<PAGE>
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
/x/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2000
OR
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 for the transition period ended________________
Commission File Number 0-23553
PHOTOGEN TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
NEVADA 36-4010347
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
7327 OAK RIDGE HIGHWAY, SUITE B
KNOXVILLE, TN 37931
(Address of principal executive offices)(Zip Code)
(865) 769-4012
(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 equity, as of the latest practicable date: 37,383,386 SHARES OF COMMON
STOCK, $.001 PAR VALUE PER SHARE, ISSUED AND OUTSTANDING AS OF August 7, 2000
=============================================================================
<PAGE>
INDEX
<TABLE>
<CAPTION>
PAGE
<S> <C> <C>
PART I. FINANCIAL INFORMATION 1
ITEM 1. FINANCIAL STATEMENTS 1
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS 7
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK 10
PART II. OTHER INFORMATION 11
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 11
ITEM 5. OTHER INFORMATION 12
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 18
</TABLE>
i
<PAGE>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
All amounts in $
<TABLE>
<CAPTION>
June 30, 2000 December 31, 1999
(Unaudited) (Audited)
------------- -----------------
<S> <C> <C>
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 932,028 $ 1,681,773
Restricted cash - 100,000
Interest receivable 99,759 84,327
Prepaid expenses 78,763 590,710
United States Treasury Notes, Total
Face Value $7,720,000 and
$5,470,000, respectively 7,716,032 5,472,564
------------ -----------
TOTAL CURRENT ASSETS $ 8,826,582 $ 7,929,374
EQUIPMENT AND LEASEHOLD IMPROVEMENTS $ 1,532,001 $ 1,279,441
DEPOSITS 529,370 29,370
INTANGIBLE ASSETS 461,806 482,639
INVESTMENT IN AND ADVANCES TO AFFILIATE 11,645,797 11,998,430
------------ ------------
TOTAL ASSETS $22,995,556 $21,719,254
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable $421,477 $ 833,163
Current portion of obligations under
capital leases 17,742 21,148
---------- -----------
TOTAL CURRENT LIABILITIES $439,219 854,311
---------- -----------
OBLIGATION UNDER CAPITAL LEASES 10,290 $ 18,356
========== ===========
SHAREHOLDERS' EQUITY
Preferred stock; par value
$.01 per share; 5,000,000
shares authorized including: - -
Series A preferred stock; 12,856 and 12,015 shares
authorized at June 30, 2000 and December 31, 1999
respectively; 12,856 and 12,015 issued and outstanding at
June 30, 2000 and December 31, 1999 respectively 128 120
Series B preferred stock; 402,000 shares authorized;
337,056 issued and outstanding at June 30, 2000 3,370 -
Common stock; par value $.001
per share; 150,000,000 shares authorized; 37,383,386 shares
issued and outstanding 37,384 37,384
Unearned consulting expense (363,787) (1,585,575)
Additional paid-in capital 36,439,332 30,977,893
Deficit accumulated during
development stage after
recapitalization (13,570,380) (8,583,235)
------------ -----------
TOTAL SHAREHOLDERS' EQUITY 22,546,047 20,846,587
------------ -----------
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY $22,995,556 $21,719,254
=========== ===========
</TABLE>
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PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
All amounts in $
<TABLE>
<CAPTION>
Cumulative Amounts
Three Months Ended Three Months Ended Six Months Ended Six Months Ended From
June 30, 2000 June 30, 1999 June 30, 2000 June 30, 1999 November 3, 1996
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
----------- ----------- ----------- ----------- -----------
REVENUES
<S> <C> <C> <C> <C> <C>
Investment Income $ 141,022 $ 47,287 $ 242,808 $ 119,307 $ 922,335
EXPENSES
General and administrative 2,698,203 1,070,675 5,229,953 1,971,445 14,492,715
------------ ------------ ------------ ------------ ------------
NET LOSS $ (2,557,181) $ (1,023,388) $ (4,987,145) $ (1,852,138) $(13,570,380)
============
DIVIDENDS ON PREFERRED STOCK (793,597) -- (1,097,571) --
------------ ------------ ------------ ------------
NET LOSS APPLICABLE TO COMMON
SHAREHOLDERS $ (3,350,778) $ (1,023,388) $ (6,084,716) $ (1,852,138)
============ ============ ============ ============
BASIC AND DILUTED NET
LOSS PER COMMON SHARE $ (.09) $ (.03) $ (.16) $ (.05)
============ ============ ============ ============
WEIGHTED AVERAGE
NUMBER OF COMMON SHARES
OUTSTANDING 37,383,386 36,875,020 37,383,386 36,875,020
============ ============ ============ ============
</TABLE>
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PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOW
(UNAUDITED)
All amounts in $
<TABLE>
<CAPTION>
Six Months Six Months Cumulative
Ended Ended Amounts From
June 30, 2000 June 30, 1999 November 3, 1996
(Unaudited) (Unaudited) (Unaudited)
----------- ----------- ----------
OPERATING ACTIVITIES
<S> <C> <C> <C>
Net income (loss) $ (4,987,145) $ (1,852,138) $(13,570,380)
Depreciation and Amortization 206,803 90,258 654,686
United States Treasury Notes
Amortization 6,532 18,191 61,584
Loss (gain) on Securities -- 64,074 (18,503)
Stock Option Compensation 45,827 -- 472,594
Issuance of warrants in exchange
for services rendered 1,364,438 -- 2,407,904
Loss from investment in affiliate 1,068,108 -- 1,374,137
Changes in operating assets and liabilities:
Prepaid expense 511,947 205,286 (78,763)
Interest receivable (15,432) 73,660 (99,759)
Accounts payable (411,686) (345,589) 421,477
------------ ------------ ------------
NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES (2,210,608) (1,746,258) (8,375,023)
------------ ------------ -----------
INVESTING ACTIVITIES
Sale of marketable securities -- -- 2,164,464
Purchase of marketable securities -- -- (2,182,967)
Purchase of United States Treasury Notes (9,070,000) (857,540) (31,107,003)
Sale of United States Treasury Notes 6,820,000 3,002,048 24,463,548
Purchase of capital assets (438,530) (191,427) (1,819,959)
Patent cost -- -- (237,335)
Investment in and advances to affiliate (715,475) -- (13,019,934)
Decrease in restricted cash 100,000 -- --
Increase in deposits (500,000) -- (529,370)
