Back to GetFilings.com
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2003
OR
|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 0-25544
Miravant Medical Technologies
- --------------------------------------------------------------------------------
(Exact name of Registrant as specified in its charter)
Delaware 77-0222872
- --------------------------------------------------------------------------------
(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
336 Bollay Drive, Santa Barbara, California 93117
- --------------------------------------------------------------------------------
(Address of principal executive offices, including zip code)
(805) 685-9880
- --------------------------------------------------------------------------------
(Registrant's telephone number, including area code)
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes |X| No |_|
Indicate the number of shares outstanding of each of the issuer's classes
of common stock, as of the latest practicable date.
Class Outstanding at August 8, 2003
----- -----------------------------
Common Stock, $.01 par value 24,282,743
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Page
Item 1. Condensed Consolidated Financial Statements
Condensed consolidated balance sheets as of June 30, 2003 and
December 31, 2002........................................................ 3
Condensed consolidated statements of operations for the three and
six months ended June 30, 2003 and 2002................................... 4
Condensed consolidated statement of stockholders' equity (deficit)
for the six months ended June 30, 2003.................................... 5
Condensed consolidated statements of cash flows for the six
months ended June 30, 2003 and 2002....................................... 6
Notes to condensed consolidated financial statements....................... 7
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations...................................... 12
Item 3. Qualitative and Quantitative Disclosures About Market Risk................. 42
Item 4. Controls and Procedures.................................................... 42
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds.................................. 42
Item 4. Submission of Matters to a Vote of Security Holders........................ 42
Item 6. Exhibits and Reports on Form 8-K........................................... 43
Signatures................................................................. 43
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, December 31,
2003 2002
-------------------- ---------------------
Assets (Unaudited)
Current assets:
Cash and cash equivalents............................................... $ 76,000 $ 723,000
Prepaid expenses and other current assets............................... 76,000 531,000
-------------------- ---------------------
Total current assets....................................................... 152,000 1,254,000
Property, plant and equipment:
Vehicles................................................................ 28,000 28,000
Furniture and fixtures.................................................. 1,398,000 1,389,000
Equipment............................................................... 5,524,000 5,531,000
Leasehold improvements.................................................. 2,721,000 3,495,000
-------------------- ---------------------
9,671,000 10,443,000
Accumulated depreciation................................................ (9,310,000) (9,837,000)
-------------------- ---------------------
361,000 606,000
Investments in affiliates.................................................. 856,000 393,000
Deferred financing costs................................................... 1,299,000 379,000
Patents, net............................................................... 742,000 978,000
Other assets............................................................... 165,000 159,000
-------------------- ---------------------
Total assets............................................................... $ 3,575,000 $ 3,769,000
==================== =====================
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable........................................................ $ 1,636,000 $ 1,361,000
Accrued payroll and expenses............................................ 648,000 628,000
Short-term debt......................................................... 10,623,000 5,238,000
-------------------- ---------------------
Total current liabilities.................................................. 12,907,000 7,227,000
Long-term liabilities:
Convertible debt........................................................ 6,182,000 1,003,000
Long-term debt.......................................................... -- 5,555,000
Sublease security deposits.............................................. 36,000 94,000
-------------------- ---------------------
Total long-term liabilities................................................ 6,218,000 6,652,000
Stockholders' equity (deficit):
Common stock, 50,000,000 shares authorized; 24,282,743 and 24,225,089 shares
issued and outstanding at June 30, 2003 and December 31, 2002,
respectively.......................................................... 181,173,000 180,255,000
Notes receivable from officers.......................................... (570,000) (570,000)
Deferred compensation................................................... (14,000) (266,000)
Accumulated other comprehensive loss.................................... 464,000 --
Accumulated deficit..................................................... (196,603,000) (189,529,000)
-------------------- ---------------------
Total stockholders' equity (deficit)....................................... (15,550,000) (10,110,000)
-------------------- ---------------------
Total liabilities and stockholders' equity (deficit)....................... $ 3,575,000 $ 3,769,000
==================== =====================
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended June 30, Six months ended June 30,
2003 2002 2003 2002
----------------- ----------------- ---------------- ----------------
Revenues:
License-contract research and development......... $ -- $ -- $ -- $ 20,000
Bulk active pharmaceutical ingredient sales....... -- -- -- 479,000
----------------- ----------------- ---------------- ----------------
Total revenues...................................... -- -- -- 499,000
Costs and expenses:
Cost of goods sold................................ -- -- -- 479,000
Research and development.......................... 1,859,000 2,307,000 3,733,000 5,224,000
Selling, general and administrative............... 1,578,000 1,315,000 2,951,000 2,686,000
----------------- ----------------- ---------------- ----------------
Total costs and expenses............................ 3,437,000 3,622,000 6,684,000 8,389,000
Loss from operations................................ (3,437,000) (3,622,000) (6,684,000) (7,890,000)
Interest and other income (expense):
Interest and other income........................ 18,000 44,000 38,000 118,000
Interest expense................................. (262,000) -- (368,000) (281,000)
Loss on sale of property, plant and equipment.... (42,000) -- (60,000) --
----------------- ----------------- ---------------- ----------------
Total net interest and other income (expense)....... (286,000) 44,000 (390,000) (163,000)
----------------- ----------------- ---------------- ----------------
Net loss............................................ $ (3,723,000) $ (3,578,000) $ (7,074,000) $ (8,053,000)
================= ================= ================ ================
Net loss per share - basic and diluted.............. $ (0.15) $ (0.19) $ (0.29) $ (0.43)
================= ================= ================ ================
Shares used in computing net loss per share......... 24,281,353 18,876,652 24,266,128 18,876,564
================= ================= ================ ================
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
(Unaudited)
Notes Accumulated
Receivable Deferred Other
Common Stock from Compensation Comprehensive Accumulated
Shares Amount Officers Loss Deficit Total
------------ -------------- ------------- --------------- -------------- -------------- -------------
Balance at December 31, 2002..24,225,089 $ 180,255,000 $ (570,000) $ (266,000) $ -- $(189,529,000) $(10,110,000)
Comprehensive loss:
Net loss.................... -- -- -- -- -- (7,074,000) (7,074,000)
Net change in accumulated
other comprehensive loss.... -- -- -- -- 464,000 -- 464,000
-------------
Total comprehensive loss..... (6,610,000)
Issuance of stock awards and
ESOPcontribution............ 57,654 30,000 -- -- -- -- 30,000
Deferred compensation and
deferred interest related
to warrants granted......... -- 888,000 -- (19,000) -- -- 869,000
Non-cash interest on officer
notes....................... -- -- (28,000) -- -- -- (28,000)
Reserve for officer notes.... -- -- 28,000 -- -- -- 28,000
Amortization of deferred
compensation................ -- -- -- 271,000 -- -- 271,000
------------ --------------- ------------- --------------- -------------- --------------- -------------
Balance at June 30, 2003.....24,282,743 $ 181,173,000 $ (570,000) $ (14,000) $ 464,000 $ (196,603,000) $(15,550,000)
============ =============== ============= =============== ============== =============== =============
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six months ended June 30,
Operating activities: 2003 2002
------------------- ----------------------
Net loss.......................................................... $ (7,074,000) $ (8,053,000)
Adjustments to reconcile net loss to net cash used by operating
activities:
Depreciation and amortization.................................. 331,000 493,000
Amortization of deferred compensation.......................... 271,000 277,000
Loss on sale of equipment...................................... 60,000 --
Reserve for patents............................................ 257,000 --
Stock awards and ESOP contribution............................. 30,000 13,000
Non-cash interest and amortization of deferred
financing costs on long-term debt............................ 349,000 326,000
Changes in operating assets and liabilities:
Accounts receivable......................................... -- 5,030,000
Prepaid expenses, inventories and other assets.............. 451,000 390,000
Accounts payable and accrued payroll........................ 237,000 (773,000)
------------------- ----------------------
Net cash used in operating activities............................. (5,088,000) (2,297,000)
Investing activities:
Purchases of marketable securities ............................... -- (44,709,000)
Proceeds from sales of marketable securities ..................... -- 46,330,000
Purchases of patents.............................................. (48,000) (43,000)
Purchases of property, plant and equipment........................ (119,000) --
Proceeds from the sale of property, plant and equipment........... -- 65,000
------------------- ----------------------
Net cash (used in) provided by investing activities............... (167,000) 1,643,000
Financing activities:
Proceeds from promissory notes, net............................... 4,838,000 --
Payments on short-term debt....................................... (230,000) --
Advances of note to officer....................................... -- (155,000)
------------------- --------------------
Net cash provided by (used in) financing activities............... 4,608,000 (155,000)
Net decrease in cash and cash equivalents......................... (647,000) (809,000)
Cash and cash equivalents at beginning of period.................. 723,000 1,458,000
------------------- ----------------------
Cash and cash equivalents at end of period........................ $ 76,000 $ 649,000
=================== ======================
Supplemental disclosures:
Cash paid for:
State taxes..................................................... $ 3,000 $ 3,000
=================== ======================
Interest ....................................................... $ 250,000 $ 1,000
=================== ======================
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Basis of Presentation
The information contained herein has been prepared in accordance with Rule
10-01 of Regulation S-X. The information at June 30, 2003 and for the three
and six month periods ended June 30, 2003 and 2002, is unaudited. In the
opinion of management, the information reflects all adjustments necessary
to make the results of operations for the interim periods a fair statement
of such operations. All such adjustments are of a normal recurring nature.
Interim results are not necessarily indicative of results for a full year.
For a presentation including all disclosures required by accounting
principles generally accepted in the United States, these condensed
consolidated financial statements should be read in conjunction with the
audited consolidated financial statements for the year ended December 31,
2002 included in the Miravant Medical Technologies Annual Report on Form
10-K filed with the Securities and Exchange Commission.
The accompanying condensed consolidated financial statements have been
prepared assuming the Company will continue as a going concern. This basis
of accounting contemplates the recovery of the Company's assets and the
satisfaction of its liabilities in the normal course of business. The
Company's independent auditors, Ernst & Young LLP, have indicated in their
report accompanying the December 31, 2002 consolidated financial statements
that, based on generally accepted auditing standards, the Company's
viability as a going concern is in question. Through June 30, 2003, the
Company had an accumulated deficit of $196.6 million and expects to
continue to incur substantial, and possibly increasing, operating losses
for the next few years due to continued spending on research and
development programs, the cost of preparing and filing a New Drug
Application, or NDA, and related follow-up expenses, the funding of
preclinical studies, clinical trials and regulatory activities and the
costs of manufacturing and administrative activities. The Company also
expects these operating losses to fluctuate due to its ability to fund the
research and development programs as well as the operating expenses of the
Company.
The Company is continuing its scaled back efforts in research and
development and the preclinical studies and clinical trials of its
products. These efforts, along with the cost of preparing an NDA for SnET2,
obtaining requisite regulatory approval, and commencing
pre-commercialization activities prior to receiving regulatory approval,
will require substantial expenditures. Once requisite regulatory approval
has been obtained, if at all, substantial additional financing will be
required for the manufacture, marketing and distribution of our product in
order to achieve a level of revenues adequate to support the Company's cost
structure. In December 2002, the Company entered into a $12.0 million
Convertible Debt and Warrant Agreement, or Debt Agreement, with a group of
private accredited investors, or the Lenders, that provides the Company the
availability to borrow up to $1.0 million per month through November 2003.
