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 September 30, 2002
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 November 8, 2002
----- -----------------------------
Common Stock, $.01 par value 23,929,598
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Page
Item 1. Condensed Consolidated Financial Statements
Condensed consolidated balance sheets as of September 30, 2002 and
December 31, 2001............................................................. 3
Condensed consolidated statements of operations for the three
and nine months ended September 30, 2002 and 2001............................... 4
Condensed consolidated statement of stockholders' equity
(deficit) for the nine months ended September 30, 2002.......................... 5
Condensed consolidated statements of cash flows for the nine
months ended September 30, 2002 and 2001........................................ 6
Notes to condensed consolidated financial statements............................. 7
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations............................................10
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds .......................................38
Item 3. Qualitative and Quantitative Disclosures About Market Risk.......................38
Item 4. Controls and Procedures..........................................................38
Item 6. Exhibits and Reports on Form 8-K.................................................39
Signatures.......................................................................40
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
2002 2001
-------------------- ---------------------
Assets (Unaudited)
Current assets:
Cash and cash equivalents............................................... $ 1,984,000 $ 1,458,000
Investments in short-term marketable securities......................... -- 4,654,000
Accounts receivable..................................................... -- 5,030,000
Inventories............................................................. -- 395,000
Prepaid expenses and other current assets............................... 1,297,000 1,024,000
-------------------- ---------------------
Total current assets....................................................... 3,281,000 12,561,000
Property, plant and equipment:
Vehicles................................................................ 28,000 28,000
Furniture and fixtures.................................................. 1,395,000 1,404,000
Equipment............................................................... 5,531,000 5,447,000
Leasehold improvements.................................................. 3,495,000 3,382,000
-------------------- ---------------------
10,449,000 10,261,000
Accumulated depreciation................................................ (9,684,000) (9,057,000)
-------------------- ---------------------
765,000 1,204,000
Investments in affiliates.................................................. 328,000 635,000
Deferred financing costs................................................... -- 913,000
Patents and other assets................................................... 579,000 810,000
-------------------- ---------------------
Total assets............................................................... $ 4,953,000 $ 16,123,000
==================== =====================
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable........................................................ $ 1,022,000 $ 2,535,000
Accrued payroll and expenses............................................ 596,000 786,000
Current portion of long-term debt....................................... 5,238,000 --
-------------------- ---------------------
Total current liabilities.................................................. 6,856,000 3,321,000
Long-term liabilities:
Long-term debt, less current portion.................................... 5,554,000 26,548,000
Sublease security deposits.............................................. 94,000 94,000
-------------------- ---------------------
Total long-term liabilities................................................ 5,648,000 26,642,000
Stockholders' equity (deficit):
Common stock, 50,000,000 shares authorized; 23,917,002 and 18,876,075 shares
issued and outstanding at September 30, 2002 and December 31, 2001,
respectively.......................................................... 179,404,000 161,496,000
Notes receivable from officers.......................................... (556,000) (864,000)
Deferred compensation................................................... (241,000) (547,000)
Accumulated other comprehensive loss.................................... (663,000) (356,000)
Accumulated deficit..................................................... (185,495,000) (173,569,000)
-------------------- ---------------------
Total stockholders' equity (deficit)....................................... (7,551,000) (13,840,000)
-------------------- ---------------------
Total liabilities and stockholders' equity (deficit)....................... $ 4,953,000 $ 16,123,000
==================== =====================
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended September 30, Nine months ended September 30,
2002 2001 2002 2001
----------------- ----------------- ---------------- ----------------
Revenues:
License-contract research and development......... -- 20,000 20,000 224,000
Bulk active pharmaceutical ingredient sales....... -- 763,000 479,000 3,049,000
Royalties......................................... -- -- -- 75,000
----------------- ----------------- ---------------- ----------------
Total revenues...................................... -- 783,000 499,000 3,348,000
Costs and expenses:
Cost of goods sold................................ -- 236,000 479,000 364,000
Research and development.......................... 2,114,000 3,692,000 7,338,000 9,825,000
Selling, general and administrative............... 1,797,000 1,418,000 4,483,000 4,492,000
----------------- ----------------- ---------------- ----------------
Total costs and expenses............................ 3,911,000 5,346,000 12,300,000 14,681,000
Loss from operations................................ (3,911,000) (4,563,000) (11,801,000) (11,333,000)
Interest and other income (expense):
Interest and other income........................ 29,000 187,000 147,000 730,000
Interest expense................................. (1,000) (524,000) (282,000) (1,705,000)
Gain on sale of property, plant and equipment.... 10,000 -- 10,000 586,000
----------------- ----------------- ---------------- ----------------
Total net interest and other income (expense)....... 38,000 (337,000) (125,000) (389,000)
----------------- ----------------- ---------------- ----------------
Net loss............................................ (3,873,000) (4,900,000) (11,926,000) (11,722,000)
================= ================= ================ ================
Net loss per share - basic and diluted.............. (0.19) (0.26) (0.61) (0.63)
================= ================= ================ ================
Shares used in computing net loss per share......... 20,580,224 18,670,704 19,450,691 18,612,873
================= ================= ================ ================
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT)
(Unaudited)
Notes Accumulated
Receivable Deferred Other
Common Stock from Compensation Comprehensive Accumulated
Shares Amount Officers and Interest Loss Deficit Total
------------ -------------- ------------- --------------- -------------- -------------- -------------
Balance at December 31, 2001..18,876,075 $ 161,496,000 $ (864,000) $ (547,000) $ (356,000) $(173,569,000) $(13,840,000)
Comprehensive loss:
Net loss.................... -- -- -- -- -- (11,926,000) (11,926,000)
Net change in accumulated
other comprehensive loss.... -- -- -- -- (307,000) -- (307,000)
-------------
Total comprehensive loss..... (12,233,000)
Issuance of stock (net of
approximately $73,000
of offering costs).......... 5,000,000 2,427,000 -- -- -- -- 2,427,000
Issuance of stock awards and
ESOP matching contribution.. 40,927 30,000 -- -- -- -- 30,000
Non-cash contributions by
Pharmacia Corporation:
Lease payments............. -- 40,000 -- -- -- -- 40,000
Debt restructuring......... -- 15,393,000 -- -- -- -- 15,393,000
Deferred compensation........ -- 18,000 -- (18,000) -- -- --
Officer notes and related
non-cash interest accrued.. -- -- (192,000) -- -- -- (192,000)
Reserve of officer and
employee loans............. -- -- 500,000 -- -- -- 500,000
Amortization of deferred
compensation................ -- -- -- 324,000 -- -- 324,000
------------ --------------- ------------- --------------- -------------- --------------- -------------
Balance at September 30, 2002..23,917,002 $ 179,404,000 $ (556,000) $ (241,000) $ (663,000) $(185,495,000) $(7,551,000)
