Washington, D.C. 20549
[X] |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2002
OR
[ ] |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-17999
Massachusetts |
04-2726691 |
|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
|
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128 Sidney Street, Cambridge, MA 02139 |
||
(Address of principal executive offices, including zip code) |
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(617) 995-2500 |
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(Registrant's telephone number, including area code) |
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.
Yes [X] No [ ]
At November 4, 2002 there were 42,871,168 shares of common stock, par value $.01 per share, of the registrant outstanding.
IMMUNOGEN, INC.
TABLE OF CONTENTS
IMMUNOGEN, INC.
CONSOLIDATED BALANCE SHEETS
AS OF SEPTEMBER 30, 2002 AND JUNE 30,
2002
|
|
September 30, |
|
June
30, |
|
||
|
|
|
|
||||
|
|
|
|
||||
(Unaudited) |
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|
|||||
|
|
|
|
|
|||
ASSETS |
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
15,239,778 |
|
$ |
16,233,408 |
|
Marketable securities |
|
111,942,398 |
|
121,606,576 |
|
||
Accounts receivable |
|
2,504,698 |
|
1,957,292 |
|
||
Unbilled revenue |
|
470,958 |
|
588,455 |
|
||
Inventory, net |
|
4,116,594 |
|
2,888,448 |
|
||
Prepaid and other current assets, net |
|
2,724,833 |
|
2,134,814 |
|
||
|
|
|
|
|
|
||
Total current assets |
|
136,999,259 |
|
145,408,993 |
|
||
|
|||||||
Property and equipment, net |
|
7,030,110 |
|
6,703,149 |
|
||
Deposit on construction in progress |
1,850,000 |
— |
|||||
Other assets |
|
333,700 |
|
43,700 |
|
||
|
|
|
|
|
|
||
Total assets |
|
$ |
146,213,069 |
|
$ |
152,155,842 |
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
||
Accounts payable |
|
$ |
573,442 |
|
$ |
580,789 |
|
Accrued compensation |
|
457,249 |
|
1,600,982 |
|
||
Other current accrued liabilities |
|
4,223,741 |
|
2,095,073 |
|
||
Current portion of deferred revenue |
|
1,905,585 |
|
2,226,868 |
|
||
|
|
|
|
|
|
||
Total current liabilities |
|
7,160,017 |
|
6,503,712 |
|
||
|
|
|
|
||||
Deferred revenue |
|
10,965,580 |
|
11,428,586 |
|
||
Other long term liabilities |
|
16,155 |
|
8,431 |
|
||
|
|
|
|
|
|
||
Total liabilities |
|
18,141,752 |
|
17,940,729 |
|
||
|
|
|
|
||||
Stockholders’ equity: |
|
|
|
||||
Common stock, $.01 par value; authorized 75,000,000 shares; issued and outstanding 44,253,888 |
|
|
|
||||
shares and 40,155,560 shares as of September 30, 2002 and June 30, 2002, respectively |
|
442,539 |
|
401,556 |
|
||
Additional paid-in capital |
|
317,025,491 |
|
317,062,204 |
|
||
Treasury stock |
(3,122,714 |
) |
— |
||||
Accumulated deficit |
|
(187,097,983 |
) |
(183,876,446 |
) |
||
Accumulated other comprehensive income |
|
823,984 |
|
627,799 |
|
||
|
|
|
|
|
|
||
Total stockholders’ equity |
|
128,071,317 |
|
134,215,113 |
|
||
|
|
|
|
|
|
||
Total liabilities and stockholders’ equity |
|
$ |
146,213,069 |
|
$ |
152,155,842 |
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2002 AND
2001
(UNAUDITED)
|
|
Three
Months Ended |
|
||||
|
|
|
|||||
|
|
2002 |
|
2001 |
|
||
|
|
|
|
||||
|
|
|
|
|
|||
Revenues: |
|
|
|
|
|
||
Revenue earned under collaboration agreements |
|
$ |
1,479,671 |
|
$ |
396,617 |
|
Clinical materials reimbursement |
|
826,269 |
|
934,561 |
|
||
Development fees |
|
40,370 |
|
94,723 |
|||
|
|
|
|
|
|
||
Total revenues |
|
2,346,310 |
1,425,901 |
||||
|
|
|
|
||||
Expenses: |
|
|
|
||||
Cost of clinical materials reimbursed |
|
752,396 |
|
934,561 |
|
||
Research and development |
|
4,109,351 |
|
2,503,556 |
|
||
General and administrative |
|
1,742,374 |
|
1,198,575 |
|
||
|
|
|
|
|
|
||
Total expenses |
|
6,604,121 |
|
4,636,692 |
|
||
|
|
|
|
|
|
||
Loss from operations |
|
(4,257,811 |
) |
(3,210,791 |
) |
||
|
|
|
|
|
|||
Interest income, net |
|
892,407 |
|
1,644,937 |
|
||
Realized gains on investments |
|
153,450 |
|
8,473 |
|
||
Other income |
|
12,692 |
|
26,670 |
|
||
|
|
|
|
|
|
||
Net loss before income tax expense |
|
(3,199,262 |
) |
(1,530,711 |
) |
||
Income tax expense |
|
22,275 |
|
61,812 |
|
||
|
|
|
|
|
|
||
Net loss |
|
$ |
(3,221,537 |
) |
$ |
(1,592,523 |
) |
|
|
|
|
|
|
||
Basic and diluted net loss per common share |
|
$ |
(0.08 |
) |
$ |
(0.04 |
) |
|
|
||||||
Basic and diluted weighted average common shares outstanding |
|
42,825,811 |
|
38,809,948 |
|||
|
|
|
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
IMMUNOGEN, INC.
CONSOLIDATED STATEMENTS OF CASH
FLOWS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2002 AND 2001
(UNAUDITED)
|
|
Three Months Ended September 30, |
|
||||
|
|
2002 |
|
2001 |
|
||
|
|
|
|
||||
Cash flows from operating activities: |
|
|
|
|
|
||
Net loss |
|
$ |
(3,221,537 |
) |
$ |
(1,592,523 |
) |
Adjustments to reconcile net loss to net cash used for operating activities: |
|
|
|
||||
Depreciation and amortization |
|
285,072 |
|
228,225 |
|
||
Realized gains on sale of marketable securities |
|
(153,450 |
) |
(8,473 |
) |
||
Compensation for stock and stock units |
|
11,994 |
|
– |
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|||
Accounts receivable |
|
(547,406 |
) |
(1,237,480 |
) |
||
Unbilled revenue |
|
117,497 |
(368,745 |
) |
|||
Inventory |
|
(1,228,146 |
) |
(730,796 |
) |
||
Prepaid and other current assets |
|
(590,019 |
) |
83,310 |
|||
Other assets |
(290,000 |
) |
– |
||||
Accounts payable |
|
178,423 |
17,363 |
||||
Accrued compensation |
|
(1,143,733 |
) |
377,212 |
|||
Deferred revenue |
|
(784,289 |
) |
(346,617 |
) |
||
Other current accrued liabilities |
|
1,552,066 |
(419,408 |
) |
|||
|
|
||||||
Net cash used for operating activities |
|
(5,813,528 |
) |
(3,997,932 |
) |
||
|
|
|
|
||||
Cash flows from investing activities: |
|
|
|
||||
Proceeds from sales and maturities of marketable securities |
|
92,059,231 |
116,939,266 |
||||
Purchases of marketable securities |
(82,045,418 |
) |
(115,767,977 |
) |
|||
Capital expenditures |
|
(797,803 |
) |
(552,052 |
) |
||
Payment of deposit on construction in progress |
(1,850,000 |
) |
– |
||||
|
|
||||||
Net cash provided by investing activities |
|
7,366,010 |
619,237 |
||||
|
|
|
|
||||
Cash flows from financing activities: |
|
|
|
||||
Repurchases of common stock |
|
(2,546,112 |
) |
– |
|
||
Proceeds from warrants exercised, net |
|
– |
|
5,035,999 |
|
||
Proceeds from stock options exercised, net |
|
– |
|
222,267 |
|
||
Principal payments on capital lease obligations |
|
– |
(2,607 |
) |
|||
|
|
||||||
Net cash provided by (used for) financing activities |
|
(2,546,112 |
) |
5,255,659 |
|
||
|
|
||||||
|
|
|
|
||||
Net change in cash and cash equivalents |
|
(993,630 |
) |
1,876,964 |
|
||
|
|
|
|
||||
Cash and cash equivalents, beginning balance |
|
16,233,408 |
|
14,822,519 |
|
||
|
|
||||||
|
|
|
|
||||
Cash and cash equivalents, ending balance |
|
$ |
15,239,778 |
|
$ |
16,699,483 |
|
|
|
|
|
|
|
||
Supplemental disclosures: |
|
|
|
|
|||
Cash paid for taxes |
|
$ |
29,000 |
|
$ |
66,912 |
|
|
|
||||||
Non-cash activities: |
|||||||
Repurchases of common stock included in other accrued liabilities |
$ |
576,602 |
$ |
– |
|||
|
|
The accompanying notes are an integral part of the consolidated financial statements.