The monthly borrowing request can be limited if certain requirements are
not met or are not satisfactory to the Lenders. As of August 11, 2003 the
Company had borrowed $6.3 million under the Debt Agreement. Also, the
Company's first payment on the debt due to Pharmacia Corporation, or
Pharmacia, in the amount of $5.0 million, plus interest from March 5, 2003
to the payment date, was due on June 30, 2003 and has been extended to
August 29, 2003. On April 16, 2003, Pharmacia was acquired by Pfizer Inc.,
or Pfizer. Pharmacia survived the transaction as a wholly owned subsidiary
of Pfizer. The Company is in discussion with Pfizer to further extend the
debt payment due date or to negotiate other payment options or terms. If
the Company cannot make the scheduled payment or negotiate new terms for
the debt repayment with Pfizer, then Pharmacia can exercise all of its
rights to secure all of the collateral under the agreement, which includes
all of the Company's assets. Executive management of Miravant believes the
Company can raise additional funding to support operations through
corporate collaborations or partnerships, licensing of SnET2 or new
products and additional equity or debt financings prior to December 31,
2003, especially based on the Company's announcement that it intends to
file an NDA for SnET2 for the treatment of wet age-related macular
degeneration, or AMD, in 2003. However, there can be no assurance that the
Company will receive the remaining $5.7 million under the Debt Agreement,
if certain requirements are not met or are not satisfactory to the Lenders,
there is no guarantee that the Company will be able to make the scheduled
debt payment to Pharmacia or that new debt repayment terms will be timely
negotiated, if at all, and there is no guarantee that the Company will be
successful in obtaining additional financing or that financing will be
available on favorable terms. If additional funding is not available when
required, the Company's executive management believes that as long as
Miravant receives the remaining $5.7 million available to the Company under
the Debt Agreement and the debt payment due to Pharmacia on August 29, 2003
is renegotiated or is extended into 2004, then the Company has the ability
to conserve cash required for operations through December 31, 2003 by the
delay or reduction in scope of one or more of its research and development
programs and adjusting, deferring or reducing salaries of employees and by
reducing operating facilities and overhead expenditures.
The preparation of condensed consolidated financial statements in
conformity with accounting principles generally accepted in the United
States requires management to make estimates and assumptions that affect
the amounts reported in the condensed consolidated financial statements and
the accompanying notes. Actual results may differ from those estimates and
such differences may be material to the condensed consolidated financial
statements.
2. Comprehensive Loss
For the six months ended June 30, 2003 and 2002, comprehensive loss
amounted to approximately $6.6 million and $8.1 million, respectively. The
difference between net loss and comprehensive loss relates to the change in
the unrealized loss or gain the Company recorded for its available-for-sale
securities on its investment in Xillix Technologies Corp.
3. Per Share Data
Basic loss per common share is computed by dividing the net loss by the
weighted average shares outstanding during the period. Diluted earnings per
share reflect the potential dilution that would occur if securities or
other contracts to issue common stock were exercised or converted to common
stock. Since the effect of the assumed exercise of common stock options and
other convertible securities was anti-dilutive, basic and diluted loss per
share as presented on the condensed consolidated statements of operations
are the same.
4. Convertible Debt Agreement
In December 2002, the Company entered into a Convertible Debt and Warrant
Purchase Agreement, or Debt Agreement, with a group of private accredited
investors, or the Lenders. The $12.0 million Debt Agreement allows the
Company to borrow up to $1.0 million per month, with any unused monthly
borrowings to be carried forward. The maximum aggregate loan amount is
$12.0 million with the last available borrowing in November 2003. The
Lenders' obligation to fund each borrowing request is subject to material
conditions described in the Debt Agreement. In addition, the Lenders may
terminate their obligations under the Debt Agreement if: (i) Miravant has
not filed an NDA by March 31, 2003, (ii) such filing has been rejected by
the U.S. Food and Drug Administration, or FDA, or (iii) Miravant, in the
reasonable judgment of the Lenders, is not meeting its business objectives.
In March 2003, the Company received a waiver from the Lenders with regard
to the NDA filing deadline of March 31, 2003 and extended the deadline to
the end of the third quarter of 2003.
In connection with the Debt Agreement, the Lenders withhold from each
borrowing a 3% drawdown fee and the Company issues to the Lenders a warrant
to purchase one-quarter (1/4) of a share of Miravant Common Stock for every
$1.00 borrowed. The exercise price of each warrant will be equal to the
greater of $1.00 per share or 150% of the average of the closing prices of
Miravant's Common Stock for the ten (10) trading days preceding the date of
the Note. In addition, upon execution of the Debt Agreement the Company
issued to the Lenders a warrant to purchase 250,000 shares of the Company's
Common Stock, with an exercise price of $0.50 per share. Each warrant will
terminate on December 31, 2008, unless previously exercised. The Company
has also agreed to provide to the Lenders certain registration rights in
connection with this transaction.
In April and May 2003, the Company received borrowings of $1.0 million in
each of those months and issued related Notes with a conversion price of
$1.32 and $1.41, respectively. The Company also issued two warrants for the
purchase of 250,000 shares per warrant with an exercise price of $1.58 and
$1.70, respectively. The Company has previously received four monthly
borrowings of $1.0 million each from December 2002 through March 2003
pursuant to the Debt Agreement and issued the Lenders separate Notes
convertible into Common Stock at a per share price of $0.97, $0.97, $1.62
and $1.53, respectively. In addition, in connection with these borrowings,
the Company issued four separate warrants for the purchase of 250,000
shares each at exercise prices of $1.17 per share, $1.16 per share, $1.95
per share and $1.83 per share, related to the December 2002, January 2003,
February 2003 and March 2003 borrowings, respectively. As of June 30, 2003,
the Company has borrowed a total of $6.0 million which is convertible into
Common Stock at an average price per share of $1.30 and has accrued
interest of $182,000 which is also convertible. The Company has also issued
warrants to purchase a total of 1,750,000 shares of Common Stock at an
average exercise price of $1.56. Subsequent to June 30, 2003, the Company
received an additional borrowing of $300,000 and issued a Note convertible
into Common Stock at a per share price of $1.30 and issued a warrant to
purchase 75,000 shares at an exercise price of $1.56.
5. 2002 Pharmacia Agreement
In connection with the Company's Contract Modification and Termination
Agreement with Pharmacia, which provided for the first debt payment to be
paid on March 5, 2003, the Company negotiated an extension on this $5.0
million debt payment to June 30, 2003. In connection with the extension of
the first debt payment date, the Company agreed to pay a total of $250,000
payable in two installments of $125,000 paid on March 24, 2003 and April
17, 2003, respectively. This amount related to the interest due through
March 5, 2003 of $229,000 and an extension fee of $21,000. Subsequently,
the Company has received an additional extension to August 29, 2003 on the
due date of the first debt payment, plus related interest from March 5,
2003 until the payment date, at no additional cost. The Company continues
to have discussions with Pfizer to further extend the debt payment due date
or to negotiate other payment options or terms.
6. Stock-Based Compensation
Statement of Financial Accounting Standard, or SFAS, No. 123, "Accounting
for Stock-Based Compensation," encourages, but does not require, companies
to record compensation expense for stock-based employee compensation plans
at fair value. The Company has chosen to continue to account for
stock-based compensation using the intrinsic value method prescribed by
Accounting Principles Board Opinion, or APB Opinion, No. 25 and related
interpretations including Financial Interpretation No. 44, "Accounting for
Certain Transactions Involving Stock Compensation - an Interpretation of
APB Opinion No. 25" in accounting for its stock option plans.
If the Company had elected to recognize stock compensation expense based on
the fair value of the options granted at grant date for its stock-based
compensation plans consistent with the method of SFAS No. 123, the
Company's net loss and loss per share would have been increased to the pro
forma amounts indicated below:
Three months ended June 30, Six months ended June 30,
2003 2002 2003 2002
----------------- ----------------- ---------------- ----------------
Net loss as reported $ (3,723,000) $ (3,578,000) $ (7,074,000) $ (8,053,000)
Stock-based employee cost included in reported
net loss -- 134,000 -- 269,000
Pro forma stock-based employee compensation
cost under SFAS No. 123 (185,000) (768,000) (444,000) (1,478,000)
----------------- ----------------- ---------------- ----------------
Pro forma net loss (3,908,000) (4,212,000) (7,518,000) (9,262,000)
================= ================= ================ ================
Loss per share - basic and diluted:
As reported $ (0.15) $ (0.19) $ (0.29) $ (0.43)
================= ================= ================ ================
Pro forma $ (0.16) $ (0.22) $ (0.31) $ (0.49)
================= ================= ================ ================
7. New Accounting Pronouncements: SFAS No.'s 145 and 146 Adoption
In April 2002, the Financial Accounting Standards Board, or FASB, issued
SFAS No. 145, "Recission of FASB statements No. 4, 44 and 64, Amendment of
FASB statement No. 13 and Technical corrections", which becomes effective
for fiscal years beginning after May 15, 2002. SFAS No. 4 and No. 64
related to reporting gains and losses from debt extinguishment. Under prior
guidance, if material gains and losses were recognized from debt
extinguishment, the amount was not included in income from operations, but
was shown as an extraordinary item net of related income tax cost or
benefit, as the case may be. Under the new guidance, all gains and losses
from debt extinguishment are subject to criteria prescribed under APB No.
30 in determining an extraordinary item classification. SFAS No. 44 is not
applicable to the Company's operations. SFAS No. 13 was amended to require
certain lease modifications with similar economic effects to be accounted
for the same way as a sale-leaseback. The Company adopted this statement
effective January 1, 2003 and the adoption did not have a material effect
on its consolidated results of operations or consolidated financial
position.
SFAS No. 146 "Accounting for the costs associated with Exit or Disposal
Activities", was issued in June 2002. This statement is effective for any
disposal or exit of business activities started after December 31, 2002.
The statement nullifies EITF 94-3, which required that once a plan of
disposal was put in motion, a liability for the estimated costs needed to
be recorded. SFAS No. 146 states that a liability should not be recorded
until the liability is incurred. This statement does not affect any
liabilities established related to exiting an operation with duplicate
facilities when acquired in a business combination. The Company adopted
this accounting guidance at the prescribed date of January 1, 2003. SFAS
No. 146 currently does not affect the Company's consolidated results of
operations or consolidated financial position.
In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and Equity".
This Statement establishes standards for classifying and measuring as
liabilities certain financial instruments that embody obligations of the
issuer and have characteristics of liabilities and equity. SFAS No. 150 is
effective for all financial instruments created or modified after May 31,
2003, and otherwise effective at the beginning of the first interim period
beginning after June 15, 2003. The adoption of SFAS No. 150 did not have a
material impact on the Company's consolidated results of operations or
consolidated financial position.
