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As filed with the Securities and Exchange Commission on December 29, 2000
Registration No. 333-50542
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
Under
The Securities Act of 1933
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MGI PHARMA, INC.
(Exact name of Registrant as specified in its charter)
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Minnesota 2384 41-1364647
(State or other (Primary Standard (I.R.S. Employer
jurisdiction Industrial Identification Number)
of incorporation or Classification Code
organization) Number)
6300 West Old Shakopee Road, Suite 110
Bloomington, Minnesota 55438
(952) 346-4700
(Address, including zip code, and telephone number, including area code, of
Registrant's principal executive offices)
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Charles N. Blitzer
Chief Executive Officer
MGI PHARMA, INC.
6300 West Old Shakopee Road, Suite 110
Bloomington, Minnesota 55438
(952) 346-4700
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
Copies to:
Timothy S. Hearn, Esq. Linda L. Griggs, Esq.
Dorsey & Whitney LLP Brian C. Miner, Esq,
220 South Sixth Street Todd A. Buchman, Esq.
Minneapolis, Minnesota 55402 Morgan, Lewis & Bockius LLP
(612) 340-2600 1800 M Street, N.W.
Facsimile: (612) 340-8827 Washington, D.C. 20036
(202) 467-7000
Facsimile: (202) 467-7176
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Approximate date of commencement of proposed sale to the public: From time
to time 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 plans, 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. [_]
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 that 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 SEC, acting pursuant to said Section 8(a), may
determine.
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++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ +
+The information in this prospectus is not complete and may be changed. We may +
+not sell these securities until the registration statement filed with the +
+Securities and Exchange Commission is effective. This prospectus is not an +
+offer to sell these securities and it is not soliciting an offer to buy these +
+securities in any state where the offer or sale is not permitted. +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
SUBJECT TO COMPLETION, DATED DECEMBER 29, 2000
5,000,000 Shares
[LOGO OF MGI PHARMA]
Common Stock
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. MGI PHARMA, INC. is
offering up to an . Closing price on December 28, 2000: $17.56 per
aggregate of share.
5,000,000 shares.
. Trading symbol:
Nasdaq National
Market--MOGN
--------
Investing in the common stock involves risk. See "Risk Factors" on page 4.
This prospectus will allow us to issue common stock over time. This means:
. we will provide a prospectus supplement each time we issue common stock;
. the prospectus supplement will inform you about the specific terms of that
offering and may also add, update or change information contained in this
document;
. you should read this document and any prospectus supplement carefully
before you invest; and
. we may sell the common stock through underwriters, through dealers,
directly to one or more institutional purchasers or through agents.
--------
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if
this prospectus is truthful or complete. Any representation to the contrary is
a criminal offense.
The date of this prospectus is .
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TABLE OF CONTENTS
<TABLE>
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<S> <C>
Summary................. 3
Risk Factors............ 4
Use of Proceeds......... 14
Plan of Distribution.... 14
</TABLE>
<TABLE>
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Page
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<S> <C>
Legal Matters............ 15
Experts.................. 15
Where You Can Find More
Information............. 15
</TABLE>
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SUMMARY
Business of MGI PHARMA
MGI PHARMA, INC. is an oncology focused pharmaceutical company. We acquire,
develop and commercialize differentiated pharmaceutical products that meet
patient needs. We currently market and promote several products through our 50-
person specialty sales organization. In 1999, we generated revenues from
product sales of approximately $18.6 million. In addition we are developing
irofulven and MG98 for the treatment of cancer. We also intend to expand our
product portfolio through the acquisition and licensing of product candidates
and approved products for sale in the United States through our specialty sales
organization.
Irofulven is our lead product candidate for the treatment of cancer. It is the
first product candidate that we are developing from our proprietary family of
naturally derived compounds called acylfulvenes. We are currently developing
irofulven for the treatment of various cancers through a series of human
trials, including Phase 1 clinical trials designed to evaluate the safety and
maximum tolerated dose using different dosing schedules, as well as Phase 2
clinical trials designed to evaluate the efficacy of irofulven in particular
types of cancer. Based on our analysis of interim results from our four Phase 2
trials of irofulven, we believe that irofulven is well-tolerated as a
chemotherapeutic, and is potentially active as an anti-tumor agent for the
treatment of ovarian, pancreatic and prostate cancers. During the first quarter
of 2001, we intend to enroll the first patient in a Phase 3 clinical trial
designed to evaluate the safety and efficacy of irofulven in approximately 300
pancreatic cancer patients whose disease has progressed following treatment
with the current standard-of-care chemotherapeutic for pancreatic cancer. We
intend to have this Phase 3 clinical trial serve as the fundamental basis for
regulatory approval of irofulven for commercial sale in the United States. We
are also studying the treatment of solid tumors with irofulven in combination
with existing chemotherapeutics. Additionally, we are developing other
acylfulvene analogs, which are different molecules within the acylfulvene
class, in preclinical animal studies.
MG98 is a product candidate we are developing for the purpose of blocking
production of the enzyme, DNA methyltransferase. DNA methyltransferase inhibits
the proper expression of genes that would otherwise slow or stop tumor growth.
MG98 has demonstrated anti-cancer activity in an ongoing Phase 1 dose
escalation trial. We initiated a Phase 2 trial of MG98 in head and neck cancer
patients in the fourth quarter of 2000, and intend to further develop MG98 in
other cancers affected by DNA methyltransferase.
Our primary commercial product, Salagen Tablets, accounted for approximately 97
percent of our product sales in 1999. We market Salagen Tablets in the United
States to oncologists as a treatment for the symptoms of radiation-induced
xerostomia, or chronic dry mouth, in head and neck cancer patients. We also
market Salagen Tablets in the United States as a treatment for the symptoms of
dry mouth associated with Sjogren's syndrome, an autoimmune disease that
damages the body's moisture-producing glands. We market Salagen Tablets outside
the United States through our alliances with international pharmaceutical
companies. Salagen Tablets are approved for commercial sale in 21 countries. We
also co-promote Azulfidine EN-tabs(R) on behalf of Pharmacia Corporation to
rheumatologists in the United States.
