AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MARCH 19, 2001
REGISTRATION NO. 333-
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
IMMUNOGEN, INC.
(Exact name of registrant as specified in its charter)
MASSACHUSETTS 04-2726691
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
128 SIDNEY STREET
CAMBRIDGE, MASSACHUSETTS 02139
(617) 995-2500
(Address, including zip code, and telephone number, including
area code, of registrant's principal executive offices)
MITCHEL SAYARE, PH.D.
PRESIDENT, CHIEF EXECUTIVE OFFICER AND CHAIRMAN OF THE BOARD
IMMUNOGEN, INC.
128 SIDNEY STREET
CAMBRIDGE, MA 02139
(617) 995-2500
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
WITH A COPY TO:
JONATHAN L. KRAVETZ, ESQ
Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
One Financial Center
Boston, MA 02111
(617) 542-6000
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: AS SOON AS
PRACTICAL AFTER THIS REGISTRATION STATEMENT BECOMES EFFECTIVE.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. / /
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933 other than securities offered only in connection with dividend or interest
reinvestment, check the following box. /X/
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. / /
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. / /
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
CALCULATION OF REGISTRATION FEE
TITLE OF EACH CLASS PROPOSED MAXIMUM PROPOSED MAXIMUM AMOUNT OF
OF SECURITIES TO AMOUNT TO BE OFFERING PRICE AGGREGATE OFFERING REGISTRATION
BE REGISTERED REGISTERED PER SHARE (1) PRICE (1) FEE
Common Stock, $.01 Par value 2,269,420 $12.78 $29,003,187.60 $7,250.80
(1) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457(c) of the Securities Act, based upon the average
of the high and low sale prices of the Common Stock, par value $.01 per
share, of ImmunoGen, Inc. (the "Common Stock"), as reported on the
Nasdaq National Market on March 16, 2001.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
PROSPECTUS
IMMUNOGEN, INC.
2,269,420 SHARES OF COMMON STOCK
(PAR VALUE OF $.01 PER SHARE)
This prospectus covers the sale by the selling stockholder listed on page 21 of
2,269,420 shares of our common stock.
We will not receive any of the proceeds from the sale of our common stock by the
selling stockholder.
OUR BUSINESS INVOLVES SIGNIFICANT RISKS. THESE RISKS ARE DESCRIBED UNDER "RISK
FACTORS" BEGINNING ON PAGE 5.
Our common stock is listed on the Nasdaq National Market under the symbol
"IMGN." On March 16, 2001, the closing sale price of our common stock on the
Nasdaq Market was $12.69 per share.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities, or passed on the
adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
The information in this prospectus is not complete and may be changed. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. No one may sell these securities nor may
offers to buy be accepted until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and is not soliciting an offer to buy these securities
in any state where the offer, solicitation or sale is not permitted.
The date of this prospectus is March 19, 2001
1
TABLE OF CONTENTS
PAGE
Prospectus Summary..................................................... 3
Risk Factors........................................................... 5
Forward-Looking Statements............................................. 20
Use of Proceeds........................................................ 20
Selling Stockholder.................................................... 21
Plan of Distribution................................................... 22
Legal Matters.......................................................... 24
Experts................................................................ 24
Incorporation of Certain Information by Reference...................... 24
Where You Can Find Additional Information.............................. 26
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE HAVE
NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION THAT IS DIFFERENT FROM
THAT CONTAINED IN THIS PROSPECTUS. THE SELLING STOCKHOLDER IS OFFERING TO SELL
AND SEEKING OFFERS TO BUY, SHARES OF OUR COMMON STOCK ONLY IN JURISDICTIONS
WHERE OFFERS AND SALES ARE PERMITTED. THE INFORMATION CONTAINED IN THIS
PROSPECTUS IS ACCURATE ONLY AS OF THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE
TIME OF DELIVERY OF THIS PROSPECTUS OR OF ANY SALE OF OUR COMMON STOCK. IN THIS
PROSPECTUS, "IMMUNOGEN," "WE," "US" AND "OUR" REFER TO IMMUNOGEN, INC. AND OUR
SUBSIDIARIES (UNLESS THE CONTEXT OTHERWISE REQUIRES).
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PROSPECTUS SUMMARY
THE FOLLOWING IS ONLY A SUMMARY. YOU SHOULD CAREFULLY READ THE MORE DETAILED
INFORMATION CONTAINED IN THIS PROSPECTUS, INCLUDING INFORMATION INCORPORATED
INTO THIS PROSPECTUS BY REFERENCE. OUR BUSINESS INVOLVES SIGNIFICANT RISKS. YOU
SHOULD CAREFULLY CONSIDER THE INFORMATION UNDER THE HEADING "RISK FACTORS"
BEGINNING ON PAGE 5.
IMMUNOGEN, INC.
We are a leading developer of antibody-based cancer therapeutics. We intend to
capitalize on the growing use of antibodies to treat cancer by using them to
deliver highly potent cell-killing, or cytotoxic, agents directly to tumor cells
with minimal harm to healthy tissue. We leverage our technology through
collaborations such as those we have entered into with GlaxoSmithKline plc,
Genentech, Inc., Abgenix, Inc., Millennium Pharmaceuticals, Inc., and British
Biotech plc.