8. Subsequent Event
In August 2003, the Company, through a short-term promissory note, received
$750,000 from a current shareholder as bridge financing until resolution of
the payment options or terms for the Pharmacia debt is completed. The note
is payable on demand and earns interest at 8% per year.
9. Reclassifications
Certain reclassifications have been made to the 2002 condensed consolidated
financial statements to conform to the current period presentation.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
This section of the Quarterly Report on Form 10-Q contains forward-looking
statements, which involve known and unknown risks and uncertainties. These
statements relate to our future plans, objectives, expectations and intentions.
These statements may be identified by the use of words such as "may," "will,"
"should," "potential," "expects," "anticipates," "intends," "plans," "believes"
and similar expressions. These statements are based on our current beliefs,
expectations and assumptions and are subject to a number of risks and
uncertainties and include statements regarding our general beliefs concerning
the efficacy and potential benefits of photodynamic therapy; our ability to
raise funds to continue operations; the timing and our ability to complete our
planned New Drug Application, or NDA, filing for the use of SnET2 to treat wet
age-related macular degeneration, or AMD, with the U.S. Food and Drug
Administration, or FDA; our ability to make or negotiate new debt repayment
terms for our first debt payment due to Pharmacia Corporation, or Pharmacia, on
August 29, 2003; our ability to continue to receive the $1.0 million monthly
borrowings through November 2003 under the December 2002 Convertible Debt
Agreement, or the Debt Agreement; our ability to resolve any issues or
contingencies associated with our NDA after it is filed with the FDA; the
assumption that we will continue as a going concern; our ability to regain our
listing status on Nasdaq; our plans to collaborate with other parties and/or
license SnET2; our ability to continue to retain employees under our current
financial circumstances; our ability to use our light production and delivery
devices in future clinical trials; our expected research and development
expenditures; our patent prosecution strategy; and our expectations concerning
the government exercising its rights to use certain of our licensed technology.
Our actual results could differ materially from those discussed in these
statements due to a number of risks and uncertainties including: failure to
obtain additional funding timely, if at all; failure to make our scheduled
payment or negotiate new debt repayment terms with Pharmacia prior to August 29,
2003 resulting in foreclosure on all of our assets; we may be unable to continue
borrowing under the Debt Agreement if we fail to meet certain requirements or if
these requirements are not met to the satisfaction of the Lenders; unanticipated
complexity or difficulty preparing and completing the NDA filing for SnET2; a
failure of our drugs and devices to receive regulatory approval; other parties
may decline to collaborate with us due to our financial condition or other
reasons beyond our control; our existing light production and delivery
technology may prove to be inapplicable or inappropriate for future studies; we
may be unable to obtain the necessary funding to further our research and
development activities and the government may change its past practices and
exercise its rights contrary to our expectations. For a more complete
description of the risks that may impact our business, see "Risk Factors", for a
discussion of certain risks, including those relating to our ability to obtain
additional funding, our ability to establish new strategic collaborations, our
operating losses, risks related to our industry and other forward-looking
statements.
The following discussion should be read in conjunction with the Condensed
Consolidated Financial Statements and Notes thereto.
General
Since our inception, we have been principally engaged in the research and
development of drugs and medical device products for use in PhotoPoint(R) PDT,
our proprietary technologies for photodynamic therapy. We have been unprofitable
since our founding and have incurred a cumulative net loss of approximately
$196.6 million as of June 30, 2003. As we currently do not have any sources of
revenues, we expect to continue to incur substantial, and possibly increasing,
operating losses for the next few years due to continued spending on research
and development programs, the cost of preparing and filing a New Drug
Application, or an NDA, and related follow-up expenses, the funding of
preclinical studies, clinical trials and regulatory activities and the costs of
manufacturing and administrative activities. We also expect these operating
losses to fluctuate due to our ability to fund the research and development
programs as well as the operating expenses of the Company.
We are continuing 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 an NDA for SnET2, obtaining requisite regulatory
approval, and commencing pre-commercialization activities prior to receiving
regulatory approval, will require substantial expenditures. Once requisite
regulatory approval has been obtained, if at all, substantial additional
financing will 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. In December 2002, we entered into a $12.0 million Convertible Debt
and Warrant Agreement, or Debt Agreement, with a group of private accredited
investors, or the Lenders, that provides us the availability to borrow up to
$1.0 million per month through November 2003. The monthly borrowing request can
be limited if certain requirements are not met or are not satisfactory to the
Lenders. As of August 11, 2003, we had borrowed $6.3 million under the Debt
Agreement. Also, our first payment on the debt due to Pharmacia Corporation, or
Pharmacia, in the amount of $5.0 million, plus interest from March 5, 2003 to
the payment date, was due on June 30, 2003 and has been extended to August 29,
2003. On April 16, 2003, Pharmacia was acquired by Pfizer Inc., or Pfizer.
Pharmacia survived the transaction as a wholly owned subsidiary of Pfizer. We
are in discussions with Pfizer to further extend the debt payment due date or to
negotiate other payment options or terms. If we cannot make the scheduled
payment or negotiate new terms for the debt repayment with Pfizer, then
Pharmacia can exercise all of its rights to secure all of the collateral under
the agreement, which includes all of our assets. Our executive management
believes we can raise additional funding to support operations through corporate
collaborations or partnerships, licensing of SnET2 or new products and
additional equity or debt financings prior to December 31, 2003, especially
based on our announcement that we intend to file an NDA for SnET2 for the
treatment of wet age-related macular degeneration, or AMD, in 2003. However,
there can be no assurance that we will receive the remaining $5.7 million under
the Debt Agreement, if certain requirements are not met or are not satisfactory
to the Lenders, there is no guarantee that we will be able to make the scheduled
debt payment to Pharmacia or that new debt repayment terms will be timely
negotiated, if at all, and there is no guarantee that we will be successful in
obtaining additional financing or that financing will be available on favorable
terms. If additional funding is not available when required, our executive
management believes that as long as we receive the remaining $5.7 million
available to us under the Debt Agreement and the debt payment due to Pharmacia
on August 29, 2003 is renegotiated or is extended into 2004, then we have the
ability to conserve cash required for operations through December 31, 2003 by
the delay or reduction in scope of one or more of our research and development
programs and adjusting, deferring or reducing salaries of employees and by
reducing operating facilities and overhead expenditures.
Our historical revenues primarily reflect income earned from licensing
agreements, grants awarded, royalties from device product sales, milestone
payments, non-commercial drug sales to Pharmacia and interest income. During
2001 and through January 2002, we sold approximately $4.8 million of the SnET2
bulk active pharmaceutical ingredient, or bulk API, to Pharmacia to be used in
preclinical studies and clinical trials and in anticipation of a potential NDA
filing for SnET2 for the treatment of AMD. The January 2002 sales of bulk API of
$479,000 was the final amount sold to Pharmacia.
Any other future potential new revenues such as license income from new
collaborative agreements, revenues from contracted services, grants awarded
and/or royalties or revenues from potential drug and device sales, if any, will
depend on, among other factors, the results from our ongoing preclinical studies
and clinical trials, the timing and outcome of applications for regulatory
approvals, including our NDA for SnET2 to be filed in 2003, our ability to
re-license SnET2 and establish new collaborative partnerships and their
subsequent level of participation in our preclinical studies and clinical
trials, our ability to have any of our potential drug and related device
products successfully manufactured, marketed and distributed, the restructuring
or establishment of collaborative arrangements for the development,
manufacturing, marketing and distribution of some of our future products. Based
on the above mentioned factors, among others, we anticipate our operating
activities will result in substantial, and possibly increasing, operating losses
for the next few years.
In December 2002, we entered into a $12.0 million Debt Agreement. The $12.0
million Debt Agreement allows us to borrow up to $1.0 million per month, with
any unused monthly borrowings to be carried forward. The maximum aggregate loan
amount is $12.0 million with the last available borrowing in November 2003. The
Lenders' obligation to fund each borrowing request is subject to material
conditions described in the Debt Agreement. In addition, the Lenders may
terminate its obligations under the Debt Agreement if: (i) Miravant has not
filed an NDA by March 31, 2003, (ii) such filing has been rejected by the U.S.
Food and Drug Administration, or FDA, or (iii) Miravant, in the reasonable
judgment of the Lenders, is not meeting its business objectives. We have
received a waiver from the Lenders with regard to the NDA filing deadline of
March 31, 2003. This deadline has been extended to the end of the third quarter
of 2003.
In January 2002, Pharmacia, after an analysis of the Phase III AMD clinical
data, determined that the clinical data results indicated that SnET2 did not
meet the primary efficacy endpoint in the study population, as defined by the
clinical trial protocol, and that they would not be filing an NDA with the FDA.
In March 2002, we regained the rights to SnET2 as well as the related data and
assets from the AMD clinical trials from Pharmacia. We completed our own
detailed analysis of the clinical data during 2002, including an analysis of the
subset groups. In January 2003, based on the results of our analysis and certain
discussions with regulatory and FDA consultants, we announced our plans to move
forward with an NDA filing for SnET2 for the treatment of AMD. We are currently
in the process of preparing the NDA filing and expect to have it completed and
filed in 2003. In addition, we are currently seeking a new collaborative partner
for PhotoPoint PDT in ophthalmology.
We were delisted by Nasdaq on July 11, 2002 and our Common Stock began
trading on the OTC Bulletin Board(R), or OTCBB, effective as of the opening of
business on July 12, 2002. The OTCBB is a regulated quotation service that
displays real-time quotes, last-sale prices and volume information in
over-the-counter equity securities. OTCBB securities are traded by a community
of market makers that enter quotes and trade reports. Our Common Stock trades
under the ticker symbol MRVT and can be viewed at www.otcbb.com. Our management
continues to review our ability to regain our listing status with Nasdaq,
however, there are no assurances we will be able to raise the additional capital
needed or to increase the current trading price of our Common Stock or meet the
other requirements to allow us to be relisted on the Nasdaq National Market or
Nasdaq Small Cap Market on a timely basis, if at all.
In ophthalmology, besides the possible use of SnET2 alone or in combination
with other therapies, we have identified a few potential next generation drug
compounds for use in various eye diseases. These drugs are in the early stage of
development and will not likely begin further development until we obtain a
corporate partner or other collaboration in ophthalmology.
In our dermatology program, we use a topical gel formulation to deliver
MV9411, a proprietary photoreactive drug, directly to the skin. In July 2001, we
completed a Phase I dermatology clinical trial and, in January 2002, we
commenced a Phase II clinical trial with MV9411 for potential use in the
treatment of plaque psoriasis, a chronic dermatological condition for which
there is no known cure. Plaque psoriasis is a disease marked by
hyperproliferation of the epidermis, resulting in inflamed and scaly skin
plaques. The Phase II clinical trial is currently ongoing and has been expanded
and we expect to complete the treatment of the patients by the third quarter
2003, with some follow-up required. If we are unable to see any satisfactory
results from the clinical trial, we will likely put any further development on
hold.