In November 2000, we acquired HEXALEN(R) (altretamine), an oral chemotherapy
for the treatment of recurrent ovarian cancer. We expect to commence marketing
HEXALEN in the first quarter of 2001.
Office Location
Our principal executive offices are located at 6300 West Old Shakopee Road,
Suite 110, Bloomington, Minnesota 55438 and our telephone number is (952) 346-
4700.
Corporate Information
We were incorporated under the name Molecular Genetics, Inc. in Minnesota in
November 1979. We have trademark protection on Salagen, MGI, MGI PHARMA and our
logo. This prospectus also includes trade names and marks of other companies.
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RISK FACTORS
You should carefully consider each of the following risks and all of the other
information set forth in this prospectus before deciding to invest in shares
of our common stock. Additional risks not presently known to us or that we
currently believe to be immaterial may also adversely affect our business. The
trading price of our common stock could decline due to any of these risks, and
you may lose all or part of your investment.
If we do not have net income in the future, we may be unable to continue our
operations.
We have a limited history of profitability. We expect to significantly
increase our research and development expenses over the next several years as
we continue to devote even more resources to the development and
commercialization of irofulven, MG98 and other product candidates. Therefore,
unless we are able to significantly increase revenues from the launch of
additional products, we will not have net income. Furthermore, because
research and development costs are generally independent of revenues, a delay
or decline in revenues from the sale of our currently available products could
cause our operating results to decline significantly in any given quarter. If
we continue to sustain losses, we may be unable to continue our business
operations as planned.
Our operating results may fluctuate significantly, which may adversely affect
our stock price.
If our operating results do not meet the expectations of investors or
securities analysts, our stock price may decline. Our operating results may
fluctuate significantly from period to period due to a variety of factors
including:
. changing demand for our current products, particularly Salagen Tablets;
. third parties introducing competing products;
. the pace and breadth of our development programs;
. expenditures we incur to acquire, license, develop and promote
additional products;
. availability of product supply from third-party manufacturers;
. changes in sales and marketing expenditures; and
. the timing of licensing and royalty revenues.
In the first six months of 2000, we had net income of $1.5 million and in the
third quarter of 2000, we had a net loss of $6.0 million, resulting in a net
loss of $4.5 million for the nine-month period ended September 30, 2000. The
change from net income in the first half of 2000 to a net loss in the nine-
month period was primarily due to the recognition of a $5.7 million expense
related to our in-licensing of a product candidate and complementary
technology.
Variations in the timing of our future revenue could also cause significant
fluctuations in operating results from period to period and may result in
unanticipated earnings shortfalls or losses. Therefore, we do not believe that
period-to-period comparisons of our operating results are meaningful. However,
securities analysts and investors may set expectations about our business
based upon past operating results. Consequently, if our operating results do
not follow past trends, our stock price may decline.
If we fail to obtain additional capital to grow our business, we may be unable
to complete our product acquisition, licensing and development programs.
Even with the proceeds from the shares offered from time to time under this
prospectus, we may need to raise additional funds for various reasons
including the following:
. to fully develop irofulven and other acylfulvene analogs;
. to acquire or license additional products or product candidates;
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. to develop products we have acquired or licensed;
. to support the marketing and sales of additional products;
. to obtain necessary working capital; and
. to fund operating losses.
We may seek additional funding through public and private financing, including
equity and debt financing. Adequate funds for these purposes may not be
available when needed or on terms acceptable to us. Insufficient funds may
cause us to delay, scale back, or abandon some or all of our product
acquisition and licensing programs and product development programs.
We depend upon the sale of Salagen Tablets for substantially all of our
product revenues. If any factor adversely impacts sales of Salagen Tablets,
our product revenues will decrease and may decrease significantly.
We currently derive substantially all of our product revenues from the sale of
Salagen Tablets. U.S. sales of Salagen Tablets represented 97 percent of our
total product sales and 74 percent of our total revenue, excluding interest
income, in the first nine months of 2000, and represented 97 percent of our
total product sales and 73 percent of our total revenue, excluding interest
income, for the year ended December 31, 1999. Any factor adversely affecting
sales of Salagen Tablets could cause our product revenues to decrease and our
stock price to decline. In March 2001, our orphan drug status for Salagen
Tablets as a treatment for the symptoms of radiation-induced xerostomia in
head and neck cancer patients will expire. As a result, competing generic
products may enter this market. In addition, we are aware of two currently
marketed products which compete with Salagen Tablets. If sales of Salagen
Tablets decline as a result of this competition, or for any other reason, our
product revenues will decrease and our stock price could decline.
If we do not receive regulatory approvals of irofulven or any of our other
product candidates, or if regulatory approval is delayed for any reason, we
will be unable to commercialize and sell our products as we expect.
Government regulation in the United States and abroad is a significant factor
in the development, manufacturing and marketing of our products. We are
currently marketing three products that have been approved by the FDA and have
two product candidates in clincial trials. Prior to marketing, each of our
product candidates must undergo an extensive regulatory approval process
conducted by the FDA in the United States and by comparable agencies in other
countries. The approval process can take many years and require the
expenditure of substantial resources. There is a risk that the FDA or a
foreign regulatory authority will not approve in a timely manner, if at all,
any product we develop. Generally, the FDA approves for sale only a very small
percentage of newly discovered pharmaceutical compounds that enter preclinical
development. Once the FDA approves a product for sale, we must also submit any
labeling, advertising and promotional material to the FDA for review. There is
a risk that the FDA will prohibit use of the marketing material in the form we
desire, which could limit the sale of our products and could cause our product
revenues to decrease and our stock price to decline.
Before we submit a regulatory application for commercial sale of irofulven or
any of our other product candidates, we will have to conduct further research
and development, including further extensive human clinical testing. There is
a risk that this research and development will not be successful and will not
result in a product that will qualify for approval by regulatory authorities
for commercial sale. Clinical testing of a pharmaceutical product is subject
to approvals by various governmental regulatory authorities. There is a risk
that regulatory authorities in the United States and elsewhere may not allow
us to conduct planned additional clinical testing of irofulven or any of our
other product candidates. There is also a risk that, if permitted, this
additional clinical testing will not prove that these product candidates are
safe and effective to the extent necessary to permit us to obtain marketing
approvals from regulatory authorities. In addition, interim or final results
we obtain in preclinical studies or in Phase 1 and Phase 2 human clinical
trials are not necessarily indicative of results that we will obtain in
subsequent or more extensive testing and commercial experience.
