement.
We
have entered into confidentiality agreements with all of our employees, members of our board of directors and consultants. Further, we have entered into assignment of invention
agreements with all of our employees.
Third-Party Trademarks
Herceptin® is a registered trademark of Genentech. Xeloda® is a registered trademark of Hoffman-La
Roche Inc. Tykerb® is a registered trademark of the GlaxoSmithKline group. Rituxan® is a registered trademark of Biogen Idec Inc.
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Item 1A. Risk Factors
THE RISKS AND UNCERTAINTIES DESCRIBED BELOW ARE THOSE THAT WE CURRENTLY BELIEVE MAY MATERIALLY AFFECT OUR COMPANY. ADDITIONAL RISKS AND UNCERTAINTIES
THAT WE ARE UNAWARE OF OR THAT WE CURRENTLY DEEM IMMATERIAL ALSO MAY BECOME IMPORTANT FACTORS THAT AFFECT OUR COMPANY.
We have a history of operating losses and expect to incur significant additional operating losses.
We have generated operating losses since our inception. As of June 30, 2011, we had an accumulated deficit of
$430.6 million. For the years ended June 30, 2011, 2010, and 2009, we generated losses of $58.3 million, $50.9 million and $31.9 million, respectively. We may never
be profitable. We expect to incur substantial additional operating expenses over the next several years as our research, development, preclinical testing, clinical trials and collaborator support
activities continue. We intend to continue to invest significantly in our product candidates. Further, we expect to invest significant resources supporting our existing collaborators as they work to
develop, test and commercialize TAP and other antibody compounds. We or our collaborators may encounter technological or regulatory difficulties as part of this development and commercialization
process that we cannot overcome or remedy. We may also incur substantial marketing and other costs in the future if we decide to establish marketing and sales capabilities to commercialize our product
candidates. None of our or our collaborators' product candidates has generated any commercial revenue and our only revenues to date have been primarily from upfront and milestone payments, research
and development support and clinical materials reimbursement from our collaborative partners. We do not expect to generate revenues from the commercial sale of our internal product candidates in the
near future, and we may never generate revenues from the commercial sale of internal products. Even if we do successfully develop products that can be marketed and sold commercially, we will need to
generate significant revenues from those products to achieve and maintain profitability. Even if we do become profitable, we may not be able to sustain or increase profitability on a quarterly or
annual basis.
If we are unable to obtain additional funding when needed, we may have to delay or scale back some of our programs or grant rights to third parties to develop and market our
product candidates.
We will continue to expend substantial resources developing new and existing product candidates, including costs associated with
research and development, acquiring new technologies, conducting preclinical studies and clinical trials, obtaining regulatory approvals and manufacturing products as well as providing certain support
to our collaborators in the development of their products. We believe that our current working capital and expected future payments from our existing collaboration arrangements will be sufficient to
meet our current and projected operating and capital requirements through fiscal 2014. However, we may need additional financing sooner due to a number of factors including:
-
- if either we incur higher than expected costs or we or any of our collaborators experience slower than expected progress
in developing product candidates and obtaining regulatory approvals;
-
- lower revenues than expected under our collaboration agreements; or
-
- acquisition of technologies and other business opportunities that require financial commitments.
We
anticipate that our current capital resources and expected future collaborator payments under existing collaborations will enable us to meet our operational expenses and capital
expenditures through fiscal year 2014. However, we cannot provide assurance that such collaborative agreement funding will, in fact, be received. Should such future collaborator payments not be earned
and paid as currently anticipated, we expect we could seek additional funding from other sources.
Additional
funding may not be available to us on favorable terms, or at all. We may raise additional funds through public or private financings, collaborative arrangements or other
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arrangements.
Debt financing, if available, may involve covenants that could restrict our business activities. If we are unable to raise additional funds through equity or debt financing when needed,
we may be required to delay, scale back or eliminate expenditures for some of our development programs or grant rights to develop and market product candidates that we would otherwise prefer to
internally develop and market. If we are required to grant such rights, the ultimate value of these product candidates to us may be reduced.
If our TAP technology does not produce safe, effective and commercially viable products, our business will be severely harmed.
Our TAP technology yields novel product candidates for the treatment of cancer. To date, no TAP product candidate has obtained
regulatory approval and the most advanced TAP product candidate is in Phase III clinical testing. Our TAP product candidates and/or our collaborators' TAP product candidates may not prove to be
safe, effective or commercially viable treatments for cancer and our TAP technology may not result in any future meaningful benefits to us or for our current or potential collaborative partners.
Furthermore, we are aware of only two compounds that are a conjugate of an antibody and a cytotoxic small molecule that have obtained approval by the FDA and are based on technology similar to our TAP
technology. One of these products was later taken off the market by its owner due to toxicity concerns. If our TAP technology fails to generate product candidates that are safe, effective and
commercially viable treatments for cancer, or fails to obtain FDA approval, our business will be severely harmed.
Clinical trials for our and our collaborative partners' product candidates will be lengthy and expensive and their outcome is uncertain.
Before obtaining regulatory approval for the commercial sale of any product candidates, we and our collaborative partners must
demonstrate through clinical testing that our product candidates are safe and effective for use in humans. Conducting clinical trials is a time-consuming, expensive and uncertain process
and typically requires years to complete. The most advanced product candidate incorporating our TAP technology is in Phase III clinical testing. In our industry, the results from preclinical
studies and early clinical trials often are not predictive of results obtained in later-stage clinical trials. Some compounds that have shown promising results in preclinical studies or early clinical
trials subsequently fail to establish sufficient safety and efficacy data necessary to obtain regulatory approval. At any time during the clinical trials, we, our collaborative partners, or the FDA
might delay or halt any clinical trials of our product candidates for various reasons, including:
-
- occurrence of unacceptable toxicities or side effects;
-
- ineffectiveness of the product candidate;
-
- insufficient drug supply;
-
- negative or inconclusive results from the clinical trials, or results that necessitate additional studies or clinical
trials;
-
- delays in obtaining or maintaining required approvals from institutions, review boards or other reviewing entities at
clinical sites;
-
- delays in patient enrollment;
-
- insufficient funding or a reprioritization of financial or other resources; or
-
- other reasons that are internal to the businesses of our collaborative partners, which they may not share with us.
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Any
failure or substantial delay in successfully completing clinical trials and obtaining regulatory approval for our product candidates or our collaborative partners' product candidates
could severely harm our business.
We and our collaborative partners are subject to extensive government regulations and we and our collaborative partners may not be able to obtain necessary regulatory
approvals.
We and our collaborative partners may not receive the regulatory approvals necessary to commercialize our product candidates, which
would cause our business to be severely harmed. Pharmaceutical product candidates, including those in development by us and our collaborative partners, are subject to extensive and rigorous government
regulation. The FDA regulates, among other things, the development, testing, manufacture, safety, record-keeping, labeling, storage, approval, advertising, promotion, sale and distribution of
pharmaceutical products. If our potential products or our collaborators' potential products are marketed abroad, they will also be subject to extensive regulation by foreign governments. None of our
product candidates has been approved for sale in the U.S. or any foreign market. The regulatory review and approval process, which includes preclinical studies and clinical trials of each product
candidate, is lengthy, complex, expensive and uncertain. Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information to the FDA for each
indication to establish the product candidate's safety and efficacy. Data obtained from preclinical studies and clinical trials are susceptible to varying interpretation, which may delay, limit or
prevent regulatory approval. The approval process may take many years to complete and may involve ongoing requirements for post-marketing studies. In light of the limited regulatory
history of monoclonal antibody-based therapeutics, regulatory approvals for our or our collaborative partners' product candidates may not be obtained without lengthy delays, if at all. Any FDA or
other regulatory approvals of our or our collaborative partners' product candidates, once obtained, may be withdrawn. The effect of government regulation may be to:
-
- delay marketing of potential products for a considerable period of time;
-
- limit the indicated uses for which potential products may be marketed;
-
- impose costly requirements on our activities; and
-
- place us at a competitive disadvantage to other pharmaceutical and biotechnology companies.
We
may encounter delays or rejections in the regulatory approval process because of additional government regulation from future legislation or administrative action or changes in FDA
policy during the period of product development, clinical trials and FDA regulatory review. Failure to comply with FDA or other applicable regulatory requirements may result in criminal prosecution,
civil penalties, recall or seizure of products, total or partial suspension of production or injunction, as well as other regulatory action against our product candidates or us. Outside the U.S., our
ability to market a product is contingent upon receiving clearances from the appropriate regulatory authorities. The foreign regulatory approval process includes similar risks to those associated with
the FDA approval process. In addition, we are, or may become, subject to various federal, state and local laws, regulations and recommendations relating to safe working conditions, laboratory and
manufacturing practices, the experimental use of animals and the use and disposal of hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our
research work. If we fail to comply with the laws and regulations pertaining to our business, we may be subject to sanctions, including the temporary or permanent suspension of operations, product
recalls, marketing restrictions and civil and criminal penalties.
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Our and our collaborative partners' product candidates will remain subject to ongoing regulatory review even if they receive marketing approval. If we or our collaborative
partners fail to comply with continuing regulations, we could lose these approvals and the sale of our products could be suspended.
Even if we or our collaborative partners receive regulatory approval to market a particular product candidate, the approval could be
conditioned on us or our collaborative partners conducting costly post-approval studies or could limit the indicated uses included in product labeling. Moreover, the product may later
cause adverse effects that limit or prevent its widespread use, force us or our collaborative partners to withdraw it from the market or impede or delay our or our collaborative partners' ability to
obtain regulatory approvals in additional countries. In addition, the manufacturer of the product and its facilities will continue to be subject to FDA review and periodic inspections to ensure
adherence to applicable regulations. After receiving marketing approval, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion and record-keeping related to
the product remain subject to extensive regulatory requirements. We or our collaborative partners may be slow to adapt, or we or our collaborative partners may never adapt, to changes in existing
regulatory requirements or adoption of new regulatory requirements.
If
we or our collaborative partners fail to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities, or if previously unknown
problems with our or our partners' products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions,
including:
-
- restrictions on the products, manufacturers or manufacturing processes;
-
- warning letters;
-
- civil or criminal penalties;
-
- fines;
-
- injunctions;
-
- product seizures or detentions;
-
- import bans;
-
- voluntary or mandatory product recalls and publicity requirements;
-
- suspension or withdrawal of regulatory approvals;
-
- total or partial suspension of production; and
-
- refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications.
Any
one of these could have a material adverse effect on our business or financial condition.
If our collaborative partners fail to perform their obligations under our agreements with them, or determine not to continue with clinical trials for particular product
candidates, our business could be severely impacted.
Our strategy for the development and commercialization of our product candidates depends, in large part, upon the formation and
maintenance of collaborative arrangements. Collaborations provide an opportunity for us to:
-
- generate cash flow and revenue;
-
- fund some of the costs associated with our internal research and development, preclinical testing, clinical trials and
manufacturing;
-
- seek and obtain regulatory approvals faster than we could on our own;
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-
- successfully commercialize existing and future product candidates; and
-
- secure access to targets which, due to intellectual property restrictions, would otherwise be unavailable to our
technology.
If
we fail to secure or maintain successful collaborative arrangements, the development and marketing of compounds that use our technology may be delayed, scaled back or otherwise may
not occur. In addition, we may be unable to negotiate other collaborative arrangements or, if necessary, modify our existing arrangements on acceptable terms. We cannot control the amount and timing
of resources our collaborative partners may devote to our product candidates. Our collaborative partners may separately pursue competing product candidates, therapeutic approaches or technologies to
develop treatments for the diseases targeted by us or our collaborative efforts, or may decide, for reasons not known to us, to discontinue development of product candidates under our agreements with
them. Any of our collaborative partners may slow or discontinue the development of a product candidate covered by a collaborative arrangement for reasons that can include, but are not limited
to:
-
- a change in the collaborative partner's strategic focus as a result of merger, management changes, adverse business
events, or other causes;
-
- a change in the priority of the product candidate relative to other programs in the collaborator's pipeline;
-
- a reassessment of the patent situation related to the compound or its target;
-
- a change in the anticipated competition for the product candidate;
-
- preclinical studies and clinical trial results; and
-
- a reduction in the financial resources the collaborator can or is willing to apply to the development of new compounds.
Even
if our collaborative partners continue their collaborative arrangements with us, they may nevertheless determine not to actively pursue the development or commercialization of any
resulting products. Also, our collaborative partners may fail to perform their obligations under the collaborative agreements or may be slow in performing their obligations. Our collaborative partners
can terminate our collaborative agreements under certain conditions. The decision to advance a product that is covered by a collaborative agreement through clinical trials and ultimately to
commercialization is in the discretion of our collaborative partners. If any collaborative partner were to terminate or breach our agreements, fail to complete its obligations to us in a timely
manner, or decide to discontinue its development of a product candidate, our anticipated revenue from the agreement and from the development and commercialization of the products would be severely
limited. If we are not able to establish additional collaborations or any or all of our existing collaborations are terminated and we are not able to enter into alternative collaborations on
acceptable terms, or at all, our continued development, manufacture and commercialization of our product candidates could be delayed or scaled back as we may not have the funds or capability to
continue these activities. If our collaborators fail to
successfully develop and commercialize TAP compounds, our business prospects would be severely harmed.
We depend on a small number of collaborators for a substantial portion of our revenue. The loss of, or a material reduction in activity by, any one of these collaborators
could result in a substantial decline in our revenue.
We have and will continue to have collaborations with a limited number of companies. As a result, our financial performance depends on
the efforts and overall success of these companies. Also, the failure of any one of our collaborative partners to perform its obligations under its agreement with us, including making any royalty,
milestone or other payments to us, could have an adverse effect on our
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financial
condition. Further, any material reduction by any one of our collaborative partners in its level of commitment of resources, funding, personnel, and interest in continued development under
its agreement with us could have an adverse effect on our financial condition. To date, we have recorded $13.5 million in milestone payments with the advancement of T-DM1. Our
agreement with Roche, through its Genentech unit, entitles us to receive up to $44 million in milestone payments and also royalties on commercial sales, if any. Failure of Roche to continue to
advance T-DM1 would have an adverse effect on our financial outlook. Also, if consolidation trends in the healthcare industry continue, the number of our potential collaborators could
decrease, which could have an adverse impact on our development efforts. If a present or future collaborator of ours were to be involved in a business combination, the collaborator's continued pursuit
and emphasis on our product development program could be delayed, diminished or terminated.
If our collaborative partners' requirements for clinical materials to be manufactured by us are significantly lower than we have estimated, our financial results and
condition could be adversely affected.
We procure certain components of finished conjugate, including DM1, DM4, and linker, on behalf of several of our collaborators. In
order to meet our commitments to our collaborative partners, we are required to enter into agreements with third parties to produce these components well in advance of our production of clinical
materials on behalf of our collaborative partners. If our collaborative partners do not require as much clinical material as we have contracted to produce and we are unable to use these materials for
our own products, we may not be able to recover our investment in these components and we may suffer significant losses. Collaborators have discontinued development of product candidates in the past
and in the periods subsequent to these discontinuations, we had significantly reduced demand for conjugated material which adversely impacted our financial results.
In
addition, we operate a conjugate manufacturing facility. A portion of the cost of operating this facility, including the cost of manufacturing personnel, is reimbursed by our
collaborators based on the number of batches of preclinical and clinical materials produced on their behalf. If we produce fewer batches of clinical materials for our collaborators, a smaller amount
of the cost of operating the conjugate manufacturing facility will be charged to our collaborative partners and our financial condition could be adversely affected.
If our antibody requirements for clinical materials to be manufactured are significantly higher than we estimated, the inability to procure additional antibody in a timely
manner could impair our ability to initiate or advance our clinical trials.
We rely on third-party suppliers to manufacture antibodies used in our own proprietary compounds. Due to the specific nature of the
antibody and availability of production capacity, there is significant lead time required by these suppliers to provide us with the needed materials. If our antibody requirements for clinical
materials to be manufactured are significantly higher than we estimated, we may not be able to readily procure additional antibody which would impair our ability to advance our clinical trials
currently in process or initiate additional trials. There can be no assurance that we will not have supply problems that could delay or stop our clinical trials or otherwise could have a material
adverse effect on our business.
We currently rely on one third-party manufacturer with commercial production experience to produce our cell-killing agents, DM1 and DM4.
We rely on a third-party supplier to manufacture materials used to make TAP compounds. Our cell-killing agents DM1 and DM4,
collectively DMx, are manufactured from a precursor, ansamitocin P3. As part of preparing to produce TAP compounds for later-stage clinical trials and commercialization, we currently use a single
supplier, Societá Italiana Corticosteroidi S.r.l., that
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converts
ansamitocin P3 to DMx. Any delay or interruption in our supply of DMx could lead to a delay or interruption in our manufacturing operations, preclinical studies and clinical trials of our
product candidates and our collaborators' product candidates, which could negatively affect our business.
We may be unable to establish the manufacturing capabilities necessary to develop and commercialize our and our collaborative partners' potential products.
Currently, we have only one conjugate manufacturing facility that we use to manufacture conjugated compounds for us and our
collaborative partners for preclinical studies and early-stage clinical testing. Two of our partners have contracted for separate, large-scale manufacturing capacity to make materials to support
potential future commercialization of their TAP compounds. We do not currently have the manufacturing capacity needed to make our product candidates for commercial sale. In addition, our manufacturing
capacity may be insufficient to complete all clinical trials contemplated by us and our collaborative partners over time. We intend to rely in part on third-party contract manufacturers to produce
sufficiently large quantities of drug materials that are and will be needed for later-stage clinical trials and commercialization of our potential products. We are currently in the process of
developing relationships with third-party manufacturers that we believe will be necessary to continue the development of our product candidates. Third-party manufacturers may not be able to meet our
needs with respect to timing, quantity or quality of materials. If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays or
difficulties in our relationships with manufacturers, our clinical trials may be delayed, thereby delaying the submission of product candidates for regulatory approval and the market introduction and
subsequent commercialization of our potential products. Any such delays may lower our revenues and potential profitability.
We have only one conjugate manufacturing facility and any prolonged and significant disruption at that facility could impair our ability to manufacture our and our
collaborative partners' product candidates for clinical testing.
Currently, in certain cases, we are contractually obligated to manufacture Phase I and non-pivotal Phase II
clinical products for companies licensing our TAP technology. We manufacture this material, as well as material for our own product candidates, in our conjugate manufacturing facility. We have only
one such manufacturing facility in which we can manufacture clinical products. Our current manufacturing facility contains highly specialized equipment and utilizes complicated production processes
developed over a number of years that would be difficult, time-consuming and costly to duplicate. Any prolonged disruption in the operations of our manufacturing facility would have a
significant negative impact on our ability to manufacture products for clinical testing on our own and would cause us to seek additional third-party manufacturing contracts, thereby increasing our
development costs. Even though we carry business interruption insurance policies, we may suffer losses as a result of business interruptions that exceed the coverage available or any losses may be
excluded under our insurance policies. Certain events, such as natural disasters, fire, political disturbances, sabotage or business accidents, which could impact our current or future facilities,
could have a significant negative impact on our operations by disrupting our product development efforts until such time as we are able to repair our facility or put in place third-party contract
manufacturers to assume this manufacturing role.
Unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives applicable to our product candidates could limit our potential product
revenue.
Antibody-based anticancer products are often much more costly to produce than traditional chemotherapeutics and tend to have
significantly higher prices. Factors that help justify the price include the high mortality associated with many types of cancer and the need for more and better treatment options.
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Regulations
governing drug pricing and reimbursement vary widely from country to country. Some countries require approval of the sales price of a drug before it can be marketed. Some
countries restrict the physicians that can authorize the use of more expensive medications. Some countries establish treatment guidelines to help limit the use of more expensive therapeutics and the
pool of patients that receive them. In some countries, including the U.S., third-party payers frequently seek discounts from list prices and are increasingly challenging the prices charged for medical
products. Because our product candidates are in the development stage, we do not know the level of reimbursement, if any, we will receive for any products that we are able to successfully develop. If
the reimbursement for any of our product candidates is inadequate in light of our development and other costs, our ability to achieve profitability would be affected.
We
believe that the efforts of governments and third-party payors to contain or reduce the cost of healthcare will continue to affect the business and financial condition of
pharmaceutical and biopharmaceutical companies. A number of legislative and regulatory proposals to change the healthcare system in the U.S. and other major healthcare markets have been proposed and
adopted in recent years. For example, the U.S. Congress enacted a limited prescription drug benefit for Medicare recipients as part of the Medicare Prescription Drug, Improvement and Modernization Act
of 2003. While the program established by this statute may increase demand for any products that we are able to successfully develop, if we participate in this program, our prices will be negotiated
with drug procurement organizations for Medicare beneficiaries and are likely to be lower than prices we might otherwise obtain. Non-Medicare third-party drug procurement organizations may
also base the price they are willing to pay on the rate paid by drug procurement organizations for Medicare beneficiaries. Also, in March 2010, President Obama signed one of the most significant
health care reform measures in decades, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, collectively referred to herein as
the PPACA. The PPACA will significantly impact the pharmaceutical industry. The PPACA will require discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid.
In addition, the PPACA imposes an annual fee, which will increase annually, on sales by branded pharmaceutical manufacturers starting in 2011. The financial impact of these discounts, increased
rebates and fees and the other provisions of the PPACA on our business is unclear and there can be no assurance that our business will not be materially adversely affected by the PPACA. In
addition, ongoing initiatives in the U.S. have increased and will continue to increase pressure on drug pricing. The announcement or adoption of any such initiative could have an adverse effect on
potential revenues from any product candidate that we may successfully develop.
We may be unable to establish sales and marketing capabilities necessary to successfully commercialize our potential products.
We currently have no direct sales or marketing capabilities. We anticipate relying on third parties to market and sell most of our
primary product candidates or we may outlicense these products prior to the time when these capabilities are needed. If we decide to market our potential products through a direct sales force, we
would need either to hire a sales force with expertise in pharmaceutical sales or to contract with a third party to provide a sales force which meets our needs. We may be unable to establish
marketing, sales and distribution capabilities necessary to commercialize and gain market acceptance for our potential products and be competitive. In addition, co-promotion or other
marketing arrangements with third parties to commercialize potential products could significantly limit the revenues we derive from these potential products, and these third parties may fail to
commercialize our compounds successfully.
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If our product candidates or those of our collaborative partners do not gain market acceptance, our business will suffer.
Even if clinical trials demonstrate the safety and efficacy of our and our collaborative partners' product candidates and the necessary
regulatory approvals are obtained, our and our collaborative partners' product candidates may not gain market acceptance among physicians, patients, healthcare payors and other members of the medical
community. The degree of market acceptance of any product candidates that we or our collaborative partners develop will depend on a number of factors, including:
-
- their degree of clinical efficacy and safety;
-
- their advantage over alternative treatment methods;
-
- our/the marketer's and our collaborative partners' ability to gain acceptable reimbursement and the reimbursement policies
of government and third-party payors; and
-
- the quality of the distribution capabilities for product candidates, both ours and our collaborative partners.
Physicians
may not prescribe any of our future products until such time as clinical data or other factors demonstrate the safety and efficacy of those products as compared to
conventional drug and other treatments. Even if the clinical safety and efficacy of therapies using our products is established, physicians may elect not to recommend the therapies for any number of
other reasons, including whether the mode of administration of our products is effective for certain conditions, and whether the physicians are already using competing products that satisfy their
treatment objectives. Physicians, patients, third-party payors and the medical community may not accept and use any product candidates that we, or our collaborative partners, develop. If our products
do not achieve significant market acceptance and use, we will not be able to recover the significant investment we have made in developing such products and our business will be severely harmed.
We may be unable to compete successfully.