We are also conducting preclinical studies with new photoselective drugs
for cardiovascular diseases, in particular for the prevention and treatment of
vulnerable plaque and restenosis. Vulnerable plaque, or VP, is an unstable,
rupture-prone inflammation within the artery walls, and restenosis is the
renarrowing of an artery that commonly occurs after balloon angioplasty for
obstructive artery disease. We are in the process of formulating a new lead
drug, MV0633, and, pending the outcome of our preclinical studies, our corporate
activities, financial considerations, and other factors, we may prepare an
Investigational New Drug application, or IND, in cardiovascular disease for
MV0633 or existing photoselective drugs. The timing of the IND is dependent on
numerous factors including preclinical results, available funding and personnel.
We are currently pursuing various potential strategic partners in the field of
cardiovascular disease. There are no guarantees that potential strategic
partners will enter into a license agreement or provide us with any potential
funding to advance our research and development programs.
As a result of our preclinical studies in cardiovascular disease, we are
evaluating the use of PhotoPoint PDT for the prevention and/or treatment of
stenosis in arterial-venous grafts, or AV grafts. AV grafts are placed in
patients with End Stage Renal Disease to provide access for hemodialysis.
Depending on the results of our discussions with potential corporate partners in
this area, as well as financial considerations and other factors, we may decide
to file an IND for the commencement of clinical trials in this field.
In oncology, we are conducting preclinical research of PhotoPoint PDT to
destroy abnormal blood vessels in tumors. We are pursuing this tumor research
with some of our photoselective drugs and also investigating combination
therapies using PhotoPoint PDT with other types of compounds.
Below is a summary of the disease programs and their related stages of
development. The information in the column labeled "Estimate of Completion of
Phase" contains forward-looking statements regarding timing of completion of
product development phases. The actual timing of completion of those phases
could differ materially from the estimates provided in the table. Additionally,
due to the uncertainty of the scientific results of any of these programs as
well as the uncertainty regarding our ability to fund these programs, we are
unable to provide an accurate estimate as to the costs, capital requirements or
the specific timing necessary to complete any of these programs. For a
discussion of the risks and uncertainties associated with the timing of
completing a product development phase for our company as well as our industry
as a whole, see the "Risk Factors" section of "Management's Discussion and
Analysis of Financial Condition and Results of Operations."
Estimate of Completion
Program Description/Indication Phase of Development of Phase
--------------------- ------------------------------ ---------------------------- ------------------------
Ophthalmology AMD (SnET2) Preparing an NDA 2003
New drug compounds Research studies Completed
Dermatology Psoriasis (MV9411) Phase II Q3 2003
Cardiovascular VP and Restenosis (MV0633
disease and other compounds) Preclinical studies **
AV Graft (SnET2) Preclinical studies **
Oncology Tumor research Research studies **
** Based on the early development stage of these programs we cannot
reasonably estimate the time at which these programs may move from a
research or preclinical development phase to the clinical trial phase. The
decision and timing of whether these programs will move to the clinical
trial phase will depend on a number of factors including the results of the
preclinical studies, the estimated costs of the programs, the availability
of alternative therapies and our ability to fund or obtain additional
financing or to obtain new collaborative partners to help fund the
programs.
Based on our ability to successfully obtain additional funding, our ability
to obtain new collaborative partners, our ability to license and pursue further
development of SnET2 for AMD or other disease indications, our ability to file
an NDA for SnET2, our ability to reduce operating costs as needed, our ability
to regain our listing status on Nasdaq 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 elect or be able to further
develop PhotoPoint PDT procedures in ophthalmology, cardiovascular disease,
dermatology, oncology or in any other indications.
Pharmacia Corporation
Over time we have entered into a number of agreements with Pharmacia to
fund our operations and develop and market SnET2. On April 16, 2003, Pharmacia
was acquired by Pfizer. Pharmacia survived the transaction as a wholly owned
subsidiary of Pfizer. In March 2002, we entered into a Contract Modification and
Termination Agreement with Pharmacia under which we regained all of the rights
and related data and assets to our lead drug candidate, SnET2, and we
restructured our outstanding debt to Pharmacia. Under the terms of the Contract
Modification and Termination Agreement, various agreements and side letters
between Miravant and Pharmacia have been terminated, most of which are related
to SnET2 license agreements and related drug and device supply agreements, side
letters, the Manufacturing Facility Asset Purchase Agreement and various
supporting agreements. We also modified our 2001 Credit Agreement with
Pharmacia.
The termination of the various agreements provided that all ownership of
the rights, related data and assets to SnET2 and the AMD clinical trials for the
treatment of AMD revert back to us. The rights transferred back to us include
the ophthalmology IND and the related filings, data and reports and the ability
to license the rights to SnET2. The assets include the lasers utilized in the
AMD clinical trials, the bulk API manufacturing equipment, all of the bulk API
inventory sold to Pharmacia in 2001 and 2002 and the finished dose formulation,
or FDF, inventory. In addition, we reassumed the lease obligations and related
property taxes for our bulk API manufacturing facility. The lease agreement
expires in March 2006 and currently has a base rent of approximately $26,000 per
month. In January 2003, we sublet this facility through December 2005.
Under the Manufacturing Facility Asset Purchase Agreement, which was
entered into in May 2001 and subsequently terminated in March 2002, Pharmacia
satisfied the following obligations:
* Pharmacia agreed to buy our existing bulk API inventory at cost for
$2.2 million. During 2001, the entire $2.2 million of the existing
bulk API inventory had been delivered to Pharmacia, recorded as
revenue and the payment had been received into the inventory escrow
account;
* Pharmacia committed, through two other purchase orders, to buy up to
an additional $2.8 million of the bulk API which would be manufactured
by us. As of December 31, 2002, we had sold $2.5 million during 2001
and 2002 of newly manufactured bulk API inventory, which had been
delivered to Pharmacia, recorded as revenue and the payment had been
received into the inventory escrow account. No further bulk API will
be sold to Pharmacia;
* Pharmacia agreed to purchase the manufacturing equipment necessary to
produce bulk API. The manufacturing equipment was purchased for
$863,000, its fair market value as appraised by an independent
appraisal firm. The payment for the purchase of the equipment was made
into an equipment escrow account;
* The interest earned by the inventory and equipment escrow accounts
accrued to us and was released in full from each escrow account in
January 2002 and March 2002, respectively. All amounts received into
escrow were recorded as accounts receivable until the amounts were
released.
The Contract Modification and Termination Agreement also modified the 2001
Credit Agreement as follows:
* The outstanding debt that we owed to Pharmacia of approximately $26.8
million, was reduced to $10.0 million plus accrued interest;
* The first payment of $5.0 million, plus interest, was due on March 5,
2003 and was subsequently extended to June 30, 2003 and then to August
29, 2003. The second payment of $5.0 million, plus interest, is due on
June 4, 2004. Interest on the debt will be recorded at the prime rate,
which was 4.75% on March 5, 2002 and 4.00% at June 30, 2003;
* In exchange for these changes and the rights to SnET2, we terminated
our right to receive a $3.2 million loan that was available under the
2001 Credit Agreement. Also, as Pharmacia has determined that they
will not file an NDA for the SnET2 PhotoPoint PDT for AMD, based upon
their overall analysis of the Phase III AMD data, we will not have
available to us an additional $10.0 million of borrowings as provided
for under the 2001 Credit Agreement. Pharmacia has no obligation to
make any further milestone payments, equity investments or to extend
us additional credit;
* The early repayment provisions were modified and many of the covenants
were eliminated or modified. Our requirement to allocate one-half of
the net proceeds from any public or private equity financings and/or
asset dispositions towards the early repayment of our debt to
Pharmacia was modified as follows:
* If our aggregate net equity financing and/or assets disposition
proceeds are less than or equal to $7.0 million, we are not
required to make an early repayment towards our Pharmacia debt.
As of June 30, 2003, our aggregate equity financings amount to
$2.5 million;
* If our aggregate net equity financing and/or assets disposition
proceeds are greater than $7.0 million but less than or equal to
$15.0 million, then we are required to apply one-third of the net
proceeds from the amount in excess of $7.0 million up to $15.0
million, or a maximum repayment of $2.7 million towards our
Pharmacia debt;
* If our aggregate net equity financing and/or assets disposition
proceeds are greater than $15.0 million but less than or equal to
$25.0 million, then we are required to apply one-half of the net
proceeds from the amount in excess of $15.0 million up to $25.0
million, or a maximum repayment of $7.7 million towards our
Pharmacia debt;
* If our aggregate net equity financing and/or assets disposition
proceeds are greater than $25.0 million, then we are required to
apply all of the net proceeds from the amount in excess of $25.0
million, or repay the entire $10.0 million plus accrued interest
towards our Pharmacia debt; and
* Any early repayment of our Pharmacia debt applies first to the
loan amount due on August 29, 2003, then to the remaining loan
amount due on June 4, 2004.
Aside from the changes made under the Contract Modification and Termination
Agreement discussed above, there were no changes made to the Warrant Agreement,
the Equity Investment Agreement and the Registration Rights Agreement with
Pharmacia.
Our first payment on our debt to Pharmacia in the amount of $5.0 million,
plus interest, is due on August 29, 2003. If we cannot make the scheduled
payment or negotiate new options or terms for the debt repayment with Pfizer,
then Pharmacia can exercise all of its rights to secure all the collateral under
the agreement, which includes all of our assets. There is no guarantee that we
will be able to make the scheduled payment or that new debt repayment terms will
be negotiated timely, if at all.
Results of Operations
Revenues. For the three months ended June 30, 2003 and June 30, 2002, we
had no revenues. For the six months ended June 30, 2003, we had no revenues
compared to $499,000 for the six months ended June 30, 2002. The fluctuations in
revenues are due to the following:
Bulk Active Pharmaceutical Ingredient Sales. In May 2001, we entered into
an Asset Purchase Agreement with Pharmacia whereby they agreed to buy bulk API
inventory through March 2002. In 2002, we recorded revenue of $479,000 related
to the newly manufactured bulk API inventory. There were no bulk API sales for
the six months ended June 30, 2003 and there will be no future bulk API sales
under this agreement as it has been terminated.
License Income. License income, which represents reimbursements of
out-of-pocket or direct costs incurred in preclinical studies and Phase III AMD
clinical trials, decreased from $20,000 for the six months ended June 30, 2002
to no reimbursement income for the six months ended June 30, 2003. The decrease
in license income is specifically related to the termination of the Pharmacia
relationship. Reimbursements received during the six months ended June 30, 2002
were primarily for costs incurred to complete preclinical studies for AMD.
We will receive no further reimbursements from Pharmacia related to any of
our ongoing preclinical studies and clinical trials and Pharmacia will not make
any more purchases of bulk API. Any future revenue will likely be related to new
collaborative agreements, and royalties or revenues from drug and device sales
upon regulatory approval and subsequent commercial sales, if any.
Cost of API Sales. In connection with the newly manufactured bulk API sold
under the terms of the Asset Purchase Agreement with Pharmacia, we recorded
$479,000 in manufacturing costs for the six months ended June 30, 2002. The
amounts recorded as cost of API sales represent the costs incurred for only the
newly manufactured bulk API in first quarter 2002. Pharmacia will not be making
any further purchases of bulk API. No cost of API sales were incurred for the
three and six months ended June 30, 2003 and no further cost of API sales are
expected until regulatory approval is received and commercial sales commence.
