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FILED PURSUANT TO RULE 424(b)(3)
REGISTRATION NO. 333-86509
TARGETED GENETICS CORPORATION
[LOGO OF TARGETED GENETICS]
500,000 Shares of
Common Stock
Alkermes, Inc. may offer for sale up to 500,000 shares of Targeted Genetics
common stock from time to time. We will not receive any proceeds from the sale
of these shares.
Alkermes may sell the shares in transactions on the Nasdaq National Market,
in privately negotiated transactions, through options or otherwise.
Our common stock is quoted on Nasdaq under the symbol "TGEN." On November 16,
2000, the last reported sales price of our common stock was $10.56 per share.
Investing in this stock involves risks.
See "Risk Factors" beginning on page 2.
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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.
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The date of this prospectus is November 17, 2000.
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RISK FACTORS
In addition to the other information contained in this prospectus, you should
read and consider the following risk factors. If any of these risks actually
occur, our business, financial condition or operating results could be
adversely affected and the trading price of our stock could decline.
If we are unable to secure financing on terms acceptable to us for future
capital needs, we will be unable to fund continuing operations.
Developing and commercializing our potential products will require
substantial additional financial resources. Because internally generated cash
flow will not fund development and commercialization of our products, we will
look to outside sources for funding. These sources could involve one or more of
the following types of transactions:
. technology partnerships;
. technology sales;
. technology licenses;
. issuing debt; or
. issuing equity.
If we cannot obtain additional financing when needed or on acceptable terms, we
will be unable to fund continuing operations.
We have a history of losses and may never become profitable, which could result
in a decline in the value of our common stock and a loss of your investment.
We have generated small amounts of revenue and incurred significant net
losses since we began business. As of September 30, 2000, we have incurred
cumulative losses totaling $138.9 million. We expect to continue to incur
substantial additional losses in the future, due primarily to the following
factors:
. all of our products are in a testing phase and have not received
regulatory approval; and
. we will spend significant amounts on operating expenses.
We may never generate profits, and if we do become profitable, we may be unable
to sustain or increase profitability on a quarterly or annual basis. As a
result, the trading price of our stock could decline and you could lose all or
part of your investment.
If our clinical trials are unsuccessful or we do not receive regulatory
approval for our products, which are in the early stage of product development,
we may be unable to generate sufficient revenue to maintain our business.
All of our potential products are in research and development or in early-
stage clinical trials. We cannot apply for regulatory approval of our potential
products until we have performed additional research and development and
testing. Our clinical trials may not demonstrate the safety and efficacy of any
potential product, and we may encounter unacceptable side effects or other
problems in the clinical trials. Should this occur, we may have to delay or
discontinue development of the potential product. After a successful clinical
trial, we cannot market any product in the United States until we receive
regulatory approval. If we are unable to gain regulatory approval of any
product after successful clinical trials, we may be unable to generate
sufficient product revenue to maintain our business.
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Delays or unexpected costs in obtaining approval of our potential products or
complying with governmental regulatory requirements could make it more
difficult to maintain or improve our financial condition.
The regulatory process in the gene therapy industry is costly, time consuming
and subject to unpredictable delays. Accordingly, we cannot predict how long it
will take or how much it will cost to obtain regulatory approvals for clinical
trials or for manufacturing or marketing our potential products. Delays in
bringing a potential product to market or unexpected costs in obtaining
regulatory approval could decrease our ability to generate product sales
revenue. In addition, all manufacturing operations are subject on an ongoing
basis to the current Good Manufacturing Practices, or GMP, requirements of the
Food and Drug Administration, or FDA. While we currently anticipate that we
will be able to manufacture products that meet this requirement, we may be
unable to attain or maintain compliance with current or future GMP
requirements. If we discover previously unknown problems after we receive
regulatory approval of a potential product or fail to comply with applicable
regulatory requirements, we may suffer restrictions on our ability to market
the product, including mandatory withdrawal of the product from the market.
This, or an unexpected increase in the cost of compliance, could make it more
difficult to maintain or improve our financial condition.
