Perspective Therapeutics, Inc. - Quarter Report: 2007 December (Form 10-Q)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the
quarterly period ended December 31, 2007
or
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the
transition period from __________ to ____________
Commission
File No. 001-33407
ISORAY,
INC.
(Exact
name of registrant as specified in its charter)
Minnesota
|
41-1458152
|
|
(State
or other jurisdiction of incorporation or
organization)
|
(I.R.S.
Employer
Identification
No.)
|
|
350
Hills St., Suite 106, Richland, Washington
|
99354
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
|
Registrant's
telephone number, including area code: (509)
375-1202
|
||
Indicate
by check mark whether the registrant has (1) filed all reports required
to
be filed by Section 13 or 15(d) of the Exchange Act during the preceding
12 months (or for such shorter period 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
o
Indicate
by check mark whether the registrant is a large accelerated filer,
an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer”, “accelerated
filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer o
Accelerated filer o
Non-accelerated filer o
Smaller
reporting company x
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
as
of the latest practicable date:
|
||
Class
|
Outstanding
as of February 4, 2007
|
|
Common
stock, $0.001 par value
|
23,090,200
|
|
ISORAY,
INC.
Table
of Contents
PART
I
|
FINANCIAL
INFORMATION
|
|||
Item
1
|
Consolidated
Unaudited Financial Statements
|
1
|
||
Consolidated
Balance Sheets
|
1
|
|||
Consolidated
Statements of Operations
|
2
|
|||
Consolidated
Statements of Cash Flows
|
3
|
|||
Notes
to Consolidated Financial Statements
|
4
|
|||
Item
2
|
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
|
11
|
||
Item
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
18
|
||
Item
4
|
Controls
and Procedures
|
19
|
||
PART
II
|
OTHER
INFORMATION
|
|||
Item
1A
|
Risk
Factors
|
19
|
||
Item
6
|
Exhibits
and Reports on Form 8-K
|
19
|
||
Signatures
|
20
|
PART
I - FINANCIAL INFORMATION
IsoRay,
Inc. and Subsidiary
Consolidated
Balance Sheets
December
31,
|
June
30,
|
||||||
2007
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,476,679
|
$
|
9,355,730
|
|||
Short-term
investments
|
8,680,137
|
9,942,840
|
|||||
Accounts
receivable, net of allowance for doubtful accounts
|
|||||||
of
$48,479 and $99,789, respectively
|
829,918
|
1,092,925
|
|||||
Inventory
|
995,233
|
880,834
|
|||||
Prepaid
expenses
|
442,993
|
458,123
|
|||||
Total
current assets
|
14,424,960
|
21,730,452
|
|||||
Fixed
assets, net of accumulated depreciation
|
6,521,545
|
3,665,551
|
|||||
Deferred
financing costs, net of accumulated amortization
|
80,473
|
95,725
|
|||||
Licenses,
net of accumulated amortization
|
467,457
|
262,074
|
|||||
Restricted
cash
|
172,500
|
-
|
|||||
Other
assets, net of accumulated amortization
|
328,421
|
322,360
|
|||||
Total
assets
|
$
|
21,995,356
|
$
|
26,076,162
|
|||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,183,082
|
$
|
1,946,042
|
|||
Accrued
payroll and related taxes
|
508,960
|
459,068
|
|||||
Accrued
interest payable
|
1,695
|
1,938
|
|||||
Deferred
revenue
|
-
|
23,874
|
|||||
Notes
payable, due within one year
|
47,189
|
49,212
|
|||||
Capital
lease obligations, due within one year
|
109,484
|
194,855
|
|||||
Asset
retirement obligation, current portion
|
-
|
131,142
|
|||||
Total
current liabilities
|
1,850,410
|
2,806,131
|
|||||
Notes
payable, due after one year
|
504,444
|
528,246
|
|||||
Capital
lease obligations, due after one year
|
8,774
|
25,560
|
|||||
Asset
retirement obligation
|
483,821
|
-
|
|||||
Total
liabilities
|
2,847,449
|
3,359,937
|
|||||
Commitments
and contingencies (see Note 9)
|
|||||||
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; 59,065 shares issued and outstanding
|
59
|
59
|
|||||
Common
stock, $.001 par value; 194,000,000 shares authorized;
|
|||||||
23,090,200
and 22,789,324 shares issued and outstanding
|
23,090
|
22,789
|
|||||
Additional
paid-in capital
|
47,221,918
|
45,844,793
|
|||||
Accumulated
deficit
|
(28,097,160
|
)
|
(23,151,416
|
)
|
|||
Total
shareholders' equity
|
19,147,907
|
22,716,225
|
|||||
Total
liabilities and shareholders' equity
|
$
|
21,995,356
|
$
|
26,076,162
|
The
accompanying notes are an integral part of these financial
statements.
1
IsoRay,
Inc. and Subsidiary
Consolidated
Statements of Operations
(Unaudited)
Three
months ended
December
31,
|
Six
months ended
December
31,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Product
sales
|
$
|
1,758,344
|
$
|
1,414,155
|
$
|
3,614,063
|
$
|
2,439,599
|
|||||
Cost
of product sales
|
2,241,795
|
1,387,394
|
4,247,297
|
2,675,539
|
|||||||||
Gross
loss
|
(483,451
|
)
|
26,761
|
(633,234
|
)
|
(235,940
|
)
|
||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
395,545
|
216,254
|
651,915
|
461,852
|
|||||||||
Sales
and marketing expenses
|
1,142,827
|
890,018
|
2,202,643
|
1,562,948
|
|||||||||
General
and administrative expenses
|
919,164
|
821,529
|
1,821,189
|
2,554,661
|
|||||||||
Total
operating expenses
|
2,457,536
|
1,927,801
|
4,675,747
|
4,579,461
|
|||||||||
Operating
loss
|
(2,940,987
|
)
|
(1,901,040
|
)
|
(5,308,981
|
)
|
(4,815,401
|
)
|
|||||
Non-operating
income (expense):
|
|||||||||||||
Interest
income
|
179,855
|
50,004
|
418,551
|
90,187
|
|||||||||
Financing
expense
|
(25,211
|
)
|
(67,413
|
)
|
(55,314
|
)
|
(120,670
|
)
|
|||||
Non-operating
income (expense), net
|
154,644
|
(17,409
|
)
|
363,237
|
(30,483
|
)
|
|||||||
Net
loss
|
$
|
(2,786,343
|
)
|
$
|
(1,918,449
|
)
|
$
|
(4,945,744
|
)
|
$
|
(4,845,884
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.12
|
)
|
$
|
(0.12
|
)
|
$
|
(0.21
|
)
|
$
|
(0.31
|
)
|
|
Weighted
average shares used in computing net loss per share:
|
|||||||||||||
Basic
and diluted
|
23,072,272
|
15,919,236
|
23,036,657
|
15,609,992
|
The
accompanying notes are an integral part of these financial
statements.