IMMUNOGEN,
INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
A. Summary of Significant Accounting Policies
The accompanying consolidated financial statements at September 30, 2002 and June 30, 2002 and for the three‑month periods ended September 30, 2002 and 2001 include the accounts of the Company and its subsidiaries, ImmunoGen Securities Corp. and Apoptosis Technology, Inc. (ATI). Although the consolidated financial statements are unaudited, they include all of the adjustments, consisting only of normal recurring adjustments, except as discussed in Prepaid and Other Current Assets, which management considers necessary for a fair presentation of the Company's financial position in accordance with accounting principles generally accepted in the United States for interim financial information. Certain information and footnote disclosures normally included in the Company's annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management's estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported period. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended June 30, 2002.
Revenue Recognition
The Company enters into out-licensing and development agreements with collaborative partners for the development of monoclonal antibody-based cancer therapeutics. The terms of the agreements typically include non-refundable license fees, payments based upon the achievement of certain milestones and royalties on product sales.
The Company currently has the following four types of out-license and development contracts.
  British Biotech plc
  GlaxoSmithKline plc
  Genentech, Inc.
  Boehringer Ingelheim International GmbH
  Millennium Pharmaceuticals, Inc.
  Genentech, Inc.
  Abgenix, Inc.
  Millennium Pharmaceuticals, Inc.
Excluding the shared product license agreement, all of these collaboration agreements provide that the Company will (i) manufacture preclinical and clinical materials for its collaborators, at the collaborators’ request and cost, (ii) receive payments upon the collaborators’ achievements of certain milestones and (iii) receive royalty payments, generally until the later of the last applicable patent expiration or 12 years after product launch. The Company is required to provide technical training and any process improvements and know-how to its collaborators during the term of the collaboration agreements. Practically, once a collaborator receives U. S. Food and Drug Administration (FDA) approval for any drug and the manufacturing process used to produce the drug, the collaborator will not be able to incorporate any process improvements or know-how into its manufacturing process without additional testing and review by the FDA. Accordingly, the Company believes that it is very unlikely that its collaborators will require the Company’s services subsequent to FDA approval.
Generally, upfront payments on product and single target licenses are deferred over the period of the Company’s substantial involvement during development. ImmunoGen employees are available to assist the Company’s collaborators during the development of the collaborators’ products. The Company estimates this development phase to begin at the inception of the contract and conclude when the product receives FDA approval. The Company believes this period of involvement is, on average, six years. At each reporting period, the Company looks at individual product facts and circumstances and reviews the estimated period of its substantial involvement to determine whether a significant change in its estimates has occurred and adjusts the deferral period appropriately to reflect any such change.
The Company defers upfront payments received from its broad option agreements over the period during which the collaborator may elect to receive a license. These periods are specific to each collaboration agreement, but are between seven and 12 years. If a collaborator selects an option to acquire a license under these agreements, any option fee is deferred and recorded over the life of the option, generally 12 to 18 months. If a collaborator exercises an option and the Company grants a single target license to the collaborator, the Company defers the license fee and accounts for the fee as it would an upfront payment on a single target collaboration agreement, as discussed above.
The Company’s shared product license collaboration with British Biotech provides for an upfront payment from British Biotech to the Company that was paid upon signing of the agreement. The agreement also stipulates that upon FDA approval of the product, the Company will pay British Biotech a milestone payment, which the Company expects will exceed the upfront payment the Company received. The Company has deferred the upfront payment and anticipates recognizing such revenue concurrent with the milestone payment that the Company is required to pay to British Biotech if and when the product receives such FDA approval. In the event that the product does not receive such FDA approval, the Company will record as revenue the non-refundable upfront payment previously received upon the termination of the license agreement.
When milestone payments are specifically tied to a separate earnings process, revenue is recognized when the milestone is achieved. In addition, when appropriate, the Company recognizes revenue from certain research payments based upon the level of research services performed during the period of the research contract. Deferred revenue represents amounts received under collaborative agreements and not yet earned pursuant to these policies. Where the Company has no continuing involvement, the Company will record non-refundable license fees as revenue upon receipt and will record milestone revenue upon achievement of the milestone by the collaborative partner.
The Company produces preclinical and clinical materials for its collaborators and, at the collaborators’ request, may perform process development work. The Company also produces preclinical material for potential collaborators under material transfer agreements. Generally, the Company is reimbursed for its fully burdened cost of producing these materials or providing these services. The Company recognizes revenue on preclinical and clinical materials when it has shipped the materials, the materials have passed all quality testing required for collaborator acceptance and title has transferred to the collaborator. The Company recognizes revenue on process development services as those services are performed.
Marketable
Securities
In accordance with the Company’s investment policy, surplus cash is invested in investment-grade corporate and U.S. Government debt securities, asset-backed and United States government agency securities, banknotes and commercial paper, typically with maturity dates of less than one year. The Company designates its marketable securities as available-for-sale securities. Marketable securities are carried at their fair value with unrealized gains and losses included in Accumulated Other Comprehensive Income. Realized gains and losses and declines in value judged to be other than temporary, if any, on available-for-sale securities are reported as realized gains or losses on investments. In determining realized gains or losses on the sale of marketable securities, the cost of securities sold is based on the specific identification method.
Unbilled Revenue
The majority of the Company’s Unbilled Revenue at September 30, 2002 and June 30, 2002 represents clinical materials that have passed quality testing, that the Company has shipped and title has transferred to the collaborator, but the Company has not yet invoiced. Also included in Unbilled Revenue are costs the Company has incurred in completing development work on behalf of its collaborators but has not yet invoiced.
Prepaid and Other Current Assets
Included in Prepaid and Other Current Assets at September 30, 2002 and June 30, 2002 is $1.5 million and $1.3 million, respectively, related to prepayments made to an antibody manufacturer to reserve manufacturing space and partial payment for antibody that had not been delivered to the Company at September 30, 2002 and June 30, 2002. Under the terms of the Company’s shared product license collaboration with British Biotech, the Company is responsible for certain manufacturing and process development costs. The Company’s actual cost to manufacture huN901 antibody exceeded its original estimates. In June 2002, the Company and British Biotech agreed that ImmunoGen and British Biotech would share the costs to manufacture antibody in excess of the original estimates and subsequently executed a letter agreement to this effect. Based upon this agreement with British Biotech, the Company determined that a valuation allowance of $648,000 and $492,000 was required to reduce the value of the prepaid material to its estimated net realizable value as of September 30, 2002 and June 30, 2002, respectively. During the three months ended September 30, 2002, the Company received a portion of the antibody to be delivered under this contract, thereby reducing the prepaid asset and related reserve by approximately $696,000 and $209,000, respectively. Subsequent to June 30, 2002, the Company expenses as incurred (or paid, in the case of prepayments) that portion of the cost of antibody that it expects to pay for under the terms of the letter agreement with British Biotech. During the quarter ended September 30, 2002, the Company recorded $365,000 as research and development expense and a related prepaid asset valuation allowance related to prepayments made to the antibody manufacturer. The cost of the huN901 antibody that was received by the Company during the quarter and the related reserve are included in raw materials inventory at September 30, 2002.
Inventory
Inventory costs primarily relate to clinical trial materials
being manufactured by the Company for its collaborators. Inventory
is stated at the lower of cost or market.
Inventory at September 30, 2002 is summarized below:
September 30, |
|||
Raw materials, net |
$ |
2,961,690 |
|
Work in process, net |
980,042 |
||
Finished goods |
174,862 |
||
|
|||
Total |
$ |
4,116,594 |
|
|
Included in inventory is a
valuation allowance of $349,000 as of September 30, 2002.
This valuation allowance represents the cost of on-hand conjugate
produced for British Biotech that the Company may not realize and,
as discussed in Prepaid and Other Current Assets, that
portion of the cost of huN901 antibody that exceeds the original
estimates that the Company is required to pay under its agreement
with British Biotech. The Company does not believe that it
will be reimbursed for the full amount of the cost of the conjugate
and has established a reserve of $140,000 to reduce the value of
huN901-DM1/BB-10901 inventory to $881,000, the Company’s
estimate of the net realizable value at September 30, 2002.
The entire huN901-DM1/BB-10901 conjugate valuation allowance
relates to work in process inventory. The huN901-DM1/BB-10901
conjugate valuation allowance was charged to research and
development expense for the year ended June 30, 2002.
DM1, the Company’s most advanced small molecule effector drug, is the cytotoxic agent used in all of its current TAP product candidates and the subject of most of its collaborations. One of the primary components required to manufacture DM1 is its precursor, ansamitocin P3. Once manufactured, the ansamitocin P3 is then converted to DM1.
In fiscal 2002, the Company entered into several agreements with two outside vendors to perform large scale manufacture of DM1 and ansamitocin P3. Under the terms of these agreements, the manufacturers, together with the Company, will improve the fermentation and conversion processes used to generate ansamitocin P3 and DM1, respectively. Pursuant to these agreements, the two outside vendors will also manufacture, under current Good Manufacturing Processes, large-scale batches of ansamitocin P3 and DM1 to be used in the manufacture of both the Company’s and its collaborators’ products. Once manufactured, the ansamitocin P3 is delivered from one vendor to the other vendor for conversion to DM1. At September 30, 2002, the Company had not yet received any final DM1 product from the DM1 manufacturer, although ansamitocin P3 had been delivered from one of the third party manufacturers to the other manufacturer who was in the process of converting the ansamitocin P3 to DM1.
