Minnesota
(State
or other jurisdiction of incorporation or organization)
|
41-1458152
(I.R.S.
Employer Identification No.)
|
350
Hills St., Suite 106
Richland,
Washington
(Address
of principal executive offices)
|
99354
(Zip
Code)
|
Issuer's
telephone number, including area code: (509)
375-1202
|
Number
of shares outstanding of each of the issuer's classes of common
equity:
|
|
Class
|
Outstanding
as of February 10, 2006
|
Common
stock, $0.001 par value
|
14,495,603
|
The
issuer is not using the Transitional Small Business Disclosure format.
|
Page
|
||
PART
I
|
FINANCIAL
INFORMATION
|
1
|
|
||
Item
1.
|
Consolidated
Unaudited Financial Statements
|
1
|
|
||
Consolidated
Unaudited Balance Sheets
|
1
|
|
|
||
Consolidated
Unaudited Statements of Operations
|
2
|
|
|
||
Consolidated
Unaudited Statements of Cash Flows
|
3
|
|
|
||
Notes
to Consolidated Unaudited Financial Statements
|
4
|
|
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of Operations
|
8
|
|
||
Item
3.
|
Controls
and Procedures
|
14
|
|
||
PART
II
|
OTHER
INFORMATION
|
15
|
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
15
|
|
||
Item
6.
|
Exhibits
and Reports on Form 8-K
|
16
|
|
||
SIGNATURES
|
17
|
(Unaudited)
|
|
|
|
||||
|
|
December
31,
|
|
June
30,
|
|
||
|
|
2005
|
|
2005
|
|||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
648,684
|
$
|
32,587
|
|||
Accounts
receivable, net
|
467,616
|
—
|
|||||
Inventory
|
156,019
|
—
|
|||||
Prepaid
expenses
|
208,942
|
—
|
|||||
Total
current assets
|
1,481,261
|
32,587
|
|||||
Fixed
assets, net of accumulated depreciation and amortization
|
1,627,443
|
—
|
|||||
Other
assets, net of accumulated amortization
|
754,305
|
—
|
|||||
Total
assets
|
$
|
3,863,009
|
$
|
32,587
|
|||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
425,048
|
$
|
21,355
|
|||
Accrued
payroll and related taxes
|
222,958
|
—
|
|||||
Accrued
interest payable
|
83,390
|
—
|
|||||
Notes
payable, due within one year
|
244,219
|
—
|
|||||
Capital
lease obligations, due within one year
|
174,930
|
—
|
|||||
Total
current liabilities
|
1,150,545
|
21,355
|
|||||
Notes
payable, due after one year
|
531,194
|
—
|
|||||
Capital
lease obligations, due after one year
|
295,874
|
—
|
|||||
Convertible
debentures payable, due after one year
|
530,000
|
—
|
|||||
Total
liabilities
|
2,507,613
|
21,355
|
|||||
Shareholders'
equity:
|
|||||||
Preferred
stock, $.001 par value; 6,000,000 shares authorized:
|
|||||||
Series
A: 1,000,000 shares allocated; no shares issued and outstanding
|
—
|
—
|
|||||
Series
B: 5,000,000 shares allocated; 292,328 and no shares issued
and
outstanding
|
292
|
—
|
|||||
Common
stock, $.001 par value; 194,000,000 shares authorized; 13,383,139
and
2,498,319 shares issued and outstanding
|
13,383
|
2,498
|
|||||
Subscriptions
receivable (Note 8)
|
(6,227,067
|
)
|
—
|
||||
Additional
paid-in capital
|
16,835,833
|
7,307,600
|
|||||
Accumulated
deficit
|
(9,267,045
|
)
|
(7,298,866
|
)
|
|||
Total
shareholders' equity
|
1,355,396
|
11,232
|
|||||
Total
liabilities and shareholders' equity
|
$
|
3,863,009
|
$
|
32,587
|
For
the three months ended
December
31,
2005
|
December
31,
2004
|
For
the six months ended
December
31,
2005
|
December
31,
2004
|
||||||||||
Product
sales
|
$
|
486,247
|
$
|
—
|
$
|
697,162
|
$
|
—
|
|||||
Cost
of product sales
|
916,274
|
—
|
1,636,440
|
—
|
|||||||||
Gross
profit (loss)
|
(430,027
|
)
|
—
|
(939,278
|
)
|
—
|
|||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
96,837
|
—
|
122,619
|
—
|
|||||||||
Sales
and marketing expenses
|
340,532
|
—
|
655,571
|
—
|
|||||||||
General
and administrative expenses
|
675,444
|
3,574
|
1,636,393
|
7,743
|
|||||||||
Total
operating expenses
|
1,112,813
|
3,574
|
2,414,583
|
7,743
|
|||||||||
Operating
loss
|
(1,542,840
|