============ =============== ============= =============== ============== =============== =============
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended September 30,
Operating activities: 2002 2001
------------------- ----------------------
Net loss.......................................................... $ (11,926,000) $ (11,722,000)
Adjustments to reconcile net loss to net cash used by operating
activities:
Depreciation and amortization.................................. 709,000 946,000
Amortization of deferred compensation.......................... 324,000 426,000
Stock awards and ESOP matching contribution.................... 30,000 1,458,000
Gain on sale of property, plant and equipment.................. (10,000) (586,000)
Non-cash interest and amortization of deferred
financing costs on long-term debt............................ 316,000 1,734,000
Provision for employee and officer loans, net of non-cash
interest on officer loans.................................... 883,000 88,000
Changes in operating assets and liabilities:
Accounts receivable......................................... 5,030,000 (3,106,000)
Prepaid expenses, inventories and other assets.............. 110,000 (1,350,000)
Accounts payable and accrued payroll and expenses........... (1,703,000) (481,000)
------------------- ----------------------
Net cash used in operating activities............................. (6,237,000) (12,593,000)
Investing activities:
Purchases of marketable securities ............................... (46,951,000) (11,203,000)
Proceeds from sales of marketable securities ..................... 51,605,000 22,695,000
Additions to patents.............................................. (228,000) (63,000)
Proceeds from the sale of property, plant and equipment........... 65,000 863,000
Purchases of property, plant and equipment........................ -- (189,000)
------------------- ----------------------
Net cash provided by investing activities......................... 4,491,000 12,103,000
Financing activities:
Proceeds from issuance of Common Stock, less issuance costs....... 2,427,000 7,000
Issuance of note to officers...................................... (155,000) (300,000)
------------------- --------------------
Net cash provided by (used in) financing activities............... 2,272,000 (293,000)
Net increase (decrease) in cash and cash equivalents.............. 526,000 (783,000)
Cash and cash equivalents at beginning of period.................. 1,458,000 1,935,000
------------------- ----------------------
Cash and cash equivalents at end of period........................ $ 1,984,000 $ 1,152,000
=================== ======================
Supplemental disclosures:
Cash paid for:
State taxes..................................................... $ 3,000 $ 13,000
=================== ======================
Interest ....................................................... $ 1,000 $ --
=================== ======================
Supplemental disclosure of non-cash transactions:
See Notes 5 and 6 of the notes to the condensed consolidated financial
statements for discussion of non-cash transactions occurring during the
nine month period ended September 30, 2002.
See accompanying notes.
MIRAVANT MEDICAL TECHNOLOGIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Basis of Presentation
The information contained herein has been prepared in accordance with Rule
10-01 of Regulation S-X. The information at September 30, 2002 and for the
three and nine month periods ended September 30, 2002 and 2001, 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, 2001 included in the Miravant Medical Technologies
Annual Report on Form 10-K, as amended, 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. Through
September 30, 2002, the Company had an accumulated deficit of $185.5
million and expects to continue to incur substantial, and possibly
increasing, operating losses for the next few years. The Company is
continuing its efforts, though at a reduced level, in its research and
development and the preclinical studies and clinical trials of its
products. These efforts, and obtaining requisite regulatory approval, prior
to commercialization, 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 its product in order to achieve a level of revenues adequate to support
the Company's cost structure. Executive management of the Company believes
that it has sufficient resources to fund the required expenditures through
December 31, 2002 at a reduced capacity. Executive management is currently
in discussions with one of its significant investors for some additional
bridge financing to extend the Company's cash resources beyond December 31,
2002. In addition, executive management also believes it can raise
additional funding to support operations through corporate collaborations
or partnerships, licensing of SnET2 or new products and equity financings
in the near future. However, there can be no assurance that the Company
will be successful in obtaining such financing or that financing will
available on favorable terms. If additional funding is not available when
required, management will begin implementing additional cost restructuring
programs by the further delay or reduction in scope of one or more of its
research and development programs and further adjusting, deferring or
reducing salaries of employees and by reducing operating and overhead
expenditures to conserve cash to be used in operations.
2. Comprehensive Loss
For the nine months ended September 30, 2002 and 2001, comprehensive loss
amounted to approximately $12.2 million and $12.0 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 its affiliate 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 reflects 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. Private Placement
In August 2002, the Company completed a private placement financing which
consisted of the sale of unregistered shares of Common Stock for gross
proceeds of $2.5 million at $0.50 per share, based on a premium of
approximately 20% of the average closing price for the prior 10 trading
days. For every two common shares acquired, the equity purchase included a
warrant to purchase one share of Common Stock at a price of $0.50 per
share, with an exercise period of 5 years from the date of grant. A group
of private investors participated in the offering. The proceeds are being
used for research, development and general corporate purposes.
5. Contract Modification and Termination Agreement with Pharmacia
On March 5, 2002, Miravant and Pharmacia entered into a Contract
Modification and Termination Agreement pursuant to which the Company
regained all of the rights and related data and assets to our lead drug
candidate, SnET2, and restructured its 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 Phase III AMD clinical
trials revert back to the Company. The rights transferred back to the
Company include the ophthalmology Investigational New Drug application, or
IND, and the related filings, data and reports and the ability to license
the rights to SnET2. The assets which the Company received ownership rights
to include the lasers utilized in the Phase III 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 to receiving back all of the bulk API inventory sold
to Pharmacia in 2001, the Company also received a payment of $479,000 for
the costs of the in-process and finished bulk API inventory manufactured
through January 23, 2002. The Company also reassumed the lease obligations
and related property taxes for its bulk API manufacturing facility. The
lease agreement expires in October 2006 and currently has a base rent of
approximately $26,000 per month. The Company is currently in negotiations
to sublease this facility.
As a condition of the Contract Modification and Termination Agreement,
Pharmacia had released to the Company $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 the Company's bulk API manufacturing
equipment in May 2001 plus interest earned through the release date.
The Contract Modification and Termination Agreement also modifies the 2001
Credit Agreement. The outstanding debt that the Company owed to Pharmacia
of approximately $26.8 million has been reduced to $10.0 million plus
accrued interest. The Company will be required to make a payment of $5.0
million plus accrued interest on each of March 4, 2003 and June 4, 2004.
Interest on the debt will be recorded at the prime rate, which has remained
4.75% since March 5, 2002. Additionally, the early repayment provisions
were modified and many of the covenants were eliminated or modified. In
exchange for these changes and the rights to SnET2, the Company terminated
its 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, the Company will not have available an
additional $10.0 million of borrowings as provided for under the 2001
Credit Agreement.