The markets in which we compete are well established and intensely competitive. We may be unable to compete successfully against our
current and future competitors. Our failure to compete successfully may result in pricing reductions, reduced gross margins and failure to achieve market acceptance for our potential products. Our
competitors include research institutions, pharmaceutical companies and biotechnology companies, such as Pfizer, Seattle Genetics, Roche and Bristol-Meyers Squibb. Many of these organizations have
substantially more experience and more capital, research and development, regulatory, manufacturing, human and other resources than we do. As a result, they may:
-
- develop products that are safer or more effective than our product candidates;
-
- obtain FDA and other regulatory approvals or reach the market with their products more rapidly than we can, reducing the
potential sales of our product candidates;
-
- devote greater resources to market or sell their products;
-
- adapt more quickly to new technologies and scientific advances;
-
- initiate or withstand substantial price competition more successfully than we can;
-
- have greater success in recruiting skilled scientific workers from the limited pool of available talent;
-
- more effectively negotiate third-party licensing and collaboration arrangements; and
-
- take advantage of acquisition or other opportunities more readily than we can.
A
number of pharmaceutical and biotechnology companies are currently developing products targeting the same types of cancer that we target, and some of our competitors' products have
entered clinical trials or already are commercially available.
31
Table of Contents
Our product candidates, if approved and commercialized, will also compete against well-established, existing, therapeutic products that are currently
reimbursed by government healthcare programs, private health insurers and health maintenance organizations. In addition, if our product candidates are approved and commercialized, we may face
competition from generic products if the product candidate is a small molecule drug, or biosimilars if the product candidate is a biologic. The route to market for generic versions of small molecule
drugs was established with the passage of the Hatch-Waxman Amendments in 1984 and for biosimilars with the passage of the PPACA in March 2010. The PPACA establishes a pathway for the FDA approval of
follow-on biologics and provides twelve years exclusivity for reference products and an additional six months exclusivity period if pediatric studies are conducted. In Europe, the European
Medicines Agency has issued guidelines for approving products through an abbreviated pathway, and biosimilars have been approved in Europe. If a biosimilar version of one of our potential products
were approved in the United States or Europe, it could have a negative effect on sales and gross profits of the potential product and our financial condition.
We
face and will continue to face intense competition from other companies for collaborative arrangements with pharmaceutical and biotechnology companies, for relationships with academic
and research institutions and for licenses to proprietary technology. In addition, we anticipate that we will face increased competition in the future as new companies enter our markets and as
scientific developments surrounding antibody-based therapeutics for cancer continue to accelerate. While we will seek to expand our technological capabilities to remain competitive, research and
development by others may render our technology or product candidates obsolete or noncompetitive or result in treatments or cures superior to any therapy developed by us.
If we are unable to protect our intellectual property rights adequately, the value of our technology and our product candidates could be diminished.
Our success depends in part on obtaining, maintaining and enforcing our patents and other proprietary rights and our ability to avoid
infringing the proprietary rights of others. Patent law relating to the scope of claims in the biotechnology field in which we operate is still evolving, is surrounded by a great deal of uncertainty
and involves complex legal, scientific and factual questions. To date, no consistent policy has emerged regarding the breadth of claims allowed in biotechnology patents. Accordingly, our pending
patent applications may not result in issued patents. Although we own numerous patents, the issuance of a patent is not conclusive as to its validity or enforceability. Through litigation, a third
party may challenge the validity or enforceability of a patent after its issuance.
Also,
patents and applications owned or licensed by us may become the subject of interference, opposition, nullity, or other proceedings in a court or patent office in the United States
or in a foreign jurisdiction to determine validity, enforceability or priority of invention, which could result in substantial cost to us. An adverse decision in such a proceeding may result in our
loss of rights under a patent or patent application. It is unclear how much protection, if any, will be given to our patents if we attempt to enforce them or if they are challenged in court or in
other proceedings. A competitor may successfully invalidate our patents or a challenge could result in limitations of the patents' coverage. In addition, the cost of litigation or interference
proceedings to uphold the validity of patents can be substantial. If we are unsuccessful in these proceedings, third parties may be able to use our patented technology without paying us licensing fees
or royalties. Moreover, competitors may infringe our patents or successfully avoid them through design innovation. To prevent infringement or unauthorized use, we may need to file infringement claims,
which are expensive and time-consuming. In an infringement proceeding, a court may decide that a patent of ours is not valid. Even if the validity of our patents were upheld, a court may
refuse to stop the other party from using the technology at issue on the ground that its activities are not covered by our patents.
32
Table of Contents
In
recent years, policymakers have also proposed reforming U.S. patent laws and regulations. For example, in March and June 2011, the House and Senate passed their respective versions of
patent reform legislation. The House and Senate must now reconcile the two bills before presenting a final bill to the President for signature into U.S. law. Although the final bill has not yet been
agreed-upon by the House and Senate, in general, the proposed legislation attempts to address issues surrounding the enforceability of patents and the increase in patent litigation by,
among other things, moving to a first-inventor-to-file system, establishing new procedures for challenging patents and establishing different methods for invalidating patents.
While we
cannot predict what form any new patent reform laws or regulations ultimately may take, final legislation could introduce new substantive rules and procedures for challenging patents, and certain
reforms that make it easier for competitors to challenge our patents could have a material adverse effect on our business and prospects.
Policing
unauthorized use of our intellectual property is difficult, and we may not be able to prevent misappropriation of our proprietary rights, particularly in countries where the
laws may not protect such rights as fully as in the United States.
In
addition to our patent rights, we also rely on unpatented technology, trade secrets, know-how and confidential information. Third parties may independently develop
substantially equivalent information and techniques or otherwise gain access to or disclose our technology. We may not be able to effectively protect our rights in unpatented technology, trade
secrets, know-how and confidential information. We require each of our employees, consultants and corporate partners to execute a confidentiality agreement at the commencement of an
employment, consulting or collaborative relationship with us. Further, we require that all employees enter into assignment of invention agreements as a condition of employment. However, these
agreements may not provide effective protection of our information or, in the event of unauthorized use or disclosure, they may not provide adequate remedies.
Any inability to license proprietary technologies or processes from third parties which we use in connection with the development and manufacture of our product candidates
may impair our business.
Other companies, universities and research institutions have or may obtain patents that could limit our ability to use, manufacture,
market or sell our product candidates or impair our competitive position. As a result, we would have to obtain licenses from other parties before we could continue using, manufacturing, marketing or
selling our potential products. Any necessary licenses may not be available on commercially acceptable terms, if at all. If we do not obtain required licenses, we may not be able to market our
potential products at all or we may encounter significant delays in product development while we redesign products or methods that are found to infringe on the patents held by others.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights held by third parties and we may be
unable to protect our rights to, or to commercialize, our product candidates.
Patent litigation is very common in the biotechnology and pharmaceutical industries. Third parties may assert patent or other
intellectual property infringement claims against us with respect to our technologies, products or other matters. From time to time, we have received correspondence from third parties alleging that we
infringe their intellectual property rights. Any claims that might be brought against us alleging infringement of patents may cause us to incur significant expenses and, if successfully asserted
against us, may cause us to pay substantial damages and limit our ability to use the intellectual property subject to these claims. Even if we were to prevail, any litigation would be costly and
time-consuming and could divert the attention of our management and key personnel from our business operations. Furthermore, as a result of a patent infringement suit, we may be forced to
stop or delay developing, manufacturing or selling potential products that incorporate the challenged
33
Table of Contents
intellectual
property unless we enter into royalty or license agreements. There may be third-party patents, patent applications and other intellectual property relevant to our potential products that
may block or compete with our products or processes. In addition, we sometimes undertake research and development with respect to potential products even when we are aware of third-party patents that
may be relevant to our potential products, on the basis that such patents may be challenged or licensed by us. If our subsequent challenge to such patents were not to prevail, we may not be able to
commercialize our potential products after having already incurred significant expenditures unless we are able to license the intellectual property on commercially reasonable terms. We may not be able
to obtain royalty or license agreements on terms acceptable to us, if at all. Even if we were able to obtain licenses to such technology, some licenses may be non-exclusive, thereby giving
our competitors access to the same technologies licensed to us. Ultimately, we may be unable to commercialize some of our potential products or may have to cease some of our business operations, which
could severely harm our business.
We use hazardous materials in our business, and any claims relating to improper handling, storage or disposal of these materials could harm our business.
Our research and development and manufacturing activities involve the controlled use of hazardous materials, chemicals, biological
materials and radioactive compounds. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials and certain waste
products. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by applicable laws and regulations, we cannot completely
eliminate the risk of accidental contamination or injury from these materials. In the event of such an accident, we could be held liable for any resulting damages, and any liability could exceed our
resources. We may be required to incur significant costs to
comply with these laws in the future. Failure to comply with these laws could result in fines and the revocation of permits, which could prevent us from conducting our business.
We face product liability risks and may not be able to obtain adequate insurance.
While we secure waivers from all participants in our clinical trials, the use of our product candidates during testing or after
approval entails an inherent risk of adverse effects, which could expose us to product liability claims. Regardless of their merit or eventual outcome, product liability claims may result
in:
-
- decreased demand for our product;
-
- injury to our reputation and significant negative media attention;
-
- withdrawal of clinical trial volunteers;
-
- costs of litigation;
-
- distraction of management; and
-
- substantial monetary awards to plaintiffs.
We
may not have sufficient resources to satisfy any liability resulting from these claims. We currently have $5 million of product liability insurance for products which are in
clinical testing. This coverage may not be adequate in scope to protect us in the event of a successful product liability claim. Further, we may not be able to maintain our current insurance or obtain
general product liability insurance on reasonable terms and at an acceptable cost if we or our collaborative partners begin commercial production of our proposed product candidates. This insurance,
even if we can obtain and maintain it, may not be sufficient to provide us with adequate coverage against potential liabilities.
34
Table of Contents
We depend on our key personnel and we must continue to attract and retain key employees and consultants.
We depend on our key scientific and management personnel. Our ability to pursue the development of our current and future product
candidates depends largely on retaining the services of our existing personnel and hiring additional qualified scientific personnel to perform research and development. We will also need to hire
personnel with expertise in clinical testing, government regulation, manufacturing, marketing and finance. Attracting and retaining qualified personnel will be critical to our success. We may not be
able to attract and retain personnel on acceptable terms given the competition for such personnel among biotechnology, pharmaceutical and healthcare companies, universities and non-profit
research institutions. Failure to retain our existing key management and scientific personnel or to attract additional highly qualified personnel could delay the development of our product candidates
and harm our business.
Our stock price can fluctuate significantly and results announced by us and our collaborators can cause our stock price to decline.
Our stock price can fluctuate significantly due to business developments announced by us and by our collaborators, as a result of
market trends and daily trading volume. The business developments that could impact our stock price include disclosures related to clinical findings with compounds that make use of our TAP technology,
new collaborations and clinical advancement or discontinuation of product candidates that make use of our TAP technology. Our stock price can also fluctuate significantly with the level of overall
investment interest in small-cap biotechnology stocks.
Our
operating results have fluctuated in the past and are likely to continue to do so in the future. Our revenue is unpredictable and may fluctuate due to the timing of
non-recurring licensing fees, decisions of our collaborative partners with respect to our agreements with them, reimbursement
for manufacturing services, the achievement of milestones and our receipt of the related milestone payments under new and existing licensing and collaboration agreements. Revenue historically
recognized under our prior collaboration agreements may not be an indicator of revenue from any future collaborations. In addition, our expenses are unpredictable and may fluctuate from quarter to
quarter due to the timing of expenses, which may include obligations to manufacture or supply product or payments owed by us under licensing or collaboration agreements. It is possible that our
quarterly and/or annual operating results will not meet the expectations of securities analysts or investors, causing the market price of our common stock to decline. We believe that
quarter-to-quarter and year-to-year comparisons of our operating results are not good indicators of our future performance and should not be relied upon
to predict the future performance of our stock price.
The potential sale of additional shares of our common stock may cause our stock price to decline.
Pursuant to shelf registration statements filed with the Securities and Exchange Commission, in fiscal 2011, we sold 7,800,000 shares
of our common stock at $12.00 per share in a public offering resulting in gross proceeds of $93.6 million; in fiscal 2010, we sold 10,350,000 shares of our common stock at $8.00 per share in a
public offering resulting in gross proceeds of $82.8 million; and in fiscal 2009, we sold 5,750,000 shares of our common stock at $7.00 per share in a public offering resulting in gross
proceeds of $40.3 million. Additionally, in fiscal 2008, a private investor purchased 7,812,500 shares of our common stock at $3.20 per share resulting in gross proceeds of $25 million.
The potential sale of additional shares of our common stock may be dilutive to our shares outstanding and may cause our stock price to decrease.
We do not intend to pay cash dividends on our common stock.
We have not paid cash dividends since our inception and do not intend to pay cash dividends in the foreseeable future. Therefore,
shareholders will have to rely on appreciation in our stock price, if any, in order to achieve a gain on an investment.
35
Table of Contents
A WARNING ABOUT FORWARD-LOOKING STATEMENTS
This report includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements relate to analyses and other information which are based on forecasts of future results and estimates of amounts that are not yet determinable. These statements also relate to our future
prospects, developments and business strategies.
These
forward-looking statements are identified by their use of terms and phrases, such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "predict,"
"project," "will" and other similar terms and phrases, including references to assumptions. These statements are contained in the "Business," "Risk Factors" and "Management's Discussion and Analysis
of Financial Condition and Results of Operations" sections, as well as other sections of this Annual Report on Form 10-K.
Forward-looking
statements in this report include, but are not limited to:
-
- successfully finding and managing the relationships with collaborative partners;
-
- the uncertainty as to whether our TAP compounds or those of our collaborators will succeed in entering human clinical
trials and uncertainty as to the results of such trials;
-
- the risk that we and/or our collaborators may not be able to obtain regulatory approvals necessary to commercialize
product candidates;
-
- the potential development of competing products and technologies; uncertainty whether our TAP technology will produce
safe, effective and commercially viable products;
-
- our ability to successfully protect our intellectual property;
-
- our reliance on third-party manufacturers to achieve supplies of our maytansinoid cell-killing agents, DM1 and
DM4;
-
- the risk that we may be unable to establish the manufacturing capabilities necessary to develop and commercialize our
potential products;
-
- the adequacy of our liquidity and capital resources;
-
- government regulation of our activities, facilities, products and personnel; the dependence on key personnel;
-
- uncertainties as to the extent of reimbursement for the costs of our potential products and related treatments by
government and private health insurers and other organizations; the potential adverse impact of government- directed health care reform; and
-
- the risk of product liability claims; and economic conditions, both generally and those specifically related to the
biotechnology industry.
These
forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those contemplated by our
forward-looking statements. These known and unknown risks, uncertainties and other factors are described in detail in the "Risk Factors" section and in other sections of this Annual Report on
Form 10-K. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 1B. Unresolved Staff Comments
None.
36
Table of Contents
Item 2. Properties
We lease approximately 89,000 square feet of laboratory and office space in a building located at 830 Winter Street, Waltham, MA. The
initial term of the 830 Winter Street lease expires on March 31, 2020, with an option for us to extend the lease for two additional five-year terms. In December 2009, we entered
into a sublease for 14,100 square feet of our office and laboratory space at 830 Winter Street, Waltham, MA through January 2015. We also lease approximately 43,850 square feet of space in Norwood,
MA, which serves as our conjugate manufacturing facility and office space. The Norwood lease expires on June 30, 2018, with an option for us to extend the lease for an additional
five-year term.
Item 3. Legal Proceedings
From time to time we may be a party to various legal proceedings arising in the ordinary course of our business. We are not currently
subject to any material legal proceedings.
Item 3.1. Executive Officers of the Registrant
ImmunoGen's executive officers are appointed by the Board of Directors at the first meeting of the Board following the annual meeting
of shareholders or at other Board meetings as appropriate, and hold office until the first Board meeting following the next annual meeting of shareholders and until a successor is chosen, subject to
prior death, resignation or removal. Information regarding our executive officers is presented below.
Daniel
M. Junius, age 59, joined ImmunoGen in 2005, and has served as our President and Chief Executive Officer since 2009. Prior to that he served as our President and Chief Operating
Officer and Acting Chief Financial Officer from July 2008 to December 2008, as our Executive Vice President and Chief Financial Officer from 2006 to July 2008, and as our Senior Vice President and
Chief Financial Officer from 2005 to 2006. Prior to joining ImmunoGen in 2005, he served as Executive Vice President and Chief Financial Officer of New England Business Service, Inc. (NEBS), a
supplier of business products and services to small businesses, from 2002 to 2004, and as Senior Vice President and Chief Financial Officer of NEBS from 1998 to 2002. Mr. Junius holds a Masters
of Management from Northwestern University's Kellogg School of Management.
John
M. Lambert, Ph.D., age 60, joined ImmunoGen in 1987, and has served as our Executive Vice President, Research and Development and Chief Scientific Officer since July 2008. Prior to
that he served as our Senior Vice President, Research and Development and Chief Scientific Officer from early
2008 to July 2008, as our Senior Vice President, Pharmaceutical Development, from 2000 to early 2008, as our Vice President, Research and Development, from 1994 to 2000, and as our Senior Director of
Research from 1987 to 1994. Prior to joining ImmunoGen, Dr. Lambert was an assistant professor at Harvard Medical School working at the Dana-Farber Cancer Institute.
Dr. Lambert holds a Ph.D. in Biochemistry from University of Cambridge in England, and completed his postdoctoral work at the University of California at Davis and at Glasgow University in
Scotland.
James
J. O'Leary, MD, age 47, joined ImmunoGen in 2008, and has served as our Vice President and Chief Medical Officer since that date. Prior to joining ImmunoGen, Dr. O'Leary
served as Senior Medical Director Clinical Oncology of Bayer Corporation, a pharmaceutical company, from 2006 to 2008. Prior to that, he served as Medical Director Clinical Oncology of Pfizer Global
Research and Development, a pharmaceutical company, from 2003 to 2006, and as Assistant Medical Director Clinical Oncology of Pfizer from 2000 to 2003. Prior to that, he served as a Medical Reviewer,
Division of Oncology Drug Products at the U.S. Food and Drug Administration from 1998 to 2000. Dr. O'Leary has a Doctor of Medicine degree from the State University of New
YorkHealth Science Center at Brooklyn.
37
Table of Contents
Gregory
D. Perry, age 51, joined ImmunoGen in 2009, and has served as our Executive Vice President and Chief Financial Officer since April 2011. Prior to that, he served as our Senior
Vice President and Chief Financial Officer from 2009 to April 2011. Prior to joining ImmunoGen, he served as Chief Financial Officer of Elixir Pharmaceuticals, Inc., a pharmaceutical company,
from 2007 to 2008. Prior to that, he served as Chief Financial Officer for Domantis Ltd., a biopharmaceutical company, in 2006, and as Senior Vice President, Finance and Chief Financial Officer
of Transkaryotic Therapies, Inc., a biopharmaceutical company, from 2003 to 2005.
Peter
J. Williams, age 57, joined ImmunoGen in August 2009, and has served as our Vice President, Business Development since that date. Prior to joining ImmunoGen, he served as a Senior
Director of Business Development at Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, from 2006 to August 2009. Prior to that, he served as Vice President of Business Development of
Link Medicine Corporation, a drug development company, from 2005 to 2006. Prior to that, he acted as an independent business development consultant from 2003 to 2006. Prior to that, he served as a
Senior Director of Business Development at Millennium Pharmaceuticals, Inc., a biopharmaceutical company, from 1998 to 2003.
Theresa
G. Wingrove, Ph.D., age 53, joined ImmunoGen in January 2011, and has served as our Vice President, Regulatory Affairs since that date. Prior to joining ImmunoGen, she served as
Vice President, Regulatory and Clinical Affairs, at Histogenics, Inc., a medical device company, from 2006 to January 2011. Prior to that, she served as Senior Director, Regulatory and Clinical
Affairs, at MediSpectra, Inc., a medical device company, from 2000 to 2006. Prior to that, she served in various
regulatory and clinical management capacities at Infusaid Inc., a subsidiary of Pfizer Inc., a pharmaceutical company, from 1988 to 1999. Dr. Wingrove holds a Ph.D. in biochemical
toxicology from the University of Rochester School of Medicine and Dentistry, and completed her postdoctoral work at the University of Rochester Medical Center.
Craig
Barrows, age 56, joined ImmunoGen in 2007, and has served as our Vice President, General Counsel and Secretary since that date. Prior to joining ImmunoGen, he served as Vice
President and General Counsel of Mercury Computer Systems, Inc., a manufacturer of high-performance digital signal and image processing systems, from 2005 to 2007. Prior to that, he
served as Vice President, General Counsel and Secretary of New England Business Service, Inc. (NEBS), a supplier of business products and services to small businesses, from 1999 to 2004, and as
General Counsel and Secretary of NEBS from 1998 to 1999.
Item 4. Reserved
38
Table of Contents
PART II
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Price of Our Common Stock and Related Stockholder Matters
Our common stock is quoted on the NASDAQ Global Market under the symbol "IMGN." The table below sets forth the high and low closing
price per share of our common stock as reported by NASDAQ:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year 2011 |
|
Fiscal Year 2010 |
|
|
|
High |
|
Low |
|
High |
|
Low |
|
First Quarter |
|
$ |
9.78 |
|
$ |
4.96 |
|
$ |
10.13 |
|
$ |
6.88 |
|
Second Quarter |
|
$ |
10.01 |
|
$ |
6.06 |
|
$ |
9.55 |
|
$ |
6.44 |
|
Third Quarter |
|
$ |
9.95 |
|
$ |
8.06 |
|
$ |
8.34 |
|
$ |
6.25 |
|
Fourth Quarter |
|
$ |
14.10 |
|
$ |
8.87 |
|
$ |
10.90 |
|
$ |
7.69 |
|
As
of August 11, 2011, the closing price per share of our common stock was $10.58, as reported by NASDAQ, and we had approximately 478 holders of record of our common stock.
We
have not paid any cash dividends on our common stock since our inception and do not intend to pay any cash dividends in the foreseeable future.
Equity Compensation Plan Information (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
(b) |
|
(c) |
|
Plan category
|
|
Number of securities to
be issued upon exercise
of outstanding options,
warrants and rights |
|
Weighted-average
exercise price of
outstanding options,
warrants and rights |
|
Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a)) |
|
Equity compensation plans approved by security holders(1) |
|
|
6,491 |
|
$ |
6.70 |
|
|
4,506 |
|
Equity compensation plans not approved by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
6,491 |
|
$ |
6.70 |
|
|
4,506 |
|
|
|
|
|
|
|
|
|
- (1)
- These
plans consist of the Restated Stock Option Plan and the 2006 Employee, Director and Consultant Equity Incentive Plan.
Recent Sales of Unregistered Securities; Uses of Proceeds from Registered Securities; Issuer Repurchases of Equity Securities
None.
39
Table of Contents
Stock Price Performance Graph
The graph and table below compare the annual percentage change in our cumulative total shareholder return on our common stock for the
period from June 30, 2006 through June 30, 2011 (as measured by dividing (i) the sum of (A) the cumulative amount of dividends for the measurement period, assuming dividend
reinvestment, and (B) the difference between our share price at the end and the beginning of the measurement period; by (ii) the share price at the beginning of the measurement period)
with the total cumulative return of the NASDAQ Stock Market Index (U.S.) and the NASDAQ Pharmaceutical Stocks Total Return Index during such period. We have not paid any dividends on our common stock,
and no dividends are included in the representation of our performance. The stock price performance on the graph below is not necessarily indicative of future price performance. This graph is not
"soliciting material," is not deemed filed with the Commission and is not to be incorporated by reference in any of our filings under the Securities Act of 1933, or the Securities Exchange Act of
1934, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing. Information used on the graph for the NASDAQ Pharmaceutical Stocks Total
Return Index and the NASDAQ Stock Market Index (U.S.) was prepared by the Center for Research in Security Prices, a source believed to be reliable, but we are not responsible for any errors or
omissions in such information.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
2010 |
|
2011 |
|
IMMUNOGEN, INC. |
|
$ |
100.00 |
|
$ |
177.32 |
|
$ |
97.76 |
|
$ |
275.37 |
|
$ |
296.13 |
|
$ |
389.51 |
|
NASDAQ STOCK MARKET INDEX (U.S.) |
|
$ |
100.00 |
|
$ |
119.20 |
|
$ |
104.24 |
|
$ |
67.19 |
|
$ |
83.27 |
|
$ |
111.02 |
|
NASDAQ PHARMACEUTICAL STOCKS TOTAL RETURN INDEX * |
|
$ |
100.00 |
|
$ |
108.85 |
|
$ |
108.47 |
|
$ |
106.00 |
|
$ |
109.35 |
|
$ |
142.01 |
|
- *
- This
index represents a group of peer issuers compiled by the Center for Research in Security Prices.