Research and Development. Research and development costs are expensed as
incurred. Research and development expenses are comprised of direct and indirect
costs. Direct costs consist of preclinical studies, clinical trials and related
clinical drug and device development and manufacturing costs, drug formulation
expenses, contract services and other research and development expenditures.
Indirect costs consist of salaries and benefits, overhead and facility costs,
and other support service expenses. Our research and development expenses
decreased from $2.3 million for the three months ended June 30, 2002 to $1.9
million for the same period in 2003. Our research and development expenses
decreased from $5.2 million for the six months ended June 30, 2002 to $3.7
million for the same period in 2003. The overall decrease in research and
development expenses is specifically related to the conclusion of the Phase III
AMD clinical trials and the completion of the preclinical studies and our AMD
clinical trial responsibilities. Our research and development expenses, net of
license reimbursement, were $2.3 million for the three months ended June 30,
2002 and $1.9 million for the same period in 2003. Our research and development
expenses, net of license reimbursement, were $5.2 million for the six months
ended June 30, 2002 and $3.7 million for the same period in 2003. Research and
development expenses for the three and six months ended June 30, 2002 and 2003
related primarily to payroll, payroll taxes, employee benefits and allocated
operating costs. Additionally, we incurred research and development expenses
for:
* Work associated with the development of new devices, delivery systems,
drug compounds and formulations for the dermatology and cardiovascular
programs;
* Preclinical studies and clinical trial costs for our Phase II
dermatology program; and
* Costs incurred to prepare the NDA for AMD in 2003.
As previously disclosed, we have four research and development programs
which we have focused our efforts: ophthalmology, dermatology, cardiovascular
disease and oncology. Research and development costs are initially identified as
direct costs and indirect costs, with only direct costs tracked by specific
program. These direct costs consist of clinical, preclinical, drug and
formulation development, device development and research costs. We do not track
our indirect research and development costs by program. These indirect costs
consist of labor, overhead and other indirect costs. The research and
development costs for specific programs represent the direct costs incurred. The
direct research and development costs by program are as follows:
Three months ended June 30, Six months ended June 30,
-------------------------------- -------------------------------------- ------------------------------------
Program 2003 2002 2003 2002
-------------------------------- ---------------- ------------------ --------------- ----------------
Direct costs:
Ophthalmology.............. $ 360,000 $ 71,000 $ 556,000 $ 91,000
Dermatology................ 46,000 200,000 202,000 258,000
Cardiovascular disease..... 75,000 47,000 260,000 220,000
Oncology................... 8,000 1,000 15,000 21,000
---------------- ------------------ --------------- ----------------
Total direct costs.............. $ 489,000 $ 319,000 $ 1,033,000 $ 590,000
Indirect costs ................. $ 1,370,000 $ 1,988,000 $ 2,700,000 $ 4,634,000
---------------- ------------------ --------------- ----------------
Total research and development
costs........................... $ 1,859,000 $ 2,307,000 $ 3,733,000 $ 5,224,000
================ ================== =============== ================
Ophthalmology. For the six months ended June 30, 2003 our direct
ophthalmology program costs have increased to $556,000 from $91,000 for the six
months ended June 30, 2002. For the three months ended June 30, 2003 our direct
ophthalmology program costs have increased to $360,000 from $71,000 for the
three months ended June 30, 2002. Costs incurred for the ophthalmology program
have consisted of clinical trial expenses for the screening, treatment and
monitoring of individuals participating in the AMD clinical trials, internal and
external preclinical study costs, drug and device development and manufacturing
costs and preparation costs for the NDA. The costs incurred and the increase for
the three and six month periods ended June 30, 2003 are specifically related to
the preparation of the NDA filing for SnET2 in AMD compared to minimal
ophthalmology activities for the same period in 2002.
Dermatology. For the six months ended June 30, 2003 our direct dermatology
program costs decreased to $202,000 from $258,000 for the six months ended June
30, 2002. For the three months ended June 30, 2003 our direct dermatology
program costs have decreased to $46,000 from $200,000 for the same period in
2002. Costs incurred in the dermatology program include expenses for drug
development and drug formulation, internal and external preclinical study costs,
and Phase II clinical trial expenses. The decrease for the three and six months
ended June 30, 2003 as compared to 2002 is due to the majority of the cost of
the Phase II clinical trial being incurred in 2002.
Cardiovascular Disease. For the six months ended June 30, 2003 our direct
cardiovascular disease program costs increased to $260,000 from $220,000 for
same period in 2002. For the three months ended June 30, 2003 our direct
cardiovascular disease program costs have increased to $75,000 from $47,000 for
the same period in 2002. Our cardiovascular disease program costs include
expenses for the development of new drug compounds and light delivery devices,
drug formulation costs, drug and device manufacturing expenses and internal and
external preclinical study costs. The increase from 2002 to 2003 is related to
the progress of the program, which required preclinical studies, as well as an
increase in development and manufacturing activities for drugs and devices used
in the preclinical studies and in preparation for future clinical trials.
Oncology. For the six months ended June 30, 2003 our direct oncology
program costs have decreased to $15,000 from $21,000 for the same period in
2002. For the three months ended June 30, 2003, our direct oncology program
costs have increased to $8,000 from $1,000 for the same period in 2002. Our
oncology program costs have primarily consisted of costs for internal and
external preclinical studies and expenses for the early development of new drug
compounds. The decrease in oncology program costs from 2002 to 2003 is related
to our decision to focus on discovery and research programs for use of
PhotoPoint PDT in oncology, rather than focus on development programs.
Indirect Costs. For the six months ended June 30, 2003 our indirect costs
have decreased to $2.7 million from $4.6 million for the same period in 2002.
For the three months ended June 30, 2003 our indirect costs have decreased to
$1.4 million from $2.0 million for the same period in 2002. Generally, the
decrease from 2002 to 2003 was attributed to a reduction in our program
activities, as well as a continued reduction in labor costs due to the reduction
in employees. The decrease was also related to the sublease of one of our
buildings, which reduced facility and overhead costs.
We expect that future research and development expenses may fluctuate
depending on available funds, continued expenses incurred in our preparation of
the NDA for SnET2, our costs for preclinical studies and clinical trials in our
ophthalmology, dermatology, cardiovascular, oncology and other programs, costs
associated with the purchase of raw materials and supplies for the production of
devices and drug for use in preclinical studies and clinical trials, results
obtained from our ongoing preclinical studies and clinical trials and the
expansion of our research and development programs, which includes the increased
hiring of personnel, the continued expansion of existing or the commencement of
new preclinical studies and clinical trials and the development of new drug
compounds and formulations.
Selling, General and Administrative. Our selling, general and
administrative expenses for the six months ended June 30, 2003 increased to $3.0
million from $2.7 million for the six months ended June 30, 2002. For the three
months ended June 30, 2003 our selling, general and administrative expenses
increased to $1.6 million compared to $1.3 million for the same period in 2002.
Selling, general and administrative expenses for the three and six months ended
June 30, 2002 and 2003 related primarily to payroll related expenses, operating
costs such as rent, utilities, professional services and insurance costs and
non-cash expenses such as stock compensation and depreciation. In the six months
ended June 30, 2003, the employee and overhead related expenses decreased from
2002 to 2003 due to the decrease in the number of administrative employees and a
decrease in facility related costs from the reduction in facilities. These
decreases were primarily offset by an increase in insurance and stock
compensation costs.
We expect future selling, general and administrative expenses to remain
consistent with prior periods although they may fluctuate depending on available
funds, and the need to perform our own marketing and sales activities, the
support required for research and development activities, the costs associated
with potential financing and partnering activities, continuing corporate
development and professional services, facility and overhead costs, compensation
expense associated with stock options and warrants granted to consultants and
expenses for general corporate matters.
Interest and Other Income. Interest and other income decreased to $38,000
for the six months ended June 30, 2003 from $118,000 for the six months ended
June 30, 2002. For the three months ended June 30, 2003 interest and other
income decreased to $18,000 from $44,000 for the same period in 2002. The
fluctuations in interest and other income are directly related to the levels of
cash and marketable securities earning interest and the rates of interest being
earned. The level of future interest and other income will primarily be subject
to the level of cash balances we maintain from period to period and the interest
rates earned.
Interest Expense. Interest expense increased from $368,000 for the six
months ended June 30, 2003 to $281,000 for the same period in 2002. For the
three months ended June 30, 2003 interest expense increased to $262,000 from
zero for the same period in 2002. In accordance with Statement of Financial
Accounting Standard, or SFAS, No. 15, with the restructuring of the Pharmacia
debt in March 2002, we reduced our outstanding debt to the total future cash
payments of the debt, which included $792,000 designated as interest and $10.0
million as principal. Also, with the restructuring of the debt, the value of the
warrants issued to Pharmacia was reduced to zero. The increase for the three and
six months ended June 30, 2003, related to the $20,000 debt extension fee and
interest related to the Pharmacia debt payment extension, which accrues at 4.25%
from March 5, 2003 to the repayment date, interest earned from the promissory
notes received during the quarter in connection with the Debt Agreement which
accrues interest at 9.4%, and the amortization of the warrants issued in
connection with each promissory note. The level of interest expense in future
periods is expected to increase as monthly borrowings on the promissory notes
are continued.
Liquidity and Capital Resources
Since inception through June 30, 2003, we have accumulated a deficit of
approximately $196.6 million and expect to continue to incur substantial, and
possibly increasing, operating losses for the next few years. We have financed
our operations primarily through private placements of Common Stock and
Preferred Stock, private placements of convertible notes and short-term notes,
our initial public offering, a secondary public offering, Pharmacia's purchases
of Common Stock and credit arrangements. As of June 30, 2003, we have received
proceeds from the sale of equity securities, convertible notes and credit
arrangements of approximately $231.5 million. We do not anticipate achieving
profitability in the next few years, as such we expect to continue to rely on
external sources of financing to meet our cash needs for the foreseeable future.
As of June 30, 2003, our condensed consolidated financial statements have been
prepared assuming we will continue as a going concern. Our independent auditors,
Ernst & Young LLP, have indicated in their report accompanying our December 31,
2002 consolidated financial statements that, based on generally accepted
auditing standards, our viability as a going concern is in question.
In March 2002, Miravant and Pharmacia entered into a Contract Modification
and Termination Agreement pursuant to which we regained all of the rights and
related data and assets to our lead drug candidate, SnET2, and restructured our
outstanding debt to Pharmacia.
Under the terms of the Contract Modification and Termination Agreement,
various agreements and side letters between Miravant and Pharmacia have been
terminated. Most of these agreements related to SnET2 license agreements and
related drug and device supply agreements, side letters, the Manufacturing
Facility Asset Purchase Agreement and various supporting agreements. The
termination of the various agreements provided that all ownership of the rights,
data and assets related to SnET2 and the AMD clinical trials revert back to us.