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We utilize various parties to conduct our preclinical and clinical testing,
such as contract research laboratories, contract research organizations,
teaching and research hospitals, and community-based clinics. We are currently
conducting drug development under three investigational new drug applications.
This research must comply with good clinical and laboratory practices as
required by the FDA. The data we obtain from manufacturing and from
preclinical and clinical testing are subject to varying interpretations that
could delay, limit or prevent regulatory approval. We also may encounter
delays or rejection due to: (1) changes in FDA policy during the period of
development, or (2) changes in the requirements for regulatory review of each
submitted New Drug Application, or NDA. Even if the FDA approves the marketing
application of a product, this approval may entail commercially unacceptable
limitations on the uses, or "indications," for which a product may be
marketed. We may need to conduct further studies to provide additional data on
product safety or effectiveness. The FDA also requires post-marketing adverse
event surveillance programs to monitor a product's side effects. These
programs are a formal system of collecting and reporting information about
serious or unexpected side effects using an approved drug.
The FDA subjects an approved product and its manufacturer to continual
regulatory review. The discovery of previously unknown problems with a product
may result in restrictions or sanctions on this product or manufacturer that
could affect the commercial viability of the product or could require
withdrawal of the product from the market. Most changes in the manufacturing
procedures we use for our approved products, including a change in
manufacturer, will require the prior approval of the FDA. This could have an
adverse effect upon our ability to continue the commercialization or sale of a
product.
Clinical trials are complex and unpredictable and may produce unexpected
results which could affect our ability to commercialize our products.
Before obtaining regulatory approvals for the commercial sale of any product
under development, including irofulven, we must demonstrate through
preclinical studies and clinical trials that the product is safe and effective
for use in each target indication. We have not commenced pivotal Phase 3
clinical trials on any of our product candidates and the FDA will most likely
require that we do so before we submit an NDA for any product candidate. The
results from preclinical animal studies and early human clinical trials may
not be predictive of the results that we will obtain in larger scale testing.
Some of the results we are announcing from Phase 2 clinical trials are interim
results and may not be predictive of future results, including final results
from such Phase 2 trials, because, among other factors, patient enrollment and
the time period for evaluating patient results are not complete. Our clinical
trials may not demonstrate the safety and efficacy required for marketing
approval of a product. If we fail to adequately demonstrate the safety and
efficacy of a product candidate, the FDA would prevent regulatory approval of
the product. There is a risk that unacceptable toxicities or side effects will
occur at any time in the course of human clinical trials or commercial use of
any product. The appearance of unacceptable toxicities or side effects could
interrupt, limit, delay or abort the development of a product or, if
previously approved and launched, require its withdrawal from the market. A
number of companies in the biotechnology industry have suffered significant
setbacks in advanced clinical trials, even after experiencing promising
results in previous animal and human studies.
The time required to complete clinical trials is dependent upon, among other
factors, the rate of patient enrollment. Patient enrollment is a function of
many factors, including:
. the size of the patient population;
. the nature of the protocol requirements;
. the diversion of patients to other trials or marketed therapies;
. our ability to recruit and manage clinical centers and associated
trials;
. the proximity of patients to clinical sites; and
. the patient eligibility criteria for the study.
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Other factors, such as lack of efficacy and unacceptable toxicities, may
result in increased costs and delays or termination of clinical trials prior
to completion. In addition, delays in manufacturing of product for our
clinical trials could impact our ability to complete our clinical trials as
planned. Furthermore, clinical trials must meet various FDA requirements, such
as institutional review board oversight, informed consent, and conformance
with good clinical practice requirements. Even after the FDA or a foreign
regulatory authority approves a product, the product may later exhibit adverse
effects that prevent its widespread use or necessitate its withdrawal from the
market. There is always a risk that any product under development may not be
safe when administered to humans.
We depend on a single supplier to provide us with the active ingredient for
the production of Salagen Tablets. If such supplier terminates its
relationship with us, or is unable to fill our demand for the ingredient, we
may be unable to produce Salagen Tablets for commercial sale.
We rely on the Fine Chemicals Division of Merck KGaA as our sole and exclusive
supplier of oral-grade pilocarpine hydrochloride, the active pharmaceutical
ingredient in Salagen Tablets. To our knowledge, there is currently no other
producer of pharmaceutical-grade pilocarpine hydrochloride that is capable of
meeting our commercial needs. If our relationship with Merck KGaA terminates,
or Merck KGaA is unable to meet our needs for any reason, we will need to find
an alternative source of pilocarpine hydrochloride. If we are unable to
identify an alternate source, we may be unable to continue producing Salagen
Tablets for commercial sale. Even if we were able to procure adequate supplies
of pilocarpine hydrochloride from an alternate source, any disruption in our
supply of pilocarpine hydrochloride could have a material adverse effect on
our ability to meet customer demand for Salagen Tablets, which could cause our
product revenues to decrease and our stock price to decline.
If our third-party manufacturer of Salagen Tablets or any of our other
products cease operations or fail to comply with applicable manufacturing
regulations, we may not be able to meet customer demand in a timely manner, if
at all.
We do not have manufacturing facilities and we rely on one third-party
manufacturer, Patheon Inc. (formerly known as Global Pharm, Inc.), for the
production of each of our products, including Salagen Tablets. We intend to
continue to rely on others to manufacture any future products, including any
products that we may acquire or license, and we have no plans to establish
manufacturing facilities. The manufacture of our products is, and will be,
subject to "good manufacturing practices" regulations prescribed by the FDA or
other standards prescribed by the appropriate regulatory agency in the country
of use. There is a risk that our manufacturers, including the current
manufacturer of Salagen Tablets, will not comply with all applicable
regulatory standards, and may not be able to manufacture Salagen Tablets or
any other product for commercial sale. If this occurs, we might not be able to
identify another third-party manufacturer on terms acceptable to us, or any
other terms.