The above graph and table assume $100 invested on June 30, 2006 with all dividends reinvested, in each of our common stock, the NASDAQ
Stock Market Index (U.S.) and the NASDAQ Pharmaceutical Stocks Total Return Index. Upon written request by any shareholder, we will promptly provide a list of the companies comprising the NASDAQ
Pharmaceutical Stocks Total Return Index.
40
Table of Contents
Item 6. Selected Financial Data
The following table (in thousands, except per share data) sets forth our consolidated financial data for each of our five fiscal years
through our fiscal year ended June 30, 2011. The information set forth below should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of
Operations" and the consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
2008 |
|
2007 |
|
Consolidated Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
19,305 |
|
$ |
13,943 |
|
$ |
27,988 |
|
$ |
40,249 |
|
$ |
38,212 |
|
Total operating expenses |
|
|
79,493 |
|
|
65,178 |
|
|
59,804 |
|
|
74,361 |
|
|
60,438 |
|
Other income (expense), net |
|
|
1,914 |
|
|
58 |
|
|
(221 |
) |
|
2,119 |
|
|
3,274 |
|
(Benefit) provision for income taxes |
|
|
|
|
|
(265 |
) |
|
(100 |
) |
|
27 |
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(58,274 |
) |
$ |
(50,912 |
) |
$ |
(31,937 |
) |
$ |
(32,020 |
) |
$ |
(18,987 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.85 |
) |
$ |
(0.87 |
) |
$ |
(0.63 |
) |
$ |
(0.75 |
) |
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average common shares outstanding |
|
|
68,919 |
|
|
58,845 |
|
|
51,068 |
|
|
42,969 |
|
|
41,759 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
191,206 |
|
$ |
110,298 |
|
$ |
71,125 |
|
$ |
47,871 |
|
$ |
59,700 |
|
Total assets |
|
|
217,641 |
|
|
137,208 |
|
|
100,704 |
|
|
83,338 |
|
|
80,421 |
|
Shareholders' equity |
|
|
139,969 |
|
|
102,048 |
|
|
66,857 |
|
|
55,299 |
|
|
58,401 |
|
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Overview
Since our inception, we have been principally engaged in the development of novel, targeted therapeutics for the treatment of cancer
using our expertise in cancer biology, monoclonal antibodies, highly potent cytotoxic, or cell-killing, agents, and the design of linkers that enable these agents to be stably attached to
the antibodies while in the blood stream and released in their fully active form after delivery to a cancer cell. An anticancer compound made using our Targeted Antibody Payload, or TAP, technology
consists of a monoclonal antibody that binds specifically to an antigen target found on cancer cells with multiple copies of one of our proprietary cell-killing agents attached using one
of our engineered linkers. Its antibody component enables a TAP compound to bind specifically to cancer cells that express a particular target antigen, the highly potent cytotoxic agent serves to kill
the cancer cell, and the engineered linker controls the release and activation of the cytotoxic agent inside the cancer cell. Our TAP technology is designed to enable the creation of highly effective,
well-tolerated anticancer products. All of our and our collaborative partners' TAP compounds currently in preclinical and clinical testing contain either DM1 or DM4 as the cytotoxic agent.
Both DM1 and DM4, collectively DMx, are our proprietary derivatives of a naturally occurring substance called maytansine. We also use our expertise in antibodies and cancer biology to develop "naked,"
or non-conjugated, antibody anticancer product candidates.
We
have entered into collaborative agreements that enable companies to use our TAP technology to develop commercial product candidates to specified targets. We have also used our
proprietary TAP technology in conjunction with our in-house antibody expertise to develop our own anticancer product candidates. Under the terms of our collaborative agreements, we are
generally entitled to upfront fees, milestone payments, and royalties on any commercial product sales. In addition, under certain
41
Table of Contents
agreements
we are entitled to research and development funding based on activities performed at our collaborative partner's request. We are reimbursed for our direct and a portion of overhead costs to
manufacture preclinical and clinical materials and, under certain collaborative agreements, the reimbursement includes a profit margin. Currently, our collaborative partners include Amgen, Bayer
HealthCare, Biotest, Novartis, Roche and Sanofi. We expect that substantially all of our revenue for the foreseeable future will result from payments under our collaborative arrangements. Details for
some of
our major and recent collaborative agreements can be found in this Form 10-K under Item 1. Business.
To
date, we have not generated revenues from commercial product sales and we expect to incur significant operating losses for the foreseeable future. As of June 30, 2011, we had
approximately $191.2 million in cash and cash equivalents compared to $110.3 million in cash, cash equivalents and marketable securities as of June 30, 2010.
We
anticipate that future cash expenditures will be partially offset by collaboration-derived proceeds, including milestone payments, royalties and upfront fees. Accordingly,
period-to-period operational results may fluctuate dramatically based upon the timing of receipt of the proceeds. We believe that our established collaborative agreements,
while subject to specified milestone achievements, will provide funding to assist us in meeting obligations under our collaborative agreements while also assisting in providing funding for the
development of internal product candidates and technologies. However, we can give no assurances that such collaborative agreement funding will, in fact, be realized in the time frames we expect, or at
all. Should we or our partners not meet some or all of the terms and conditions of our various collaboration agreements, we may be required to secure alternative financing arrangements and/or defer or
limit some or all of our research, development and/or clinical projects. However, we cannot provide assurance that any such opportunities presented by additional strategic partners or alternative
financing arrangements will be entirely available to us, if at all.
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the U.S. The
preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of
contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to our collaborative agreements, inventory and stock-based compensation. We base
our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from these estimates.
We
believe the following critical accounting policies reflect our more significant judgments and estimates used in the preparation of our consolidated financial statements.
We enter into licensing and development agreements with collaborative partners for the development of monoclonal antibody based
anticancer therapeutics. The terms of these agreements contain multiple deliverables which may include (i) licenses, or options to obtain licenses, to our TAP technology, (ii) rights to
future technological improvements, (iii) research activities to be performed on behalf of the collaborative partner, and (iv) the manufacture of preclinical or clinical materials for the
collaborative partner. Payments to us under these agreements may include non-refundable license fees, option fees, exercise fees, payments for research activities, payments for the
manufacture of preclinical or clinical materials, payments based upon the achievement of certain milestones and royalties on product sales. We follow the provisions of ASC Topic 605-25,
"Revenue RecognitionMultiple-Element Arrangements," and ASU No. 2010-17, "Revenue RecognitionMilestone Method," in accounting for these agreements.
Effective July 1, 2010, we adopted ASU No. 2009-13, "Multiple-Deliverable Revenue Arrangements", which amends ASC Topic 605-25. In order to account for these
agreements, we must
42
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identify
the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on whether certain criteria are met, including whether the
delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied
to each of the separate units.
At
June 30, 2011, we had the following three types of agreements with the parties identified below:
-
- Exclusive development and commercialization licenses to use our TAP technology and/or certain other intellectual property
to develop compounds to a single target antigen (exclusive licenses):
Amgen
(two single-target licenses)
Bayer
HealthCare (one single-target license)
Biotest
(one single-target license)
Roche,
through its Genentech unit (five single target licenses)
Sanofi
(license to multiple individual targets)
-
- Option/research agreement for a defined period of time to secure development and commercialization licenses to use our TAP
technology to develop anticancer compounds to a limited number of targets on established terms (broad option agreement):
-
- Non-exclusive license to our humanization technology:
There
are no performance, cancellation, termination or refund provisions in any of our arrangements that contain material financial consequences to us.
The deliverables under an exclusive license agreement generally include the exclusive license to our TAP technology, and may also
include deliverables related to rights to future technological improvements, research activities to be performed on behalf of the collaborative partner and the manufacture of preclinical or clinical
materials for the collaborative partner.
Generally,
exclusive license agreements contain non-refundable terms for payments and, depending on the terms of the agreement, provide that we will (i) at the
collaborator's request, provide research services which are reimbursed at a contractually determined rate, (ii) at the collaborator's request, manufacture and provide to them preclinical and
clinical materials which are reimbursed at our cost, or, in some cases, cost plus a margin, (iii) earn payments upon the achievement of certain milestones and (iv) earn royalty payments,
generally until the later of the last applicable patent expiration or 10 to 12 years after product launch. Royalty rates may vary over the royalty term depending on our intellectual property
rights. We may provide technical assistance and share any technology improvements with our collaborators during the term of the collaboration agreements. We do not directly control when any
collaborator will request research or manufacturing services, achieve milestones or become liable for royalty payments. As a result, we cannot predict when we will recognize revenues in connection
with any of the foregoing.
43
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In
determining the units of accounting, management evaluates whether the exclusive license has standalone value, from the undelivered elements, to the collaborative partner based on the
consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of TAP
technology research expertise in the general marketplace. If we can conclude that the license has stand alone value and therefore will be accounted for as a separate unit of accounting,we then
determine the estimated selling prices of the license and all other units of accounting based on market conditions, similar arrangements entered into by third parties, and entity-specific factors such
as the terms of our previous collaborative agreements, recent preclinical and clinical testing results of therapeutic products that use our TAP technology, our pricing practices and pricing
objectives, the likelihood that technological improvements will be made, the likelihood that technological improvements made will be used by our collaborators and the nature of the research services
to be performed on behalf of our collaborators and market rates for similar services.
Upfront
payments on single-target licenses are deferred if facts and circumstances dictate that the license does not have standalone value. The determination of the length of the period
over which to defer revenue is subject to judgment and estimation and can have an impact on the amount of revenue
recognized in a given period. Our employees are generally available to assist our collaborators during the development of their products. We generally estimate this development phase to begin at the
inception of the collaboration agreement and conclude at the end of non-pivotal Phase II testing. We believe this period of involvement is, depending on the nature of the license,
on average six and one-half years. Quarterly, we reassess our periods of substantial involvement over which we amortize our upfront license fees and make adjustments as appropriate. In the
event a collaborator elects to discontinue development of a specific product candidate under a single target license, but retains its right to use our technology to develop an alternative product
candidate to the same target or a target substitute, we would cease amortization of any remaining portion of the upfront fee until there is substantial preclinical activity on another product
candidate and its remaining period of substantial involvement can be estimated. In the event that a single target license were to be terminated, we would recognize as revenue any portion of the
upfront fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination.
Upfront
payments on single-target licenses may be recognized upon delivery of the license if facts and circumstances dictate that the license has standalone value from the undelivered
elements, which generally include rights to future technological improvements, research services and the manufacture of preclinical and clinical materials.
We
recognize revenue related to research services that represent separate units of accounting as they are performed, as long as there is persuasive evidence of an arrangement, the fee is
fixed or determinable, and collection of the related receivable is probable. We recognize revenue related to the rights to future technological improvements over the estimated period that the rights
will be in force.
We
may also produce preclinical and clinical materials for our collaborators. We are reimbursed for our direct costs and a portion of our overhead costs to produce clinical materials. We
recognize revenue on preclinical and clinical materials when the materials have passed all quality testing required for collaborator acceptance and title and risk of loss have transferred to the
collaborator.
We
may also produce research material for potential collaborators under material transfer agreements. Additionally, we perform research activities, including developing antibody specific
conjugation processes, on behalf of our collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development. Generally, we are reimbursed for
certain of our direct and overhead costs of producing these materials or providing these services. We record the amounts received for the preclinical materials produced or services performed as a
component of research and development support revenue. We also develop conjugation processes for materials for
44
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later
stage testing and commercialization for certain collaborators. We are reimbursed for certain of our direct and overhead costs and may receive milestone payments for developing these processes
which are recorded as a component of research and development support revenue.
Our
license agreements have milestone fees which generally meet the criteria of ASU No. 2010-17 "Revenue RecognitionMilestone Method," and accordingly,
revenue is recognized when such milestones are achieved.
The accounting for broad option agreements is dependent on the nature of the option granted to the collaborative partner. For broad
option agreements where the option to secure a development and commercialization license to our TAP technology is considered substantive, we defer upfront payments received from these agreements and
recognize this revenue over the period during which the collaborator could elect to take an option for a development and commercialization license. These periods are specific to each collaboration
agreement. If a collaborator takes an option to acquire a development and commercialization license under these agreements, any substantive option fee is deferred and recognized over the life of the
option, generally 12 to 18 months. If a collaborator exercises an option and we grant a single target development and commercialization license to the collaborator, we account for any license
fee as we would an upfront payment on a single target license, as discussed above. Upon exercise of an option to acquire a development and commercialization license, we would recognize any remaining
deferred option fee or exercise fee as we would an upfront payment on a single target license as discussed above. In the event a broad option/research agreement were to be terminated, we would
recognize as revenue any portion of the upfront fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination. We recognize revenue
related to research activities as they are performed, as long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is probable.
For
broad option agreements where the option to secure a development and commercialization license to our TAP technology is not considered substantive, we account for any fees received
as we would an upfront payment on a single target license, as discussed above.
We
do not directly control when any collaborator will exercise its options for development and commercialization licenses. As a result, we cannot predict when we will recognize revenues
in connection with any of the foregoing.
We received up-front payments related to the non-exclusive license of our humanization technology and have
deferred these payments, and are recognizing the revenue over the term of the agreement.
We review our estimates of the net realizable value of our inventory at each reporting period. Our estimate of the net realizable value
of our inventory is subject to judgment and estimation. The actual net realizable value of our inventory could vary significantly from our estimates. We consider quantities of raw materials in excess
of twelve-month projected usage that are not supported by firm, fixed collaborator orders and projections at the time of the assessment to be excess. During fiscal years 2011 and 2010, we obtained
additional quantities of DMx from our supplier which amounted to more material than would be required by our collaborators over the next twelve months and as a result, we recorded $1.7 million
and $900,000, respectively, of charges to research and development expense related to raw material inventory identified as excess. We also recorded $28,000 to write down certain raw material inventory
to its net realizable value, which is also included in research and development
45
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expense
for the year ended June 30, 2010. No similar costs were recorded during the year ended June 30, 2009. Our collaborators' estimates of their clinical material requirements are
based upon expectations of their clinical trials, including the timing, size, dosing schedule and the maximum tolerated dose likely to be reached for the compound being evaluated. Our collaborators'
actual requirements for clinical materials may vary significantly from their projections. Significant differences between our collaborators' actual manufacturing orders and their projections could
result in our actual twelve-month usage of raw materials varying significantly from our estimated usage at an earlier reporting period. Reductions in collaborators' projections could indicate that we
have additional excess raw material inventory and we would then evaluate the need to record further write-downs, which would be included as charges to research and development expense.
As of June 30, 2011, the Company is authorized to grant future awards under one share-based compensation plan, which is the
ImmunoGen, Inc. 2006 Employee, Director and Consultant Equity Incentive Plan. The stock-based awards are accounted for under ASC Topic 718, "CompensationStock Compensation,"
pursuant to which the estimated grant date fair value of awards is charged to the statement of operations over the requisite service period, which is the vesting period. Such amounts have been reduced
by our estimate of forfeitures for unvested awards.
The
fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model. Expected volatility is based exclusively on historical volatility data
of our stock. The expected term of stock options granted is based exclusively on historical data and represents the period of time that stock options granted are expected to be outstanding. The
expected term is calculated for and applied to one group of stock options as we do not expect substantially different exercise or post-vesting termination behavior amongst our employee
population. The risk-free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options. Estimated forfeitures are
based on historical data as well as current trends. Stock compensation cost incurred during the years ended June 30, 2011, 2010 and 2009 was $5.5 million, $4.2 million and
$4.0 million, respectively. During fiscal year 2009, we recorded approximately $843,000 of stock compensation cost related to the modification of certain outstanding common stock options in
accordance with our former Chief Executive Officer's succession plan.
Results of Operations
Revenues
Our total revenues for the year ended June 30, 2011 were $19.3 million compared with $13.9 million and
$28.0 million for the years ended June 30, 2010 and 2009, respectively. The $5.4 million increase in revenues in fiscal year 2011 from fiscal year 2010 is attributable to higher
revenues from research and development support, license and milestone fees and clinical materials reimbursement, as discussed below. The $14.1 million decrease in revenues in fiscal year 2010
from fiscal year 2009 is attributable to all revenue categories, as discussed below.
46
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Research and development support was $7.3 million for the year ended June 30, 2011, $5.4 million for the year ended June 30, 2010, and
$7.6 million for the year ended June 30, 2009. These amounts primarily represent research funding earned based on actual resources utilized under our agreements with our collaborators as
shown in the table below. Also included in research and development support revenue are fees for developing antibody-specific conjugation processes on behalf of our collaborators and potential
collaborators during the early evaluation and preclinical testing stages of drug development. The amount of research and development support revenue we earn is directly related to the number of our
collaborators and potential collaborators, the stage of development of our collaborators' product candidates and the resources our collaborators allocate to the development effort. As such, the amount
of development fees may vary widely from quarter to quarter and year to year. Total revenue recognized from research and development support from each of our collaborative partners in the years ended
June 30, 2011, 2010 and 2009 is included in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
Research and Development Support
|
|
2011 |
|
2010 |
|
2009 |
|
Collaborative Partner: |
|
|
|
|
|
|
|
|
|
|
|
Amgen |
|
$ |
3,971 |
|
$ |
3,470 |
|
$ |
8 |
|
|
Bayer HealthCare |
|
|
452 |
|
|
96 |
|
|
227 |
|
|
Biogen Idec |
|
|
2 |
|
|
186 |
|
|
621 |
|
|
Biotest |
|
|
896 |
|
|
1,041 |
|
|
1,361 |
|
|
Roche |
|
|
3 |
|
|
424 |
|
|
238 |
|
|
Novartis |
|
|
1,338 |
|
|
|
|
|
|
|
|
Sanofi |
|
|
144 |
|
|
148 |
|
|
4,861 |
|
|
Other |
|
|
450 |
|
|
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
7,256 |
|
$ |
5,365 |
|
$ |
7,566 |
|
|
|
|
|
|
|
|
|
Revenue
from license and milestone fees for the year ended June 30, 2011 increased approximately $695,000 to $6.4 million from $5.7 million in the year ended
June 30, 2010. Revenue from license and milestone fees for the year ended June 30, 2009 was $15.1 million. Included in license and milestone fees for the year ended
June 30, 2011 were a $1.0 million milestone payment related to the initiation of Phase I clinical testing of SAR566658 by Sanofi and a $2.0 million milestone payment
related to the IND filing of BAY 94-9343 by Bayer HealthCare. Included in license and milestone fees for the year ended June 30, 2010 were $1 million and $500,000 of
preclinical milestones earned pursuant to our agreements with Bayer HealthCare and Sanofi, respectively, as well as a $1 million milestone related to the initiation of Phase I clinical
testing of SAR650984 by Sanofi. Included in license and milestone fees for the year ended June 30, 2009 was a $6.5 million milestone related to the initiation of Phase III
clinical testing of trastuzumab emtansine, or T-DM1, by Roche, a $4 million milestone related to the initiation of Phase II clinical testing of AVE1642 by Sanofi and a
$500,000 milestone related to the initiation of Phase I clinical testing of BT-062 by Biotest. Also during the year ended June 30, 2009, Millennium Pharmaceuticals and
Boehringer Ingelheim agreed to terminate their licenses with us that were no longer being used to develop products and as a result, we recognized as license and milestone fees $361,000 and $486,000,
respectively, of upfront fees previously deferred. The amount of license and milestone fees we earn is directly related to the number of our collaborators and potential collaborators, the resources
our collaborators allocate to the advancement of the product candidates, the number of clinical trials our collaborators conduct and the speed of enrollment and overall success in those trials. 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 from each of our
47
Table of Contents
collaborative
partners in the years ended June 30, 2011, 2010 and 2009 is included in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
License and Milestone Fees
|
|
2011 |
|
2010 |
|
2009 |
|
Collaborative Partner: |
|
|
|
|
|
|
|
|
|
|
|
Amgen |
|
$ |
1,123 |
|
$ |
689 |
|
$ |
511 |
|
|
Bayer HealthCare |
|
|
2,615 |
|
|
1,616 |
|
|
410 |
|
|
Biogen Idec |
|
|
28 |
|
|
157 |
|
|
228 |
|
|
Biotest |
|
|
130 |
|
|
149 |
|
|
669 |
|
|
Boehringer Ingelheim |
|
|
|
|
|
|
|
|
486 |
|
|
Janssen Biotech |
|
|
62 |
|
|
114 |
|
|
138 |
|
|
Roche |
|
|
|
|
|
38 |
|
|
6,651 |
|
|
Millennium |
|
|
|
|
|
|
|
|
361 |
|
|
Sanofi |
|
|
2,435 |
|
|
2,935 |
|
|
5,663 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,393 |
|
$ |
5,698 |
|
$ |
15,117 |
|
|
|
|
|
|
|
|
|
Deferred
revenue of $53.9 million at June 30, 2011 represents payments received from our collaborators pursuant to our license agreements, including a $45 million
upfront payment received from Novartis during the current fiscal year, which we have yet to earn pursuant to our revenue recognition policy.
Clinical
materials reimbursement increased by approximately $2.8 million to $5.7 million in the year ended June 30, 2011 compared to $2.9 million in the year
ended June 30, 2010. We earned clinical materials reimbursement of $5.3 million during the year ended June 30, 2009. During the years ended June 30, 2011, 2010 and 2009, we
shipped clinical materials in support of a number of our collaborators' clinical trials, as well as preclinical materials in support of certain collaborators' development efforts and DMx shipments to
certain collaborators in support of development and manufacturing efforts. The increase in clinical materials reimbursement in fiscal year 2011 as compared to fiscal year 2010 is primarily due to
greater clinical material shipped in support of one of our collaborator's trials due to advancement of the trial, as well as shipments of preclinical and clinical material to a certain collaborator
for future, planned clinical testing. The decrease in clinical materials reimbursement in fiscal year 2010 as compared to fiscal year 2009 is primarily related to less clinical material shipped in
support of two of our collaborators' trials due to various factors, including the dosage schedule and speed of enrollment within the trials. We are reimbursed for certain of our direct and overhead
costs to produce clinical materials plus, for certain programs, a profit margin. The amount of clinical materials reimbursement we earn, and the related cost of clinical materials charged to research
and development expense, is directly related to the number of clinical trials our collaborators are preparing or have underway, the speed of enrollment in those trials, the dosage schedule of each
clinical trial and the time period, if any, during which patients in the trial receive clinical benefit from the clinical materials, and the supply of clinical-grade material to our collaborators for
process development and analytical
purposes. As such, the amount of clinical materials reimbursement revenue and the related cost of clinical materials charged to research and development expense may vary significantly from quarter to
quarter and year to year.