Our lead product candidate, huC242-DM1/SB-408075, is in two Phase I/II human
clinical trials for the treatment of colorectal, pancreatic and certain
non-small-cell lung cancers. In published preclinical studies, a non-humanized
version of this drug completely eliminated transplanted human colorectal tumors
in mice with no detectable toxicity. Our second product candidate,
huN901-DM1/BB-10901, is a treatment for small-cell lung cancer. In published
preclinical studies, huN901-DM1 completely eliminated human small-cell lung
cancer tumors in mice with no detectable toxicity.
We call our product candidates tumor-activated prodrugs, or TAPs. Each of our
TAPs consists of an antibody chemically linked, or conjugated, to a small
molecule drug, known as an effector molecule. The antibodies we use target and
bind to antigens primarily expressed on certain types of cancer cells. Once
bound to the cell surface, the cell internalizes our TAP, triggering the release
of the effector molecules which then kill the cell. We design our effector
molecules to be significantly more potent than traditional chemotherapeutics and
to remain chemically inactive and non-toxic until inside the cell.
Cancer is a leading cause of death worldwide and the second leading cause of
death in the United States with approximately 1.2 million new cases and over
550,000 deaths expected this year. Existing cancer therapies, including surgery,
radiation therapy and chemotherapy often prove to be incomplete, ineffective or
toxic to the patient. We have developed our TAP technology to address this unmet
therapeutic need.
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We believe our TAP product candidates will offer advantages over other cancer
treatments because we design them to have all of the following attributes:
- HIGH SPECIFICITY. We develop our TAPs with antibodies that bind to
specific markers primarily expressed on certain types of cancer cells to
pinpoint treatment to the targeted cell or tumor.
- HIGH POTENCY. We use highly potent small molecule effector drugs which
are at least 100 to 1000 times more cytotoxic than traditional
chemotherapeutics.
- STABLE LINKAGE AND RELEASE. We design our TAPs with a highly stable link
between the antibody and the effector molecule, allowing the potency of the
effector molecule to be released only after the TAP is inside the cell.
- MINIMAL TOXICITY. We expect our TAPs will offer the potential for an
improved quality of life for patients due to reduced toxicity and more
tolerable side effects.
- NON-IMMUNOGENIC. We use fully-humanized antibodies and non-protein-based
small molecule effector drugs in our TAP products. This reduces the risk
that our TAPs will elicit an attack by the body's immune system, which
could render them ineffective before they reach the cancerous cells.
Our goal is to be the leader in the development of antibody-based cancer
treatments. To achieve our objective, we intend to implement the following
strategies:
- expand our product pipeline;
- license our technology;
- retain significant product rights; and
- broaden our technology base.
We organized as a Massachusetts corporation in March 1981. Our principal
executive offices are located at 128 Sidney Street, Cambridge, Massachusetts
02139, and our telephone number is (617) 995-2500. We maintain a web site at
http://www.immunogen.com. We do not intend for the information on our web site
to be incorporated by reference into this prospectus.
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RISK FACTORS
YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW BEFORE MAKING AN
INVESTMENT DECISION. YOU SHOULD ALSO REFER TO THE OTHER INFORMATION IN THIS
PROSPECTUS, INCLUDING OUR CONSOLIDATED FINANCIAL STATEMENTS AND RELATED NOTES,
AND ADDITIONAL INFORMATION INCORPORATED IN THIS PROSPECTUS BY REFERENCE. 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.
RISKS RELATING TO OUR COMPANY AND BUSINESS
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 chemotherapeutic
product 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 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 and
expensive process and may take years to complete. Our most advanced product
candidate, huC242-DM1/SB-408075, is only in the Phase I/II stage of clinical
trials and our second most advanced product, huN901-DM1, is in preclinical
testing.
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 data of safety and
effectiveness necessary to obtain regulatory approval. At any time during the
clinical trials,
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we, our collaborative partners or the FDA might delay or halt any clinical
trials for our product candidates for various reasons, including:
- ineffectiveness of the product candidate;
- discovery of unacceptable toxicities or side effects;
- development of disease resistance or other physiological factors; or
- delays in patient enrollment.
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, 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:
- fund our internal research and development, preclinical testing, clinical
trials and manufacturing;
- seek and obtain regulatory approvals;
- successfully commercialize existing and future product candidates; and
- develop antibodies for additional product candidates, and discover
additional cell surface markers for antibody development.
If we fail to secure or maintain successful collaborative arrangements, our
development and marketing activities may be delayed or reduced. We may also be
unable to negotiate additional 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,
huC242-DM1/SB-408075 and huN901-DM1, respectively. The development, regulatory
approval and commercialization of these two product candidates depend primarily
on the efforts of these collaborative partners. We cannot control the amount and
timing of resources our partners may devote to our products. Our partners
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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. If any collaborative partner
were to terminate or breach our agreement, or otherwise fail to complete its
obligations 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 and we may not have the
funds or capability to do this.