)
|
(3,574
|
)
|
(3,353,861
|
)
|
(7,743
|
)
|
|||||
Non-operating
income (expense):
|
|||||||||||||
Interest
income
|
3,193
|
—
|
10,152
|
—
|
|||||||||
Financing
expense
|
(195,480
|
)
|
—
|
(351,108
|
)
|
—
|
|||||||
Debt
conversion expense (Note 7)
|
(244,097
|
)
|
—
|
(244,097
|
)
|
—
|
|||||||
Non-operating
income (expense), net
|
(436,384
|
)
|
—
|
(585,053
|
)
|
—
|
|||||||
Net
loss
|
$
|
(1,979,224
|
)
|
$
|
(3,574
|
)
|
$
|
(3,938,914
|
)
|
$
|
(7,743
|
)
|
|
Net
loss per weighted-average share of common stock
|
$
|
(0.17
|
)
|
Nil
|
$
|
(0.36
|
)
|
Nil
|
|||||
Basic
weighted average shares outstanding
|
11,852,047
|
2,415,214
|
10,844,913
|
2,415,214
|
|||||||||
For
the six months ended
|
|||||||
December
31,
|
December
31,
|
||||||
2005
|
2004
|
||||||
Net
loss
|
$
|
(3,938,914
|
)
|
$
|
(7,743
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating activities:
|
|||||||
Depreciation
and amortization of fixed assets
|
95,432
|
—
|
|||||
Amortization
of deferred financing costs and other assets
|
103,546
|
—
|
|||||
Compensation
recorded in connection with issuance of common stock
|
330,000
|
—
|
|||||
Rent
expense paid by issuance of common stock
|
30,009
|
—
|
|||||
Repair
and maintenance expense paid by issuance of common stock
|
14,752
|
—
|
|||||
Debt
conversion expense (Note 7)
|
244,097
|
—
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable, net
|
(417,647
|
)
|
—
|
||||
Inventory
|
(74,093
|
)
|
—
|
||||
Prepaid
expenses
|
62,350
|
—
|
|||||
Accounts
payable
|
(291,895
|
)
|
(75
|
)
|
|||
Accrued
payroll and related taxes
|
65,032
|
—
|
|||||
Accrued
interest payable
|
42,065
|
—
|
|||||
Other
accrued expenses
|
—
|
395
|
|||||
|
|||||||
Net
cash used by operating activities
|
(3,735,266
|
)
|
(7,423
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of fixed assets
|
(347,357
|
)
|
—
|
||||
Additions
to other assets
|
(64,096
|
)
|
—
|
||||
Net
cash used by investing activities
|
(411,453
|
)
|
—
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Funds
advanced by officer/shareholder
|
—
|
7,423
|
|||||
Net
advances on line of credit
|
200,000
|
—
|
|||||
Proceeds
from issuance of notes payable
|
250,000
|
—
|
|||||
Proceeds
from sales of convertible debentures payable
|
550,000
|
—
|
|||||
Principal
payments on notes payable
|
(279,926
|
)
|
—
|
||||
Principal
payments on capital lease obligations
|
(66,329
|
)
|
—
|
||||
Proceeds
from cash sales of common stock, net of issuance costs
|
2,324,168
|
—
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of warrants
|
59,565
|
—
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of options
|
72,928
|
—
|
|||||
Payments
to common shareholders in lieu of issuing fractional shares
|
(734
|
)
|
—
|
||||
Net
cash provided by financing activities
|
3,109,672
|
7,423
|
|||||
Net
decrease in cash and cash equivalents
|
(1,037,047
|
)
|
—
|
||||
Cash
and cash equivalents, beginning of period
|
1,685,731
|
—
|
|||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
648,684
|
$
|
—
|
|||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
205,497
|
$
|
—
|
|||
Non-cash
investing and financing activities:
|
|||||||
Exchange
of convertible debentures payable for shares of common stock
|
$
|
3,607,875
|
|||||
|
|||||||
Fixed
assets acquired by capital lease obligations
|
$
|
507,947
|
|||||
Prepaid
rent paid by issuance of common stock
|
$
|
90,026
|
|||||
|
For
the three months ended
|
For
the six months ended
|
|||||||||||
|
December
31,
|
December
31,
|
December
31,
|
December
31,
|
|||||||||
|
2005
|
2004
|
2005
|
2004
|
|||||||||
|
|
|
|
|
|||||||||
Net
loss, as reported
|
$
|
(1,979,224
|
)
|
$
|
(3,574
|
)
|
$
|
(3,938,914
|
)
|
$
|
(7,743
|
)
|
|
|
|||||||||||||
|
|||||||||||||
Less:
Stock-based compensation expense determined under fair value method
