As filed with the Securities and Exchange Commission on May 20, 2004
Registration No. 333-109367
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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POST-EFFECTIVE AMENDMENT NO. 3
TO
FORM S-2
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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MIRAVANT MEDICAL TECHNOLOGIES
(Exact name of registrant as specified in its charter)
Delaware 77-0222872
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
336 Bollay Drive
Santa Barbara, California 93117
(805) 685-9880
(Address, including zip code, and telephone number, including area code,
of registrant's principal executive offices)
GARY S. KLEDZIK, Ph.D.
Chief Executive Officer
Miravant Medical Technologies
336 Bollay Drive
Santa Barbara, California 93117
(805) 685-9880
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
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Copies to:
JOHN T. SHERIDAN, Esq.
JASON P. SEBRING, Esq.
Wilson Sonsini Goodrich & Rosati, a Professional Corporation
650 Page Mill Road
Palo Alto, CA 94304-1050
(650) 493-9300
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Approximate date of commencement of proposed sale to the public:
FROM TIME TO TIME AFTER THIS REGISTRATION STATEMENT BECOMES EFFECTIVE.
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If any of the securities 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 this Form is a post-effective amendment filed pursuant to Rule 462(d)
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. |_|
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The registrant hereby amends this registration statement on such date or
dates as may be necessary to delay its effective date until the registrant shall
file a further amendment which specifically states that this registration
statement shall thereafter become effective in accordance with section 8 (a) of
the Securities Act of 1933 or until the registration statement shall become
effective on such date as the commission, acting pursuant to said section 8 (a),
may determine.
We have not authorized any dealer, salesperson or any other person to give
any information or to represent anything not contained in this prospectus. You
must not rely on any unauthorized information. This prospectus does not offer to
sell or seek an offer to buy any shares in any jurisdiction where it is
unlawful. The information contained in this prospectus is correct only as of the
date of this prospectus, regardless of the time of the delivery of this
prospectus or any sale of the shares.
EXPLANATORY NOTE
This is not a new offering or new registration of selling securityholders.
This is a Post-Effective Amendment No. 3 to Form S-2 of Miravant Medical
Technologies (333-109367) filed on October 1, 2003. The purpose of this
Post-Effective Amendment is to update certain disclosures throughout the
document and in the selling securityholders table. The prospectus also
incorporates by reference the information contained in the Company's Annual
Report on Form 10-K for the year ended December 31, 2003 and in the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2004.
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8,745,000 Shares of Common Stock of
MIRAVANT MEDICAL TECHNOLOGIES
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PROSPECTUS
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May [ ], 2004
TABLE OF CONTENTS
Page
Summary..........................................................4
Recent Developments..............................................5
Risk Factors.....................................................8
Use of Proceeds.................................................23
Selling Securityholders.........................................24
Plan of Distribution............................................28
Description of Capital Stock....................................29
Where You Can Find More Information.............................30
Note Regarding Forward-Looking Statements.......................30
Legal Matters...................................................31
Experts.........................................................31
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. THE
SELLING SECURITYHOLDERS MAY NOT SELL THESE SECURITIES UNTIL THE RELATED
REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS
EFFECTIVE.
.........
SUBJECT TO COMPLETION, DATED MAY [ _ ], 2004
PROSPECTUS
8,745,000 Shares of Common Stock of
MIRAVANT MEDICAL TECHNOLOGIES
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The selling securityholders listed in this prospectus may offer and sell up
to 8,745,000 shares of Common Stock of Miravant Medical Technologies for their
own account. We will not receive any proceeds from such sales. Of these shares,
4,500,000 shares are issuable upon the conversion of the debentures issued, up
to 480,000 shares of Common Stock reserved for issuance of interest payments on
those debentures and 3,375,000 shares are to be issued upon the exercise of
related warrants issued in connection with the private debt offering in August
2003, and 390,000 shares were issued in connection with an agreement to retire
$10.6 million of debt. Pursuant to Rule 416 under the Securities Act, this
prospectus also covers an indeterminate number of additional securities that may
become issuable from time to time in connection with any stock split, stock
dividend or similar transaction.
Our Common Stock is listed on the OTC Bulletin Board Quotation System, or
the OTCBB, under the symbol "MRVT." On May 19, 2004, the last reported sale
price for our Common Stock on the OTCBB was $1.98 per share.
Investment in our Common Stock involves a high degree of risk. See "Risk
Factors" beginning on page 6 to read about factors you should consider before
buying shares of our Common Stock.
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Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
accuracy or adequacy of this prospectus. Any representation to the contrary is a
criminal offense.
The date of this prospectus is May [__], 2004
SUMMARY
We are a pharmaceutical research and development company specializing in
photodynamic therapy, or PDT, a treatment modality based on drugs that respond
to light. When activated by light, these drugs induce a photochemical reaction
in the presence of oxygen that can be used to locally destroy diseased cells and
abnormal blood vessels. We have branded our novel version of PDT technology with
the trademark PhotoPoint(R). Our drugs and devices are in various stages of
development and have not yet been evaluated by the FDA for regulatory approval.
Our most advanced drug, PhotoPoint SnET2, has completed Phase III clinical
trials for the treatment of wet age-related macular degeneration, or AMD, and on
March 31, 2004 we submitted a New Drug Application, or NDA, for its marketing
approval.
We believe that PhotoPoint PDT is a platform technology that has the
potential to provide safe and effective treatments for a number of diseases
including those in ophthalmology, dermatology, cardiovascular disease and
oncology. Our current objective is to develop our PhotoPoint technology for
disease indications with large potential market opportunities and/or unmet
medical needs. Our strategy is to develop PhotoPoint PDT as a primary therapy
and, where appropriate, as a combination therapy with other treatments such as
surgery or drug therapy to achieve efficacious clinical results.
We believe that commercial success will depend upon safety and efficacy
outcomes, regulatory approvals, competition, third-party reimbursements and
other factors such as the manufacturing, marketing, sales and distribution of
our products. At this time, the scope of our business is research and
development with limited manufacturing capabilities. For large-scale
manufacturing, marketing, sales and distribution activities, we may elect to use
outside contractors and/or develop these capabilities internally, or seek
strategic collaborations with pharmaceutical and medical device partners in
certain therapeutic areas.
We were incorporated in Delaware in 1989 and, effective September 15, 1997,
changed our name from PDT, Inc. to Miravant Medical Technologies. Our executive
offices and the offices of our three subsidiaries, Miravant Pharmaceuticals,
Inc., Miravant Systems, Inc. and Miravant Cardiovascular, Inc., are located at
336 Bollay Drive, Santa Barbara, California 93117. Our telephone number is (805)
685-9880. Unless otherwise indicated, all references to us also include our
subsidiaries.
RECENT DEVELOPMENTS
On March 31, 2004 we submitted an NDA to the U.S. Food and Drug
Administration, or FDA, seeking marketing approval of SnET2-PDT as a new
treatment for patients with wet AMD. Wet AMD, a vision-threatening disorder, is
characterized by the growth of abnormal blood vessels (subfoveal choroidal
neovascularization, or CNV) at the back of the eye. The CNV lesions leak fluid
and blood that can lead to severe loss of central vision. SnET2-PDT uses a
light-activated drug designed to selectively destroy the abnormal blood vessels
and stabilize vision loss. Our NDA submission is based on clinical data from two
randomized, placebo-controlled, parallel group Phase III studies conducted at 60
U.S. ophthalmology centers. The study population included patients with CNV
associated with AMD who were followed for two years and evaluated for
re-treatment every 13 weeks. Our decision to submit an NDA came after we
completed a comprehensive analyses of the Phase III AMD clinical data for two
independent trials completed in December 2001 and after holding discussions with
our regulatory consultants and the ophthalmic division of the FDA. Our analyses
showed positive results in a significant number of PhotoPoint SnET2 treated
patients versus placebo control patients in the "per protocol" population. The
per protocol population consists of those patients who received the exposure to
the SnET2 treatment regimen pre-specified in the clinical study protocol,
comprising a smaller number of patients than the total study population. Within
60 days of NDA submission, the FDA will make a determination to accept or refuse
to file the NDA and, if accepted, will designate its review status. SnET2-PDT
has previously been designated a fast-track product by the FDA, and Miravant is
requesting priority review status for the drug, which, if granted, could result
in the NDA being reviewed within six months of filing acceptance.
On April 23, 2004, we entered into a Securities Purchase Agreement with a
group of institutional investors, pursuant to which we sold 4,564,000 shares of
Common Stock at $2.25 per share, resulting in proceeds to us of approximately
$10.3 million. No warrants were issued in connection with this offering. In
addition, we entered into a registration rights agreement with these investors
pursuant to which we are obligated to file a registration statement with the
Securities and Exchange Commission, or SEC, covering the resale of these shares
of Common Stock, which was filed on April 29, 2004.
In February 2004, we entered into an Unsecured Convertible Debenture
Purchase Agreement, or the February 2004 Debt Agreement, with certain private
accredited investors, or the February 2004 Lenders. Under the February 2004 Debt
Agreement we issued $2.0 million worth of convertible debentures maturing on
February 5, 2008 with interest accruing at 8% per year, due and payable
quarterly, with the first interest payment due on April 1, 2004. At our option
and subject to certain restrictions, we may make interest payments in cash or in
shares of our Common Stock, or the interest can be added to the outstanding
principal of the note. Each convertible debenture issued pursuant to the
February 2004 Debt Agreement is convertible at the holder's option into shares
of our Common Stock at $2.00 per share. Upon the occurrence of certain events of
default, the holders of the convertible debentures may require that they be
repaid prior to maturity. These events of default include our failure to pay
amounts due under the debentures or to otherwise perform any material covenant
in the February 2004 Debt Agreement or other related documents.
In August 2003, we entered into an Unsecured Convertible Debenture and
Warrant Purchase Agreement, or the 2003 Debt Agreement, with certain private
accredited investors, or the 2003 Lenders. Under the 2003 Debt Agreement we
borrowed $6.0 million, with interest accruing at 8% per year and due and payable
quarterly, with the first interest payment due on October 1, 2003. The principal
amount matures on August 28, 2006. At our option and subject to certain
restrictions, we may make interest payments in cash or in shares of Common
Stock. Upon the occurrence of certain events of default, the holders of the
convertible debentures may require that they be repaid prior to maturity. Some
of the events of default include if we fail to pay amounts due under the
debentures or to otherwise perform any material covenant in the 2003 Debt
Agreement or other related documents, or the rejection of our NDA submission by
the FDA or the occurrence of certain insolvency-related events. In connection
with the 2003 Debt Agreement, we issued two warrants to each 2003 Lender to
purchase a total of 4,750,000 shares of our Common Stock, each with an
expiration date of August 28, 2008 and an exercise price of $1.00 per share. As
of May 14, 2004, $2.6 million of the notes have been converted into 2,600,000
shares of Common Stock and warrants covering 1,425,000 shares of Common Stock
have been exercised.
In March 2003, we amended our December 2002 Convertible Debt and Warrant
Purchase Agreement, or the 2002 Debt Agreement, that we entered into with a
group of private accredited investors, or the 2002 Lenders. The 2002 Debt
Agreement allows us to borrow up to $1.0 million per month. For each borrowing a
note is issued, which is due on December 31, 2008 and earns interest of 9.4% per
year. The interest is payable monthly and can be added to the outstanding
principal of each note, paid in cash or paid in the form of Common Stock. In
April 2004, based on our recent $10.3 million funding, we and the 2002 Lenders
have mutually agreed to terminate the borrowing obligations under the 2002 Debt
Agreement. As of May 14, 2004, we had borrowed $6.3 million under the 2002 Debt
Agreement and have issued to the 2002 Lenders warrants to purchase 3,150,000
shares of our Common Stock with an exercise price of $1.00 and upon the
execution of the 2002 Debt Agreement, we issued an origination warrant to
purchase 250,000 shares of our Common Stock, with an exercise price of $0.50 per
share. Warrants for the purchase of 1,575,000 shares will terminate on August
28, 2008 and warrants for the purchase of 1,825,000 shares will terminate on
December 31, 2008, unless previously exercised.
Based on our ability to successfully obtain additional funding, our ability
to obtain new collaborative partners, our ability to license and pursue
development and commercialization of SnET2 for AMD or other disease indications,
our ability to reduce operating costs as needed, our ability to regain our
listing status on Nasdaq or an alternative exchange and various other economic
and development factors, such as the cost of the programs, reimbursement and the
available alternative therapies, we may or may not be able to or elect to
further develop PhotoPoint PDT procedures in ophthalmology, cardiovascular
disease, dermatology, oncology or in any other indications. If we are unable to
secure additional funding we may be unable to continue as a going concern.
RISK FACTORS
FACTORS AFFECTING FUTURE OPERATING RESULTS
The following section of this report describes material risks and
uncertainties relating to Miravant and our business. Our business operations may
be impaired by additional risks and uncertainties that we are not aware of or
that we currently consider immaterial. Our business, results of operations or
cash flows may be adversely affected if any of the following risks actually
occur. In such case, the trading price of our Common Stock could decline.
RISKS RELATED TO OUR BUSINESS
WE HAVE A HISTORY OF SIGNIFICANT OPERATING LOSSES AND EXPECT TO CONTINUE TO HAVE
LOSSES IN THE FUTURE, WHICH MAY FLUCTUATE SIGNIFICANTLY AND WE MAY NEVER ACHIEVE
PROFITABILITY.
We have incurred significant losses since our inception in 1989 and, as of
March 31, 2004, had an accumulated deficit of approximately $202.5 million. In
each of the last three years, we have increased our borrowings through the sale
of various debt instruments in order to sustain our business operations. We
expect to continue to incur significant, and possibly increasing, operating
losses over the next few years, and we believe we will be required to obtain
substantial additional debt or equity financing to fund our operations during
this time as we seek to achieve a level of revenues sufficient to support our
anticipated cost structure. Our independent auditors, Ernst & Young LLP, have
indicated in their report accompanying our December 31, 2003 consolidated
financial statements that, based on generally accepted auditing standards, our
viability as a going concern is in question.
Although we continue to incur costs for research and development,
preclinical studies, clinical trials and general corporate activities, we have
continued to adhere to our cost restructuring program we implemented in 2002
which has helped reduce our overall costs. Our ability to achieve and sustain
profitability depends upon our ability, alone or with others, to receive
regulatory approval on our NDA submission for SnET2 in AMD, to successfully
complete the development of our proposed products, obtain the required
regulatory clearances and manufacture and market our proposed products. No
revenues have been generated from commercial sales of SnET2 and only limited
revenues have been generated from sales of our devices. Our ability to achieve
significant levels of revenues within the next few years is dependent on the
timing of receiving regulatory approval, if at all, for SnET2 in AMD and our
ability to establish a collaboration with a corporate partner or other sales
organization to commercialize SnET2 once regulatory approval is received, if at
all. Our revenues to date have consisted of license reimbursements, grants
awarded, royalties on our devices, SnET2 bulk active pharmaceutical ingredient,
or bulk API sales, milestone payments, payments for our devices, and interest
income. We do not expect any significant revenues until we have established a
collaborative partnering agreement, receive regulatory approval and commence
commercial sales.