The rights transferred back to us include the ophthalmology IND and the related
filings, data and reports and the ability to license the rights to SnET2. The
assets which we received ownership rights to include the lasers utilized in the
AMD clinical trials, the bulk API manufacturing equipment, all of the bulk API
inventory sold to Pharmacia in 2001 and 2002 and the FDF inventory. In addition
to receiving back all of the bulk API inventory sold to Pharmacia in 2001, we
also received a payment of approximately $479,000 for the costs of the
in-process and finished bulk API inventory manufactured through January 23,
2002. We reassumed the lease obligations and related property taxes for our bulk
API manufacturing facility. The lease agreement expires in October 2006 and
currently has a base rent of approximately $26,000 per month. In January 2003,
we sublet this facility through December 2005.
As a condition of the Contract Modification and Termination Agreement,
Pharmacia released to us in March 2002 the $880,000, which included accrued
interest, held in an equipment escrow account, which was originally scheduled
for release in June 2002. These funds represent the $863,000 purchase price that
Pharmacia paid under the Manufacturing Facility Asset Purchase Agreement for the
purchase of our bulk API manufacturing equipment in May 2001 plus interest
earned through the release date.
The Contract Modification and Termination Agreement also modified the 2001
Credit Agreement. The outstanding debt that we owed to Pharmacia of
approximately $26.8 million was reduced to $10.0 million plus accrued interest.
We will be required to make a payment of $5.0 million, plus interest, on each of
August 29, 2003 and June 4, 2004. Interest on the debt will be recorded at the
prime rate, which was 4.75% at March 5, 2002, 4.25% beginning in November 2002
and 4.00% starting on June 27, 2003. Additionally, the early repayment
provisions and many of the covenants were eliminated or modified. In exchange
for these changes and the rights to SnET2, we terminated our right to receive a
$3.2 million loan that was available under the 2001 Credit Agreement. Also, as
Pharmacia has determined that they will not file an NDA for the SnET2 PhotoPoint
PDT for AMD and the Phase III clinical trial data did not meet certain clinical
statistical standards, as defined by the clinical trial protocols, we will not
have available an additional $10.0 million of borrowings as provided for under
the 2001 Credit Agreement.
In August 2003, we received a short-term promissory note of $750,000 from a
current shareholder as bridge financing until resolution of the payment options
or terms for the Pharmacia debt is completed. The note is payable on demand and
earns interest at 8% per year.
Statement of Cash Flows
Net cash required for operations for the six months ended June 30, 2003 and
2002 was $5.1 million and $2.3 million, respectively. For the six months ended
June 30, 2003, the net cash used for operations was increased due to a decrease
in prepaid and other assets and an increase in accounts payable and accrued
wages. The net cash required for operations in 2002 is primarily related to the
release of the $5.1 million contained in the inventory and equipment escrow
accounts which was offset by an overall decrease in accounts payable and accrued
wages. For the six months ended June 30, 2003, the net cash used for operations
was increased due to a decrease in prepaid and other assets and an increase in
accounts payable and accrued wages.
For the six months ended June 30, 2003 net cash used in investing
activities was $167,000 and for the six months ended June 30, 2002, net cash
provided by investing activities was $1.6 million, respectively. The net cash
provided by financing activities for the six months ended June 30, 2002 was
primarily related to the proceeds from the net sales and purchases of marketable
securities. For the six months ended June 30, 2003, net cash used in investing
activities consisted of the purchases of patents, property, plant and equipment.
For the six month periods ended June 30, 2003 net cash provided by
financing activities was $4.6 million and for the six months ended June 30,
2002, net cash required in financing activities was $155,000. The net cash
required for financing activities in 2002 related to loans provided to executive
officers of the Company. The net cash provided by financing activities for the
six months ended June 30, 2003 was primarily related to the net proceeds
received from the five monthly $1.0 million borrowings received during the first
six months of the year offset by payment to Pharmacia of interest due.
We will need substantial additional resources to develop our products. The
timing and magnitude of our future capital requirements will depend on many
factors, including:
* Our ability to make the $5.0 million, plus interest, payments on the
debt due to Pharmacia on the related payment dates of August 29, 2003
and June 4, 2004;
* Our ability to successfully negotiate new debt repayment terms on our
$10.0 million debt plus interest due to Pharmacia if we cannot make
the scheduled payments;
* Our ability to continue our efforts to reduce our use of cash, while
continuing to advance programs;
* Our ability to meet our obligations under the Debt Agreement;
* The viability of SnET2 for future use;
* The costs and time involved in preparing an NDA filing for SnET2;
* Our ability to obtain regulatory approval for our NDA when, and if,
filed;
* Our ability to establish additional collaborations and/or license
SnET2;
* The cost of performing pre-commercialization activities;
* Our ability to raise equity financing or use stock awards for employee
and consultant compensation;
* Our ability to regain our listing status on Nasdaq;
* 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.
As of June 30, 2003, our condensed consolidated financial statements have
been prepared assuming we will continue as a going concern. 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 an NDA for SnET2, obtaining requisite regulatory approval, and
commencing pre-commercialization activities prior to receiving regulatory
approval, will require substantial expenditures. Once requisite regulatory
approval has been obtained, if at all, substantial additional financing will 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. In
December 2002, we entered into a Debt Agreement that provides us the
availability to borrow up to $1.0 million per month through November 2003. The
monthly borrowing request can be limited if certain requirements are not met or
are not satisfactory to the Lenders. As of August 11, 2003, we had borrowed $6.3
million under the Debt Agreement. Also, our first payment on our debt to
Pharmacia, in the amount of $5.0 million, plus interest from March 5, 2003 to
the payment date, is due on August 29, 2003. We are in discussions with Pfizer
to further extend the debt payment due date or to negotiate other payment
options or terms. If we cannot make the scheduled payment or negotiate new terms
for the debt repayment with Pfizer, then Pharmacia can exercise all of its
rights to secure all of the collateral under the agreement, which includes all
of our assets. Our executive management believes we can raise additional funding
to support operations through corporate collaborations or partnerships,
licensing of SnET2 or new products and additional equity or debt financings
prior to December 31, 2003, especially based on our announcement that we intend
to file an NDA for SnET2 for the treatment of AMD in 2003. However, there can be
no assurance that we will receive the remaining $5.7 million under the Debt
Agreement, if certain requirements are not met or are not satisfactory to the
Lenders, there is no guarantee that we will be able to make the scheduled debt
payment to Pharmacia or that new debt repayment terms will be timely negotiated,
if at all, and there is no guarantee that we will be successful in obtaining
additional financing or that financing will be available on favorable terms. If
additional funding is not available when required, our executive management
believes that as long as we receive the remaining $5.7 million available to us
under the Debt Agreement and the debt payment due to Pharmacia on August 29,
2003 is renegotiated or is extended into 2004, then we have the ability to
conserve cash required for operations through December 31, 2003 by the delay or
reduction in scope of one or more of our research and development programs and
adjusting, deferring or reducing salaries of employees and by reducing operating
facilities and overhead expenditures to conserve cash to be used in operations.
Our ability to raise funds has become more difficult as our stock has been
delisted from trading on the Nasdaq National Market. Any inability to obtain
additional financing would adversely affect our business and could cause us to
significantly reduce or cease operations. Our ability to generate substantial
additional funding to continue our research and development activities,
preclinical studies and clinical trials and manufacturing, and administrative
activities and to pursue any additional investment opportunities is subject to a
number of risks and uncertainties and will depend on numerous factors including:
* Our ability to successfully prepare and file an NDA for SnET2 in 2003;
* The outcome from the FDA upon the potential NDA filing;
* The potential future use of SnET2 for ophthalmology or other disease
indications;
* Our ability to successfully raise funds in the near future through
public or private equity or debt financings, or establish
collaborative arrangements or raise funds from other sources;
* The potential for equity investments, collaborative arrangements,
license agreements or development or other funding programs that are
at terms acceptable to us, in exchange for manufacturing, marketing,
distribution or other rights to products developed by us;
* The extent to which our obligation to pay Pharmacia a portion of the
funds received in our financing activities will hinder our fundraising
efforts;
* Our requirement to allocate certain percentages of net proceeds from
any public or private equity financings and/or asset dispositions, as
defined earlier, towards the repayment of our debt of $10.0 million
plus interest due to Pharmacia under the Contract Modification and
Termination Agreement;
* The future development and results of our Phase II dermatology
clinical trial and our ongoing cardiovascular and oncology preclinical
studies;
* The amount of funds received from outstanding warrant and stock option
exercises, if any;
* Our ability to maintain, renegotiate, or terminate our existing
collaborative arrangements;
* Our ability to receive any funds from the sale of our 33% equity
investment in Ramus, consisting of 2,000,000 shares of Ramus Preferred
Stock and 59,112 shares of Ramus Common Stock, neither of which are
publicly traded and the fair market value of which is currently
negligible; and
* Our ability to liquidate our equity investment in Xillix, consisting
of 2,691,904 shares of Xillix Common Stock, which is publicly traded
on the Toronto Stock Exchange under the symbol (XLX.TO), but has
historically had small trading volume.
We cannot guarantee that additional funding will be available to us now,
when needed, or if at all. If additional funding is not available in the near
term, we will be required to scale back our research and development programs,
preclinical studies and clinical trials and administrative activities or cease
operations. As a result, we would not be able to successfully develop our drug
candidates or commercialize our products and we would never achieve
profitability. Our independent auditors, Ernst & Young LLP, have indicated in
their report accompanying our December 31, 2002 consolidated financial
statements that, based on generally accepted auditing standards, our viability
as a going concern is in question.
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
OUR BUSINESS IS NOT EXPECTED TO BE PROFITABLE FOR THE FORESEEABLE FUTURE AND WE
WILL NEED ADDITIONAL FUNDS TO CONTINUE OUR OPERATIONS PAST DECEMBER 31, 2003. IF
WE FAIL TO OBTAIN ADDITIONAL FUNDING OR MEET THE REQUIREMENTS OF OUR DECEMBER
2002 CONVERTIBLE DEBT AND WARRANT AGREEMENT, OR DEBT AGREEMENT, WE COULD BE
FORCED TO SIGNIFICANTLY SCALE BACK OR CEASE OPERATIONS.
Since our inception we have incurred losses totaling $196.6 million as of
June 30, 2003 and have never generated enough funds through our operations to
support our business. We are continuing our efforts in research and development
and the preclinical studies and clinical trials of our products. These efforts,
along with the cost of preparing a New Drug Application, or NDA, for SnET2,
obtaining requisite regulatory approval, and commencing pre-commercialization
activities prior to receiving regulatory approval, will require substantial
expenditures. Once requisite regulatory approval has been obtained, if at all,
substantial additional financing will 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. In December 2002, we entered into a $12.0 million
Debt Agreement with a group of private accredited investors, or the Lenders,
that provides us the availability to borrow up to $1.0 million per month through
November 2003, subject to certain limitations. The monthly borrowing request can
be limited if certain requirements are not met or are not satisfactory to the
Lenders. As of August 11, 2003, we have borrowed $6.3 million under the Debt
Agreement. Our executive management believes that as long as the remaining $5.7
million remains available to us under the Debt Agreement and the debt payment
due to Pharmacia on August 29, 2003 is renegotiated or is extended into 2004, we
then have the ability to conserve cash required for operations through December
31, 2003 by the delay or reduction in scope of one or more of our research and
development programs and adjusting, deferring or reducing salaries of employees
and by reducing operating facilities and overhead expenditures.