Material changes to an approved product, such as manufacturing changes or
additional labeling claims, require further FDA review and approval. Once we
obtain approval, the FDA may withdraw it. Further, if we, our corporate
partners or our contract manufacturers fail to comply with applicable FDA and
other regulatory requirements at any stage during the regulatory process, the
FDA may impose sanctions, including:
. marketing or manufacturing delays;
. warning letters;
. fines;
. product recalls or seizures;
. injunctions;
. refusal of the FDA to review pending market approval applications or
supplements to approval applications;
. total or partial suspension of production;
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. civil penalties;
. withdrawals of previously approved marketing applications; or
. criminal prosecutions.
We may derive additional revenues from product co-promotion arrangements. If
these arrangements terminate for any reason, our revenues could decrease and
our stock price could decline.
In 1999, we entered into an agreement with Pharmacia Corporation to co-promote
Azulfidine EN-tabs(R) in the United States. We may enter into additional co-
promotion arrangements in the future. These co-promotion arrangements may
provide us with revenue to partially fund our operations. We have no control
over how our co-promotion partners run their own businesses, and existing or
future co-promotion partners may pursue and develop drugs which compete with
our co-promoted products. If our co-promotion partners terminate these
arrangements for any reason, or if we fail to successfully co-promote these
products, our revenues could decrease and our stock price could decline.
Our business strategy depends on our ability to identify, acquire, license and
develop product candidates and identify, acquire or license approved products.
As part of our business strategy we plan to identify, acquire, license and
develop product candidates and identify, acquire and license approved products
for markets that we can reach through our marketing and distribution channels.
If we fail to acquire or license, develop and commercialize additional
products or product candidates, or fail to promote or market commercially
successful products, we may not achieve expectations of our future performance
and our stock price could decline. Because we do not directly engage in basic
research or drug discovery, we must rely upon third parties to sell or license
product opportunities to us. Other companies, including some with
substantially greater financial, marketing and sales resources, are competing
with us to acquire or license such products or product candidates. We may not
be able to acquire or license rights to additional products or product
candidates on acceptable terms, if at all. Furthermore, we may not be able to
successfully develop any product candidates we acquire or license. In
addition, we may acquire or license new products with different marketing
strategies, distribution channels and bases of competition than those of our
current products. Therefore, we may not be able to compete favorably in those
product categories.
If we are unable to maintain relationships with third-party collaborators or
enter into new relationships, our research and development costs may increase,
and we may not be able to develop any of our product candidates in a timely
manner, if at all.
We enter into relationships with third-party collaborators, including
manufacturers, to assist us in the development of our product candidates. Our
collaborators include public research institutions, contract research
organizations, teaching and research hospitals, community-based clinics,
contract testing laboratories, contract product formulation organizations,
contract packaging and distribution companies, contract manufacturers and
license partners. We consider our arrangements with Patheon Inc. and Dainippon
Pharmaceutical Co. Ltd. to be significant. If any of our collaborators
breaches or terminates its agreement with us, or otherwise fails to conduct
its collaborative activities in a timely manner, we may experience significant
delays in the development or commercialization of the product candidate or the
research program covered by the agreement and we may need to devote additional
funds or other resources to these activities. Furthermore, if we are unable to
enter into new or alternative arrangements to continue these activities, or
are unable to continue these activities on our own, we may have to terminate
the development program.
Our continued success will depend in large part upon the efforts of outside
parties. For the research, development, manufacture and commercialization of
our products, we will likely enter into various arrangements with other
corporations, licensors, licensees, outside researchers, consultants and
others. However, we cannot be certain of the actions these parties will take,
and there is a risk that:
. we will be unable to negotiate acceptable collaborative arrangements to
develop or commercialize our products;
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. any arrangements with third-parties will not be successful;
. third-party collaborators will not fulfill their obligations to us under
any arrangements entered into with them;
. current or potential collaborators will pursue treatments for other
diseases or seek alternative means of developing treatments for the
diseases targeted by our programs or products; or
. the FDA will believe that our third-party manufacturers are in
compliance with good manufacturing practice requirements, which could
interrupt product supply or result in recall of previously distributed
products.
We rely on multinational and foreign pharmaceutical companies to develop and
commercialize our products and product candidates in markets outside the
United States.
Our strategy for commercialization of our products in foreign markets is to
enter into development and marketing alliances with multinational and foreign
pharmaceutical companies. We have entered into alliances with various
companies related to the marketing of Salagen Tablets in markets outside the
United States. We have entered into an agreement with Dainippon Pharmaceutical
Co., Ltd. for the development and commercialization of irofulven in Japan,
with Kissei Pharmaceutical Co., Ltd. for the development and commercialization
of Salagen Tablets in Japan and Pharmacia Corporation (formerly Pharmacia &
Upjohn Company) for the development and commercialization of Salagen Tablets
in Canada. Revenues from strategic alliances typically include milestone
payments and payments based on product sales. Our continued relationships with
strategic partners are dependent in part on the successful achievement of
development milestones. If we or our partners do not achieve these milestones,
or we are unable to enter into agreements with our partners to modify their
terms, these agreements could terminate, which could cause a loss of licensing
revenue, a loss of future commercial product potential and a decline in our
stock price.
In April 2000, we entered into an agreement with CIBA Vision AG, a Novartis
company, to replace Chiron B.V. as our partner for the sale of Salagen Tablets
in Europe. During the transition of regulatory and marketing responsibilities
from Chiron B.V. to CIBA Vision AG, issues may arise that could delay CIBA
Vision's commercialization plans for Salagen Tablets.
We depend upon licensing revenue from our marketing partners for a material
portion of our total revenue. Future licensing revenues from these partners
will likely fluctuate from quarter to quarter and year to year depending on:
. the achievement of milestones by us or our partners;
. the amount of product sales and royalty generating activities; and
. the timing of initiating additional licensing relationships.