WE DEPEND ON A SMALL NUMBER OF COLLABORATORS FOR A SUBSTANTIAL PORTION OF OUR
REVENUE. THE LOSS OF 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 collaboration
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. 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 December 31, 2000,
we had an accumulated deficit of $159.0 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 and clinical trial
activities increase. We intend to invest significantly in our products and bring
more of the product development process in-house prior to entering into
collaborative arrangements. We may also incur substantial marketing and other
costs in the future if we decide to establish marketing and sales capabilities
to commercialize certain of our products. None of our product candidates has
generated any commercial revenue and our only revenues to date have been
primarily from up-front and milestone payments from our collaboration 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 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.
7
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 fail. 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, 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 candidates' 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, we cannot assure you that
regulatory approvals for our products will 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:
- delay marketing of potential products for a considerable period of time;
- limit the indicated uses for which potential products may be marketed;
- impose costly requirements on our activities; and
- provide competitive advantage to other pharmaceutical and biotechnology
companies.
We may encounter delays or rejections in the regulatory approval process because
of additional government regulation from future legislation or administrative
action or changes in FDA policy during the period of product development,
clinical trials and FDA regulatory review. Failure to comply with 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.
8
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 manufacturing facility for the manufacture of
products necessary for clinical testing. We do not have sufficient manufacturing
capacity to manufacture 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 large quantities of drug
materials 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 manufacturing operations may be suspended.
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WE RELY ON ONE SUPPLIER FOR THE PRIMARY COMPONENT TO MANUFACTURE OUR SMALL
MOLECULE EFFECTOR DRUG, DM1. ANY PROBLEMS EXPERIENCED BY SUCH 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 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 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:
- the degree of clinical efficacy and safety;
- cost-effectiveness of our product candidates;
- their advantage over alternative treatment methods;
10
- reimbursement policies of government and third-party payors; and
- the quality of our or our collaborative partners' marketing and
distribution capabilities for our product candidates.
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 such 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 indications. Our product candidates, if successfully
developed, will compete with a number of drugs and therapies manufactured and
marketed by major pharmaceutical and other biotechnology companies. Our products
may also compete with new products currently under development by others.
Physicians, patients, third-party payors and the medical community may not
accept and utilize 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:
- develop products that are safer or more effective than our product
candidates;
- obtain FDA and other regulatory approvals or reach the market with their
products more rapidly than we can, reducing the potential sales of our
product candidates;
- devote greater resources to market or sell their products;
- adapt more quickly to new technologies and scientific advances;
- initiate or withstand substantial price competition more successfully
than we can;
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- have greater success in recruiting skilled scientific workers from the
limited pool of available talent;
- more effectively negotiate third-party licensing and collaboration
arrangements; and
- take advantage of acquisition or other opportunities more readily than we
can.
A number of pharmaceutical and biotechnology companies are currently developing
products targeting the same types of cancer that we target, and some of our
competitors' products have entered clinical trials or already are commercially
available. 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 is dependent 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 and 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 U.S. Patent and Trademark Office to determine
priority of invention which 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 subject to such a proceeding. We cannot assure you
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. It is
possible
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that a competitor may successfully challenge our patents or that a challenge
will result in limitations of their coverage. In addition, the cost of
litigation or interference proceedings to uphold the validity of patents can be
substantial. If we are unsuccessful in such 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.
WE MAY BE SUBJECT TO SUBSTANTIAL COSTS AND LIABILITY OR BE PROHIBITED FROM
COMMERCIALIZING OUR POTENTIAL PRODUCTS AS A RESULT OF LITIGATION AND OTHER
PROCEEDINGS RELATING TO PATENT RIGHTS.
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 could 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.
13
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.
OUR 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 will have
to obtain licenses from other parties before we could continue using,
manufacturing, marketing or selling our potential products. Any such 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 potentially infringing products or methods.
WE FACE UNCERTAINTIES OVER REIMBURSEMENT AND HEALTHCARE REFORM.
In both domestic and foreign markets, future sales of our potential products, if
any, will depend in part on the availability of reimbursement from third-party
payors such as government health administration authorities, private health
insurers and other organizations. Third-party payors are increasingly
challenging the price and cost-effectiveness of medical products and services.
Significant uncertainty exists as to the reimbursement status of newly-approved
health care products. Even if they were to obtain regulatory approval, our
product candidates may not be considered cost-effective and adequate third-party
reimbursement may not be available to enable us to maintain price levels
sufficient to realize an appropriate return on our investments in product
development. Legislation and regulations affecting the pricing of
pharmaceuticals may change before any of our product candidates is approved for
marketing. Adoption of such
14
legislation and regulations could further limit reimbursement for medical
products and services. If the government and third-party payors fail to provide
adequate coverage and reimbursement rates for our potential products, the market
acceptance of our products may be adversely affected.
