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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 MARCH 31, 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 MAY 10, 2000
================================================================================
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INDEX
<TABLE>
<CAPTION>
PAGE
<S> <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..............6
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK.........................................10
PART II. OTHER INFORMATION.................................................10
ITEM 5. OTHER INFORMATION ........................................10
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K..........................14
</TABLE>
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<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>
March 31, 2000 December 31, 1999
(Unaudited) (Audited)
------------- -----------------
ASSETS
CURRENT ASSETS
<S> <C> <C>
Cash and cash equivalents $1,007,820 $ 1,681,773
Restricted cash 50,000 100,000
Interest receivable 110,097 84,327
Prepaid expenses 338,542 590,710
United States Treasury Notes, Total
Face Value $9,420,000 and
$5,470,000, respectively 9,415,151 5,472,564
------------ -----------
TOTAL CURRENT ASSETS $10,921,610 $ 7,929,374
EQUIPMENT AND LEASEHOLD IMPROVEMENTS $ 1,453,412 $ 1,279,441
DEPOSITS 529,370 29,370
INTANGIBLE ASSETS 472,223 482,639
INVESTMENT IN AND ADVANCES TO AFFILIATE 11,849,768 11,998,430
------------ ------------
TOTAL ASSETS $25,226,383 $21,719,254
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable $800,389 $ 833,163
Current portion of obligations under
capital leases 15,486 21,148
---------- -----------
TOTAL CURRENT LIABILITIES $815,875 854,311
-------- -----------
OBLIGATION UNDER CAPITAL LEASES 18,356 $ 18,356
========== ===========
SHAREHOLDERS' EQUITY
Preferred stock; par value
$.01 per share; 5,000,000
shares authorized including: - -
Series A preferred stock; 12,015 shares authorized; 12,015
issued and outstanding at March 31, 2000 120 120
Series B preferred stock; 402,000 shares authorized;
337,056 issued and outstanding at March 31, 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 (1,051,950) (1,585,575)
Additional paid-in capital 36,416,427 30,977,893
Deficit accumulated during
development stage after
recapitalization (11,013,199) (8,583,235)
------------ -----------
TOTAL SHAREHOLDERS' EQUITY 24,392,152 20,846,587
------------ -----------
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY $25,226,383 $21,719,254
=========== ===========
</TABLE>
1
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PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
All amounts in $
<TABLE>
<CAPTION>
Three Months Ended Three Months Ended Cumulative Amounts
March 31, 2000 March 31, 1999 From November 3, 1996
(Unaudited) (Unaudited) (Unaudited)
REVENUES
<S> <C> <C> <C>
Investment Income $ 101,786 $ 72,020 $ 781,313
EXPENSES
General and administrative 2,531,750 900,770 11,794,512
------------ ------------ ------------
NET LOSS $ (2,429,964) $ (828,750) $(11,013,199)
============
DIVIDENDS ON PREFERRED STOCK (303,974) --
------------ ------------
NET LOSS APPLICABLE TO COMMON
SHAREHOLDERS $ (2,733,938) $ (828,750)
============ ============
BASIC AND DILUTED NET
LOSS PER COMMON SHARE $ (.07) $ (.02)
============ ============
WEIGHTED AVERAGE
NUMBER OF COMMON SHARES OUTSTANDING 37,383,386 36,875,020
============ ============
</TABLE>
2
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PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOW
(UNAUDITED)
All amounts in $
<TABLE>
<CAPTION>
Three Months Three Months Cumulative
Ended Ended Amounts From
March 31, 2000 March 31, 1999 November 3, 1996
(Unaudited) (Unaudited) (Unaudited)
OPERATING ACTIVITIES
<S> <C> <C> <C>
Net income (loss) $ (2,429,964) $ (828,750) $(11,013,199)
Depreciation and Amortization 95,717 27,431 543,600
United States Treasury Notes
Amortization 7,413 2,986 62,465
Loss on Securities -- -- (18,503)
Stock Option Compensation 22,914 32,037 449,681
Issuance of warrants in exchange
for services rendered 676,275 -- 1,719,741
Loss from investment in affiliate 459,003 -- 765,032
Changes in operating assets and liabilities:
Prepaid expense 252,168 117,797 (338,542)
Interest receivable (25,770) 57,246 (110,097)
Accounts payable (32,774) (229,010) 800,389
------------ ------------ ------------
NET CASH PROVIDED (USED) BY
OPERATING ACTIVITIES (975,018) (820,263) (7,139,433)
------------ ------------ ------------
INVESTING ACTIVITIES
Sale of marketable securities -- -- 2,164,464
Purchase of marketable securities -- -- (2,182,967)
Purchase of United States Treasury Notes (7,350,000) (555,478) (29,387,003)
Sale of United States Treasury Notes 3,400,000 1,502,048 21,043,548
Purchase of capital assets (259,272) (15,879) (1,640,701)