for
all stock options, net of related tax benefit
|
$
|
(3,254
|
)
|
$
|
—
|
(159,254
|
)
|
$
|
-
|
||||
Profoma
net loss
|
$
|
(1,982,478
|
)
|
$
|
(3,574
|
)
|
$
|
(4,098,168
|
)
|
$
|
(7,743
|
)
|
|
|
|||||||||||||
Basic
net loss per common share:
|
|||||||||||||
As
reported
|
$
|
(0.17
|
)
|
$
|
(0.00
|
)
|
$
|
(0.36
|
)
|
$
|
(0.00
|
)
|
|
Proforma
|
$
|
(0.17
|
)
|
$
|
(0.00
|
)
|
$
|
(0.38
|
)
|
$
|
(0.00
|
)
|
|
|
|||||||||||||
Diluted
net loss per common share:
|
|||||||||||||
As
reported
|
$
|
(0.17
|
)
|
$
|
(0.00
|
)
|
$
|
(0.36
|
)
|
$
|
(0.00
|
)
|
|
Proforma
|
$
|
(0.17
|
)
|
$
|
(0.00
|
)
|
$
|
(0.38
|
)
|
$
|
(0.00
|
)
|
· |
Our
independent accountants have expressed uncertainty about our ability
to
continue as a going concern.
|
· |
Our
revenues depend upon one product, our 131Cs
brachytherapy seed, which is used to treat only one type of cancer
as of
the date of this report, although it is approved to treat any malignant
tissue.
|
· |
We
have limited data on the clinical performance of the 131Cs
seed.
|
· |
We
will need to raise additional capital to fund our operations through
2006.
|
· |
The
passage of Initiative 297, which may in the future impose restrictions
on
sites generating certain types of radioactive wastes in Washington,
may
result in the relocation of our manufacturing
operations.
|
· |
We
have limited manufacturing experience and may not be able to meet
future
demand without increasing our supply of the isotopes used to manufacture
our product and also increasing our level of
staffing.
|
· |
We
have limited specific experience with the sales and marketing of
the
131Cs
seed.
|
· |
Our
quarterly operating results will be subject to significant
fluctuations.
|
· |
We
rely heavily on a limited number of
suppliers.
|
· |
We
are subject to uncertainties regarding reimbursement for use of our
product.
|
· |
It
is possible that other treatments may be deemed superior to brachytherapy
for the treatment of cancer and if this were to occur, demand for
our
product would decline.
|
· |
Our
industry is intensely competitive, and many of our competitors are
larger
than we are and possess greater
resources.
|
· |
We
may be unable to adequately protect or enforce our intellectual property
rights or secure rights to third-party patents, the value of our
granted
patent and our patents pending is uncertain, and one of our licensed
patents may be terminated under certain
conditions.
|
· |
Failure
to comply with government regulations, which are quite complex, could
harm
our business.
|
· |
Our
business exposes us to product liability claims and also involves
environmental risks.
|
· |
We
rely heavily upon our executive officers and key scientific
personnel.
|
· |
Our
ability to expand into foreign markets is
uncertain.
|
· |
Our
ability to successfully commercialize our product is
uncertain.
|
· |
Our
reporting obligations as a public company are
costly.
|
· |
There
is a limited market for our common stock, and our stock price is
likely to
be volatile.
|
· |
Our
common stock may be subject to penny stock regulation.
|
· |
Future
sales by shareholders of the shares available for sale in the public
market, or the perception that such sales may occur, may depress
the price
of our common stock.
|
(a)
|
Exhibits: | ||
|
31.1
|
Rule
13a-14(a)/15d-14(a) Certification of Principal Executive
Officer
|
|
|
31.2
|
Rule
13a-14(a)/15d-14(a) Certification of Principal Financial
Officer
|
|
|
32.1
|
Section
1350 Certifications
|
|
(b)
|
Reports on Form 8-K: |
Dated:
February 17, 2006
|
||
ISORAY, INC., a Minnesota corporation | ||
|
|
|
By: | /s/ Roger E. Girard | |
Roger E. Girard, Chief Executive Officer |
||
By: | /s/ Michael K. Dunlop | |
Michael K. Dunlop, Chief Financial Officer |