In accordance with Statement of Financial Standards No. 15, or SFAS No. 15,
"Accounting by Debtors and Creditors for Troubled Debt Restructurings", the
Company permanently reduced the debt due to Pharmacia to the total future
cash payments of the debt, including amounts designated as interest and
principal. The total future cash payments, at the current interest rate,
are estimated to be $10.8 million. The difference between the total debt
outstanding of $25.9 million (net of the unamortized debt issuance costs of
$851,000) and the total future cash payments of the restructured debt of
$10.8 million was recorded as an increase to stockholders' equity due to
Pharmacia being a greater than 10% stockholder in the Company as of March
5, 2002. Additionally, the net book value of the API manufacturing
equipment received from Pharmacia, approximately $274,000, was recorded as
an increase to property, plant and equipment and stockholders' equity.
Therefore, the Company recorded a total increase to stockholders' equity in
the first quarter of 2002 of $15.4 million.
The Contract Modification and Termination Agreement also provided for the
transfer of ownership of several assets back to the Company, including the
lasers utilized in the Phase III AMD clinical trials, the bulk API and FDF
inventories and the bulk API manufacturing equipment used to manufacture
SnET2. As discussed above the Company recorded the transfer of ownership of
the API manufacturing equipment at its net carrying value prior to the sale
to Pharmacia, which was $274,000. Under generally accepted accounting
principles, there was no value recorded on the balance sheet for the
transfer of ownership of the lasers, the bulk API and FDF inventory, since
these assets, according to the Company's accounting policies, had been
expensed as research and development costs in prior years.
6. Notes Receivable from Officers and Employees
As disclosed in Note 3 in the Company's consolidated financial statements
for the year ended December 31, 2001 in the Company's annual report on Form
10-K, as amended, filed with the Securities and Exchange Commission, the
Company has made loans to officers and employees over the years secured by
stock and stock options and certain unsecured loans. In light of the
decrease in the Company's stock price and certain other factors affecting
the collectibility of these loans, the Company recorded a reserve for these
loans to officers and employees in the amount of $920,000 in the quarter
ended September 30, 2002. Of the amount recorded, $270,000 is included in
research and development expenses and $650,000 is included in general and
administrative expenses in the statements of operations for the three and
nine month periods ended September 30, 2002. As of September 30, 2002, the
balance of these loans, net of reserves, is $595,000.
7. New Accounting Pronouncements: SFAS No. 144 Adoption
In October 2001, the Financial Accounting Standards Board issued SFAS No.
144, "Accounting for the Impairment or Disposal of Long-Lived Assets" or
SFAS No. 144. SFAS No. 144 addresses financial accounting and reporting for
the impairment or disposal of long-lived assets and discontinued
operations. SFAS No. 144 is effective for all fiscal years beginning after
December 15, 2001. The Company adopted SFAS No. 144 in January 2002 and the
adoption has not had a material effect on the Company's consolidated
financial statements.
8. Reclassifications
Certain reclassifications have been made to the 2001 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 our 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 ability to fund our
operations through December 31, 2002 in a reduced capacity; our ability to raise
funding through collaborations, licensing arrangements, financing transactions
or obtaining a line of credit from certain of our current private investors, the
timing of the completion of our analysis of the clinical data from the SnET2
Phase III wet age-related macular degeneration, or AMD, clinical trials; the
expected completion of our ongoing dermatology clinical trials; our
cardiovascular program strategies; and our expected general and administrative
expenditures. Our actual results could differ materially from those discussed in
these statements due to a number of risks and uncertainties including: our
actual expenditures exceeding our projections; other parties may decline to
collaborate with us due to our financial condition or other reasons beyond our
control; we may be unable to locate parties willing to invest in our securities;
unanticipated complexity or difficulty in analyzing clinical trial data; we may
be unable to obtain the necessary funding to further our research and
development activities or our ongoing programs may encounter difficulties or
fail to meet objectives; and our general and administrative costs may not remain
level due to expenses associated with financing and partnering activities or
other matters. 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(TM) PDT,
our proprietary technologies for photodynamic therapy. We have been unprofitable
since our founding and have incurred a cumulative net loss of approximately
$185.5 million as of September 30, 2002. As we currently do not have any
significant 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 funding of preclinical
studies, clinical trials and regulatory activities 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 believe that we have sufficient resources to fund
the required expenditures through December 31, 2002 at a reduced capacity.
Executive management is currently in discussions with one of our significant
investors for some additional bridge financing to extend our cash resources
beyond December 31, 2002. In addition, executive management also believes we can
raise additional funding to support operations through corporate collaborations
or partnerships, licensing of SnET2 or new products and equity financings in the
near future. However, there can be no assurance that we will be successful in
obtaining such financing or that financing will available on favorable terms. If
additional funding is not available when required, management will begin
implementing additional cost restructuring programs by the further delay or
reduction in scope of one or more of our research and development programs and
further adjusting, deferring or reducing salaries of employees and by reducing
operating and overhead expenditures to conserve cash to be used in operations.
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 New
Drug Application, or NDA, filing for SnET2 for the treatment of wet age-related
macular degeneration, or AMD. The January 2002 sales of bulk API 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 from potential drug and device sales, if any, will depend on,
among other factors, the results from our ongoing preclinical studies and
clinical trials, including those of the completed Phase III AMD clinical trials,
the timing and outcome of applications for regulatory approvals, 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. We
anticipate our operating activities will result in substantial, and possibly
increasing, operating losses for the next several years.
In August 2002, we completed a private placement financing which consisted
of the sale of unregistered shares of Common Stock for gross proceeds of $2.5
million at $0.50 per share, based on a premium of approximately 20% of the
average closing price for the prior 10 trading days. For every two common shares
acquired, the equity purchase included a warrant to purchase one share of Common
Stock at a price of $0.50 per share, with an exercise period of 5 years from the
date of grant. A group of private investors participated in the offering. The
proceeds are being used for research, development and general corporate
purposes. Executive management is currently in discussions with some members of
this group, as well as other investors, for some potential bridge financing
during the fourth quarter 2002. There are no guarantees we will be able to
complete another private placement or other financing with this group of
investors or any other potential investors prior to December 31, 2002 or at all.
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 overall
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 U.S. Food and Drug Administration, or FDA. Based on Pharmacia's
analysis of the AMD clinical data, we may not be able to proceed with our plans
to seek regulatory approval of SnET2 as formerly planned. In March 2002, we
regained the license rights to SnET2 as well as the related data and assets from
the Phase III AMD clinical trials from Pharmacia. In addition, we have
terminated our license collaboration with Pharmacia, and we intend to seek a new
collaborative partner for PhotoPoint PDT in ophthalmology. We are currently
conducting our own detailed analysis of the clinical data, including an analysis
of the subset groups and, based on the results of our analysis, we will
determine the future potential development of SnET2, including the potential use
of SnET2 in other disease indications.