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 such materials and certain waste
products. Although we believe that our safety procedures for handling and
disposing of such materials comply with the standards prescribed by such laws
and regulations, the risk of accidental contamination or injury from these
materials cannot be completely eliminated. In the event of such an accident, we
could be held liable for any resulting damages, and any such 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:
- decreased demand for our product;
- injury to our reputation and significant media attention;
- withdrawal of clinical trial volunteers;
- costs of litigation;
- distraction of management; and
- substantial monetary awards to plaintiffs.
We may not have sufficient resources to satisfy any liability resulting from
these claims. We currently have $5.0 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 such insurance or obtain general
15
product liability insurance on reasonable terms and at an acceptable cost if we
or our collaborative partners begin commercial production of our proposed
product candidates or that such insurance will be in sufficient amounts 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 the principal members of our scientific and management personnel.
Our ability to pursue the development of our current and future product
candidates depends largely on retaining the services of our existing personnel
and hiring additional qualified scientific personnel to perform research and
development. We will also need to hire personnel with expertise in clinical
testing, government regulation, manufacturing, marketing and finance. Attracting
and retaining qualified personnel will be critical to our success. We may not be
able to attract and retain personnel on acceptable terms given the competition
for such personnel among biotechnology, pharmaceutical and healthcare companies,
universities and non-profit research institutions. Failure to retain our
existing key management and scientific personnel or to attract additional highly
qualified personnel could delay the development of our product candidates and
harm our business.
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. We believe that the
net proceeds of our November 16, 2000 offering, 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:
- higher costs and slower progress than expected in developing product
candidates and obtaining regulatory approvals;
- acquisition of technologies and other business opportunities that require
financial commitments; or
- lower revenues than expected under our collaboration agreements.
Additional funding may not be available to us on favorable terms, if at all. We
may raise additional funds through public or private financings, collaborative
arrangements or other arrangements. Debt financing, if available, may involve
covenants which could restrict our business activities. If we are unable to
raise additional funds through equity or debt financing
16
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 develop and market
internally. 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, 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.
RISKS RELATING TO THIS OFFERING
OUR STOCK PRICE IS HIGHLY VOLATILE AND AN INVESTMENT IN OUR STOCK COULD DECLINE
IN VALUE.
The market price and trading volume of shares of our common stock are volatile,
and we expect them to continue to be volatile for the foreseeable future. For
example, during the period between December 31, 1999 and December 31, 2000, our
common stock closed as high as $43.81 per share and as low as $4.94 per share.
Factors affecting our stock price include:
- announcements of technological innovations or new commercial therapeutic
products by us or our competitors;
- failure to achieve operating results projected by securities analysts;
- changes in earnings estimates or recommendations by securities analysts;
- progress or setbacks with preclinical and clinical trials;
- changes or proposed changes in government regulation of healthcare;
- developments in our industry;
17
- developments in patent or other proprietary rights, and litigation
concerning these rights;
- developments in our relationship with collaborative partners;
- public concern as to the safety and efficacy of our products;
- fluctuations in our revenues and operating results or those of our
competitors; and
- general market conditions.
In addition, stock prices for many companies in the technology and emerging
growth sectors have experienced wide fluctuations that have often been unrelated
to the operating performance of such companies.
FUTURE ISSUANCES AND SALES OF SHARES OF OUR COMMON STOCK UPON THE EXERCISE OF
OUTSTANDING WARRANTS AND OPTIONS MAY RESULT IN DILUTION OF OUR COMMON STOCK.
Dilution is likely to occur upon conversion of the outstanding warrants and upon
exercise of outstanding stock options.
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, you will have to rely on
appreciation in our stock price in order to achieve a gain on your investment.
FUTURE ISSUANCES AND SALES OF SHARES OF OUR COMMON STOCK UPON THE EXERCISE OF
OUTSTANDING WARRANTS AND OPTIONS MAY ADVERSELY AFFECT THE MARKET PRICE OF OUR
COMMON STOCK OR IMPAIR OUR ABILITY TO RAISE CAPITAL.
As of December 31, 2000, there were warrants outstanding to purchase an
aggregate of 2,967,233 shares of our common stock and options outstanding to
purchase an aggregate of 2,949,341 shares of our common stock. There were also
other warrants to purchase an amount of shares equal to $11.1 million divided by
the average of the closing sale price per share of our common stock on the
Nasdaq National Market for the five consecutive trading days preceding the
exercise date. As of December 31, 2000, options to purchase 2,019,020 shares
were then exercisable and all of the warrants were exercisable. In addition to
the 2,269,420 shares that may be sold pursuant to this prospectus, following the
exercise of most of our outstanding warrants, almost all of the shares to be
issued upon the exercise of our other outstanding options and warrants may be
sold freely in the public market because they either have been registered under
currently effective registration statements or may be sold in compliance with
Rule 144 under the Securities Act. In other cases, we have granted certain
demand and piggy back registration rights
18
which are currently available. An increase in the number of shares of our common
stock that will become available for the sale in the public market may adversely
affect the market price of our common stock. This, in turn, could impair our
ability to raise additional capital through the sale of equity securities.