In addition, our first payment on our debt to Pharmacia Corporation, or
Pharmacia, in the amount of $5.0 million, plus interest, was due on March 5,
2003, was initially extended to June 30, 2003 and then extended to August 29,
2003. Executive management also believes we can raise additional funding to
support operations through corporate collaborations or partnerships, licensing
of SnET2 or new products and additional equity or debt financings prior to
December 31, 2003, especially due to our announcement that we intend to file an
NDA for SnET2 in 2003. However, there can be no assurance that we will receive
the remaining $5.7 million under the Debt Agreement, if certain requirements are
not met or are not satisfactory to the Lenders, or that we will be able to make
our first payment to Pharmacia on August 29, 2003 or negotiate new payment
options or terms, and there is no guarantee that we will be successful in
obtaining additional financing or that financing will available on favorable
terms. Our independent auditors, Ernst & Young LLP, have indicated in their
report accompanying our December 31, 2002 consolidated financial statements
that, based on generally accepted auditing standards, our viability as a going
concern is in question.
We will need additional resources in the near term to complete the NDA
filing for SnET2, to develop our products and to continue our operations. If we
do not receive sufficient funding prior to December 2003, and are unable to
extend the debt payment due to Pharmacia into 2004 and are required to pay it on
August 29, 2003, we may be forced to significantly reduce or cease operations.
The timing and magnitude of our future capital requirements will depend on many
factors, including:
* Our ability to make the $5.0 million, plus interest, payments on the
debt due to Pharmacia on the related payment dates of August 29, 2003
and June 4, 2004;
* Our ability to successfully negotiate new debt repayment terms on our
$10.0 million debt plus interest due to Pharmacia if we cannot make
the scheduled payments;
* Our ability to continue our efforts to reduce our use of cash, while
continuing to advance programs;
* Our ability to meet our obligations under the Debt Agreement;
* The viability of SnET2 for future use;
* The costs and time involved in preparing an NDA filing for SnET2;
* Our ability to obtain regulatory approval for our NDA when, and if,
filed;
* Our ability to establish additional collaborations and/or license
SnET2;
* The cost of performing pre-commercialization activities;
* Our ability to raise equity financing or use stock awards for employee
and consultant compensation;
* Our ability to regain our listing status on Nasdaq;
* 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 are actively seeking 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. No
commitments for such corporate collaborations are currently in place. Any
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 may
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.
UNDER THE CONTRACT MODIFICATION AND TERMINATION AGREEMENT ENTERED INTO WITH
PHARMACIA IN MARCH 2002, OUR OUTSTANDING DEBT TO PHARMACIA OF $10.0 MILLION
REMAINS SECURED BY ALL OF OUR ASSETS. THE FIRST $5.0 MILLION WAS DUE ON MARCH 5,
2003 AND HAS BEEN EXTENDED TO AUGUST 29, 2003. IF WE BECOME UNABLE TO REPAY OUR
BORROWINGS OR ARE UNABLE TO NEGOTIATE NEW DEBT REPAYMENT TERMS OR VIOLATE THE
COVENANTS UNDER THIS AGREEMENT, PHARMACIA COULD FORECLOSE ON OUR ASSETS, WHICH
WOULD HAVE A MATERIAL ADVERSE AFFECT ON OUR BUSINESS AND WE MAY BE FORCED TO
CEASE OPERATIONS.
Under the terms of the Contract Modification and Termination Agreement with
Pharmacia, who was acquired by Pfizer Inc., or Pfizer, on April 16, 2003 and is
now a wholly-owned subsidiary of Pfizer, we have outstanding debt to Pharmacia
of $10.0 million which is secured by all of our assets. Our first payment was
due on our debt to Pharmacia in the amount of $5.0 million, plus interest, on
March 5, 2003 and was extended to August 29, 2003. We continue to have
discussions with Pfizer regarding extending the debt payment due date or
negotiate other payment options or terms. If we are unable to extend the debt
payment due date or negotiate new options or terms for the debt repayment with
Pfizer, then Pharmacia can exercise all of its rights to secure all of the
collateral under the agreement, which includes all of our assets. There is no
guarantee that if we can extend the debt payment due date or new debt repayment
terms will be timely negotiated, if at all. Our ability to comply with all
covenants and to make scheduled payments, early repayments as required or to
refinance our debt obligations will depend on our financial and operating
performance, which in turn will be subject to prevailing economic conditions and
certain financial, business and other factors, including factors that are beyond
our control. If our cash flow and capital resources become insufficient to fund
our debt service obligations or we otherwise default under the Contract
Modification and Termination Agreement, Pharmacia could accelerate the debt and
foreclose on our assets. As a result, we could be forced to obtain additional
financing at very unfavorable terms or significantly reduce or cease operations.
OUR ABILITY TO CONTINUE TO BORROW $1.0 MILLION PER MONTH THROUGH NOVEMBER 2003
UNDER THE DEBT AGREEMENT ENTERED INTO IN DECEMBER 2002 IS CONTINGENT ON US
MEETING CERTAIN OBLIGATIONS. IF THESE OBLIGATIONS ARE NOT MET OR ARE NOT
SATISFACTORY TO THE LENDERS, WE MAY BE UNABLE TO BORROW THE FUNDS AS PLANNED AND
THIS MAY FORCE US TO SIGNIFICANTLY REDUCE OR CEASE OPERATIONS.
In December 2002, we entered into a Debt Agreement with a group of private
accredited investors, or the Lenders. The $12.0 million Debt Agreement allows us
to borrow up to $1.0 million per month, with any unused monthly borrowings to be
carried forward. We have borrowed $6.3 million under this agreement through
August 11, 2003. The maximum aggregate loan amount is $12.0 million with the
last available borrowing in November 2003. The Lenders' obligation to fund each
borrowing request is subject to material conditions described in the Debt
Agreement. In addition, the Lenders may terminate its obligations under the Debt
Agreement if: (i) Miravant has not filed an NDA by March 31, 2003, (ii) such
filing has been rejected by the U.S. Food and Drug Administration, or FDA, or
(iii) Miravant, in the reasonable judgment of the Lenders, is not meeting its
business objectives. We have received a waiver from the Lenders with regard to
the March 31, 2003 NDA filing deadline. This deadline has been extended to the
end of the third quarter 2003. However, there is no guarantee we will receive
the remaining $5.7 million under this agreement, and if we are unable to borrow
the remaining $5.7 million as planned we may be forced to significantly reduce
or cease operations.
OUR EXISTING LOAN OBLIGATIONS TO PHARMACIA, OVERALL CURRENT MARKET ENVIRONMENT
AND OUR OTC BULLETIN BOARD(R), OR OTCBB, LISTING STATUS WILL MAKE OBTAINING
ADDITIONAL FUNDING DIFFICULT.
Our ability to obtain additional funding by December 31, 2003 to operate
our business may be impeded by a number of factors including:
* We currently owe Pharmacia $10.0 million, and are obligated to pay a
portion of net proceeds from any public or private equity financings
and/or asset dispositions towards the repayment of the $10.0 million
plus accrued interest due to Pharmacia under the Contract Modification
and Termination Agreement:
* If our aggregate net equity financing and/or assets disposition
proceeds are less than or equal to $7.0 million, we are not
required to make an early repayment towards our Pharmacia debt.
As of March 31, 2003, our aggregate equity financings amount to
$2.5 million;
* If our aggregate net equity financing and/or assets disposition
proceeds are greater than $7.0 million but less than or equal to
$15.0 million, then we are required to apply one-third of the net
proceeds from the amount in excess of $7.0 million up to $15.0
million, or a maximum repayment of $2.7 million towards our
Pharmacia debt;
* If our aggregate net equity financing and/or assets disposition
proceeds are greater than $15.0 million but less than or equal to
$25.0 million, then we are required to apply one-half of the net
proceeds from the amount in excess of $15.0 million up to $25.0
million, or a maximum repayment of $7.7 million towards our
Pharmacia debt;
* If our aggregate net equity financing and/or assets disposition
proceeds are greater than $25.0 million, then we are required to
apply all of the net proceeds from the amount in excess of $25.0
million, or repay the entire $10.0 million plus accrued interest
towards our Pharmacia debt; and
* Any early repayment of our Pharmacia debt applies first to the
loan due on June 30, 2003, then to the remaining loan amount due
on June 4, 2004;
* Our Common Stock is currently being traded on the OTCBB and there is
no guarantee we will be able to regain our listing status on Nasdaq,
in the near term or at all; and
* As a result of many current economic and political factors, the
present market for raising capital is relatively difficult and we may
be unable to raise the funding we need timely, if at all, if certain
economic and political factors do not improve.
We will need a substantial amount of funding to further our programs and to
complete our planned NDA filing for SnET2 in 2003, and investors may be
reluctant to invest in our equity securities if the funds necessary to grow our
business are instead used to pay down our existing debt obligations to
Pharmacia. Investors may also be reluctant to provide us funds for fear that
Pharmacia may foreclose on our assets. The fact that our Common Stock is no
longer listed for trading on Nasdaq may also discourage investors or result in a
discount on the price that investors may pay for our securities. We will also
have to overcome investor concerns about many current economic and political
factors. These and other factors may prevent us from obtaining additional
financing as required in the near term on favorable terms or at all.
PREPARING AND FILING AN NDA REQUIRES SIGNIFICANT EXPENSES, THE APPROPRIATE
PERSONNEL AND ACCESS TO CONSULTANTS AND OTHER RESOURCES AS NEEDED. OUR PLANS TO
COMPLETE AN NDA FILING WITH THE FDA FOR SNET2 FOR THE TREATMENT OF AMD IN 2003
IS DEPENDENT ON OUR ABILITY TO SUCCESSFULLY RAISE SUBSTANTIAL ADDITIONAL
FUNDING, OR ENGAGE A COLLABORATIVE PARTNER, AND TO ENGAGE CONSULTANTS AND
PERSONNEL AS NEEDED ALL IN A TIMELY MANNER. IF WE ARE UNABLE TO MEET THESE
REQUIREMENTS, OUR PLANS TO FILE AN NDA WITH THE FDA MAY BE SIGNIFICANTLY DELAYED
OR MAY NOT GET FILED AT ALL.
In January 2002, Pharmacia, after an analysis of the Phase III AMD clinical
data, determined that the clinical data results indicated that SnET2 did not
meet the primary efficacy endpoint in the study population, as defined by the
clinical trial protocol, and that they would not be filing an NDA with the FDA.