The actual amount of ansamitocin P3 and DM1 that will be produced is highly uncertain. The Company currently anticipates that a significant amount of ansamitocin P3 and DM1 will be manufactured for the Company over the next three to five years at these manufacturers. If the Company’s and the manufacturers’ process development efforts are successful, the amount of ansamitocin P3 and/or DM1 produced could be higher than expected. As a result, the Company anticipates that its working capital investment in ansamitocin P3 and DM1 inventory will be significant.
The Company produces preclinical and clinical materials for its collaborators either in anticipation or support of clinical trials, or for process development and analytical purposes. Under the terms of supply agreements with two of its collaborators, the Company receives rolling six month firm fixed orders for conjugate that the Company is required to manufacture and rolling twelve month manufacturing projections for how much conjugate the collaborator expects to need in any given twelve-month period. The Company’s other collaboration agreements do not require that the collaborators provide firm fixed manufacturing orders, although the collaborators provide the Company with the collaborators’ projected conjugate requirements. The amount of clinical materials produced is directly related to the number of on-going clinical trials for which the Company is producing clinical material for its collaborators, the speed of enrollment in those trials and the dosage schedule of each clinical trial. As a result, the actual amount of conjugate that the Company manufactures can differ significantly from the collaborator projections. To the extent that a collaborator has provided the Company with a firm fixed order, the collaborator will be required to reimburse the Company the full cost of the conjugate, and any margin thereon, even if the collaborator subsequently cancels the manufacturing run.
The Company accounts for the DM1 and ansamitocin P3 inventory as follows:
a) |
That portion of the DM1 or ansamitocin P3 that the Company intends to use in the production of its own products is expensed as incurred; |
b) |
To the extent that the Company has firm fixed orders or collaborator projections for no more than twelve months, the Company capitalizes the value of DM1 and ansamitocin P3 that will be used in the production of conjugate subject to these firm fixed orders and/or projections; |
c) |
The Company considers more than a twelve-month supply of ansamitocin P3 and/or DM1 that is not supported by collaborators' firm fixed orders to be excess and will establish a reserve to write down any such excess ansamitocin P3 or DM1. Any reserve so established will be charged to research and development expense. |
At September 30, 2002, the Company’s on-hand supply of DM1, including $1.7 million of DM1 inventory the Company acquired from GlaxoSmithKline and the ansamitocin P3 held at its third party manufacturers, represented less than a twelve-month supply based upon current collaborator firm fixed orders and projections. Any changes to the Company’s collaborators’ projections could result in significant changes in the Company’s estimate of the net realizable value of DM1 and ansamitocin P3 inventory. Reductions in collaborators’ projections could indicate that the Company has excess DM1 and/or ansamitocin P3 inventory and the Company would then evaluate the need to record additional valuation allowances, included as charges to research and development, to record the DM1 and/or ansamitocin P3 inventory at its estimated net realizable value. Increases in collaborators’ projections and/or firm fixed orders could result in a reversal of previously established valuation allowances and an associated reduction in research and development expense.
Computation of Net Loss
Per Common Share
Basic and diluted net loss per common share is calculated based
upon the weighted average number of common shares outstanding
during the period. Diluted net loss per common share incorporates
the dilutive effect of stock options, warrants and other
convertible securities. Common stock equivalents, as calculated in
accordance with the treasury-stock accounting method, equaled
813,556 and 4,403,677 for the three months ended September 30, 2002
and 2001, respectively. Common stock equivalents have not been
included in the net loss per common share calculations for the
three months ended September 30, 2002 and 2001 because their effect
is anti-dilutive.
Comprehensive Loss
The Company presents comprehensive loss in
accordance with Statement of Financial Accounting Standards (SFAS)
No. 130, “Reporting Comprehensive Income.” For the
three months ended September 30, 2002 and 2001, total comprehensive loss equaled $3.0
million and $675,000, respectively. Comprehensive loss was
comprised entirely of net loss and the change in net unrealized
gains recognized on available-for-sale securities.
Reclassifications
Certain prior
year balances have been reclassified to conform to current year
presentation.
B.
Agreements
On October 8, 2002, Boehringer Ingelheim GmbH confirmed with the Company that clinical trials of the novel anti-cancer agent composed of ImmunoGen's DM1 Tumor-Activated Prodrug (TAP) technology and Boehringer Ingelheim's anti-CD44v6 antibody had been initiated on or about September 24, 2002. The achievement of this milestone triggered a milestone payment of $1.0 million from Boehringer Ingelheim to ImmunoGen. This milestone payment is included in collaboration revenue in the accompanying statement of operations for the three months ended September 30, 2002. The Company received cash payment of this milestone from Boehringer Ingelheim on October 4, 2002.
In June 2002, GlaxoSmithKline informed the Company that it has elected not to advance cantuzumab mertansine into Phase II clinical development under the present terms of the companies’ license agreement. The Company has conducted, and continues to conduct, negotiations with GlaxoSmithKline. However, should the Company determine that it is not in the best interests of ImmunoGen to enter into a revised agreement with GlaxoSmithKline, or if the Company cannot reach satisfactory terms on a revised agreement, rights to cantuzumab mertansine will be returned to ImmunoGen and the Company will be free to develop and/or relicense the product as it considers most appropriate.
The Company continues to
recognize a portion of the deferred upfront payment received from
GlaxoSmithKline over the Company’s estimated period of
involvement during development, assuming that the collaboration
with GlaxoSmithKline will continue. At September 30, 2002,
approximately $389,000 of the previously received upfront payment
remained as deferred revenue. In the event that the
collaboration agreement with GlaxoSmithKline is terminated, the
Company will recognize as revenue that portion of the upfront
payment that remains in deferred revenue at the date of any such
termination.
C.
Capital Stock
In July 1997, the Company’s majority-owned subsidiary, Apoptosis Technology, Inc. (ATI), entered into a collaboration agreement with BioChem Pharma. As previously disclosed in the Company's annual reports on Form 10-K, as part of the agreement, BioChem Pharma received warrants to purchase shares of common stock of the Company equal to $11.1 million, the amount BioChem Pharma invested in ATI during the three-year research term. On July 29, 2002, Shire Biochem, Inc. (Shire), as successor in interest to BioChem Pharma, delivered to the Company a notice of exercise of warrants to acquire the number of shares of common stock of the Company equal to $11.1 million divided by the average of the closing price per share, as reported by Nasdaq, for the five days preceding the exercise of such warrants. As provided by the terms of the warrants, Shire delivered 11,125 shares of ATI in lieu of cash to exercise the warrants. The Company issued to Shire 4,096,098 shares of restricted common stock of the Company. Upon the request of Shire and pursuant to the Registration Rights Agreement dated July 31, 1997 between the two parties, on September 26, 2002, the Company filed a registration statement on Form S-3 with the Securities and Exchange Commission to register the resale by Shire of the shares of common stock issued upon the exercise of the warrants.
On August 27, 2002, the Company announced that, effective
immediately, its Board of Directors had authorized the repurchase
of up to 4.1 million shares of the Company's common stock. The
repurchases are to be made at the discretion of management and as
market conditions warrant. No time limit was set for the completion
of the repurchase program. As of September 30, 2002, the
Company had repurchased 952,800 shares of its common stock at a
total cost of $3.1 million.
Under the
Company's 2001 Non-Employee Director Stock Plan, approved in
November 2001, the Company issued 2,230 shares of common stock and
1,852 stock units to Non-Employee Directors of the Company during
the three months ended September 30, 2002.
D.
Commitments and Contingencies
In March
2002, the Company settled a claim with a third party and its
principals (together, the “Settling Parties”) relating
to compensation for the provision of services. The settlement
of the claim included the issuance of restricted shares of the
Company’s common stock (the “Settlement
Proceeds”) in favor of the Settling Parties. The
Settling Parties have recently alleged that the Company failed to
disclose material information during the course of the settlement
negotiations that had an effect on the value of the Settlement
Proceeds. Attorneys for the Settling Parties have notified
the Company that they intend to file a complaint with respect to
this matter in the United States District Court for the District of
Massachusetts if the issue is not settled. The Company expressly denies these allegations and believes that a
settlement of the claim is probable and, accordingly, has accrued
$400,000 as the currently estimated amount of settlement. The
reserve was charged to general and administrative expense during
the three months ended September 30, 2002.
ITEM 2.
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
OVERVIEW
Since the Company’s inception, we have been principally engaged in the development of antibody-based cancer therapeutics. Our proprietary, tumor‑activated prodrug, or TAP, technology combines extremely potent, small‑molecule drugs with monoclonal antibodies that recognize and bind specifically to tumor cells. Our targeted delivery technology increases the potency of these cancer‑specific antibodies, which allow our drugs to kill cancer cells with minimal harm to healthy tissue. The cytotoxic agent we currently use in all of our TAP products is the maytansinoid DM1, a chemical derivative of a naturally occurring substance called maytansine.