19
FORWARD-LOOKING STATEMENTS
This prospectus, including the sections entitled "Prospectus Summary" and "Risk
Factors," contains forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Securities Exchange Act of 1934.
These statements relate to future events of our future financial and operating
performance and involve known and unknown risks, uncertainties and other factors
that may cause our or our industry's actual results, levels of activity,
performance or achievements to be materially different from that expressed or
implied by these forward-looking statements. These risks and other factors
include, among other things, those listed under "Risk Factors" and elsewhere in
this prospectus. In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "expects," "plans," "anticipates,"
"believes," "estimates," "predicts," "potential," "continue," "our future
success depends," "seek to continue" or the negative of these terms or other
comparable terminology. These statements are only predictions. Actual events or
results may differ materially. In evaluating these statements, you should
specifically consider various factors, including the risks outlined under "Risk
Factors." These factors may cause our actual results to differ materially from
any forward-looking statement.
Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, levels of
activity, performance or achievements. Moreover, neither we nor any other person
assumes responsibility for the accuracy and completeness of these statements. We
do not intend to update any of the forward-looking statements after the date of
this prospectus to conform these statements to actual results except as required
by law.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of our common stock by the
selling stockholder.
20
SELLING STOCKHOLDER
The shares of Common Stock offered hereby by the selling stockholder are
issuable to the selling stockholder upon exercise of 2,269,420 warrants. The
warrants have exercise prices ranging between $3.57 and $5.37 per share and
expire between September 10, 2001 and April 5, 2003. We will receive proceeds of
$10.4 million if all of the warrants are exercised. The selling stockholder,
including its transferees, pledgees or donees, or its successors, may from time
to time offer and sell any or all of the common stock offered under this
prospectus.
The following table shows information, as of March 19, 2001, with respect to the
selling stockholder and the principal amounts of our common stock it
beneficially owns and the number of shares that may be offered under this
prospectus. The information is based on information provided by or on behalf of
the selling stockholder.
The selling stockholder may offer all, some or none of the common stock. Thus,
we cannot estimate the amount of the common stock that will be held by the
selling stockholder upon termination of any sale.
SHARES OWNED
NUMBER OF AFTER THE
NAME OF SELLING SHARES OWNED PRIOR TO MAXIMUM NUMBER OF OFFERING (1)
STOCKHOLDER THE OFFERING SHARES OFFERED NUMBER PERCENT (1)
Capital Ventures International 2,609,420 2,269,420 340,000 *
(1) Number of shares and percentage after the completion of the offering
assumes that all of the shares held by the selling stockholder and being
offered under this prospectus are sold, that the shares are sold to
unaffiliated third parties and that the selling stockholder acquires no
additional shares of common stock before completion of this offering.
*Less than 1%.
21
PLAN OF DISTRIBUTION
We are registering the shares of Common Stock on behalf of the selling
stockholder, including its pledgees, donees, transferrees or other successors in
interest. The shares of Common Stock may be sold in one or more transactions at
fixed prices, at prevailing market prices at the time of sale, at prices related
to the prevailing market prices, at varying prices determined at the time of
sale, or at negotiated prices. These sales may be effected at various times in
one or more of the following transactions (which may include block
transactions), or in other kinds of transactions:
o transactions on the Nasdaq National Market or on any national
securities exchange or U.S. inter-dealer system of a registered
national securities association on which our common stock may be
listed or quoted at the time of sale;
o in the over-the-counter market;
o in private transactions and transactions otherwise than on these
exchanges or systems or in the over-the-counter market;
o in connection with short sales of the shares;
o by pledge to secure debt and other obligations;
o through the writing of options, whether the options are listed on an
options exchange or otherwise;
o in connection with the writing of non-traded and exchange-traded call
options, in hedge transactions and in settlement of other transactions
in standardized or over-the-counter options;
o through a combination of any of the above transactions; or
o any other method permitted by law.
The selling stockholder and its successors, including their transferees,
pledgees or donees or their successors, may sell the common stock directly to
purchasers or through underwriters, broker-dealers or agents, who may receive
compensation in the form of discounts, concessions or commissions from the
selling stockholder or the purchasers. These discounts, concessions or
commissions as to any particular underwriter, broker-dealer or agent may be in
excess of those customary in the types of transactions involved.
22
In addition, any securities covered by this prospectus which qualify for sale
pursuant to Rule 144 or Regulation S of the Securities Act may be sold under
Rule 144 or Regulation S rather than pursuant to this prospectus.
From time to time the selling stockholder may engage in short sales, short sales
against the box, puts and calls and other transactions in securities of the
Company or derivatives thereof, and may sell and deliver the shares in
connection therewith. From time to time the selling stockholder may pledge its
shares pursuant to the margin provisions of its customer agreements with its
broker. Upon a default by the selling stockholder, the broker may offer and sell
the pledged shares of Common Stock from time to time.
The selling stockholder and any brokers participating in such sales may be
deemed to be underwriters within the meaning of the Securities Act. There can be
no assurance that the selling stockholder will sell any or all of the shares of
Common Stock offered hereunder.