2
IsoRay,
Inc. and Subsidiary
Consolidated
Statements of Cash Flows
(Unaudited)
Six
months ended December 31,
|
|||||||
2007
|
2006
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,945,744
|
)
|
$
|
(4,845,884
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
|||||||
Depreciation
and amortization of fixed assets
|
586,866
|
184,510
|
|||||
Amortization
of deferred financing costs and other assets
|
90,541
|
69,580
|
|||||
Amortization
of discount on short-term investments
|
(119,149
|
)
|
-
|
||||
Loss
on settlement of ARO liability (Note 7)
|
(135,120
|
)
|
|||||
Accretion
of asset retirement obligation
|
14,703
|
3,091
|
|||||
Noncash
share-based compensation
|
354,613
|
897,887
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable, net
|
263,007
|
(385,554
|
)
|
||||
Inventory
|
(114,399
|
)
|
(68,518
|
)
|
|||
Prepaid
expenses
|
15,130
|
(51,060
|
)
|
||||
Accounts
payable and accrued expenses
|
(762,960
|
)
|
258,288
|
||||
Accrued
payroll and related taxes
|
49,892
|
154,338
|
|||||
Accrued
interest payable
|
(243
|
)
|
(780
|
)
|
|||
Deferred
revenue
|
(23,874
|
)
|
-
|
||||
Net
cash used by operating activities
|
(4,726,737
|
)
|
(3,784,102
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of fixed assets
|
(2,969,764
|
)
|
(487,456
|
)
|
|||
Additions
to licenses and other assets
|
(286,733
|
)
|
(27,657
|
)
|
|||
Change
in restricted cash
|
(172,500
|
)
|
-
|
||||
Purchases
of short-term investments
|
(10,593,828
|
)
|
-
|
||||
Proceeds
from the sale or maturity of short-term investments
|
11,975,680
|
-
|
|||||
Net
cash used by investing activities
|
(2,047,145
|
)
|
(515,113
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Principal
payments on notes payable
|
(25,825
|
)
|
(33,745
|
)
|
|||
Principal
payments on capital lease obligations
|
(102,157
|
)
|
(88,484
|
)
|
|||
Proceeds
from cash sales of common shares pursuant to private placement,
net of
offering costs
|
-
|
4,702,931
|
|||||
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
|
1,010,913
|
611,997
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of
options
|
11,900
|
590,463
|
|||||
Net
cash provided by financing activities
|
894,831
|
5,791,871
|
|||||
Net
(decrease) increase in cash and cash equivalents
|
(5,879,051
|
)
|
1,492,656
|
||||
Cash
and cash equivalents, beginning of period
|
9,355,730
|
2,207,452
|
|||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
3,476,679
|
$
|
3,700,108
|
|||
Non-cash
investing and financing activities:
|
|||||||
Increase
in fixed assets related to asset retirement obligation
|
$
|
473,096
|
$
|
-
|
|||
Cashless
exercise of common stock options
|
-
|
50,000
|
The
accompanying notes are an integral part of these financial
statements.
3
IsoRay,
Inc.
Notes
to the Unaudited Consolidated Financial Statements
For
the three and six-month periods ended December 31, 2007 and
2006
1.
|
Basis
of Presentation
|
The
accompanying consolidated financial statements are those of IsoRay, Inc., and
its wholly-owned subsidiaries (IsoRay or the Company). All significant
intercompany accounts and transactions have been eliminated in
consolidation.
The
accompanying interim consolidated financial statements have been prepared in
conformity with U.S. generally accepted accounting principles, consistent in
all
material respects with those applied in the Company’s Annual Report on Form
10-KSB for the fiscal year ended June 30, 2007. The financial information is
unaudited but reflects all adjustments, consisting only of normal recurring
accruals, which are, in the opinion of the Company’s management, necessary for a
fair statement of the results for the interim periods presented. Interim results
are not necessarily indicative of results for a full year. The information
included in this Form 10-Q should be read in conjunction with the Company’s
Annual Report on Form 10-KSB for the fiscal year ended June 30,
2007.
2. |
Accounting
for Uncertainty in Income
Taxes
|
On
July
1, 2007, the Company adopted Financial Accounting Standards Board Interpretation
No. 48 (FIN No. 48) Accounting
for Uncertainty in Income Taxes.
FIN No.
48 clarifies the accounting for uncertainty in income taxes recognized in
accordance with SFAS No. 109 “Accounting for Income Taxes,” prescribing a
recognition threshold and measurement attribute for the recognition and
measurement of a tax position taken or expected to be taken in a tax return.
In
the course of its assessment, management has determined that the Company, its
subsidiary, and its predecessors is subject to examination of its income tax
filings in the United States and state jurisdictions for the 2003 through 2006
tax years. In the event that the Company is assessed penalties and or interest;
penalties will be charged to other operating expense and interest will be
charged to interest expense.
The
Company adopted FIN No. 48 using the modified prospective transition method,
which requires the application of the accounting standard as of July 1, 2007.
There was no impact on the financial statements as of and for the three and
six
months ended December 31, 2007 as a result of the adoption of FIN No. 48. In
accordance with the modified prospective transition method, the financial
statements for prior periods have not been restated to reflect, and do not
include, the impact of FIN No. 48.
3. |
Loss
per Share
|
The
Company accounts for its income (loss) per common share according to Statement
of Financial Accounting Standard (SFAS) No. 128, Earnings
Per Share.