------------ ------------ ------------
NET CASH PROVIDED (USED) BY INVESTING ACTIVITIES (3,804,005) 1,953,081 (22,268,556)
------------ ------------ ------------
FINANCING ACTIVITIES
Proceeds from issuance of equity 5,276,340 -- 30,298,716
Proceeds from capital contributions by stockholders -- -- 1,911,674
Cost of recapitalization -- -- (371,111)
Principal payments on capital lease
obligations (11,472) (98,655) (263,672)
------------ ------------ ------------
NET CASH PROVIDED (USED) BY FINANCING ACTIVITIES 5,264,868 (98,655) 31,575,607
------------ ------------ ------------
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (749,745) 108,168 932,028
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 1,681,773 652,226 --
------------ ------------ ------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 932,028 $ 760,394 $ 932,028
============ ============ ============
</TABLE>
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PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF SHAREHOLDERS' EQUITY
(UNAUDITED)
All amounts (except shares) in $
<TABLE>
<CAPTION>
Preferred Stock Preferred Stock Common Stock
--------------- --------------- ------------
Series A Series B
-------- --------
Shares Amount Shares Amount Shares Amount
------ ------ ------ ------ ------ ------
<S> <C> <C> <C> <C> <C> <C>
Contribution of Capital -- $ -- -- $ -- -- $ --
Net loss for the period ended December 31, 1996 -- -- -- -- -- --
-----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1996 -- -- -- -- -- --
Net loss and capital contributions for the
period January 1, 1997 to May 15, 1997 -- -- -- -- -- --
-----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at May 15, 1997 -- -- -- -- -- --
Issuance of common stock -- -- -- -- 6,312,833 6,313
Effect of recapitalization and merger -- -- -- -- 29,687,178 29,687
Cost associated with recapitalization
and merger -- -- -- -- -- --
Net loss for the period May 16, 1997 to
December 31, 1997 -- -- -- -- -- --
-----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1997 -- -- -- -- 36,000,000 36,000
Issuance of common stock -- -- -- -- 875,020 875
Costs associated with common stock issuance -- -- -- -- -- --
Options issued to consultants -- -- -- -- -- --
Net loss for the year ended
December 31, 1998 -- -- -- -- -- --
-----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1998 -- -- -- -- 36,875,020 36,875
Exercise of stock options -- -- -- -- 4,500 5
Issuance of warrants and options -- -- -- -- -- --
Issuance of common stock -- -- -- -- 503,866 504
Issuance of preferred stock 12,015 120 -- -- -- --
Net loss for the year ended
December 31, 1999 -- -- -- -- -- --
-----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1999 12,015 120 -- -- 37,383,386 37,384
Issuance of warrants and options -- -- -- -- -- --
Issuance of preferred stock dividend-Series A 841 8 -- -- -- --
Issuance of preferred stock-Series B -- -- 337,056 3,370 -- --
Net loss for six months ended
June 30, 2000 -- -- -- -- -- --
-----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at June 30, 2000 12,856 128 337,056 3,370 37,383,386 37,384
</TABLE>
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<PAGE>
<TABLE>
<CAPTION>
Deficit
Accumulated
Unearned Additional During the
Members' Consulting Paid-in Development
Capital Expense Capital Stage Total
- ----------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Contribution of Capital 7,268 $ - $ - $ - $ 7,268
Net loss for the period ended
December 31, 1996 (1,779) - - - (1,779)
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1996 5,489 - - - 5,489
Net loss and capital
contributions for the
period January 1, 1997 to
May 15, 1997 3,511 - - (3,511) -
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at May 15, 1997 9,000 - - (3,511) 5,489
Issuance of common stock - - 1,797,137 - 1,803,450
Effect of recapitalization and merger (9,000) - 1,181,500 1,732 1,203,919
Cost associated with recapitalization
and merger - - (371,111) - (371,111)
Net loss for the period
May 16, 1997 to December 31, 1997 - - - (554,702) (554,702)
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1997 - - 2,607,526 (556,481) 2,087,045
Issuance of common stock - - 6,999,125 - 7,000,000
Costs associated with common
stock issuance - - (50,000) - (50,000)
Options issued to consultants - - 45,446 - 45,446
Net loss for the year ended
December 31, 1998 - - - (1,973,913) (1,973,913)
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1998 - - 9,602,097 (2,530,394) 7,108,578
Exercise of stock options - - 50,058 - 50,063
Issuance of warrants and options - (1,585,575) 3,664,749 - 2,079,174
Issuance of common stock - - 6,082,150 - 6,082,654
Issuance of preferred stock - - 11,578,839 - 11,578,959
Net loss for the year ended
December 31, 1999 - - - (6,052,841) (6,052,841)
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1999 - (1,585,575) 30,977,893 (8,583,235) 20,846,587
Amortization of unearned consulting expense - 1,364,438 - - 1,364,438
Stock option compensation - 45,827 - - 45,827
Issuance of preferred stock
dividend-Series A - - (8) - -
Issuance of preferred stock-Series B - - 5,272,970 - 5,276,340
Net loss for six months ended
June 30, 2000 - - - (4,987,145) (4,987,145)
- ----------------------------------------------------------------------------------------------------------------------
Balance, at June 30, 2000 - (363,787) 36,439,332 (13,570,380) 22,546,047
- ----------------------------------------------------------------------------------------------------------------------
</TABLE>
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<PAGE>
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
June 30, 2000
1. BASIS OF PRESENTATION
The accompanying unaudited condensed financial statements have been
prepared in accordance with generally accepted accounting principles for interim
financial information pursuant to Regulation S-K. Accordingly, they do not
include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals) considered
necessary for a fair presentation have been included. Operating results for the
six months ended June 30, 2000 are not necessarily indicative of the results
that may be expected for the year ended December 31, 2000.