Failure to recruit patients could delay or prevent clinical trials of our
potential products, which could cause a delay or inability to develop our
potential products.
Identifying and qualifying patients to participate in testing our potential
products is critical to our near-term success. The timing of our clinical
trials depends on the speed at which we can recruit patients to participate in
testing our products. Delays in recruiting or enrolling patients to test our
products could result in increased costs, delays in advancing our product
development, delays in proving the usefulness of our technology or termination
of the clinical trials altogether. Any of these could delay or prevent the
development of our product candidates.
Our business will not succeed if our technology and products fail to achieve
market acceptance.
Even if our or our corporate partners' potential products succeed in clinical
trials and are approved for marketing, these products may never achieve market
acceptance. Competing gene delivery products or alternative treatment methods,
including more traditional approaches to treating disease, may be more
effective or may be more economically feasible than our products. Moreover,
doctors, patients, the medical community in general or the public may never
accept or use any products based on gene delivery or other technologies
developed by us or our corporate partners.
We may be unable to adequately protect our proprietary rights, which may limit
our ability to compete effectively.
Our success depends in part on our ability to protect our proprietary rights.
We own or have licenses to patents on a number of genes, processes, practices
and techniques critical to our present and potential products. If we fail to
obtain and maintain patent protection for this technology, our competitors
could market competing products using those genes, processes, practices and
techniques. The failure of our licensors to obtain and maintain patent
protection for technology they license to us could similarly harm our business.
Patent positions in the field of biotechnology are highly uncertain and involve
complex legal, scientific and factual questions. Our patent applications may
not result in issued patents. Even if we secure a patent, the patent may not
provide meaningful protection.
We also rely on unpatented proprietary technology. Because this technology
does not benefit from the protection of patents, we may be unable to
meaningfully protect this proprietary technology from unauthorized use or
misappropriation by a third party.
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Intellectual property claims and litigation could subject us to significant
liability for damages and invalidation of our proprietary rights.
As the biotechnology industry expands, the risk increases that other
companies may claim that our processes and potential products infringe on their
patents. Defending these claims would be costly and would likely divert
management's attention and resources away from our operations. If we infringe
on another company's patented processes or technology, we may have to pay
damages or obtain a license in order to continue manufacturing or marketing the
affected product or using the affected process. If we are unable to obtain a
license, or obtain a license on acceptable terms, we may be unable to develop
or commercialize some or all of our potential products and our business could
be harmed.
Our potential tgAAV-CF product uses our proprietary AAV delivery technology
to deliver a normal copy of a CFTR gene to which we have rights under a
nonexclusive license. The United States Patent and Trademark Office has
declared an interference proceeding to determine the priority of invention of
this gene. If the eventual outcome does not favor our licensor, we would have
to secure a license to the CFTR gene from the prevailing party to continue
developing tgAAV-CF. The costs of licensing the CFTR gene could be substantial
and could include royalties greater than those we currently pay. If we cannot
secure this license on acceptable terms and on a timely basis, we may be unable
to develop or deliver our potential tgAAV-CF product.
We may be unable to develop and commercialize some of our potential products if
our relationships with scientific collaborators and corporate partners are not
successful.
Our success also depends on the continued availability of outside scientific
collaborators to perform research and develop processes to advance and augment
our internal efforts. Competition for collaborators in gene therapy is intense.
If we are unsuccessful in recruiting or maintaining our relationships with
scientific collaborators, we could experience delays in our research and
development or loss of access to important enabling technology. Even if we
establish new scientific collaborations or other partnerships, they may never
result in the successful development of products.
The development and commercialization of many of our potential products, and
therefore the success of our business, substantially depends on the performance
of our collaborators. If our corporate partners do not commit sufficient
resources to our research and development programs or the commercialization of
our products, the preclinical or clinical development related to the
collaboration could be delayed or terminated. Our current or future
collaborators may develop or market competing products or alternative
technologies. In addition, disputes may arise with respect to ownership of
technology developed under any such collaborations. Moreover, our corporate
partners may terminate any existing partnerships, and we may be unable to enter
into additional collaborations on acceptable terms, or at all.