Historically, we have recognized revenue from initial license fees in the
period in which the agreement was signed if there were no significant
performance obligations remaining. Revenue from milestone payments is
recognized when the milestones are achieved. We have recognized $1.6 million
of irrevocable license payments we received during the nine-month period ended
September 30, 2000. In December 1999, the SEC issued Staff Accounting Bulletin
No. 101--Revenue Recognition in Financial Statements, or SAB 101. SAB 101
reflects the SEC's views on revenue recognition. SAB 101 requires the deferral
of revenue until the culmination of the earnings process. Accordingly, license
fees and milestone payments must be deferred and recognized over the period
over which the revenue is deemed to be earned. SAB 101 does not set forth
guidance on what constitutes the culmination of the earnings process where
there are initial license, milestone and royalty payments. Further, there is
significant uncertainty about the life over which to recognize the revenue,
particularly where royalties continue to be payable until the last related
patent expires. For example, no written guidance addresses whether it would be
acceptable to amortize the revenue over the estimated product development
period, which is a shorter
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period than the estimated life of the patents. Due to the uncertainties noted
above, we have not completed our evaluation of the impact of SAB 101 on our
financial statements. Effective from January 1, 1994, when we recognized our
first licensing revenue, to December 31, 2000, we have recognized cumulative
licensing revenue for initial license payments, milestone and royalty payments
of approximately $15.1 million which will have to be evaluated for deferral
under SAB 101. Subject to further guidance regarding SAB 101, the amount that
we will need to defer, if any, remains uncertain.
We believe that our partners in these development and marketing alliances have
an economic motivation to perform their contractual responsibilities, but we
cannot control the amount and timing of resources they devote to these
activities. The terms of these alliances generally provide that they may be
terminated prior to their expiration under circumstances that may be outside
our control. The early termination of one or more of these strategic alliances
could cause a loss of licensing revenue, a loss of future commercial product
potential and a decline in our stock price. There is a risk that we will not
be able to negotiate additional strategic alliances on acceptable terms or
that such future alliances will not be successful.
If we fail to compete successfully with our large, multinational competitors,
our product revenues could decrease and our stock price could decline.
Competition in the pharmaceutical industry is intense. Most of our competitors
are large, multinational pharmaceutical companies that have considerably
greater financial, sales, marketing and technical resources than we do. Most
of our present and potential competitors also have dedicated research and
development capabilities that may allow them to develop new or improved
products that compete with our products. Currently, MedImmune, Inc. and Snow
Brand Pharmaceuticals, Inc. have drugs that are approved for sale and compete
in the same markets as Salagen Tablets. Other pharmaceutical companies are
developing products which, if approved by the FDA, will compete directly with
Salagen Tablets. Our competitors could also develop and introduce generic
drugs comparable to Salagen Tablets, or drugs or other therapies that address
the underlying causes of the symptoms which Salagen Tablets treat. If a
product developed by a competitor is more effective than our product, or
priced lower than our product, then our product sales could be adversely
affected, our product revenue could decrease and our stock price could
decline.
We are dependent on our key personnel. If we are not able to attract and
retain key employees and consultants, our product development, marketing and
commercialization plans could be harmed.
We are highly dependent on the members of our scientific and management staff.
If we are not able to retain any of these persons, our product development,
marketing and commercialization plans may suffer and our stock price could
decline. In particular, we depend on the services of Charles N. Blitzer, our
President and Chief Executive Officer, and other members of senior management.
We maintain a key person life insurance policy for Mr. Blitzer in the amount
of $5 million. None of our executive officers has an employment agreement with
us. If we are unable to retain our scientific and management staff, we will
need to hire additional qualified personnel for us to pursue our product
development, marketing and commercialization plans. 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. If we are not able to
attract and retain qualified personnel, our product development, marketing and
commercialization plans will suffer and our stock price could decline.
If we are unable to keep up with rapid technological changes in the
pharmaceutical or biotechnology industries, we may be unable to continue our
operations.
The pharmaceutical and biotechnology industries have experienced rapid and
significant technological change. We expect that pharmaceutical technology and
biotechnology will continue to develop rapidly. Our future success will
depend, in large part, on our ability to develop and maintain technology that
is competitive. If other companies achieve technological developments in their
products, our products may become obsolete before they are marketed or before
we recover any of our development and commercialization expenses incurred with
respect to such products. In addition, alternative therapies or new medical
treatments could alter existing treatment
10
<PAGE>
regimens, and thereby reduce the need for one or more of our products, which
could result in the termination of the development in one or more of our
product candidates, or in the decline in sales of one of our approved
products, which could cause our stock price to decline.
If we are unable to obtain intellectual property protection, or protect our
proprietary technology, we may be unable to compete effectively and our stock
price may decline.
Our ability to compete effectively with other companies will depend, in part,
on our ability to:
. maintain the proprietary nature of our products;
. obtain and enforce our patent and other proprietary rights; and
. operate without infringing upon the proprietary rights of others.
The FDA awarded us orphan drug status for Salagen Tablets in 1994 as a
treatment for the symptoms of xerostomia induced by radiation therapy in head
and neck cancer patients and in 1998 for the symptoms of dry mouth associated
with Sjogren's syndrome. Orphan drug designation provides market exclusivity
for seven years after the FDA approves a product for marketing. Our orphan
drug protection for Salagen Tablets will expire in March 2001 for the
treatment of symptoms of radiation-induced xerostomia in head and neck cancer
patients and in 2005 for the Sjogren's syndrome indication. Upon expiration of
our orphan drug protection for Salagen Tablets, we may face competition from
manufacturers of generic versions of Salagen Tablets.
We hold an exclusive, worldwide license on patents and patent applications
covering acylfulvene proprietary rights. The license applicable to these
technologies is subject to certain statutory rights held by the U.S.
Government. Even though we have licensed these patents, we may not have
exclusive rights to all possible acylfulvene analogs, all possible methods of
using acylfulvene analogs to treat tumors or all possible synthetic methods
for preparing acylfulvenes. In addition, we licensed rights to patents and
patent applications covering MG98 and the small molecule DNA methyltransferase
inhibitors. Protection of these rights and creation of additional rights
involve joint responsibilities between us and MethylGene Inc.
We will be able to protect our proprietary rights from unauthorized use by
third parties only to the extent that our proprietary rights are covered by
valid and enforceable patents or are effectively maintained as trade secrets.