EVEN THOUGH WE RAISED $10.3 MILLION IN APRIL 2004, WE WILL LIKELY NEED
ADDITIONAL FUNDS IN 2005 TO CONTINUE OUR OPERATIONS, AND IF WE FAIL TO OBTAIN
ADDITIONAL FUNDING, WE WOULD BE FORCED TO SIGNIFICANTLY SCALE BACK OR CEASE
OPERATIONS.
We are continuing our scaled-back efforts in research and development and
the preclinical studies and clinical trials of our products. These efforts,
along with the cost of preparing and the follow-up associated with the NDA
submission for SnET2, obtaining requisite regulatory approval, and commencing
pre-commercialization and manufacturing activities prior to receiving regulatory
approval, has required and will require substantial expenditures. Once requisite
regulatory approval has been obtained, if at all, substantial additional
financing will likely be required for the manufacture, marketing and
distribution of our product in order to achieve a level of revenues adequate to
support our cost structure.
The timing and magnitude of our future capital requirements will depend on
many factors, including:
* Our ability to obtain regulatory acceptance of the NDA submission and
subsequent approval;
* The cost of performing pre-commercialization activities;
* Our ability to establish additional collaborations and/or license
SnET2 or our other new products;
* Our ability to continue our efforts to conserve our use of cash, while
continuing to advance programs;
* Our ability to meet our obligations under the 2002 Debt Agreement,
2003 Debt Agreement and February 2004 Debt Agreement;
* The viability of SnET2 for future use;
* Our ability to raise equity financing or use stock awards for employee
and consultant compensation;
* Our ability to regain our listing status on Nasdaq or an alternative
exchange;
* The pace of scientific progress and the magnitude of our research and
development programs;
* The scope and results of preclinical studies and clinical trials;
* The costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims;
* The costs involved in any potential litigation;
* Competing technological and market developments; and
* Our dependence on others for development and commercialization of our
potential products.
We believe that as a result of our $10.3 million funding in April 2004, we
will have sufficient cash to fund operations through December 31, 2004 and into
the first quarter of 2005. If we are unable to raise funds when we may need them
we believe we can delay or reduce in scope one or more of our research and
development programs and to adjust, defer or reduce salaries of employees and to
reduce operating facilities and overhead expenditures.
We continue to seek additional capital needed to fund our operations
through corporate collaborations or partnerships, through licensing of SnET2 or
new products and through public or private equity or debt financings. Our
inability to obtain additional financing would adversely affect our business and
could cause us to significantly scale back or cease operations. If we are
successful in obtaining additional equity or convertible debt financing this is
likely to result in significant dilution to our stockholders. In addition, any
new securities issued may have rights, preferences or privileges senior to those
securities held by our current stockholders.
WE ARE HIGHLY LEVERAGED, OUR RECENT DEBT AND EQUITY AGREEMENTS HAVE FURTHER
DILUTED OUR EXISTING STOCKHOLDERS AND OUR DEBT SERVICE REQUIREMENTS MAKE US
VULNERABLE TO ECONOMIC DOWNTURN AND IMPOSE RESTRICTIONS ON OUR OPERATIONS.
The face amount of our debt outstanding was approximately $11.7 million as
of May 14, 2004. There is no certainty that our cash balance and our financing
arrangements, will be sufficient to finance our operating requirements, and our
indebtedness may restrict our ability to obtain additional financing in the
future. The issuance of additional shares of common stock in April 2004 and
warrants to purchase Common Stock in connection with the 2002 and 2003 Debt
Agreements and related negotiations with existing debtors has resulted in the
issuance of significant amounts of securities which has a dilutive effect on our
existing stockholders. Also, we are highly leveraged, which may place us at a
competitive disadvantage and makes us more susceptible to downturns in our
business in the event our cash balances are not sufficient to cover our debt
service requirements. In addition, the February 2004 Debt Agreement, the 2003
Debt Agreement and the 2002 Debt Agreement contain certain covenants that impose
operating and financial restrictions on us. These covenants may affect our
ability to conduct operations to raise additional financing or to engage in
other business activities that may be in our interest. In addition, if we cannot
achieve the financial results necessary to maintain compliance with these
covenants, we could be declared in default.
OUR FUTURE SUCCESS IS HIGHLY DEPENDENT ON REGULATORY APPROVAL AND SUCCESSFUL
COMMERCIALIZATION OF SNET2. IF OUR SUBMISSION FOR SNET2 DOES NOT SUPPORT THE
ACCEPTANCE FOR FILING OR APPROVAL OF THE NDA BY THE FDA FOR ANY REASON, OUR
BUSINESS WILL BE SUBSTANTIALLY HARMED. ADDITIONALLY, WE CANNOT BE ASSURED THAT
WE WILL BE ABLE TO MAINTAIN OUR FAST-TRACK DESIGNATION WITH THE FDA BECAUSE OF
SUBSEQUENT FDA APPROVALS RECEIVED FOR THE TREATMENT OF AMD TO THIRD PARTIES.
Within 60 days of our NDA submission, the FDA will make a determination to
accept or refuse to file the NDA and, if accepted, will designate its review
status. We cannot guarantee the FDA will accept our NDA for filing. In the event
that the FDA does not accept our NDA for fling, we may be required to provide
additional information or conduct additional clinical trials before resubmitting
our NDA and before the FDA may accept our NDA for substantive review. If this
occurs, there is likely to be a substantial delay in the approval process and it
is less likely that SnET2 will be approved. This delay would have an immediate
material adverse effect on our business and would likely further depress the
price of our stock.
Even if the FDA accepts our submission for filing, the FDA may not
ultimately approve our NDA for SnET2. This approval process may take a
significant amount of time and the FDA's approval, if any, may be contingent
upon satisfying additional requirements. For instance, the FDA may require
follow-up clinical trials or pre-clinical studies prior to final approval, which
may be costly and may cause a significant delay in the timing of receiving FDA
approval. If the FDA does approve this NDA, the approved label claims could be
for a limited market, resulting in smaller than expected markets and revenue.
Additionally, we received a fast-track designation on our clinical program in
1998 primarily due to the lack of an existing approved treatment for AMD.
Subsequently, there has been an approval by the FDA for the treatment of a
specific portion of the AMD disease, thus, there can be no guarantee that we
will be able to maintain our fast-track designation, and related benefits, from
the FDA, which may further delay the timing of a potential FDA approval. Any
delay in receiving FDA approval further limits our ability to begin market
commercialization and harms our on-going funding requirements and our business.
Additionally, we might be forced to substantially scale down our operations or
sell certain of our assets, and it is likely the price of our stock would
decline precipitously.
EVEN IF WE RECEIVE REGULATORY APPROVAL OF SNET2 FOR THE TREATMENT OF AMD, SNET2
MAY NOT BE COMMERCIALLY SUCCESSFUL.
Even if SnET2 receives regulatory approval, patients and physicians may not
readily accept it, which would result in lower than projected sales and
substantial harm to our business. Acceptance will be a function of SnET2 being
clinically useful and demonstrating superior therapeutic effect with an
acceptable side-effect profile, as compared to currently existing or future
treatments. In addition, even if SnET2 does achieve market acceptance, we may
not be able to maintain that market acceptance over time if new products are
introduced that are more favorably received than SnET2 or render SnET2 obsolete.
WE FACE INTENSE COMPETITION AND OUR FAILURE TO COMPETE EFFECTIVELY, PARTICULARLY
AGAINST LARGER, MORE ESTABLISHED PHARMACEUTICAL AND MEDICAL DEVICE COMPANIES,
WILL CAUSE OUR BUSINESS TO SUFFER.
Many of our competitors have substantially greater financial, technical and
human resources than we do, and may also have substantially greater experience
in developing products, conducting preclinical studies or clinical trials,
obtaining regulatory approvals and manufacturing and marketing and distribution.
Further, our competitive position could be harmed by the establishment of patent
protection by our competitors. The existing competitors or other companies may
succeed in developing technologies and products that are more safe, effective or
affordable than those being developed by us or that would render our technology
and products less competitive or obsolete.
We are aware that other companies are marketing or developing certain
products to prevent, diagnose or treat diseases for which we are developing
PhotoPoint PDT. These products, as well as others of which we may not be aware,
may adversely affect the existing or future market for our products. Competitive
products may include, but are not limited to, drugs such as those designed to
inhibit angiogenesis or otherwise target new blood vessels, certain medical
devices, such as drug-eluting stents and other photodynamic therapy treatments.
We are aware of various competitors involved in the photodynamic therapy or
AMD sector. We understand that these companies are conducting preclinical
studies and/or clinical trials in various countries and for a variety of disease
indications. Our direct competitors in our sector include QLT Inc., or QLT, DUSA
Pharmaceuticals, or DUSA, Axcan Pharm Inc., or Axcan, Eyetech Pharmacueticals
Inc., or Eyetech, and Pharmacyclics. QLT's drug Visudyne(R) has received
marketing approval in the United States and certain other countries for the
treatment of AMD and has been commercialized by Novartis. Axcan and DUSA have
photodynamic therapy drugs, both of which have received marketing approval in
the United States - Photofrin(R) (Axcan) for the treatment of certain oncology
indications and Levulan(R) (DUSA Pharmaceuticals) for the treatment of actinic
keratoses, a dermatological condition. Pharmacyclics has a photodynamic therapy
drug that has not received marketing approval, which is being used in certain
preclinical studies and/or clinical trials for ophthalmology, oncology and
cardiovascular indications. Eyetech is currently completing a Phase III clinical
trial in AMD and is expected to submit an NDA in 2004. We are aware of other
drugs and devices under development by these and other competitors in additional
disease areas for which we are developing PhotoPoint PDT. These competitors as
well as others that we are not aware of, may develop superior products or reach
the market prior to PhotoPoint PDT and render our products non-competitive or
obsolete.
AS A RESULT OF OUR SHARES BEING DELISTED FROM TRADING ON NASDAQ, OUR ABILITY TO
RAISE ADDITIONAL CAPITAL MAY BE LIMITED OR IMPAIRED.
We were delisted by Nasdaq on July 11, 2002 and our Common Stock began
trading on the Over-The-Counter Bulletin Board(R), or OTCBB, effective as of the
opening of business on July 12, 2002. Our management continues to review our
ability to regain our listing status with Nasdaq or an alternative exchange,
however, we cannot guarantee we will be able to raise the additional capital
needed or to increase the current trading price of our Common Stock to allow us
to meet the relisting requirements for the Nasdaq National Market or the Nasdaq
Small Cap Market or an alternative exchange on a timely basis, if at all, and
there is no guarantee that any of the stock market exchanges would approve our
relisting request even if we met all the listing requirements. Our ability to
obtain additional funding, beyond our current funding agreements is impeded by a
number of factors including that fact that our Common Stock is currently being
traded on the OTCBB and may prevent us from obtaining additional financing as
required in the near term on favorable terms or at all.
OUR FINANCIAL CONDITION AND COST REDUCTION EFFORTS COULD RESULT IN DECREASED
EMPLOYEE MORALE AND LOSS OF EMPLOYEES AND CONSULTANTS WHO ARE CRITICAL TO OUR
SUCCESS.
Our success in the future will depend in large part on our ability to
attract and retain highly qualified scientific, management and other personnel
and to develop and maintain relationships with leading research institutions and
consultants. We are highly dependent upon principal members of our management,
key employees, scientific staff and consultants, which we may retain from time
to time. We currently have limited cash and capital resources and our ability to
raise funds is questionable, causing our business outlook to be uncertain.
Additionally, due to our ongoing limited cash balances, we try to utilize stock
options and stock awards as a key component of short-term and long-term
compensation. However, given the volatility of our stock and the uncertainty of
our long-term prospects, our ability to use stock options and stock awards as
compensation may be limited. These measures, along with our financial condition,
may cause employees to question our long-term viability and increase our
turnover. These factors may also result in reduced productivity and a decrease
in employee morale causing our business to suffer. We do not have insurance
providing us with benefits in the event of the loss of key personnel. Our
consultants may be affiliated with or employed by others, and some have
consulting or other advisory arrangements with other entities that may conflict
or compete with their obligations to us.
IF WE ARE NOT ABLE TO MAINTAIN AND SUCCESSFULLY ESTABLISH NEW COLLABORATIVE AND
LICENSING ARRANGEMENTS WITH OTHERS, OUR BUSINESS WILL BE HARMED.
Our business model is based on establishing collaborative relationships
with other parties both to license compounds upon which our products and
technologies are based and to manufacture, market and sell our products. As a
development company we must have access to compounds and technologies to license
for further development. For example, we are party to a License Agreement with
the University of Toledo, the Medical College of Ohio and St. Vincent Medical
Center, of Toledo, Ohio, collectively referred to as Toledo, to license or
sublicense certain photoselective compounds, including SnET2. Similarly, we must
also establish relationships with suppliers and manufacturers to build our
medical devices and to manufacture our compounds. We have partnered with Iridex
for the manufacture of certain light sources and have entered into an agreement
with Fresenius for supply of the final dose formulation of SnET2. Due to the
expense of the drug approval process it is critical for us to have relationships
with established pharmaceutical companies to offset some of our development
costs in exchange for a combination of manufacturing, marketing and distribution
rights. We formerly had a significant relationship with Pharmacia for the
development of SnET2 for the treatment of AMD, which was terminated in March
2002. To further develop SnET2 for AMD or other indications it is essential that
we establish a new collaborative relationship with another party.
We are currently at various stages of discussions with various companies
regarding the establishment of new collaborations. If we are not successful in
establishing new collaborative partners for the potential development of SnET2
or our other molecules, we may not be able to pursue further development of such
drugs and/or may have to reduce or cease our current development programs, which
would materially harm our business. Even if we are successful in establishing
new collaborations, they are subject to numerous risks and uncertainties
including the following:
* Our ability to negotiate acceptable collaborative arrangements;
* Future or existing collaborative arrangements may not be successful or
may not result in products that are marketed or sold;
* Collaborative partners are free to pursue alternative technologies or
products either on their own or with others, including our
competitors, for the diseases targeted by our programs and products;
* Our partners may fail to fulfill their contractual obligations or
terminate the relationships described above, and we may be required to
seek other partners, or expend substantial resources to pursue these
activities independently; and
* Our ability to manage, interact and coordinate our timelines and
objectives with our strategic partners may not be successful.
ALL OF OUR PRODUCTS, EXCEPT SNET2 AND MV9411, ARE IN AN EARLY STAGE OF
DEVELOPMENT AND ALL OF OUR PRODUCTS, INCLUDING SNET2 AND MV9411, MAY NEVER BE
SUCCESSFULLY COMMERCIALIZED.
