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
|
|
Check
whether the issuer has (1) filed all reports required to be filed
by
Section 13 or 15(d) of the Exchange Act during the past 12 months
(or for
such shorter period the Company was required to file such reports),
and
(2) has been subject to such filing requirements for the past 90
days.
Yes x
No
o
Indicate
by check mark whether the Registrant is a shell company (as defined
in
Rule 12b-2 of the Exchange Act): Yes o
No
x
|
|
Number
of shares outstanding of each of the issuer's classes of common
equity:
|
|
Class
|
Outstanding
as of February 7, 2007
|
Common
stock, $0.001 par value
|
16,815,360
|
Transitional
Small Business Disclosure Format : Yes o
No
x
|
|
|
|
Page
|
|
PART
I FINANCIAL INFORMATION
|
|
|
1
|
|
|
|
|
|
|
Item
1. Consolidated Unaudited Financial Statements
|
|
|
1
|
|
|
|
|
|
|
Consolidated
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
|
|
|
9
|
|
|
|
|
|
|
Item
3. Controls and Procedures
|
|
|
16
|
|
|
|
|
|
|
PART
II OTHER INFORMATION
|
|
|
17
|
|
|
|
|
|
|
Item
6. Exhibits and Reports on Form 8-K
|
|
|
17
|
|
|
|
|
|
|
SIGNATURES
|
|
|
18
|
|
Consolidated
Balance Sheets
|
|||||||
December
31,
|
|||||||
2006
|
June
30,
|
||||||
(Unaudited)
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,700,108
|
$
|
2,207,452
|
|||
Accounts
receivable, net of allowance for doubtful accounts
|
|||||||
of
$49,306 and $85,183, respectively
|
982,001
|
596,447
|
|||||
Inventory
|
229,899
|
161,381
|
|||||
Prepaid
expenses
|
212,606
|
161,546
|
|||||
Total
current assets
|
5,124,614
|
3,126,826
|
|||||
Fixed
assets, net of accumulated depreciation
|
1,945,239
|
1,642,293
|
|||||
Deferred
financing costs, net of accumulated amortization
|
230,645
|
274,358
|
|||||
Licenses,
net of accumulated amortization
|
263,363
|
273,475
|
|||||
Other
assets, net of accumulated amortization
|
350,889
|
338,987
|
|||||
Total
assets
|
$
|
7,914,750
|
$
|
5,655,939
|
|||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
842,584
|
$
|
584,296
|
|||
Accrued
payroll and related taxes
|
718,983
|
614,645
|
|||||
Accrued
interest payable
|
11,206
|
11,986
|
|||||
Notes
payable, due within one year
|
47,189
|
51,351
|
|||||
Capital
lease obligations, due within one year
|
197,227
|
183,554
|
|||||
Convertible
debentures payable, due within one year
|
455,000
|
455,000
|
|||||
Total
current liabilities
|
2,272,189
|
1,900,832
|
|||||
Notes
payable, due after one year
|
551,974
|
581,557
|
|||||
Capital
lease obligations, due after one year
|
118,258
|
220,415
|
|||||
Asset
retirement obligation
|
70,516
|
67,425
|
|||||
Total
liabilities
|
3,012,937
|
2,770,229
|
|||||
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; 77,080 and 144,759 shares issued
and
|
|||||||
outstanding
|
77
|
145
|
|||||
Common
stock, $.001 par value; 100,000,000 shares authorized;
|
|||||||
16,296,045
and 15,157,901 shares issued and outstanding
|
16,296
|
15,158
|
|||||
Subscriptions
receivable
|
-
|
(6,122,007
|
)
|
||||
Additional
paid-in capital
|
23,277,585
|
22,538,675
|
|||||
Accumulated
deficit
|
(18,392,145
|
)
|
(13,546,261
|
)
|
|||
Total
shareholders' equity
|
4,901,813
|
2,885,710
|
|||||
Total
liabilities and shareholders' equity
|
$
|
7,914,750
|
$
|
5,655,939
|
|||
The
accompanying notes are an integral part of these financial
statements.