Our pending patent applications, those we may file in the future, or those we
license from third parties, may not result in patents being issued. Patents,
if issued, may be challenged, invalidated or circumvented. In addition, other
entities may develop similar technologies that fall outside the scope of our
patents. Thus, any patent rights that we own or license from third parties may
not provide sufficient protection against potential competitors.
It is possible that our core technologies or activities taken in the course of
developing or selling our products will infringe the patents of others. In the
event that our technologies infringe the patents or violate other proprietary
rights of third parties and those patents or rights are enforceable, we and
our corporate partners may be prevented from pursuing product development or
commercialization. The laws of foreign countries may not protect our
intellectual property rights to the same extent as do the laws of the United
States.
In addition to patents, we rely on trade secrets and proprietary know-how. We
protect our proprietary technology and processes in part by confidentiality
agreements with our collaborative partners, employees and consultants. There
is a risk that:
. these confidentiality agreements will be breached;
. we will not have adequate remedies for any breach of these agreements;
. our trade secrets will otherwise become known; or
. our trade secrets will be independently discovered and used by
competitors.
The biotechnology and pharmaceutical industries have been characterized by
litigation regarding patents and other intellectual property rights. If we
become involved in any litigation, interference or other administrative
11
<PAGE>
proceedings, we will incur substantial expense and the efforts of our
technical and management personnel will be diverted. An adverse determination
may subject us to significant liabilities or require us to cease using the
technology or to seek licenses that may not be available from third parties on
commercially favorable terms, if at all, or to cease manufacturing and selling
our products. This could cause us to terminate the development of one or more
of our product candidates, to discontinue marketing an existing product, or to
pay royalties to a third party. Any of these events could result in a decline
in our stock price.
If the use of one of our products harms people, we may be subject to costly
and damaging product liability claims.
We face exposure to product liability claims in the event that the use of our
product is alleged to have harmed someone. Although we have taken, and
continue to take, what we believe are appropriate precautions, there is a risk
that we will not be able to avoid significant product liability exposure. We
currently have product liability insurance in the amount of $15 million per
occurrence and in the aggregate for the year. There is a risk that our
insurance will not be sufficient to cover any potential claims. There is also
a risk that adequate insurance coverage will not be available in the future on
commercially reasonable terms, if at all. The successful assertion of an
uninsured product liability or other claim against us could cause us to incur
a significant expense to pay such a claim, could adversely affect our product
development and could cause a decline in our product revenue and stock price.
In addition to product liability risks associated with sales of our products,
we may be liable to the claims of individuals who participate in clinical
trials of our products. A number of patients who participate in trials are
already critically ill when they enter a trial. The waivers we obtain may not
be enforceable and may not protect us from liability or the costs of product
liability litigation. Our product liability insurance may not provide adequate
protection against potential liabilities. Moreover, we may not be able to
maintain our insurance on acceptable terms. As a result of these factors, a
product liability claim, even if successfully defended, could cause us to
incur a significant expense to defend such a claim, could adversely affect our
product development and could cause a decline in our product revenue and stock
price.
If we issue a product recall, we may not sell as much of our products in the
future and we may incur significant expenses.
We, the FDA or other government agencies having regulatory authority for
product sales may issue product recalls at the discretion of the issuing
party. Product recalls may occur due to manufacturing issues, safety concerns
or other reasons. Although none of our products have been recalled, product
recalls may occur in the future on these or other grounds. We do not carry any
insurance to cover the risk of a product recall. Any product recall could have
a material adverse effect on our product revenue and could cause our stock
price to decline.
If we or patients using our products are unable to obtain adequate
reimbursement from government health administration authorities, private
health insurers and other organizations, our product sales and stock price
could decline.
Our profitability will depend in part on: (1) the price we are able to charge
for our products, and (2) the availability of adequate reimbursement for our
products from third-party payors, such as government entities, private health
insurers and managed care organizations. Salagen Tablets generally have been
eligible for reimbursement from third-party payors, however, third-party
payors are increasingly challenging the pricing of medical products and
services. There is much uncertainty as to the pricing flexibility
pharmaceutical companies will have with respect to newly approved healthcare
products. In the United States, we expect that there will continue to be a
number of federal and state proposals to implement government control of
pricing and profitability of prescription pharmaceuticals. Cost controls, if
mandated by a government agency, could decrease the price that we receive for
our current or future products. Cost controls could also prevent the recovery
of potentially substantial development costs and an appropriate profit margin.
This could cause our product revenues to decrease and our stock price to
decline.
12
<PAGE>
There is also much uncertainty about the reimbursement status of healthcare
products. Federal and state regulations govern or influence the reimbursement
status of healthcare products in many situations. Although third-party
reimbursement is not currently an issue for us, there is a risk that
reimbursement will not be available in the future for our products, or that
such third-party reimbursement will not be adequate. If government entities
and other third-party payors do not provide adequate reimbursement levels for
our products, our product development and product revenues would be materially
and adversely affected and our stock price could decline. In recent years,
various parties have proposed a number of legislative and regulatory proposals
aimed at changing the nation's healthcare system. These proposals, if enacted,
could have a material adverse effect on our product development and product
revenues and could cause our stock price to decline. In certain countries,
regulatory authorities must also approve the sales price of a product after
they grant marketing approval. There is a risk that we will not be able to
obtain satisfactory prices in foreign markets even if we obtain marketing
approval from foreign regulatory authorities.
Our operations, and the operations of our third party contractors, involve
hazardous materials which could expose us to liability if environmental damage
occurs.
Our business activities involve the controlled use of hazardous materials. We
cannot eliminate the risk of accidental contamination or injury from these
materials. In the event of an accident or environmental discharge, third
parties may hold us liable for any resulting damages, which may exceed our
financial resources and may have a material adverse effect on our product
development and product revenues.
Our stock price is volatile which may result in significant losses to
shareholders.
There has been significant volatility in the market prices of pharmaceutical
and biotechnology companies' securities. Various factors and events may have a
significant impact on the market price of our common stock. These factors
include:
. fluctuations in our operating results;
. announcements of technological innovations or acquisitions or licensing
of therapeutic products or product candidates by us or our competitors;
. published reports by securities analysts;
. positive or negative progress with our clinical trials;
. governmental regulation, including healthcare reimbursement policies;
. developments in patent or other proprietary rights;
. developments in our relationship with collaborative partners;
. public concern as to the safety and efficacy of our products; and
. general market conditions.