Patent cost -- (237,335)
Investment in and advances to affiliate (310,341) -- (12,614,800)
Decrease in restricted cash 50,000 -- (50,000)
Increase in deposits (500,000) -- (529,370)
------------ ------------ -------------
NET CASH PROVIDED (USED)
BY INVESTING ACTIVITIES (4,969,613) 930,691 (23,434,164)
------------ ------------ ------------
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 (5,662) (92,586) (257,862)
------------ ------------ ------------
NET CASH PROVIDED (USED) BY
FINANCING ACTIVITIES (5,270,678) (92,586) 31,581,417
------------ ------------ ------------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS (673,953) 17,842 1,007,820
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD 1,681,773 652,226 --
------------ ------------ ------------
CASH AND CASH
EQUIVALENTS AT END OF PERIOD $ 1,007,820 $ 670,068 $ 1,007,820
============ ============ ============
</TABLE>
3
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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-Series B - - 337,056 3,370 - -
Net loss for three months ended - - - - - -
March 31, 2000
- ----------------------------------------------------------------------------------------------------------------------------------
BALANCE, at March 31, 2000 12,015 120 337,056 3,370 37,383,386 37,384
- ----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
4
<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 (1,779) - - - (1,779)
December 31, 1996
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1996 5,489 - - - 5,489
Net loss and capital 3,511 - - (3,511) -
contributions for the
period January 1, 1997 to
May 15, 1997
- ----------------------------------------------------------------------------------------------------------------------
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 - - - (554,702) (554,702)
May 16, 1997 to December 31, 1997
- ----------------------------------------------------------------------------------------------------------------------
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 - - (50,000) - (50,000)
stock issuance
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 - - - (6,052,841) (6,052,841)
December 31, 1999
- ----------------------------------------------------------------------------------------------------------------------
BALANCE, at December 31, 1999 - (1,585,575) 30,977,893 (8,583,235) 20,846,587
Issuance of warrants and options - 533,625 165,564 - 699,189
Issuance of preferred stock-Series B - - 5,272,970 - 5,276,340
Net loss for three months ended - - - (2,429,964) (2,429,964)
March 31, 2000
- ----------------------------------------------------------------------------------------------------------------------
Balance, at March 31, 2000 - (1,051,950) 36,416,427 (11,013,199) 24,392,152
- ----------------------------------------------------------------------------------------------------------------------
</TABLE>
4
<PAGE>
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
March 31, 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
three months ended March 31, 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 March 31, 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.
5
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
INTRODUCTION
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 the Company's actual
results in the future to differ materially from expected results.
We are an emerging development-stage biotechnology company focused on
developing minimally invasive products for the treatment and diagnosis of
disease. Over the last two years, as a result of our research into new
technologies, and acquisitions or licensing from other third parties, we have
developed a platform of core technologies which we believe will support multiple
products and applications. Our technology portfolio now includes the following:
multi-photon excitation, photochemistry and non-invasive diagnostics (which
includes lymphography and multi-photon excitation).
We are principally engaged in the research and development of drugs and
medical device products for use in human therapeutic and diagnostic
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 photoactive agents for the purpose of
destroying diseased cells, removing tissue or identifying and diagnosing
disease. 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 other foreign jurisdictions.
Our platform of proposed products allows us to select among multiple drug
and energy combinations in order to optimize treatment efficacy and safety. We
believe that tailoring the technology to fit the problem and the market should
result in safer, more effective and more widely accepted therapeutic and
diagnostic products. 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 in markets such as oncology,
dermatology and ophthalmology.