Our products, except SnET2 and MV9411, are at an early stage of development
and our ability to successfully commercialize these products, including SnET2
and MV9411, is dependent upon:
* Successfully completing our research or product development efforts or
those of our collaborative partners;
* Successfully transforming our drugs or devices currently under
development into marketable products;
* Obtaining the required regulatory approvals;
* Manufacturing our products at an acceptable cost and with appropriate
quality;
* Favorable acceptance of any products marketed; and
* Successful marketing and sales efforts of our corporate partner(s).
We may not be successful in achieving any of the above, and if we are not
successful, our business, financial condition and operating results would be
adversely affected. The time frame necessary to achieve these goals for any
individual product is long and uncertain. Most of our products currently under
development will require significant additional research and development and
preclinical studies and clinical trials, and all will require regulatory
approval prior to commercialization. The likelihood of our success must be
considered in light of these and other problems, expenses, difficulties,
complications and delays.
OUR PRODUCTS, INCLUDING SNET2 AND MV9411, MAY NOT SUCCESSFULLY COMPLETE THE
CLINICAL TRIAL PROCESS AND WE MAY BE UNABLE TO PROVE THAT OUR PRODUCTS ARE SAFE
AND EFFICACIOUS.
All of our drug and device products currently under development will
require extensive preclinical studies and/or clinical trials prior to regulatory
approval for commercial use, which is a lengthy and expensive process. None of
our products, except SnET2, have completed testing for efficacy or safety in
humans, and none of our products, including SnET2, have been approved for any
purpose by the FDA. Some of the risks and uncertainties related to safety and
efficacy testing and the completion of preclinical studies and clinical trials
include:
* Our ability to demonstrate to the FDA that our products are safe and
efficacious;
* Our products may not be as efficacious as our competitors' products;
* Our ability to successfully complete the testing for any of our
compounds within any specified time period, if at all;
* Clinical outcomes reported may change as a result of the continuing
evaluation of patients;
* Data obtained from preclinical studies and clinical trials are subject
to varying interpretations which can delay, limit or prevent approval
by the FDA or other regulatory authorities;
* Problems in research and development, preclinical studies or clinical
trials that will cause us to delay, suspend or cancel clinical trials;
and
* As a result of changing economic considerations, competitive or new
technological developments, market approvals or changes, clinical or
regulatory conditions, or clinical trial results, our focus may shift
to other indications, or we may determine not to further pursue one or
more of the indications currently being pursued.
Data already obtained from preclinical studies and clinical trials of our
products under development do not necessarily predict the results that will be
obtained from future preclinical studies and clinical trials. A number of
companies in the pharmaceutical industry, including biotechnology companies like
us, have suffered significant setbacks in advanced clinical trials, even after
promising results in earlier clinical trials. Moreover, our clinical trials may
not demonstrate the sufficient levels of safety and efficacy necessary to obtain
the requisite regulatory approval or may not result in marketable products. The
failure to adequately demonstrate the safety and effectiveness of a product
under development could delay or prevent regulatory approval of the potential
product and would materially harm our business.
THE PRICE OF OUR COMMON STOCK HAS BEEN AND MAY CONTINUE TO BE VOLATILE.
From time to time and in particular during the year ended December 31,
2003, the price of our Common Stock has been highly volatile. These fluctuations
create a greater risk of capital losses for our stockholders as compared to less
volatile stocks. From January 1, 2003 to May 14, 2004, our Common Stock price,
per Nasdaq and OTCBB closing prices, has ranged from a high of $4.10 to a low of
$0.71.
The market prices for our Common Stock, and the securities of emerging
pharmaceutical and medical device companies, have historically been highly
volatile and subject to extreme price fluctuations, which may reduce the market
price of the Common Stock. Extreme price fluctuations could be the result of the
following:
* The acceptance for filing of our NDA for SnET2 in AMD by the FDA;
* The results of the FDA review of our NDA submission and our ability to
receive approval from the FDA for commercialization;
* Announcements concerning Miravant or our collaborators, competitors or
industry;
* Our ability to successfully establish new collaborations and/or
license SnET2 or our other new products;
* The impact of dilution from past or future equity or convertible debt
financings;
* The results of our testing, technological innovations or new
commercial products;
* The results of our testing, technological innovations or new
commercial products;
* The results of preclinical studies and clinical trials by us or our
competitors;
* Technological innovations or new therapeutic products;
* Our ability to regain our listing status on Nasdaq or an alternative
exchange;
* Public concern as to the safety, efficacy or marketability of products
developed by us or others;
* Comments by securities analysts;
* The achievement of or failure to achieve certain milestones;
* Litigation, such as from stockholder lawsuits or patent infringement;
and
* Governmental regulations, rules and orders, or developments concerning
safety of our products.
In addition, the stock market has experienced extreme price and volume
fluctuations. This volatility has significantly affected the market prices of
securities of many emerging pharmaceutical and medical device companies for
reasons frequently unrelated or disproportionate to the performance of the
specific companies. If these broad market fluctuations cause the trading price
of our Common Stock to decline further, we may be unable to obtain additional
capital that we may need through public or private financing activities and our
stock may not be relisted on Nasdaq or an alternative exchange, further
exacerbating our ability to raise funds and limiting our stockholders' ability
to sell their shares. Because outside financing is critical to our future
success, large fluctuations in our share price that harm our financing
activities could cause us to significantly alter our business plans or cease
operations altogether.
WE MAY RELY ON THIRD PARTIES TO ASSIST US WITH THE REGULATORY REVIEW PROCESS FOR
THE NDA, IF NEEDED, AND TO CONDUCT CLINICAL TRIALS ON OUR PRODUCTS, AND IF THESE
RESOURCES FAIL, OUR ABILITY TO COMPLETE THE NDA REVIEW PROCESS OR SUCCESSFULLY
COMPLETE CLINICAL TRIALS WILL BE ADVERSELY AFFECTED AND OUR BUSINESS WILL
SUFFER.
To date, we have limited experience in conducting clinical trials. We have
relied on Parexel International, a large clinical research organization, or CRO,
as well as numerous other consultants, to assist in preparation of our NDA,
which we submitted to the FDA on March 31, 2004. Additionally, we relied on
Pharmacia, our former corporate partner, and Inveresk, Inc., formerly ClinTrials
Research, Inc., a CRO, to complete our Phase III AMD clinical trials and we
currently rely on a Parexel International for our Phase II dermatology clinical
trials. We may need to rely on Parexel International and other consultants and
third parties to complete the review of the NDA by the FDA. We will either need
to rely on third parties, including our collaborative partners, to design and
conduct any required clinical trials or expend resources to hire additional
personnel or engage outside consultants or contract research organizations to
administer current and future clinical trials. We may not be able to find
appropriate third parties to design and conduct clinical trials or we may not
have the resources to administer clinical trials in-house. The failure to have
adequate resources for completing the review process of the NDA, and conducting
and managing clinical trials will have a negative impact on our ability to
develop marketable products and would harm our business. Other CROs may be
available in the event that our current CROs fail; however there is no guarantee
that we would be able to engage another organization in a timely manner, if at
all. This could cause delays in our clinical trials and our development
programs, which could materially harm our business.
WE RELY ON PATIENT ENROLLMENT TO CONDUCT CLINICAL TRIALS, AND OUR INABILITY TO
CONTINUE TO ATTRACT PATIENTS TO PARTICIPATE WILL HAVE A NEGATIVE IMPACT ON OUR
CLINICAL TRIAL RESULTS.
Our ability to complete clinical trials is dependent upon the rate of
patient enrollment. Patient enrollment is a function of many factors including:
* The nature of our clinical trial protocols;
* Existence of competing protocols or treatments;
* Size and longevity of the target patient population;
* Proximity of patients to clinical sites; and
* Eligibility criteria for the clinical trials.
A specific concern for potential future AMD clinical trials, if any, is
that there currently is an approved treatment for AMD and patients enrolled in
future AMD clinical trials, if any, may choose to drop out of the trial or
pursue alternative treatments. This could result in delays or incomplete
clinical trial data.
We cannot make assurances that we will obtain or maintain adequate levels
of patient enrollment in current or future clinical trials. Delays in planned
patient enrollment may result in increased costs, delays or termination of
clinical trials, which could result in slower introduction of our potential
products, a reduction in our revenues and may prevent us from becoming
profitable. In addition, the FDA may suspend clinical trials at any time if,
among other reasons, it concludes that patients participating in such trials are
being exposed to unacceptable health risks. Failure to obtain and keep patients
in our clinical trials will delay or completely impede test results, which will
negatively impact the development of our products and prevent us from becoming
profitable.
WE MAY FAIL TO ADEQUATELY PROTECT OR ENFORCE OUR INTELLECTUAL PROPERTY RIGHTS,
OUR PATENTS AND OUR PROPRIETARY TECHNOLOGY, WHICH WILL MAKE IT EASIER FOR OTHERS
TO MISAPPROPRIATE OUR TECHNOLOGY AND INHIBIT OUR ABILITY TO BE COMPETITIVE.
Our success will depend, in part, on our and our licensors' ability to
obtain, assert and defend our patents, protect trade secrets and operate without
infringing the proprietary rights of others. The exclusive license relating to
various drug compounds, including our leading drug candidate SnET2, may become
non-exclusive if we fail to satisfy certain development and commercialization
objectives. The termination or restriction of our rights under this or other
licenses for any reason would likely reduce our future income, increase our
costs and limit our ability to develop additional products.
The patent position of pharmaceutical and medical device firms generally is
highly uncertain. Some of the risks and uncertainties include:
* The patent applications owned by or licensed to us may not result in
issued patents;
* Our issued patents may not provide us with proprietary protection or
competitive advantages;
* Our issued patents may be infringed upon or designed around by others;
* Our issued patents may be challenged by others and held to be invalid
or unenforceable;
* The patents of others may prohibit us from developing our products as
planned; and
* Significant time and funds may be necessary to defend our patents.
We are aware that our competitors and others have been issued patents
relating to photodynamic therapy. In addition, our competitors and others may
have been issued patents or filed patent applications relating to other
potentially competitive products of which we are not aware. Further, our
competitors and others may in the future file applications for, or otherwise
obtain proprietary rights to, such products. These existing or future patents,
applications or rights may conflict with our or our licensors' patents or
applications. Such conflicts could result in a rejection of our or our
licensors' applications or the invalidation of the patents.
Further exposure could arise from the following risks and uncertainties:
* We do not have contractual indemnification rights against the
licensors of the various drug patents;
* We may be required to obtain licenses under dominating or conflicting
patents or other proprietary rights of others;
* Such licenses may not be made available on terms acceptable to us, if
at all; and
* If we do not obtain such licenses, we could encounter delays or could
find that the development, manufacture or sale of products requiring
such licenses is foreclosed.
We also seek to protect our proprietary technology and processes in part by
confidentiality agreements with our collaborative partners, employees and
consultants. These agreements could be breached and we may not have adequate
remedies for any breach.
The occurrence of any of these events described above could harm our
competitive position. If such conflicts occur, or if we believe that such
products may infringe on our proprietary rights, we may pursue litigation or
other proceedings, or may be required to defend against such litigation. We may
not be successful in any such proceeding. Litigation and other proceedings are
expensive and time consuming, regardless of whether we prevail. This can result
in the diversion of substantial financial, managerial and other resources from
other activities. An adverse outcome could subject us to significant liabilities
to third parties or require us to cease any related research and development
activities or product sales.
WE HAVE LIMITED MANUFACTURING CAPABILITY AND EXPERIENCE AND THUS RELY HEAVILY
UPON THIRD PARTIES. IF WE ARE UNABLE TO MAINTAIN AND DEVELOP OUR PAST
MANUFACTURING CAPABILITY, OR IF WE ARE UNABLE TO FIND SUITABLE THIRD PARTY
MANUFACTURERS AND OUR OPERATING RESULTS COULD SUFFER.
Prior to our being able to supply drugs for commercial use, our
manufacturing facilities must comply with Good Manufacturing Practices, or GMPs.
In addition, if we elect to outsource manufacturing to third-party
manufacturers, these facilities also have to satisfy GMP and FDA manufacturing
requirements. To be successful, our products must be manufactured in commercial
quantities under current GMPs and must be at acceptable costs. Although we
intend to manufacture drugs and devices at clinical manufacturing levels, we
have not yet manufactured any products under GMPs which can be released for
commercial use, and we have limited experience in manufacturing in commercial
quantities. We were licensed by the State of California to manufacture bulk API
at one of our Santa Barbara, California facilities for clinical trial and other
use. This particular manufacturing facility was closed in 2002 and has been
reconstructed in our existing operating facility. The manufacturing facility at
the new location is operational, pending required regulatory approvals by the
State of California and federal regulatory agencies, and has recently completed
production of compatibility and stability batches.
In the original manufacturing facility, we have manufactured bulk API, the
process up to the final formulation and packaging step for SnET2, which we
currently have in inventory. We believe the quantities we have in inventory are
enough to support an initial commercial launch of SnET2, though there can be no
assurance that SnET2 and our new manufacturing facility will be approved by the
FDA or that if such approval is received, the existing commercial bulk API
inventory will be approved for commercial use. We also have the ability to
manufacture light producing devices and light delivery devices, and conduct
other production and testing activities to support current clinical programs, at
this location. However, we have limited capabilities, personnel and experience
in the manufacture of finished drug product, and, at commercial levels, light
producing and light delivery devices and utilize outside suppliers, contracted
or otherwise, for certain materials and services related to our manufacturing
activities.
We currently have the capacity, in conjunction with our manufacturing
suppliers Fresenius and Iridex, to manufacture products at certain commercial
levels and we believe we will be able to do so under GMPs with subsequent FDA
approval. If we receive FDA or other regulatory approval, we may need to expand
our manufacturing capabilities and/or depend on our collaborators, licensees or
contract manufacturers for the expanded commercial manufacture of our products.
If we expand our manufacturing capabilities, we will need to expend substantial
funds, hire and retain significant additional personnel and comply with
extensive regulations. We may not be able to expand successfully or we may be
unable to manufacture products in increased commercial quantities for sale at
competitive prices. Further, we may not be able to enter into future
manufacturing arrangements with collaborators, licensees, or contract
manufacturers on acceptable terms or at all. If we are not able to expand our
manufacturing capabilities or enter into additional commercial manufacturing
agreements, our commercial product sales, as well as our overall business growth
could be limited, which in turn could prevent us from becoming profitable or
viable as a business. We are currently the sole manufacturer of bulk API for
SnET2, Fresenius is the sole manufacturer of the final dose formulation of SnET2
and Iridex is currently the sole supplier of the light producing devices used in
our AMD clinical trials. All currently have commercial quantity capabilities. At
this time, we have no readily available back-up manufacturers to produce the
bulk API for SnET2, or the final formulation of SnET2 at commercial levels or
back-up suppliers of the light producing devices. If Fresenius could no longer
manufacture for us or Iridex was unable to supply us with devices, we could
experience significant delays in production or may be unable to find a suitable
replacement, which would reduce our revenues and harm our ability to
commercialize our products and become profitable.