2. LONG-TERM DEPOSIT
The Company entered into an operating lease for laboratory equipment
beginning January 1, 2000. The Company was required to provide cash collateral
of $500,000 for future lease payments. The $500,000 will be invested in United
States treasury notes and will be under the control of the lessor. The Company
has recorded the $500,000 as a long-term deposit at June 30, 2000.
3. Series B Preferred Stock
In February 2000, the Company completed a private placement of its Series
B convertible preferred stock ("Series B"). The Company received cash proceeds,
net of related expenses, of $5,276,340 in exchange for 337,056 shares of the
Series B stock. The Series B has an annual dividend rate of 6%. Such dividends
are to be cumulative, shall compound on an annual basis and are payable annually
by the issuance of additional preferred Series B stock. The Company has a
deficit. As a result, the dividends have been recorded against paid-in capital.
The Series B is subordinate to the Series A preferred stock. Each share of the
Series B is convertible into one share of common stock (if converted before
December 31, 2000), into 1.2 shares of common stock (if converted during 2001)
and into 1.4 shares of common stock (if converted in 2002 and thereafter). The
Series B is redeemable at the Company's option after January 1, 2002.
4. Stock Incentive Plans
In May 2000, the shareholders approved a Senior Executive Long-Term
Incentive Compensation Plan, which provides for the granting of up to 3,000,000
stock options to employees who are executive officers. Options
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<PAGE>
granted may be either "incentive stock options," within the meaning of Section
422A of the Internal Revenue Code, or nonqualified options.
The stock options are exercisable over a period determined by the Board
of Directors (through its Compensation Committee), but generally no longer than
10 years after the date they are granted.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Photogen Technologies, Inc. and its wholly-owned subsidiary Photogen,
Inc. are collectively referred to as "Photogen," the "Company," "we," or "us."
Statements in this document that are not strictly historical are
"forward-looking" statements that are made pursuant to the safe harbor provision
of the Private Securities Litigation Reform Act of 1995 and are subject to the
Risk Factors described below in Item 5 "Other Information." Forward-looking
statements involve known and unknown risks, which may cause our actual results
in the future to differ materially from expected results.
Photogen is an emerging development-stage biotechnology company
focused on developing minimally invasive products for the treatment and
diagnosis of cancer, pre-cancerous conditions and other diseases. We have
assembled a platform of core technologies which we believe will support
multiple products and applications. We have not completed development of any
diagnostic or therapeutic product or process at this time and have no revenue
from operations.
We have discovered new methods and apparatus for using energy from
lasers, X-rays or other sources to selectively activate photoactive agents
within tissue sufficient to produce a range of beneficial therapeutic and
diagnostic outcomes. These discoveries include methods, materials and devices
that are used to produce light or other energy, and development of photoactive
agents, for the purpose of destroying diseased cells, removing tissue or
identifying and diagnosing disease.
We are pursuing development of our three core technologies:
- Photochemistry: We are working with PH-10 to develop treatments
for focal cancers within the body and for treatment of diseased
tissue on the surface of the body. PH-10 is a compound that
accumulates in diseased tissue and absorbs x-rays and light
energy, thereby destroying the tissue.
- Lymphography: We are the exclusive licensee to a special group of
proprietary nanoparticulates (and related methods) used in
lymphography. Nanoparticulates are tiny particles that can be
injected into a patient's lymphatic system to precisely locate and
diagnose the spread of cancer.
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<PAGE>
- Multiphoton excitation: Our proprietary laser technology uses
ultrashort, pulsed bursts of long wavelength light to activate
photoactive agents and other compounds to destroy diseased tissue.
Multiphoton excitation also has applications in imaging for
diagnostic purposes.
Our proposed products have the potential to replace numerous surgical and
similar invasive treatments and diagnostics, reduce side effects (including
those resulting from chemotherapy), improve treatment efficacy, and lower the
overall cost of care for oncology and other applications.