We have entered into collaborative agreements that allow companies to use our TAP technology to develop commercial products containing their antibodies. We also use our proprietary TAP technology in conjunction with our in-house antibody expertise to develop our own anti-cancer products. We licensed certain rights to our two most advanced, internally developed TAP product candidates to companies that have product development and commercialization capabilities that we wished to access. The terms of the collaborative agreements vary, reflecting the value we add to the development of any particular product candidate, however, the agreements generally provide that we receive upfront and milestone payments, royalties on sales of any resulting products and reimbursement of our fully burdened cost to manufacture preclinical and clinical materials. Under certain agreements, we receive our fully burdened cost to manufacture preclinical and clinical materials plus a profit margin. Currently, our collaborative partners include GlaxoSmithKline plc, Genentech, Inc., Abgenix, Inc., British Biotech plc, Millennium Pharmaceuticals, Inc. and Boehringer Ingelheim International GmbH. We expect that substantially all of our revenue for the foreseeable future will result from payments under our collaborative arrangements.
In June 2002, GlaxoSmithKline informed us that they have elected not to advance cantuzumab mertansine into Phase II clinical development under the present terms of our license agreement. We have conducted, and continue to conduct, negotiations with GlaxoSmithKline. However, should we determine that it is not in the best interests of the Company to enter into a revised agreement with GlaxoSmithKline, or we cannot reach satisfactory terms on a revised agreement, rights to cantuzumab mertansine will be returned to ImmunoGen and we will be free to develop and/or re-license the product as we consider most appropriate.
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 September 30, 2002, we had approximately $127.2 million in cash and marketable securities. We anticipate that our current capital resources and future collaboration payments, if any, will enable the Company to meet its operational expenses and capital expenditures for at least the next three fiscal years. We do not anticipate that we will have a commercially approved product within the foreseeable future. Research and development expenses are expected to increase in the near term as we continue our development efforts. In the next nine months we expect to pay out approximately $0.2 million to further expand our development and pilot manufacturing facility in Norwood, Massachusetts. On July 23, 2002, we signed a sublease on approximately 15,000 square feet of laboratory and office space in a building located at 148 Sidney Street, Cambridge, Massachusetts. We expect that we will spend in the range of $1.8 million to $2.0 million over the next six to nine months to renovate this additional space.
On August 27, 2002, we announced that, effective immediately, our Board of Directors had authorized the open market repurchase of up to 4.1 million shares of ImmunoGen common stock. The repurchases are to be made at the discretion of management and as market conditions warrant. No time limit was set for the completion of the repurchase program. As of September 30, 2002, the Company had repurchased 952,800 shares of its common stock at a total cost of $3.1 million. We anticipate that we will purchase additional shares of our common stock and that the total cost of the shares repurchased will be significant. As our repurchases are at management’s discretion and subject to market conditions, we are unable to estimate the total cost of the repurchase program or the period during which such repurchases may take place.
We anticipate that the increase in our total cash expenditures will be partially offset by collaboration-derived proceeds. Accordingly, period-to-period operational results may fluctuate dramatically. 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 allowing 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. 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.
Critical Accounting Policies
In December 2001, the U.S. Securities and Exchange Commission (SEC) requested that all registrants discuss their "critical accounting policies" in management's discussion and analysis of financial condition and results of operations. In addition, under the Sarbanes-Oxley Act of 2002, the Company’s independent auditors will be required to disclose in their reports to, and discuss with, the Audit Committee the critical accounting policies used by ImmunoGen. The SEC indicated that a "critical accounting policy" is one that is both important to the portrayal of the company's financial condition and results and that requires management's most difficult, subjective or complex judgments. Such judgments are often the result of a need to make estimates about the effect of matters that are inherently uncertain. While our significant accounting policies are more fully described in Note A to our consolidated financial statements included in this report, we currently believe the following accounting policies to be critical:
Revenue Recognition
We currently have four types of out-license and development contracts.
  British Biotech plc
  GlaxoSmithKline plc
  Genentech, Inc.
  Boehringer Ingelheim International GmbH
  Millennium Pharmaceuticals, Inc.
  Genentech, Inc.
  Abgenix, Inc.
  Millennium Pharmaceuticals, Inc.
Excluding the shared product license agreement, all of these collaboration agreements provide that we will (i) manufacture preclinical and clinical materials for our collaborators, at their request and cost, (ii) receive payments upon our collaborators’ achievements of certain milestones and (iii) receive royalty payments, generally until the later of the last applicable patent expiration or 12 years after product launch. We are required to provide technical training and any process improvements and know-how to our collaborators during the term of the collaboration agreements. Practically, once a collaborator receives U.S. Food and Drug Administration (FDA) approval for any drug and the manufacturing process used to produce the drug, our collaborator will not be able to incorporate any process improvements or know-how into their manufacturing process without additional testing and review by the FDA. Accordingly, we believe that it is very unlikely that our collaborators will require our services subsequent to FDA approval.
Generally, upfront payments on product and single target licenses are deferred over the period of our substantial involvement. We are available to assist our collaborators during the development of their products. We estimate this development phase to begin at the inception of the contract and conclude when the product receives FDA approval. We believe this time period is, on average, six years. At each reporting period we look at individual product facts and circumstances and review the estimated period of our substantial involvement. Significant changes in our estimates could result in changes to the deferral period. In the event that the product or a single target license were 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 defer upfront payments we receive from our broad option agreements over the period during which the collaborator may elect to receive a license. These periods are specific to each collaboration agreement, but are between seven and 12 years. If a collaborator selects an option to acquire a license under these agreements, any option fee is deferred and recorded over the life of the option, generally 12 to 18 months. If our collaborator exercises an option and we grant a single target license to the collaborator, we defer the license fee and account for it as we would an upfront payment on a single target collaboration agreement, as discussed above.
Our shared product license collaboration provides for an upfront payment from our collaborator to us that was paid at the start of the agreement and, upon FDA approval of the product, we will pay the collaborator a milestone payment, which we expect will exceed the upfront payment we have received. We have deferred the upfront payment and anticipate recognizing such revenue concurrent with the milestone payment that is required from us when and if the product receives such FDA approval. In the event that the product does not receive such FDA approval, we will record as revenue the non-refundable upfront payment we previously received upon the termination of the license agreement.
When milestone payments are specifically tied to a separate
earnings process, revenue is recognized when the milestone is
achieved. In addition, when appropriate, we recognize revenue from
certain research payments based upon the level of research services
performed during the period of the research contract. Deferred
revenue represents amounts received under collaborative agreements
and not yet earned pursuant to these policies. Where we have no
continuing involvement, we will record non-refundable license fees
as revenue upon receipt and will record milestone revenue upon
achievement of the milestone by the collaborative partner.
The Company produces preclinical and clinical materials for its
collaborators and, at the collaborators’ request, may perform
process development work. The Company also produces
preclinical material for potential collaborators under material
transfer agreements. Generally, the Company is reimbursed for
its fully burdened cost of producing these materials or providing
these services. The Company recognizes revenue on preclinical
and clinical materials when it has shipped the materials, the
materials have passed all quality testing required for collaborator
acceptance and title has transferred to the collaborator. The
Company recognizes revenue on process development services as those
services are performed.
Inventory
Inventory costs primarily relate to clinical trial materials being manufactured for our collaborators. Inventory is stated at the lower of cost or market. We evaluate the estimated net realizable value of inventory at each reporting period. If necessary, we establish a valuation allowance to record inventory at its estimated net realizable value. At September 30, 2002, inventory valuation allowances of $349,000 represent the cost of on-hand conjugate and huN901 antibody produced for British Biotech that we may not realize.
Under the terms of our shared product license collaboration with British Biotech, we are responsible for certain manufacturing and process development costs. Our actual cost to manufacture the huN901 antibody and conjugate exceeded our original estimates. In June 2002, we agreed that ImmunoGen and British Biotech would share the costs to manufacture huN901 antibody in excess of our estimates and determined the amount we would be reimbursed for huN901-DM1/BB-10901 conjugate and huN901 antibody. As of September 30, 2002 the reserve related to huN901-DM1/BB-10901 and huN901 antibody inventory was $349,000, which represents that portion of the cost of the on-hand conjugate and huN901 antibody that British Biotech may not reimburse. During the three months ended September 30, 2002, we wrote down $121,000 of huN901-DM1/BB-10901-conjugate cost against the $261,000 valuation allowance previously established. The write down did not result in any additional charge or reversal of any portion of the previously established valuation allowance. At September 30, 2002, approximately $140,000 and $209,000 of the inventory valuation allowance represents the remaining cost of on hand conjugate produced for British Biotech and huN901 antibody that we may not realize, respectively.
DM1, our most advanced small molecule effector drug, is the cytotoxic agent used in all of our current TAP product candidates and the subject of most of our collaborations. One of the primary components required to manufacture DM1 is its precursor, ansamitocin P3. Once manufactured, the ansamitocin P3 is then converted to DM1.