Under
the provisions of SFAS No. 128, primary and fully diluted earnings per share
are
replaced with basic and diluted earnings per share. Basic earnings per share
is
calculated by dividing net income (loss) available to common shareholders by
the
weighted average number of common shares outstanding, and does not include
the
impact of any potentially dilutive common stock equivalents. Common stock
equivalents, including warrants to purchase the Company's common stock and
common stock issuable upon the conversion of notes payable, are excluded from
the calculations when their effect is antidilutive. At December 31, 2007 and
2006, the calculation of diluted weighted average shares does not include
preferred stock, options, or warrants that are potentially convertible into
common stock as those would be antidilutive due to the Company’s net loss
position.
4
Securities
that could be dilutive in the future as of December 31, 2007 and 2006 are as
follows:
December
31,
|
|||||||
2007
|
2006
|
||||||
Preferred
stock
|
59,065
|
77,080
|
|||||
Preferred
stock warrants
|
-
|
28,614
|
|||||
Common
stock warrants
|
3,255,774
|
4,707,131
|
|||||
Common
stock options
|
3,210,981
|
3,184,639
|
|||||
Convertible
debentures
|
-
|
109,639
|
|||||
Total
potential dilutive securities
|
6,525,820
|
8,107,103
|
4. Short-Term
Investments
The
Company’s short-term investments are classified as available-for-sale and
recorded at fair market value. As of December 31, 2007 and June 30, 2007, the
amortized cost of the Company’s short-term investments equaled their fair market
value. Accordingly, there were no unrealized gains or losses as of December
31,
2007 or June 30, 2007.
The
Company’s short-term investments consisted of the following at December 31, 2007
and June 30, 2007:
December
31,
|
June
30,
|
||||||
2007
|
2007
|
||||||
Municipal
debt securities
|
$
|
4,000,000
|
$
|
3,000,000
|
|||
Corporate
debt securities
|
4,680,137
|
6,942,840
|
|||||
$
|
8,680,137
|
$
|
9,942,840
|
5. Inventory
Inventory
consists of the following at December 31, 2007 and June 30, 2007:
December
31,
|
June
30,
|
||||||
2007
|
2007
|
||||||
Raw
materials
|
$
|
732,516
|
$
|
682,327
|
|||
Work
in process
|
214,757
|
120,242
|
|||||
Finished
goods
|
47,960
|
78,265
|
|||||
$
|
995,233
|
$
|
880,834
|
6. Restricted
Cash
The
Washington Department of Health, effective October 2007, has required the
Company to provide collateral for the decommissioning of its facility. To
satisfy this requirement, the Company established two CDs totaling $172,500
in
separate banks. The CDs both have original maturities of three months but are
classified as long-term as the Company does not anticipate decommissioning
the
facility until the end of the current lease plus the lease option periods.
These
funds are to be used to settle the Company’s remaining asset retirement
obligations (Note 7).
5
7. Asset
Retirement Obligations
SFAS
No.
143, Asset
Retirement Obligations,
establishes standards for the recognition, measurement and disclosure of legal
obligations associated with the costs to retire long-lived assets. Accordingly,
under SFAS No. 143, the fair value of the future retirement costs of the
Company’s leased assets are recorded as a liability on a discounted basis when
they are incurred and an equivalent amount is capitalized to property and
equipment. The initial recorded obligation, which was discounted using the
Company’s credit-adjusted risk-free rate, is reviewed periodically to reflect
the passage of time and changes in the estimated future costs underlying the
obligation. The Company amortizes the initial amount capitalized to property
and
equipment and recognizes accretion expense in connection with the discounted
liability over the estimated remaining useful life of the leased
assets.
In
fiscal
year 2006, the Company established an initial asset retirement obligation of
$63,040 which represented the discounted cost of cleanup that the Company
anticipated it would have to incur at the end of its equipment and property
leases in its old production facility. This amount was determined based on
discussions with qualified production personnel and on historical evidence.
During fiscal year 2007, the Company reevaluated its obligations based on
discussions with the Washington Department of Health and determined that the
initial asset retirement obligation should be increased by an additional
$56,120. During the second quarter of fiscal year 2008, the Company removed
all
radioactive residuals and tenant improvements from its old production facility
and returned the facility to the lessor. The Company had an asset retirement
obligation of $135,120 accrued for this facility but total costs incurred to
decommission the facility were $274,163 resulting in an additional expense
of
$139,043 that is included in cost of products sold. The additional expense
is
mainly due to unanticipated construction costs to return the facility to its
previous state. The Company originally believed that the lessor would retain
many of the leasehold improvements in the building, but the lessor instead
required their removal.
In
September 2007, a new asset retirement obligation of $473,096 was established
representing the discounted cost of the Company’s obligations to remove any
residual radioactive materials and any unwanted leasehold improvements at the
end of the lease term at its new production facility. The estimate was developed
by qualified production personnel and the general contractor of the new
facility. The Company has reviewed the estimate again based on its experience
with decommissioning its old facility and believes that the original estimate
continues to be applicable.
During
the six month periods ended December 31, 2007 and 2006, the asset retirement
obligation changed as follows:
Six
months ended December 31,
|
|||||||
2007
|
2006
|
||||||
Beginning
balance
|
$
|
131,142
|
$
|
67,425
|
|||
New
obligations
|
473,096
|
-
|
|||||
Settlement
of existing obligation
|
(135,120
|
)
|
-
|
||||
Accretion
of discount
|
14,703
|
3,091
|
|||||
Ending
balance
|
$
|
483,821
|
$
|
70,516
|
8. Share-Based
Compensation
Effective
July 1, 2006, the Company adopted SFAS No. 123R, Share-Based
Payment,
using
the modified prospective method. The following table presents the share-based
compensation expense recognized in accordance with SFAS No. 123R during the
three and six months ended December 31, 2007 and 2006:
Three
months
|
Six
months
|
||||||||||||
ended
December 31,
|
ended
December 31,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Cost
of product sales
|
$
|
36,827
|
$
|
20,492
|
$
|
73,830
|
$
|
71,325
|
|||||
Research
and development
|
11,550
|
7,879
|
23,100
|
19,714
|
|||||||||
Sales
and marketing expenses
|
59,557
|
52,456
|
119,114
|
99,237
|
|||||||||
General
and administrative expenses
|
59,072
|
35,617
|
138,569
|
707,611
|
|||||||||
Total
share-based compensation
|
$
|
167,006
|
$
|
116,444
|
$
|
354,613
|
$
|
897,887
|
6
As
of
December 31, 2007, total unrecognized compensation expense related to
stock-based options was $1,229,517 and the related weighted-average period
over
which it is expected to be recognized is approximately 1.02 years.