WE HAVE LIMITED MARKETING CAPABILITY AND EXPERIENCE AND THUS RELY HEAVILY UPON
THIRD PARTIES IN THIS REGARD.
We have no direct experience in marketing, distributing and selling our
pharmaceutical or medical device products. We will need to develop a sales force
or rely on our collaborators or licensees or make arrangements with others to
provide for the marketing, distribution and sale of our products. We currently
intend to rely on Iridex for any medical device needs for the AMD program. Our
marketing, distribution and sales capabilities or current or future arrangements
with third parties for such activities may not be adequate for the successful
commercialization of our products.
OUR PRODUCTS MAY EXHIBIT ADVERSE SIDE EFFECTS THAT PREVENT THEIR WIDESPREAD
ADOPTION OR THAT NECESSITATE WITHDRAWAL FROM THE MARKET.
Our PhotoPoint PDT drug and device products may exhibit undesirable and
unintended side effects that may prevent or limit their commercial adoption and
use. One such side effect upon the adoption of our PhotoPoint PDT drug and
device products as potential therapeutic agents may be a period of
photosensitivity for a certain period of time after receiving PhotoPoint PDT.
This period of photosensitivity is generally dose dependent and typically
declines over time. Even upon receiving approval by the FDA and other regulatory
authorities, our products may later exhibit adverse side effects that prevent
widespread use or necessitate withdrawal from the market. The manifestation of
such side effects could cause our business to suffer.
ACCEPTANCE OF OUR PRODUCTS IN THE MARKETPLACE IS UNCERTAIN, AND FAILURE TO
ACHIEVE MARKET ACCEPTANCE WILL HARM OUR BUSINESS.
Even if approved for marketing, our products may not achieve market
acceptance. The degree of market acceptance will depend upon a number of
factors, including:
* The establishment and demonstration in the medical community of the
safety and clinical efficacy of our products and their potential
advantages over existing therapeutic products and diagnostic and/or
imaging techniques. For example, if we are able to eventually obtain
approval of our drugs and devices to treat cardiovascular restenosis
we will have to demonstrate and gain market acceptance of this as a
method of treatment over use of drug coated stents and other
restenosis treatment options;
* Pricing and reimbursement policies of government and third-party
payors such as insurance companies, health maintenance organizations
and other plan administrators; and
* The possibility that physicians, patients, payors or the medical
community in general may be unwilling to accept, utilize or recommend
any of our products.
If our products are not accepted due to these or other factors our business
will not develop as planned and may be harmed.
OUR ABILITY TO ESTABLISH AND MAINTAIN AGREEMENTS WITH OUTSIDE SUPPLIERS MAY NOT
BE SUCCESSFUL AND OUR FAILURE TO DO SO COULD ADVERSELY AFFECT OUR BUSINESS.
We depend on outside suppliers for certain raw materials and components for
our products. Although most of our raw materials and components are available
from various sources, such raw materials or components may not continue to be
available to our standards or on acceptable terms, if at all, and alternative
suppliers may not be available to us on acceptable terms, if at all. Further, we
may not be able to adequately produce needed materials or components in-house.
We are currently dependent on single, contracted sources for certain key
materials or services used by us in our drug development, light producing and
light delivery device development and production operations. We are seeking to
establish relationships with additional suppliers, however, we may not be
successful in doing so and may encounter delays or other problems. If we are
unable to produce our potential products in a timely manner, or at all, our
sales would decline, our development activities could be delayed or cease and as
a result we may never achieve profitability.
WE MAY NOT HAVE ADEQUATE PROTECTION AGAINST PRODUCT LIABILITY OR RECALL, WHICH
COULD SUBJECT US TO LIABILITY CLAIMS THAT COULD MATERIALLY HARM OUR BUSINESS.
The testing, manufacture, marketing and sale of human pharmaceutical
products and medical devices entail significant inherent, industry-wide risks of
allegations of product liability. The use of our products in clinical trials and
the sale of our products may expose us to liability claims. These claims could
be made directly by patients or consumers, or by companies, institutions or
others using or selling our products. The following are some of the risks
related to liability and recall:
* We are subject to the inherent risk that a governmental authority or
third party may require the recall of one or more of our products;
* We have not obtained product liability insurance that would cover a
claim relating to the clinical or commercial use or recall of our
products;
* In the absence of product liability insurance, claims made against us
or a product recall could result in our being exposed to large damages
and expenses;
* If we obtain product liability insurance coverage in the future, this
coverage may not be available at a reasonable cost and in amounts
sufficient to protect us against claims that could cause us to pay
large amounts in damages; and
* Liability claims relating to our products or a product recall could
negatively affect our ability to obtain or maintain regulatory
approval for our products.
We currently do not expect to obtain product liability insurance until we
have an approved product and begin distributing the product for commercial use.
We plan to obtain product liability insurance to cover our indemnification
obligations to Iridex for third party claims relating to any of our potential
negligent acts or omissions involving our SnET2 drug technology or PhotoPoint
PDT light device technology. A successful product liability claim could result
in monetary or other damages that could harm our business, financial condition
and additionally cause us to cease operations.
OUR BUSINESS COULD SUFFER IF WE ARE UNSUCCESSFUL IN INTEGRATING BUSINESS
COMBINATIONS AND STRATEGIC ALLIANCES.
We may expand our operations and market presence by entering into business
combinations, joint ventures or other strategic alliances with other companies.
These transactions create risks, such as:
* The difficulty assimilating the operations, technology and personnel
of the combined companies;
* The disruption of our ongoing business, including loss of management
focus on existing businesses and other market developments;
* Problems retaining key technical and managerial personnel; expenses
associated with the amortization of goodwill and other purchased
intangible assets;
* Additional operating losses and expenses of acquired businesses;
* The impairment of relationships with existing employees, customers and
business partners; and
* Additional losses from any equity investments we might make.
We may not succeed in addressing these risks, and we may not be able to
make business combinations and strategic investments on terms that are
acceptable to us. In addition, any businesses we may acquire may incur operating
losses.
WE RELY ON THE AVAILABILITY OF CERTAIN UNPROTECTED INTELLECTUAL PROPERTY RIGHTS,
AND IF ACCESS TO SUCH RIGHTS BECOMES UNAVAILABLE, OUR BUSINESS COULD SUFFER.
Our trade secrets may become known or be independently discovered by
competitors. Furthermore, inventions or processes discovered by our employees
will not necessarily become our property and may remain the property of such
persons or others.
In addition, certain research activities relating to the development of
certain patents owned by or licensed to us were funded, in part, by agencies of
the United States Government. When the United States Government participates in
research activities, it retains certain rights that include the right to use the
resulting patents for government purposes under a royalty-free license.
We also rely upon unpatented trade secrets, and no assurance can be given
that others will not independently develop substantially equivalent proprietary
information and techniques, or otherwise gain access to our trade secrets or
disclose such technology, or that we can meaningfully protect our rights to our
unpatented trade secrets and know-how.
In the event that the intellectual property we do or will rely on becomes
unavailable, our ability to be competitive will be impeded and our business will
suffer.
OUR PREFERRED STOCKHOLDER RIGHTS PLAN MAKES EFFECTING A CHANGE OF CONTROL OF
MIRAVANT MORE DIFFICULT, WHICH MAY DISCOURAGE OFFERS FOR SHARES OF OUR COMMON
STOCK.
Our Board of Directors has adopted a Preferred Stockholder Rights Plan, or
Rights Plan. The Rights Plan may have the effect of delaying, deterring, or
preventing changes in our management or control of Miravant, which may
discourage potential acquirers who otherwise might wish to acquire us without
the consent of the Board of Directors. Under the Rights Plan, if a person or
group acquires 20% or more of our Common Stock, all holders of rights (other
than the acquiring stockholder) may, upon payment of the purchase price then in
effect, purchase Common Stock having a value of twice the purchase price. In
April 2001, the Rights Plan was amended to increase the trigger percentage from
20% to 25% as it applies to Pharmacia and excluded shares acquired by Pharmacia
in connection with our 2001 Credit Agreement with Pharmacia, and from the
exercise of warrants held by Pharmacia. We also waived the provisions of the
Rights Plan with respect to the securities issued to the 2003 Lenders pursuant
to the 2003 Debt Agreement, including the shares of Common Stock issuable upon
conversion or exercise of such securities and any other securities that may in
the future be issued to the 2003 Lenders pursuant to their participation rights
under the 2003 Debt Agreement with respect to future financings by Miravant. In
the event that we are involved in a merger or other similar transaction where we
are not the surviving corporation, all holders of rights (other than the
acquiring stockholder) shall be entitled, upon payment of the then in effect
purchase price, to purchase Common Stock of the surviving corporation having a
value of twice the purchase price. The rights will expire on July 31, 2010,
unless previously redeemed.
OUR CHARTER AND BYLAWS CONTAIN PROVISIONS THAT MAY PREVENT TRANSACTIONS THAT
COULD BE BENEFICIAL TO STOCKHOLDERS.
Our charter and bylaws restrict certain actions by our stockholders. For
example:
* Our stockholders can act at a duly called annual or special meeting
but they may not act by written consent;
* Special meetings of stockholders can only be called by our chief
executive officer, president, or secretary at the written request of a
majority of our Board of Directors; and
* Stockholders also must give advance notice to the secretary of any
nominations for director or other business to be brought by
stockholders at any stockholders' meeting.
Some of these restrictions can only be amended by a super-majority vote of
members of the Board and/or the stockholders. These and other provisions of our
charter and bylaws, as well as certain provisions of Delaware law, could prevent
changes in our management and discourage, delay or prevent a merger, tender
offer or proxy contest, even if the events could be beneficial to our
stockholders. These provisions could also limit the price that investors might
be willing to pay for our Common Stock.
In addition, our charter authorizes our Board of Directors to issue shares
of undesignated preferred stock without stockholder approval on terms that the
Board may determine. The issuance of preferred stock could decrease the amount
of earnings and assets available for distribution to our other stockholders or
otherwise adversely affect their rights and powers, including voting rights.
Moreover, the issuance of preferred stock may make it more difficult or may
discourage another party from acquiring voting control of us.
BUSINESS INTERRUPTIONS COULD ADVERSELY AFFECT OUR BUSINESS.
Our operations are vulnerable to interruption in the event of war,
terrorism, fire, earthquake, power loss, floods, telecommunications failure and
other events beyond our control. We do not have a detailed disaster recovery
plan. Our facilities are all located in the State of California and were subject
to electricity blackouts as a consequence of a shortage of available electrical
power. There is no guarantee that this electricity shortage has been permanently
resolved, as such, we may again in the future experience unexpected blackouts.
Though we do have back-up electrical generation systems in place, they are for
use for a limited time and in the event these blackouts continue or increase in
severity, they could disrupt the operations of our affected facilities. In
addition, we may not carry adequate business interruption insurance to
compensate us for losses that may occur and any losses or damages incurred by us
could be substantial.
RISKS RELATED TO OUR INDUSTRY
WE ARE SUBJECT TO UNCERTAINTIES REGARDING HEALTH CARE REIMBURSEMENT AND REFORM.
Our products may not be covered by the various health care providers and
third party payors. If they are not covered, our products may not be purchased
or sold as expected. Our ability to commercialize our products successfully will
depend, in part, on the extent to which reimbursement for these products and
related treatment will be available from government health administration
authorities, private health insurers, managed care entities and other
organizations. These payers are increasingly challenging the price of medical
products and services and establishing protocols and formularies, which
effectively limit physicians' ability to select products and procedures.
Uncertainty exists as to the reimbursement status of health care products,
especially innovative technologies. Additionally, reimbursement coverage, if
available, may not be adequate to enable us to achieve market acceptance of our
products or to maintain price levels sufficient for realization of an
appropriate return on our products.
The efforts of governments and third-party payors to contain or reduce the
cost of healthcare will continue to affect our business and financial condition
as a biotechnology company. In foreign markets, pricing or profitability of
medical products and services may be subject to government control. In the
United States, we expect that there will continue to be federal and state
proposals for government control of pricing and profitability. In addition,
increasing emphasis on managed healthcare has increased pressure on pricing of
medical products and will continue to do so. These cost controls may prevent us
from selling our potential products profitability, may reduce our revenues and
may affect our ability to raise additional capital.
In addition, cost control initiatives could adversely affect our business
in a number of ways, including:
* Decreasing the price we, or any of our partners or licensees, receive
for any of our products;
* Preventing the recovery of development costs, which could be
substantial; and
* Minimizing profit margins.
Further, our commercialization strategy depends on our collaborators. As a
result, our ability to commercialize our products and realize royalties may be
hindered if cost control initiatives adversely affect our collaborators.
FAILURE TO OBTAIN PRODUCT APPROVALS OR COMPLY WITH ONGOING GOVERNMENTAL
REGULATIONS COULD ADVERSELY AFFECT OUR BUSINESS.
The production and marketing of our products and our ongoing research and
development, preclinical studies and clinical trial activities are subject to
extensive regulation and review by numerous governmental authorities in the
United States, including the FDA, and in other countries. All drugs and most
medical devices we develop must undergo rigorous preclinical studies and
clinical trials and an extensive regulatory approval process administered by the
FDA under the Food, Drug and Cosmetic Act, or FDC Act, and comparable foreign
authorities, before they can be marketed. These processes involve substantial
cost and can often take many years. We have limited experience in, and limited
resources available for regulatory activities and we rely on our collaborators
and outside consultants. Failure to comply with the applicable regulatory
requirements can, among other things, result in non-approval, suspensions of
regulatory approvals, fines, product seizures and recalls, operating
restrictions, injunctions and criminal prosecution. To date, none of our product
candidates being developed have been submitted for approval or have been
approved by the FDA or any other regulatory authority for marketing.
Some of the risks and uncertainties relating to United States Government
regulation include:
* Delays in obtaining approval or rejections due to regulatory review of
each submitted new drug, device or combination drug/device application
or product license application, as well as changes in regulatory
policy during the period of product development;
* If regulatory approval of a product is granted, such approval may
entail limitations on the uses for which the product may be marketed;
* If regulatory approval is obtained, the product, our manufacturer and
the manufacturing facilities are subject to continual review and
periodic inspections;
* If regulatory approval is obtained, such approval may be conditional
on the satisfaction of the completion of clinical trials or require
additional clinical trials;
* Later discovery of previously unknown problems with a product,
manufacturer or facility may result in restrictions on such product or
manufacturer, including withdrawal of the product from the market and
litigation; and
* Photodynamic therapy products have been categorized by the FDA as
combination drug-device products. If current or future photodynamic
therapy products do not continue to be categorized for regulatory
purposes as combination products, then:
- The FDA may require separate drug and device submissions; and
- The FDA may require separate approval by regulatory authorities.