All proceeds from any sales will be the property of the selling stockholder who
will bear the expense of the underwriting discounts and selling commissions, if
any, and its own legal fees.
23
LEGAL MATTERS
The validity of the shares of common stock offered hereby is being passed upon
for us by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston,
Massachusetts.
EXPERTS
The financial statements incorporated in this Registration Statement by
reference to the Annual Report on Form 10-K for the year ended June 30, 2000,
have been so incorporated in reliance on the report of PricewaterhouseCoopers
LLP, independent accountants, given on the authority of said firm as experts in
auditing and accounting.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The Securities and Exchange Commission allows us to "incorporate by reference"
the information we file with them, which means that we can disclose important
information to you by referring you to those documents that we have previously
filed with the Commission or documents that we will file with the Commission in
the future. The information incorporated by reference is considered to be part
of this prospectus, and later information that we file with the Commission will
automatically update and supersede this information. We incorporate by reference
the documents listed below, and any future filings made with the Commission
under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934,
until we close this offering. The documents we incorporate by reference are:
(a) our Annual Report on Form 10-K for the fiscal year ended June 30, 2000;
(b) our Quarterly Reports on Form 10-Q for the fiscal quarters ended
September 30, 2000 and December 31, 2000;
(c) our proxy materials on Schedule 14A as filed with the Commission on
October 12, 2000;
(d) our Current Reports on Form 8-K filed with the Commission on September
11, 2000, October 10, 2000 and March 7, 2001 and on Form 8-K/A filed with
the Commission on October 10, 2000; and
(e) the description of our capital stock contained in our registration
statement on Form 8-A under the Securities Exchange Act of 1934 (File No.
0-17999), including amendments or reports filed for the purpose of updating
such description.
You may request a copy of these filings, at no cost, by writing or telephoning
us at the following address and number: ImmunoGen, Inc., Attention: Investor
Relations, 128 Sidney Street, Cambridge, Massachusetts 02139; telephone number
(617) 995-2500.
24
To the extent that any statements contained in a document incorporated by
reference are modified or superseded by any statements contained in this
prospectus, such statements shall not be deemed incorporated in this prospectus
except as so modified or superseded.
All documents subsequently filed by us pursuant to Section 13(a), 13(c), 14 or
15(d) of the Exchange Act and prior to the termination of this offering are
incorporated by reference and become a part of this prospectus from the date
such documents are filed. Any statement contained in this prospectus or in a
document incorporated by reference is modified or superseded for purposes of
this prospectus to the extent that a statement contained in any subsequently
filed document modifies or supersedes such statement.
25
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the Securities and Exchange Commission. You may read and copy
any materials we file with the Commission at the Commission's public reference
room at 450 Fifth Street, N.W., Washington, D.C. 20549. Please call the
Commission at 1-800-SEC-0330 for more information on its public reference rooms.
The Commission also maintains an Internet Website at http://www.sec.gov that
contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the Commission.
Our common stock is quoted on the Nasdaq National Market. You may inspect
reports and other information concerning us at the offices of the National
Association of Securities Dealers, Inc., 1735 K Street, N.W., Washington, D.C.
We have filed with the Commission a registration statement (which contains this
prospectus) on Form S-3 under the Securities Act of 1933. The registration
statement relates to the common stock offered by the selling stockholder. This
prospectus does not contain all of the information set forth in the registration
statement and the exhibits and schedules to the registration statement. Please
refer to the registration statement and its exhibits and schedules for further
information with respect to us and our common stock. Statements contained in
this prospectus as to the contents of any contract or other document are not
necessarily complete and, in each instance, we refer you to the copy of that
contract or document filed as an exhibit to the registration statement. You may
read and obtain a copy of the registration statement and its exhibits and
schedules from the Commission, as described in the preceding paragraph.
26
PART II. INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following expenses incurred in connection with the sale of the securities
being registered will be borne by the Company. Other than the SEC registration
fee, the amounts stated are estimates.
SEC Registration Fee...................................................... $ 7,250.80
Legal Fees and Expenses................................................... $10,000.00
Accounting Fees and Expenses.............................................. $ 4,000.00
Miscellaneous............................................................. $ 2,500.00
----------
TOTAL..................................................................... $23,750.80
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Article 6(d) of the Company's Restated Articles of Organization provides as
follows:
"(d) The liability of the Directors of the Corporation shall be limited to the
fullest extent permitted by Section 13(b)(1 1/2) of the Massachusetts Business
Corporation Law."