Executive management is currently pursuing various potential strategic
partners in fields of ophthalmology and cardiovascular disease. In the field of
ophthalmology we entered into a non-binding letter of intent with Bausch & Lomb
in June 2002, for SnET2 for the treatment of AMD. As of October 1, 2002 the
letter of intent has expired, however, we continue to have discussions with
Bausch & Lomb regarding this opportunity. Bausch & Lomb may still continue to
pursue potential licensing opportunities with us for SnET2, or other compounds,
however, at this time we have not entered into any definitive or exclusive
agreements with them. In the field of cardiovascular disease, we are in
discussions with various potential strategic partners, but also have not entered
into any definitive or exclusive agreements. There are no guarantees that Bausch
& Lomb or any other potential strategic partner will enter into a license
agreement or provide us with any potential funding to advance our research and
development programs.
We were notified by Nasdaq on July 11, 2002 that our Common Stock would be
delisted and begin trading on the over-the-counter bulletin board, 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 executive management intends to make every effort to regain
our listing status on the Nasdaq National Market, however, there is no guarantee
we will be able to raise the additional capital needed or to increase the
current trading price of our Common Stock to allow us to meet the listing
requirements for the Nasdaq National 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 obtaining 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 we expect to
complete the clinical trial by the end of 2002.
We are also conducting preclinical studies of SnET2 with existing and new
photoselective drugs for cardiovascular diseases, in particular for the
prevention and treatment of vulnerable plaque and restenosis. Vulnerable plaque
is unstable and a rupture-prone inflamation 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
with some existing photoselective drugs and financial considerations and other
factors, we may prepare an Investigational New Drug application, or IND, in
cardiovascular disease for MV0633 or one of the existing photoselective drugs.
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
graft disease in arterial-venous grafts, or AV grafts. AV grafts are placed in
patients with End Stage Renal Disease to provide access for herrodialysis.
Pending the results of our preclinical studies as well as financial
considerations and other factors, we may choose to file an IND for the
commencement of clinical trials in this field.
In oncology, we are conducting preclinical research of our photoselective
therapy to destroy abnormal blood vessels in tumors. We are pursuing this tumor
research with some of our new photoselective drugs and also investigating
combination therapies with PhotoPoint PDT and other types of compounds.
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 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 be able to or elect 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. 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 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 Phase III 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 Phase III 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 October 2006 and currently has a base
rent of approximately $26,000 per month. We are currently in negotiations to
sublease this facility.
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 September 30, 2002, we had sold $2.5 million 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;
* We will be required to make a payment of $5.0 million plus accrued
interest on each of March 4, 2003 and June 4, 2004. Interest on the
debt will be recorded at the prime rate, which has remained 4.75%
since March 5, 2002;
* 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;
* 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 March 4, 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.
Results of Operations
Revenues. For the nine months ended September 30, 2002, our revenues
decreased to $499,000 from $3.3 million for the same period in 2001. For the
three months ended September 30, 2002, we had no revenues compared to $783,000
for the three months ended September 30, 2001. 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. We recorded revenue related to bulk API sales of
$763,000 and $3.0 million for the three and nine month periods ended September
30, 2001, respectively, and $479,000 in January 2002. No further bulk API was
sold to Pharmacia after January 2002, and as such there were no bulk API
revenues for the three months ended September 30, 2002.
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 to $20,000 for the nine months ended September 30,
2002 from $224,000 for the nine months ended September 30, 2001. There was no
license income for the three month period ended September 30, 2002 compared to
$20,000 of license income for the three months ended September 30, 2001. The
decrease in license income is specifically related to the conclusion of the
Phase III AMD clinical trials in December 2001 and the completion of the
preclinical studies and our AMD clinical trial responsibilities. Reimbursements
received during 2001 and 2002 were primarily for costs incurred to complete
preclinical studies and clinical trial oversight for AMD.
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.
Subsequently, in March 2002, we entered into a Contract Modification and
Termination Agreement with Pharmacia whereby Pharmacia has agreed to reimburse
us for all of our finished and in-process lots of bulk API for approximately
$479,000. 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.
Cost of Goods Sold. 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 nine months ended September 30, 2002
compared to $364,000 for the same period in 2001. There were no manufacturing
costs for the three month period ended September 30, 2002 compared to $236,000
for the same period in 2001. The amounts recorded as cost of goods sold in 2002
represent the costs incurred for only the newly manufactured bulk API in 2002.
The amounts recorded for cost of goods sold in 2001 represent the costs for the
final preparation of existing bulk API that had been manufactured in 1999 and
2000 and recorded as research and development expenses in those periods. No
further cost of goods sold are expected, as Pharmacia will not be making any
further purchases of bulk API.
Research and Development. Research and development expenses 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 to $7.3 million for the nine months ended September 30, 2002 compared
to $9.8 million for the same period in 2001. For the three months ended
September 30, 2002, our research and development expenses decreased to $2.1
million compared to $3.7 million for the same period in 2001. The overall
decrease in research and development expenses is specifically related to the
conclusion of the Phase III AMD clinical trials in December 2001 and the
completion of the preclinical studies and our AMD clinical trial
responsibilities. Our research and development expenses, net of license
reimbursement, were $7.3 million for the nine months ended September 30, 2002
and $9.6 million for the same period in 2001. Our research and development
expenses, net of license reimbursement, were $2.1 million for the three months
ended September 30, 2002 and $3.7 million for the same period in 2001. Research
and development expenses for the three and nine months ended September 30, 2002
and 2001 related primarily to payroll, payroll taxes, employee benefits and
allocated operating costs. Additionally, the Company incurred research and
development expenses for:
* Development 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 I and
Phase II dermatology program; and
* Costs incurred to complete preclinical studies for the Phase III
AMD program in 2001 and to compile and review the Phase III AMD
clinical data in 2002.