Research and Development Expenses
Our net 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,
48
Table of Contents
(iii) development
related to clinical and commercial manufacturing processes and (iv) manufacturing operations. Our research and development efforts have been primarily focused in the
following areas:
-
- activities pursuant to our development and license agreements with various collaborators;
-
- activities related to the process, preclinical and clinical development of our internal product candidates;
-
- process improvements related to the production of DM1, DM4 and strain development of their precursor,
ansamitocin P3;
-
- development activities with contract manufacturers for the antibody component of our internal product candidates, and DM1,
DM4 and their precursor, ansamitocin P3;
-
- production costs for the supply of antibody for our internal product candidates;
-
- production costs for the supply of DMx for our and our partners' preclinical and clinical activities;
-
- operation and maintenance of our conjugate manufacturing facility, including production of our own and our collaborators'
clinical materials;
-
- process improvements to our TAP technology;
-
- evaluation of potential antigen targets;
-
- evaluation of internally developed and/or in-licensed product candidates and technologies; and
-
- development and evaluation of additional cytotoxic agents and linkers.
Research
and development expense for the year ended June 30, 2011 increased $13.2 million to $63.5 million from $50.3 million for the year ended
June 30, 2010. Research and development expense was $45.9 million for the year ended June 30, 2009. Research and development salaries and related expenses increased by
$3.6 million in the year ended June 30, 2011 compared to the year ended June 30, 2010 and increased by $1.8 million in the year ended June 30, 2010 compared to the
year ended June 30, 2009. The average number of our research personnel increased to 192 for the year ended June 30, 2011 compared to 176 for the year ended June 30, 2010. We had
an average of 175 for the year ended June 30, 2009. Included in salaries and related expenses for the year ended June 30, 2011 is $3.3 million of stock compensation costs compared
to $2.7 million and $1.7 million of stock compensation costs for fiscal years 2010 and 2009, respectively. The higher stock compensation costs in fiscal years 2011 and 2010 are driven by
higher stock prices and increases in the number of annual options granted. Clinical
trial costs increased $2.1 million during fiscal year 2011 compared to fiscal year 2010 and increased $1.1 million in fiscal year 2010 compared to fiscal year 2009 due primarily to
higher patient enrollment and increased site management costs driven from expanded sites. Additionally, antibody development and supply expense increased $2.6 million during fiscal year 2011
compared to fiscal year 2010 and increased $644,000 in fiscal year 2010 compared to fiscal year 2009 due to the advancement of our internal programs and timing of supply requirements.
We
are unable to accurately estimate which potential product candidates, if any, will eventually move into our internal preclinical research program. We are unable to reliably estimate
the costs to develop these products as a result of the uncertainties related to discovery research efforts as well as preclinical and clinical testing. Our decision to move a product candidate into
the clinical development phase is predicated upon the results of preclinical tests. We cannot accurately predict which, if any, of the discovery stage product candidates will advance from preclinical
testing and move into our internal clinical development program. The 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
49
Table of Contents
of
our product candidates is highly uncertain and may not ever 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):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
Research and Development Expense
|
|
2011 |
|
2010 |
|
2009 |
|
Research |
|
$ |
15,208 |
|
$ |
14,200 |
|
$ |
13,965 |
|
Preclinical and Clinical Testing |
|
|
16,884 |
|
|
12,892 |
|
|
9,762 |
|
Process and Product Development |
|
|
7,238 |
|
|
5,959 |
|
|
6,037 |
|
Manufacturing Operations |
|
|
24,123 |
|
|
17,229 |
|
|
16,140 |
|
|
|
|
|
|
|
|
|
Total Research and Development Expense |
|
$ |
63,453 |
|
$ |
50,280 |
|
$ |
45,904 |
|
|
|
|
|
|
|
|
|
ResearchResearch 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, fees to in-license
certain technology, facilities and lab supplies. Research expenses increased $1.0 million to $15.2 million in fiscal year 2011 from fiscal year 2010 and $235,000 to $14.2 million
in fiscal year 2010 from fiscal year 2009. The increase in fiscal 2011 was principally due to an increase in salaries and related expenses and an increase in contract service expense related to
research studies conducted during the year. The increase in fiscal year 2010 was principally the result of an increase in stock compensation costs.
Preclinical and Clinical TestingPreclinical 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 our own 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 $4.0 million to $16.9 million in fiscal year 2011 from fiscal 2010 and
$3.1 million to $12.9 million in fiscal year 2010 from fiscal year 2009. The increase in fiscal year 2011 was primarily the result of an increase in clinical trial costs and an increase
in salaries and related expenses. The increase in fiscal year 2010 was primarily the result of an increase in clinical trial costs, an increase in consulting fees for regulatory assistance and
preclinical studies conducted, and an
50
Table of Contents
increase
in salaries and related expenses due to the addition of two executive officers and higher salary levels.
Process and Product DevelopmentProcess 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 and facility expenses. Total development expenses increased $1.2 million to
$7.2 million in fiscal year 2011 from fiscal year 2010 and expenses decreased $78,000 to $6.0 million in fiscal year 2010 from fiscal year 2009. The increase in fiscal year 2011 was
primarily the result of an increase in salaries and related expenses, as well as an increase in contract service expense due to increased outsourcing of certain release and stability testing of
internal antibodies.
Manufacturing OperationsManufacturing operations expense includes costs to manufacture preclinical and clinical materials for our own and our
collaborators' product candidates, quality control and quality assurance activities and costs to support the operation and maintenance of our conjugate manufacturing facility. Such expenses include
personnel, raw materials for our and our collaborators' preclinical studies and clinical trials, development costs with contract manufacturing organizations, manufacturing supplies, and facilities
expense. Manufacturing operations expense increased $6.9 million to $24.1 million in fiscal year 2011 from fiscal year 2010 and $1.1 million to
$17.2 million in fiscal year 2010 from fiscal year 2009. The increase in fiscal year 2011 was primarily the result of (i) an increase in cost of clinical materials reimbursed for
clinical materials shipped to partners during the current period and amounts of DMx written off as excess; (ii) an increase in antibody development and supply expense; (iii) an increase
in raw materials used in production due to increased manufacturing activity; (iv) an increase in contract service expense; and (v) an increase in salaries and related expenses. Partially
offsetting these increases, overhead utilization absorbed by the manufacture of clinical materials on behalf of our collaborators increased. The increase in fiscal year 2010 was primarily the result
of (i) a decrease in overhead utilization from the manufacture of clinical materials on behalf of our collaborators; (ii) an increase in antibody supply and development expenses; and
(iii) an increase in stock compensation costs. Partially offsetting these increases, contract service expense decreased and cost of clinical materials reimbursed decreased.
Antibody
expense in anticipation of potential future clinical trials, as well as our ongoing trials, was $3.7 million in fiscal year 2011, $1.1 million in fiscal year 2010,
and $503,000 in fiscal year 2009. The process of antibody production is lengthy as is the lead time to establish a satisfactory production process at a vendor. Accordingly, costs incurred related to
antibody production and development have fluctuated from period to period and we expect these cost fluctuations to continue in the future.
General and Administrative Expenses
General and administrative expenses for the year ended June 30, 2011 increased $1.1 million to $16.0 million from
$14.9 million for the year ended June 30, 2010. General and administrative expenses for the year ended June 30, 2009 were $13.9 million. The increase in fiscal year 2011 as
compared to fiscal year 2010 was primarily due to an increase in patent expenses and an increase in salaries and related expenses, partially offset by a decrease in other general corporate expenses.
The increase in fiscal year 2010 as compared to fiscal year 2009 was primarily due to an increase in patent expenses, an increase in consulting fees, an increase in directors' fees and an increase in
other general corporate expenses, partially offset by a decrease in salaries and related expenses. During fiscal year 2009, the Company recognized a total of $1.6 million in stock compensation
expense and other compensation costs related to our former Chief Executive Officer's succession plan and the termination of an executive.
51
Table of Contents
Investment Income, net
Investment income for the years ended June 30, 2011, 2010 and 2009 was $218,000, $176,000 and $583,000, respectively. The
decrease in investment income in fiscal years 2011 and 2010 from fiscal year 2009 is primarily the result of lower yields on investments reflecting lower market rates.
Other-than-Temporary Impairment
During the year ended June 30, 2009, we recognized $516,000 in charges for the impairment of
available-for-sale securities that were determined to be other-than-temporary following a decline in value. No similar charges were recognized during
the years ended June 30, 2011 and 2010.
Other Income (Expense), net
Other income (expense), net for the years ended June 30, 2011, 2010 and 2009 was $1.7 million, $(118,000) and ($288,000),
respectively. Net realized gains (losses) on investments were $341,000 and ($33,000), for the years ended June 30, 2011 and 2009, respectively. There were no gains or losses recognized during
the year ended June 30, 2010. During the years ended June 30, 2011, 2010 and 2009, we recorded net gains (losses) on foreign currency forward contracts of $189,000, $(219,000) and
$(234,000), respectively. We incurred $(57,000), $104,000, and $(29,000) in foreign currency exchange (losses) and gains related to obligations with non-U.S. dollar-based suppliers during
the years ended June 30, 2011, 2010 and 2009, respectively. In addition, during fiscal year 2011, we recognized $1.2 million of federal grant funding awarded under the Patient Protection
and Affordable Care Act of 2010 to develop new anticancer therapies.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2011 |
|
2010 |
|
|
|
(In thousands)
|
|
Cash, cash equivalents and marketable securities |
|
$ |
191,206 |
|
$ |
110,298 |
|
Working capital |
|
|
186,959 |
|
|
103,296 |
|
Shareholders' equity |
|
|
139,969 |
|
|
102,048 |
|
Cash used for operating activities |
|
|
(7,989 |
) |
|
(40,584 |
) |
Cash used for investing activities |
|
|
(660 |
) |
|
(882 |
) |
Cash provided by financing activities |
|
|
90,699 |
|
|
80,983 |
|
Cash Flows
We require cash to fund our operating expenses, including the advancement of our own clinical programs, and to make capital
expenditures. Historically, we have
funded our cash requirements primarily through equity financings in public markets and payments from our collaborators, including equity investments, license fees, milestones and research funding. As
of June 30, 2011, we had approximately $191.2 million in cash, cash equivalents and marketable securities. Net cash used for operations was $8.0 million, $40.6 million and
$13.3 million during the years ended June 30, 2011, 2010 and 2009, respectively. The principal use of cash in operating activities for all periods presented was to fund our net loss.
Cash used in operations in fiscal 2011 benefited from the $45 million upfront payment received from Novartis in October 2010 with the establishment of a technology access collaboration between
the companies.
52
Table of Contents
Net cash (used for) provided by investing activities was $(660,000), $(882,000) and $12.0 million for the years ended June 30, 2011, 2010 and 2009,
respectively, and substantially represents cash inflows from the sales and maturities of marketable securities partially offset by capital expenditures. Capital expenditures were $2.0 million,
$1.5 million and $1.9 million for the fiscal years ended June 30, 2011, 2010 and 2009, respectively. Capital expenditures for the years ended June 30, 2011, 2010 and 2009
consisted primarily of laboratory equipment and computer software applications.
Net
cash provided by financing activities was $90.7 million, $81.0 million and $39.4 million for the years ended June 30, 2011, 2010 and 2009, respectively,
which includes the proceeds from the exercise of 550,000, 634,000 and 416,000 stock options, respectively. Also, pursuant to public offerings, in fiscal 2011, we issued and sold 7,800,000 shares of
our common stock resulting in net proceeds of $88.0 million, in fiscal 2010, we issued and sold 10,350,000 shares of our common stock resulting in net proceeds of $77.5 million and in
fiscal 2009, we issued and sold 5,750,000 shares of our common stock resulting in net proceeds of $38 million.
We
anticipate that our current capital resources and expected future collaborator payments under existing collaborations will enable us to meet our operational expenses and capital
expenditures through fiscal year 2014. However, we cannot provide assurance that such collaborative agreement funding will, in fact, be received. Should we or our partners not meet some or all of the
terms and conditions of our various collaboration agreements, we may be required to pursue additional strategic partners, secure
alternative financing arrangements, and/or defer or limit some or all of our research, development and/or clinical projects.
Contractual Obligations
Below is a table that presents our contractual obligations and commercial commitments as of June 30, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
Total |
|
Less than
One Year |
|
1-3
Years |
|
4-5
Years |
|
More than
5 Years |
|
Waltham lease obligation(1) |
|
$ |
46,101 |
|
$ |
4,994 |
|
$ |
10,055 |
|
$ |
10,522 |
|
$ |
20,530 |
|
Other operating lease obligations |
|
|
6,378 |
|
|
886 |
|
|
1,794 |
|
|
1,838 |
|
|
1,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
52,479 |
|
$ |
5,880 |
|
$ |
11,849 |
|
$ |
12,360 |
|
$ |
22,390 |
|
|
|
|
|
|
|
|
|
|
|
|
|
- (1)
- Lease
agreement was signed on July 27, 2007. In December 2009, we entered into a sublease for 14,100 square feet of our office and
laboratory space at 830 Winter Street, Waltham, MA through January 2015. We will receive approximately $2.2 million in minimum rental payments over the remaining term of the sublease,
which is not included in the table above.
In
addition to the above table, we are contractually obligated to make future success-based regulatory milestone payments in conjunction with certain collaborative agreements. These
payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, we may be required to pay such amounts. Therefore, the timing
of any future payment is not reasonably estimable. As a result, these contingent payments have not been included in the table above or recorded in our consolidated financial statements. As of
June 30, 2011, the maximum amount that may be payable in the future under such arrangements is approximately $43.0 million.
53
Table of Contents
Recent Accounting Pronouncements
In May 2011, the FASB issued ASU No. 2011-04, "Fair Value Measurement." This ASU clarifies the concepts related to
highest and best use and valuation premise, blockage factors and other premiums and discounts, the fair value measurement of financial instruments held in a portfolio and of those instruments
classified as a component of shareholders' equity. The guidance includes enhanced disclosure requirements about recurring Level 3 fair value measurements, the use of nonfinancial assets, and
the level in the fair value hierarchy of assets and liabilities not recorded at fair value. The provisions of this ASU are effective prospectively for interim and annual periods beginning on or after
December 15, 2011. Early application is prohibited. We do not expect the adoption of these provisions to have a significant impact on our financial statements.
In
June 2011, the FASB issued ASU No. 2011-05, "Comprehensive Income." This ASU intends to enhance comparability and transparency of other comprehensive income
components. The guidance provides an option to present total comprehensive income, the components of net income and the components of other comprehensive income in a single continuous statement or two
separate but consecutive statements. This ASU eliminates the option to present other comprehensive income components as part of the statement of changes in shareholders' equity. The provisions of this
ASU will be applied retrospectively for interim and annual periods beginning after December 15, 2011. Early application is permitted. We do not expect the adoption of these provisions to have a
significant impact on our financial statements.
Off-Balance Sheet Arrangements
None.
Item 7A. Quantitative and Qualitative Disclosure About Market Risk
We maintain an investment portfolio in accordance with our investment policy. The primary objectives of our investment policy are to
preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Although our investments are subject to credit risk, our investment policy specifies credit quality standards
for our investments and limits the amount of credit exposure from any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and will decrease in value if
market interest rates increase. However, due to the conservative nature of our investments and relatively short duration, interest rate risk is mitigated. We do not own derivative financial
instruments in our investment portfolio. Accordingly, we do not believe that there is any material market risk exposure with respect to derivative or other financial instruments that would require
disclosure under this item.
Our
foreign currency hedging program uses forward contracts to manage the foreign currency exposures that exist as part of our ongoing business operations. The contracts are denominated
in Euros and have maturities of less than one year. Our foreign currency risk management strategy is principally designed to mitigate the future potential financial impact of changes in the value of
transactions, anticipated transactions and balances denominated in foreign currency, resulting from changes in foreign currency exchange rates.
Our
market risks associated with changes in foreign currency exchange rates are concentrated primarily in a portfolio of short duration foreign currency forward contracts. Generally,
these contracts provide
that we receive certain foreign currencies and pay U.S. dollars at specified exchange rates at specified future dates. Although we are exposed to credit and market risk in the event of future
nonperformance by a counterparty, management has no reason to believe that such an event will occur.
54
Table of Contents
Item 8. Financial Statements and Supplementary Data
IMMUNOGEN, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
Page |
Report of Independent Registered Public Accounting Firm |
|
56 |
Consolidated Financial Statements: |
|
|
|
Consolidated Balance Sheets as of June 30, 2011 and 2010 |
|
57 |
|
Consolidated Statements of Operations for the Years Ended June 30, 2011, 2010, and 2009 |
|
58 |
|
Consolidated Statements of Shareholders' Equity for the Years Ended June 30, 2011, 2010, and 2009 |
|
59 |
|
Consolidated Statements of Cash Flows for the Years Ended June 30, 2011, 2010, and 2009 |
|
60 |
|
Notes to Consolidated Financial Statements |
|
61 |
55
Table of Contents
Report of Independent Registered Public Accounting Firm
The
Board of Directors and Shareholders of ImmunoGen, Inc.
We
have audited the accompanying consolidated balance sheets of ImmunoGen, Inc. as of June 30, 2011 and 2010, and the related consolidated statements of operations,
shareholders' equity, and cash flows for each of the three years in the period ended June 30, 2011. Our audits also included the financial statement schedule listed in the Index at
Item 15. These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements and schedule based
on our audits.
We
conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In
our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of ImmunoGen, Inc. at June 30, 2011
and 2010, and the consolidated results of its operations and its cash flows for each of the three years in the period ended June 30, 2011, in conformity with U.S. generally accepted accounting
principles. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the
information set forth therein.
We
also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), ImmunoGen, Inc.'s internal control over financial
reporting as of June 30, 2011, based on criteria established in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
and our report dated August 29, 2011 expressed an unqualified opinion thereon.
Boston,
Massachusetts
August 29, 2011
56
Table of Contents
IMMUNOGEN, INC.
CONSOLIDATED BALANCE SHEETS
In thousands, except per share amounts
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2011 |
|
June 30,
2010 |
|
ASSETS |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
191,206 |
|
$ |
109,156 |
|
Marketable securities |
|
|
|
|
|
1,142 |
|
Accounts receivable |
|
|
4,668 |
|
|
1,795 |
|
Unbilled revenue |
|
|
1,488 |
|
|
1,595 |
|
Inventory |
|
|
480 |
|
|
1,242 |
|
Restricted cash |
|
|
1,019 |
|
|
574 |
|
Prepaid and other current assets |
|
|
2,664 |
|
|
1,614 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
201,525 |
|
|
117,118 |
|
Property and equipment, net of accumulated depreciation |
|
|
13,409 |
|
|
16,326 |
|
Long-term restricted cash |
|
|
2,549 |
|
|
3,568 |
|
Other assets |
|
|
158 |
|
|
196 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
217,641 |
|
$ |
137,208 |
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,213 |
|
$ |
3,064 |
|
Accrued compensation |
|
|
4,723 |
|
|
4,201 |
|
Other accrued liabilities |
|
|
3,305 |
|
|
2,404 |
|
Current portion of deferred lease incentive |
|
|
979 |
|
|
979 |
|
Current portion of deferred revenue |
|
|
2,346 |
|
|
3,174 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
14,566 |
|
|
13,822 |
|
Deferred lease incentive, net of current portion |
|
|
7,583 |
|
|
8,562 |
|
Deferred revenue, net of current portion |
|
|
51,545 |
|
|
8,488 |
|
Other long-term liabilities |
|
|
3,978 |
|
|
4,288 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
77,672 |
|
|
35,160 |
|
Commitments and contingencies (Note H) |
|
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
|
|
|
Preferred stock, $.01 par value; authorized 5,000 shares; no shares issued and outstanding |
|
|
|
|
|
|
|
Common stock, $.01 par value; authorized 100,000 shares; issued and outstanding 76,281 and 67,931 shares as of June 30, 2011 and 2010,
respectively |
|
|
763 |
|
|
679 |
|
Additional paid-in capital |
|
|
569,843 |
|
|
473,450 |
|
Accumulated deficit |
|
|
(430,637 |
) |
|
(372,363 |
) |
Accumulated other comprehensive income |
|
|
|
|
|
282 |
|
|
|
|
|
|
|
|
|
Total shareholders' equity |
|
|
139,969 |
|
|
102,048 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
217,641 |
|
$ |
137,208 |
|
|
|
|
|
|
|
The
accompanying notes are an integral part of the consolidated financial statements.
57
Table of Contents
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
In thousands, except per share amounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Research and development support |
|
$ |
7,256 |
|
$ |
5,365 |
|
$ |
7,566 |
|
|
License and milestone fees |
|
|
6,393 |
|
|
5,698 |
|
|
15,117 |
|
|
Clinical materials reimbursement |
|
|
5,656 |
|
|
2,880 |
|
|
5,305 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
19,305 |
|
|
13,943 |
|
|
27,988 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
63,453 |
|
|
50,280 |
|
|
45,904 |
|
|
General and administrative |
|
|
16,040 |
|
|
14,898 |
|
|
13,900 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
79,493 |
|
|
65,178 |
|
|
59,804 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(60,188 |
) |
|
(51,235 |
) |
|
(31,816 |
) |
Investment income, net |
|
|
218 |
|
|
176 |
|
|
583 |
|
Other-than-temporary impairment |
|
|
|
|
|
|
|
|
(516 |
) |
Other income (expense), net |
|
|
1,696 |
|
|
(118 |
) |
|
(288 |
) |
|
|
|
|
|
|
|
|
Loss before benefit for income taxes |
|
|
(58,274 |
) |
|
(51,177 |
) |
|
(32,037 |
) |
Benefit for income taxes |
|
|
|
|
|
(265 |
) |
|
(100 |
) |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(58,274 |
) |
$ |
(50,912 |
) |
$ |
(31,937 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.85 |
) |
$ |
(0.87 |
) |
$ |
(0.63 |
) |
|
|
|
|
|
|
|
|
Basic and diluted weighted average common shares outstanding |
|
|
68,919 |
|
|
58,845 |
|
|
51,068 |
|
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of the consolidated financial statements.
