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Quotes & Info
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| IMGN > SEC Filings for IMGN > Form 10-Q on 30-Jan-2013 | All Recent SEC Filings |
30-Jan-2013
Quarterly Report
OVERVIEW
Since our inception, we have been principally engaged in the development of novel, targeted antibody-based 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 remain 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 to the antibody 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. With some TAP compounds, the antibody component also has anticancer activity of its own. Our TAP technology is designed to enable the creation of highly effective, well-tolerated anticancer product candidates. All of the TAP compounds currently in clinical testing contain either DM1 or DM4 as the cytotoxic agent. Both DM1 and DM4, collectively DMx, are our proprietary derivatives of a cytotoxic agent called maytansine. We also have expertise in antibodies and cancer biology to develop "naked," or non-conjugated, antibody anticancer product candidates.
We have used our proprietary TAP technology in conjunction with our in-house antibody expertise to develop our own anticancer product candidates. We have also entered into collaborative agreements that enable companies to use our TAP technology to develop commercial product candidates to specified targets. 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 agreements we are compensated for research and development activities performed at our collaborative partner's request at negotiated prices which are generally consistent with what other third parties would charge. We are compensated to manufacture preclinical and clinical materials and deliver cytotoxic agent at negotiated prices which are generally consistent with what other third parties would charge. Currently, our collaborative partners are Amgen, Bayer HealthCare, Biotest, Lilly, 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 collaborative agreements with recent activity follow. Details for our other significant agreements can be found in our 2012 Annual Report on Form 10-K
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 (a) test our maytansinoid TAP technology with Amgen's antibodies under a right-to-test, or research, license, (b) take options, with certain restrictions, to individual targets selected by Amgen on either an exclusive or non-exclusive basis for specified option periods and (c) upon exercise of those options, take exclusive or non-exclusive licenses to use our maytansinoid TAP technology to develop and commercialize products for the specified targets on
previously agreed-upon terms. Under the right-to-test agreement, in September 2009, November 2009 and December 2012, Amgen took three development and commercialization licenses and we received an exercise fee of $1 million for each license taken. We have deferred each $1 million exercise fee and are recognizing these amounts as revenue ratably over the respective estimated periods of our substantial involvement. For each development and commercialization license taken, we are entitled to receive an exercise fee of $1 million and up to a total of $34 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones per development and commercialization license are categorized as follows: development milestones - $9 million; regulatory milestones - $20 million; and sales milestones - $5 million. In November 2011, the Investigational New Drug (IND) applications for two compounds developed under the September 2009 and November 2009 development and commercialization licenses became active, which triggered two $1 million milestone payments to us. These payments are included in license and milestone fees for the three and six months ended December 31, 2011.
Sanofi-In July 2003, we entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and commercialize antibody-based products. The product candidates (targets) currently in the collaboration include SAR3419 (CD19), SAR650984 (CD38), SAR566658 (DS6, also known as CA6) and at least one earlier-stage compound that has yet to be disclosed. For each of the targets included in the collaboration at this time, we are entitled to receive up to a total of $21.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones - $7.5 million; and regulatory milestones - $14 million. Through December 31, 2012, we have received and recognized an aggregate of $16 million in milestone payments under this agreement for compounds covered under this agreement now or in the past, including a $3 million milestone payment earned related to the initiation of a Phase IIb clinical trial (as defined in the agreement) for SAR3419, which is included in license and milestone fee revenue for the three and six months ended December 31, 2011.
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 December 31, 2012, we had approximately $211.0 million in cash and cash equivalents compared to $160.9 million in cash and cash equivalents as of June 30, 2012.
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 operating results may fluctuate dramatically based upon the timing of receipt of the proceeds. We believe that our established collaboration agreements, while subject to specified milestone achievements, will provide funding to assist us in meeting obligations under our collaborative agreements while also 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 pursue additional strategic partners, 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.
There were no significant changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K for the fiscal year ended June 30, 2012.
RESULTS OF OPERATIONS
Comparison of Three Months ended December 31, 2012 and 2011
Revenues
Our total revenues for the three months ended December 31, 2012 and 2011 were $2.6 million and $7.6 million, respectively. The $5.0 million decrease in revenues in the three months ended December 31, 2012 from the same period in the prior year is attributable to a decrease in license and milestone fees and clinical materials revenue, partially offset by an increase in research and development support revenue, all of which are discussed below.