Section 6.6 of the Company's By-Laws provides as follows:
"Section 6.6 Indemnification of Officers, Directors, and Members of the
Scientific Advisory Board. The corporation shall indemnify and hold
harmless each person, now or hereafter an officer or Director of the
corporation, or a member of the Scientific Advisory Board, from and against
any and all claims and liabilities to which he may be or become subject by
reason of his being or having been an officer, Director of member of the
Scientific Advisory Board of the corporation or by reason of his alleged
acts or omissions as an officer, Director or member of the Scientific
Advisory Board of the corporation, and shall indemnify and reimburse each
such officer, Director and member of the Scientific Advisory Board against
and for any and all legal and other expenses reasonably incurred by him in
connection with any such claims and liabilities, actual or threatened,
whether or not at or prior to the time which so indemnified, held harmless
and reimbursed he has ceased to be an officer, Director or member of the
Scientific Advisory Board of the corporation, except with respect to any
matter as to which such officer, Director or member of the Scientific
Advisory Board of the corporation shall have been adjudicated in any
proceeding not to have acted in good faith in the reasonable belief that
his action was in the best interest of the corporation; provided, however,
that prior to such final adjudication the corporation may compromise and
settle any such claims and liabilities and pay such expenses, if such
settlement or payment or both appears, in the judgment of a majority of
those members of the Board of Directors who are not involved in such
matters, to be for the best interest of the corporation as evidenced by a
resolution to that effect adopted after receipt by the corporation of a
written opinion of counsel for the corporation, that, based on the facts
available to such counsel, such officer, Director or member of the
Scientific Advisory Board of the corporation has not been guilty of acting
in a manner that would prohibit indemnification.
Such indemnification may include payment by the corporation of expenses incurred
in defending a civil or criminal action proceeding in advance of the final
disposition of such action or proceeding, upon receipt of an undertaking by the
person indemnified to repay such payment if he shall be adjudicated not to be
entitled to indemnification under this section.
The corporation shall similarly indemnify and hold harmless persons who serve at
its express written request as directors or officers of another organization in
which the corporation owns shares or of which it is a creditor.
The right of indemnification herein provided shall be in addition to and not
exclusive of any other rights to which any officer, Director or member of the
Scientific Advisory Board of the corporation, or any such persons who serve at
its request as aforesaid, may otherwise be lawfully entitled. As used in this
Section, the terms "officer," "Director," and "member of the Scientific Advisory
Board" include their respective heirs, executors, and administrators.
II-1
ITEM 16. EXHIBITS.
EXHIBIT
NUMBER DESCRIPTION
4.1 Article 4 of the Restated Articles of Organization of the
Registrant (previously filed as Exhibit No. 3.1 to the
Registrant's Registration Statement on Form S-1, File No.
33-38883, and incorporated herein by reference)
4.2 Form of Common Stock Certificate (previously filed as
Exhibit No. 4.2 to the Registrant's Registration Statement
on Form S-1, File No. 33-31219, and incorporated herein by
reference)
5.1 Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C., with respect to the legality of the securities being
registered
23.1 Consent of PricewaterhouseCoopers LLP
23.2 Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
(included in Exhibit 5.1)
24.1 Power of Attorney (included on signature page)
ITEM 17. UNDERTAKINGS.
(a) The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to section 13(a) or section 15(d) of
the 1934 Act (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to section 15(d) of the 1934 Act) that is
incorporated by reference in the registration statement shall be deemed to
be a new registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(b) The undersigned registrant hereby undertakes to deliver or cause to be
delivered with the prospectus, to each person to whom the prospectus is
sent or given, the latest annual report to security holders that is
incorporated by reference in the prospectus and furnished pursuant to and
meeting the requirements of Rule 14a-3 or Rule 14c-3 under the Securities
Exchange Act of 1934; and, where interim financial information required to
be presented by Article 3 of Regulation S-X are not set forth in the
prospectus, to deliver, or cause to be delivered to each person to whom the
prospectus is sent or given, the latest quarterly report that is
specifically incorporated by reference in the prospectus to provide such
interim financial information.
(c) Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the Commission such
indemnification is against public policy as expressed in the Securities Act
and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
Registrant of expenses incurred or paid by a director, officer or
controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the
Registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Securities Act and will be governed by
the final adjudication of such issue.
For purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant
II-2
pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall
be deemed to be part of this registration statement as of the time it was
declared effective.
For the purpose of determining any liability under the Securities Act of 1933,
each post-effective amendment that contains a form of prospectus shall be deemed
to be a new registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act, as amended, the Registrant
has duly caused this Form S-3 Registration Statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in Cambridge, Massachusetts on
March 19, 2001.
IMMUNOGEN, INC.
BY: /s/ MITCHEL SAYARE
-------------------------------
Mitchel Sayare, CHAIRMAN OF THE
BOARD, PRESIDENT AND
CHIEF EXECUTIVE OFFICER
POWER OF ATTORNEY
The registrant and each person whose signature appears below constitutes and
appoints Mitchel Sayare, his, her or its true and lawful attorney-in-fact and
agent, with full power of substitution and resubstitution, for him, her or it
and in his, her or its name, place and stead, in any and all capacities, to sign
and file (i) any and all amendments (including post-effective amendments) to
this Registration Statement, with all exhibits thereto, and other documents in
connection therewith, and (ii) a registration statement, and any and all
amendments thereto, relating to the offering covered hereby filed pursuant to
Rule 462(b) under the Securities Act of 1933, with the Securities and Exchange
Commission, granting unto said attorney-in-fact and agent full power and
authority to do and perform each and every act and thing requisite or necessary
to be done in and about the premises, as fully to all intents and purposes as
he, she or it might or could do in person, hereby ratifying and confirming all
that said attorney-in-fact and agent or his substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Registration
Statement has been signed below by the following persons in the capacities and
on the dates indicated.