The
Company currently provides stock-based compensation under three equity incentive
plans approved by the Board of Directors. Options granted under each of the
plans have a ten year maximum term, an exercise price equal to at least the
fair
market value of the Company’s common stock on the date of the grant, and varying
vesting periods as determined by the Board. For stock options that vest over
time, the Company recognizes compensation cost on a straight-line basis over
the
requisite service period for the entire award.
A
summary
of stock option activity within the Company’s share-based compensation plans for
the six months ended December 31, 2007 is as follows:
Weighted
|
|||||||||||||
Weighted
|
Average
|
||||||||||||
Average
|
Remaining
|
Aggregate
|
|||||||||||
Number
of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Options
|
Price
|
Term
|
Value
|
||||||||||
Outstanding
at December 31, 2007
|
3,210,981
|
$
|
2.68
|
8.04
|
$
|
863,361
|
|||||||
Vested
and expected to vest at
|
|||||||||||||
December
31, 2007
|
3,171,547
|
$
|
2.66
|
8.04
|
$
|
863,361
|
|||||||
December
31, 2007
|
2,463,800
|
$
|
2.28
|
7.77
|
$
|
863,361
|
The
aggregate intrinsic value of options exercised during the six months ended
December 31, 2007 and 2006 was $25,300 and $1,557,600, respectively. The
Company’s current policy is to issue new shares to satisfy option
exercises.
During
the three and six months ended December 31, 2007, the Company did not grant
any
stock options. The weighted average fair value of stock option awards granted
and the key assumptions used in the Black-Scholes valuation model to calculate
the fair value are as follows:
Three
months
|
Six
months
|
||||||||||||
ended
December 31,
|
ended
December 31,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Weighted
average fair value of options granted
|
$
|
-
|
$
|
2.14
|
$
|
-
|
$
|
2.11
|
|||||
Key
assumptions used in determining fair value:
|
|||||||||||||
Weighted
average risk-free interest rate
|
-
|
%
|
4.74
|
%
|
-
|
%
|
4.88
|
%
|
|||||
Weighted
average life of the option (in years)
|
-
|
6.00
|
-
|
5.58
|
|||||||||
-
|
%
|
75.00
|
%
|
-
|
%
|
75.00
|
%
|
||||||
Expected
dividend yield
|
-
|
%
|
0.00
|
%
|
-
|
%
|
0.00
|
%
|
7
The
Black-Scholes option valuation model was developed for use in estimating the
fair value of traded options which have no vesting restrictions and are fully
transferable. In addition, option valuation models require the input of highly
subjective assumptions, including the expected stock price volatility. Because
changes in the subjective input assumptions can materially affect the fair
value
estimate, in management’s opinion, the existing models do not necessarily
provide a reliable single measure of the fair value of its employee stock
options. The risk-free interest rate is based on the U.S. treasury security
rate
in effect as of the date of grant. The expected lives of options and the stock
price volatility are based on historical data of the Company.
9. Commitments
and Contingencies
Patent
and Know-How Royalty License Agreement
The
Company is the holder of an exclusive license to use certain “know-how”
developed by one of the founders of a predecessor to the Company and licensed
to
the Company by the Lawrence Family Trust, a Company shareholder. The terms
of
this license agreement require the payment of a royalty based on the Net Factory
Sales Price, as defined in the agreement, of licensed product sales. Because
the
licensor’s patent application was ultimately abandoned, only a 1% “know-how”
royalty based on Net Factory Sales Price, as defined in the agreement, remains
applicable. To date, management believes there have been no product sales
incorporating the “know-how” and therefore no royalty is due pursuant to the
terms of the agreement. Management believes that ultimately no royalties should
be paid under this agreement as there is no intent to use this “know-how” in the
future.
The
licensor of the “know-how” has disputed management’s contention that it is not
using this “know-how”. On September 25, 2007 and again on October 31, 2007, the
Company participated in nonbinding mediation regarding this matter; however,
no
settlement was reached with the Lawrence Family Trust. As of February 11, 2008,
the parties remain in negotiations to reach a mutually agreeable settlement.
If
no settlement is reached, the parties may demand binding
arbitration.
License
Agreement with IBt
In
February 2006, the Company signed a license agreement with International
Brachytherapy SA (IBt), a Belgian company, covering North America and providing
the Company with access to IBt’s Ink Jet production process and its proprietary
polymer seed technology for use in brachytherapy procedures using Cs-131. Under
the original agreement royalty payments were to be paid on net sales revenue
incorporating the technology.
On
October 12, 2007, the Company entered into Amendment No. 1 (the Amendment)
to
its License Agreement dated February 2, 2006 with IBt. The Company paid license
fees of $275,000 (under the original agreement) and $225,000 (under the
Amendment) during fiscal years 2006 and 2007, respectively. The Amendment
eliminates the previously required royalty payments based on net sales revenue,
and the parties intend to negotiate terms for future payments by the Company
for
polymer seed components to be purchased at IBt's cost plus a to-be-determined
profit percentage. No agreement has been reached on these terms and there is
no
assurance that the parties will consummate an agreement pursuant to such
terms.
Perma-Fix
Lease
On
October 10, 2007, the Company executed a Lease Agreement with Perma-Fix
Northwest Richland, Inc. (Perma-Fix). The Lease Agreement had an effective
date of September 1, 2007, and provided for the continuation of the Company's
lease of its PIRL facility located at 2025 Battelle Boulevard, Richland,
Washington. The Company originally leased this facility from Nuvotec USA,
Inc. under a Lease Agreement dated February 9, 2005, but Nuvotec USA, Inc.
subsequently sold the facility to Perma-Fix. The new lease term was
through January 31, 2008, with early termination permitted upon 45 days prior
written notice. The Company terminated this lease in mid-December 2007.