Research and development support revenue was $2.0 million for the three months ended December 31, 2012 compared with $945,000 for the three months ended December 31, 2011. These amounts primarily represent research funding earned based on actual resources utilized under our agreements with our collaborators 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 research and development support revenue 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 three-month periods ended December 31, 2012 and 2011 is included in the following table (in thousands):
Three Months Ended December 31,
Research and Development Support 2012 2011
Collaborative Partner:
Amgen $ 128 $ 201
Biotest 338 160
Lilly 200 8
Novartis 1,370 576
Total $ 2,036 $ 945
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Revenues from license and milestone fees for the three months ended December 31, 2012 decreased $5.6 million to $429,000 from $6.0 million in the same period ended December 31, 2011. 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 from license and milestone fees recognized from each of our collaborative partners in the three-month periods ended December 31, 2012 and 2011 is included in the following table (in thousands):
Three Months Ended December 31,
License and Milestone Fees 2012 2011
Collaborative Partner:
Amgen $ 256 $ 2,300
Bayer HealthCare - 521
Biotest 6 32
Centocor - 5
Sanofi 167 3,167
Total $ 429 $ 6,025
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Deferred revenue of $71.7 million as of December 31, 2012 primarily represents payments received from our collaborators pursuant to our license agreements, including a $20 million upfront payment received from Lilly during fiscal 2012 and a $45 million upfront payment received from Novartis during fiscal 2011, both of which we have yet to earn pursuant to our revenue recognition policy.
Clinical materials revenue decreased $500,000 in the three months ended December 31, 2012, to $147,000 from $647,000 in the three months ended December 31, 2011. We are compensated at negotiated prices which are generally consistent with what other third-parties would charge. The amount of clinical materials revenue 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 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 research and development expenses relate to (i) research to evaluate new
targets and to develop and evaluate new antibodies, linkers and cytotoxic
agents, (ii) preclinical testing of our own and, in certain instances, our
collaborators' product candidates, and the cost of our own clinical trials,
(iii) development related to clinical and commercial manufacturing processes and
(iv) manufacturing operations which also includes raw materials.
Research and development expense for the three months ended December 31, 2012 increased $6.1 million to $21.7 million from $15.6 million for the three months ended December 31, 2011. The increase was primarily due to (i) increased antibody
development and supply expenses; (ii) increased clinical trial costs;
(iii) decreased overhead utilization absorbed by the manufacture of clinical
materials on behalf of our collaborators; and (iv) increased salaries and
related expenses due primarily to additional headcount, increased health
insurance costs and a sign-on bonus awarded to the newly appointed Chief
Development Officer. The number of our research and development personnel
increased to 225 as of December 31, 2012 compared to 207 at December 31, 2011.
The higher stock compensation costs in the current period are driven primarily
by higher stock prices resulting in higher fair values. A more detailed
discussion of research and development expense in the period follows.
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 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):
Three Months Ended December 31,
Research and Development Expense 2012 2011
Research $ 4,280 $ 4,204
Preclinical and Clinical Testing 6,998 4,991
Process and Product Development 1,874 1,769
Manufacturing Operations 8,504 4,595
Total Research and Development Expense $ 21,656 $ 15,559
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Research: Research includes expenses associated with activities to identify and evaluate new targets and to develop and evaluate new antibodies, linkers and cytotoxic agents for our products and in support of our collaborators. Such expenses primarily include personnel, contract services, facilities and lab supplies. Research expenses for the three months ended December 31, 2012 increased $76,000 compared to the three months ended December 31, 2011. This increase is primarily the result of an increase in salaries and related expenses. We expect research expenses for fiscal 2013 to be slightly higher than fiscal 2012.