In fiscal 2002, we entered into several agreements with two outside vendors to perform large scale manufacture of DM1 and ansamitocin P3. Under the terms of these agreements, we, together with the manufacturers, will improve the fermentation and conversion processes used to generate ansamitocin P3 and DM1, respectively. Pursuant to these agreements, the two outside vendors will also manufacture, under current Good Manufacturing Processes, large-scale batches of ansamitocin P3 and DM1 to be used in the manufacture of both our own and our collaborators’ products. Once manufactured, the ansamitocin P3 is delivered from one vendor to the other vendor for conversion to DM1. At September 30, 2002, we had not yet received any final DM1 product from the DM1 manufacturer, although ansamitocin P3 had been delivered from one of the third party manufacturers to the other manufacturer who was in the process of converting the ansamitocin P3 to DM1.
The actual amount of ansamitocin P3 and DM1 that will be produced is highly uncertain. We anticipate that a significant amount of ansamitocin P3 and DM1 will be manufactured for us over the next three to five years at these manufacturers. If our and our manufacturers’ process development efforts are successful, the amount of ansamitocin P3 and/or DM1 produced could be higher than expected. As a result, we anticipate that our working capital investment in ansamitocin P3 and DM1 inventory will be significant.
We produce preclinical and clinical materials for our collaborators either in anticipation or support of clinical trials, or for process development and analytical purposes. Under the terms of supply agreements with two of our collaborators, we receive rolling six month firm fixed orders for conjugate that we are required to manufacture and rolling twelve month manufacturing projections for how much conjugate the collaborator expects to need in any given twelve month period. Our other collaboration agreements do not require that the collaborators provide firm fixed manufacturing orders, although the collaborators provide us with their projected conjugate requirements. The amount of clinical materials produced is directly related to the number of on-going clinical trials for which we are producing clinical material for our collaborators, the speed of enrollment in those trials and the dosage schedule of each clinical trial. As a result, the actual amount of conjugate that we manufacture can differ significantly from the collaborator projections. To the extent that a collaborator has provided us a firm fixed order, the collaborator will be required to reimburse us the full cost of the conjugate, and any margin thereon, even if the collaborator subsequently cancels the manufacturing run.
We account for the DM1 and ansamitocin P3 inventory as follows:
a) |
That portion of the DM1 or ansamitocin P3 that we intend to use in the production of our own products is expensed as incurred; |
b) |
To the extent that we have firm fixed orders or collaborator projections for no more than twelve months, we capitalize the value of DM1 and ansamitocin P3 that will be used in the production of conjugate subject to these firm fixed orders and/or projections; |
c) |
We consider more than a twelve-month supply of ansamitocin P3 and/or DM1 that is not supported by collaborators' firm fixed orders to be excess and will establish a reserve to write down any such excess ansamitocin P3 or DM1. Any reserve so established will be charged to research and development expense. |
At September 30, 2002, our on-hand supply of DM1, including $1.7 million of DM1 inventory we acquired from GlaxoSmithKline and the ansamitocin P3 held at its third party manufacturers, represented less than a twelve-month supply, based upon current collaborator firm fixed orders and projections. Any changes to our collaborators’ projections could result in significant changes in our estimate of the net realizable value of our DM1 and ansamitocin P3 inventory. Reductions in collaborators’ projections could indicate that we have excess DM1 and/or ansamitocin P3 inventory and we would then evaluate the need to record additional valuation allowances, included as charges to research and development, to record the DM1 and/or ansamitocin P3 inventory at its estimated net realizable value. Increases in collaborators’ projections and/or firm fixed orders could result in a reversal of previously established valuation allowances and an associated reduction in research and development expense.
RESULTS OF
OPERATIONS
Comparison of Three Months ended September 30,
2002 and 2001
Revenues
Our total revenues for the
three months ended September 30, 2002 were $2.3 million compared with $1.4 million for
the three months ended September
30, 2001. The 65% increase in revenues
in the quarter ended September 30, 2002 compared to the same period
in the prior year is primarily attributable to a milestone achieved
under our single target license agreement with Boehringer
Ingelheim. On October 8, 2002, Boehringer
Ingelheim confirmed to us that clinical trials of the novel
anti-cancer agent composed of ImmunoGen's DM1 Tumor-Activated
Prodrug (TAP) technology and Boehringer Ingelheim's anti-CD44v6
antibody had been initiated on or about September 24, 2002. The
achievement of this milestone triggered a milestone payment of $1.0
million from Boehringer Ingelheim to us. This milestone
payment was recognized as revenue during the three months ended
September 30, 2002. We received cash payment of the milestone
from Boehringer Ingelheim on October 4, 2002.
During the three
months ended September 30, 2002 we recognized collaboration revenue of $42,000 from
GlaxoSmithKline, $161,000 from Genentech, $125,000 from Abgenix,
$111,000 from Millennium and the $1.0 million from Boehringer
Ingelheim referred to above. During the same period in 2001,
we recognized collaboration revenue of $51,000 from
GlaxoSmithKline, $177,000 from Genentech, $100,000 from Abgenix and
$69,000 from Millennium. Deferred revenue of $12.9 million as of
September 30, 2002 represents accumulated progress payments
received from collaborators pursuant to contract revenues not yet
earned.
We continue to recognize a portion of the deferred upfront payment received from GlaxoSmithKline over our estimated period of involvement during the development of cantuzumab mertansine, assuming that the collaboration with GlaxoSmithKline will continue. At September 30, 2002, approximately $389,000 of the previously received upfront payment remained as deferred revenue. In the event that the collaboration agreement with GlaxoSmithKline is terminated, we will recognize as revenue that portion of the upfront payment that remains in deferred revenue at the date of any such termination.
Clinical materials reimbursement of $826,000 in the three months ended September 30, 2002 represents reimbursement for our manufacture of preclinical and clinical materials for our collaborators. In the same period in 2001, clinical materials reimbursement was $935,000. The cost of clinical materials reimbursed for the quarters ending September 30, 2002 and 2001 were $752,000 and $935,000, respectively. Under certain collaboration agreements, we are reimbursed our fully burdened cost to produce clinical materials plus a profit margin. During the quarter ended September 30, 2002, we earned clinical materials reimbursement on which we were entitled to a profit margin of $74,000. The amount of clinical materials reimbursement we earn, and the related cost of clinical materials reimbursed, is directly related to (i) the number of on-going clinical trials for which we are producing clinical material for our collaborators, 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 (ii) our production of clinical grade material on behalf of our collaborators, either in anticipation of clinical trials, or for process development and analytical purposes. As such, the amount of clinical materials reimbursement and the related cost of clinical materials reimbursed may vary from quarter to quarter and annually.
We report research and development expense net of reimbursements we
receive from our collaborators. Our net research and
development expenses consist of (i) research to identify and
evaluate new targets, antibodies and cytotoxic drugs, (ii)
preclinical testing and clinical trials of our own and, in certain
instances, our collaborators’ product candidates, and (iii)
development related to improving clinical and commercial
manufacturing processes. Our research efforts are primarily
focused in the following areas:
GlaxoSmithKline is currently completing one phase I clinical trial
of cantuzumab mertansine. The length of this trial is
dependent upon how well the remaining patient tolerates the
cantuzumab mertansine and the period, if any, during which the
patient derives clinical benefit from the administration of the
TAP. The actual length of this trial may vary from our
estimates. Additionally, GlaxoSmithKline is the sponsor of
this trial and, as such, has control over the clinical trial
schedule and progress. We are funding a portion of the cost
of this on-going phase I clinical trial. In June 2002,
GlaxoSmithKline informed us that they have elected not to advance
cantuzumab mertansine into Phase II clinical development under the
present terms of our license agreement. We have conducted and
continue to conduct negotiations with GlaxoSmithKline. However,
should we determine that it is not in the best interests of the
Company to enter into a revised agreement with GlaxoSmithKline, or
we cannot reach satisfactory terms on a revised agreement, the
rights to cantuzumab mertansine will be returned to ImmunoGen and
we will either develop and/or re-license the product as we consider
most appropriate.
British Biotech is currently conducting two phase I clinical trials
of huN901-DM1/ BB-10901. The first Phase I study is being conducted
in the United States. British Biotech is also conducting a second
Phase I clinical trial of huN901-DM1/BB-10901 in the United
Kingdom. We anticipate that both trials of huN901-DM1/ BB-10901
will be completed in calendar year 2003. However, the actual length
of these trials may vary from our estimates. Additionally,
British Biotech is the sponsor of this trial and, as such, has
control over the clinical trial schedule and progress. In addition to
retaining commercial rights to huN901-DM1/BB-10901 worldwide
excluding the European Union and Japan, we retain worldwide
manufacturing rights. Under the terms of the contract, we are
responsible for all clinical and commercial manufacturing process
development. We continue process development efforts to
improve clinical huN901 antibody production. Under an
arrangement with Genzyme Transgenics Corporation, we are
investigating the viability of commercial production of huN901
antibody using transgenic goats. We also continue to develop
various other processes related to the commercial manufacture of
the huN901-DM1/ BB-10901 conjugate. We anticipate that
we will continue to devote significant financial and human
resources to these efforts over the next five years.