As previously disclosed, we have four research and development programs for
which we have focused our research and development 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
specific program research and development costs represent the direct costs
incurred. Certain reclassifications have been made to direct costs and indirect
costs for the three and nine month periods ended September 30, 2002, based on
further analysis of these costs during the periods then ended. The direct
research and development costs by program are as follows:
Three months ended September 30, Nine months ended September 30,
-------------------------------- ----------------------------------------- --------------------------------------
Program 2002 2001 2002 2001
-------------------------------- ---------------- --------------------- --------------- ------------------
Direct costs:
Ophthalmology.............. $ 61,000 $ 84,000 $ 195,000 $ 400,000
Dermatology................ 33,000 186,000 291,000 533,000
Cardiovascular disease..... 188,000 322,000 1,025,000 781,000
Oncology................... 17,000 228,000 39,000 324,000
---------------- --------------------- --------------- ------------------
Total direct costs.............. $ 299,000 $ 820,000 $1,550,000 $ 2,038,000
Indirect costs ................. 1,815,000 2,872,000 5,788,000 7,787,000
---------------- --------------------- --------------- ------------------
Total research and development
costs........................... $2,114,000 $ 3,692,000 $7,338,000 $ 9,825,000
================ ===================== =============== ==================
Ophthalmology. Our direct ophthalmology program costs have decreased from
$400,000 for the nine months ended September 30, 2001 to $195,000 for the same
period in 2002. For the three months ended September 30, 2002 our direct
ophthalmology program costs have decreased to $61,000 compared to $84,000 for
the same period in 2001. Costs incurred in 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, and drug and device development and manufacturing
costs. The decrease for both the three and nine month periods ended September
30, 2002 is specifically related to the conclusion of the Phase III AMD clinical
trials in December 2001 and the completion of the SnET2 preclinical studies and
our AMD clinical trial responsibilities. Additionally, costs for 2002 have
primarily consisted of Clinical Research Organization expenses for the analysis
of the AMD clinical data.
Dermatology. Our direct dermatology program costs decreased from $533,000
for the nine months ended September 30, 2001 to $291,000 for the same period in
2002. For the three months ended September 30, 2002 our direct dermatology
program costs have decreased to $33,000 compared to $186,000 for the same period
in 2001. Costs incurred in the dermatology program include expenses for drug
development and drug formulation, internal and external preclinical study costs,
and Phase I and Phase II clinical trial expenses. The decrease for the nine
months ended September 30, 2002 as compared to 2001 is due to 2002 consisting
primarily of only the cost of the Phase II clinical trial, while 2001 consisted
primarily of the cost for the Phase I clinical trial as well as expenditures
related to preclinical studies and device and drug formulation development and
manufacturing.
Cardiovascular Disease. Our direct cardiovascular disease program costs
increased from $781,000 for the nine months ended September 30, 2001 to $1.0
million for same period in 2002. For the three months ended September 30, 2002
our direct cardiovascular disease program costs have decreased to $188,000
compared to $322,000 for the same period in 2001. 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
expense and internal and external preclinical study costs. The increase from
2001 to 2002 is related to the progress of the program, which has required
preclinical studies, as well as, an increase in development and manufacturing
activities for drug and devices used in the preclinical studies and in
preparation for future clinical trials.
Oncology. Our direct oncology program costs have decreased from $324,000
for the nine months ended September 30, 2001 to $39,000 for the same period in
2002. For the three months ended September 30, 2002, our direct oncology program
costs have decreased to $17,000 compared to $228,000 for the same period in
2001. Our oncology program costs have primarily consisted of costs for internal
and external preclinical study costs and expenses for the early development of
new drug compounds. The decrease in oncology program costs from 2001 to 2002 is
related to our decision to focus on more discovery and research programs for use
of PhotoPoint PDT in oncology.
Indirect Costs. Our indirect costs have decreased from $7.8 million for the
nine months ended September 30, 2001 to $5.8 million for the same period in
2002. For the three months ended September 30, 2002 our indirect costs have
decreased to $1.8 million compared to $2.9 million for the same period in 2001.
Generally, the decrease from 2001 to 2002 was attributed to a reduction in our
responsibilities in the AMD program, as well as a continued reduction in labor
costs due to employee attrition. The decrease was also related to the sublease
of one of our buildings, which reduced facility and overhead costs.
We expect future research and development expenses may fluctuate depending
on available funds, continued expenses incurred in our 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 nine months ended September 30, 2002 were
consistent at $4.5 million as compared to $4.5 million for the nine months ended
September 30, 2001. For the three months ended September 30, 2002 our selling,
general and administrative expenses increased slightly to $1.8 million compared
to $1.4 million for the same period in 2001. Selling, general and administrative
expenses for the three and nine month periods ended September 30, 2001 and 2002
related primarily to payroll, payroll taxes, employee benefits and operating
costs such as rent and utilities. These expenses have decreased from 2001 to
2002 as a result of a decrease in the number of administrative employees as well
as a temporary reduction in wages taken by all employees during the first
quarter of 2002. These decreases in 2002 were offset by employee and officer
loan reserves of $650,000 recorded in the three month period ended September 30,
2002.
As disclosed in Note 3 in our consolidated financial statements for the
year ended December 31, 2001 in our annual report on Form 10-K, as amended,
filed with the Securities and Exchange Commission, we have made loans to
officers and employees over the years secured by stock and stock options and
certain unsecured loans. In light of the decrease in our stock price and certain
other factors affecting the collectibility of these loans, we recorded a reserve
for these loans to officers and employees in the amount of $920,000, of which
$650,000 is included in general and administrative expenses and $270,000 is
included in research and development expenses. As of September 30, 2002, the
balance of these loans, net of reserves, is $595,000.
We expect future selling, general and administrative expenses to remain
consistent with prior periods although they may fluctuate depending on available
funds, and the support required for research and development activities, the
costs associated with potential financing and partnering activities, continuing
corporate development and professional services, 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 $147,000
for the nine months ended September 30, 2002 from $730,000 for the nine months
ended September 30, 2001. For the three months ended September 30, 2002 interest
and other income decreased to $29,000 from $187,000 for the same period in 2001.
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 decreased to $282,000 for the nine
months ended September 30, 2002 from $1.7 million for the same period in 2001.
For the three months ended September 30, 2002 interest expense decreased to
$1,000 from $524,000 for the same period in 2001. The decrease for both the
three and nine month periods was primarily related to the restructuring of the
Pharmacia loans in March 2002, which provided for interest for only two months
in 2002. In accordance with the Statement of Financial Accounting Standards No.
15, 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. Therefore, unless there is an increase in the
prime rate used of 4.75%, no further interest expense will be recorded for the
Pharmacia loans. The level of other interest expense in future periods is not
currently expected to be material.
Liquidity and Capital Resources
Since inception through September 30, 2002, we have accumulated a deficit
of approximately $185.5 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 September 30, 2002, we have
received proceeds from the sale of equity securities, convertible notes and
credit arrangements of approximately $225.5 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 September 30, 2002, our condensed consolidated financial
statements have been prepared assuming we will continue as a going concern.