58
Table of Contents
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
In thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
Accumulated
Other
Comprehensive
Income (Loss) |
|
|
|
|
|
|
|
Additional
Paid-In
Capital |
|
Accumulated
Deficit |
|
Total
Shareholders'
Equity |
|
Comprehensive
(Loss) |
|
|
|
Shares |
|
Amount |
|
Balance at June 30, 2008 |
|
|
50,778 |
|
$ |
508 |
|
$ |
344,498 |
|
$ |
(289,568 |
) |
$ |
(139 |
) |
$ |
55,299 |
|
|
|
|
Unrealized losses on marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15 |
) |
|
(15 |
) |
|
(15 |
) |
Cumulative effect adjustment relating to the adoption of ASC Topic 320 |
|
|
|
|
|
|
|
|
|
|
|
54 |
|
|
(54 |
) |
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
(31,937 |
) |
|
|
|
|
(31,937 |
) |
|
(31,937 |
) |
Stock options exercised |
|
|
416 |
|
|
4 |
|
|
1,310 |
|
|
|
|
|
|
|
|
1,314 |
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
3,956 |
|
|
|
|
|
|
|
|
3,956 |
|
|
|
|
Restricted stock issued |
|
|
3 |
|
|
|
|
|
20 |
|
|
|
|
|
|
|
|
20 |
|
|
|
|
Issuance of common stock in a public offering, net of issuance costs |
|
|
5,750 |
|
|
57 |
|
|
37,988 |
|
|
|
|
|
|
|
|
38,045 |
|
|
|
|
Directors' deferred share unit compensation |
|
|
|
|
|
|
|
|
175 |
|
|
|
|
|
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2009 |
|
|
56,947 |
|
$ |
569 |
|
$ |
387,947 |
|
$ |
(321,451 |
) |
$ |
(208 |
) |
$ |
66,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(31,952 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
490 |
|
|
490 |
|
|
490 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
(50,912 |
) |
|
|
|
|
(50,912 |
) |
|
(50,912 |
) |
Stock options exercised |
|
|
634 |
|
|
6 |
|
|
3,455 |
|
|
|
|
|
|
|
|
3,461 |
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
4,170 |
|
|
|
|
|
|
|
|
4,170 |
|
|
|
|
Issuance of common stock in a public offering, net of issuance costs |
|
|
10,350 |
|
|
104 |
|
|
77,418 |
|
|
|
|
|
|
|
|
77,522 |
|
|
|
|
Directors' deferred share unit compensation |
|
|
|
|
|
|
|
|
460 |
|
|
|
|
|
|
|
|
460 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
|
67,931 |
|
$ |
679 |
|
$ |
473,450 |
|
$ |
(372,363 |
) |
$ |
282 |
|
$ |
102,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(50,422 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses on marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(282 |
) |
|
(282 |
) |
|
(282 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
(58,274 |
) |
|
|
|
|
(58,274 |
) |
|
(58,274 |
) |
Stock options exercised |
|
|
550 |
|
|
6 |
|
|
2,713 |
|
|
|
|
|
|
|
|
2,719 |
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
5,452 |
|
|
|
|
|
|
|
|
5,452 |
|
|
|
|
Issuance of common stock in a public offering, net of issuance costs |
|
|
7,800 |
|
|
78 |
|
|
87,902 |
|
|
|
|
|
|
|
|
87,980 |
|
|
|
|
Directors' deferred share unit compensation |
|
|
|
|
|
|
|
|
326 |
|
|
|
|
|
|
|
|
326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2011 |
|
|
76,281 |
|
$ |
763 |
|
$ |
569,843 |
|
$ |
(430,637 |
) |
$ |
|
|
$ |
139,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(58,556 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
59
Table of Contents
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
In thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(58,274 |
) |
$ |
(50,912 |
) |
$ |
(31,937 |
) |
Adjustments to reconcile net loss to net cash used for operating activities: |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
4,937 |
|
|
4,838 |
|
|
4,995 |
|
|
Loss on sale/disposal of fixed assets |
|
|
9 |
|
|
41 |
|
|
18 |
|
|
Amortization of deferred lease incentive obligation |
|
|
(979 |
) |
|
(979 |
) |
|
(975 |
) |
|
(Gain) loss on sale of marketable securities |
|
|
(341 |
) |
|
|
|
|
33 |
|
|
Other-than-temporary impairment of investments |
|
|
|
|
|
|
|
|
516 |
|
|
(Gain) loss on forward contracts |
|
|
(189 |
) |
|
219 |
|
|
234 |
|
|
Stock and deferred share unit compensation |
|
|
5,778 |
|
|
4,640 |
|
|
4,235 |
|
|
Deferred rent |
|
|
(4 |
) |
|
55 |
|
|
1,450 |
|
|
Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(2,873 |
) |
|
(49 |
) |
|
(1,350 |
) |
|
|
Unbilled revenue |
|
|
107 |
|
|
(1,034 |
) |
|
2,911 |
|
|
|
Inventory |
|
|
762 |
|
|
594 |
|
|
280 |
|
|
|
Prepaid and other current assets |
|
|
(1,038 |
) |
|
(386 |
) |
|
312 |
|
|
|
Restricted cash |
|
|
574 |
|
|
366 |
|
|
366 |
|
|
|
Other assets |
|
|
38 |
|
|
(171 |
) |
|
13 |
|
|
|
Accounts payable |
|
|
149 |
|
|
1,820 |
|
|
(167 |
) |
|
|
Accrued compensation |
|
|
522 |
|
|
61 |
|
|
2,976 |
|
|
|
Other accrued liabilities |
|
|
604 |
|
|
1,393 |
|
|
(2,871 |
) |
|
|
Deferred revenue |
|
|
42,229 |
|
|
(1,080 |
) |
|
4,877 |
|
|
|
Proceeds from landlord for tenant improvements |
|
|
|
|
|
|
|
|
750 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used for operating activities |
|
|
(7,989 |
) |
|
(40,584 |
) |
|
(13,334 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from maturities or sales of marketable securities |
|
|
1,201 |
|
|
834 |
|
|
14,227 |
|
|
|
Purchases of marketable securities |
|
|
|
|
|
|
|
|
(25 |
) |
|
|
Purchases of property and equipment, net |
|
|
(2,029 |
) |
|
(1,534 |
) |
|
(1,896 |
) |
|
|
Proceeds (payments) from settlement of forward contracts |
|
|
168 |
|
|
(182 |
) |
|
(311 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used for) provided by investing activities |
|
|
(660 |
) |
|
(882 |
) |
|
11,995 |
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from stock options exercised |
|
|
2,719 |
|
|
3,462 |
|
|
1,314 |
|
|
|
Proceeds from common stock issuance, net |
|
|
87,980 |
|
|
77,521 |
|
|
38,045 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
90,699 |
|
|
80,983 |
|
|
39,359 |
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
82,050 |
|
|
39,517 |
|
|
38,020 |
|
Cash and cash equivalents, beginning of period |
|
|
109,156 |
|
|
69,639 |
|
|
31,619 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
191,206 |
|
$ |
109,156 |
|
$ |
69,639 |
|
|
|
|
|
|
|
|
|
Supplemental disclosure: |
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
1 |
|
$ |
1 |
|
$ |
1 |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
60
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2011
A. Nature of Business and Plan of Operations
ImmunoGen, Inc. (the Company) was incorporated in Massachusetts in 1981 and is focused on the development of antibody-based anticancer therapeutics. The Company has incurred
operating losses and negative cash flows from operations since inception, incurred a net loss of approximately $58.3 million during the fiscal year ended June 30, 2011, and has an
accumulated deficit of approximately $430.6 million as of June 30, 2011. The Company has primarily funded these losses through payments received from its collaborations and equity
financings. To date, the Company has no product revenue and management expects operating losses to continue for the foreseeable future. The Company believes that its existing cash and cash equivalents
as of June 30, 2011, excluding any future milestone payments, royalties and research and development funding that the Company expects to receive under its existing collaborations, will be
sufficient to allow it to fund its current operating plan through fiscal 2013.
The
Company may raise additional funds through equity or debt financings or generate revenues from collaborative partners through a combination of upfront license payments, milestone
payments, research funding, and clinical material reimbursement. There can be no assurance that the Company will be able to obtain additional debt or equity financing or generate revenues from
collaborative partners, on terms acceptable to the Company, or at all. The failure of the Company to obtain sufficient funds on
acceptable terms when needed could have a material adverse effect on the Company's business, results of operations and financial condition and require the Company to defer or limit some or all of its
research, development and/or clinical projects.
The
Company is subject to risks common to companies in the biotechnology industry including, but not limited to, the development by its competitors of new technological innovations,
dependence on key personnel, protection of proprietary technology, manufacturing and marketing limitations, collaboration arrangements, third-party reimbursements and compliance with governmental
regulations.
B. Summary of Significant Accounting Policies
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, ImmunoGen Securities Corp.
(established in December 1989), and ImmunoGen Europe Limited (established in October 2005). All intercompany transactions and balances have been eliminated.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (U.S.)
requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
The Company has evaluated all events or transactions that occurred after June 30, 2011 up through the date the Company issued
these financial statements. Effective July 2011, Biogen Idec
61
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
terminated
its exclusive license to the Company's TAP technology to develop and commercialize therapeutic compounds to the target Cripto. As a result of the termination, in July 2011 the Company
recognized the remaining $270,000 of the $1 million upfront fee received from Biogen Idec upon execution of the license which had been previously deferred.
The Company enters into licensing and development agreements with collaborative partners for the development of monoclonal
antibody-based anticancer therapeutics. The terms of these agreements contain multiple deliverables which may include (i) licenses, or options to obtain licenses, to the Company's TAP
technology, (ii) rights to future technological improvements, (iii) research activities to be performed on behalf of the collaborative partner, and (iv) the manufacture of
preclinical or clinical materials for the collaborative partner. Payments to the Company under these agreements may include non-refundable license fees, option fees, exercise fees,
payments for research activities, payments for the manufacture of preclinical or clinical materials, payments based upon the achievement of certain milestones and royalties on product sales. The
Company follows the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 605-25, "Revenue RecognitionMultiple-Element
Arrangements," and ASU No. 2010-17, "Revenue RecognitionMilestone Method," in accounting for these agreements. Effective July 1, 2010, the Company adopted
Accounting Standards Update (ASU) No. 2009-13, "Multiple-Deliverable Revenue Arrangements", which amends FASB ASC Topic 605-25. In order to account for these agreements,
the Company must identify the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on if certain criteria are met, including whether
the delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are
applied to each of the separate units.
At
June 30, 2011, the Company had the following three types of agreements with the parties identified below:
-
- Exclusive development and commercialization licenses to use the Company's TAP technology and/or certain other intellectual
property to develop compounds to a single target antigen (exclusive licenses):
Amgen
(two single-target licenses)
Bayer
HealthCare (one single-target license)
Biotest
(one single-target license)
Roche,
through its Genentech unit (five single-target licenses)
Sanofi
(license to multiple individual targets)
62
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
-
- Option/research agreement for a defined period of time to secure development and commercialization licenses to use the
Company's TAP technology to develop anticancer compounds to a limited number of targets on established terms (broad option agreement):
-
- Non-exclusive license to the Company's humanization technology:
There
are no performance, cancellation, termination or refund provisions in any of our arrangements that contain material financial consequences to the Company.
The
deliverables under an exclusive license agreement generally include the exclusive license to the Company's TAP technology, and may also include
deliverables related to rights to future technological improvements, research activities to be performed on behalf of the collaborative partner and the manufacture of preclinical or clinical materials
for the collaborative partner.
Generally,
exclusive license agreements contain non-refundable terms for payments and, depending on the terms of the agreement, provide that the Company will (i) at
the collaborator's request, provide research services which are reimbursed at a contractually determined rate, (ii) at the collaborator's request, manufacture and provide to them preclinical
and clinical materials which are reimbursed at the Company's cost, or, in some cases, cost plus a margin, (iii) earn payments upon the achievement of certain milestones and (iv) earn
royalty payments, generally until the later of the last applicable patent expiration or 10 to 12 years after product launch. Royalty rates may vary over the royalty term depending on the
Company's intellectual property rights. The Company may provide technical assistance and share any technology improvements with its collaborators during the term of the collaboration agreements. The
Company does not directly control when any collaborator will request research or manufacturing services, achieve milestones or become liable for royalty payments. As a result, the Company cannot
predict when it will recognize revenues in connection with any of the foregoing.
In
determining the units of accounting, management evaluates whether the exclusive license has standalone value, from the undelivered elements, to the collaborative partner based on the
consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of TAP
technology research expertise in the general marketplace. If the Company concludes that the license has stand alone value and therefore will be accounted for as a separate unit of accounting, the
Company then determines the estimated selling prices of the license and all other units of accounting based on market conditions, similar arrangements entered into by third parties, and
entity-specific factors such as the terms of the Company's previous collaborative agreements, recent preclinical and clinical testing results of therapeutic products that use the Company's TAP
technology, the Company's pricing practices and
63
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
pricing
objectives, the likelihood that technological improvements will be made, the likelihood that technological improvements made will be used by the Company's collaborators and the nature of the
research services to be performed on behalf of its collaborators and market rates for similar services.
Upfront
payments on single-target licenses are deferred if facts and circumstances dictate that the license does not have standalone value. The determination of the length of the period
over which to defer revenue is subject to judgment and estimation and can have an impact on the amount of revenue recognized in a given period. The Company's employees are generally available to
assist its collaborators during the development of their products. The Company generally estimates this development phase to begin at the inception of the collaboration agreement and conclude at the
end of non-pivotal Phase II testing. The Company believes this period of involvement is, depending on the nature of the license, on average six and one-half years.
Quarterly, the Company reassesses its periods of substantial involvement over which the Company amortizes its upfront license fees and makes adjustments as appropriate. In the event a collaborator
elects to discontinue development of a specific product candidate under a single target license, but retains its right to use the Company's technology to develop an alternative product candidate to
the same target or a target substitute, the Company would cease amortization of any remaining portion of the upfront fee until there is substantial preclinical activity on another product candidate
and its remaining period of substantial involvement can be estimated. In the event that a single target license were to be terminated, the Company would recognize as revenue any portion of the upfront
fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination.
Upfront
payments on single-target licenses may be recognized upon delivery of the license if facts and circumstances dictate that the license has standalone value from the undelivered
elements, which generally include rights to future technological improvements, research services and the manufacture of preclinical and clinical materials.
The
Company recognizes revenue related to research services that represent separate units of accounting as they are performed, as long as there is persuasive evidence of an arrangement,
the fee is fixed or determinable, and collection of the related receivable is probable. The Company recognizes
revenue related to the rights to future technological improvements over the estimated period that the rights will be in force.
The
Company may also produce preclinical and clinical materials for its collaborators. The Company is reimbursed for its direct costs and a portion of its overhead costs to produce
clinical materials. The Company recognizes revenue on preclinical and clinical materials when the materials have passed all quality testing required for collaborator acceptance and title and risk of
loss have transferred to the collaborator.
The
Company may also produce research material for potential collaborators under material transfer agreements. Additionally, the Company performs research activities, including
developing antibody specific conjugation processes, on behalf of its collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development.
Generally, the Company is reimbursed for certain of its direct and overhead costs of producing these materials or providing these services. The Company records the amounts received for the preclinical
materials produced or services performed as a component of research and development support revenue. The Company also develops
64
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
conjugation
processes for materials for later stage testing and commercialization for certain collaborators. The Company is reimbursed for certain of its direct and overhead costs and may receive
milestone payments for developing these processes which are recorded as a component of research and development support revenue.
The
Company's license agreements have milestone fees which generally meet the criteria of ASU No. 2010-17, "Revenue RecognitionMilestone Method," and
accordingly, revenue is recognized when such milestones are achieved.
The
accounting for broad option agreements is dependent on the nature of the option granted to the collaborative partner. For broad option agreements where the
option to secure a development and commercialization license to the Company's TAP technology is considered substantive, the Company defers upfront payments received and recognizes this revenue over
the period during which the collaborator could elect to take an option for a development and commercialization license. These periods are specific to each collaboration agreement. If a collaborator
takes an option to acquire a development and commercialization license under these agreements, any substantive option fee is deferred and recognized over the life of the option, generally 12 to
18 months. If a collaborator exercises an option and the Company grants a single target development and commercialization license
to the collaborator, the Company accounts for any license fee as it would an upfront payment on a single target license, as discussed above. Upon exercise of an option to acquire a development and
commercialization license, the Company would also recognize any remaining deferred option fee or exercise fee as it would an upfront payment on a single target license as discussed above. In the event
a broad option/research agreement were to be terminated, the Company would recognize as revenue any portion of the upfront fee that had not previously been recorded as revenue, but was classified as
deferred revenue, at the date of such termination. The Company recognizes revenue related to research activities as they are performed, as long as there is persuasive evidence of an arrangement, the
fee is fixed or determinable, and collection of the related receivable is probable.
For
broad option agreements where the option to secure a development and commercialization license to the Company's TAP technology is not considered substantive, the Company accounts for
any fees received as it would an upfront payment on a single target license, as discussed above.
The
Company does not directly control when any collaborator will exercise its options for development and commercialization licenses. As a result, the Company cannot predict when it will
recognize revenues in connection with any of the foregoing.
The
Company received up-front payments related to the non-exclusive license of the Company's humanization technology and has deferred
these payments, and is recognizing the revenue over the term of the agreement.
65
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
Inventory costs primarily relate to clinical trial materials being manufactured for sale to the Company's collaborators. Inventory is
stated at the lower of cost or market as determined on a first-in, first-out (FIFO) basis. Inventory at June 30, 2011 and 2010 is $480,000 and $1.2 million,
respectively, and consists entirely of raw materials inventory.
Raw
materials inventory consists entirely of DM1 or DM4, our proprietary cell-killing agents, which are included in all Targeted Antibody Payload, or TAP, product candidates
currently in preclinical and clinical testing with our collaborators. All raw materials inventory is currently procured from a single supplier.
Inventory
cost is stated net of write-downs of $2.0 million and $939,000 as of June 30, 2011 and June 30, 2010, respectively. The write-downs represent the cost of
raw materials that the Company considers to be in excess of a twelve-month supply based on firm, fixed orders and projections from its collaborators as of the respective balance sheet date.
Due
to yield fluctuations, the actual amount of raw materials that will be produced in future periods under third-party supply agreements is highly uncertain. As such, the amount of raw
materials produced could be more than is required to support the development of the Company's collaborators' product candidates. Such excess supply, as determined under the Company's inventory reserve
policy, is charged to research and development expense.
The
Company produces preclinical and clinical materials for its collaborators either in anticipation of or in support of preclinical studies and clinical trials, or for process
development and analytical purposes. Under the terms of supply agreements with its collaborators, the Company generally receives rolling six-month firm, fixed orders for conjugate that the
Company is required to manufacture, and rolling twelve-month manufacturing projections for the quantity of conjugate the collaborator expects to need in any given twelve-month period. The amount of
clinical material produced is directly related to the number of collaborator anticipated or on-going clinical trials for which the Company is producing clinical material, the speed of
enrollment in those trials, the dosage schedule of each clinical trial and the time period, if any, during which patients in the trial receive clinical benefit from the clinical materials. Because
these elements are difficult to estimate over the course of a trial, substantial differences between collaborators' actual manufacturing orders and their projections could result in usage of raw
materials varying significantly from estimated usage at an earlier reporting period. To the extent that a collaborator has provided the Company with a firm, fixed order, the collaborator is required
by contract to reimburse the Company the full cost of the conjugate and any agreed margin thereon, even if the collaborator subsequently cancels the manufacturing run.
The
Company capitalizes raw material as inventory upon receipt and accounts for the raw material inventory as follows:
- a)
- to
the extent that the Company has up to twelve months of firm, fixed orders and/or projections from its collaborators, the Company capitalizes the value of
raw materials that will be used in the production of conjugate subject to these firm, fixed orders and/or projections;
- b)
- the
Company considers more than a twelve month supply of raw materials that is not supported by firm, fixed orders and/or projections from its collaborators
to be excess and
66
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
During
fiscal years 2011 and 2010, the Company obtained additional amounts of DMx from its supplier which yielded more material than would be required by the Company's collaborators over
the next twelve months and as a result, the Company recorded $1.7 million and $900,000, respectively, of charges to research and development expense related to raw material inventory identified
as excess. The Company also recorded $28,000 as research and development expense to write down certain raw material inventory to its net realizable value in fiscal 2010. No similar costs were recorded
during the year ended June 30, 2009. Increases in the Company's on-hand supply of raw materials, or a reduction to the Company's collaborators' projections, could result in
significant changes in the Company's estimate of the net realizable value of such raw material inventory. Reductions in collaborators' projections could indicate that the Company has additional excess
raw material inventory and the Company would then evaluate the need to record further write-downs as charges to research and development expense.
The majority of the Company's unbilled revenue at June 30, 2011 and 2010 represents research funding earned based on actual
resources utilized under the Company's various collaborator agreements.
Restricted cash at June 30, 2011 and 2010 are cash balances securing irrevocable letters of credit required for the Company to
receive value added tax reimbursements related to payments to foreign vendors for activities performed and as security deposits for the Company's leased facilities.
Other accrued liabilities consisted of the following at June 30, 2011 and 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2011 |
|
2010 |
|
Accrued contract payments |
|
$ |
684 |
|
$ |
324 |
|
Accrued clinical trial costs |
|
|
1,068 |
|
|
537 |
|
Accrued professional services |
|
|
652 |
|
|
709 |
|
Accrued employee benefits |
|
|
277 |
|
|
233 |
|
Accrued public reporting charges |
|
|
78 |
|
|
111 |
|
Other current accrued liabilities |
|
|
546 |
|
|
490 |
|
|
|
|
|
|
|
Total |
|
$ |
3,305 |
|
$ |
2,404 |
|
|
|
|
|
|
|
67
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
The Company's research and development expenses are charged to expense as incurred and relate to (i) research to evaluate new
targets and to develop and evaluate new antibodies, linkers and cytotoxic agents, (ii) preclinical testing of its own and, in certain instances, its collaborators' product candidates, and the
cost of its own clinical trials, (iii) development related to clinical and commercial manufacturing processes and (iv) manufacturing operations. Payments made by the Company in advance
for research and development services not yet provided and/or materials not yet delivered and accepted are recorded as prepaid expenses and are included in the accompanying Consolidated Balance Sheets
as prepaid and other current assets.
The Company uses the liability method to account for income taxes. Deferred tax assets and liabilities are determined based on
differences between the financial reporting and income tax basis of assets and liabilities, as well as net operating loss carry forwards and tax credits and are measured using the enacted tax rates
and laws that will be in effect when the differences reverse. A valuation allowance against net deferred tax assets is recorded if, based on the available evidence, it is more likely than not that
some or all of the deferred tax assets will not be realized.
Cash and cash equivalents are primarily maintained with three financial institutions in the U.S. Deposits with banks may exceed the
amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. The Company's cash equivalents consist principally of U.S.
Government treasury bills with original maturities of less than three months and a money market fund with underlying investments primarily being U.S. Government-issued securities and high quality,
short-term commercial paper. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of marketable securities. The Company held no
marketable securities as of June 30, 2011. The Company's investment policy, approved by the Board of Directors, limits the amount it may invest in any one type of investment, thereby reducing
credit risk concentrations.
Derivative
instruments include a portfolio of short duration foreign currency forward contracts intended to mitigate the risk of exchange fluctuations for existing or anticipated
receivable and payable balances denominated in foreign currency. Derivatives are estimated at fair value and classified as other current
assets or liabilities. The fair value of these instruments represents the present value of estimated future cash flows under the contracts, which are a function of underlying interest rates, currency
rates, related volatility, counterparty creditworthiness and duration of the contracts. Changes in these factors or a combination thereof may affect the fair value of these instruments.
The
Company does not designate foreign currency forward contracts as hedges for accounting purposes, and changes in the fair value of these instruments are recognized in earnings during
the period of change. Because the Company enters into forward contracts only as an economic hedge, any gain or loss on the underlying foreign-denominated existing or anticipated receivable or payable
balance would be offset by the loss or gain on the forward contract. Net gains (losses) on forward
68
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
contracts
for the years ended June 30, 2011, 2010 and 2009 were $189,000, ($219,000) and ($234,000), respectively, and are included in the accompanying Consolidated Statement of Operations as
other income (expense), net. As of June 30, 2011, the Company had outstanding forward contracts with notional amounts equivalent to approximately $1.6 million
(€1.1 million), all maturing on or before September 9, 2012. As of June 30, 2010, the Company had outstanding forward contracts with notional amounts equivalent to
approximately $1.6 million (€1.3 million). The Company does not anticipate using derivative instruments for any purpose other than hedging exchange rate exposure.
Cash equivalents consist principally of money market funds and U.S. Government treasury bills with original maturities of three months
or less at the date of purchase.
The Company invests in marketable securities of highly rated financial institutions and investment-grade debt instruments and limits
the amount of credit exposure with any one entity. The Company has classified its marketable securities as "available-for-sale" and, accordingly, carries such securities at
aggregate fair value. Unrealized gains and losses, if any, are reported as a component of other comprehensive income (loss) in shareholders' equity. The amortized cost of debt securities in this
category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretions are included in investment income, net, as well as interest and dividends.
Realized gains and losses on available-for-sale securities are included in other income (expense), net.
Charges for the impairment of available-for-sale securities that were determined to be other-than-temporary and related to a credit loss are included in
the accompanying Consolidated Statement of Operations as other-than-temporary impairment. The cost of securities sold is based on the specific identification method.
In April 2009, the Company implemented a newly issued accounting standard which provides guidance for the recognition, measurement and
presentation of other-than-temporary impairments. Under this standard, an other-than-temporary impairment must be recognized through earnings if an
investor has the intent to sell the debt security or if it is more likely than not that the investor will be required to sell the debt security before recovery of its amortized cost basis. In the
event of a credit loss, only the amount associated with the credit loss is recognized in net income (loss). The amount of loss relating to other factors is recorded in accumulated other comprehensive
income (loss). As a result of the adoption, in fiscal 2009, $54,000 of previously recognized other-than-temporary impairment charges was reclassified to other comprehensive
income (loss) as a cumulative effect adjustment.