Our three internally developed product candidates that are most
advanced at September 30, 2002 are huMy9-6-DM1, an anti-IGF1-R
antibody and a third product. huMy9-6-DM1 is a humanized
monoclonal antibody conjugated to DM1 and is directed against acute
myeloid leukemia. huMy9-6-DM1 is in early preclinical
development. We intend to continue to conduct preclinical
safety and efficacy studies on huMy9-6-DM1. Pending the
successful preclinical development of huMy9-6-DM1 and favorable
outcome of preclinical safety and efficacy studies and any other
studies, we expect to be prepared to file an Investigational New
Drug application (IND) for huMy9-6-DM1 in the next 15 to 21
months. The actual filing of this IND is dependent upon the
development of huMy9-6-DM1 and the results of any and all
preclinical studies and the financial and human resources that we
are able to direct to the development of the product and completion
of the IND application. As a result, the timing of the filing
of this IND, if it occurs at all, may vary from our
estimates.
Anti-IGF1-R antibody is a naked antibody directed against breast,
lung and prostate cancers. We are performing preclinical
experiments to evaluate candidate antibodies and, pending the
results of these studies, expect to move one antibody into
preclinical development in calendar year 2003. Our third,
undisclosed, potential product is directed at a specific cancer and
is in the early stages of preclinical development.
The cost to develop new products and advance those products to the
IND stage can be significant. Worldwide antibody
manufacturing capacity is currently constrained, and, generally,
manufacturing capacity must be reserved months in advance of
production. We anticipate that we will incur substantial
costs to reserve manufacturing space and manufacture humanized
antibody. We expect to devote substantial financial and human
resources to the development of our three most advanced products
for the foreseeable future. We review the results of all
preclinical studies and tests to evaluate the viability of products
under development. We evaluate the value of each potential
product at each stage of development to determine when, if ever, we
should consider out-licensing the product. We
are unable to reliably estimate the costs to develop our potential
products as a result of the uncertainties related to preclinical
and clinical testing. Our decision to move a product into the
clinical development phase is predicated upon the results of
preclinical tests. We cannot accurately predict which, if any, of
our product candidates will move into clinical development. The
costs to take a product through clinical trials is dependent upon,
among other things, the medical indications, the timing, size and
dosing schedule of each clinical trial, the number of patients
enrolled in each trial, and the speed at which patients are
enrolled and treated. In many cases, we are unable to determine
what, if any, indication a particular product candidate will treat
until we have completed extensive preclinical studies. Given the
uncertainties related to new drug development, we are currently
unable to estimate when, if ever, our potential product candidates
will generate revenues and cash flows.
DM1 is the cytotoxic agent that we currently use in the manufacture
of all of our collaborators’ and our own conjugates. In
order to enhance manufacturing yields, we have devoted substantial
resources to improve the strain of the microorganism that produces
ansamitocin P3, the precursor to DM1. We also continue to
devote considerable resources to improve the DM1 manufacturing
processes. In connection with these efforts, we anticipate
that we will incur research and development expense of $1.7 million
to $2.0 million over the next twelve months.
We generally do not track our historical research and development
costs by project; rather, we track such costs by department and
expense category. For this reason, we cannot accurately
estimate with any degree of certainty what our historical costs
have been for any particular research and development project. We
believe that our research and development costs by project would be
confidential and the disclosure of such costs could have a material
negative effect on our ability to negotiate with our suppliers,
collaborators and potential collaborators and, accordingly, would
not disclose our individual project research and development
expense. Research and development
expenses for the three months ended September
30, 2002 increased 64% to $4.1 million from
$2.5 million for the three months ended September 30, 2001. Under the terms of
our shared product license collaboration with British Biotech, we
are responsible for certain manufacturing and process development
costs. To date, the actual cost to manufacture huN901 antibody has
exceeded our original estimates. In June 2002, we agreed with
British Biotech that we would share in the costs of huN901 antibody
in excess of our estimates. We recorded an additional reserve
of $365,000 as a charge to research and development expense for the
three months ended September 30, 2002 related to prepayments we
made to produce huN901 antibody. The reserve is equal to our
estimate of that portion of the cost in excess of our original
estimates that we will pay under the terms of our June 2002
agreement with British Biotech. The actual realized value of the
prepaid asset may differ from our estimate based upon actual
manufacturing yields. During the three months
ended September 30, 2002 and 2001, we produced three and eight
batches of conjugates, respectively, on behalf of certain
collaborators. Due to lower utilization of the Norwood pilot
manufacturing plant during the three months ended September 30,
2002, manufacturing and quality control costs included in research
and development expense increased approximately $650,000.
This increase represents costs of operating the Norwood plant that
we were unable to allocate to cost of batches manufactured on
behalf of our collaborators during the quarter. The number of
research and development personnel increased to 84 at September 30,
2002 compared to 61 at September 30, 2001. Research and
development base salaries and wages increased by $359,000 in the
three months ended September 30, 2002 compared to the three months
ended September 30, 2001 as a result of the personnel
increases. Included in salaries and wages for the three
months ended September 30, 2001 was approximately $211,000 related
to estimated and accrued bonuses. There is no similar expense
or accrual in the three-month period ended September 30, 2002.
Patent costs increased $101,000 in the quarter ended September 30,
2002 compared to the same period in the prior year. We expect
future research and development expenses to increase as we continue
development of our product candidates and technologies. In September 2001 we
entered into a process development agreement with a third party.
Under the original terms of the agreement, the third party and
ImmunoGen shared equally certain development costs. This
agreement required the third party to reimburse us for a portion of
certain development costs that we had expensed in prior periods,
which, due to the nature of the agreement, was accounted for as a
reduction of research and development expenses totaling $439,000 in
the quarter ended September 30, 2001. General and
Administrative Expenses
General and administrative expenses for the three months ended
September 30, 2002 increased 45% to $1.7 million from $1.2 million
for the three months ended September 30, 2001. Legal and
accounting services increased by approximately $270,000. A
legal settlement reserve of $400,000 was recorded during the three
months ended September 30, 2002, for the probable settlement
related to a claim asserted against the Company in July 2002.
General and administrative expenses for the three months ended
September 30, 2002 and 2001 are reported net of $26,000 and
$226,000, respectively, of expenses for which we are entitled to
reimbursement from our collaborators. Included in general and
administrative salaries and wages for the three months ended
September 30, 2001 was approximately $81,000 related to estimated
and accrued bonuses. There is no similar expense or accrual
in the three-month period ended September 30, 2002.
Interest
Income
Interest income for the three months ended September 30, 2002 decreased 46% to
$892,000 from $1.6 million for the three months ended September 30, 2001. The decrease is
primarily a result of lower rates of return on investments and
lower average cash and investment balances.
Realized gains on investments were $153,000 and $8,000 for the
three months ended September 30, 2002 and 2001, respectively. The increase is
attributable to the timing of investment sales. LIQUIDITY AND CAPITAL
RESOURCES 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. If our TAP technology
does not produce safe, effective and commercially viable products,
our business will be severely harmed.
Our TAP technology is a novel approach to the treatment of cancer.
None of our TAP product candidates has obtained regulatory approval
and all of them are in early stages of development. Our 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 meaningful benefits to our current or potential
collaborative partners. Furthermore, we are aware of only one
antibody-drug conjugate that has obtained FDA approval and is based
on technology similar to our TAP technology. If our TAP technology
fails to generate product candidates that are safe, effective and
commercially viable treatments for cancer, and fails to obtain FDA
approval, our business will be severely harmed. Clinical trials for our
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 preclinical testing and clinical trials that
our product candidates are safe and effective for use in humans.
Conducting clinical trials is a time consuming, expensive and
uncertain process and may take years to complete. Our most advanced
product candidates, cantuzumab mertansine and huN901-DM1/BB-10901,
are only in the Phase I stage of clinical trials. Historically, the
results from preclinical testing and early clinical trials have
often not been predictive of results obtained in later clinical
trials. Frequently, drugs that have shown promising results in
preclinical or early clinical trials subsequently fail to establish
sufficient safety and effectiveness 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 for our product candidates for various reasons,
including:
The results of the clinical trials may fail to demonstrate the
safety or effectiveness of our product candidates to the extent
necessary to obtain regulatory approval or that commercialization
of our product candidates is worthwhile. Any failure or substantial
delay in successfully completing clinical trials and obtaining
regulatory approval for our product candidates could severely harm
our business. If our collaborative
partners fail to perform their obligations under our agreements, or
determine not to continue with clinical trials for particular
product candidates, our ability to develop and market potential
products could be severely limited.
Our strategy for the development and commercialization of our
product candidates depends, in large part, upon the formation of
collaborative arrangements. Collaborations allow us to:
If we fail to secure or maintain successful collaborative
arrangements, our development and marketing activities may be
delayed or scaled back. In addition, we may be unable to
negotiate other collaborative arrangements or, if necessary, modify
our existing arrangements on acceptable terms. We have entered into
collaboration agreements with GlaxoSmithKline and British Biotech
with respect to our two most advanced product candidates,
cantuzumab mertansine and huN901-DM1/BB-10901, respectively. The
development, regulatory approval and commercialization of our two
clinical-stage product candidates depend primarily on the efforts
of these collaborative partners. We have also entered into
collaborations with Genentech, Abgenix, Millennium, and
Boehringer Ingelheim. We cannot control the amount
and timing of resources our partners may devote to our products.