|
IsoRay,
Inc. and Subsidiary
|
|||||||||||||
Consolidated
Statements of Operations
|
|||||||||||||
(Unaudited)
|
|||||||||||||
Three
months ended December 31,
|
Six
months ended December 31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Product
sales
|
$
|
1,414,155
|
$
|
486,247
|
$
|
2,439,599
|
$
|
697,162
|
|||||
Cost
of product sales
|
1,387,394
|
916,274
|
2,675,539
|
1,636,440
|
|||||||||
Gross
margin / (loss)
|
26,761
|
(430,027
|
)
|
(235,940
|
)
|
(939,278
|
)
|
||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
216,254
|
96,837
|
461,852
|
122,619
|
|||||||||
Sales
and marketing expenses
|
890,018
|
340,532
|
1,562,948
|
655,571
|
|||||||||
General
and administrative expenses
|
821,529
|
675,444
|
2,554,661
|
1,636,393
|
|||||||||
Total
operating expenses
|
1,927,801
|
1,112,813
|
4,579,461
|
2,414,583
|
|||||||||
Operating
loss
|
(1,901,040
|
)
|
(1,542,840
|
)
|
(4,815,401
|
)
|
(3,353,861
|
)
|
|||||
Non-operating
income (expense):
|
|||||||||||||
Interest
income
|
50,004
|
3,193
|
90,187
|
10,152
|
|||||||||
Financing
expense
|
(67,413
|
)
|
(195,480
|
)
|
(120,670
|
)
|
(351,108
|
)
|
|||||
Debt
conversion expense
|
-
|
(244,097
|
)
|
-
|
(244,097
|
)
|
|||||||
Non-operating
income (expense), net
|
(17,409
|
)
|
(436,384
|
)
|
(30,483
|
)
|
(585,053
|
)
|
|||||
Net
loss
|
$
|
(1,918,449
|
)
|
$
|
(1,979,224
|
)
|
$
|
(4,845,884
|
)
|
$
|
(3,938,914
|
)
|
|
Basic
and Diluted loss per share
|
$
|
(0.12
|
)
|
$
|
(0.17
|
)
|
$
|
(0.31
|
)
|
$
|
(0.36
|
)
|
|
Shares
used in computing net loss per share:
|
|||||||||||||
Basic
and Diluted
|
15,919,236
|
11,852,047
|
15,609,992
|
10,844,913
|
|||||||||
The
accompanying notes are an integral part of these financial
statements.
|
IsoRay,
Inc. and Subsidiary
|
|||||||
Consolidated
Statements of Cash Flows
|
|||||||
(Unaudited)
|
|||||||
Six
months ended December 31,
|
|||||||
2006
|
2005
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,845,884
|
)
|
$
|
(3,938,914
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating activities:
|
|||||||
Depreciation
and amortization of fixed assets
|
184,510
|
95,432
|
|||||
Amortization
of deferred financing costs and other assets
|
69,580
|
103,546
|
|||||
Accretion
of asset retirement obligation
|
3,091
|
-
|
|||||
Noncash
share-based compensation
|
897,887
|
-
|
|||||
Merger
consulting fees paid by 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
|
-
|
244,097
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable, net
|
(385,554
|
)
|
(417,647
|
)
|
|||
Inventory
|
(68,518
|
)
|
(74,093
|
)
|
|||
Prepaid
expenses
|
(51,060
|
)
|
62,350
|
||||
Accounts
payable and accrued expenses
|
258,288
|
(291,895
|
)
|
||||
Accrued
payroll and related taxes
|
154,338
|
65,032
|
|||||
Accrued
interest payable
|
(780
|
)
|
42,065
|
||||
Net
cash used by operating activities