8
10. Subsequent
Events
Extension
of Warrants
On
January 8, 2008, the Board of Directors retroactively extended the expiration
dates of warrants issued pursuant to its private placement memoranda dated
October 17, 2005 and February 1, 2006 for an additional one year period. These
warrants began expiring in October 2007. Based on the extension, the warrants
will now expire between October 2008 and February 2009. No other terms or
conditions of the warrants were changed. The change in expiration dates affected
outstanding warrants to purchase 2,102,142 shares of common stock. Of these
outstanding warrants there were warrants to purchase 18,000 shares held by
two
directors of the Company. Prior to the extension, warrants to purchase 1,186,219
shares of common stock had passed their original expiration dates.
For
the
non-director warrants, the change in expiration date was a modification of
the
original warrant based on market conditions and was accounted for as a financing
transaction similar to an extension of time in the offering of shares in a
stock
sale. Therefore there was no effect on the statement of operations as the
Company had previously determined that under SFAS 133 and EITF 00-19 these
warrants were equity instruments rather than derivatives.
The
Company viewed the change in the director warrants as a modification of an
existing warrant in accordance with SFAS 123R. The fair value of the modified
warrant was calculated using the Black-Scholes valuation model as $0.30 per
warrant. The fair value of the original warrant immediately before the
modification was calculated as zero as all of their warrants had previously
expired. Total compensation cost of $5,400 was recorded in January 2008 relating
to the modification of the warrants held by the two directors.
Director
Not Standing for Re-Election
On
January 8, 2008, Stephen Boatwright, one of the Company's directors, informed
the Company that he would not stand for re-election at the Company's 2008 Annual
Meeting of Shareholders, to be held on February 20, 2008, and that he will
cease
serving as a director of the Company on that date. There was no disagreement,
as
defined in 17 CFR 240.3b-7, between the Company and Mr. Boatwright that resulted
in Mr. Boatwright's decision not to stand for re-election.
By-Law
Amendments
On
January 8, 2008, the Board of Directors of the Company adopted Amended and
Restated By-Laws, which were effective immediately. The Board of Directors
amended and restated Section 1 of Article III of the By-Laws to give the Board
of Directors the right to determine the number of directors, within a range
of 1
to 10, that will serve on the Board at any given time, and to remove the term
limit for directors. Prior to the amendment, shareholders had the ability to
determine the number of directors, within a range of 1 to 10, that would serve
on the Board at any given time, and directors were subject to a five year term
limit.
9
The
Board
of Directors also amended and restated Section 3.B. of Article III of the
By-Laws to shorten the required notice of Board meetings to five days. Prior
to
the amendment, fourteen days notice was required for Board meetings.
Shareholders
have the right to change or repeal any of the By-Laws as described in Section
4
of Article VII.
2008
Employee Stock Option Plan
On
January 8, 2008, the Board of Directors unanimously adopted, subject to
shareholder approval, the 2008 Employee Stock Option Plan (2008 Option Plan).
The 2008 Option Plan allows the Board of Directors to grant options to purchase
up to 2,000,000 shares of common stock to selected employees, consultants,
and
advisors of the Company. The 2008 Option Plan is on the Company’s proxy ballot
to be voted on by shareholders at the annual meeting to be held on February
20,
2008.
Russian
Agreement
On
January 23, 2008, the Company announced that it had become a 30% owner in a
Russian limited liability company, UralDial, LLC, a new medical isotope
manufacturing and distribution company based in Yekaterinburg, Russia. Under
the
terms of the UralDial Charter, the Company will own a 30% share in the new
company, through its newly formed subsidiary, IsoRay International LLC. UNONA
Holdings, a private holding company, will have a 40% ownership interest and
a
30% ownership interest will be held by Russian engineers and scientists involved
in the new company. All capital investments for the new manufacturing plant
and
the development of centers of excellence are expected to be provided by UNONA
Holdings in support of the Russian government’s new men’s health
initiatives.
10
ITEM
2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF
OPERATIONS
Caution
Regarding Forward-Looking Information
In
addition to historical information, this Form 10-Q contains certain
“forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the
express purpose of availing IsoRay, Inc. of the protections of the safe harbor
provisions of the PSLRA.
All
statements contained in this Form 10-Q, other than statements of historical
facts, that address future activities, events or developments are
forward-looking statements, including, but not limited to, statements containing
the words "believe," "expect," "anticipate," "intends," "estimate," "forecast,"
"project," and similar expressions . All statements other than statements of
historical fact are statements that could be deemed forward-looking statements,
including any statements of the plans, strategies and objectives of management
for future operations; any statements concerning proposed new products,
services, developments or industry rankings; any statements regarding future
economic conditions or performance; any statements of belief; and any statements
of assumptions underlying any of the foregoing. These statements are based
on
certain assumptions and analyses made by us in light of our experience and
our
assessment of historical trends, current conditions and expected future
developments as well as other factors we believe are appropriate under the
circumstances. However, whether actual results will conform to the expectations
and predictions of management is subject to a number of risks and uncertainties
described under “Risk Factors” beginning on page 19 below and in the “Risk
Factors” section of our Form 10-KSB for the fiscal year ended June 30, 2007 that
may cause actual results to differ materially.
Consequently,
all of the forward-looking statements made in this Form 10-Q are qualified
by
these cautionary statements and there can be no assurance that the actual
results anticipated by management will be realized or, even if substantially
realized, that they will have the expected consequences to or effects on our
business operations. Readers are cautioned not to place undue reliance on such
forward-looking statements as they speak only of the Company's views as of
the
date the statement was made. The Company undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Critical
Accounting Policies and Estimates
The
discussion and analysis of the Company’s financial condition and results of
operations are based upon its consolidated financial statements, which have
been
prepared in accordance with accounting principles generally accepted in the
United States of America. The preparation of these financial statements requires
management to make estimates and judgments that affect the reported amounts
of
assets, liabilities, revenues and expenses, and related disclosure of contingent
liabilities. On an on-going basis, management evaluates past judgments and
estimates, including those related to bad debts, inventories, accrued
liabilities, and contingencies. Management bases its estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions. The accounting policies
and
related risks described in the Company’s annual report on Form 10-KSB for the
fiscal year ended June 30, 2007, as filed with the Securities and Exchange
Commission on September 28, 2007 are those that depend most heavily on these
judgments and estimates. As of December 31, 2007, there have been no
material changes to any of the critical accounting policies contained
therein.