The trading price of our common stock has been, and could continue to be,
subject to wide fluctuations in response to these factors, including the sale
or attempted sale of a large amount of our common stock into the market. Our
stock price ranged from $11.50 to $54.75 per share during the year ended
December 31, 2000. Broad market fluctuations may also adversely affect the
market price of our common stock.
Our charter documents, our shareholder rights plan and Minnesota law contain
provisions that could delay or prevent an acquisition of our company.
Our charter documents contain provisions that may discourage third parties
from seeking to acquire our company. These provisions include:
. advance notice requirements for shareholder proposals and nominations;
and
13
<PAGE>
. the authority of the board of directors to issue, without shareholder
approval, preferred stock with such terms as the board of directors may
determine.
In addition, our board of directors has adopted a shareholder rights plan, or
"poison pill," which enables our board of directors to issue preferred stock
purchase rights that would be triggered by an acquisition of 15 percent or
more of the outstanding shares of our common stock. These provisions and
specific provisions of Minnesota law relating to business combinations with
interested shareholders may have the effect of delaying, deterring or
preventing a merger or change in control. Some of these provisions may
discourage a future acquisition of our company even if shareholders would
receive an attractive value for their shares or if a significant number of our
shareholders believed such a proposed transaction to be in their best
interest. As a result, shareholders who desire to participate in such a
transaction may not have the opportunity to do so.
Our management will have broad discretion as to the use of proceeds from
shares offered from time to time under this prospectus.
Our management will have broad discretion regarding how we use the net
proceeds from shares offered from time to time under this prospectus. You will
be relying on the judgment of management regarding the application of the
proceeds. The results and effectiveness of our use of the proceeds are
uncertain.
USE OF PROCEEDS
We intend to use the net proceeds from shares offered from time to time under
this prospectus to fund research and development, product commercialization,
potential product acquisitions, product development opportunities, working
capital and other general corporate purposes. We have discussions on an
ongoing basis regarding potential acquisitions and in-licensing opportunities
that are complementary to our business. We reserve the right, at the sole
discretion of our board of directors, to reallocate our use of proceeds in
response to these and other factors. Pending these uses, we intend to invest
the net proceeds from shares offered from time to time under this prospectus
in interest-bearing investment-grade securities.
PLAN OF DISTRIBUTION
We may sell our common stock from time to time (1) through underwriters; (2)
through dealers; (3) directly to one or more purchasers; or (4) through
agents. A prospectus supplement will detail the terms of the offering of the
common stock we offer thereby, including the name or names of any
underwriters, dealers, purchasers or agents, the purchase price of the common
stock and the proceeds to us from such sale, any underwriting discounts and
other items constituting underwriters' compensation, the public offering
price, and any discounts or concessions allowed or reallowed or paid to
dealers.
If we use underwriters in the sale, the underwriters will acquire the common
stock for their own account and may resell the common stock from time to time
in one or more transactions, including negotiated transactions, at a fixed
public offering price or at varying prices the parties determine at the time
of sale. The obligations of the underwriters to purchase the common stock will
be subject to certain conditions precedent, and the underwriters will be
obligated to purchase all the common stock offered by the prospectus
supplement if they purchase any of the securities. Any initial public offering
price and any discounts or concessions allowed or reallowed or paid to dealers
may be changed from time to time.
We may sell our common stock directly or through any firm we designate from
time to time. The prospectus supplement will detail the name of any agent
involved in the offer or sale of the common stock for which we the prospectus
supplement is delivered and any commissions we pay to the agent. Unless
otherwise indicated in the prospectus supplement, any such agent is acting on
a best efforts basis for the period of its appointment.
Underwriters, dealers and agents may be entitled under agreements they enter
into with us to indemnification by us against civil liabilities, including
liabilities under the Securities Act of 1933. Underwriters, dealers and agents
may engage in transactions with or perform services for us in the ordinary
course of business.
14
<PAGE>
LEGAL MATTERS
The validity of the issuance of the shares of common stock offered by us from
time to time under this prospectus will be passed upon for us by Dorsey &
Whitney LLP, Minneapolis, Minnesota.
EXPERTS
Our financial statements as of December 31, 1998 and 1999 and for each of the
years in the three-year period ended December 31, 1999 have been incorporated
by reference in this prospectus in reliance upon the report of KPMG LLP,
independent certified public accountants, incorporated by reference in this
prospectus, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the Securities and Exchange Commission a registration
statement on Form S-3 with respect to the common stock offered by this
prospectus. This prospectus, which constitutes a part of the registration
statement, does not include all of the information contained in the
registration statement. For further information about us and our common stock,
you should review the registration statement and its exhibits and schedules.
You may read and copy any document we file with the Commission at its public
reference room at 450 Fifth Street, NW, Washington, DC 20549, as well as at
its regional offices located at 7 World Trade Center, Suite 1300, New York, NY
10048 and Citicorp Center, 500 West Madison Street, Suite 1400, Chicago, IL
60661. Please call the Commission at 1-800-SEC-0330 for further information
about its public reference facilities and copy charges. Our filings are also
available to the public from the Commission's web site at http://www.sec.gov.
We file periodic reports, proxy statements and other information with the
Commission. These periodic reports, proxy statements and other information are
available for inspection and copying at the Commission's public reference room
and the regional offices listed above and can be obtained over the Internet
through the Commission's web site.
The Commission allows us to incorporate by reference information into this
prospectus. This allows us to disclose important information to you by
referring you to another document filed separately with the Commission. The
information we incorporate by reference is deemed to be part of this
prospectus, except for any information superceded by information contained
directly in this prospectus.
The documents that we are incorporating by reference are:
. our annual report on Form 10-K for the fiscal year ended December 31,
1999, as amended by Form 10-K/A-1 filed on March 31, 2000;
. our quarterly report on Form 10-Q for the quarter ended March 31, 2000
filed on May 5, 2000;
. our quarterly report on Form 10-Q for the quarter ended June 30, 2000
filed on August 11, 2000;
. our quarterly report on Form 10-Q for the quarter ended September 30,
2000 filed on November 14, 2000;
. our Form 8-A, filed on October 25, 1982, as amended on July 20, 1987;
and our Form 8-A filed on July 15, 1998, as amended on March 20, 2000,
all of which contain descriptions of our common stock;
. our Form 8-K filed on March 20, 2000;
. our Form 8-K filed on July 25, 2000; and
. our Form 8-K filed on December 1, 2000.