Some of the risks and uncertainties of international governmental
regulation include:
* Foreign regulatory requirements governing testing, development,
marketing, licensing, pricing and/or distribution of drugs and devices
in other countries;
* Our drug products may not qualify for the centralized review procedure
or we may not be able to obtain a national market application that
will be accepted by other European Union, or EU, member states;
* Our devices must also meet the European Medical Device Directive
effective in 1998. The Directive requires that our manufacturing
quality assurance systems and compliance with technical essential
requirements be certified with a CE Mark authorized by a registered
notified body of an EU member state prior to free sale in the EU; and
* Registration and approval of a photodynamic therapy product in other
countries, such as Japan, may include additional procedures and
requirements, preclinical and clinical studies, and may require the
assistance of native corporate partners.
WE MAY NOT BE ABLE TO KEEP UP WITH RAPID CHANGES IN THE BIOTECHNOLOGY AND
PHARMACEUTICAL INDUSTRIES THAT COULD MAKE SOME OR ALL OF OUR PRODUCTS
NON-COMPETITIVE OR OBSOLETE. COMPETING PRODUCTS AND TECHNOLOGIES MAY MAKE SOME
OR ALL OF OUR PROGRAMS OR POTENTIAL PRODUCTS NONCOMPETITIVE OR OBSOLETE.
Our industry is subject to rapid, unpredictable and significant
technological change. Competition is intense. Well-known pharmaceutical,
biotechnology, device and chemical companies are marketing other therapies for
the treatment of AMD. Doctors may prefer familiar methods that they are
comfortable using rather than try our products. Many companies are also seeking
to develop new products and technologies for medical conditions for which we are
developing treatments. Our competitors may succeed in developing products that
are safer or more effective than ours and in obtaining regulatory marketing
approval of future products before we do. We anticipate that we will face
increased competition as new companies enter our markets and as the scientific
development of PhotoPoint PDT evolves.
We expect that our principal methods of competition with other photodynamic
therapy companies will be based upon such factors as:
* The ease of administration of our photodynamic therapy;
* The degree of generalized skin sensitivity to light;
* The number of required doses; * The safety and efficacy profile;
* The selectivity of our drug for the target lesion or tissue of
interest;
* The type, cost and price of our light systems;
* The cost and price of our drug; and
* The amount reimbursed for the drug and device treatment by third-party
payors.
We cannot give any assurance that new drugs or future developments in
photodynamic therapy or in other drug technologies will not harm our business.
Increased competition could result in:
* Price reductions;
* Lower levels of third-party reimbursements;
* Failure to achieve market acceptance; and
* Loss of market share.
Any of the above could have an adverse effect on our business. Further, we
cannot give any assurance that developments by our competitors or future
competitors will not render our technology obsolete.
OUR INDUSTRY IS SUBJECT TO TECHNOLOGICAL UNCERTAINTY, WHICH MAY RENDER OUR
PRODUCTS AND DEVELOPMENTS OBSOLETE AND OUR BUSINESS MAY SUFFER.
The pharmaceutical industry is subject to rapid and substantial
technological change. Developments by others may render our products under
development or our technologies noncompetitive or obsolete, or we may be unable
to keep pace with technological developments or other market factors.
Technological competition in the industry from pharmaceutical, biotechnology and
device companies, universities, governmental entities and others diversifying
into the field is intense and is expected to increase. These entities represent
significant competition for us. Acquisitions of, or investments in, competing
pharmaceutical or biotechnology companies by large corporations could increase
such competitors' financial, marketing, manufacturing and other resources.
We are engaged in the development of novel therapeutic technologies,
specifically photodynamic therapy. As a result, our resources are limited and we
may experience technical challenges inherent in such novel technologies.
Competitors have developed or are in the process of developing technologies that
are, or in the future may be, the basis for competitive products. Some of these
products may have an entirely different approach or means of accomplishing
similar therapeutic, diagnostic and imaging effects compared to our products. We
are aware that three of our competitors in the market for photodynamic therapy
drugs have received marketing approval of their product for certain uses in the
United States or other countries. Our competitors may develop products that are
safer, more effective or less costly than our products and, therefore, present a
serious competitive threat to our product offerings.
The widespread acceptance of therapies that are alternatives to ours may
limit market acceptance of our products even if commercialized. The diseases for
which we are developing our therapeutic products can also be treated, in the
case of cancer, by surgery, radiation and chemotherapy, and in the case of
restenosis, by surgery, angioplasty, drug therapy and the use of devices to
maintain and open blood vessels. These treatments are widely accepted in the
medical community and have a long history of use. The established use of these
competitive products may limit the potential for our products to receive
widespread acceptance if commercialized.
Our understanding of the market opportunities for our PhotoPoint PDT is
derived from a variety of sources, and represents our best estimate of the
overall market sizes presented in certain disease areas. The actual market size
and market share which we may be able to obtain may vary substantially from our
estimates, and is dependent upon a number of factors, including:
* Competitive treatments or diagnostic tools, either existing or those
that may arise in the future;
* Performance of our products and subsequent labeling claims; and
* Actual patient population at and beyond product launch.
OUR PRODUCTS ARE SUBJECT TO OTHER STATE AND FEDERAL LAWS, FUTURE LEGISLATION AND
REGULATIONS SUBJECTING US TO COMPLIANCE ISSUES THAT COULD CREATE SIGNIFICANT
ADDITIONAL EXPENDITURES AND LIMIT THE PRODUCTION AND DEMAND FOR OUR POTENTIAL
PRODUCTS.
In addition to the regulations for drug or device approvals, we are subject
to regulation under state, federal or other law, including regulations for
worker occupational safety, laboratory practices, environmental protection and
hazardous substance control. We continue to make capital and operational
expenditures for protection of the environment in amounts which are not
material. Some of the risks and uncertainties related to laws and future
legislation or regulations include:
* Our future capital and operational expenditures related to these
matters may increase and become material;
* We may also be subject to other present and possible future local,
state, federal and foreign regulation;
* Heightened public awareness and concerns regarding the growth in
overall health care expenditures in the United States, combined with
the continuing efforts of governmental authorities to contain or
reduce costs of health care, may result in the enactment of national
health care reform or other legislation or regulations that impose
limits on the number and type of medical procedures which may be
performed or which have the effect of restricting a physician's
ability to select specific products for use in certain procedures;
* Such new legislation or regulations may materially limit the demand
and manufacturing of our products. In the United States, there have
been, and we expect that there will continue to be, a number of
federal and state legislative proposals and regulations to implement
greater governmental control in the health care industry;
* The announcement of such proposals may hinder our ability to raise
capital or to form collaborations; and
* Legislation or regulations that impose restrictions on the price that
may be charged for health care products or medical devices may
adversely affect our results of operations.
We are unable to predict the likelihood of adverse effects which might
arise from future legislative or administrative action, either in the United
States or abroad.
OUR BUSINESS IS SUBJECT TO ENVIRONMENTAL PROTECTION LAWS AND REGULATIONS, AND IN
THE EVENT OF AN ENVIRONMENTAL LIABILITY CLAIM, WE COULD BE HELD LIABLE FOR
DAMAGES AND ADDITIONAL SIGNIFICANT UNEXPECTED COMPLIANCE COSTS, WHICH COULD HARM
OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
We are subject to federal, state, county and local laws and regulations
relating to the protection of the environment. In the course of our business, we
are involved in the handling, storage and disposal of materials that are
classified as hazardous. Our safety procedures for the handling, storage and
disposal of such materials are designed to comply with applicable laws and
regulations. However, we may be involved in contamination or injury from these
materials. If this occurs, we could be held liable for any damages that result,
and any such liability could cause us to pay significant amounts of money and
harm our business. Further, the cost of complying with these laws and
regulations may increase materially in the future.
USE OF PROCEEDS
Miravant will not receive any of the proceeds from the sale of the Common
Stock by the selling securityholders. All proceeds from the sale of the Common
Stock will be for the accounts of the selling securityholders.
SELLING SECURITYHOLDERS
In August 2003, we entered into a $6.0 Unsecured Convertible Debenture and
Warrant Purchase Agreement, or 2003 Debt Agreement, pursuant to which we issued
and sold to certain of the selling securityholders, for aggregate consideration
of $6.0 million and net proceeds to the Company of approximately $5.6 million:
* $6.0 million aggregate principal amount of convertible debentures,
initially convertible into 6.0 million shares of our Common Stock at a
conversion price of $1.00 per share, subject to adjustment; and
* Warrants to purchase an aggregate of 4,500,000 shares of our Common
Stock at an initial exercise price of $1.00 per share, subject to
adjustment.
Pursuant to a registration rights agreement entered into in connection with
the 2003 Debt Agreement, we agreed to prepare and file with the Securities and
Exchange Commission, or SEC, a registration statement covering the resale of the
shares of Common Stock issuable upon conversion of those convertible debentures
and exercise of those warrants. Certain of the purchasers of convertible
debentures and warrants agreed that, until the number of authorized shares of
our Common Stock has been increased to at least 75 million shares, they will not
convert their debentures or exercise their warrants, and accordingly waived
their registration rights for such period. As of March 25, 2004, the number of
authorized shares of our Common Stock has been increased to 75 million and a
separate registration statement was filed during April 2004 to cover these
shares. Accordingly, such purchasers are not included as selling securityholders
under this prospectus except to the extent of the shares of Common Stock
allocated to them as being reserved for issuance as interest payments on the
debentures held by them, as described in the following paragraph.
Interest on the convertible debentures accrues at a rate of 8% per annum
and is required to be paid quarterly through maturity on August 28, 2006. Under
the terms of the debentures, we are permitted under certain circumstances to
make interest payments on such debentures in shares of our Common Stock. One of
the requirements for our use of shares of Common Stock to make interest payments
is that the shares to be so issued must be covered by an effective registration
statement. Accordingly, we are including in this registration statement 480,000
additional shares of our Common Stock, which are reserved for issuance as
interest payments on the debentures, allocated pro rata among the holders of the
debentures. That number of shares is equal to the number of shares of Common
Stock that we would be required to issue on the $6.0 million principal amount of
debentures over a one-year period, based upon a valuation of the shares of
Common Stock for such purpose at the current $1.00 conversion price of the
debentures. In actuality, if we elect to make an interest payment in shares of
Common Stock, our Common Stock would be valued for such purpose at its average
closing sales price over the five day period immediately preceding the
applicable interest payment date, which could be higher or lower than the
current conversion price of the debentures and, therefore, result in the
issuance of fewer or more shares. In the event that we wanted to issue more than
480,000 shares of Common Stock as interest payments on the debentures, we would
have to either amend this registration statement or file a new registration
statement to include those shares.
In addition, at the same time as we entered into the 2003 Debt Agreement,
we issued to Pharmacia AB, a wholly-owned subsidiary of Pfizer, Inc., or
Pharmacia, 390,000 shares of our Common Stock as partial consideration for the
retirement of $10.6 million of debt owed by us to Pharmacia, and those shares
are also being registered herein pursuant to a registration rights agreement
between us and Pharmacia.
The following table sets forth certain information known to us with respect
to the ownership of our Common Stock as of May 14, 2004, and as adjusted to
reflect the sale of Common Stock offered by each selling securityholder known by
us to own our Common Stock. The table sets forth information for each selling
securityholder as follows:
* The name of the selling securityholder;
* The number of shares and the percentage of Common Stock the selling
securityholder beneficially owns before this offering;
* The number of shares of Common Stock the selling securityholder may
sell under this prospectus; and
* Assuming the selling securityholder sells all the shares that he, she
or it may sell under this prospectus, the number of shares and the
percentage of Common Stock the selling securityholder will
beneficially own after completion of the offering.
The percentage of shares of Common Stock beneficially owned is based on
34,757,807 shares outstanding on May 14, 2004. The number of shares of Common
Stock outstanding used in calculating the percentage for each listed selling
securityholder includes shares of Common Stock underlying warrants and
convertible debentures held by such selling securityholder that are exercisable
within 60 calendar days of May 14, 2004, but excludes shares of Common Stock
underlying options, warrants or convertible securities held by any other person.
Except as indicated below, and subject to applicable community property laws,
each person identified in the table has sole voting and investment power with
respect to all shares of Common Stock owned by them. To prevent dilution to the
selling securityholder, pursuant to Rule 416 under the Securities Act, the
numbers in the table below may change due to stock splits, stock dividends or
similar events involving our Common Stock.
The number of shares beneficially owned by the selling securityholders is
determined under rules promulgated by the SEC. However, no holder of debentures
or warrants issued pursuant to the 2003 Debt Agreement is entitled to convert
any debentures into, or exercise any warrants for, Common Stock, or dispose of
any debentures or any warrants, or vote any debentures, to the extent that such
right to effect such conversion, exercise, disposition or vote would result in
the holder or any of its affiliates together beneficially owning more than 4.95%
of the outstanding shares of Common Stock. Therefore, while included in the
number of shares offered in the table below, shares which a selling
securityholder is prevented from acquiring as a result of the limitation
described in the preceding sentence are not shown as beneficially owned by that
securityholder. In addition, because it is our option to pay interest on the
debentures in shares of Common Stock, the holders of the debentures do not have
the right to acquire those shares. Therefore, while included in the number of
shares offered in the table below, shares which we have reserved for issuance as
interest payments on the debentures are not shown as beneficially owned by the
securityholders. As a result, the number of shares that the selling
securityholders may sell pursuant to this prospectus may exceed the number of
shares of Common Stock beneficially owned by them as determined pursuant to the
rules promulgated by the SEC.
This table is prepared based on information supplied to us by the listed
selling securityholders. The term "selling securityholder" includes the
securityholders listed below and their pledges, donees, transferees and other
successors in interest. The table assumes that the selling securityholders sell
all of the shares offered under this prospectus. However, because the selling
securityholders may offer from time to time all or some of their shares under
this prospectus, or in another permitted manner, no assurances can be given as
to the actual number of shares that will be sold by the selling securityholders
or that will be held by the selling securityholders after completion of the
sales. In addition, the shares benefically owned after the offering does not
reflect the possible sale of additional shares of Common Stock, the resale of
which may be or has been registered by the Company pursuant to separate
registration statements. Information concerning the selling securityholders may
change from time to time and changed information will be presented in a
supplement to this prospectus if and when required. Within the past three years,
the selling securityholders have not held any positions or offices with us.