Our core technologies are proprietary, and are either protected by issued
U.S. and foreign patents or are subject to patent applications pending in the
U.S. and foreign jurisdictions. As discussed below (see "Risk Factors" in Item
5), disputes about intellectual property are common in our industry, and we are
routinely involved in discussions with others about the ownership of
intellectual property or whether an item of intellectual property interferes
with or infringes the rights of another person or entity. We believe that none
of these matters is material to our financial condition or results of operation.
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We have not generated revenues from the sale of any proposed
diagnostic or therapeutic products or other operations, and we continue to
experience losses. Our net loss for the six months ended June 30, 2000 was
$4,987,145, compared to a loss of $1,852,138 for the six month period ended
June 30, 1999. For the three months ended June 30, 2000, our net losses for
this quarter increased to $2,557,181 from $1,023,388 for the three months
ended June 30, 1999. The increase in losses is attributable primarily to the
expenses of our clinical development office in Massachusetts, preparing for
clinical trials, leasing CT equipment, conducting studies pursuant to
preclinical research agreements and other research, initiating supply
arrangements, and other general and administrative costs.
We expect to continue to incur increasing losses for at least the next
several years as we intensify research and development, preclinical and
clinical testing, regulatory approval activities and engage in or provide for
the manufacture and/or sale of any products that we may develop. In
particular, we are presently a party to two research contracts with various
third parties that will require an expenditure of a total of $189,717 over
the remaining terms of those contracts for the protocols currently under
investigation. Additional projects may be undertaken with those institutions
for compensation to be agreed upon at that time. During the six months
ended June 30, 2000, we spent approximately $438,530 to acquire equipment
necessary to support animal preclinical and human clinical trials. During the
next twelve months we expect to spend approximately $794,750 to obtain new
equipment. Pursuant to the Amended and Restated Certificate of Designation,
Preferences and Rights of Series a Preferred Stock ("Certificate of
Designations"), in May 2000 we made a mandatory payment-in-kind dividend of
841 shares of Series A preferred stock ("Series A Preferred") to our Series A
stockholder. Under the Certificate of Designations the holder of Series A
Preferred is entitled to a mandatory payment-in-kind dividend equal to 7%
(i.e., 0.07 additional shares of Series A Preferred) which is cumulative,
compounds on a semi-annual basis and is payable twice a year. At the next
regularly scheduled Board of Directors meeting, the Board will increase the
authorized shares of Series A Preferred to provide for the mandatory
payment-in-kind dividend.
Our investment income for the six months ended June 30, 2000 was
$242,808, compared to $119,307 of investment income for the six month period
June 30, 1999. For the three months ended June 30, 2000, our investment
income increased to $141,022, compared to $47,287 for the three months ended
June 30, 1999. The increase in investment income resulted primarily from
investment of
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<PAGE>
the $5,276,340 in net proceeds we received from the private placement of our
Series B Convertible Preferred Stock ("Series B Preferred") in February 2000. We
expect our investment income to fluctuate as our capital decreases or increases.
The proceeds of the sales of our stock are invested primarily in United States
Government obligations. Because we have no revenues from operations at this
time, investment of such funds in that manner is necessary to avoid becoming
subject to the Investment Company Act of 1940.
LIQUIDITY; CAPITAL RESOURCES
We have used, and expect over the next 12 months to use, the gross
proceeds from our 1999 sale of common stock to affiliates of Elan Corporation
and the gross proceeds from our February 2000 private placement of Series B
convertible preferred stock for corporate overhead and operating expenses,
animal trials, the purchase or lease of scientific and laboratory equipment and
related facilities, legal and regulatory consulting fees and for other working
capital purposes, assuming we have no revenues during that period. We expect our
use of capital to increase as we move toward initiating clinical trials.
We have a $4.8 million credit facility from Elan to fund a portion of
the operations of the Sentigen joint venture we formed with affiliates of
Elan in October 1999. Any borrowings under this facility bear interest at 8%
per annum and is convertible at Elan's election into our Common Stock at a
conversion price of $18.15 per share. We have also received a binding
commitment from one of our principal shareholders and directors, Mr.
Tannebaum, to make a $1 million credit facility available to us. If we
utilize Mr. Tannebaum's credit facility, borrowings will bear interest at 6%
per year and interest only will be paid annually, with the principal due in
five years. The loan would be secured by a lien on all of our assets.
Our use of cash and capital resources for the second quarter of the 2000
fiscal year averaged approximately $600,000 per month. As of June 30, 2000 we
had approximately $8,648,000 available to meet our operating expenses. At the
current rate of spending, we will exhaust our funds by approximately June 30,
2001. We can adjust our use of cash and capital by not renewing or by seeking to
modify research or other contracts; or by seeking alternative methods of paying
for portions of the research and other contract obligations, such as issuing
stock rather than paying in cash (which may dilute stockholders). We expect to
consider additional financing transactions in the future. See "Risk Factors --
We must obtain significant additional financing," below.
PLAN OF OPERATION
During the next twelve months, we will focus our efforts on completing
preclinical studies, beginning human trial and human pilot studies on selected
indications, preparing for the design and assembly of laser and other treatment
devices, preparing to manufacture clinical quantities of our drug formulations
and preparation of required filings to FDA and foreign regulatory bodies.