In March 2002, we regained the license rights to SnET2 as well as the related
data and assets from the AMD clinical trials from Pharmacia. We completed our
own detailed analysis of the clinical data during 2002, including an analysis of
the subset groups. In January 2003, based on the results of our analysis and
certain discussions with regulatory and FDA consultants, we announced our plans
to move forward with an NDA filing for SnET2 for the treatment of AMD. We are
currently in the process of preparing the NDA filing and expect to have it
completed and filed in 2003. In addition, we are currently seeking a new
collaborative partner for PhotoPoint PDT in ophthalmology. The cost of preparing
an NDA requires a significant amount of funding and personnel. We will have to
engage numerous consultants and clinical research organizations, or CROs, to
assist in the preparation of the NDA. Our ability to engage the appropriate CROs
and consultants in a timely manner and have them available to us when we need
them is costly and may cause delays in the filing of the NDA. Additionally, our
ability to raise funding or engage a collaborative partner to assist us in the
funding and preparation of the NDA may not be available to us in a timely manner
or not at all. If we are unable to raise adequate funding, we will likely have
to further reduce our funding and development efforts of our other programs and
adjust our overall business structure to reduce expenses. If we are unable to
file an NDA for SnET2 as a result of funding or other constraints or if the FDA
does not accept our filing, this could severely harm our business.
ONCE OUR NDA FOR SNET2 FOR THE TREATMENT OF AMD IS FILED, IF FILED AT ALL, THERE
CAN BE NO ASSURANCE THAT WE WILL BE ABLE TO GET APPROVAL FROM THE FDA OR THAT
ISSUES UNDERLYING ANY CONTINGENT APPROVAL RECEIVED WILL BE ADEQUATELY AND TIMELY
RESOLVED BY US OR THAT SUCH APPROVAL WILL MEET OUR MARKETING AND REVENUE
EXPECTATIONS. ADDITIONALLY, WE CAN NOT 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.
If we are able to file our NDA for SnET2 for the treatment of AMD, there
can be no guarantee that we will be able to get an approval from the FDA or that
we will be able to resolve any issues or contingent requirements requested by
the FDA. For instance, the FDA may require follow-up clinical 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.
THE CURRENT TRADING PRICE OF OUR COMMON STOCK, OUR MARKET CAPITALIZATION AND THE
AMOUNT OF OUR STOCKHOLDER'S EQUITY AND NET TANGIBLE ASSETS, HAS RESULTED IN OUR
SHARES BEING DELISTED FROM TRADING ON NASDAQ. AS A RESULT OF BEING DELISTED FROM
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 OTCBB effective as of the opening of business on July 12, 2002.
The OTCBB is a regulated quotation service that displays real-time quotes,
last-sale prices and volume information in over-the-counter equity securities.
OTCBB securities are traded by a community of market makers that enter quotes
and trade reports. Our Common Stock trades under the ticker symbol MRVT and can
be viewed at www.otcbb.com. Our management continues to review our ability to
regain our listing status with Nasdaq, however, there are no guarantees 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 on a timely basis,
if at all, and there is no guarantee that Nasdaq would approve our relisting
request even if we met all the listing requirements.
OUR FINANCIAL CONDITION AND COST REDUCTION EFFORTS COULD RESULT IN DECREASED
EMPLOYEE MORALE AND LOSS OF EMPLOYEES AND CONSULTANTS 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 that our current stock options outstanding are
significantly de-valued, the current value of our stock is low 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. These efforts may not be successful; 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. 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 trials.
In collaboration with Pharmacia, in December 2001, we completed two Phase
III ophthalmology clinical trials for the treatment of AMD with our lead drug
candidate, SnET2. In January 2002, Pharmacia, after an analysis of the Phase III
AMD clinical data, determined that the clinical data results indicated that
SnET2 did not meet the primary efficacy endpoint in the study population, as
defined by the clinical trial protocol, and that they would not be filing an NDA
with the FDA. In March 2002, we regained the rights to SnET2 as well as the
related data and assets from the AMD clinical trials from Pharmacia. We
completed our own detailed analysis of the clinical data during 2002, including
an analysis of the subset groups. In January 2003, based on the results of our
analysis and discussions with regulatory and FDA consultants, we announced our
plans to move forward with an NDA filing for SnET2 for the treatment of AMD. We
are currently in the process of preparing the NDA filing and expect to have it
completed and filed in 2003. In addition, we have terminated our license
collaboration with Pharmacia, and are currently seeking a new collaborative
partner for PhotoPoint PDT in ophthalmology. If we are unable to file an NDA for
SnET2 as a result of funding or other constraints or if our filing is not
accepted by the FDA, this could adversely affect our funding and development
efforts for our other programs and severely harm our business.
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.
WE HAVE A HISTORY OF SIGNIFICANT OPERATING LOSSES AND EXPECT TO CONTINUE TO HAVE
LOSSES IN THE FUTURE, WHICH MAY FLUCTUATE SIGNIFICANTLY. WE MAY NEVER ACHIEVE
PROFITABILITY OR BE ABLE TO MAINTAIN PROFITABILITY.
We have incurred significant losses since our inception in 1989 and, as of
June 30, 2003, had an accumulated deficit of approximately $196.6 million. We
expect to continue to incur significant, and possibly increasing, operating
losses over the next few years. Although we continue to incur costs for research
and development, preclinical studies, clinical trials and general corporate
activities, we have currently implemented a cost restructuring program which we
expect will help to reduce our overall costs. Our ability to achieve sustained
profitability depends upon our ability, alone or with others, to receive
regulatory approval on our NDA filing 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 our ability to
establish a corporate partner collaboration and/or license SnET2 and the timing
of receiving regulatory approval, if at all, for SnET2 in AMD. 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.
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,
2002, 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, 2002 to August 12, 2003, our Common Stock
price, per Nasdaq and OTCBB closing prices, has ranged from a high of $9.90 to a
low of $0.25.
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:
* Our ability to successfully file an NDA for SnET2;
* Our ability to continue to borrow monthly under the Debt Agreement
through November 2003;
* Our ability to make the $5.0 million, plus interest, payments on the
debt due to Pharmacia on the related payment dates of August 29, 2003
and June 4, 2004;
* Our ability to successfully negotiate new debt repayment terms on our
$10.0 million debt plus interest due to Pharmacia if we cannot make
the scheduled payments;
* Announcements concerning Miravant or our collaborators, competitors or
industry;
* Our ability to successfully establish new collaborations and/or
license SnET2;
* The results of the FDA review of our intended NDA filing, when and if
it is filed;
* 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;
* 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 further exacerbating our ability to raise
funds and limiting your ability to sell your 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 RELY ON THIRD PARTIES TO CONDUCT CLINICAL TRIALS ON OUR PRODUCTS, AND IF
THESE RESOURCES FAIL, OUR ABILITY TO SUCCESSFULLY COMPLETE CLINICAL TRIALS WILL
BE ADVERSELY AFFECTED AND OUR BUSINESS WILL SUFFER.
To date, we have limited experience in conducting clinical trials. We had
relied on Pharmacia, our former corporate partner, and Inveresk, Inc., formerly
ClinTrials Research, Inc., a CRO, for our Phase III AMD clinical trials and we
rely on a contract research organization for our Phase II dermatology clinical
trials. 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 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 assure 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. Although we believe
we should be able to achieve such objectives, we may not be successful.
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 AND MARKETING 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, OUR OPERATING RESULTS COULD SUFFER AND WE MAY ENCOUNTER DELAYS IN
CONNECTION WITH OUR PLANNED NDA FILING AND APPROVAL.
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 shut down 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 is currently producing
compatability 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. We believe the
quantities we have manufactured and 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 an 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.
EFFECTING A CHANGE OF CONTROL OF MIRAVANT WOULD BE 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. 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 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 well-established
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.
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
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 Pharmaceuticals, or Axcan, and Pharmacyclics.
QLT's drug Visudyne 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. We are aware
of other drugs and devices under development by these and other photodynamic
therapy 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.
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.
ITEM 3. QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
Our market risk disclosures involve forward-looking statements. Actual
results could differ materially from those projected in the forward-looking
statements. We are exposed to market risk related to changes in interest rates.
The risks related to foreign currency exchange rates are immaterial and we do
not use derivative financial instruments.
From time to time, we maintain a portfolio of highly liquid cash
equivalents maturing in three months or less as of the date of purchase. Given
the short-term nature of these investments and that our borrowings outstanding
are under variable interest rates, we are not subject to significant interest
rate risk.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures. Our management evaluated,
with the participation of our Chief Executive Officer and our Chief Financial
Officer, the effectiveness of our disclosure controls and procedures as of the
end of the period covered by this Quarterly Report on Form 10-Q. Based on this
evaluation, our Chief Executive Officer and our Chief Financial Officer have
concluded that our disclosure controls and procedures are effective to ensure
that information we are required to disclose in reports that we file or submit
under the Securities Exchange Act of 1934 is recorded, processed, summarized and
reported within the time periods specified in Securities and Exchange Commission
rules and forms.
Changes in internal control over financial reporting. There was no change
in our internal control over financial reporting that occurred during the period
covered by this Quarterly Report on Form 10-Q that has materially affected, or
is reasonably likely to materially affect, our internal control over financial
reporting.
PART II. OTHER INFORMATION
ITEM 2. Changes in Securities and Use of Proceeds
In December 2002, the Company entered into a Convertible Debt and Warrant
Purchase Agreement, or Debt Agreement, with a group of private accredited
investors, or the Lenders. In January 2003, February 2003, March 2003, April
2003 and May 2003 in exchange for borrowings by the Company of $1.0 million in
each of those months under the Debt Agreement, the Company issued the Lenders
notes convertible into Common Stock at a per share price of $0.97, $1.62, $1.53,
$1.32 and $1.41 for January 2003, February 2003, March 2003, April 2003 and May
2003, respectively . In addition, in connection with these borrowings, the
Company issued five separate warrants, each to purchase 250,000 shares of Common
Stock at exercise prices of $1.16 per share, $1.95 per share, $1.83 per share,
$1.58 per share and $1.69 per share related to the respective January 2003,
February 2003, March 2003, April 2003 and May 2003 borrowings.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On June 12, 2003, the Company held its Annual Meeting of Stockholders. The
following individuals were elected to the Board of Directors:
Votes Votes
For Withheld
--------------- --------------
Larry S. Barels 21,399,780 13,271
Charles T. Foscue 21,399,780 13,271
Gary S. Kledzik, Ph.D. 21,399,780 13,271
David E. Mai 21,399,780 13,271
In addition, the stockholders also approved the following proposals:
Votes Votes Broker
For Against Abstained Non-Votes
-------------- -------------- --------------- ----------------
1. Proposal to ratify the selection of
the Company's independent auditors. 21,397,676 8,550 6,825 --
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
Exhibit 31.1 Certification of Chief Executive Officer pursuant to
Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Exhibit 31.2 Certification of Chief Accounting Officer pursuant to
Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Exhibit 99.1 Certification of Chief Executive Officer and Chief
Financial Officer pursuant to 18 u.S.C. Section 1350,as adopted
pursuant to section 906 of the sarbanes-oxley act of 2002
(b) Reports on Form 8-K.
On June 27, 2003, we filed a Form 8-K to report that we entered into
an agreement with Pharmacia AB, an indirect, wholly-owned subsidiary
of Pharmacia Corporation, regarding the extension of payment dates
under the parties' credit agreement.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed in its behalf by the
undersigned thereunto duly authorized.
Miravant Medical Technologies
Date: August 14, 2003 By: /s/ John M. Philpott
-----------------------
John M. Philpott
Chief Financial Officer
(on behalf of the Company and as
Principal Financial Officer and
Principal Accounting Officer)