We also are incorporating by reference any future filings made by us with the
SEC under Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of
1934 until the completion of the offering of shares from time to
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<PAGE>
time under this prospectus. The most recent information that we file with the
SEC automatically updates and supercedes more dated information.
You can obtain a copy of any documents which are incorporated by reference in
this prospectus (other than an exhibit to a filing unless that exhibit is
specifically incorporated by reference into that filing) at no cost, by
writing or telephoning William Brown, at MGI PHARMA, INC., 6300 West Old
Shakopee Road, Suite 110, Minneapolis, MN 55438, (952) 346-4700.
------------
You should rely only on the information contained in this document or to which
we have referred you. We have not authorized anyone to provide you with
information that is different. This document may only be used where it is
legal to sell these securities. The information in this document may only be
accurate on the date of this document.
16
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following is an itemized statement of the estimated amounts of expenses
payable by the Registrant, other than underwriting discounts and commissions,
in connection with the registration of the common stock offered hereby. All
amounts are estimates except the SEC registration fee.
<TABLE>
<S> <C>
SEC Registration Fee............................................ $ 11,352
Legal Fees and Expenses......................................... 120,000
Accounting Fees and Expenses.................................... 65,000
Printing Fees................................................... 70,000
Transfer Agent Fees............................................. 1,500
Miscellaneous................................................... 52,148
--------
Total......................................................... $320,000
</TABLE>
Item 15. Indemnification of Officers and Directors
Minnesota Statutes Section 302A.521 provides that a corporation shall
indemnify any person made or threatened to be made a party to a proceeding by
reason of the former or present official capacity of such person against
judgments, penalties, fines (including, without limitation excise taxes
assessed against such person with respect to any employee benefit plan),
settlements and reasonable expenses, including attorneys' fees and
disbursements, incurred by such person in connection with the proceeding, if,
with respect to the acts or omissions of such person complained of in the
proceeding, such person (1) has not been indemnified therefor by another
organization or employee benefit plan; (2) acted in good faith; (3) received
no improper personal benefit and Section 302A.255 (with respect to director
conflicts of interest), if applicable, has been satisfied; (4) in the case of
a criminal proceeding, had no reasonable cause to believe the conduct was
unlawful; and (5) reasonably believed that the conduct was in the best
interests of the corporation in the case of acts or omissions in such person's
official capacity for the corporation or reasonably believed that the conduct
was not opposed to the best interests of the corporation in the case of acts
or omissions in such person's official capacity for other affiliated
organizations. The Bylaws of the Company provide that the Company shall
indemnify its officers and directors under such circumstances and to the
extent permitted by Section 302A.521 as now enacted or hereafter amended.
Item 16. Exhibits
<TABLE>
<CAPTION>
Exhibit
Number Description of Exhibit
------- ----------------------
<C> <S>
5.1 Opinion of Dorsey & Whitney LLP*
23.1 Consent of KPMG LLP**
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit 5.1)*
24.1 Power of Attorney (included on signature page)*
</TABLE>
--------
* Previously filed
** Filed herewith
Item 17. Undertakings
(a) Rule 415 Offering. The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement: (i) to include
any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) to reflect in the prospectus any facts or events arising after the
effective date of the
II-1
<PAGE>
registration statement, or the most recent post-effective amendment
thereof, which, individually or in the aggregate, represent a fundamental
change in the information set forth in the registration statement; and
(iii) to include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment 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.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
(b) Filings Incorporating Subsequent Exchange Act Documents by Reference. The
undersigned registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act of 1933, each filing of the registrant's
annual report pursuant to Section 13(a) or Section 15(d) of the Securities
Exchange Act of 1934, 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.
Insofar as indemnification for liabilities arising under the Securities Act of
1933 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 Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities
Act of 1933 and therefore is 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.
(c) Registration Statement Permitted by Rule 430A. The undersigned registrant
hereby undertakes that:
(1) For purposes of determining 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 pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act of 1933 shall be deemed to be part
of this registration statement as of the time it was declared effective.
(2) For the purpose of determining 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-2
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933 the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this Amendment No. 1
to the Registration Statement on Form S-3 to be signed on its behalf by the
undersigned, thereunto duly authorized in the City of Bloomington, State of
Minnesota, on December 29, 2000.
MGI PHARMA, INC.
By: /s/ Charles N. Blitzer
__________________________________
Charles N. Blitzer,
President and Chief Executive
Officer
Pursuant to the requirements of the Securities Act of 1933, as amended, this
Amendment No. 1 to the Registration Statement on Form S-3 has been signed
below by the following persons in the capacities indicated on December 29,
2000:
Signature Title
By: President, Chief Executive Officer
/s/ Charles N. Blitzer and Director (principal executive
---------------------------------- officer)
Charles N. Blitzer
By: Chief Financial Officer and
/s/ William C. Brown Secretary (principal financial and
---------------------------------- accounting officer)
William C. Brown
By: Director
*
----------------------------------
Andrew J. Ferrara
By: Director
*
----------------------------------
Joseph S. Frelinghuysen
By: Director
*
----------------------------------
Michael E. Hanson
By: Director
*
----------------------------------
Hugh E. Miller
By: Director
*
----------------------------------
Timothy G. Rothwell
By: Director
*
----------------------------------
Lee J. Schroeder
By: Director
*
----------------------------------
Arthur L. Weaver, M.D.
/s/ William C. Brown
*By:
----------------------------------
Attorney-In-Fact
II-3
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit
Number Description of Exhibit
------- ----------------------
<C> <S>
5.1 Opinion of Dorsey & Whitney LLP*
23.1 Consent of KPMG LLP**
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit 5.1)*
24.1 Power of Attorney (included on signature page)*
</TABLE>
--------
* Previously filed
** Filed herewith