Shares Beneficially Owned Shares Beneficially Owned
Prior to Offering Shares Being After Offering
Name of Selling Stockholder Number Percent Offered Number Percent
--------------------------- ------ ------- ------- ------ -------
Manasa Corp. 183,000 (1) * 183,000 - 0%
IFP, LLC 915,000 (2) 2.57% 915,000 - 0%
Harvest Capital, L.P. 387,227 (3) 1.11% 252,540 134,687 *
New Americans, LLC 109,347 (4) * 69,540 39,807 *
Harvest Offshore Investors, Ltd. 830,833 (5) 2.36% 530,700 300,133 *
Symmetry Capital Partners, L.P. 223,900 (6) * 223,900 - 0%
Symmetry Capital Qualified Partners, L.P. 151,798 (7) * 151,798 - 0%
Asset Management 695,748 (8) 1.88% 695,748 - 0%
Symmetry Capital Offshore Fund, Ltd. 104,822 (9) * 104,822 - 0%
Symmetry Parallax Partners, L.P. 104,732 (10) * 104,732 - 0%
Carlisle Capital, LLC 258,000 (11) * 183,000 75,000 *
Judy Grossman 549,000 (12) 1.56% 549,000 - 0%
Abrams Goldscheider Family Partnership 308,000 (13) * 183,000 125,000 *
Versant Capital Management LLC 1,281,000 (14) 3.56% 1,281,000 - 0%
Lorimor Corp. 915,000 (15) 2.57% 915,000 - 0%
Pharmacia AB 750,000 (16) 2.13% 390,000 360,000 *
Arden Arbitrage Partners, L.P. 97,052 (17) * 62,220 34,832 *
Silver Creek Investments, Ltd. 1,372,500 (18) 3.90% 497,500 875,000 2.50%
Bomoseen Investments, Ltd. 1,372,500 (19) 3.90% 497,500 875,000 2.50%
Dandelion International, Ltd. 1,143,750 (20) 3.27% 268,750 875,000 2.50%
Morebath Holdings Limited 1,309,067 (21) 3.74% 228,750 1,080,317 3.09%
Tioman Finance Limited 1,309,067 (21) 3.74% 228,750 1,080,317 3.09%
Kinaro Investments, S.A. 1,309,067 (21) 3.74% 228,750 1,080,317 3.09%
* Represents ownership of less than one percent (1%) of our Common Stock.
(1) Includes (i) 100,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $100,000
at the current conversion price of $1.00 per share, (ii) 8,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 75,000 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(2) Includes (i) 500,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $500,000
at the current conversion price of $1.00 per share, (ii) 40,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 375,000 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(3) The shares of Common Stock beneficially owned by the selling
securityholder includes 134,687 shares of our Common Stock
beneficially owned in addition to the shares being offered. The number
of shares being offered includes (i) 138,000 shares of our Common
Stock issuable upon conversion of debentures in the aggregate
principal amount of $138,000 at the current conversion price of $1.00
per share, (ii) 11,040 shares of our Common Stock issuable as interest
payments on those debentures during the first year following the
issuance thereof assuming a valuation of our Common Stock of $1.00 per
share for such purpose, and (iii) 103,500 shares of our Common Stock
issuable upon exercise of warrants at a per share exercise price of
$1.00.
(4) The shares of Common Stock beneficially owned by the selling
securityholder includes 39,807 shares of our Common Stock beneficially
owned in addition to the shares being offered. The number of shares
being offered includes (i) 38,000 shares of our Common Stock issuable
upon conversion of debentures in the aggregate principal amount of
$38,000 at the current conversion price of $1.00 per share, (ii) 3,040
shares of our Common Stock issuable as interest payments on those
debentures during the first year following the issuance thereof
assuming a valuation of our Common Stock of $1.00 per share for such
purpose, and (iii) 28,500 shares of our Common Stock issuable upon
exercise of warrants at a per share exercise price of $1.00.
(5) The shares of Common Stock beneficially owned by the selling
securityholder includes 300,133 shares of our Common Stock
beneficially owned in addition to the shares being offered. The number
of shares being offered includes (i) 290,000 shares of our Common
Stock issuable upon conversion of debentures in the aggregate
principal amount of $290,000 at the current conversion price of $1.00
per share, (ii) 23,200 shares of our Common Stock issuable as interest
payments on those debentures during the first year following the
issuance thereof assuming a valuation of our Common Stock of $1.00 per
share for such purpose, and (iii) 217,500 shares of our Common Stock
issuable upon exercise of warrants at a per share exercise price of
$1.00.
(6) Includes (i) 122,350 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $122,350
at the current conversion price of $1.00 per share, (ii) 9,788 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 91,762 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(7) Includes (i) 82,950 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $82,950
at the current conversion price of $1.00 per share, (ii) 6,636 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 62,212 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(8) Includes (i) 380,190 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $380,190
at the current conversion price of $1.00 per share, (ii) 30,415 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 285,143 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(9) Includes (i) 57,280 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $57,280
at the current conversion price of $1.00 per share, (ii) 4,582 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 42,960 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(10) Includes (i) 57,230 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $57,230
at the current conversion price of $1.00 per share, (ii) 4,578 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 42,923 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(11) Includes 75,000 shares of our Common Stock issuable upon the exercise
of a warrant to purchase 75,000 shares of our Common Stock at a per
share exercise price of $1.00, in addition to the shares being
offered. Includes (i) 100,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $100,000
at the current conversion price of $1.00 per share, (ii) 8,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 75,000 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(12) Includes (i) 300,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $300,000
at the current conversion price of $1.00 per share, (ii) 24,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 225,000 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(13) The shares of Common Stock beneficially owned by the selling
securityholder includes 125,000 shares of our Common Stock
beneficially owned in addition to the shares being offered. Includes
(i) 100,000 shares of our Common Stock issuable upon conversion of
debentures in the aggregate principal amount of $100,000 at the
current conversion price of $1.00 per share, (ii) 8,000 shares of our
Common Stock issuable as interest payments on those debentures during
the first year following the issuance thereof assuming a valuation of
our Common Stock of $1.00 per share for such purpose, and (iii) 75,000
shares of our Common Stock issuable upon exercise of warrants at a per
share exercise price of $1.00.
(14) The number of shares being offered includes (i) 700,000 shares of our
Common Stock issuable upon conversion of debentures in the aggregate
principal amount of $700,000 at the current conversion price of $1.00
per share, (ii) 56,000 shares of our Common Stock issuable as interest
payments on those debentures during the first year following the
issuance thereof assuming a valuation of our Common Stock of $1.00 per
share for such purpose, and (iii) 525,000 shares of our Common Stock
issuable upon exercise of warrants at a per share exercise price of
$1.00.
(15) Includes (i) 500,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $500,000
at the current conversion price of $1.00 per share, (ii) 40,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 375,000 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(16) Includes 360,000 shares of our Common Stock issuable upon the exercise
of a warrant to purchase 360,000 shares of our Common Stock at a per
share exercise price of $1.00, in addition to the shares being
offered. The number of shares being offered includes 390,000 shares of
our Common Stock issued in connection with an agreement to retire our
debt with Pharmacia.
(17) The share of Common Stock beneficially owned by the selling
securityholder includes 34,832 shares of our Common Stock beneficially
owned in addition to the shares being offered. The number of shares
being offered includes (i) 34,000 shares of our Common Stock issuable
upon conversion of debentures in the aggregate principal amount of
$34,000 at the current conversion price of $1.00 per share, (ii) 2,720
shares of our Common Stock issuable as interest payments on those
debentures during the first year following the issuance thereof
assuming a valuation of our Common Stock of $1.00 per share for such
purpose, and (iii) 25,500 shares of our Common Stock issuable upon
exercise of warrants at a per share exercise price of $1.00.
(18) Includes (i) 500,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $500,000
at the current conversion price of $1.00 per share, and (ii) 375,000
shares of our Common Stock issuable upon exercise of warrants at a per
share exercise price of $1.00, in addition to the shares being
offered. Includes (i) 250,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $250,000
at the current conversion price of $1.00 per share, (ii) 60,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 187,500 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(19) Includes (i) 500,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $500,000
at the current conversion price of $1.00 per share, and (ii) 375,000
shares of our Common Stock issuable upon exercise of warrants at a per
share exercise price of $1.00, in addition to the shares being
offered. Includes (i) 250,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $250,000
at the current conversion price of $1.00 per share, (ii) 60,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 187,500 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(20) Includes (i) 500,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $500,000
at the current conversion price of $1.00 per share, and (ii) 375,000
shares of our Common Stock issuable upon exercise of warrants at a per
share exercise price of $1.00, in addition to the shares being
offered. Includes (i) 125,000 shares of our Common Stock issuable upon
conversion of debentures in the aggregate principal amount of $125,000
at the current conversion price of $1.00 per share, (ii) 50,000 shares
of our Common Stock issuable as interest payments on those debentures
during the first year following the issuance thereof assuming a
valuation of our Common Stock of $1.00 per share for such purpose, and
(iii) 93,750 shares of our Common Stock issuable upon exercise of
warrants at a per share exercise price of $1.00.
(21) Includes (i) 816,667 shares of our Common Stock issuable upon the
conversion of various notes from the 2002 Debt Agreement, (ii) 166,667
shares of our Common Stock issuable upon the exercise of a warrant to
purchase 166,667 shares of our Common Stock at a per share exercise
price of $1.00 from the 2002 Debt Agreement, and (iii) 96,983 shares
of our Common Stock issuable as interest payments on those notes, in
addition to the shares being offered. Includes (i) 125,000 shares of
our Common Stock issuable upon conversion of debentures in the
aggregate principal amount of $125,000 at the current conversion price
of $1.00 per share, (ii) 10,000 shares of our Common Stock issuable as
interest payments on those debentures during the first year following
the issuance thereof assuming a valuation of our Common Stock of $1.00
per share for such purpose, and (iii) 93,750 shares of our Common
Stock issuable upon exercise of warrants at a per share exercise price
of $1.00.
PLAN OF DISTRIBUTION
We will not receive any proceeds from the sale of the shares. The shares
are being offered on behalf of the selling securityholders. The shares may be
sold or distributed from time to time by the selling securityholders, or by
pledgees, donees or transferees of, or other successors in interest to, the
selling securityholders, directly to one or more purchasers, including pledgees,
or through brokers, dealers or underwriters who may act solely as agents or may
acquire shares as principals, at market prices prevailing at the time of sale,
at prices related to such prevailing market prices, at negotiated prices, or at
fixed prices, which may change. The selling securityholders will act
independently of us in making decisions with respect to the timing, manner and
size of each sale of the Common Stock covered in this prospectus.
The sale of the shares may be effected in one or more of the following
methods:
* ordinary brokers' transactions and transactions in which the broker
solicits purchasers, which may include long or short sales;
* transactions involving cross or block trades in which the broker or
dealer so engaged will attempt to sell the shares as agent, but may
position and resell a portion of the block as principal to facilitate
the transaction, or otherwise on the OTC Bulletin Board;
* purchases by brokers, dealers or underwriters as principal and resale
by such purchasers for their own accounts pursuant to this prospectus;
* "at the market" to or through market makers or into an existing market
for the shares;
* in other ways not involving market makers or established trading
markets, including direct sales to purchases or sales effected through
agents;
* through transactions in options, swaps or other derivatives, whether
exchange-listed or otherwise; or
* any combination of the foregoing, or by any other legally available
means.
In addition, the selling securityholders or their pledgees, donees,
transferees or other successors in interest may enter into hedging transactions
with brokers or dealers who may engage in short sales of shares in the course of
hedging the positions they assume with the selling securityholders. The selling
securityholders or their pledgees, donees, transferees or other successors in
interest may also enter into option or other transactions with brokers or
dealers that require the delivery by such brokers or dealers of the shares,
which shares may be resold thereafter pursuant to this prospectus. The selling
securityholders or their pledgees, donees, transferees or other successors in
interest may also pledge their shares to brokers or dealers or other financial
institutions and, upon a default by such a holder, the brokers, dealers or
financial institutions may offer and sell the pledged shares.
Brokers, dealers, underwriters or agents participating in the distribution
of the shares as agents may receive compensation in the form of commissions,
discounts or concessions from the selling securityholders and/or purchasers of
the shares for whom such brokers, dealers, underwriters or agents may act as
agent, or to whom they may sell as principal, or both, which compensation as to
a particular broker, dealer, underwriter or agent may be less than or in excess
of customary commissions. The selling securityholders and any broker, dealer,
underwriter or agent who act in connection with the sale of shares hereunder may
be deemed to be "underwriters" within the meaning of the Securities Act, and any
commissions they receive and proceeds of any sale of shares may be deemed to be
underwriting discounts and commissions under the Securities Act. Neither we nor
any selling securityholder can presently estimate the amount of such
compensation. We know of no existing arrangements between any selling
securityholders, any other stockholder, or any broker, dealer, underwriter or
agent relating to the sale or distribution of the shares.
We have agreed with the selling securityholders to keep the registration
statement of which this prospectus is a part effective until the shares being
offered hereby may be sold without registration or restriction pursuant to Rule
144(k) promulgated under the Securities Act or, if earlier, until the
distribution contemplated in this prospectus has been completed. We have also
agreed to indemnify, in certain circumstances, the selling securityholders, any
underwriters that participate in the distribution of the shares and certain
control and other persons related to the foregoing persons against certain
liabilities, including liabilities under the Securities Act. The selling
securityholders have agreed to indemnify us, as well as certain related persons,
in certain circumstances against certain liabilities, including liabilities
under the Securities Act. We have further agreed to pay all reasonable costs and
expenses incurred by us or the selling securityholders in connection with the
registration of the shares under the Securities Act, including all registration
and filing fees and our legal and accounting fees and legal fees of counsel
selected by the selling securityholders.
The selling securityholders are not obligated to, and there is no assurance
that the selling securityholders will, sell any or all of the shares of Common
Stock covered in the prospectus.
DESCRIPTION OF CAPITAL STOCK
Our certificate of incorporation authorizes us to issue 105,000,000 shares
of capital stock, of which 75,000,000 shares are Common Stock, $0.01 par value,
and 30,000,000 shares of preferred stock, $0.01 par value. As of May 14, 2004,
there were issued and outstanding 34,757,807 shares of Common Stock, options to
purchase 5,174,441 shares of Common Stock, warrants to purchase 10,111,250
shares of Common Stock and other securities convertible into approximately
10,700,000 shares of Common Stock. As described below, certain holders of
convertible securities and warrants have agreed not to convert such securities
into or exercise such warrants for shares of Common Stock until the number of
authorized shares of our Common Stock has been sufficiently increased.
Holders of the Common Stock are entitled to one vote for each share held in
the election of directors and in all other matters to be voted on by
stockholders. Cumulative voting is permitted in the election of directors.