We expect that our technologies will be useful in a multitude of
treatment and diagnostic applications, all of which are important. We intend
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to focus our current efforts on developing PH-10 and lymphography for the
diagnosis and treatment of focal tumors (a tumor that is confined to a
specific area of the body); and we are developing a plan to determine which
specific focal tumors to begin working on. We believe this should enable us
to have the greatest impact in an area of significant need.
Indeed, over the next twelve months, we intend to devote a significant
majority of our financial and other resources to preparing for and initiating
clinical development of PH-10 for treatment of focal tumors, and clinical
development of our lymphography technology. With respect to PH-10, our goal
is to file an Investigational New Drug (IND) application with the FDA which,
if approved, would enable us to begin human clinical trials for treatment of
either liver cancer, head and neck cancer, breast cancer, prostate cancer or
another type of focal tumor in the next several months. We also hope to begin
phase II clinical trials of our lymphography technology -- which is being
developed through our joint venture with affiliates of Elan Corporation -- in
2001, depending on the availability of a supply of nanoparticulate materials.
We also plan to sponsor one or more grants to conduct human pilot
studies. The purpose of these pilot studies will be to develop data to enable us
to pursue additional applications of our technology for treatment of
pre-cancerous conditions such as Barretts esophagus or actinic keratosis. This
data should also enable us to determine how best to work with potential
licensees with respect to the use of our technologies in treatments for
psoriasis, hair removal and similar applications.
With the funds we received from financing in 1999 and in the first
quarter of 2000, plus the credit available from Elan (to fund a portion of the
anticipated development costs of Sentigen) and from Mr. Tannebaum, we believe we
will have enough cash resources for our current commitments during the next
twelve months. However, as we progress toward and into human clinical trials,
our use of capital will increase and will continue to do so at an accelerating
pace. Greater capital resources would enable us to quicken and expand our
research and development activities over that 12-month period; and our failure
to raise additional capital will (absent a suitable collaborative agreement
providing for a third party to take over these functions) significantly impair
our ability to conduct further research and development activities beyond those
currently contracted for and our ability to seek regulatory approval for any
possible product resulting from that research. In any event, complete
development and commercialization of our technology will require substantial
additional funds. See "Risk Factors -- We must obtain significant additional
financing," below. Accordingly, we are continuously evaluating capital formation
activities and opportunities, either as part of collaborative arrangements with
third parties or through offerings of equity or debt unrelated to
collaborations.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
None.
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PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
We had our annual meeting of stockholders on May 17, 2000,
pursuant to a notice and proxy statement sent to stockholders on or about April
19, 2000. The annual meeting of our Board of Directors immediately followed the
stockholders' meeting.
At the annual meeting of shareholders, the stockholders took
the following actions:
- Approved an amendment to the Company's Articles of Incorporation
to increase the size of the Board of Directors to seven and to
permit vacancies in the Board between regular elections to be
filled in the manner provided in the Bylaws; by a vote of
33,405,202 shares for the proposal, 10,493 shares against, and
3,520 shares abstaining (including broker non-votes).
- Elected the following five nominees to the Board of Directors:
<TABLE>
<CAPTION>
Shares
Abstaining
(Including
Shares Shares Broker
For Against Non-votes)
------ -------- -----------
<S> <C> <C> <C>
Eugene Golub 28,906,433 0 4,512,782
Lester H. McKeever, Jr. 33,410,800 0 8,415
Theodore Tannebaum 28,906,433 0 4,512,782
Eric A. Wachter, Ph.D. 33,410,900 0 8,315
Robert J. Weinstein, M.D. 28,906,833 0 4,512,382
</TABLE>
- Approved our 2000 Long Term Incentive Compensation Plan covering
2,000,000 shares of Common Stock for awards of options or
restricted stock; by a vote of 31,890,016 shares for the proposal,
13,288 shares against, and 4,825 shares abstaining (including
broker non-votes).
- Ratified the engagement of BDO Seidman, LLP as our independent
certified public accountants for 2000; by a vote of 33,413,325 for
the proposal, 2,560 shares against, and 3,330 shares abstaining
(including broker non-votes).
As a result of these stockholder actions, a number of amendments to the
Company's Bylaws became effective. These Bylaw amendments permit the Board to
appoint directors to fill vacancies between regular elections and change the
requirement that certain matters be approved by all of the directors to a
requirement that five of seven of the directors approve certain matters.
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At the Board meeting immediately following the stockholders' meeting, the
directors took a number of actions, including:
- Approving Taffy J. Williams, Ph.D.'s employment as President and
Chief Executive Officer;
- Electing Dr. Williams as a director;
- Approving our Senior Executive Long Term Incentive Compensation
Plan (the Company expects to obtain shareholder approval of this
plan in the near future);
- Granting Dr. Williams options to acquire 3,000,000 shares of
Common Stock pursuant to the Senior Executive Long Term Incentive
Compensation Plan;
- Electing Aidan King as a director (Mr. King replaced Vince Fabiano
as Elan International Services, Ltd.'s designee to our Board. Mr.
Fabiano withdrew his name from consideration prior to the annual
meeting.); and
- Approving an Indemnity Agreement to be entered into with
directors.