If we are unable to license necessary technology from third parties, we may be
unable to successfully develop and commercialize our potential products.
Our success depends on our ability to enter into licensing arrangements with
commercial or academic organizations to obtain technology used in developing or
commercializing our or our partners' product candidates. Various license
agreements give us and our partners rights to use technologies owned or
licensed by third parties in research, development and commercialization of our
potential products. Disputes may arise regarding rights to inventions and know-
how resulting from the joint creation or use of intellectual property by us and
our licensors or scientific collaborators. In addition, many of our in-
licensing agreements contain milestone-based termination provisions. If we or
any of our corporate partners fail to meet agreed milestones, a licensor could
terminate the relevant agreement.
If we are unable to maintain our current licenses and obtain additional
licenses in the future on acceptable terms, we and our corporate partners may
be required to expend significant time and resources to develop or
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in-license replacement technology. If we are unable to do so, we may be unable
to develop or commercialize some or all of our potential products and our
business may suffer.
If we or our business partners are unable to successfully market and distribute
any potential product, our business will be harmed.
We have no experience in sales and marketing. To market any products that may
result from our development programs, we will need to develop marketing and
sales capabilities, either on our own or with others. We intend to enter into
collaborations with corporate partners to utilize the mature marketing and
distribution capabilities of our partners. While we believe that these
collaborative partners will be motivated to market and distribute our potential
products, our current and potential future partners may not commit sufficient
resources to commercializing our technology on a timely basis. If our business
partners do not successfully market and distribute our products and we are
unable to develop sufficient marketing and distribution capabilities on our
own, our business will be harmed.
The intense competition and rapid technological change in our market may result
in pricing pressures and failure of our potential products to achieve market
acceptance.
We presently face competition from other companies developing gene therapy
technologies and from companies using more traditional approaches to treating
human diseases. Most of our competitors have substantially more experience and
financial and infrastructure resources than we do in the following areas:
. research and development;
. clinical trials;
. obtaining FDA and other regulatory approvals;
. manufacturing; and
. marketing and distribution.
Consequently, our competitors may be able to commercialize new products more
rapidly than we do, or manufacture and market competitive products more
successfully than we do. This could result in pricing pressures or our products
failing to achieve market acceptance.
In addition, gene therapy is a new and rapidly evolving field and is expected
to continue to undergo significant and rapid technological change. Rapid
technological development by our competitors could result in our actual and
proposed technologies, products or processes losing market share or becoming
obsolete.
If we do not attract and retain qualified personnel, we will be unable to
successfully and timely develop our potential products.
Our future success depends in part on our ability to attract and retain key
employees. We have programs in place to retain personnel, including programs to
create a positive work environment and competitive compensation packages.
Because competition for employees in our field is intense, however, we may be
unable to retain our existing personnel or attract additional qualified
employees. If we experience turnover or difficulties recruiting new employees,
our research and development could be delayed and we could experience
difficulties in generating sufficient revenue to maintain our business.
Our limited manufacturing capability may limit our ability to successfully
introduce our potential products.
We currently do not have the capacity to manufacture large-scale clinical or
commercial quantities of our potential products. To do so, we will need to
expand our current facilities and staff or supplement them through
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the use of contract providers. We have recently leased a building for the
purpose of developing a facility to manufacture AAV vectors for Phase III and
early commercial purposes. This manufacturing facility, if successfully
developed, as well as any future manufacturing facilities that we may
construct, will be subject to initial and ongoing regulation by the FDA and
other governmental agencies. We may be unable to obtain regulatory approval for
or maintain in operation this or any other manufacturing facility. If we are
unable to obtain and maintain the necessary manufacturing capabilities, either
alone or through third parties, we will be unable to introduce sufficient
product to sustain our business.
Our use of hazardous materials to develop our potential products exposes us to
liability risks and the risk of regulatory limitation of our use of these
materials, either of which could harm our financial condition and reduce our
ability to generate product sales revenue.