Holders of Common Stock are entitled to receive dividends as may be declared
from time to time by the board of directors out of funds legally available. In
the event of a liquidation, dissolution or winding up, holders of Common Stock
are to share in all assets remaining after the payment of liabilities and
preferences of outstanding preferred stock, if any. The holders of Common Stock
shall have no preemptive or conversion rights and are not subject to further
calls or assessments. There are no redemption or sinking fund provisions
applicable to the Common Stock. The rights of the holders of the Common Stock
are subject to any rights that may be fixed for holders of preferred stock. All
of the outstanding shares of Common Stock are fully paid and non-assessable.
On July 13, 2000 our Board of Directors designated 50,000 shares of Series
B Junior Participating Preferred Stock pursuant to the Preferred Stockholder
Rights Plan dated July 13, 2000. Each one one-thousandth of a share of Series B
Junior Preferred has rights and preferences substantially equivalent to those of
one common share. Our Board of Directors has the authority, without approval of
the stockholders, to issue all of the unissued shares of preferred stock that
are currently authorized in one or more series and to fix the number of shares
and the rights, preferences, privileges, qualifications, restrictions and
limitations of each series. As of May 14, 2004, we had no shares of preferred
stock outstanding.
Section 203 of the General Corporation Law of the State of Delaware
provides, in general, that a stockholder acquiring more than 15% of the
outstanding voting stock of a corporation subject to the statute (referred to in
this prospectus as an Interested Stockholder) but less than 85% of such stock
may not engage in certain business combinations (as defined in Section 203) with
the corporation for a period of three years subsequent to the date on which the
stockholder became an Interested Stockholder unless (i) prior to such time the
corporation's board of directors approved either the business combination or the
transaction in which the stockholder became an Interested Stockholder or (ii)
the business combination is approved by the corporation's board of directors and
is authorized by a vote of at least 66 2/3% of the outstanding voting stock of
the corporation not owned by the Interested Stockholder. To the extent that the
issuance of the convertible debentures and warrants pursuant to the 2003 Debt
Agreement rendered any purchaser thereunder an Interested Stockholder, our board
of directors has specifically approved such transactions for purposes of Section
203 of the Delaware General Corporation Law, and, accordingly, the prohibitions
on business combinations set forth in such section would not be applicable to
such stockholder.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement on Form S-2 that we
filed with the Securities and Exchange Commission, or SEC, under the Securities
Act of 1933. Certain information in the registration statement has been omitted
from this prospectus in accordance with the rules of the SEC. We file annual,
quarterly and special reports, proxy statements and other information with the
SEC. Our filings are available to the public over the Internet at the SEC's web
site at http://www.sec.gov. You may also read and copy any document we file at
the SEC's Public Reference Rooms in Washington, D.C., New York, New York and
Chicago, Illinois. The Public Reference Room in Washington D.C. is located at
450 Fifth Street, N.W. Please call the SEC at 1-800-SEC-0330 for further
information on the Public Reference Rooms. Additional information about Miravant
can be obtained from our Internet website at http://www.miravant.com.
The SEC allows us to "incorporate by reference" certain of the information
required by this prospectus, which means that we can disclose important
information to you by referring you to those documents. The information
incorporated by reference is an important part of this prospectus. We
incorporate by reference the documents listed below:
* Annual report on Form 10-K for the fiscal year ended December 31,
2003;
* Quarterly report on Form 10-Q for the fiscal quarter ended March 31,
2004;
* Definitive proxy statement filed with the SEC on April 30, 2004;
* Form 8-K filed on February 12, 2004;
* Form 8-K filed on April 1, 2004; and
* Form 8-K filed April 28, 2004.
Upon receipt of an oral or written request we will provide, free of charge,
to any person to whom a prospectus is delivered, a copy of any or all of
information that has been incorporated by reference in the prospectus but not
delivered with the prospectus, other than the exhibits to those documents.
Please direct your written requests to: Investor Relations, Miravant Medical
Technologies, 336 Bollay Drive, Santa Barbara, California 93117. Please direct
your oral requests to: Investor Relations at (805) 685-9880.
You should rely only on the information incorporated by reference or
provided in this prospectus or any prospectus supplement. We have not authorized
anyone else to provide you with different information. We are not making an
offer of our Common Stock in any state where the offer is not permitted. You
should not assume that the information in this prospectus or any prospectus
supplement is accurate as of any date other than the date on the front page of
those documents.
This prospectus is accompanied by Miravant's Annual Report on Form 10-K for
the fiscal year ended December 31, 2003 and its Quarterly Report on Form 10-Q
for the quarter ended March 31, 2004.
..
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain information contained, referred to or incorporated by reference in
this prospectus constitute forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements deal with our current plans,
intentions, beliefs and expectations and statements of future economic
performance. Statements containing terms like "believes," "may," "will,"
"should," "potential," "does not believe," "plans," "expects," "intends,"
"estimates," "continues," "anticipates" and other phrases of similar meaning are
considered to imply uncertainty and are forward-looking statements. In addition,
any statements that refer to expectations, projections or other
characterizations of future events or circumstances are forward-looking
statements.
Forward-looking statements involve known and unknown risks and
uncertainties that may cause our actual results in future periods to differ
materially from what is currently anticipated. We make cautionary statements
throughout this prospectus, including under "Risk Factors." You should read
these cautionary statements as being applicable to all related forward-looking
statements wherever they appear in this prospectus, the materials referred to in
this prospectus and the materials incorporated by reference into this
prospectus. No forward-looking statement is a guarantee of future performance
and you should not place undue reliance on any forward-looking statement.
LEGAL MATTERS
The validity of the resale of the shares of Common Stock registered hereby
will be passed upon for Miravant by Wilson Sonsini Goodrich & Rosati, P.C., Palo
Alto, California.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements included in our annual report on Form 10-K for the year
ended December 31, 2003, as set forth in their report (which contains an
explanatory paragraph describing conditions that raise substantial doubt about
our ability to continue as a going concern as described in Note 1 to our
consolidated financial statements), which is incorporated by reference in this
prospectus and elsewhere in the registration statement. Our consolidated
financial statements are incorporated by reference in reliance on Ernst & Young
LLP's report, given on their authority as experts in accounting and auditing.
PART II.
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the estimated expenses to be incurred in
connection with the issuance and distribution of the securities being registered
hereby:
SEC registration fee................................................................................$ 923
Accounting fees and expenses........................................................................ 10,000*
Legal fees and expenses............................................................................. 40,000*
Printing expenses................................................................................... 0
Miscellaneous....................................................................................... 10,000*
-------------------------
TOTAL......................................................................................... $60,923*
-------------------------
*Estimated
Item 15. Indemnification of Directors and Officers.
Section 145 of the Delaware General Corporation Law authorizes a
corporation to indemnify its directors, officers, employees or other agents in
terms sufficiently broad to permit indemnification (including reimbursement for
expenses incurred) under certain circumstances for liabilities arising under the
Securities Act. The Registrant's certificate of incorporation and bylaws provide
indemnification of its directors and officers to the maximum extent permitted by
the Delaware General Corporation Law. In addition, the Registrant has entered
into indemnification agreements with its directors and officers.
Item 16. Exhibits.
Incorporating
Exhibit Reference
Number Description (if applicable)
- ------ ----------- ---------------
3.1 Amended and Restated Articles of Incorporation dated April 21, 2004. [Z][3.1]
4.1 Specimen Certificate of Common Stock. [B][4.1]
4.2 Form of Convertible Promissory Note. [A][4.3]
4.3 Form of Indenture. [A][4.4]
4.4 Special Registration Rights Undertaking. [A][4.5]
4.5 Undertaking Agreement dated August 31, 1994. [A][4.6]
4.6 Letter Agreement dated March 10, 1994. [A][4.7]
4.7 Form of $10,000,000 Common Stock and Warrants Offering Investment Agreement. [A][4.8]
4.8 Form of $35 Amended and Restated Common Stock Purchase Warrant. [C][4.1]
4.9 Form of Additional $35 Common Stock Purchase Warrant. [C][4.2]
4.10 Warrant to Purchase 10,000 Shares of Common Stock between the Registrant and [D][4.12]
Charles S. Love.*
4.11 Form of $20 Private Placement Warrant Agreement Amendment No. 1. [F [4.13]
4.12 Form of Common Stock Purchase Warrant between the Registrant and Nida & Maloney.
4.13 Form of Common Stock Purchase Warrant between the Registrant and Pharmacia
Corporation.
4.14 Preferred Stock Rights Agreement dated July 13, 2000. [E] [4.1]
4.15 Form of Common Stock Purchase Warrant between the Registrant and Purchasers [S] [10.3]
dated August 28, 2002.
4.16 Form of Note Warrant between the Registrant and the Purchaser dated December 19, [T] [10.4]
2002.
4.17 Form of Convertible Promissory Note between the Registrant and the Purchaser dated August [U] [4.1]
28, 2003.
4.18 Form of 50% Warrant between the Registrant and the Purchaser dated August 28, 2003. [U] [4.2]
4.19 Form of 25% Warrant between the Registrant and the Purchaser dated August 28, [U] [4.3]
2003.
4.20 Registration Rights Agreement dated August 28, 2003 between the Registrant and
the Purchaser. [U] [4.4]
4.21 Amendment to Registration Rights Agreement dated February 18, 1999 between the Registrant [U] [4.5]
and Pharmacia.
4.22 Amendment to Warrant Agreements dated February 18, 1999 between the Registrant and [U] [4.6]
Pharmacia.
4.23 Securities Purchase Agreement dated August 28, 2002 between the Registrant and [S] [10.1]
the Purchasers.
4.24 Registration Rights Agreement dated August 28, 2002 between the Registrant and [S] [10.2]
the Purchasers.
4.25 Common Stock Warrant Purchase Certificate dated August 28, 2002 between the [S] [10.3]
Registrant and the Purchasers.
4.26 Registration Rights Agreement dated December 19, 2002 between the Registrant and [T] [10.2]
the Purchasers.
4.27 Form of Convertible Promissory Note between the Registrant and the Purchaser. [T] [10.3]
4.28 Form of Note Warrant between the Registrant and the Purchaser. [T] [10.4]
4.29 Loan Origination Warrant dated December 20, 2002 between the Registrant and the [T] [10.5]
Purchaser.
4.30 Registration Rights Agreement dated February 5, 2004 between the Registrant and [V] [4.1]
the Purchasers.
4.31 Form of Convertible Promissory Note between the Registrant and the Purchaser [V] [4.2]
dated February 5, 2004.
4.32 Registration Rights Agreement dated April 23, 2004 between the Registrant and [X] [4.1]
the Purchasers.
5.1 Form of Legal Opinion of Wilson Sonsini Goodrich & Rosati, P.C. [AA] [5.1]
10.1 PDT, Inc. Stock Option Plan dated September 19, 1989.** [A][10.9]
10.2 PDT, Inc. Stock Option Plan dated September 3, 1992.** [A][10.10]
10.3 PDT, Inc. 1994 Stock Option Plan dated December 2, 1994.** [A][10.11]
10.4 PDT, Inc. Non-Employee Directors' Stock Option Plan.** [A][10.12]
10.5 License Agreement dated July 1, 1989 between the Registrant and The University
of Toledo, The Medical College of Ohio and St. Vincent Medical Center as [G][10.17]
amended.*
10.6 Form of Directors' and Officers' Indemnification Agreement. [A][10.22]
10.7 Amendment to PDT, Inc. Stock Option Plan dated September 19, 1989.** [H] [10.1]
10.8 Amendment to PDT, Inc. 1994 Stock Option Plan dated December 2, 1994.** [H][10.2]
10.9 Development and Distribution Agreement between Registrant and Iridex [I][10.1]
Corporation.*
10.10 Commercial Lease Agreement between Registrant and Santa Barbara Business Park, a [I][10.2]
California Limited Partnership.(1)
10.11 PDT, Inc. 1996 Stock Compensation Plan.** [J]
10.12 Form of Amendment No. 3 to 1989 Stock Option Agreement.** [K][10.4]
10.13 Investment Agreement dated December 27, 1996 between PDT Cardiovascular, Inc.
and Ramus Medical Technologies.* [L] [10.16]
10.14 Co-Development Agreement dated December 27, 1996 between PDT Cardiovascular,
Inc. and Ramus Medical Technologies. [L] [10.17]
10.15 Series A Preferred Stock Registration Rights Agreement dated December 27, 1996
between PDT Cardiovascular, Inc. and Ramus Medical Technologies.* [L] [10.18]
10.16 Amended and Restated 1996 Stock Compensation Plan.** [M]
10.17 PDT, Inc. 401(k)-Employee Stock Ownership Plan.** [N][10.2]
10.18 Credit Agreement dated April 1, 1998 between the Registrant and Ramus Medical [O][10.5]
Technologies.*
10.19 Convertible Promissory Note dated April 1, 1998 between the Registrant and Ramus [O][10.6]
Medical Technologies.*
10.20 Strategic Alliance Agreement dated June 2, 1998 between the Registrant and [O][10.7]
Xillix Technologies Corp.*
10.21 Subscription Agreement relating to the Registrant's Common Stock dated June 2, [O][10.8]
1998 between the Registrant and Xillix Technologies Corp.
10.22 Subscription Agreement relating to Xillix's Common Stock dated June 2, 1998 [O][10.9]
between the Registrant and Xillix Technologies Corp.
10.23 Commercial Lease Agreement dated May 27, 1998 between the Registrant and [A][10.4]
Raytheon Company.
10.24 Miravant Medical Technologies 2000 Stock Compensation Plan.** [P] [4.1]
10.25 Amendment No. 9 dated as of January 1, 2001 to Employment Agreement between the [Q] [10.1]
Registrant and Gary S. Kledzik.**
10.26 Amendment No. 14 dated as of January 1, 2001 to Employment Agreement between the [Q] [10.2]
Registrant and David E. Mai.**
10.27 Amendment No. 6 dated as of January 1, 2001 to Employment Agreement between the [Q] [10.3]
Registrant and John M. Philpott.**
10.28 Contract Modification and Termination Agreement dated March 5, 2002 between the [R] [10.1]
Registrant and Pharmacia Corporation.
10.29 Convertible Debt and Warrant Purchase Agreement dated December 19, 2002 between the [T] [10.1]
Registrant and the Purchasers.
Convertible Debt and Warrant Purchase Agreement dated August 28, 2003 between the
10.30 Registrant and the Purchaser. [U][10.1]
10.31 Subordination Agreement dated August 28, 2003 between the Registrant and the Purchaser. [U][10.2]
10.32 Termination and Release Agreement dated August 13, 2003 between the Registrant and
Pharmacia, AB. [U[10.3]
10.33 Side Letter Agreement dated August 28, 2003 between the Registrant and the Purchaser. [U][10.4]
10.34 Unsecured Convertible Debt Purchase Agreement dated February 5, 2004 between the
Registrant and the Purchaser. [V] [10.1]
13.1 Annual Report on Form 10-K for the year ended December 31, 2003. [W]
13.2 Quarterly Report on Form 10-Q for the quarter ended March 31, 2004. [Y]
23.1 Consent of Independent Auditors.
- -------------------------------------------
[A] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Registration Statement on Form S-1 (File No.