ITEM 5. OTHER INFORMATION
RISK FACTORS
This Form 10-Q contains "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve risks, uncertainties and other factors that may cause our
actual results or performance to differ materially from any results or
performance expressed or implied by those statements. Examples of
forward-looking statements include predictive statements, statements that depend
on or refer to future events or conditions, which include words such as
"expects," "anticipates," "intends,""plans," "believes," "estimates," "should,"
"may" or similar expressions, or statements that involve hypothetical events.
The following are some of the key risk factors that may affect our future
results:
WE ARE A DEVELOPMENT STAGE COMPANY, WE HAVE CONDUCTED ONLY LIMITED STUDIES ON
OUR TECHNOLOGIES AND WE DO NOT HAVE ANY PRODUCTS OR REVENUES FROM SALES.
Our Company and our technology are in an early stage of development. We
have not generated revenues from sales or operations, and we do not expect to
generate any significant revenues for at least several years.
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Use of our technology has been limited primarily to laboratory
experiments or animal testing and only one compound has completed Phase I
clinical trials in humans. We have therefore not yet conducted substantive
studies on the effectiveness of any compound on human subjects. The drug and
device products we currently contemplate developing will require significant
additional research and development, preclinical and clinical testing and
regulatory approval before they can be manufactured and sold. We cannot assure
that we will be able to develop our technology into marketable products or that
the technology will be effective for diagnosis or treatment of human diseases.
As a result of changing economic considerations, market, clinical or regulatory
conditions, or clinical trial results, we may shift our focus or determine not
to continue one or more of the projects we are currently pursuing.
WE HAVE A HISTORY OF LOSSES AND MAY NOT ACHIEVE OR MAINTAIN FUTURE PROFITS OR
PAYMENT OF DIVIDENDS.
We have incurred losses since the beginning of our operations.
As of June 30, 2000, we have incurred total losses of approximately
$13,570,380. We expect our losses to increase in the future as our
financial resources are used for research and development, preclinical
and clinical testing, regulatory activities, manufacturing, marketing and
other related expenses. We may not be able to achieve or maintain
profitability in the future. We have never declared or paid any cash
dividends to stockholders, and do not expect to do so in the foreseeable
future.
WE MUST OBTAIN SIGNIFICANT ADDITIONAL FINANCING.
Under the present circumstances, we have sufficient capital to
conduct operations for over twelve months (depending on the pace of our
spending for preclinical and clinical trials and other commitments;
which, to an extent, we can adjust to preserve cash). We will need
substantial additional financing for our research, clinical testing,
product development and marketing programs. We cannot accurately estimate
the amount of additional financing required; however, the amount could be
an additional $30 - 50 million or more. Depending on market conditions,
we will attempt to raise additional capital through stock and debt
offerings, collaborative relationships and other available sources.
Additional funds may not be available on acceptable terms, if at all, and
existing stockholders may be diluted as a result of those offerings.
If we sell additional equity, Elan has a preemptive right until
October 2003 to participate in that offering. If in our next third-party
financing we sell common stock at a price less than $13 per share, we
must issue additional shares to Elan so
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that Elan's overall price for its common stock equals the effective
price in that other offering.
If we sell additional equity, Elan has a preemptive right until
October 2003 to participate in that offering. If in our next third-party
financing we sell common stock at a price less than $13 per share, we
must issue additional shares to Elan so that Elan's overall price for
its common stock equals the effective price in that other offering.
OUR PROPOSED PRODUCTS ARE SUBJECT TO EXTENSIVE TESTING AND GOVERNMENT REGULATION
AND APPROVAL, INCLUDING BY THE FOOD AND DRUG ADMINISTRATION ("FDA").
Most of our proposed drug and device products have not begun,
and none has completed, the FDA's extensive approval process which must
be completed before proposed products can be sold in interstate
commerce. This process includes preclinical and clinical testing for
effective use and safety in animals and humans and it can be extremely
costly. The time frame necessary to perform these tasks for any
individual product is long and uncertain, and we may encounter problems
or delays which we cannot predict at this time. Even if clinical trials
are successful, our proposed products may not demonstrate sufficient
effectiveness or safety to warrant approval by the FDA or other
regulatory authorities. Any regulatory approval may not cover the
clinical symptoms or indications that we may seek. Marketing our
products in other countries will require seeking and obtaining
regulatory approvals comparable to those required in the U.S.
LOSS OF PATENT AND OTHER INTELLECTUAL PROPERTY PROTECTION WOULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
One factor which may bear on our success is our ability to
obtain, assert and defend our patents, protect trade secrets and
operate without infringing the intellectual property of others. Among
the important risks in this area are that:
- Our patent applications may not result in issued patents.
Moreover, any issued patents may not provide us with adequate
protection of our intellectual property or competitive advantages.
- Various countries limit the subject matter that can be patented
and limit the ability to enforce patents in the medical field,
which may limit our ability to obtain or utilize such patents
against third parties.
- Our inventions may be "reverse engineered" by our competitors, and
third parties may challenge our existing patents and seek to hold
them invalid or unenforceable.
- Existing or future patents or patent applications (and the
products or methods they cover) of our competitors (or others,
such as research institutions or universities) may interfere,
invalidate, conflict with or infringe our patents or patent
applications. Similarly, the use of the methods or technologies
contained in our patents and other
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intellectual property may conflict with or infringe the rights of
others.
- If an advance is made that qualifies as a joint invention, the
joint inventor or his or her employer may have rights in the
invention.