Our research and development activities involve the controlled use of
hazardous materials. Although we believe that our safety procedures for
handling and disposing of these materials comply with applicable laws and
regulations, we cannot eliminate the risk of accidental contamination or injury
from hazardous materials. If a hazardous material accident occurred, we would
be liable for any resulting damages. This liability could exceed our financial
resources. Additionally, hazardous materials are subject to regulatory
oversight. Accidents unrelated to our operations could cause federal, state or
local regulatory agencies to restrict our access to hazardous materials needed
in our research and development efforts. If our access to these materials is
limited, we could experience delays in our research and development programs.
Paying damages or experiencing delays caused by restricted access could reduce
our ability to generate product sales revenue and make it more difficult to
fund our operations.
The costs of product liability and other claims and product recalls could
exceed the amount of our insurance, which could significantly harm our
financial condition or our reputation.
Our business activities expose us to the risk of liability claims or product
recalls and any adverse publicity that might result from a liability claim
against us. We currently have only limited amounts of liability insurance, and
the amounts of claims against us may exceed our insurance coverage. Liability
insurance is expensive and may not continue to be available on acceptable
terms. A product liability or other claim not covered by insurance or in excess
of our insurance or a product recall could significantly harm our financial
condition or our reputation.
Our recent acquisition of Genovo, Inc. and any future acquisitions could be
costly, difficult to integrate and disruptive of our business.
In September 2000, we acquired Genovo, Inc., a privately held biotechnology
company specializing in viral gene delivery. In the future, we may acquire
additional complementary companies, products or technologies. Managing the
Genovo acquisition entails, and any future acquisition will entail, numerous
operational and financial risks and strains, including:
. difficulties in assimilating the operations, technologies, products or
potential products and personnel of the acquired company;
. potential loss of key employees of the acquired company;
. disruption of our business;
. diversion of management's attention from our core business;
. assumption of known and unknown liabilities;
. higher-than-expected acquisition and integration costs and charges
against earnings; and
. potentially dilutive issuances of equity securities.
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We may be unable to successfully integrate Genovo or any future acquisition
with our existing operations or successfully develop any acquired product
candidates or technologies. We may not gain any substantial benefit from the
Genovo acquisition or any products, technologies or businesses that we acquire
in the future, notwithstanding the expenditure of a significant amount of time
and financial, personnel and other resources.
Market fluctuations or volatility could cause the market price of our common
stock to decline.
In recent years the stock market in general and the market for biotechnology-
related companies in particular have experienced extreme price and volume
fluctuations, often unrelated to the operating performance of the affected
companies. Our common stock has experienced, and is likely to continue to
experience, these fluctuations in price, regardless of our performance. These
fluctuations could cause the market price of our common stock to decline.
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SELLING SHAREHOLDER
The following table provides information regarding Alkermes, Inc. and the
number of shares being offered by Alkermes. The percentage ownership data is
based on the number of shares of our common stock outstanding as of March 10,
2000, the most recent practicable date before the effectiveness of the
registration statement of which this prospectus is a part. The information
regarding shares beneficially owned after the offering assumes the sale of all
shares offered by Alkermes.
<TABLE>
<CAPTION>
Shares Beneficially
Shares That May Be Sold Owned After Offering
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Shares Beneficially Percentage of Shares Percentage of
Owned Before Common Stock Being Common Stock
Beneficial Owner Offering Outstanding Offered Amount Outstanding
---------------- ------------------- ------------- ------- ------ -------------
<S> <C> <C> <C> <C> <C>
Alkermes,
Inc. .......... 500,000 1.5% 500,000 -- --
</TABLE>
Except as a shareholder, Alkermes has not had a material relationship with
Targeted Genetics, or any of its affiliates, within the past three years.
Alkermes received all of the shares covered by this prospectus from Targeted
Genetics in a private transaction on June 9, 1999. All of the shares were
"restricted securities" under the Securities Act before this registration.