The
Company conducts periodic reviews to identify and evaluate each investment that has an unrealized loss, which exists when the current fair value of an individual security is less
than its amortized cost basis. Unrealized losses on available-for-sale securities that are determined to be temporary, and not related to credit loss, are recorded in
accumulated other comprehensive income (loss).
69
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
For
available-for-sale debt securities with unrealized losses, management performs an analysis to assess whether it intends to sell or whether it would more
likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where the Company intends to sell a security, or may be required to do so, the security's
decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded in the statement of operations as an
other-than-temporary impairment charge. When this is not the case, the Company performs additional analysis on all securities with unrealized losses to evaluate losses
associated with the creditworthiness of the security. Credit losses are identified where the Company does not expect to receive cash flows, based on using a single best estimate, sufficient to recover
the
amortized cost basis of a security and these are recognized as other-than-temporary impairment.
As of July 1, 2008, the Company partially adopted the provisions of ASC Topic 820, "Fair Value Measurements and Disclosures,"
for financial assets and liabilities recognized at fair value on a recurring basis. ASC Topic 820 defines fair value, establishes a framework for measuring fair value in accordance with accounting
principles generally accepted in the U.S., and expands disclosures about fair value measurements. Certain provisions of ASC Topic 820 related to other non-financial assets and liabilities
were adopted by the Company on July 1, 2009 and did not have a material impact on its financial position or results of operations upon adoption; however, this standard may impact the Company in
subsequent periods and require additional disclosures.
Fair
value is defined under ASC Topic 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable
inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy to measure fair value which is based on three levels of inputs, of which the first two are considered
observable and the last unobservable, as follows:
-
- Level 1Quoted prices in active markets for identical assets or liabilities.
-
- Level 2Inputs other than Level 1 that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the assets or liabilities.
-
- Level 3Unobservable inputs that are supported by little or no market activity and that are significant
to the fair value of the assets or liabilities.
70
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
As
of June 30, 2011, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy
for the Company's financial assets measured at fair value on a recurring basis as of June 30, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at June 30, 2011 Using |
|
|
|
|
|
Quoted Prices in
Active Markets for
Identical Assets |
|
Significant Other
Observable Inputs |
|
Significant
Unobservable
Inputs |
|
|
|
Total |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
Cash, cash equivalents and restricted cash |
|
$ |
194,774 |
|
$ |
194,774 |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
194,774 |
|
$ |
194,774 |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
As
of June 30, 2010, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy
for the Company's financial assets measured at fair value on a recurring basis as of June 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at June 30, 2010 Using |
|
|
|
|
|
Quoted Prices in
Active Markets for
Identical Assets |
|
Significant Other
Observable Inputs |
|
Significant
Unobservable
Inputs |
|
|
|
Total |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
Cash, cash equivalents and restricted cash |
|
$ |
113,298 |
|
$ |
113,298 |
|
$ |
|
|
$ |
|
|
Available-for-sale marketable securities |
|
|
1,142 |
|
|
|
|
|
1,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
114,440 |
|
$ |
113,298 |
|
$ |
1,142 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
The
fair value of the Company's investments is generally determined from market prices based upon either quoted prices from active markets or other significant observable market
transactions at fair value.
The
carrying amounts reflected in the consolidated balance sheets for accounts receivable, unbilled revenue, prepaid and other current assets, accounts payable, accrued compensation, and
other accrued liabilities approximate fair value due to their short-term nature.
Property and equipment are stated at cost. The Company provides for depreciation based upon expected useful lives using the
straight-line method over the following estimated useful lives:
|
|
|
Machinery and equipment |
|
5 years |
Computer hardware and software |
|
3 years |
Furniture and fixtures |
|
5 years |
Leasehold improvements |
|
Shorter of remaining lease term or 7 years |
Maintenance
and repairs are charged to expense as incurred. Upon retirement or sale, the cost of disposed assets and the related accumulated depreciation are removed from the accounts
and any resulting gain or loss is included in the statement of operations. The Company recorded $9,000, $41,000
71
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
and
$18,000 of losses on the sale/disposal of certain furniture and equipment during the years ended June 30, 2011, 2010, and 2009, respectively.
In accordance with ASC Topic 360, "Property, Plant, and Equipment," the Company continually evaluates whether events or circumstances
have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. The Company
evaluates the realizability of its long-lived assets based on cash flow expectations for the related asset. Any write-downs are treated as permanent reductions in the carrying amount of
the assets. Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company's long-lived assets were impaired.
Basic and diluted net loss per common share is calculated based upon the weighted average number of common shares outstanding during
the period. The Company's common stock equivalents, as calculated in accordance with the treasury-stock accounting method, are shown in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
Options outstanding to purchase common stock |
|
|
6,491 |
|
|
6,065 |
|
|
5,529 |
|
Common stock equivalents under treasury stock method |
|
|
1,901 |
|
|
1,853 |
|
|
848 |
|
The
Company's common stock equivalents have not been included in the net loss per share calculation because their effect is anti-dilutive due to the Company's net loss
position.
As of June 30, 2011, the Company is authorized to grant future awards under one employee share-based compensation plan, which is
the ImmunoGen, Inc. 2006 Employee, Director and Consultant Equity Incentive Plan, or the 2006 Plan. On November 16, 2010, the Company's shareholders approved an amendment to the 2006
Plan to increase the number of shares of common stock authorized for issuance thereunder by 4,000,000. As amended, the 2006 Plan provides for the issuance of Stock Grants, the grant of Options and the
grant of Stock-Based Awards for up to 8,500,000 shares of the Company's common stock, as well as any shares of common stock that are represented by awards granted under the previous stock option plan,
the ImmunoGen, Inc. Restated Stock Option Plan, or the Former Plan, that are forfeited, expire or are cancelled without delivery of shares of common stock; provided, however, that no more than
5,900,000 shares shall be added to the Plan from the Former Plan, pursuant to this provision. Option awards are granted with an exercise price equal to the market price of the Company's stock at the
date of grant. Options vest at various periods of up to four years and may be exercised within ten years of the date of grant.
The
stock-based awards are accounted for under ASC Topic 718, "CompensationStock Compensation." Pursuant to Topic 718, the estimated grant date fair value of awards is
charged to the
72
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
statement
of operations over the requisite service period, which is the vesting period. Such amounts have been reduced by an estimate of forfeitures of all unvested awards. The fair value of each
stock option is estimated on the date of grant using the Black-Scholes option-pricing model with the assumptions noted in the following table. As the Company has not paid dividends since inception,
nor does it expect to pay any dividends for the foreseeable future, the expected dividend yield assumption is zero. Expected volatility is based exclusively on historical volatility data of the
Company's stock. The expected term of stock options granted is based exclusively on historical data and represents the period of time that stock options granted are expected to be outstanding. The
expected term is calculated for and applied to one group of stock options as the Company does not expect substantially different exercise or post-vesting termination behavior amongst its
employee population. The risk-free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options.
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
Dividend |
|
|
None |
|
|
None |
|
|
None |
|
Volatility |
|
|
58.81 |
% |
|
59.90 |
% |
|
63.11 |
% |
Risk-free interest rate |
|
|
2.43 |
% |
|
3.19 |
% |
|
2.40 |
% |
Expected life (years) |
|
|
7.2 |
|
|
7.0 |
|
|
7.2 |
|
Using
the Black-Scholes option-pricing model, the weighted average grant date fair values of options granted during fiscal 2011, 2010 and 2009 were $5.51, $5.83, and $2.73 per share,
respectively.
Stock
compensation expense related to stock options granted under the 2006 Plan was $5.5 million, $4.2 million and $4.0 million during the fiscal years ended
June 30, 2011, 2010, and 2009, respectively. During the year ended June 30, 2009, the Company recorded approximately $843,000 of stock-based compensation expense related to certain stock
options previously granted to the former Chief Executive Officer of the Company that were modified in accordance with the succession plan approved by the Company's Board of Directors in September
2008. No similar charges were recorded during the years ended June 30, 2011 and 2010.
73
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
A
summary of option activity under the Plan as of June 30, 2011, and changes during the twelve month period then ended is presented below (in thousands, except weighted-average
data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Stock
Options |
|
Weighted-
Average
Exercise
Price |
|
Weighted-
Average
Remaining
Life in Yrs |
|
Aggregate
Intrinsic
Value |
|
Outstanding at June 30, 2010 |
|
|
6,065 |
|
$ |
7.09 |
|
|
|
|
|
|
|
Granted |
|
|
1,679 |
|
$ |
9.11 |
|
|
|
|
|
|
|
Exercised |
|
|
(550 |
) |
$ |
4.94 |
|
|
|
|
|
|
|
Forfeited/Canceled |
|
|
(703 |
) |
$ |
17.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2011 |
|
|
6,491 |
|
$ |
6.70 |
|
|
6.61 |
|
$ |
35,644 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2011vested or unvested and expected to vest |
|
|
5,847 |
|
$ |
6.91 |
|
|
6.40 |
|
$ |
32,576 |
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2011 |
|
|
3,834 |
|
$ |
5.25 |
|
|
5.17 |
|
$ |
26,597 |
|
|
|
|
|
|
|
|
|
|
|
As
of June 30, 2011, the estimated fair value of unvested employee awards was $6.6 million, net of estimated forfeitures. The weighted-average remaining vesting period for
these awards is approximately three years.
A
summary of option activity for shares vested during the fiscal years ended June 30, 2011, 2010 and 2009 is presented below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
Total fair value of shares vested |
|
$ |
3,427 |
|
$ |
2,410 |
|
$ |
2,838 |
|
Total intrinsic value of options exercised |
|
|
3,467 |
|
|
1,888 |
|
|
920 |
|
Cash received for exercise of stock options |
|
|
2,719 |
|
|
3,462 |
|
|
1,314 |
|
The Company presents comprehensive loss in accordance with ASC Topic 220, Comprehensive
Income. Comprehensive loss is comprised of the Company's net loss for the period and unrealized gains and losses on available-for-sale marketable
securities.
During the three fiscal years ended June 30, 2011, the Company continued to operate in one reportable business segment under the
management approach of ASC Topic 280, Segment Reporting, which is the business of discovery of monoclonal antibody-based anticancer therapeutics.
74
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
B. Summary of Significant Accounting Policies (Continued)
The
percentages of revenues recognized from significant customers of the Company in the years ended June 30, 2011, 2010 and 2009 are included in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
Collaborative Partner:
|
|
2011 |
|
2010 |
|
2009 |
|
Amgen |
|
|
41 |
% |
|
32 |
% |
|
2 |
% |
Sanofi |
|
|
23 |
% |
|
28 |
% |
|
45 |
% |
Bayer HealthCare |
|
|
17 |
% |
|
15 |
% |
|
2 |
% |
Biogen Idec |
|
|
1 |
% |
|
13 |
% |
|
7 |
% |
Biotest |
|
|
9 |
% |
|
9 |
% |
|
13 |
% |
Roche |
|
|
|
% |
|
3 |
% |
|
26 |
% |
There
were no other customers of the Company with significant revenues in the years ended June 30, 2011, 2010 and 2009.
In May 2011, the FASB issued ASU No. 2011-04, "Fair Value Measurement." This ASU clarifies the concepts related to
highest and best use and valuation premise, blockage factors and other premiums and discounts, the fair value measurement of financial instruments held in a portfolio and of those instruments
classified as a component of shareholders' equity. The guidance includes enhanced disclosure requirements about recurring Level 3 fair value measurements, the use of nonfinancial assets, and
the level in the fair value hierarchy of assets and liabilities not recorded at fair value. The provisions of this ASU are effective prospectively for interim and annual periods beginning on or after
December 15, 2011. Early application is prohibited. The Company does not expect the adoption of these provisions to have a significant impact on our financial statements.
In
June 2011, the FASB issued ASU No. 2011-05, "Comprehensive Income." This ASU intends to enhance comparability and transparency of other comprehensive income
components. The guidance provides an option to present total comprehensive income, the components of net income and the components of other comprehensive income in a single continuous statement or two
separate but consecutive statements. This ASU eliminates the option to present other comprehensive income components as part of the statement of changes in shareholders' equity. The provisions of this
ASU will be applied retrospectively for interim and annual periods beginning after December 15, 2011. Early application is permitted. The Company does not expect the adoption of these
provisions to have a significant impact on our financial statements.
75
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements
Significant Collaborative Agreements
In May 2000, the Company granted Roche, through its Genentech unit, an exclusive license to the Company's maytansinoid TAP technology
for use with antibodies or other proteins that target HER2, such as trastuzumab. Under the terms of this agreement, Roche has exclusive worldwide rights to develop and commercialize maytansinoid TAP
compounds with antibodies that target HER2. Roche is responsible for the manufacturing, product development and marketing of any products resulting from the agreement. The Company is reimbursed for
any preclinical and clinical materials that the Company manufactures under the agreement. The Company received a $2 million non-refundable payment from Roche upon execution of the
agreement. The Company is also entitled to up to $44 million in milestone payments from Roche under this agreement, as amended in May 2006, in addition to royalties on the net sales of any
resulting products. Roche began Phase II evaluation of T-DM1 in July 2007 and the Company earned and recognized a $5 million milestone payment with this event. Roche began
Phase III evaluation of T-DM1 in February 2009 and the Company earned and recognized a $6.5 million milestone payment with this event. This milestone is included in license
and milestone fees for the fiscal year ended June 30, 2009. Through June 30, 2011, the Company has received and recognized $13.5 million in milestone payments related to
T-DM1. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company's
past involvement in the research and manufacturing of this product, these milestones were deemed substantive.
Roche,
through its Genentech unit, also has licenses for the exclusive right to use the Company's maytansinoid TAP technology with antibodies to four undisclosed targets, which were
granted under the terms of a separate May 2000 right-to-test agreement with Genentech. For each of these licenses the Company received a $1 million license fee and is
entitled to receive up to $38 million in milestone payments and also royalties on the sales of any resulting products. Roche is responsible for the development, manufacturing, and marketing of
any products resulting from these licenses. Roche no longer has the right to take additional licenses under the right-to-test agreement. The Company received
non-refundable technology access fees totaling $5 million for the eight-year term of the agreement. The upfront fees were deferred and recognized ratably over the period
during which Genentech could elect to obtain product licenses.
In September 2000, the Company entered into a ten-year right-to-test agreement with
Abgenix, Inc., which was later acquired by Amgen. The agreement provides Amgen with the right to test the Company's maytansinoid TAP technology with antibodies to a defined number of targets on
either an exclusive and non-exclusive basis for specified option periods and to take exclusive or non-exclusive licenses to use our maytansinoid TAP technology to develop
products for individual targets on agreed-upon terms. The Company received a $5 million technology access fee in September 2000. Under the agreement, in September 2009 and November
2009, the Company entered into two development and license agreements with Amgen and received a $1 million upfront payment with each license taken. The Company has deferred the
$1 million upfront payments and is recognizing these amounts as revenue ratably over the estimated period of substantial involvement. In addition to the
76
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements (Continued)
$1 million
upfront payment, the Company is entitled to earn milestone payments potentially totaling $34 million per target for each compound developed under the
right-to-test agreement, as well as royalties on the commercial sales of any resulting products. In September 2010, the Company granted Amgen a combination of exclusive and
non-exclusive options to test our TAP technology with antibodies to specific antigen targets. For each option taken, Amgen paid us a nominal fee. These options provide Amgen with the right
to take a license for each of these targets, during the time period allowed, on the license terms established in the September 2000 agreement. Amgen no longer has the right to designate new targets
under this agreement, although the option periods with respect to the designated targets for the options granted will remain in effect for the remainder of the respective option periods.
In July 2003, the Company entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and
commercialize antibody-based anticancer therapeutics.
The
agreement provides Sanofi with worldwide commercialization rights to new anticancer therapeutics developed to targets that were included in the collaboration, including the right to
use the Company's TAP technology and humanization technology in the creation of therapeutics to these targets. The product candidates (targets) as of June 30, 2011 in the collaboration include
SAR3419 (CD19), SAR566658 (DS6, also known as CA6), SAR650984 (CD38) and other earlier-stage compounds that have yet to be disclosed.
The
collaboration agreement entitles the Company to receive milestone payments potentially totaling $21.5 million for each therapeutic now included in the collaboration agreement.
Through June 30, 2011, the Company has earned and recognized a total of $5 million in milestone payments related to the three product candidates noted above and a target not yet
disclosed, including a $1 million milestone payment earned in September 2010 related to the initiation of Phase I clinical testing of SAR566658 which is included in license and milestone
fee revenue for the year ended June 30, 2011. The Company also earned and recognized an aggregate of $8 million of milestone payments related to two product candidates previously in the
collaboration that have been returned to the Company along with the rights to the respective targets. At the time of execution of this agreement, there was significant uncertainty as to whether these
milestones would be achieved. In consideration of this, as well as the Company's past involvement in the research and manufacturing of these products, these milestones were deemed substantive.
The
agreement also entitles the Company to royalties on the commercial sales of any resulting products if and when such sales commence. Sanofi is responsible for the cost of the
development, manufacturing and marketing of any products created through the collaboration. The Company is reimbursed for any preclinical and clinical materials that it makes under the agreement. The
collaboration agreement also provides the Company an option to certain co-promotion rights in the U.S. on a product-by-product basis. The terms of the collaboration
agreement allow Sanofi to terminate the Company's co-promotion rights if there is a change of control of the company.
As
part of this agreement, Sanofi paid the Company an upfront fee of $12 million in August 2003. Inclusive of all of its allowed extensions, the agreement enabled the Company to
receive committed
77
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements (Continued)
research
funding totaling $79.3 million over the five years of the research collaboration. The two companies subsequently agreed to extend the date of research funding through
October 31, 2008 to enable completion of previously agreed-upon research. The Company recorded the research funding as it was earned based upon its actual resources utilized in the
collaboration. The Company earned $81.5 million of committed funding over the duration of the research program, of which $2.7 million was recognized during fiscal year 2009. The Company
is now compensated for research performed for Sanofi on a mutually agreed-upon basis.
In
October 2006, Sanofi licensed non-exclusive rights to use the Company's proprietary resurfacing technology to humanize antibodies to targets not included in the
collaboration, including antibodies for non-cancer applications. This license provides Sanofi with the non-exclusive right to use the Company's proprietary humanization
technology through August 31, 2011 with the right to extend for one or more additional periods of three years each by providing the Company with written notice prior to expiration of the
then-current license term. Under the terms of the license, the Company is entitled to a $1 million license fee, half of which was paid upon contract signing and the second half was
paid in August 2008, and in addition, the
Company is entitled to receive milestone payments potentially totaling $4.5 million for each antibody humanized under this agreement and also royalties on commercial sales, if any.
In
August 2008, Sanofi exercised its option under a separate 2006 agreement for expanded access to ImmunoGen's TAP technology. The exercise of this option enables Sanofi to evaluate,
with certain restrictions, the Company's maytansinoid TAP technology with antibodies to targets that were not included in the existing research collaboration between the companies and to license the
exclusive right to use the technology to develop products to specific targets on the terms in the 2006 agreement. ImmunoGen is entitled to earn upfront and milestone payments potentially totaling
$32 million per target for each compound developed under the 2006 agreement, as well as royalties on the commercial sales of any resulting products. ImmunoGen also is entitled to manufacturing
payments for any materials made on behalf of Sanofi. The Company received $3.5 million with the exercise of this option in August 2008, in addition to the $500,000 ImmunoGen received in
December 2006 with the signing of the option agreement. The agreement has a three-year term from the date of the exercise of the option and can be renewed by Sanofi for one additional
three-year term by payment of a $2 million fee by August 31, 2011.
In July 2006, the Company entered into a development and license agreement with Biotest AG. The agreement grants Biotest exclusive
rights to use our maytansinoid TAP technology to develop and commercialize therapeutic compounds to the target CD138. The Company received a $1 million upfront payment upon execution of the
agreement and could potentially receive up to $35.5 million in milestone payments, as well as royalties on the sales of any resulting products. The Company receives payments for manufacturing
any preclinical and clinical materials made at the request of Biotest. In September 2008, Biotest began Phase I evaluation of BT062 which triggered a $500,000 milestone payment to the Company.
This milestone is included in license and milestone fees for the fiscal year ended June 30, 2009. At the time of execution of this agreement, there was significant uncertainty as to
78
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements (Continued)
whether
this milestone would be achieved. In consideration of this, as well as the Company's past involvement in the research and manufacturing of this product, this milestone was deemed substantive.
The
agreement also provides the Company with the right to elect at specific stages during the clinical evaluation of any compound created under this agreement, to participate in the U.S.
development and commercialization of that compound in lieu of receiving royalties on U.S. sales of that product and the milestone payments not yet earned. The Company can exercise this right by making
a payment to Biotest of an agreed-upon fee of $5 million or $15 million, depending on the stage of development. Upon exercise of this right, the Company would share equally
with Biotest the associated
costs of product development and commercialization in the U.S. along with the profit, if any, from U.S. product sales.
In October 2008, the Company entered into a development and license agreement with Bayer HealthCare. The agreement grants Bayer
HealthCare exclusive rights to use the Company's maytansinoid TAP technology to develop and commercialize therapeutic compounds to mesothelin. Bayer HealthCare is responsible for the research,
development, manufacturing and marketing of any products resulting from the license. The Company received a $4 million upfront payment upon execution of the agreement, andfor each
compound developed and marketed by Bayer HealthCare under this collaborationthe Company could potentially receive up to $170.5 million in milestone payments; additionally, the
Company is entitled to receive royalties on the sales of any resulting products. The Company also is entitled to receive payments for manufacturing any preclinical and clinical materials at the
request of Bayer HealthCare as well as for any related process development activities. The Company has deferred the $4 million upfront payment and is recognizing this amount as revenue ratably
over the estimated period of substantial involvement. In September 2009, Bayer HealthCare achieved a preclinical milestone which triggered a $1 million payment to the Company which is included
in license and milestone fees for the fiscal year ended June 30, 2010. In June 2011, Bayer HealthCare reached a clinical milestone which triggered a $2 million payment to the Company
which is included in license and milestone fees for the fiscal year ended June 30, 2011. At the time of execution of this agreement, there was significant uncertainty as to whether these
milestones would be achieved. In consideration of this, as well as the Company's past involvement in the research and manufacturing of this product, these milestones were deemed substantive.
In October 2010, the Company entered into an agreement with Novartis Institutes for BioMedical Research, Inc. (Novartis). The
agreement initially provides Novartis with a research license to test the Company's TAP technology with Novartis' antibodies and an option to take exclusive development and commercialization licenses
to use ImmunoGen's TAP technology to develop therapeutic products for a specified number of individual antigen targets. The initial term of the research license is for three years and it may be
extended by Novartis for up to two one-year periods by the payment of additional consideration. The terms of the agreement also require Novartis to exercise its option for the development
and commercialization licenses by the end of the research term. The Company received a $45 million upfront payment in connection with the execution of the agreement, and for each
79
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements (Continued)
development
and commercialization license for an antigen target, the Company is entitled to receive milestone payments potentially totaling $200.5 million plus royalties on product sales, if
any. The Company also is entitled to receive payments for manufacturing preclinical and clinical materials at the request of Novartis as well as for research and development activities performed on
behalf of Novartis. Novartis is responsible for the development, manufacturing and marketing of any products resulting from this agreement.