Litigation over patents and other intellectual property rights
occurs frequently in our industry, and there is a risk that we may not
prevail if we become involved in such litigation. Further, interference
may occur over the rights to certain inventions, and there is a risk
that we may not prevail in such an interference. Those disputes can be
expensive and time consuming, even if we win. Intellectual property
disputes are often settled through licensing arrangements that could be
costly to us. In any intellectual property litigation, it is possible
that licenses necessary to settle the dispute would not be available,
or that we would not be able to redesign our technologies to avoid any
claimed infringement.
Confidentiality agreements covering our intellectual property
may be violated and we may not have adequate remedies for any
violation. Also, our intellectual property may in other ways become
known or be independently discovered by competitors.
To the extent we use intellectual property through licenses or
sub-licenses (as is the case for some of our lymphography technology),
our rights are subject to us performing the terms of the license or
sub-license agreement with third parties. Our rights are also subject
to the actions of third parties we may not be able to control, such as
our sub-licensor complying with the terms of its license with the
patent owner and the patent owner maintaining the patent.
In some cases where U.S. Government funding was used to
support a project, certain intellectual property is subject to the
Government's "march in" rights which include a royalty-free license
under certain circumstances pursuant to 35 U.S.C. Section 202(c).
WE ARE HIGHLY DEPENDENT UPON A SMALL NUMBER OF EMPLOYEES AND CONSULTANTS WHO
PROVIDE SCIENTIFIC AND MANAGEMENT EXPERTISE.
These individuals have entered into employment or consulting
agreements, confidentiality and/or non-competition agreements with us.
We could suffer competitive disadvantage, loss of intellectual property
rights or other material adverse effects on our business and results of
operations if any employee or consultant violates or terminates these
agreements or terminates their association with us. Our growth and
future success also depends upon the continued involvement and
contribution from these
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individuals, as well as our ability to attract and retain highly
qualified personnel now and in the future.
BECAUSE WE DO NOT HAVE, AND MAY NOT DEVELOP, MANUFACTURING OR CLINICAL TESTING
FACILITIES OR MARKETING RESOURCES FOR OUR PROPOSED PRODUCTS, WE WILL HAVE TO
RELY ON THIRD PARTIES AND COLLABORATIVE RELATIONSHIPS.
We must continue to enter into collaborative relationships
with third parties for additional research and development, preclinical
and clinical testing, manufacturing, marketing and distribution of our
proposed products. We will also be dependent on third parties for the
supply of activation hardware (e.g., lasers and X-ray devices) and for
supplies of photodynamic drugs, nanoparticulates and other therapeutic
and diagnostic agents. We have several research and supply agreements
with third parties. However, we may not be able to negotiate other
acceptable collaborative and supply arrangements in the future.
Collaborative relationships may limit or restrict our operations or may
not result in an adequate supply of necessary resources. Our
collaborative partners could also pursue alternative technologies as a
means of developing or marketing products for the diseases targeted by
our collaborative programs. If a third party we are collaborating with
fails to perform under its agreement or fails to meet regulatory
standards, this could delay or prematurely terminate clinical testing
of our proposed products.
OUR POTENTIAL MARKETS ARE EXTREMELY COMPETITIVE.
We face substantial competition from competitors with greater
financial, technical and human resources and with greater experience in
developing products, conducting preclinical or clinical testing,
obtaining regulatory approvals, manufacturing and marketing. Our
competitors include firms in the field of photodynamic therapy as well
as other fields generally relating to the diagnosis and treatment of
disease using different technologies or scientific and medical
approaches. Examples of those technologies are novel chemotherapy or
other drugs, and hyperthermic and ultrasound procedures. Some of these
firms have drugs or devices that have completed or are in advanced
stages of clinical trials and regulatory approvals.
Others may develop technologies and obtain patent protection
that could render our technologies or products obsolete or less
competitive or our patents invalid or unenforceable. Due to the
inherent risk of failure associated with the testing, development and
production of new and innovative technologies, our technologies and
products may be found to be ineffective, have unanticipated limitations
or otherwise be unsuccessful in the marketplace. Also, although we
believe our estimates of the possible size of markets for our potential
products are based on
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information we consider reliable (including data from the American
Cancer Society and similar sources in the public domain), that
data or our analysis of the data could prove incorrect.
WE CANNOT PREDICT THE EFFECT OF CHANGES IN HEALTH CARE REIMBURSEMENT AND
LEGISLATIVE REFORM ON OUR BUSINESS.
Our success will depend, in part, on the extent to which
health insurers, managed care entities and similar organizations
provide coverage or reimbursement for the medical procedures and
devices we plan to develop. These third-party payors are increasingly
challenging the price of medical procedures and services and
establishing guidelines that may limit physicians' selections of
innovative products and procedures. We also cannot predict the effect
of any current or future legislation or regulations relating to
third-party coverage or reimbursement on our business. We may not be
able to achieve market acceptance of our proposed products or maintain
price levels sufficient to achieve or maintain any profits on our
proposed products if adequate reimbursement coverage is not available.
A SMALL GROUP OF STOCKHOLDERS CONTROLS PHOTOGEN.
A small group of our officers, directors and others control
approximately 85% of our outstanding Common Stock. Several of our
principal stockholders are also parties to a Voting Agreement
concerning the election of certain designees to the Board of Directors
of Photogen Technologies, Inc. and Photogen, Inc. This group of
stockholders can significantly influence Photogen and the direction of
our business and affairs. This concentration of ownership may delay or
prevent a change in control of Photogen, and may also result in a small
supply of shares available for purchase in the public securities
markets. These factors may affect the market and the market price for
our Common Stock in ways that do not reflect the intrinsic value of the
stock.