SIGNATURE TITLE DATE
--------- ----- ----
Chairman of the Board of Directors,
/s/ MITCHEL SAYARE President and Chief Executive
- --------------------------------- Officer (principal executive March 19, 2001
Mitchel Sayare officer)
/s/ WALTER A. BLATTLER Executive Vice President, Science
- --------------------------------- and Technology, Treasurer and March 19, 2001
Walter A. Blattler Director
/s/ GREGG D. BELOFF Chief Financial Officer and
- --------------------------------- Vice President, Finance (principal March 19, 2001
Gregg D. Beloff financial and accounting officer)
/s/ DAVID W. CARTER
- --------------------------------- Director March 19, 2001
David W. Carter
/s/ MICHAEL R. EISENSON
- --------------------------------- Director March 19, 2001
Michael R. Eisenson
/s/ STUART F. FEINER
- --------------------------------- Director March 19, 2001
Stuart F. Feiner
/s/ MARK S. SKALETSKY
- --------------------------------- Director March 19, 2001
Mark S. Skaletsky
II-4
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
4.1 Article 4 of the Restated Articles of Organization of the
Registrant (previously filed as Exhibit No. 3.1 to the
Registrant's Registration Statement on Form S-1, File No.
33-38883, and incorporated herein by reference)
4.2 Form of Common Stock Certificate (previously filed as
Exhibit No. 4.2 to the Registrant's Registration Statement
on Form S-1, File No. 33-31219, and incorporated herein by
reference)
5.1 Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.,
with respect to the legality of the securities being
registered
23.1 Consent of PricewaterhouseCoopers LLP
23.2 Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
(included in Exhibit 5.1)
24.1 Power of Attorney (included on signature page)
II-5
EXHIBIT 5.1
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
One Financial Center
Boston, Massachusetts 02111
617 542 6000
617 542 2241 (fax)
March 16, 2001
ImmunoGen, Inc.
128 Sidney Street
Cambridge, Massachusetts 02139
Ladies and Gentlemen:
We have acted as counsel to ImmunoGen, Inc., a Massachusetts corporation (the
"Company"), in connection with the preparation and filing with the Securities
and Exchange Commission of a Registration Statement on Form S-3 (the
"Registration Statement"), pursuant to which the Company is registering under
the Securities Act of 1933, as amended, a total of 2,269,420 shares (the
"Shares") of its common stock, $.01 par value per share (the "Common Stock"),
for resale to the public. The Shares are being sold by the selling stockholder
identified in the Registration Statement. This opinion is being rendered in
connection with the filing of the Registration Statement.
In connection with this opinion, we have examined the Company's Restated
Articles of Organization and By-Laws, both as currently in effect; such other
records of the corporate proceedings of the Company and certificates of the
Company's officers as we have deemed relevant; and the Registration Statement
and the exhibits thereto.
In our examination, we have assumed the genuineness of all signatures, the legal
capacity of natural persons, the authenticity of all documents submitted to us
as originals, the conformity to original documents of all documents submitted to
us as certified, photostatic or facsimile copies and the authenticity of the
originals of such copies.
Based upon the foregoing, we are of the opinion that (i) the Shares have been
duly and validly authorized by the Company and (ii) the Shares, when sold, will
be duly and validly issued, fully paid and non-assessable shares of the Common
Stock.
Our opinion is limited to the laws of The Commonwealth of Massachusetts and the
federal laws of the United States of America, and we express no opinion with
respect to the laws of any other jurisdiction. No opinion is expressed herein
with respect to the qualification of the Shares under the securities or blue sky
laws of any state or any foreign jurisdiction.
The foregoing opinion is rendered as of the date hereof. We assume no obligation
to update such opinion to reflect any facts or circumstances which may hereafter
come to our attention or changes in the law which may hereafter occur. We
understand that you wish to file this opinion as an exhibit to the Registration
Statement, and we hereby consent thereto. We hereby further consent to the
reference to us under the caption "Legality of Common Stock" in the prospectus
included in the Registration Statement.
Very truly yours,
/s/ Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
-------------------------------
Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
BOSTON NEW YORK RESTON WASHINGTON NEW HAVEN
EXHIBIT 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in this Registration
Statement on Form S-3 to register 2,269,420 shares of common stock of our report
dated July 28, 2000, except for Note N as to which the date is September 7,
2000, relating to the financial statements which appear in ImmunoGen, Inc.'s
Annual Report on Form 10-K for the year ended June 30, 2000.
We also consent to the reference to us under the heading "Experts" in such
Registration Statement.
/s/ PRICEWATERHOUSECOOPERS LLP
------------------------------
PricewaterhouseCoopers LLP
Boston, Massachusetts
March 19, 2001