To date, we have concentrated our development activity on three product
applications: psoriasis, lymphography and prostate cancer. We selected these
applications because of our belief that each represents promising opportunities,
competitive treatments are less effective, and each application may lead to
follow-on applications. We expect this approach to allow us to leverage our
technology and resources more effectively and offer shorter time frames to bring
these and other potential products into the marketplace. For example, our work
in psoriasis may lead to techniques for treatments for conditions requiring very
shallow light penetration. Similarly, our prostate cancer research could lead to
treatments for breast, lung, head and neck cancer.
6
<PAGE>
Our business model for producing and selling our proposed products accounts
for the start-up nature of our company, the high capital needs of new drug
development and the existing resources available for both manufacturing and
product distribution. Our goal is to leverage our cash, technology and human
resources in a manner that accelerates product development and sales revenues,
and minimizes equity dilution.
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. For the three months ended March 31, 2000, our net losses increased
to $2,429,964 from $828,750 for the three months ended March 31, 1999. The
increase in losses is attributable primarily to the opening of our new
clinical development office in Massachusetts including hiring five new
employees and leasing additional offices, leasing CT equipment (including a
$500,000 deposit for the lease of that equipment), issuing warrants in
exchange for consulting services, 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 three research contracts with various third parties
that will require an expenditure of a total of $496,797 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 three months ended March 31, 2000, we spent
approximately $233,581 to acquire equipment necessary to support animal
preclinical and human clinical trials, and on development of photoactive agents
and targeting systems. During the next twelve months we expect to spend
approximately $870,750 to obtain new equipment.
For the three months ended March 31, 2000, our investment income increased
to $101,786 from $72,020 for the three months ended March 31, 1999. The increase
in investment income resulted primarily from investment of 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.
7
<PAGE>
OPERATIONAL MATTERS
We have a number of ongoing research projects underway:
Psoriasis. The research study protocol to treat psoriasis by activating
our radiosensitizer PH-10 with green light (delivered by a laser) in humans
that we plan to conduct in Denmark was completed and approved by the relevant
local ethics committee. Once we receive approval of the Danish Medicines
Agency we plan to begin the human study.
Radiosensitizer. We have completed the data on ortho-voltage for our
radiosensitizer and mega-voltage studies have begun in conjunction with our
Research Agreement with Tufts University.
Ocular Melanoma. The final portion of the preclinical work for ocular
melanoma treatment in rabbits that is being conducted at Massachusetts Eye
and Ear Infirmary by Dr. Lucy Young has been approved and funded. The study
continues to exhibit an over 80% eradication of tumor's in rabbits with a
single treatment. During the final portion of this preclinical work, we plan
to treat a series of larger tumors in rabbits and expect the study to be
completed in the summer of 2000.
Barretts Esophagus. Through our research agreement relating to Barretts
Esophagus with the University of Tennessee School of Veterinary Medicine, we
have completed preclinical studies of our procedure of selectively targeting and
treating canine esophageal tissue with a topical application of PH-10 and green
light. This procedure appears to have been well tolerated by the animals with
little or no collateral cell damage. Further studies are underway to demonstrate
the efficacy of PH-10 and green light on induced tumors in hampsters.
Two-Photon Imaging. Development of our two-photon imaging procedure
which could allow multi-photon imaging to progress from the laboratory into
clinical use is progressing and we expect to complete these studies in the
third quarter of 2000. If successful we anticipate out-licensing the
technology to third parties for advanced instrument development.
During the first quarter, we retained a consultant to assist us with
regulatory filings and obtaining FDA approval for our products and granted that
person warrants to acquire 15,000 shares of our Common Stock at an exercise
price of $15.625 per share. The warrants will vest in January 2001 (provided the
consulting arrangement has not been terminated before then).
We were recently issued a patent from the U.S. Patent and Trademark Office
covering our apparatus for treatment using two-photon excitation ("TPE") for
activation of photoactive agents below a tissue surface and using TPE at a
confocal region which can be positioned at various ranges of tissue depth. TPE
is an advanced, light-based technology that uses ultrashort, pulsed bursts of
long-wavelength light to destroy cancerous and diseased tissue. It also can be
used for various diagnostic applications. TPE is in various stages of
pre-clinical research for use in indications such as melanoma treatment, hair
removal and biomedical research and clinical diagnostics. This patent is also
directed to an apparatus for treating tissue with light to promote simultaneous
TPE and an apparatus to focus the light at a variety of depths ranging from the
tissue surface to depths substantially below the surface.