11
Results
of Operations
Three
months ended December 31, 2007 compared to three months ended December 31,
2006
Product
sales.
The
Company generated sales of $1,758,344 during the three months ended December
31,
2007, compared to sales of $1,414,155 for the three months ended December 31,
2006. The increase of $344,189 or 24% is due to increased sales volume of the
Company’s Proxcelan Cs-131 brachytherapy seeds. During the three months ended
December 31, 2007, the Company sold its Proxcelan seeds to 53 different medical
centers as compared to 33 medical centers during the corresponding period of
2006.
Cost
of product sales.
Cost of
product sales was $2,241,795 for the three months ended December 31, 2007
compared to cost of product sales of $1,387,394 during the three months ended
December 31, 2006. The major components of the increase of $854,401 or 62%
were
depreciation, materials, occupancy costs, personnel costs, and preload expenses.
Depreciation expenses increased approximately $287,000 due to the depreciation
on the new production facility and new equipment. Materials increased
approximately $229,000 mainly due to ordering and using more isotope in the
three months ended December 31, 2007 compared to the corresponding period of
2006 and a higher unit price from our primary isotope supplier in 2007 compared
to 2006. The increase in pricing came as a result of a price increase effective
in February 2007 coupled with the Company’s failure to order sufficient volume
of isotope to obtain more favorable pricing. Occupancy costs increased
approximately $52,000 due to the higher rent on our new production facility
and
due to continued rent payments on the old facility through the middle of
December 2007 as the Company completed its decommissioning. Personnel costs,
including payroll, benefits, and related taxes, increased approximately $58,000
as the number of production personnel increased. Preload expenses increased
by
approximately $50,000 due to the higher volume of sales and due to continued
start-up costs of the Company’s internal preload facility. In January 2008, the
Company’s internal preload facility began shipping preloaded strands on a
limited basis.
During
the quarter ended December 31, 2007, the Company removed all radioactive
residuals and tenant improvements from its old production facility and returned
the facility to the lessor. The Company had an asset retirement obligation
of
$135,120 accrued for this facility but total costs incurred to decommission
the
facility were $274,163 resulting in an additional expense of $139,043 that
is
included in cost of products sold. The additional expense is mainly due to
unanticipated construction costs to return the facility to its previous state.
The Company originally believed that the lessor would retain many of the
leasehold improvements in the building, but the lessor instead required their
removal.
Gross
loss / margin. Gross
loss was $483,451 for the three month period ended December 31, 2007. This
represents a decrease in the Company’s gross profit margin of $510,212 or 1,907%
over the corresponding period of 2006’s gross margin of $26,761. The increase in
gross loss is due to the Company’s higher revenues being more than offset by
higher production costs and the costs of decommissioning the old production
facility.
Research
and development expenses.
Research
and development expenses for the three month period ended December 31, 2007
were
$395,545 which represents an increase of $179,291 or 83% over research and
development expenses of $216,254 for the three month period ended December
31,
2006. The increase is due to higher personnel, protocol, consulting, and other
miscellaneous expenses. Personnel costs, including payroll, benefits, and
related taxes, increased approximately $29,000 due to higher salaries to
research and development personnel. Protocol expenses increased approximately
$76,000 mainly due to payments for the Company’s randomized prospective clinical
study, its dual-therapy study, and its continued monitoring and updating of
the
mono-therapy study. Consulting expenses increased approximately $58,000 which
is
mainly due to the Company’s ongoing project to increase the efficiency of
isotope production. Various miscellaneous expenses increased by approximately
$29,000.
12
Sales
and marketing expenses.
Sales
and marketing expenses were $1,142,827 for the three months ended December
31,
2006. This represents an increase of $252,809 or 28% compared to expenditures
in
the three months ended December 31, 2006 of $890,018 for sales and marketing.
Personnel expenses, including payroll, benefits, and related taxes, increased
approximately $209,000 due to higher commissions paid due to higher revenues
and
an increase in sales force. Travel expenses increased approximately $38,000
due
to the increase in sales force. Consulting expenses increased approximately
$37,000 mainly due to payments to consultants to develop technical publications
and other materials, to represent the Company at professional society meetings,
and to serve as members of the Company’s Cesium Advisory Group. The latter is a
new advisory group comprised of radiation oncologists and physicists that met
for the first time in December 2007. The purchase of market research reports
and
the purchase of subscriptions for US medical residents and development of new
brochures and other marketing aids increased expenses by approximately $49,000.
These increases were partially offset by decreases of approximately $49,000
in
convention and tradeshow expenses and $31,000 in hiring costs.
General
and administrative expenses.
General
and administrative expenses for the three months ended December 31, 2007 were
$919,164 compared to general and administrative expenses of $821,529 for the
corresponding period of 2006. The increase of $97,635 or 12% is mainly due
to
increased legal, share-based compensation, and personnel expenses partially
offset by decreased travel expenses. Legal expenses increased by approximately
$79,000 due to costs incurred for contract drafting and review of the Company’s
interest in the new Russian entity and the IBt strategic global alliance
agreements and for mediation costs with the Lawrence Family Trust. Without
these
fees, legal expenses would have decreased by approximately $42,000. Share-based
compensation increased approximately $23,000 as a result of additional grants
of
stock options that occurred in March and June 2007. Personnel expenses,
including payroll, benefits, and related taxes, increased approximately $20,000
owing to a slight increase in headcount and salary increases. These increases
were partially offset by a decrease in travel and related expenses of
approximately $34,000.
Operating
loss.
Due to
the Company’s rapid structural growth and related marketing costs and sales
force needed to capture additional market share, an increase in production
costs, and significant research and development expenditures, the Company has
not been profitable and has generated operating losses since its inception.
In
the three months ended December 31, 2007, the Company had an operating loss
of
$2,940,987 which is an increase of 1,039,947 or 55% over the operating loss
of
$1,901,040 for the three months ended December 31, 2006.
Interest
income.