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 Phase III AMD clinical trials will
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 Phase III AMD clinical trials, the bulk API manufacturing
equipment, all of the bulk API inventory sold to Pharmacia in 2001 and 2002 and
the final drug formulation, or 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
effective March 2002. The lease agreement expires in October 2006 and currently
has a base rent of approximately $26,000 per month. We are currently in
negotiations to sublease this facility.
As a condition of the Contract Modification and Termination Agreement,
Pharmacia has 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 has been reduced to $10.0 million plus accrued
interest. We will be required to make a payment of $5.0 million plus accrued
interest on each of March 4, 2003 and June 4, 2004. Interest on the debt will be
recorded at the prime rate, which has remained 4.75% since March 5, 2002.
Additionally, the early repayment provisions were modified 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 connection with the borrowings received under 2001 Credit Agreement, we
have issued warrants to purchase 360,000 shares of Common Stock at an exercise
price of $11.87 per warrant share for 120,000 shares, $14.83 per warrant share
for 120,000 shares and $20.62 per warrant share for 120,000 shares. The warrants
to purchase 360,000 shares of Common Stock are callable by us if the average
closing prices of the Common Stock for 30 trading days, preceding such request,
exceeds the related warrant exercise price.
Statement of Cash Flows
Net cash required for operations for the nine months ended September 30,
2002 and 2001 was $6.2 million and $12.6 million, respectively. The net cash
required for operations in 2002 is primarily related to the net loss recorded
for the period and a decrease in accounts payable and accrued expenses, offset
by the release of the $5.1 million contained in the inventory and equipment
escrow receivable accounts. For the nine months ended September 30, 2001, the
net cash required for operations was due primarily to the amount and timing of
the funds received from Pharmacia for reimbursable research and development
costs, the gain recorded on the sale of the API manufacturing equipment to
Pharmacia and the increase in receivables associated with the escrow accounts
with Pharmacia, which was offset by an increase in stock awards issued.
For the nine months ended September 30, 2002 and September 30, 2001, net
cash provided by investing activities was $4.5 million and $12.0 million,
respectively. The net cash provided by investing activities for both periods was
primarily related to the proceeds from the net sales and purchases of marketable
securities. In addition, for the period ended September 30, 2001 net cash
provided by investing activities also related to Pharmacia's purchase of our API
manufacturing equipment.
For the nine month periods ended September 30, 2002 net cash provided by
financing activities was $2.3 million and for the nine months ended September
30, 2001 net cash required for financing was $293,000. The net cash provided by
financing activities was related to the net proceeds from the August 2002 $2.5
million private placement. The net cash required for financing activities in
2001 related to loans provided to executive officers of the Company.
We need substantial additional resources to develop our products. The
timing and magnitude of our current and future capital requirements will depend
on many factors, including:
* Our ability to implement an additional effective cost restructuring
program to reduce our use of cash;
* Our ability to establish additional collaborations;
* The viability of SnET2 for future use;
* Our ability to regain our listing status on Nasdaq;
* Our ability to raise equity financing or use stock awards for employee
and consultant compensation;
* 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 time and costs involved in obtaining regulatory approvals;
* 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 implemented a cost restructuring program in January 2002 and have
incurred employee attrition throughout 2002 which has allowed us to reduce our
overall use of cash from operations currently and in future periods. Based on
our current cash and investment balances we anticipate that we only have
sufficient cash to fund our operations through December 31, 2002 at a reduced
capacity. Executive management is currently in discussions with one of our
significant investors for some additional bridge financing to extend our cash
resources beyond December 31, 2002. In addition, executive management also
believes we can raise additional funding to support operations through corporate
collaborations or partnerships, licensing of SnET2 or new products and equity
financings in near future. However, there can be no assurance that we will be
successful in obtaining such financing or that financing will available on
favorable terms. If additional funding is not available when required,
management will begin implementing additional cost restructuring programs by the
further delay or increased reductions in scope of one or more of our research
and development programs and further adjusting, deferring or reducing salaries
of employees and by reducing operating and overhead expenditures to conserve
cash to be used in operations. For this reason our independent auditors have
indicated that there is substantial doubt about our ability to continue as a
going concern. 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:
* The future development decisions related to the ongoing analysis of
the data from our Phase III AMD clinical trials;
* The future development and results of our Phase II dermatology
clinical trial and our ongoing cardiovascular and oncology preclinical
studies;
* 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 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 early repayment of our debt of $10.0
million plus accrued interest due to Pharmacia under the Contract
Modification and Termination Agreement;
* 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 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;
* 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 very small trading volume; and
* Our ability to collect the loan and accrued interest provided to Ramus
under their credit agreement with us.
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.
RISK FACTORS
FACTORS AFFECTING FUTURE OPERATING RESULTS
The following section of this report describes material risks and
uncertainties relating to our company and its 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 2002. IF WE
FAIL TO OBTAIN ADDITIONAL FUNDING, WE COULD BE FORCED TO SCALE BACK OR CEASE
OPERATIONS.
Since our inception we have incurred losses totaling $185.5 million as of
September 30, 2002 and have never generated enough funds through our operations
to support our business. Although we implemented a cost restructuring program in
January 2002 that will allow us to reduce our overall use of cash from
operations in future periods, we currently anticipate that we only have
sufficient cash to fund our operations through December 31, 2002 at a reduced
capacity. Our independent auditors, Ernst & Young LLP, have indicated in their
report accompanying our year end consolidated financial statements that, based
on generally accepted accounting principles, our viability as a going concern is
in question. We will need substantial additional resources in the near term to
continue to develop our products. If we do not receive funding by the end of
December 2002 we may be forced to cease operations. The timing and magnitude of
our future capital requirements will depend on many factors, including:
* Our ability to implement an additional effective cost restructuring
program to reduce our use of cash;
* Our ability to establish additional collaborations;
* The viability of SnET2 for future use;
* Our ability to regain our listing status on Nasdaq;
* Our ability to raise equity financing or use stock awards for employee
and consultant compensation;
* 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 time and costs involved in obtaining regulatory approvals;
* 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 plan to actively seek additional capital needed to fund our operations
through corporate collaborations or partnerships, through licensing of SnET2 or
new products and through public or private equity or debt financings. No
commitments for such collaborations or funding 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 financing it 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.
IF THE DATA FROM OUR COMPLETED PHASE III AMD CLINICAL TRIALS DO NOT PRESENT ANY
PROSPECT OF FUTURE DEVELOPMENT FOR SNET2, THEN WE MAY BE UNABLE TO SUCCESSFULLY
ESTABLISH ONE OR MORE NEW COLLABORATIVE PARTNERSHIPS, WHICH COULD MATERIALLY
HARM OUR BUSINESS.