33-87138).
[B] Incorporated by reference from the exhibit referred to in brackets
contained in Amendment No. 2 to the Registrant's Registration Statement on
Form S-1 (File No. 33-87138).
[C] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated June 30, 1998 (File No.
0-25544).
[D] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended March 31,
1998 (File No. 0-25544).
[E] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8A dated July 18, 2000 (File No.
0-25544).
[F] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-K for the year ended December 31,
1999 (File No. 0-25544).
[G] Incorporated by reference from the exhibit referred to in brackets
contained in Amendment No. 1 to the Registrant's Registration Statement on
Form S-1 (File No. 33-87138).
[H] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended September 30,
1995 (File No. 0-25544).
[I] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended June 30, 1996
(File No. 0-25544).
[J] Incorporated by reference from the Registrant's 1996 Definitive Proxy
Statement filed June 18, 1996
[K] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended September 30,
1996 (File No. 0-25544).
[L] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-K for the year ended December 31,
1996 (File No. 0-25544).
[M] Incorporated by reference from the Registrant's 1996 Definitive Proxy
Statement filed April 24, 1997.
[N] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended June 30, 1997
(File No. 0-25544).
[O] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended June 30, 1998
(File No. 0-25544).
[P] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form S-8 dated August 29, 2000 (File No.
0-25544).
[Q] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended March 31,
2001 (File No. 0-25544).
[R] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated March 11, 2002 (File No.
0-25544).
[S] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated September 3, 2002 (File No.
0-25544).
[T] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated December 19, 2002 (File No.
0-25544).
[U] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated August 28, 2003 (File No.
0-25544).
[V] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated February 12, 2004 (File No.
0-25544).
[W] As filed with the Commission on March 29, 2004.
[X] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated April 27, 2004 (File No.
0-25544).
[Y] As filed with the Commission on May 13, 2004.
[Z] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended March 31,
2004 (File No. 0-25544).
[AA] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Registration Statement on Form S-2 filed with
the Commission on October 1, 2003 (File No. 333-109367]
** Management contract or compensatory plan or arrangement.
* Confidential portions of this exhibit have been deleted and filed
separately with the Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934.
(1) The material has been filed separately on paper pursuant to a request
granted by the Commission for a continuing hardship exemption from filing
electronically.
Item 17. Undertakings.
(a) 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)(2) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the 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. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar
value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate
offering price set forth in the "Calculation of Registration
Fee" table in the effective registration statement;
(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) 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 is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the Registrant of expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act of 1933 and will be governed by the final adjudication of such
issue.
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-2 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Santa Barbara, State of California, on May 20, 2004.
MIRAVANT MEDICAL TECHNOLOGIES
By: /s/ Gary S. Kledzik
--------------------
Gary S. Kledzik, Ph.D.,
Chief Executive Officer
KNOW ALL MEN BY THESE PRESENTS, that the person whose signature appears
below hereby constitutes and appoints Gary S. Kledzik, Ph.D. and John M.
Philpott, or either of them, his attorneys-in-fact and agents, each with full
power of substitution for him and in his name, place and stead, in any and all
capacities, to sign any or all amendments to this Registration Statement and any
registration statements for the same offerings effective upon filing pursuant to
Rule 462(b), and to file the same with all exhibits thereto and other documents
in connection therewith, with the Securities and Exchange Commission, granting
unto each of said attorneys-in-fact and agents full power and authority to do so
and perform each and every act and thing requisite and necessary to be done in
connection with such registration statements, as fully to all intents and
purposes as he might or could do in person, hereby ratifying and confirming all
that either of said attorneys-in-fact and agents, or his substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Name Title Date
/s/ Gary S. Kledzik Chairman of the Board and Chief Executive Officer May 20, 2004
- --------------------- (principal executive officer)
Gary S. Kledzik
/s/ David E. Mai Director and President May 20, 2004
- ----------------
David E. Mai
/s/ John M. Philpott Chief Financial Officer (principal financial officer May 20, 2004
- -------------------- and principal accounting officer)
John M. Philpott
/s/ Charles T. Foscue May 20, 2004
- ---------------------
Charles T. Foscue Director
/s/ Barry Johnson May 20, 2004
- -----------------
Barry Johnson Director
Incorporating
Exhibit Reference
Number Description (if applicable)
- ------ ----------- ---------------
3.1 Amended and Restated Articles of Incorporation dated April 21, 2004. [Z][3.1]
4.1 Specimen Certificate of Common Stock. [B][4.1]
4.2 Form of Convertible Promissory Note. [A][4.3]
4.3 Form of Indenture. [A][4.4]
4.4 Special Registration Rights Undertaking. [A][4.5]
4.5 Undertaking Agreement dated August 31, 1994. [A][4.6]
4.6 Letter Agreement dated March 10, 1994. [A][4.7]
4.7 Form of $10,000,000 Common Stock and Warrants Offering Investment Agreement. [A][4.8]
4.8 Form of $35 Amended and Restated Common Stock Purchase Warrant. [C][4.1]
4.9 Form of Additional $35 Common Stock Purchase Warrant. [C][4.2]
4.10 Warrant to Purchase 10,000 Shares of Common Stock between the Registrant and [D][4.12]
Charles S. Love.*
4.11 Form of $20 Private Placement Warrant Agreement Amendment No. 1. [F [4.13]
4.12 Form of Common Stock Purchase Warrant between the Registrant and Nida & Maloney.
4.13 Form of Common Stock Purchase Warrant between the Registrant and Pharmacia
Corporation.
4.14 Preferred Stock Rights Agreement dated July 13, 2000. [E] [4.1]
4.15 Form of Common Stock Purchase Warrant between the Registrant and Purchasers [S] [10.3]
dated August 28, 2002.
4.16 Form of Note Warrant between the Registrant and the Purchaser dated December 19, [T] [10.4]
2002.
4.17 Form of Convertible Promissory Note between the Registrant and the Purchaser dated August [U] [4.1]
28, 2003.
4.18 Form of 50% Warrant between the Registrant and the Purchaser dated August 28, 2003. [U] [4.2]
4.19 Form of 25% Warrant between the Registrant and the Purchaser dated August 28, [U] [4.3]
2003.
4.20 Registration Rights Agreement dated August 28, 2003 between the Registrant and
the Purchaser. [U] [4.4]
4.21 Amendment to Registration Rights Agreement dated February 18, 1999 between the Registrant [U] [4.5]
and Pharmacia.
4.22 Amendment to Warrant Agreements dated February 18, 1999 between the Registrant and [U] [4.6]
Pharmacia.
4.23 Securities Purchase Agreement dated August 28, 2002 between the Registrant and [S] [10.1]
the Purchasers.
4.24 Registration Rights Agreement dated August 28, 2002 between the Registrant and [S] [10.2]
the Purchasers.
4.25 Common Stock Warrant Purchase Certificate dated August 28, 2002 between the [S] [10.3]
Registrant and the Purchasers.
4.26 Registration Rights Agreement dated December 19, 2002 between the Registrant and [T] [10.2]
the Purchasers.
4.27 Form of Convertible Promissory Note between the Registrant and the Purchaser. [T] [10.3]
4.28 Form of Note Warrant between the Registrant and the Purchaser. [T] [10.4]
4.29 Loan Origination Warrant dated December 20, 2002 between the Registrant and the [T] [10.5]
Purchaser.
4.30 Registration Rights Agreement dated February 5, 2004 between the Registrant and [V] [4.1]
the Purchasers.
4.31 Form of Convertible Promissory Note between the Registrant and the Purchaser [V] [4.2]
dated February 5, 2004.
4.32 Registration Rights Agreement dated April 23, 2004 between the Registrant and [X] [4.1]
the Purchasers.
5.1 Form of Legal Opinion of Wilson Sonsini Goodrich & Rosati, P.C. [AA] [5.1]
10.1 PDT, Inc. Stock Option Plan dated September 19, 1989.** [A][10.9]
10.2 PDT, Inc. Stock Option Plan dated September 3, 1992.** [A][10.10]
10.3 PDT, Inc. 1994 Stock Option Plan dated December 2, 1994.** [A][10.11]
10.4 PDT, Inc. Non-Employee Directors' Stock Option Plan.** [A][10.12]
10.5 License Agreement dated July 1, 1989 between the Registrant and The University
of Toledo, The Medical College of Ohio and St. Vincent Medical Center as [G][10.17]
amended.*
10.6 Form of Directors' and Officers' Indemnification Agreement. [A][10.22]
10.7 Amendment to PDT, Inc. Stock Option Plan dated September 19, 1989.** [H] [10.1]
10.8 Amendment to PDT, Inc. 1994 Stock Option Plan dated December 2, 1994.** [H][10.2]
10.9 Development and Distribution Agreement between Registrant and Iridex [I][10.1]
Corporation.*
10.10 Commercial Lease Agreement between Registrant and Santa Barbara Business Park, a [I][10.2]
California Limited Partnership.(1)
10.11 PDT, Inc. 1996 Stock Compensation Plan.** [J]
10.12 Form of Amendment No. 3 to 1989 Stock Option Agreement.** [K][10.4]
10.13 Investment Agreement dated December 27, 1996 between PDT Cardiovascular, Inc.
and Ramus Medical Technologies.* [L] [10.16]
10.14 Co-Development Agreement dated December 27, 1996 between PDT Cardiovascular,
Inc. and Ramus Medical Technologies. [L] [10.17]
10.15 Series A Preferred Stock Registration Rights Agreement dated December 27, 1996
between PDT Cardiovascular, Inc. and Ramus Medical Technologies.* [L] [10.18]
10.16 Amended and Restated 1996 Stock Compensation Plan.** [M]
10.17 PDT, Inc. 401(k)-Employee Stock Ownership Plan.** [N][10.2]
10.18 Credit Agreement dated April 1, 1998 between the Registrant and Ramus Medical [O][10.5]
Technologies.*
10.19 Convertible Promissory Note dated April 1, 1998 between the Registrant and Ramus [O][10.6]
Medical Technologies.*
10.20 Strategic Alliance Agreement dated June 2, 1998 between the Registrant and [O][10.7]
Xillix Technologies Corp.*
10.21 Subscription Agreement relating to the Registrant's Common Stock dated June 2, [O][10.8]
1998 between the Registrant and Xillix Technologies Corp.
10.22 Subscription Agreement relating to Xillix's Common Stock dated June 2, 1998 [O][10.9]
between the Registrant and Xillix Technologies Corp.
10.23 Commercial Lease Agreement dated May 27, 1998 between the Registrant and [A][10.4]
Raytheon Company.
10.24 Miravant Medical Technologies 2000 Stock Compensation Plan.** [P] [4.1]
10.25 Amendment No. 9 dated as of January 1, 2001 to Employment Agreement between the [Q] [10.1]
Registrant and Gary S. Kledzik.**
10.26 Amendment No. 14 dated as of January 1, 2001 to Employment Agreement between the [Q] [10.2]
Registrant and David E. Mai.**
10.27 Amendment No. 6 dated as of January 1, 2001 to Employment Agreement between the [Q] [10.3]
Registrant and John M. Philpott.**
10.28 Contract Modification and Termination Agreement dated March 5, 2002 between the [R] [10.1]
Registrant and Pharmacia Corporation.
10.29 Convertible Debt and Warrant Purchase Agreement dated December 19, 2002 between the [T] [10.1]
Registrant and the Purchasers.
Convertible Debt and Warrant Purchase Agreement dated August 28, 2003 between the
10.30 Registrant and the Purchaser. [U][10.1]
10.31 Subordination Agreement dated August 28, 2003 between the Registrant and the Purchaser. [U][10.2]
10.32 Termination and Release Agreement dated August 13, 2003 between the Registrant and
Pharmacia, AB. [U[10.3]
10.33 Side Letter Agreement dated August 28, 2003 between the Registrant and the Purchaser. [U][10.4]
10.34 Unsecured Convertible Debt Purchase Agreement dated February 5, 2004 between the
Registrant and the Purchaser. [V] [10.1]
13.1 Annual Report on Form 10-K for the year ended December 31, 2003. [W]
13.2 Quarterly Report on Form 10-Q for the quarter ended March 31, 2004. [Y]
23.1 Consent of Independent Auditors.
- -------------------------------------------
[A] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Registration Statement on Form S-1 (File No.
33-87138).
[B] Incorporated by reference from the exhibit referred to in brackets
contained in Amendment No. 2 to the Registrant's Registration Statement on
Form S-1 (File No. 33-87138).
[C] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated June 30, 1998 (File No.
0-25544).
[D] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended March 31,
1998 (File No. 0-25544).
[E] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8A dated July 18, 2000 (File No.
0-25544).
[F] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-K for the year ended December 31,
1999 (File No. 0-25544).
[G] Incorporated by reference from the exhibit referred to in brackets
contained in Amendment No. 1 to the Registrant's Registration Statement on
Form S-1 (File No. 33-87138).
[H] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended September 30,
1995 (File No. 0-25544).
[I] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended June 30, 1996
(File No. 0-25544).
[J] Incorporated by reference from the Registrant's 1996 Definitive Proxy
Statement filed June 18, 1996
[K] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended September 30,
1996 (File No. 0-25544).
[L] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-K for the year ended December 31,
1996 (File No. 0-25544).
[M] Incorporated by reference from the Registrant's 1996 Definitive Proxy
Statement filed April 24, 1997.
[N] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended June 30, 1997
(File No. 0-25544).
[O] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended June 30, 1998
(File No. 0-25544).
[P] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form S-8 dated August 29, 2000 (File No.
0-25544).
[Q] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended March 31,
2001 (File No. 0-25544).
[R] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated March 11, 2002 (File No.
0-25544).
[S] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated September 3, 2002 (File No.
0-25544).
[T] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated December 19, 2002 (File No.
0-25544).
[U] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated August 28, 2003 (File No.
0-25544).
[V] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated February 12, 2004 (File No.
0-25544).
[W] As filed with the Commission on March 29, 2004.
[X] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 8-K dated April 27, 2004 (File No.
0-25544).
[Y] As filed with the Commission on May 13, 2004.
[Z] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Form 10-Q for the quarter ended March 31,
2004 (File No. 0-25544).
[AA] Incorporated by reference from the exhibit referred to in brackets
contained in the Registrant's Registration Statement on Form S-2 filed with
the Commission on October 1, 2003 (File No. 333-109367]
** Management contract or compensatory plan or arrangement.
* Confidential portions of this exhibit have been deleted and filed
separately with the Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934.
(1) The material has been filed separately on paper pursuant to a request
granted by the Commission for a continuing hardship exemption from filing
electronically.