Interest
income was $179,856 for the three months ended December 31, 2007. This
represents an increase of $129,852 or 260% compared to interest income of
$50,004 for the three months ended December 31, 2006. Interest income is mainly
derived from excess funds held in money market accounts and invested in
short-term investments.
Financing
expense.
Financing expense for the three months ended December 31, 2007 was $25,211
or a
decrease of $42,202 or 63% from financing expense of $67,413 for the
corresponding period in 2006. Included in financing expense is interest expense
of approximately $18,000 and $46,000 for the three months ended December 31,
2007 and 2006, respectively. The decrease in interest expense is due to the
maturity and payoff of the convertible debentures during the fiscal year ended
June 30, 2007. The remaining balance of financing expense represents the
amortization of deferred financing costs which decreased due to the write-off
in
fiscal year 2007 of the deferred financing costs relating to the Columbia River
Bank line of credit.
13
Six
months ended December 31, 2007 compared to six months ended December 31,
2006
Product
sales.
Sales
for the six months ended December 31, 2007 were $3,614,063 compared to sales
of
$2,439,599 for the six months ended December 31, 2005. The increase of
$1,174,464 or 48% was due to increased sales volume of the Company’s Proxcelan
Cs-131 brachytherapy seeds. During the six months ended December 31, 2007 the
Company sold its Cs-131 seeds to 65 different medical centers as compared to
35
centers during the corresponding period of 2006.
Cost
of product sales.
Cost of
product sales was $4,247,297 for the six months ended December 31, 2007 which
represents an increase of $1,571,758 or 59% compared to cost of product sales
of
$2,675,539 during the six months ended December 31, 2006. Materials expense
increased approximately $523,000 mainly due to ordering and using more isotope
in the six months ended December 31, 2007 compared to the corresponding period
of 2006 and a higher unit price from our main supplier in 2007 compared to
2006.
Depreciation expense increased approximately $405,000 owing to the new
production facility and new production equipment that was added in the past
six
months. Preload expenses increased approximately $188,000 due to higher sales
volumes and due to continued start-up costs of the Company’s internal preload
facility. Personnel expenses, including payroll, benefits, and related taxes,
increased approximately $177,000 due to hiring of additional production
personnel to support higher production levels. Occupancy costs increased
approximately $95,000 as the Company entered into a lease for a new production
facility in March 2007 and continued to pay rent on its old production facility
through mid-December 2007.
The
Company also had the following increases in cost of product sales expenditures
that are directly related to the new facility that was opened in September
2007.
The Company ordered isotope for the old facility to ensure adequate supply
based
on sales forecasts while it prepared to transition into the new production
facility. To ensure a smooth transition with no missed order shipments, the
Company ordered an additional $38,000 of isotope in September 2007 that was
not
utilized as the removal and transportation of the isotope from the old facility
to the new facility presented logistical challenges that made it cost
prohibitive. As part of opening the new facility, the Company incurred
approximately $20,000 of wages and related taxes for personnel to perform
equipment set-up and validation. The Company also expensed approximately $82,000
of production materials and small tools for the new facility, none of which
individually exceeded the $2,500 threshold the Company uses in determining
whether to capitalize production equipment.
During
the six months ended December 31, 2007, the Company removed all radioactive
residuals and tenant improvements from its old production facility and returned
the facility to the lessor. The Company had an asset retirement obligation
of
$135,120 accrued for this facility but total costs incurred to decommission
the
facility were $274,163 resulting in an additional expense of $139,043 that
is
included in cost of products sold. The additional expense is mainly due to
unanticipated construction costs to return the facility to its previous state.
The Company originally believed that the lessor would retain many of the
leasehold improvements in the building, but instead required their
removal.
Gross
loss. Gross
loss was $633,234 for the six month period ended December 31, 2007. This
represents an increase of $397,294 or 168% over the corresponding period of
2006’s gross loss of $235,940. The increase is due to the increase in production
costs more than offsetting the increase in revenues.
14
Research
and development expenses.
Research
and development expenses for the six months ended December 31, 2007 were
$651,915 which represents an increase of $190,063 or 41% over the research
and
development expenses of $461,852 for the corresponding period of 2006. The
major
components of the increase were personnel, protocol, consulting, and travel
expenses. Personnel expenses, including payroll, benefits, and related taxes,
increased approximately $43,000 due to higher salaries for research and
development personnel. Protocol expenses increased approximately $34,000 mainly
due to payments for the Company’s randomized prospective clinical study, its
dual-therapy study, and its continued monitoring and updating of the
mono-therapy study. Consulting expenses increased approximately $67,000 which
is
mainly due to the Company’s ongoing project to increase the efficiency of
isotope production. Travel expenses increased approximately $31,000 due to
increased trips to Russia for the Company’s interest
in the new Russian entity that
was
announced in January 2008 and to Belgium to review work on the polymer
technology licensed from IBt.
Sales
and marketing expenses.
Sales
and marketing expenses were $2,202,643 for the six months ended December 31,
2007. This represents an increase of $639,695 or 41% compared to expenditures
in
the six months ended December 31, 2006 of $1,562,948 for sales and marketing.
Personnel expenses, including payroll, benefits, and related taxes, increased
approximately $454,000 due to higher commissions paid due to higher revenues
and
an increase in average headcount. Travel expenses increased approximately
$70,000 due to the increase in average headcount. Consulting expenses increased
approximately $84,000, mainly due to payments to consultants to develop
technical publications and other materials, to represent the Company at
professional society meetings, to serve as members of the Company’s Cesium
Advisory Group (a new advisory group comprised of radiation oncologists and
physicists that met for the first time in December 2007), and increased expenses
for a lobbying group. Dues and subscriptions increased approximately $30,000
mainly due to the purchase of market research reports and the purchase of
subscriptions for US medical residents. Marketing and advertising increased
approximately $88,000 as the Company created new brochures and other marketing
aids. These increases were partially offset by a decrease of approximately
$95,000 in convention and tradeshow expenses as the Company reduced its overall
budget for ASTRO and the smaller tradeshows.
General
and administrative expenses.
General
and administrative expenses for the six months ended December 31, 2007 were
$1,821,189 compared to general and administrative expenses of $2,554,661 for
the
corresponding period of 2006. The decrease of $733,472 or 29% is primarily
due
to a decrease in share-based compensation of approximately $569,000 and a
one-time severance accrual of $288,000 in the corresponding period of 2006.