|
(3,784,102
|
)
|
(3,735,266
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of fixed assets
|
(487,456
|
)
|
(347,357
|
)
|
|||
Additions
to licenses and other assets
|
(27,657
|
)
|
(64,096
|
)
|
|||
Net
cash used by investing activities
|
(515,113
|
)
|
(411,453
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Net
advances on bank 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
|
(33,745
|
)
|
(279,926
|
)
|
|||
Principal
payments on capital lease obligations
|
(88,484
|
)
|
(66,329
|
)
|
|||
Proceeds
from cash sales of common stock, net of offering costs
|
4,702,931
|
2,324,168
|
|||||
Proceeds
from cash sales of preferred stock, pursuant to exercise of warrants
|
8,709
|
-
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of warrants
|
611,997
|
59,565
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of options
|
590,463
|
72,928
|
|||||
Payments
to common shareholders in lieu of issuing fractional shares
|
-
|
(734
|
)
|
||||
Net
cash provided by financing activities
|
5,791,871
|
3,109,672
|
|||||
Net
increase in cash and cash equivalents
|
1,492,656
|
(1,037,047
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
2,207,452
|
1,685,731
|
|||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
3,700,108
|
$
|
648,684
|
|||
Non-cash
investing and financing activities:
|
|||||||
Cashless
exercise of common stock options
|
$
|
50,000
|
$
|
-
|
|||
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
|
|||||
The
accompanying notes are an integral part of these financial
statements.
|
1.
|
Basis
of Presentation
|
Three
months
|
Six
months
|
||||||||||||
ended
December 31,
|
ended
December 31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Cost
of product sales
|
$
|
20,492
|
$
|
-
|
$
|
71,325
|
$
|
-
|
|||||
Research
and development
|
7,879
|
-
|
19,714
|
-
|
|||||||||
Sales
and marketing
|
52,456
|
-
|
99,237
|
-
|
|||||||||
General
and administrative
|
35,617
|
-
|
707,611
|
-
|
|||||||||
Total
share-based compensation
|
$
|
116,444
|
$
|
-
|
$
|
897,887
|
$
|
-
|
Shares
|
Price
(a)
|
Life
(b)
|
Value
(c)
|
||||||||||
Outstanding
at June 30, 2006
|
3,129,692
|
$
|
2.05
|
||||||||||
Granted
(d)
|
727,900
|
3.14
|
|||||||||||
Cancelled
|
(129,454
|
)
|
1.19
|
||||||||||
Exercised
|
(543,499
|
)
|
1.18
|
||||||||||
Outstanding
at December 31, 2006
|
3,184,639
|
$
|
2.49
|
8.84
|
$
|
8,029,758
|
|||||||
Expected
to vest at December 31, 2006
|
3,149,762
|
$
|
2.47
|
8.84
|
$
|
7,997,372
|
|||||||
Vested
and exercisable at December 31, 2006
|
2,543,997
|
$
|
2.16
|
8.71
|
$
|
7,223,876
|
(a) |
Weighted
average price per share.
|
(b) |
Weighted
average remaining contractual life.
|
(c) |
Aggregate
intrinsic value.
|
(d) |
All
options granted had exercise prices equal to the ending market price
of
the Company’s common stock on the grant
date.