In
accordance with ASU No. 2009-13, the Company identified all of the deliverables at the inception of the agreement. The significant deliverables were determined to
be the research license, the exclusive development and commercialization licenses, rights to future technological improvements, and the research services. The Company has determined that the research
license together with the development and commercialization licenses represent one unit of accounting as the research license does not have standalone value from the development and commercialization
licenses. The Company has also determined that this unit of accounting does have standalone value from the rights to future technological improvements and the research services. As a result, the
rights to future technological improvements and the research services are considered separate units of accounting. The estimated selling prices for these units of accounting were determined based on
market conditions, similar arrangements entered into by third parties and entity-specific factors such as the terms of the Company's previous collaborative agreements, recent preclinical and clinical
testing results of therapeutic products that use the Company's TAP technology, the Company's pricing practices and pricing objectives, the likelihood that technological improvements will be made, the
likelihood that technological improvements made will be used by Novartis and the nature of the research services to be performed for Novartis and market rates for similar services. The arrangement
consideration was allocated to the deliverables based on the relative selling price method. Of the $45 million upfront payment received from Novartis, $41.2 million has been allocated to
the development and commercialization licenses and $3.8 million has been allocated to the rights to future technological improvements. The Company will recognize license revenue as each
exclusive development and commercialization license is delivered pursuant to the terms of the agreement. At the time the first license is taken, the $3.8 million allocated to future
technological improvements will commence amortization over the estimated life of the agreement, or 25 years. The Company does not control when Novartis will exercise its options for development
and commercialization licenses. As a result, the
Company cannot predict when it will recognize the related license revenue except that it will be within the term of the research license. The Company will recognize research services revenue as the
related services are delivered.
No
license revenue has been recognized related to this agreement for the year ended June 30, 2011, as no exclusive development and commercialization licenses have been delivered.
Accordingly, the entire $45 million upfront payment is included in long-term deferred revenue at June 30, 2011.
The
adoption of ASU No. 2009-13 did not have a material impact on the timing or pattern of revenue recognition relative to the agreement nor is expected to in future
periods.
In December 2004, the Company entered into a development and license agreement with a predecessor to Janssen Biotech (formerly known as
Centocor Ortho Biotech), a wholly owned
80
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements (Continued)
subsidiary
of Johnson & Johnson. Under the terms of this agreement, Janssen was granted exclusive worldwide rights to develop and commercialize anticancer therapeutics that consist of the
Company's maytansinoid cell-killing agent attached to an av integrin-targeting antibody that was developed by Janssen. Under the terms of the
agreement, the Company received an upfront payment of $1 million upon execution of the agreement.
In
December 2007, the Company licensed from Janssen the exclusive, worldwide right to develop and commercialize a TAP compound, IMGN388, that consists of an
av integrin-targeting antibody developed by them and one of the Company's maytansinoid cell-killing agents. This license reallocates the parties'
respective responsibilities and financial obligations from the license referenced above. Janssen has the right to opt-in on future development and commercialization of IMGN388 at an
agreed-upon stage in early clinical testing. Should Janssen not exercise this right, Janssen would be entitled to receive milestone payments potentially totaling $30 million, with
the first payment due upon the completion of a successful Phase III trial, and also royalties on IMGN388 sales, if any. In this event, ImmunoGen has the right to obtain a new partner for
IMGN388, with certain restrictions. Should Janssen exercise its opt-in right, ImmunoGen would receive an opt-in fee and be released from its obligation to pay Janssen any
milestone payments or royalties on sales. Both companies would contribute to the costs of developing the compound. The two companies would share equally any profits on the sales of the compound in the
U.S. and ImmunoGen
would receive royalties on any international sales. The companies have agreed to share certain third-party payments. In June 2008, the FDA approved the IND application for IMGN388. This event
triggered a $1 million milestone payment to a third-party, half of which was paid by ImmunoGen. As of June 30, 2011, the maximum amount that may be payable in the future to such
third-parties under this agreement is $11 million.
Effective
July 2011, Biogen Idec terminated its exclusive license to the Company's TAP technology to develop and commercialize therapeutic compounds to the target Cripto. This license
was granted pursuant to the Development and License Agreement between the Company and Biogen Idec dated October 1, 2004. As a result of the termination, during the first quarter of fiscal 2012,
the Company recognized the remaining $270,000 of the $1 million upfront fee received from Biogen Idec upon execution of the license which had been previously deferred.
In
July 2008, the Company received notice of Millennium Pharmaceuticals Inc.'s election to terminate its exclusive license to the Company's TAP technology to develop and
commercialize antibody-based cytotoxic products directed to the prostate specific membrane antigen (PSMA) target. This license was granted pursuant to the Access, Option and License Agreement between
the Company and Millennium dated March 30, 2001. As a result of the termination, the Company recognized the remaining $361,000 of the $1 million upfront fee received from Millennium upon
execution of the license which had been previously deferred, and is included in license and milestone fees for the fiscal year ended June 30, 2009.
In
August 2008, the Company received notice of Boehringer Ingelheim's election to terminate its exclusive license to use the Company's technology to develop and commercialize TAP
compounds to CD44 or the alternative target selected. This license was granted pursuant to the Development and License Agreement between the Company and Boehringer Ingelheim dated November 27,
2001. As a result of the termination, the Company recognized the remaining $486,000 of the $1 million upfront fee received from Boehringer Ingelheim upon execution of the license agreement
which had been
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Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
C. Agreements (Continued)
previously
deferred, and is included in license and milestone fees for the fiscal year ended June 30, 2009.
D. Marketable Securities
As of June 30, 2011, $191.2 million in cash, U.S. Government treasury bills, and money market funds consisting principally of U.S. Government-issued securities and high
quality, short-term commercial paper were classified as cash and cash equivalents.
As
of June 30, 2010, $109.2 million in cash and money market funds were classified as cash and cash equivalents. The Company's cash, cash equivalents and marketable
securities as of June 30, 2010 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost |
|
Gross
Unrealized
Gains |
|
Gross
Unrealized
Losses |
|
Estimated
Fair Value |
|
Cash and money market funds |
|
$ |
109,156 |
|
$ |
|
|
$ |
|
|
$ |
109,156 |
|
Asset-backed securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current |
|
|
25 |
|
|
8 |
|
|
|
|
|
33 |
|
|
Non-current |
|
|
810 |
|
|
291 |
|
|
(17 |
) |
|
1,084 |
|
Corporate notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current |
|
|
25 |
|
|
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
110,016 |
|
$ |
299 |
|
$ |
(17 |
) |
$ |
110,298 |
|
Less amounts classified as cash and cash equivalents |
|
|
(109,156 |
) |
|
|
|
|
|
|
|
(109,156 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities |
|
$ |
860 |
|
$ |
299 |
|
$ |
(17 |
) |
$ |
1,142 |
|
|
|
|
|
|
|
|
|
|
|
During
fiscal year 2011, the Company sold the remaining marketable securities held in its investment portfolio at June 30, 2010, resulting in realized gains of $347,000 and
realized losses of $(6,000). In 2010, the Company had no realized losses or gains. In 2009, the Company realized losses of $(33,000) and had no realized gains.
As
of June 30, 2010, the Company had 13 individual securities in its investment portfolio, of which four were in an unrealized loss position. The aggregate fair value of
investments with unrealized losses was approximately $348,000 as of June 30, 2010, and all of which had been in an unrealized loss position for a year or more, as of June 30, 2010. See
Note B Other-than-Temporary Impairments. The Company reviewed its investments with unrealized losses and determined there
were no other-than-temporary impairments as of June 30, 2010.
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
E. Property and Equipment
Property and equipment consisted of the following at June 30, 2011 and 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2011 |
|
2010 |
|
Leasehold improvements |
|
$ |
25,473 |
|
$ |
25,272 |
|
Machinery and equipment |
|
|
12,622 |
|
|
12,083 |
|
Computer hardware and software |
|
|
3,900 |
|
|
2,072 |
|
Furniture and fixtures |
|
|
1,266 |
|
|
1,273 |
|
Assets under construction |
|
|
374 |
|
|
1,235 |
|
|
|
|
|
|
|
|
|
$ |
43,635 |
|
$ |
41,935 |
|
Less accumulated depreciation |
|
|
(30,226 |
) |
|
(25,609 |
) |
|
|
|
|
|
|
Property and equipment, net |
|
$ |
13,409 |
|
$ |
16,326 |
|
|
|
|
|
|
|
Depreciation
expense was approximately $4.9 million, $4.8 million and $5.0 million for the years ended June 30, 2011, 2010 and 2009, respectively.
F. Income Taxes
The difference between the Company's expected tax benefit, as computed by applying the U.S. federal corporate tax rate of 34% to loss before the benefit for income taxes, and actual tax
is reconciled in the following chart (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2011 |
|
2010 |
|
2009 |
|
Loss before income tax expense |
|
$ |
(58,274 |
) |
$ |
(51,177 |
) |
$ |
(32,037 |
) |
|
|
|
|
|
|
|
|
Expected tax benefit at 34% |
|
$ |
(19,813 |
) |
$ |
(17,400 |
) |
$ |
(10,893 |
) |
State tax benefit net of federal benefit |
|
|
(1,815 |
) |
|
(2,002 |
) |
|
(677 |
) |
Increase in valuation allowance, net |
|
|
16,410 |
|
|
11,991 |
|
|
1,531 |
|
Expired loss and credit carryforwards |
|
|
5,610 |
|
|
6,858 |
|
|
7,924 |
|
Other |
|
|
(392 |
) |
|
288 |
|
|
2,015 |
|
|
|
|
|
|
|
|
|
Benefit for income taxes |
|
$ |
|
|
$ |
(265 |
) |
$ |
(100 |
) |
|
|
|
|
|
|
|
|
At
June 30, 2011, the Company has net operating loss carryforwards of approximately $228.1 million available to reduce federal taxable income, if any, that expire in 2012
through 2031 and $136.3 million available to reduce state taxable income, if any, that expire in fiscal 2012 through fiscal 2031. Included in the federal and state carryforwards is
$5.6 million related to deductions from the exercise of stock options and the related tax benefit will result in an increase in additional paid-in capital if and when realized
through a reduction of taxes paid in cash. The Company also has federal and state research tax credits of approximately $11.1 million available to offset federal and state income taxes, which
expire beginning in fiscal 2012. Due to the degree of uncertainty related to the ultimate use of the loss carryforwards and tax credits, the Company has established a valuation allowance to fully
reserve these tax benefits.
83
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IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
F. Income Taxes (Continued)
Deferred
income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used
for income tax purposes. Significant components of the Company's deferred tax assets as of June 30, 2011 and 2010 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2011 |
|
2010 |
|
Net operating loss carryforwards |
|
$ |
82,533 |
|
$ |
85,459 |
|
Research and development tax credit carryforwards |
|
|
9,590 |
|
|
7,986 |
|
Property and other intangible assets |
|
|
807 |
|
|
197 |
|
Deferred revenue |
|
|
21,168 |
|
|
4,581 |
|
Stock-based compensation |
|
|
2,308 |
|
|
1,510 |
|
Deferred lease incentive |
|
|
3,363 |
|
|
3,747 |
|
Other liabilities |
|
|
2,676 |
|
|
2,444 |
|
|
|
|
|
|
|
Total deferred tax assets |
|
$ |
122,445 |
|
$ |
105,924 |
|
Valuation allowance |
|
|
(122,445 |
) |
|
(105,924 |
) |
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
The
valuation allowance increased by $16.5 million during 2011 due primarily to the greater net loss recognized during the year compared to last and deferred revenue timing
differences, partially offset by the expiration of net operating loss carryforwards.
Utilization
of the NOL and R&D credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could
occur in the future as provided by Section 382 of the Internal Revenue Code of 1986, as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and R&D
credit carry forwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions
increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. Since the Company's
formation, it has raised capital through the issuance of capital stock on several occasions (both pre and post initial public offering) which, combined with the purchasing shareholders' subsequent
disposition of those shares, may have resulted in a change of control, as defined by Section 382, or could result in a change of control in the future upon subsequent disposition. The Company
has not currently completed a study to assess whether a change of control has occurred or whether there have been multiple changes of control since its formation due to the significant complexity and
cost associated with such study and the possibility that there could be additional changes in control in the future. If the Company has experienced a change of control at any time since its formation,
utilization of its NOL or R&D credit carry forwards would be subject to an annual limitation under Section 382 which is determined by first multiplying the value of the Company's stock at the
time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in
expiration of a portion of the NOL or R&D credit carry forwards before utilization. Further, until a study is
84
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
F. Income Taxes (Continued)
completed
and any limitation known, no amounts are being presented as an uncertain tax position. The Company does not expect to have any taxable income for at least the next several years.
The
Company did not recognize any interest and penalties associated with unrecognized tax benefits in the accompanying consolidated financial statements. The Company does not expect any
material changes to the unrecognized benefits within 12 months of the reporting date. Due to existence of the valuation allowance, future changes in our unrecognized tax benefits will not
impact our effective tax rate. The Company's loss carryforwards are subject to adjustment by state and federal taxing authorities, commencing when those losses are utilized to reduce taxable income.
Included
in other income (expense), net for the fiscal year ended June 30, 2011 is $1.2 million of federal grant funding the Company was awarded under the Patient
Protection and Affordable Care Act of 2010
to develop new anticancer therapies. As of June 30, 2011, the Company had received $1.1 million of this amount and the remaining balance was received in July 2011.
G. Capital Stock
On May 19, 2011, the Company filed a Registration Statement on Form S-3 with the Securities and Exchange
Commission. Pursuant to the shelf registration statement, in May 2011 and June 2011, the Company issued and sold a total of 7,800,000 shares of its common stock at $12.00 per share through a public
offering resulting in gross proceeds of $93.6 million.
On
April 9, 2010, the Company filed a Registration Statement on Form S-3 with the Securities and Exchange Commission. Pursuant to the shelf registration
statement, in May 2010, the Company issued and sold 10,350,000 shares of its common stock at $8.00 per share through a public offering resulting in gross proceeds of $82.8 million.
On
July 11, 2007, the Company filed a Registration Statement on Form S-3 with the Securities and Exchange Commission. Pursuant to the shelf registration
statement, in June 2009, the Company issued and sold 5,750,000 shares of its common stock at $7.00 per share through a public offering resulting in gross proceeds of $40.3 million.
At June 30, 2011, the Company has reserved 11.26 million shares of authorized common stock for the future issuance of
shares under the 2006 Plan. See "Stock-Based Compensation" in Note B for a description of the 2006 Plan and the Former Plan.
As of June 30, 2011, the 2006 Plan was the only employee share-based compensation plan of the Company. During the year ended
June 30, 2011, holders of options issued under the 2006 Plan and the Former Plan exercised their rights to acquire an aggregate of 549,974 shares of common stock at prices ranging from $3.00 to
$12.56 per share. The total proceeds to the Company from these option exercises were approximately $2.7 million.
85
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
G. Capital Stock (Continued)
The
Company has granted options at the fair market value of the common stock on the date of such grant. The following options and their respective weighted- average exercise prices per
share were exercisable at June 30, 2011, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
Exercisable
(in thousands) |
|
Weighted-
Average
Exercise Price |
|
June 30, 2011 |
|
|
3,834 |
|
$ |
5.25 |
|
June 30, 2010 |
|
|
4,011 |
|
$ |
6.88 |
|
June 30, 2009 |
|
|
3,906 |
|
$ |
7.25 |
|
In November 2001, the Company's shareholders approved the establishment of the 2001 Non-Employee Director Stock Plan, or
the 2001 Director Plan, and 50,000 shares of common stock to be reserved for grant thereunder. The 2001 Director Plan provided for the granting of awards to Non-Employee Directors and, at
the election of Non-Employee Directors, to have all or a portion of their awards in the form of cash, stock, or stock units. All stock or stock units are immediately vested. The number of
stock or stock units issued was determined by the market value of the Company's common stock on the last date of the Company's fiscal quarter for which the services are rendered. The 2001 Director
Plan was administered by the Board of Directors which was authorized to interpret the provisions of the 2001 Director Plan, determine which Non-Employee Directors would be granted awards,
and determine the number of shares of stock for which a stock right will be granted. The 2001 Director Plan was replaced in 2004 by the 2004 Non-Employee Director Compensation and Deferred
Share Unit Plan.
During
the years ended June 30, 2011, 2010 and 2009, the Company recorded approximately $44,000, $10,000, and $84,000 in compensation expense, respectively, related to
approximately 15,000 stock units outstanding under the 2001 Director Plan. The value of the stock units is adjusted to market value at each reporting period. No stock units have been issued under the
2001 Plan subsequent to June 30, 2004.
In June 2004, the Board of Directors approved the establishment of the 2004 Non-Employee Director Compensation and Deferred
Share Unit Plan, or the 2004 Director Plan. The 2004 Director Plan provided for the compensation of Non-Employee Directors, awarding their annual retainers in the form of deferred share
units, and, at their discretion, to have all or a portion of their other compensation such as meeting fees in the form of cash or deferred share units. The deferred share units for annual retainers
vested one-twelfth monthly over the next year after the award; other deferred share units vested immediately upon issuance. The number of deferred share units issued was determined by the
market value of the Company's common stock on the last date of the Company's fiscal year prior to the fiscal year for which services were rendered. The deferred share units were to be paid out in cash
to each non-employee director based upon the market value of the Company's common stock on the date of such director's retirement from the Board of Directors of the Company. The 2004
Director Plan was administered by the Board of Directors.
86
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
G. Capital Stock (Continued)
The
2004 Director Plan was amended on September 5, 2006. Under the terms of the amended 2004 Director Plan, the redemption amount of deferred share units will be paid in shares of
common stock of the Company under the 2006 Plan in lieu of cash. As a result of the change in payout structure, the value of the vested awards was transferred to additional paid-in capital
as of the modification date and the total value of the awards, as calculated on the modification date, was expensed over the remainder of the vesting period. Accordingly, the value of the share units
is fixed and will no longer be adjusted to market value at each reporting period. In addition, the amended 2004 Director Plan changed the vesting for annual retainers to take place quarterly over the
three years after the award and the number of deferred share units awarded for all compensation is now based on the market value of the Company's common stock on the date of the award.
On September 16, 2009, the Board adopted a new Compensation Policy for Non-Employee Directors, which superseded the
2004 Plan and made certain changes to the compensation of its non-employee directors. The policy was amended on November 11, 2009 to provide that, whenever the Board has a
non-employee Chairman
in lieu of a Lead Director, the cash payment for the non-employee Chairman of the Board shall be the same as the cash compensation that would otherwise have been payable to the Lead
Director. Effective November 12, 2009, non-employee directors became entitled to receive annual meeting fees and committee fees under the new policy. The new policy made changes to
the equity portion of the non-employee director compensation, but left the cash portion unchanged. Effective November 11, 2009, non-employee directors became entitled to
receive deferred stock units under the new policy as follows:
-
- New non-employee directors will be initially awarded a number of deferred stock units having an aggregate
market value of $65,000, based on the closing price of our common stock on the date of their initial election to the Board. These awards will vest quarterly over three years from the date of grant,
contingent upon the individual remaining a director of ImmunoGen as of each vesting date.
-
- On the first anniversary of a non-employee director's initial election to the Board, such
non-employee director will be awarded a number of deferred stock units having an aggregate market value of $30,000, based on the closing price of our common stock on such date of grant and
pro-rated based on the number of whole months remaining between the first day of the month in which such grant date occurs and the first October 31 following the grant date. These
awards will generally vest quarterly over approximately the period from the grant date to the first November 1 following the grant date, contingent upon the individual remaining a director of
ImmunoGen as of each vesting date.
-
- Thereafter, non-employee directors in general will be annually awarded a number of deferred stock units having
an aggregate market value of $30,000, based on the closing price of our common stock on the date of our annual meeting of shareholders. These awards will vest quarterly over approximately one year
from the date of grant, contingent upon the individual remaining a director of ImmunoGen as of each vesting date.
87
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
G. Capital Stock (Continued)
As
with the 2004 Plan, vested deferred stock units are redeemed on the date a director ceases to be a member of the Board, at which time such director's deferred stock units will be
settled in shares of our common stock issued under our 2006 Plan at a rate of one share for each vested deferred stock unit then held. Any deferred stock units that remain unvested at that time will
be forfeited. The new policy provides that all unvested deferred stock units will automatically vest immediately prior to the occurrence of a change of control, as defined in the 2006 Plan.
In
connection with the adoption of the new compensation policy, the Board also amended the 2004 Plan as follows:
-
- All unvested deferred stock awards (other than any unvested initial awards) were vested in full on September 16,
2009 unless the date such deferred stock units were credited to the non-employee director was less than one year prior to September 16, 2009, in which case such unvested deferred
stock units will vest on the first anniversary of the date such deferred stock units were credited to the non-employee director.
-
- All unvested deferred stock awards will automatically vest immediately prior to the occurrence of a change of control.
On
September 22, 2010, the Board revised the Compensation Policy for Non-Employee Directors to provide that, in addition to the compensation they received previously,
they would also become entitled to receive stock option awards having a grant date fair value of $30,000, determined using the Black-Scholes option pricing model measured on the date of grant, which
would be the date of the annual meeting of shareholders. These options will vest quarterly over approximately one year from the date of grant. Any new directors will receive a pro-rated
award, depending on their date of election to the Board. The directors received a total of 49,688 options on November 16, 2010, and the related compensation expense is included in the amounts
discussed in the "Stock-based Compensation" section of footnote B above.
Pursuant
to the Compensation Policy for Non-Employee Directors and the 2004 Director Plan, as amended, the Company recorded approximately:
-
- $326,000 in compensation expense during the year ended June 30, 2011 related to the issuance of 39,000 deferred
share units and 225,000 deferred share units previously issued under the 2004 Director Plan;
-
- $460,000 in compensation expense during the year ended June 30, 2010 related to the issuance of 42,000 deferred
share units and 183,000 deferred share units previously issued under the 2004 Director Plan; and
-
- $175,000 in compensation expense during the year ended June 30, 2009 related to the issuance of 54,000 deferred
share units and 129,000 deferred share units previously issued under the 2004 Director Plan.
88
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
H. Commitments and Contingencies
Effective July 27, 2007, the Company entered into a lease agreement with Intercontinental Fund III for the rental of
approximately 89,000 square feet of laboratory and office space at 830 Winter Street, Waltham, MA. The Company uses this space for its corporate headquarters and other operations. The initial
term of the lease is for twelve years with an option for the Company to extend the lease for two additional terms of five years. The Company is required to pay certain operating expenses for the
leased premises subject to escalation charges for certain expense increases over a base amount. The Company entered into a sublease in December 2009 for 14,100 square feet of this space in Waltham
through January 2015, with the sublessee having an option to extend the term for an additional two years.
As
part of the lease agreement, the Company received a construction allowance of up to approximately $13.3 million to build out laboratory and office space to the Company's
specifications. After completion, the Company had recorded $12.0 million of leasehold improvements under the construction allowance. The Company received $10.8 million from the landlord
and paid out the same amount towards these leasehold improvements. The remaining balance of the improvements was paid directly by the landlord. The lease term began on October 1, 2007, when the
Company obtained physical control of the space in order to begin construction.
Under
the terms of the agreement, any remaining construction allowance was to be applied evenly as a credit to rent for the first year. The final balance of the construction allowance
was determined in August 2008, resulting in a credit of $1.3 million to the Company from the landlord during the fiscal year 2009 relating to the first year of occupancy.
At
June 30, 2011, the Company also leases facilities in Norwood, MA under an agreement through 2018 with an option to extend the lease for an additional term of five years. The
Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount.
Facilities
rent expense, net of sublease income, was approximately $4.6 million, $5.4 million and $5.0 million during fiscal years 2011, 2010 and 2009, respectively.