In collaboration with Pharmacia, in December 2001, we completed two Phase
III ophthalmology clinical trials for the treatment of age-related macular
degeneration, or 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 a New Drug Application, or NDA, with the Food and
Drug Administration, or FDA. Based on Pharmacia's analysis of the AMD clinical
data, we may not be able to proceed with our plans to seek regulatory approval
of SnET2 as formerly planned. In March 2002, we regained the license rights to
SnET2 as well as the related data and assets from the Phase III AMD clinical
trials from Pharmacia. We are currently conducting our own detailed analysis of
the clinical data, including an analysis of the subset groups and, based on the
results of our analysis, we will determine the future potential development of
SnET2, including the potential use of SnET2 in other disease indications. In
addition, we have terminated our license collaboration with Pharmacia, and we
have held discussions with various potential corporate partners to seek a new
collaborations for PhotoPoint PDT in ophthalmology. If we cease development
efforts for SnET2 it could adversely affect our funding and development efforts
for our other programs and severely harm our business.
Additionally, if discussions with the FDA on our clinical data from our
completed Phase III AMD clinical trials does not present an opportunity to file
an NDA with the FDA for SnET2, we then may be required to conduct another
clinical trial, which will require substantial funding and time. We may be
unable to obtain corporate funding or other financing to conduct this clinical
trial which would materially harm our business.
THE LOAN REPAYMENT OBLIGATIONS UNDER OUR CONTRACT MODIFICATION AND TERMINATION
AGREEMENT WITH PHARMACIA MAY PRECLUDE US FROM OBTAINING ADDITIONAL FUNDING AND,
IF WE BECOME UNABLE TO REPAY OUR BORROWINGS OR VIOLATE THE COVENANTS UNDER THIS
AGREEMENT, PHARMACIA COULD FORECLOSE ON OUR ASSETS.
In connection with the termination of our license collaboration with
Pharmacia, we entered into a Contract Modification and Termination Agreement on
March 5, 2002. Under the Contract Modification and Termination Agreement our
outstanding debt 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 accrued interest on each of March 4, 2003 and June 4, 2004.
Interest on the debt will be recorded at the prime rate, which has remained
4.75% since March 5, 2002. The outstanding debt to Pharmacia is secured by all
of our assets. Our ability to comply with all covenants and to make scheduled
payments, apply 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.
Additionally, under the Contract Modification and Termination Agreement we
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 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;
* 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 March 4, 2003, then to the remaining loan amount due on
June 4, 2004.
We will need a substantial amount of funding to further our programs 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. Investors may also be reluctant to provide us funds for fear that
Pharmacia may foreclose on our assets.
WE WERE DELISTED FROM NASDAQ, WHICH MAY DECREASE THE LIQUIDITY OF OUR STOCK AND
MAY LIMIT OR IMPAIR OUR ABILITY TO RAISE ADDITIONAL CAPITAL.
On July 12, 2002 our common stock ceased trading on Nasdaq due to our
inability to satisfy the Nasdaq continued listing requirements concerning the
size of our market capitalization and the minimum bid price of our stock. We
were notified on July 12, 2002 that our common stock would begin trading on the
over-the-counter, or OTC, bulletin board, 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 OTC equity
securities. OTCBB securities are traded by a community of market makers that
enter quotes and trade reports. Our delisting could reduce the ability of our
stockholders to purchase or sell shares as quickly and as inexpensively as they
have done historically. For instance, failure to obtain listing on another
market or exchange may make it more difficult for traders to sell our
securities. Broker-dealers may be less willing or able to sell or make a market
in our common stock. Not maintaining a listing on a major stock market may:
* Result in a decrease in the trading price of our common stock;
* Lessen interest by institutions and individuals in investing in our
common stock;
* Make it more difficult to obtain analyst coverage; and
* Make it more difficult for us to raise capital in the future.
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. Because we currently have limited cash and capital resources, the
efficacy of our primary drug development candidate is questionable and we have
reduced the scope of our research and development activities, our business
outlook is uncertain. In January 2002, we implemented measures to reduce our
expenses to provide us more flexibility. These actions, which included
temporarily reducing our employees salaries, offering voluntary severance
packages for a limited time, and subsequent layoffs and attrition, have reduced
our payroll costs since the beginning of the year by approximately 40%.
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, unfavorable clinical data results from the Phase III AMD
clinical trials and limited research and development programs, may cause
employees to question our long-term viability and future career development
prospect, and increase our attrition rate. 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 THIRD PARTIES, 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 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. To further develop SnET2 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,
including those based upon existing letter agreements;
* 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;
* If our partners fail to fulfill their contractual obligations or
terminate the relationships described above, we may be required to
seek other partners, or expend substantial resources to pursue these
activities independently, which may or 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.
Also, as discussed above with regard to our lead drug candidate, SnET2, our
clinical trials may not demonstrate the sufficient levels of safety and efficacy
necessary to obtain the requisite regulatory approval or may not result in
marketable products. The failure to adequately demonstrate the safety and
effectiveness of a product under development could delay or prevent regulatory
approval of the potential product and would materially harm our business.
THE PRICE OF OUR COMMON STOCK HAS BEEN AND MAY CONTINUE TO BE VOLATILE.
From time to time and in particular during the past year, 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
September 30, 2001 to September 30, 2002, our Common Stock price, per Nasdaq and
OTCBB closing prices, has ranged from a high of $11.26 to a low of $0.26.
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 current and future cash position and expenditures;
* Future development decisions related to the results of our Phase III
AMD clinical trials;
* Announcements concerning Miravant or our collaborators, competitors or
industry;
* Our ability to successfully establish new collaborations;
* 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;
* Litigation;
* 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; 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 significantly decline, we may be unable to obtain
additional capital that we may need through public or private financing
activities. 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 WE
NO LONGER HAVE ACCESS TO THESE THIRD PARTIES, 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
previously relied on Pharmacia, our former corporate partner, and Inveresk,
Inc., formerly ClinTrials Research, Inc., or Inveresk, a contract research
organization, for our Phase III AMD clinical trials. We continue rely on
Inveresk to assist us in the analysis of our Phase III AMD clinical data and for
possible preparation of an NDA or future Phase III AMD clinical trials and a
contract research organization for our Phase II dermatology clinical trials. In
the future, 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 contract research
organizations may be available in the event that our current contract research
organizations 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.
BECAUSE WE RELY ON PATIENT ENROLLMENT TO CONDUCT CLINICAL TRIALS, IF WE ARE
UNABLE TO CONTINUE TO ATTRACT PATIENTS TO PARTICIPATE IN THESE TRAILS, THERE MAY
BE 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 is that there
currently is an approved treatment for AMD, which may cause patients enrolled in
future AMD clinical trials, if any, 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.