OUR STOCK PRICE IS VOLATILE.
The price and trading volume of our Common Stock has
fluctuated and is likely to continue to fluctuate significantly for
reasons that may not have any relationship to our operating performance
or other factors that traditionally determine a company's value. The
following factors may have an impact on the price of our stock:
- Announcements by us or others regarding scientific discoveries,
technological innovations, commercial products, patents or
proprietary rights;
- The progress of preclinical or clinical trials;
- Changes in government regulation;
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- Public concern about the safety of devices or drugs;
- Limited coverage by securities analysts;
- Changes in our financial performance from period to period;
securities analysts' reports; and general market conditions.
OUR COMMON STOCK COULD BE DELISTED FROM THE NASDAQ SMALLCAP MARKET WHICH WOULD
MAKE TRADING IN OUR STOCK MORE DIFFICULT.
Since November 1999, our Common Stock has been quoted in the
Nasdaq SmallCap Market. Our shares could be subsequently delisted if we
failed to maintain the listing requirements of the Nasdaq SmallCap
Market, which would force us to list our shares on the OTC Bulletin
Board or some other quotation medium, such as "pink sheets," depending
upon our ability to meet the specific listing requirements of those
quotation systems. As a result, an investor might find it more
difficult to dispose of, or to obtain accurate price quotations for,
our shares. Delisting might also reduce the visibility, liquidity, and
price of our Common Stock. If our Common Stock were delisted from the
Nasdaq SmallCap Market and were not traded on another national
securities exchange, we could become subject to "penny stock"
regulations that impose additional sales practice disclosure and market
making requirements on broker-dealers who sell or make a market in our
stock. If that were to occur, the rules of the SEC would generally
define "penny stock" to be common stock that has a market price of less
than $5.00 per share. If our stock became subject to penny stock
regulations, it would adversely affect the ability and willingness of
broker-dealers who sell or make a market in our Common Stock and of
investors to sell our stock in the secondary market.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
The following is a list of exhibits filed as part of this Form 10-Q.
Exhibits that were previously filed are incorporated by reference. For exhibits
incorporated by reference, the location of the exhibit in the previous filing is
indicated in parenthesis.
EXHIBIT NO. DESCRIPTION
3.1 Restated Articles of Incorporation of Photogen Technologies, Inc.
(Filed as exhibit 3.1 to the Company's Current Report on Form 8-K
dated May 17, 2000 and incorporated herein by reference.)
3.2 Amended and Restated Certificate of Designations, Preferences and
Rights of Series A Preferred Stock. (Filed as exhibit 3.5 to the
Company's Quarterly Report on Form 10-QSB for the quarter ended
September 30, 1999 and incorporated herein by reference.)
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3.3 Certificate of Designation, Preferences and Rights of Series B
Convertible Preferred Stock. (Filed as exhibit 3 to the Company's
Current Report on Form 8-K dated February 18, 2000 and
incorporated herein by reference.)
3.4 Bylaws of Photogen Technologies, Inc. (Filed as exhibit 3.2 to the
Company's Current Report on Form 8-K dated May 17, 2000 and
incorporated herein by reference.)
3.5 Charter of Photogen, Inc. (Filed as exhibit 3.3 to the Company's
Registration Statement on Form 10-SB dated December 24, 1997 and
incorporated herein by reference.)
3.6 Amended and Restated Bylaws of Photogen, Inc. (Filed as exhibit
3.3 to the Company's Current Report on Form 8-K dated May 17, 2000
and incorporated herein by reference.)
27 Financial Data Schedule.
(b) Reports on Form 8-K.
We filed a Current Report on Form 8-K dated May 17, 2000 reporting the
results of our annual meeting of stockholders.
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
Photogen Technologies, Inc.
/s/ Taffy J. Williams
---------------------------------
Date: August 14, 2000 Taffy J. Williams, Ph.D., President and
Chief Executive Officer
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EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
+3.1 Restated Articles of Incorporation of Photogen Technologies, Inc.
(Filed as exhibit 3.1 to the Company's Current Report on Form 8-K
dated May 17, 2000.)
+3.2 Amended and Restated Certificate of Designations, Preferences and
Rights of Series A Preferred Stock. (Filed as exhibit 3.5 to the
Company's Quarterly Report on Form 10-QSB for the quarter ended
September 30, 1999.)
+3.3 Certificate of Designation, Preferences and Rights of Series B
Convertible Preferred Stock. (Filed as exhibit 3 to the Company's
Current Report on Form 8-K dated February 18, 2000.)
+3.4 Bylaws of Photogen Technologies, Inc. (Filed as exhibit 3.2 to the
Company's Current Report on Form 8-K dated May 17, 2000.)
+3.5 Charter of Photogen, Inc. (Filed as exhibit 3.3 to the Company's
Registration Statement on Form 10-SB dated December 24, 1997.)
+3.6 Amended and Restated Bylaws of Photogen, Inc. (Filed as exhibit
3.3 to the Company's Current Report on Form 8-K dated May 17,
2000.
*27 Financial Data Schedule.
+ Incorporated by reference from the filing indicated.
* Filed herewith.
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