As
of June 30, 2011, the minimum rental commitments, including real estate taxes and other expenses, for the next five fiscal years and thereafter under the
non-cancelable operating lease agreements discussed above are as follows (in thousands):
|
|
|
|
|
2012 |
|
$ |
5,880 |
|
2013 |
|
|
5,880 |
|
2014 |
|
|
5,969 |
|
2015 |
|
|
6,169 |
|
2016 |
|
|
6,191 |
|
Thereafter |
|
|
22,390 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
52,479 |
|
Total minimum rental income from subleases |
|
|
(2,240 |
) |
|
|
|
|
Total minimum lease payments, net |
|
$ |
50,239 |
|
|
|
|
|
89
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
H. Commitments and Contingencies (Continued)
The Company is contractually obligated to make potential future success-based regulatory milestone payments in conjunction with certain
collaborative agreements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, the Company may be required to
pay such amounts. Further, the timing of any future payment is not reasonably estimable. As of June 30, 2011, the maximum amount that may be payable in the future under such arrangements is
approximately $43.0 million.
The Company is not party to any material litigation.
I. Employee Benefit Plans
The Company has a deferred compensation plan under Section 401(k) of the Internal Revenue Code (the 401(k) Plan). Under the 401(k) Plan, eligible employees are permitted to
contribute, subject to certain limitations, up to 100% of their gross salary and the Company's matching contribution is 50% of the first 6% of the eligible employees' contributions. In fiscal years
2011, 2010 and 2009, the Company's contributions to the 401(k) Plan totaled approximately $467,000, $450,000, and $429,000, respectively.
90
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
J. Quarterly Financial Information (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year 2011 |
|
|
|
First Quarter
Ended
September 30, 2010 |
|
Second Quarter
Ended
December 31, 2010 |
|
Third Quarter
Ended
March 31, 2011 |
|
Fourth Quarter
Ended
June 30, 2011 |
|
|
|
(In thousands, except per share data)
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development support |
|
$ |
1,495 |
|
$ |
2,005 |
|
$ |
2,190 |
|
$ |
1,566 |
|
|
License and milestone fees |
|
|
1,810 |
|
|
866 |
|
|
858 |
|
|
2,859 |
|
|
Clinical materials reimbursement |
|
|
106 |
|
|
1,307 |
|
|
2,163 |
|
|
2,080 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
3,411 |
|
|
4,178 |
|
|
5,211 |
|
|
6,505 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
13,425 |
|
|
16,004 |
|
|
15,763 |
|
|
18,261 |
|
|
General and administrative |
|
|
3,364 |
|
|
3,688 |
|
|
4,550 |
|
|
4,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
16,789 |
|
|
19,692 |
|
|
20,313 |
|
|
22,699 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(13,378 |
) |
|
(15,514 |
) |
|
(15,102 |
) |
|
(16,194 |
) |
|
Other income, net |
|
|
490 |
|
|
1,281 |
|
|
99 |
|
|
44 |
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax expense |
|
|
(12,888 |
) |
|
(14,233 |
) |
|
(15,003 |
) |
|
(16,150 |
) |
|
Income tax expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(12,888 |
) |
$ |
(14,233 |
) |
$ |
(15,003 |
) |
$ |
(16,150 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.19 |
) |
$ |
(0.21 |
) |
$ |
(0.22 |
) |
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
91
Table of Contents
IMMUNOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
AS OF JUNE 30, 2011
J. Quarterly Financial Information (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year 2010 |
|
|
|
First Quarter
Ended
September 30, 2009 |
|
Second Quarter
Ended
December 31, 2009 |
|
Third Quarter
Ended
March 31, 2010 |
|
Fourth Quarter
Ended
June 30, 2010 |
|
|
|
(In thousands, except per share data)
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development support |
|
$ |
782 |
|
$ |
1,283 |
|
$ |
1,805 |
|
$ |
1,495 |
|
|
License and milestone fees |
|
|
1,831 |
|
|
827 |
|
|
1,266 |
|
|
1,774 |
|
|
Clinical materials reimbursement |
|
|
486 |
|
|
998 |
|
|
243 |
|
|
1,153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
3,099 |
|
|
3,108 |
|
|
3,314 |
|
|
4,422 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,188 |
|
|
12,211 |
|
|
12,091 |
|
|
13,790 |
|
|
General and administrative |
|
|
3,592 |
|
|
3,886 |
|
|
3,447 |
|
|
3,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
15,780 |
|
|
16,097 |
|
|
15,538 |
|
|
17,763 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(12,681 |
) |
|
(12,989 |
) |
|
(12,224 |
) |
|
(13,341 |
) |
|
Other income (expense), net |
|
|
144 |
|
|
(19 |
) |
|
(3 |
) |
|
(64 |
) |
|
|
|
|
|
|
|
|
|
|
Loss before income tax benefit |
|
|
(12,537 |
) |
|
(13,008 |
) |
|
(12,227 |
) |
|
(13,405 |
) |
|
Income tax benefit |
|
|
(162 |
) |
|
|
|
|
(103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(12,375 |
) |
$ |
(13,008 |
) |
$ |
(12,124 |
) |
$ |
(13,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.22 |
) |
$ |
(0.23 |
) |
$ |
(0.21 |
) |
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
92
Table of Contents
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
- 1.
- Disclosure Controls and Procedures
The
Company's management, with the participation of its principal executive officer and principal financial officer, has evaluated the effectiveness of the Company's disclosure controls
and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Annual
Report on Form 10-K. Based on such evaluation, the Company's principal executive officer and principal financial officer have concluded that, as of the end of such period, the
Company's disclosure controls and procedures were adequate and effective.
- 2.
- Internal Control Over Financial Reporting
- (a)
- Management's Annual Report on Internal Control Over Financial Reporting
Management
of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, the Company's principal executive and principal financial
officers and effected by the Company's board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles in the U.S. and includes those policies and procedures that:
-
- pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and
dispositions of the assets of the Company;
-
- provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the
Company; and
-
- provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of
the Company's assets that could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods
are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management
assessed the effectiveness of the Company's internal control over financial reporting as of June 30, 2011. In making this assessment, management used the criteria
established in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, or
COSO.
Based
on this assessment, management has concluded that, as of June 30, 2011 the Company's internal control over financial reporting is effective.
Ernst &
Young LLP, the Company's independent registered public accounting firm, has issued a report on the effectiveness of the Company's internal control over financial
reporting as of June 30, 2011. This report appears immediately below.
93
Table of Contents
- (b)
- Attestation Report of the Independent Registered Public Accounting Firm
Report of Independent Registered Public Accounting Firm
The
Board of Directors and Shareholders of ImmunoGen, Inc.
We
have audited ImmunoGen, Inc.'s internal control over financial reporting as of June 30, 2011, based on criteria established in Internal ControlIntegrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). ImmunoGen, Inc.'s management is responsible for maintaining effective internal
control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management's Annual Report on Internal Control
Over Financial Reporting. Our responsibility is to express an opinion on the company's internal control over financial reporting based on our audit.
We
conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control
over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and
performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A
company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures
that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In
our opinion, ImmunoGen, Inc. maintained, in all material respects, effective internal control over financial reporting as of June 30, 2011 based on the COSO criteria.
We
also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of ImmunoGen, Inc. as of
June 30, 2011 and
2010, and the related consolidated statements of operations, shareholders' equity, and cash flows for each of the three years in the period ended June 30, 2011 and our report dated
August 29, 2011 expressed an unqualified opinion thereon.
Boston,
Massachusetts
August 29, 2011
94
Table of Contents
- (c)
- Changes in Internal Control Over Financial Reporting
There
have not been any changes in the Company's internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f)
under the Exchange Act) during the quarter ended June 30, 2011 that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial
reporting.
- 3.
- Limitations on the Effectiveness of Controls
The
Company's management, including its principal executive officer and principal financial officer, does not expect that the Company's disclosure controls and procedures or its internal
control over financial reporting will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to
their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within an
organization have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
Additionally,
controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system
of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our stated goals under all
potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the
inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Item 9B. Other Information
None.
95
Table of Contents
PART III
The information called for by Part III of Form 10-K (Item 10Directors, Executive Officers
and Corporate Governance of the Registrant, Item 11Executive Compensation, Item 12Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters, Item 13Certain Relationships and Related Transactions, and Director Independence, and Item 14Principal Accounting Fees and Services) is
incorporated by reference from our proxy statement related to our 2011 annual meeting of shareholders, which will be filed with the Securities and Exchange Commission not later than October 28,
2011 (120 days after the end of the fiscal year covered by this Annual Report on Form 10-K), except that information required by Item 10 concerning our executive
officers appears in Part I, Item 3.1 of this Annual Report on Form 10-K.
96
Table of Contents
PART IV
Item 15. Exhibits, Financial Statement Schedules
(1) See
"Index to Consolidated Financial Statements" at Item 8 of this Annual Report on Form 10-K. Schedules not included herein are omitted
because they are not applicable or the required information appears in the accompanying Consolidated Financial Statements or Notes thereto.
(2) The
following schedule is filed as part of this Annual Report on Form 10-K:
Schedule IIValuation
and Qualifying Accounts for the years ended June 30, 2011, 2010 and 2009.
97
Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
|
IMMUNOGEN, INC. |
|
|
By: |
|
/s/ DANIEL M. JUNIUS
Daniel M. Junius President and
Chief Executive Officer
(Principal Executive Officer) |
Dated:
August 29, 2011
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant in the capacities and on the
dates indicated.
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ DANIEL M. JUNIUS
Daniel M. Junius |
|
President, Chief Executive Officer and Director
(Principal Executive Officer) |
|
August 29, 2011 |
/s/ GREGORY D. PERRY
Gregory D. Perry |
|
Executive Vice President and
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
August 29, 2011 |
/s/ STEPHEN MCCLUSKI
Stephen McCluski |
|
Chairman of the Board of Directors |
|
August 29, 2011 |
/s/ MITCHEL SAYARE
Mitchel Sayare |
|
Director |
|
August 29, 2011 |
/s/ DAVID W. CARTER
David W. Carter |
|
Director |
|
August 29, 2011 |
/s/ NICOLE ONETTO, M.D.
Nicole Onetto |
|
Director |
|
August 29, 2011 |
/s/ MARK SKALETSKY
Mark Skaletsky |
|
Director |
|
August 29, 2011 |
/s/ JOSEPH VILLAFRANCA
Joseph Villafranca |
|
Director |
|
August 29, 2011 |
/s/ RICHARD WALLACE
Richard Wallace |
|
Director |
|
August 29, 2011 |
/s/ HOWARD PIEN
Howard Pien |
|
Director |
|
August 29, 2011 |
98
Table of Contents
EXHIBIT INDEX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference |
|
|
Exhibit
Number
|
|
Exhibit Description |
|
Filed
with this
Form 10-K |
|
Form |
|
Filing Date
with SEC |
|
Exhibit
Number |
|
|
3.1 |
|
Restated Articles of Organization, as amended |
|
|
|
|
|
10-Q |
|
|
April 30, 2010 |
|
|
3.1 |
|
|
3.2 |
|
Amended and Restated By-Laws |
|
|
|
|
|
8-K |
|
|
April 6, 2007 |
|
|
3.1 |
|
|
4.1 |
|
Article 4 of Restated Articles of Organization, as amended (see Exhibit 3.1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.2 |
|
Form of Common Stock certificate |
|
|
|
|
|
S-1 |
|
|
November 15, 1989
(File No. 33-31219) |
|
|
4.2 |
|
|
10.1 |
|
Leases dated as of December 1, 1986 and June 21, 1988 by and between James H. Mitchell, Trustee of New Providence Realty Trust, lessor, and Charles River Biotechnical Services, Inc. ("Lessee"),
together with Assignment of Leases dated June 29, 1989 between Lessee and the Registrant |
|
|
|
|
|
S-1 |
|
|
September 22, 1989
(File No. 33-31219) |
|
|
10.10 |
|
|
10.1(a) |
|
First Amendment to Lease dated May 9, 1991 by and between James H. Mitchell, Trustee of New Providence Realty Trust, lessor, and the Registrant |
|
|
|
|
|
S-1 |
|
|
November 6, 1991
(File No. 33-43725) |
|
|
10.10a |
|
|
10.1(b) |
|
Confirmatory Second Amendment to Lease dated September 17, 1997 by and between James H. Mitchell, Trustee of New Providence Realty Trust, lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 26, 1997 |
|
|
10.10 |
|
|
10.1(c) |
|
Third Amendment and Partial Termination of Lease dated as of August 8, 2000 by and between James H. Mitchell, Trustee of New Providence Realty Trust, lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 2, 2008 |
|
|
10.1(c |
) |
|
10.1(d) |
|
Fourth Amendment to Lease dated as of October 3, 2000 by and between James H. Mitchell, Trustee of New Providence Realty Trust, lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 2, 2008 |
|
|
10.1(d |
) |
|
10.1(e) |
|
Fifth Amendment to Lease dated as of June 7, 2001 by and between James H. Mitchell, Trustee of New Providence Realty Trust, lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 2, 2008 |
|
|
10.1(e |
) |
|
10.1(f) |
|
Sixth Amendment to Lease dated as of April 30, 2002 by and between Bobson 333 L.L.C., lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 2, 2008 |
|
|
10.1(f |
) |
|
10.1(g) |
|
Seventh Amendment to Lease dated as of October 20, 2005 by and between Bobson 333 L.L.C., lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 2, 2008 |
|
|
10.1(g |
) |
|
10.1(h) |
|
Eighth Amendment to Lease dated as of February 21, 2007 by and between Bobson 333 L.L.C., lessor, and the Registrant |
|
|
|
|
|
10-K |
|
|
September 2, 2008 |
|
|
10.1(h |
) |
|
10.1(i) |
|
Ninth Amendment to Lease dated as of November 17, 2010 by and between Bobson 333 LLC and the Registrant |
|
|
|
|
|
8-K |
|
|
November 18, 2010 |
|
|
10.1 |
|
99
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference |
|
|
Exhibit
Number
|
|
Exhibit Description |
|
Filed
with this
Form 10-K |
|
Form |
|
Filing Date
with SEC |
|
Exhibit
Number |
|
|
10.2 |
|
Lease Agreement, dated as of July 27, 2007, by and between Intercontinental Fund III 830 Winter Street LLC, landlord, and the Registrant |
|
|
|
|
|
10-Q |
|
|
November 7, 2007 |
|
|
10.2 |
|
|
10.3 |
|
Research and License Agreement dated as of May 22, 1981 by and between the Registrant and Sidney Farber Cancer Institute, Inc. (now Dana-Farber Cancer Institute, Inc.), with addenda dated as of
August 13, 1987 and August 22, 1989 |
|
|
|
|
|
S-1 |
|
|
September 22, 1989
(File No. 33-31219) |
|
|
10.1 |
|
|
10.4* |
|
License Agreement dated effective May 2, 2000 by and between the Registrant and Genentech, Inc. |
|
|
|
|
|
10-K |
|
|
September 27, 2000 |
|
|
10.51 |
|
|
10.4(a)* |
|
Amendment to License Agreement for Anti-HER2 Antibodies, dated as of May 3, 2006, between the Registrant and Genentech, Inc. |
|
|
|
|
|
10-K |
|
|
August 28, 2006 |
|
|
10.32 |
|
|
10.4(b)* |
|
Amendment to License Agreements made effective as of March 11, 2009, between the Registrant and Genentech, Inc. |
|
|
|
|
|
10-Q |
|
|
May 7, 2009 |
|
|
10.1 |
|
|
10.5* |
|
Option and License Agreement dated September 5, 2000 by and between the Registrant and Amgen Inc. (as successor-in-interest to Abgenix, Inc.) |
|
|
|
|
|
8-K/A |
|
|
October 10, 2000 |
|
|
10.1 |
|
|
10.6* |
|
Collaboration and License Agreement dated as of July 30, 2003 by and between the Registrant and sanofi-aventis U.S. LLC (as successor-in-interest to Aventis Pharmaceuticals Inc.) |
|
|
|
|
|
10-Q |
|
|
November 14, 2003 |
|
|
10.1 |
|
|
10.6(a)* |
|
Amendment No. 1, dated as of August 31, 2006, to the Collaboration and License Agreement between the Registrant and sanofi-aventis U.S. LLC |
|
|
|
|
|
10-Q |
|
|
November 3, 2006 |
|
|
10.1 |
|
|
10.6(b)* |
|
Amendment No. 2, dated as of October 11, 2007, to the Collaboration and License Agreement between the Registrant and sanofi-aventis U.S. LLC |
|
|
|
|
|
10-Q |
|
|
February 7, 2008 |
|
|
10.4 |
|
|
10.6(c)* |
|
Amendment No. 3, dated as of August 31, 2008, to the Collaboration and License Agreement between the Registrant and sanofi-aventis U.S. LLC |
|
|
|
|
|
10-Q |
|
|
February 6, 2009 |
|
|
10.7 |
|
|
10.7* |
|
License Agreement dated as of October 5, 2006 by and between the Registrant and sanofi-aventis U.S. LLC |
|
|
|
|
|
10-Q |
|
|
February 8, 2007 |
|
|
10.1 |
|
|
10.8* |
|
Option and License Agreement dated as of December 21, 2006 by and between the Registrant and sanofi-aventis U.S. LLC |
|
|
|
|
|
10-Q |
|
|
February 8, 2007 |
|
|
10.2 |
|
|
10.9* |
|
Collaborative Development and License Agreement dated as of July 7, 2006 by and between the Registrant and Biotest AG |
|
|
|
|
|
10-Q |
|
|
November 3, 2006 |
|
|
10.2 |
|
|
10.9(a)* |
|
Amendment No. 1, dated August 23, 2006, to Collaborative Development and License Agreement by and between the Registrant and Biotest AG |
|
|
|
|
|
10-Q |
|
|
November 3, 2006 |
|
|
10.3 |
|
100
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference |
|
|
Exhibit
Number
|
|
Exhibit Description |
|
Filed
with this
Form 10-K |
|
Form |
|
Filing Date
with SEC |
|
Exhibit
Number |
|
|
10.10* |
|
Clinical Supply Agreement effective as of December 12, 2010 by and between the Registrant and Societá Italiana Corticosteroidi S.r.l. (Sicor) |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.1 |
|
|
10.11 |
|
Restated Stock Option Plan |
|
|
|
|
|
8-K |
|
|
February 7, 2006 |
|
|
10.1 |
|
|
10.11(a) |
|
Form of Incentive Stock Option Agreement |
|
|
|
|
|
8-K |
|
|
February 7, 2006 |
|
|
10.2 |
|
|
10.11(b) |
|
Form of Non-Qualified Stock Option Agreement |
|
|
|
|
|
8-K |
|
|
February 7, 2006 |
|
|
10.3 |
|
|
10.12 |
|
2006 Employee, Director and Consultant Equity Incentive Plan, as amended and restated through November 16, 2010 |
|
|
|
|
|
8-K |
|
|
November 18, 2010 |
|
|
10.2 |
|
|
10.12(a) |
|
Form of Incentive Stock Option Agreement for Executives |
|
|
|
|
|
S-8 |
|
|
November 15, 2006 |
|
|
99.4 |
|
|
10.12(b) |
|
Form of Non-Qualified Stock Option Agreement for Executives |
|
|
|
|
|
S-8 |
|
|
November 15, 2006 |
|
|
99.5 |
|
|
10.12(c) |
|
Form of Non-Qualified Stock Option Agreement for Directors |
|
|
|
|
|
10-Q |
|
|
October 29, 2010 |
|
|
10.1 |
|
|
10.12(d) |
|
Form of Restricted Stock Agreement for Executives |
|
|
|
|
|
S-8 |
|
|
November 15, 2006 |
|
|
99.9 |
|
|
10.12(e) |
|
Form of Restricted Stock Agreement for Directors |
|
|
|
|
|
S-8 |
|
|
November 15, 2006 |
|
|
99.8 |
|
|
10.12(f) |
|
Form of Director Deferred Stock Unit Agreement |
|
|
|
|
|
10-Q |
|
|
October 29, 2010 |
|
|
10.1 |
|
|
10.13 |
|
2001 Non-Employee Director Stock Plan |
|
|
|
|
|
S-8 |
|
|
December 18, 2001 |
|
|
99 |
|
|
10.14 |
|
2004 Non-Employee Director Compensation and Deferred Stock Unit Plan, as amended through September 16, 2009 |
|
|
|
|
|
10-Q |
|
|
November 4, 2009 |
|
|
10.1 |
|
|
10.15 |
|
Form of Proprietary Information, Inventions and Competition Agreement between the Registrant and each of its executive officers |
|
|
|
|
|
10-Q |
|
|
February 8, 2007 |
|
|
10.15 |
|
|
10.16 |
|
Amendment to Stock Option Agreements dated as of September 24, 2008 between the Registrant and Mitchel Sayare |
|
|
|
|
|
10-Q |
|
|
October 31, 2008 |
|
|
10.1 |
|
|
10.17 |
|
Severance Agreement dated as of December 1, 2010 between the Registrant and Craig Barrows |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.2 |
|
|
10.18 |
|
Severance Agreement dated as of December 1, 2010 between the Registrant and Daniel M. Junius |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.3 |
|
|
10.19 |
|
Severance Agreement dated as of December 1, 2010 between the Registrant and John M. Lambert |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.4 |
|
|
10.20 |
|
Severance Agreement dated as of December 1, 2010 between the Registrant and James J. O'Leary |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
105 |
|
|
10.21 |
|
Severance Agreement dated as of December 1, 2010 between the Registrant and Gregory D. Perry |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.6 |
|
|
10.22 |
|
Severance Agreement dated as of December 1, 2010 between the Registrant and Peter Williams |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.7 |
|
101
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference |
|
|
Exhibit
Number
|
|
Exhibit Description |
|
Filed
with this
Form 10-K |
|
Form |
|
Filing Date
with SEC |
|
Exhibit
Number |
|
|
10.23 |
|
Severance Agreement dated as of January 18, 2011 between the Registrant and Theresa G. Wingrove |
|
|
|
|
|
10-Q |
|
|
February 8, 2011 |
|
|
10.8 |
|
|
10.24 |
|
Compensation Policy for Non-Employee Directors, as amended through September 22, 2010 |
|
|
|
|
|
10-Q |
|
|
October 29, 2010 |
|
|
10.1 |
|
|
10.25 |
|
Summary of Annual Executive Bonus Program |
|
|
|
|
|
10-Q |
|
|
November 7, 2007 |
|
|
10.1 |
|
|
10.26 |
|
Employment Agreement dated as of July 27, 2011 between the Registrant and Gregory D. Perry |
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
21 |
|
Subsidiaries of the Registrant |
|
|
|
|
|
10-K |
|
|
August 30, 2007 |
|
|
21 |
|
|
23 |
|
Consent of Ernst & Young LLP |
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
31.1 |
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
31.2 |
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
32 |
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
X |
|
|
|
|
|
|
|
|
|
|
- *
- Portions
of this Exhibit were omitted, as indicated by [***], and have been filed separately with the Secretary of the Commission
pursuant to the Registrant's application requesting confidential treatment.
-
- Exhibit
is a management contract or compensatory plan, contract or arrangement required to be filed as an exhibit to the annual report on
Form 10-K.
102
Table of Contents
IMMUNOGEN, INC.
SCHEDULE IIVALUATION AND QUALIFYING ACCOUNTS
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COLUMN ADESCRIPTION
|
|
COLUMN B |
|
COLUMN C
ADDITIONS |
|
COLUMN D |
|
COLUMN E |
|
Inventory Valuation Allowance
|
|
Balance at
Beginning
of Period |
|
Charged
to Costs
and
Expenses |
|
Use of
Zero
Value
Inventory |
|
Balance at
End of
Period |
|
Year End June 30, 2011 |
|
$ |
939 |
|
$ |
1,664 |
|
$ |
(610 |
) |
$ |
1,993 |
|
Year End June 30, 2010 |
|
$ |
1,784 |
|
$ |
927 |
|
$ |
(1,772 |
) |
$ |
939 |
|
Year End June 30, 2009 |
|
$ |
2,534 |
|
|
|
|
$ |
(750 |
) |
$ |
1,784 |
|
103