Our partners may separately pursue competing products, therapeutic
approaches or technologies to develop treatments for the diseases
targeted by us or our collaborative efforts. Even if our partners
continue their contributions to the collaborative arrangements,
they may nevertheless determine not to actively pursue the
development or commercialization of any resulting products. Also,
our partners may fail to perform their obligations under the
collaboration agreements or may be slow in performing their
obligations. Our 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 sole
discretion of our collaborative partners. If any
collaborative partner were to terminate or breach our agreement, or
fail to complete its obligations to us in a timely manner, our
anticipated revenue from the agreement and development and
commercialization of our products could 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, we
may be required to undertake product development, manufacture and
commercialization of our products ourselves, and we may not have
the funds or capability to do this. If our collaborators fail
to successfully develop and commercialize TAP products our business
will be severely harmed. The
outcome of our ongoing negotiations with GlaxoSmithKline relating
to cantuzumab mertansine is uncertain and may ultimately be
unfavorable to us.
In June 2002, GlaxoSmithKline informed us that they have elected
not to advance cantuzumab mertansine into Phase II clinical
development under the present terms of our license agreement with
them. We have conducted and continue to
conduct negotiations with GlaxoSmithKline. However,
renegotiation of the agreement will be time-consuming, and we may
not be able to renegotiate the agreement on terms that are
favorable to us. If we ultimately decide that entering into a
renegotiated agreement with GlaxoSmithKline is not in our best
interests, or we cannot reach satisfactory terms on a revised
agreement, the rights to cantuzumab mertansine will be returned to
us. This will mean that we will either proceed with clinical
trials of cantuzumab mertansine on our own, which will be
time-consuming and expensive, or find another collaborative partner
that will undertake the clinical trials, which will require us to
negotiate another collaborative agreement, possibly on terms that
are less favorable to us than the existing GlaxoSmithKline
agreement. 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
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. 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 a material adverse
effect on our financial condition. Further, any material reduction
by any one of our collaborative partners in their level of
commitment of resources, funding, personnel, and interest in
continued development under its agreement with us could have a
material adverse effect on our financial condition. 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. 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
September 30, 2002, we had an accumulated deficit of
$187.1 million. 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
trial and collaborator support activities increase. We intend to
continue to invest significantly in our products and bring more of
the product development process in-house, which will be a
time-consuming and expensive process. Further, we
expect to invest significant resources supporting our existing
collaborators as they work to develop, test and commercialize TAP
products, and 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 products. None of our product candidates has
generated any commercial revenue and our only revenues to date have
been primarily from upfront and milestone payments and clinical
materials reimbursement from our collaborative partners. We do not
expect to generate revenues from the commercial sale of our
products in the foreseeable future, and we may never generate
revenues from the commercial sale of 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. We are subject to
extensive government regulations and we may not be able to obtain
regulatory approvals.
We or our collaborative partners may not receive the regulatory
approvals necessary to commercialize our product candidates, which
could cause our business to be severely harmed. Our product
candidates 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 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 United States 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 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
products may not be obtained without lengthy delays, if at all. Any
FDA or other regulatory approvals of our product candidates, once
obtained, may be withdrawn. The effect of government regulation may
be to:
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 applicable 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
United States, our ability to market a product is contingent upon
receiving clearances from the appropriate regulatory authorities.
This foreign regulatory approval process includes all of the risks
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. We may be unable to
establish the manufacturing capabilities necessary to develop and
commercialize our potential products.
Currently, we only have one pilot scale manufacturing facility for
the manufacture of products necessary for clinical testing. We do
not have sufficient manufacturing capacity to manufacture all of
our product candidates in quantities necessary for commercial sale.
In addition, our manufacturing capacity may be inadequate to
complete all clinical trials contemplated by us 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 clinical trials and commercialization of our
potential products. 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 may develop our manufacturing capacity in part by expanding our
current facilities or building new facilities. Either of these
activities would require substantial additional funds and we would
need to hire and train significant numbers of employees to staff
these facilities. We may not be able to develop manufacturing
facilities that are sufficient to produce drug materials for
clinical trials or commercial use. We and any third‑party
manufacturers that we may use must continually adhere to Current
Good Manufacturing Practices regulations enforced by the FDA
through its facilities inspection program. If our facilities or the
facilities of third‑party manufacturers cannot pass a
pre-approval plant inspection, the FDA approval of our product
candidates will not be granted. In complying with these regulations
and foreign regulatory requirements, we and any of our
third‑party manufacturers will be obligated to expend time,
money and effort on production, record‑keeping and quality
control to assure that our potential products meet applicable
specifications and other requirements. If we or any
third‑party manufacturer with whom we may contract fail to
maintain regulatory compliance, we or the third party may be
subject to fines and/or manufacturing operations may be
suspended. We have only one
in-house pilot manufacturing facility, and any prolonged and
significant disruption at that facility could hurt our ability to
manufacture products for clinical testing.
Currently, we are contractually obligated to manufacture Phase I
and non-pivotal Phase II clinical products for certain of our
collaborators. We manufacture this material in a pilot scale
manufacturing facility. We only have 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 manufacturing interruption insurance policies, we may suffer
losses as a result of business interruptions that exceed the
coverage available under our insurance policies. Certain events,
such as natural disasters, fire, 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.
Any inability to
license from third parties their proprietary technologies or
processes which we use in connection with the development and
manufacture of our TAP 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
could infringe on the patents held by others. We rely on single
source suppliers to manufacture the primary component for our small
molecule effector drug and DM1 itself. Any problems experienced by
either supplier could negatively affect our
operations.
We rely on third‑party suppliers for some of the materials
used in the manufacturing of our TAP product candidates and small
molecule effector drugs. Our most advanced small molecule effector
drug is DM1. DM1 is the cytotoxic agent used in all of our current
TAP product candidates and the subject of most of our
collaborations. One of the primary components required to
manufacture DM1 is its precursor, ansamitocin P3. Currently, only
one vendor manufactures and is able to supply us with this
material. Any problems experienced by this vendor could result in a
delay or interruption in the supply of ansamitocin P3 to us until
this vendor cures the problem or until we locate an alternative
source of supply. Any delay or interruption in our supply of
ansamitocin P3 would likely lead to a delay or interruption in our
manufacturing operations and preclinical and clinical trials of our
product candidates, which could negatively affect our
business. We also have an agreement
with only one vendor to convert ansamitocin P3 to DM1. Any problems
experienced by this vendor could result in a delay or interruption
in the supply of DM1 to us until this vendor cures the problem or
until we locate an alternative source of supply. Any delay or
interruption in our supply of DM1 would likely lead to a delay or
interruption in our manufacturing operations and preclinical and
clinical trials of our product candidates or our
collaborators’ product candidates, which could negatively
affect our business. 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. If we decide to market our potential
products through a direct sales force, we would need to either hire
a sales force with expertise in pharmaceutical sales or contract
with a third party to provide a sales force to meet 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 potential products
successfully. If our product
candidates do not gain market acceptance, our business will
suffer.
Even if clinical trials demonstrate the safety and efficacy of our
product candidates and the necessary regulatory approvals are
obtained, our product candidates may not gain market acceptance
among physicians, patients, healthcare payors and the medical
community. The degree of market acceptance of any product
candidates that we develop will depend on a number of factors,
including:
Physicians will not recommend therapies using 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, we will not
be able to recover the significant investment we have made in
developing such products and our business would 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 pharmaceutical companies, biotechnology
companies, chemical companies, academic and research institutions
and government agencies. Many of these organizations have
substantially more experience and more capital, research and
development, regulatory, manufacturing, sales, marketing, human and
other resources than we do. As a result, they may:
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. In addition,
our product candidates, if approved and commercialized, will
compete against well-established, existing, therapeutic products
that are currently reimbursed by government health administration
authorities, private health insurers and health maintenance
organizations. 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 prodrug and
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 TAP 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
several 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 proceedings in the United
States Patent and Trademark Office to determine priority of
invention that could result in substantial cost to us. An adverse
decision in an interference 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 and they are challenged in court or in
other proceedings. A competitor may successfully challenge 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. 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 and confidential information. Others 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 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.
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. If we are forced to
litigate or undertake other proceedings in order to enforce our
intellectual property rights, we may be subject to substantial
costs and liability or be prohibited from commercializing our
potential products.
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. Any claims that
might be brought against us relating to 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 intellectual property unless we enter
into royalty or license agreements. Furthermore, because patent
applications in the United States are maintained in secrecy until a
patent issues, others may have filed patent applications for
technology covered by our pending applications. 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 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.
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:
We may not have sufficient resources to satisfy any liability
resulting from these claims. We currently have $5.0 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 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. 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, business development, marketing and
finance. Attracting and retaining qualified personnel is 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. 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 products.
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 and clinical trials, obtaining regulatory approvals and
manufacturing products as well as supporting our collaborators in
the development of their TAP products. We believe that our current
working capital and future payments, if any, from our collaboration
arrangements will be sufficient to meet our operating and capital
requirements for at least the next three years. However, we
may need additional financing sooner due to a number of factors
including:
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 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. Fluctuations in our
quarterly revenue and operating results may cause our stock price
to decline.