LIQUIDITY; CAPITAL RESOURCES
We have used, and expect over the next 12 months to use, the gross
proceeds from our fourth quarter 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
8
<PAGE>
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. We have also received a binding commitment from one of
our principal shareholders and director nominees, 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 first three months of the
2000 fiscal year averaged approximately $713,000 per month. As of March 31,
2000 we had approximately $10,427,819 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
will also continue with animal studies and evaluation of proprietary photoactive
agent candidates, pursuing patent protection and seeking potential research and
development and collaboration candidates.
We will consider faster growth in personnel and facilities if that would
present opportunities to increase our product pipeline, or opportunities for
more rapid FDA approval or to attain licensing revenues. We intend to structure
our research and development and collaborative arrangements to make the fullest
possible use of personnel and facilities provided by the parties with whom we
may contract.
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 12
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.
9
<PAGE>
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
None.
PART II. OTHER INFORMATION
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.
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
March 31, 2000, we have incurred total losses of approximately $11,031,199.
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 may exhaust our available capital
by approximately June 30, 2001 (depending on the pace of our spending for
preclinical and clinical trials). We will need substantial additional
financing for our research, clinical
10
<PAGE>
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 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
also 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, our use of
the methods or technologies contained in our patents and other
intellectual property may conflict or infringe the rights of others.
11
<PAGE>
- 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
individuals, as well as our ability to attract and retain highly qualified
personnel now and in the future
BECAUSE WE DO NOT HAVE, AND DO NOT INTEND TO 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 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.
12
<PAGE>
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.
Our competitors 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 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
13
<PAGE>
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;
- 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
is 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.
14
<PAGE>
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 June 17, 1998 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.)
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 Registration Statement on Form 10-SB dated December 24, 1997
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 3.4 to
the Company's Annual Report on Form 10-KSB for the year ended December
31, 1998 and incorporated herein by reference.)
27 Financial Data Schedule.
15
<PAGE>
(b) Reports on Form 8-K.
The following reports on Form 8-K were filed in the three month period
ended March 31, 2000:
1. Report on Form 8-K dated January 6, 2000, announcing the appointment
of Jay B. Zimmerman, M.Ed. as its Vice President of Clinical Data
Management.
2. Report on Form 8-K dated January 25, 2000 announcing a Product
Distribution Agreement with Coherent Laser Group, Inc.
3. Report on Form 8-K dated February 7, 2000 announcing that the Company
had initiated a formal search for a new Chief Executive Officer.
4. Report on Form 8-K dated February 18, 2000 announcing the completion
of the Company's private placement of Series B Convertible Preferred
Stock providing gross proceeds to the Company of $5.5 million.
16
<PAGE>
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/ Timothy C. Scott
---------------------------------------
Date: May 15, 2000 Timothy C. Scott, President and
Chief Financial Officer
17
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION
<S> <C>
+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 June 17, 1998.)
+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 Registration Statement on Form 10-SB dated December
24, 1997.)
+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 3.4
to the Company's Annual Report on Form 10-KSB for the year ended
December 31, 1998.)
*27 Financial Data Schedule.
</TABLE>
+ Incorporated by reference from the filing indicated.
* Filed herewith.
18
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM FORM 10-Q
FOR THE 3 MONTHS ENDED MARCH 31, 2000 AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-2000
<PERIOD-START> JAN-01-2000
<PERIOD-END> MAR-31-2000
<CASH> 1,007,820
<SECURITIES> 9,415,151
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 10,921,610
<PP&E> 1,932,405
<DEPRECIATION> (478,993)
<TOTAL-ASSETS> 25,226,383
<CURRENT-LIABILITIES> 815,875
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0
3,490
<COMMON> 37,384
<OTHER-SE> 24,351,278
<TOTAL-LIABILITY-AND-EQUITY> 25,226,383
<SALES> 0
<TOTAL-REVENUES> 101,786
<CGS> 0
<TOTAL-COSTS> 2,531,750
<OTHER-EXPENSES> 0
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