Alkermes has represented to us that it purchased the shares for its own
account, for investment only and not with a view towards selling or
distributing them, except in sales registered under the Securities Act of 1933
or exempted from the registration requirements of the Securities Act. In
recognition of the fact that Alkermes, even though purchasing the shares for
investment, may wish to be legally permitted to sell its shares when it deems
appropriate, we agreed with Alkermes to file a registration statement to
register the resale of the shares and to prepare and file all amendments and
supplements necessary to keep the registration statement effective until the
earlier of (1) the date on which Alkermes has sold all the shares or (2) the
date on which Alkermes may sell all of the shares under Rule 144(k) under the
Securities Act.
PLAN OF DISTRIBUTION
Alkermes or its transferees or other successors-in-interest may sell the
shares of common stock offered by this prospectus from time to time, in one or
more transactions. Alkermes may sell the shares at fixed prices that may
change, at market prices at the time of sale or at negotiated prices. Alkermes
may sell the shares
. through the Nasdaq National Market or any other national securities
exchange on which our common stock is then listed,
. in privately negotiated transactions,
. through options or otherwise, or
. through a combination of these.
Alkermes may sell the shares to or through broker-dealers, who may receive
compensation in the form of discounts, concessions or commissions from Alkermes
or the purchasers. Any broker-dealer may act as a broker-dealer on behalf of
Alkermes in connection with the offering of the shares. We will not receive any
of the proceeds from the sale of the shares by Alkermes.
Alkermes may sell any shares covered by this prospectus that qualify for sale
under Rule 144 of the Securities Act in transactions complying with Rule 144,
rather than through this prospectus.
If required, we will distribute a supplement to this prospectus to describe
material changes in the terms of the offering. We have the right to suspend the
use of this prospectus for up to 30 days if we notify Alkermes of an event that
would cause the information about us in this prospectus us to become untrue or
omit to state a material fact.
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Any broker-dealers who assist in the sale of the shares covered by this
prospectus may be considered "underwriters" within the meaning of Section 2(11)
of the Securities Act. Any commissions they receive or profits they earn on the
resale of the shares may be underwriting discounts and commissions under the
Securities Act. Subject to limited exceptions, we have agreed to bear all
expenses in connection with the registration and sale of the shares being
offered by Alkermes. We have also agreed to indemnify Alkermes and the broker-
dealers who act in connection with the sale of the shares against liabilities
they incur in connection with the sale of the shares, including liabilities
under the Securities Act.
Alkermes may be unable to sell any or all of the shares covered by this
prospectus.
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VALIDITY OF COMMON STOCK
Perkins Coie LLP, Seattle, Washington has provided Alkermes with an opinion
that the shares of common stock offered by this prospectus are duly authorized,
validly issued, fully paid and nonassessable.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our financial
statements included in our annual report on Form 10-K for the year ended
December 31, 1999, as described in their report, which is incorporated by
reference into this prospectus and elsewhere into the registration statement of
which this prospectus is a part. Our financial statements are incorporated by
reference in reliance on Ernst & Young LLP's report, given on their authority
as experts in accounting and auditing.
Ernst & Young, chartered accountants, have audited the financial statements
of Emerald Gene Systems, Ltd. included in our annual report on Form 10-K for
the year ended December 31, 1999, as described in their report, which is
incorporated by reference into this prospectus and elsewhere in the
registration statement of which this prospectus is a part. The financial
statements of Emerald Gene Systems, Ltd. are incorporated by reference in
reliance on Ernst & Young, chartered accountants' report, given on their
authority as experts in accounting and auditing.