Preclinical and Clinical Testing: Preclinical and clinical testing includes expenses related to preclinical testing of our own and, in certain instances, our collaborators' product candidates, regulatory activities, and the cost of 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 for the three months ended December 31, 2012 increased $2.0 million to $7.0 million compared to $5.0 million for the three months ended December 31, 2011. This increase is primarily the result of an increase in clinical trial costs due primarily to site expansion and higher patient enrollment for the IMGN901 007 study, increased costs incurred for the IMGN853 trial which was initiated during the second half of fiscal 2012, and data management costs incurred to finalize the IMGN388 study, as well as an increase in salaries and related expenses. We expect preclinical and clinical testing expenses for fiscal 2013 to be significantly higher than fiscal 2012 due to increased activities to advance our wholly owned product candidates.
Process and Product Development: Process and product development expenses include costs for development of clinical and commercial manufacturing processes for our own and collaborator compounds. Such expenses include the costs of personnel, contract services and facility expenses. For the three months ended December 31, 2012, total development expenses increased
$105,000 compared to the three months ended December 31, 2011. This increase is primarily the result of an increase in salaries and related expenses and an increase in disposable costs driven by increased activities. We expect process and product development expenses for fiscal 2013 to be slightly higher than fiscal 2012.
Manufacturing Operations: Manufacturing operations expense includes costs to manufacture preclinical and clinical materials for our own and our collaborator's product candidates, and 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. For the three months ended December 31, 2012, manufacturing operations expense increased $3.9 million to $8.5 million compared to $4.6 million in the same period last year. The increase in the three months ended December 31, 2012 as compared to the three months ended December 31, 2011 is primarily the result of (i) an increase in antibody development and supply expense driven primarily by our IMGN901, IMGN853 and IMGN289 programs; (ii) a decrease in overhead utilization absorbed by the manufacture of clinical materials on behalf of our collaborators; and (iii) an increase in salaries and related expenses. We expect manufacturing operations expense for fiscal 2013 to be significantly higher than fiscal 2012 due primarily to increased third-party costs to produce finished drug product for clinical use.
General and Administrative Expenses
General and administrative expenses for the three months ended December 31, 2012 increased $630,000 to $5.5 million compared to $4.8 million for the three months ended December 31, 2011. This increase is primarily due to an increase in patent expenses and an increase in recruitment fees. We expect general and administrative expenses for fiscal 2013 to be slightly higher than fiscal 2012.
Other Income, net
Other income, net for the three months ended December 31, 2012 and 2011 is
included in the following table (in thousands):
Three Months Ended December 31,
Other Income, net 2012 2011
Interest Income $ 39 $ 9
Other Income, net 76 14
Total Other Income, net $ 115 $ 23
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Comparison of Six Months ended December 31, 2012 and 2011
Revenues
Our total revenues for the six months ended December 31, 2012 and 2011 were $6.7 million and $10.2 million, respectively. The $3.5 million decrease in revenues in the six months ended December 31, 2012 from the same period in the prior year is attributable to a decrease in license and milestone fees, partially offset by an increase in research and development support revenue and clinical materials revenue, all of which are discussed below.
Research and development support revenue was $3.4 million for the six months ended December 31, 2012 compared with $2.0 for the six months ended December 31, 2011. These amounts primarily represent research funding earned based on actual resources utilized under our agreements with our collaborators 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 research and development support revenue 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 six-month periods ended December 31, 2012 and 2011 is included in the following table (in thousands):
Six Months Ended December 31,
Research and Development Support 2012 2011
Collaborative Partner:
Amgen $ 212 $ 541
Bayer HealthCare - 6
Biotest 453 304
Lilly 423 8
Novartis 2,318 1,144
Sanofi 7 10
Total $ 3,413 $ 2,013
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Revenues from license and milestone fees for the six months ended December 31, 2012 decreased $5.8 million to $1.4 million from $7.2 million in the same period ended December 31, 2011. 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 from license and milestone fees recognized from each of our collaborative partners in the six-month periods ended December 31, 2012 and 2011 is included in the following table (in thousands):
Six Months Ended December 31,
License and Milestone Fees 2012 2011
Collaborative Partner:
Amgen $ 496 $ 2,599
Bayer HealthCare 521 797
Biogen Idec - 270
Biotest 12 65
Centocor - 19
Sanofi 333 3,462
Total $ 1,362 $ 7,212
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Clinical materials revenue increased $1.0 million in the six months ended December 31, 2012, to $1.9 million from $928,000 in the six months ended December 31, 2011. We are compensated at negotiated prices which are generally . . .
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