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 in
the future, our quarterly 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 comparisons of our operating results are not a
good indicator of our future performance and should not be relied
upon to predict the future performance of our stock
price. 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
in order to achieve a gain on an investment. ITEM 3. Quantitative and Qualitative Disclosures
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. ITEM 4. Controls and Procedures (a) Evaluation of
Disclosure Controls and Procedures
Within the 90-day period prior to the filing of this report, the
Company's principal executive officer and principal financial
officer evaluated the effectiveness of the Company's disclosure
controls and procedures (as defined in Exchange Act Rules 13a-14(c)
and 15d-14(c)) and have concluded, based on such evaluation, that
the design and operation of the Company's disclosure controls and
procedures were adequate and effective to ensure that material
information relating to the Company, including its consolidated
subsidiaries, was made known to them by others within those
entities, particularly during the period in which this Quarterly
Report on Form 10-Q was being prepared. (b) Changes in
Internal Controls
There were no significant changes in the Company's internal
controls or in other factors that could significantly affect those
controls subsequent to the date of their evaluation, nor were there
any significant deficiencies or material weaknesses in the
Company’s internal controls. Accordingly, no corrective
actions were required or undertaken. ITEM 2. Changes in Securities and Use of
Proceeds.
On July 29, 2002, Shire BioChem, Inc. (Shire) exercised warrants to
acquire 4,096,098 restricted shares of common stock of the Company.
Shire delivered 11,125 shares of ATI in lieu of cash to exercise
the warrants.
On August 27, 2002, the Company announced that, effective
immediately, its Board of Directors had authorized the repurchase
of up to 4.1 million shares of the Company's common stock. The
repurchases are to be made at the discretion of management and as
market conditions warrant. No time limit was set for the completion
of the repurchase program. As of September 30, 2002, the
Company had repurchased 952,800 shares of its common stock at a
total cost of $3.1 million. Through November 4, 2002, the
Company had repurchased 1,384,220 shares of its common stock at a
total cost of $4.4 million. (a)
Exhibits
Pursuant to the requirements of the Securities Exchange Act of
1934, as amended, the Registrant has duly caused this report to be
signed on its behalf by the undersigned thereunto duly
authorized. ImmunoGen, Inc. Date: November 12, 2002 By: /s/ Mitchel Sayare Mitchel Sayare President and Chief Executive Officer Date: November 12, 2002 By: /s/ Gregg D. Beloff Gregg D. Beloff Chief Financial Officer and Vice President, Finance CERTIFICATIONS I, Mitchel Sayare, certify
that: 1. I have reviewed
this quarterly report on Form 10-Q of ImmunoGen, Inc.; 2. Based on my
knowledge, this quarterly report does not contain any untrue
statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading
with respect to the period covered by this quarterly
report; 3. Based on my
knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in
all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the
periods presented in this quarterly report. 4. The
registrant’s other certifying officers and I are responsible
for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-14 and 15d-14) for the
registrant and have: a) designed such
disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities,
particularly during the period in which this quarterly report is
being prepared; b) evaluated the
effectiveness of the registrant’s disclosure controls and
procedures as of a date within 90 days prior to the filing of this
quarterly report (the “Evaluation Date”);
and c) presented in this
quarterly report our conclusions about the effectiveness of the
disclosure controls and procedures based on our evaluation as of
the Evaluation Date; 5. The
registrant’s other certifying officers and I have disclosed,
based on our most recent evaluation, to the registrant’s
auditors and the audit committee of the registrant’s board of
directors (or persons performing the equivalent
functions): a) all significant
deficiencies in the design or operation of internal controls which
could adversely affect the registrant’s ability to record,
process, summarize and report financial data and have identified
for the registrant’s auditors any material weaknesses in
internal controls; and b) any fraud, whether
or not material, that involves management or other employees who
have a significant role in the registrant’s internal
controls; and 6. The
registrant’s other certifying officers and I have indicated
in this quarterly report whether there were significant changes in
internal controls or in other factors that could significantly
affect internal controls subsequent to the date of our most recent
evaluation, including any corrective actions with regard to
significant deficiencies and material weaknesses. Date: November 12,
2002 __________/s/ Mitchel
Sayare _____________ I, Gregg D. Beloff,
certify that: 1. I have reviewed
this quarterly report on Form 10-Q of ImmunoGen, Inc.; 2. Based on my
knowledge, this quarterly report does not contain any untrue
statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading
with respect to the period covered by this quarterly
report; 3. Based on my
knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in
all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the
periods presented in this quarterly report. 4. The
registrant’s other certifying officers and I are responsible
for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-14 and 15d-14) for the
registrant and have: a) designed such
disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities,
particularly during the period in which this quarterly report is
being prepared; b) evaluated the
effectiveness of the registrant’s disclosure controls and
procedures as of a date within 90 days prior to the filing of this
quarterly report (the “Evaluation Date”);
and c) presented in this
quarterly report our conclusions about the effectiveness of the
disclosure controls and procedures based on our evaluation as of
the Evaluation Date; 5. The
registrant’s other certifying officers and I have disclosed,
based on our most recent evaluation, to the registrant’s
auditors and the audit committee of the registrant’s board of
directors (or persons performing the equivalent
functions): a) all significant
deficiencies in the design or operation of internal controls which
could adversely affect the registrant’s ability to record,
process, summarize and report financial data and have identified
for the registrant’s auditors any material weaknesses in
internal controls; and b) any fraud, whether
or not material, that involves management or other employees who
have a significant role in the registrant’s internal
controls; and 6. The
registrant’s other certifying officers and I have indicated
in this quarterly report whether there were significant changes in
internal controls or in other factors that could significantly
affect internal controls subsequent to the date of our most recent
evaluation, including any corrective actions with regard to
significant deficiencies and material weaknesses. Date: November 12,
2002 ___________/s/ Gregg D. Beloff
____________
Realized Gains on Investments
As of September 30,
2002, we had approximately $15.2 million in cash and cash
equivalents and $111.9 million of marketable securities. In
November 2000, we completed a public offering of 4.0 million shares
of our common stock. Net proceeds of the offering were $124.8
million. We have used a portion of the net proceeds from the
offering for working capital and general corporate purposes,
including research and development. Since July 1, 2000, we
have financed the net cash used to support operating activities
primarily from various collaborative and financing sources. These
sources include upfront and milestone payments received under our
collaboration agreements with GlaxoSmithKline, Genentech, Abgenix,
Millennium, and Boehringer Ingelheim, the sale of equity securities
to Abgenix, the exercise of a put option by GlaxoSmithKline, the
exercise of stock options and warrants to purchase common stock and
income earned on invested assets.
Net cash used in operations during the three-month period
ended September 30,
2002 was $5.8 million compared to $4.0 million during the
three-month period ended September
30, 2001. This increase in operational cash
use is largely due to the increase in operating expenses discussed
previously, as well as the cash payout of the 2002 bonus in July
2002.
Net cash provided by investing activities was $7.3 million for
the three months ended September
30, 2002 compared to $619,000 for the three
months ended September 30, 2001. Cash provided by investing activities in the
three months ended September 30, 2002 and 2001 reflects the net proceeds of sales and
maturities of marketable securities net of capital purchases. In
addition, during the quarter ended September 30, 2002, we paid a
deposit of $1.9 million relating to the renovation of the
laboratory and office space we have leased at 148 Sidney Street.
Capital purchases were $798,000 and $552,000 for the three months
ended September 30,
2002 and 2001, respectively, and consisted primarily of costs
associated with the purchase of new equipment and the build-out of
our existing Norwood, Massachusetts development and pilot
manufacturing facility.
Net cash used for financing activities was $2.5 million for the
three months ended September 30, 2002 compared to net cash provided by financing
activities of $5.3 million for the three months ended
September 30, 2001. For
the three months ended September 30, 2002 net cash used for
financing activities reflects the repurchase of 756,600 shares of
common stock of the Company. At September 30, 2002, the
Company had commitments to purchase an additional 196,200 shares
for $576,602. For the three months ended September 30, 2001, net cash provided by
financing activities reflects the proceeds from exercises of
warrants and stock options.
We anticipate that our capital resources and future
collaborator payments, if any, will enable us to meet our
operational expenses and capital expenditures for at least the next
three fiscal years. We believe that the proceeds from our
November 2000 public stock offering in addition to our established
collaborative agreements will provide funding sufficient to allow
us to meet our obligations under all collaborative agreements while
also allowing us to develop product candidates and technologies not
covered by collaborative agreements. However, we cannot assure you
that such collaborative agreement funding will, in fact, be
realized. Should we 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.
ITEM 6.
Exhibits and Reports on Form 8-K.
None.
(b) Reports on Form 8-K
None.
(principal executive officer)
(principal financial and accounting officer)
Mitchel Sayare
Chairman of the Board of
Directors,
Chief Executive Officer
and President
Gregg D. Beloff
Vice President and Chief Financial
Officer