KPMG LLP, independent auditors, have audited the financial statements of
Genovo, Inc. as of June 30, 2000 and 1999 and for the years then ended and for
the period from September 12, 1992 (inception) to June 30, 2000, included in
our current report on Form 8-K/A dated September 19, 2000 and amended November
9, 2000, which is incorporated by reference into this prospectus and elsewhere
in the registration statement of which this prospectus is a part, in reliance
on the report of KPMG LLP, incorporated by reference into this prospectus and
the registration statement, and on the authority of that firm as experts in
accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. Our SEC filings are available to the public over the
Internet at the SEC's website at http://www.sec.gov. The SEC's website contains
reports, proxy statements and other information regarding issuers, such as
Targeted Genetics, that file electronically with the SEC. You may also read and
copy any document we file with the SEC at the SEC's Public Reference Room at
450 Fifth Street, N.W., Washington, D.C. 20549. You may also obtain copies of
the documents at prescribed rates by writing to the Public Reference Section of
the SEC at 450 Fifth Street, N.W., Washington, D.C. 20549. Please call the SEC
at 1-800-SEC-0330 for further information on the operation of its Public
Reference Room.
The SEC allows us to "incorporate by reference" into this prospectus the
information we have filed with the SEC, which is considered to be part of this
prospectus. We incorporate by reference the documents listed below:
. Our annual report on Form 10-K for the fiscal year ended December 31,
1999;
. Our quarterly reports on Form 10-Q for the quarters ended March 31,
2000, and June 30, 2000 and September 30, 2000;
. Our current reports on Form 8-K, filed on August 23, 2000, September 13,
2000 and October 2, 2000 (as amended November 9, 2000); and
. The description of our capital stock contained in our registration
statements on Form 8-A, filed April 26, 1994 and October 22, 1996,
including any amendments or reports we have filed to update that
description.
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We also incorporate by reference all documents we file under Section 13(a),
13(c) 14 or 15(d) of the Exchange Act (a) after the filing date of the
registration statement of which this prospectus is a part and before the
effectiveness of the registration statement and (b) after the effectiveness of
the registration statement and before the shares registered under the
registration statement are sold. The most recent information that we file with
the SEC automatically updates and supercedes older information. The information
contained in any such filing will be deemed to be a part of this prospectus as
of the date on which the document is filed, and any older information that has
been modified or superceded will not be deemed to be part of this prospectus.
You may request a copy of these filings, at no cost, by writing or
telephoning us at the following address:
Targeted Genetics Corporation
Attention: Investor Relations
1100 Olive Way, Suite 100
Seattle, Washington 98101
(206) 623-7612
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained in or incorporated by reference into this
prospectus are forward-looking statements. Forward-looking statements involve
current expectations or forecasts of future events and other statements that
are not historical facts. Inaccurate assumptions and known or unknown risks and
uncertainties can affect the accuracy of forward-looking statements. Any or all
of the forward-looking statements contained in this prospectus, incorporated by
reference into this prospectus, or included in any materials we release to the
public from time to time may turn out to be incorrect. Actual results could
differ materially from those expressed in the forward-looking statements for a
number of reasons, including the factors discussed in the section of this
prospectus entitled Risk Factors.
You should not unduly rely on these forward-looking statements, which speak
only as of the date of this prospectus. We undertake no obligation to update
any forward-looking statements to reflect new information or circumstances or
the occurrence of unanticipated events. Other risks besides those described in
this prospectus could also affect actual results. Moreover, we cannot assess
the impact of any particular risk factor on our business or the extent to which
any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
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You should rely only on the information contained in this prospectus.
Neither we nor Alkermes, Inc. has authorized anyone to give you different
information or representations. This prospectus is an offer to sell, and a
solicitation of offers to buy, the shares offered by this prospectus only in
jurisdictions where offers and sales are permitted.
The information contained in this prospectus is correct only as of the date
of this prospectus, regardless of the time of delivery of this prospectus or
any sale of the common stock offered by this prospectus.
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TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
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<S> <C>
Risk Factors............................................................... 2
Selling Shareholder........................................................ 8
Plan of Distribution....................................................... 8
Validity of Common Stock................................................... 10
Experts.................................................................... 10
Where You Can Find More Information........................................ 10
Special Note Regarding Forward-Looking Statements.......................... 12
</TABLE>
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500,000 Shares
[LOGO OF TARGETED GENETICS]
TARGETED GENETICS CORPORATION
Common Stock
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PROSPECTUS
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November 17, 2000
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