|
Three
months
|
Six
months
|
||||||||||||
ended
December 31,
|
ended
December 31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Weighted
average fair value of options granted
|
$
|
2.14
|
$
|
1.55
|
$
|
2.11
|
$
|
0.91
|
|||||
Key
assumptions used in determining fair value:
|
|||||||||||||
Weighted
average risk-free interest rate
|
4.74
|
%
|
4.34
|
%
|
4.88
|
%
|
4.53
|
%
|
|||||
Expected
life of the option (in years)
|
6.00
|
5.00
|
5.58
|
7.59
|
|||||||||
Expected
stock price volatility
|
75.00
|
%
|
30.69
|
%
|
75.00
|
%
|
30.18
|
%
|
|||||
Expected
dividend yield
|
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
Three
months
|
Six
months
|
||||||
ended
|
ended
|
||||||
December
31,
|
December
31,
|
||||||
2005
|
2005
|
||||||
Net
loss, as reported
|
$
|
1,979,224
|
$
|
3,938,914
|
|||
Stock-based
compensation expense determined under fair value methods for all
stock
options
|
3,254
|
159,254
|
|||||
Proforma
net loss
|
$
|
1,982,478
|
$
|
4,098,168
|
|||
Net
loss per share:
|
|||||||
Basic,
as reported
|
$
|
0.17
|
$
|
0.36
|
|||
Basic,
pro forma
|
$
|
0.17
|
$
|
0.38
|
December
31,
|
|||||||
2006
|
2005
|
||||||
Preferred
stock
|
77,080
|
292,328
|
|||||
Preferred
stock warrants
|
28,614
|
221,812
|
|||||
Common
stock warrants
|
4,707,131
|
1,653,346
|
|||||
Common
stock options
|
3,184,639
|
2,817,768
|
|||||
Convertible
debentures
|
109,639
|
127,711
|
|||||
Total
potential dilutive securities
|
8,107,103
|
5,112,965
|
Three
months
|
Six
months
|
||||||||||||
ended
December 31,
|
ended
December 31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Cost
of product sales
|
$
|
20,492
|
$
|
-
|
$
|
71,325
|
$
|
-
|
|||||
Research
and development
|
7,879
|
-
|
19,714
|
-
|
|||||||||
Sales
and marketing
|
52,456
|
-
|
99,237
|
-
|
|||||||||
General
and administrative
|
35,617
|
-
|
707,611
|
-
|
|||||||||
Total
share-based compensation
|
$
|
116,444
|
$
|
-
|
$
|
897,887
|
$
|
-
|
· |
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
disease.
|
· |
The
lease on our production facility ends in October 2007 and although
management is negotiating a lease for a new production facility,
there can
be no assurance that any new facility will be licensed and the necessary
leasehold improvements completed by the time our current lease
expires.
|
· |
We
have limited data on the clinical performance of the 131Cs
seed.
|
· |
We
will need to raise additional capital to fund our operations until
we
reach profitability.
|
· |
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
are subject to the risk that certain third parties may mishandle
our
product.
|
· |
Our
quarterly operating results will be subject to significant
fluctuations.
|
· |
We
rely heavily on a limited number of suppliers, particularly on our
Russian
suppliers of 131Cs
which amount to well over 50% of the raw materials needed for our
production.
|
· |
Future
production increases will depend on our ability to acquire larger
quantities of 131Cs
and hire more employees.
|
· |
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 could 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 the expertise of our executive officers and key
scientific personnel.
|
· |
Our
ability to expand into foreign markets is
uncertain.
|
· |
Our
ability to expand operations and manage growth 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.
|
§ |
Reviewed
the duties of all accounting personnel and reassigned any conflicting
duties to other personnel;
|
§ |
Established
daily management reviews of cash and account receivables activities
and
positions;
|
§ |
Distributed
monthly operating results for review by management in an appropriate
time
frame; and
|
§ |
Established
monthly reconciliation procedures including review by the appropriate
supervisor.
|
§ |
Established
monthly reconciliation procedures including review by the appropriate
supervisor;
|
§ |
Established
and implemented various accounting policies and procedures;
and
|
§ |
Distributed
monthly operating results for review by management in an appropriate
time
frame.
|
(a) |
Exhibits:
|
(b) |
Reports
on Form 8-K:
|
Dated:
February 14, 2007
|
|
|
|
|
|
|
ISORAY,
INC., a Minnesota corporation
|
|
|
|
|
|
By
|
/s/ Roger
E. Girard
|
|
Roger
E. Girard, Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By
|
/s/ Jonathan
R. Hunt
|
|
Jonathan
R. Hunt, Chief Financial Officer
|