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. In addition, 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 TO SATISFY OUR MANUFACTURING NEEDS.
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 may
manufacture drugs and devices at some commercial 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 are
licensed by the State of California to manufacture SnET2 bulk active
pharmaceutical ingredient, or bulk API, at our Santa Barbara, California
facility for clinical trial and other use. This facitility is currently being
shut-down, and can be restarted to begin manufacturing, if needed. We currently
have in inventory significant quantities of the bulk API, the process up to the
final formulation and packaging step, which we believe would provide adequate
supplies for future clinical trials and initial commercial launch. We also have
the ability to manufacture light producing devices and light delivery devices,
and conduct other production and testing activities, at this location. However,
we have limited capabilities, personnel and experience in the manufacture of
finished drug product, 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 restart or 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 restart or expand capacity for our API
manufacturing 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. 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.
Both currently have commercial quantity capabilities. At this time, we have no
readily available back-up manufacturers to produce 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 EXPERIENCE IN THE MARKETING, DISTRIBUTION AND SALE OF OUR
PRODUCTS.
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 cardiac 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 materials and components are available from
various sources, we are dependent on certain suppliers for key materials or
services used in our drug and light producing and light delivery device
development and production operations. One supplier is Fresenius, which
processes our SnET2 drug substance into a sterile injectable formulation and
packages it in vials for distribution. We expect to continue to develop new
drugs and new drug formulations both in-house and using external suppliers,
which may or may not have similar dependencies on suppliers. Another supplier is
Iridex, which provided the light producing devices used in our AMD clinical
trials and can be used for future commercial use in ophthalmology. We recently
regained ownership of the bulk API and finished dose formulation, or FDF,
inventories and lasers from Pharmacia. Based on the quantities received, we are
not expected to need additional bulk API, FDF, or lasers in the near term. These
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 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 entails 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 may in the future,
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 Miravant is 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 by 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 have in the past been 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.
TERRORIST ATTACKS, SUCH AS THE ATTACKS THAT OCCURRED IN NEW YORK AND WASHINGTON,
D.C. ON SEPTEMBER 11, 2001, AND OTHER ACTS OF VIOLENCE OR WAR MAY AFFECT THE
MARKETS IN WHICH WE OPERATE, OUR OPERATIONS AND OUR PROFITABILITY.
Terrorist attacks may negatively effect our operations. These attacks or
armed conflicts may directly impact our physical facilities or those of our
suppliers or customers, which could result in higher expenses and/or lower
revenue. Furthermore, these attacks may make travel of our sales and support
staff more difficult and more expensive and ultimately affect the sales of our
products.
Also as a result of terrorism, the United States has entered into an armed
conflict, which could have a further impact on our domestic and international
sales. Political and economic instability in some regions of the world may also
result and could negatively impact our business.
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 payors 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 new Medical Device Directive effective
in Europe 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 PROGRAMS OR
POTENTIAL PRODUCTS NON-COMPETITIVE 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 to continue using
familiar methods they are comfortable with using rather than trying 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 current 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 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 Pharmaceuticals)
for the treatment of certain oncology indications and Levulan(R) (DUSA
Pharmaceuticals / Berlex Laboratories) 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, QLT, Axcan and Dusa, 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.
PART II. OTHER INFORMATION
ITEM 2.CHANGES IN SECURITIES AND USE OF PROCEEDS
(c) Recent Sales of Unregistered Securities.
In August 2002, the Company completed a private placement financing which
consisted of the sale of unregistered shares of Common Stock for $2.5 million at
$0.50 per share, based on a premium of approximately 20% of the average closing
price for the prior 10 trading days. For every two common shares acquired, the
equity purchase included a warrant to purchase one share of Common Stock at a
price $0.50 per share, with an exercise period of 5 years from the date of
grant. In addition, we also issued a warrant to purchase 300,000 shares of
Common Stock to one of our current stockholders who helped facilitate the
private placement. A group of approximately 10 private investors, all of whom
were "accredited investors" as such term is used in the Securities Act of 1933,
as amended (the "Securities Act"), participated in the offering. The shares of
Common Stock and warrants were issued pursuant to an exemption from registration
under Rule 506 promulgated under Regulation D of the Securities Act. The
proceeds are being used for research, development and general corporate
purposes.
ITEM 3.QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
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.
(a) Evaluation of disclosure controls and procedures.
Our chief executive officer and our chief financial officer, after
evaluating our "disclosure controls and procedures" (as defined in Securities
Exchange Act of 1934 (the "Exchange Act") Rules 13a-14(c) and 15-d-14(c)) as of
a date (the "Evaluation Date") within 90 days before the filing date of this
Quarterly Report on Form 10-Q, have concluded that as of the Evaluation Date,
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 Exchange
Act is recorded, processed, summarized and reported within the time periods
specified in Securities and Exchange Commission rules and forms.
(b) Changes in internal controls.
Subsequent to the Evaluation Date, there were no significant changes in our
internal controls or in other factors that could significantly affect our
disclosure controls and procedures, nor were there any significant deficiencies
or material weaknesses in our internal controls. As a result, no corrective
actions were required or undertaken.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
Exhibit 4.17 Securities Purchase Agreement dated August 28, 2002 between
the Registrant and certain Purchasers named therein (incorporated by
reference to the Current Report on Form 8-K filed by the registrant on
September 3, 2002).
Exhibit 4.18 Registration Rights Agreement dated August 28, 2002 between
the Registrant and certain purchasers of Common Stock named therein
(incorporated by reference to the Current Report on Form 8-K filed by
the registrant on September 3, 2002).
Exhibit 4.19 Common Stock Warrant Purchase Certificate dated August 28,
2002 between the Registrant and certain purchasers named therein
(incorporated by reference to the Current Report on Form 8-K filed by
the registrant on September 3, 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.
Exhibit 99.2 Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to Section 13(a) or 15(d) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
(b) Reports on Form 8-K.
1) Current Event Report on Form 8-K filed on July 12, 2002 announcing
that the registrant received a notification from Nasdaq, following two
separate requests for extensions, that it had not met certain
requirements for continued listing and that the Company's common stock
will begin trading on the OTC bulletin board (OTCBB), effective as of
the opening of business on July 12, 2002.
2) Current Event Report on Form 8-K filed on September 3, 2002 announcing
that the registrant sold and issued to a group of private investors
(i) unregistered shares of common stock at $0.50 per share for
aggregate proceeds $2.5 million and (ii) for every two shares of
common stock acquired, a warrant to purchase one share of common stock
at $0.50 per share.
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: November 14, 2002
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)