Travel expenses also decreased approximately $66,000. These decreases were
partially offset by increases in legal expenses and public company expenses.
Legal expenses increased by approximately $64,000 due to costs incurred for
contract drafting and review of the Company’s interest in the new Russian
entity, the IBt strategic global alliance agreements and mediation costs with
the Lawrence Family Trust. Without these fees, legal expenses would have
decreased by approximately $146,000. Public company expenses increased
approximately $89,000 owing to the new director compensation plan instituted
in
fiscal year 2008.
Operating
loss.
Due to
the Company’s rapid structural growth and related need to capture additional
market share, the hiring of additional sales and marketing personnel, product
revenues not covering production costs, and significant research and development
expenditures, the Company has not been profitable and has generated operating
losses since its inception. In the six months ended December 31, 2007, the
Company had an operating loss of $5,308,981 which is an increase of $493,580
or
10% over the operating loss of $4,815,401 for the six months ended December
31,
2006.
15
Interest
income.
Interest
income was $418,551 for the six months ended December 31, 2007. This represents
an increase of $328,364 or 364% compared to interest income of $90,187 for
the
three months ended December 31, 2007. Interest income is mainly derived from
excess funds held in money market accounts and invested in short-term
investments.
Financing
expense.
Financing expense for the six months ended December 31, 2007 was $55,314 or
a
decrease of $65,356 or 54% from financing expense of $120,670 for the
corresponding period in 2006. Included in financing expense is interest expense
of approximately $40,000 and $77,000 for the six months ended December 31,
2007
and 2006, respectively. The decrease in interest expense is due to the maturity
and payment of the convertible debentures during the fiscal year ended June
30,
2007. The remaining balance of financing expense represents the amortization
of
deferred financing costs which decreased due to the write-off in fiscal year
2007 of the deferred financing costs relating to the Columbia River Bank line
of
credit.
Liquidity
and capital resources.
The
Company has historically financed its operations through cash investments from
shareholders. During the six months ended December 31, 2007, the Company’s
primary source of cash was the exercise of common stock warrants and options
for
$983,000 and the Company primarily used existing cash reserves to fund its
operations and capital expenditures.
Cash
flows from operating activities
Cash
used
in operating activities was $4.7 million for the six months ended December
31,
2007 compared to $3.8 million for the six months ended December 31, 2006. Cash
used by operating activities is net loss adjusted for non-cash items and changes
in operating assets and liabilities. The increase in cash usage is mainly due
to
an increase in operating assets and liabilities related to a large decrease
in
accounts payable and accrued expenses. This is due to a payment in July 2007
for
enriched barium that was included in the Company’s June 2007 accounts payable
balance.
Cash
flows from investing activities
Cash
used
in investing activities was approximately $1.9 million and $515,000 for the
six
months ended December 31, 2007 and 2006, respectively. Cash expenditures for
fixed assets were approximately $3.0 million and $487,000 during the six months
ended December 31, 2007 and 2006, respectively. The large increase is mainly
due
to construction of our new facility and equipment purchases for the new
facility. This was partially offset by net proceeds of approximately $1.4
million from the sale of short-term securities.
Cash
flows from financing activities
During
the six months ended December 31, 2007, the Company issued 290,876 shares of
common stock pursuant to the exercise of common stock options and warrants.
The
Company received $1,022,813 in cash pursuant to these exercises.
Projected
2008 Liquidity and Capital Resources
At
December 31, 2007, cash and cash equivalents amounted to $3,649,179 and
short-term investments amounted to $8,680,137 compared to $9,355,730 of cash
and
cash equivalents and $9,942,840 of short-term investments at June 30,
2007.
The
Company had approximately $3.6 million of cash and $7.6 million of short-term
investments as of February 4, 2008. As of that date management believed that
the
Company’s monthly required cash operating expenditures were approximately
$600,000 excluding capital expenditure requirements. The Company’s cash
operating expenditures were higher than this level during the six months ended
December 31, 2007 but this was mainly due to the additional expenditures
necessary to make the new facility operational while maintaining operations
at
the previous facility.
16
Assuming
operating costs expand proportionately with revenue increases, other
applications are pursued for seed usage outside the prostate market, protocols
are expanded supporting the integrity of the Company’s product and sales and
marketing expenses continue to increase, management believes the Company will
reach breakeven with revenues of approximately $2 million per month.
Management’s plans to attain breakeven and generate additional cash flows
include increasing revenues from both new and existing customers, developing
additional therapies, and maintaining cost control. However, there can be no
assurance that the Company will attain profitability or that the Company will
be
able to attain its aggressive revenue targets. If the Company does not
experience the necessary increases in sales or if it experiences unforeseen
manufacturing constraints, the Company may need to obtain additional funding.
As
the sales for the quarter ended December 31, 2007 declined, the Company is
now
focusing on reducing its production costs and making its sales force more
efficient.
The
Company expects to finance its future cash needs through the sale of equity
securities, solicitation to warrant holders to exercise their warrants, and
possibly strategic collaborations or debt financing or through other sources
that may be dilutive to existing shareholders. If the Company needs to raise
additional money to fund its operations, funding may not be available to it
on
acceptable terms, or at all. If the Company is unable to raise additional funds
when needed, it may not be able to continue to market its products as planned
or
continue development and obtain regulatory approval of its future products.
If
the Company raises additional funds through equity sales, these sales may be
dilutive to existing investors.
Long-Term
Debt and Capital Lease Agreements
IsoRay
had two loan facilities in place as of December 31, 2007. The first loan is
from
the Benton-Franklin Economic Development District (BFEDD) in an original
principal amount of $230,000 and was funded in December 2004. It bears interest
at eight percent and has a sixty month term with a final balloon payment. As
of
December 31, 2007, the principal balance owed was $174,491. This loan is secured
by certain equipment, materials and inventory of the Company, and also required
personal guarantees, for which the guarantors were issued approximately 70,455
shares of common stock. The second loan is from the Hanford Area Economic
Investment Fund Committee (HAEIFC) and was originated in June 2006. The loan
originally had a total facility of $1,400,000 which was reduced in September
2007 to the amount of the Company’s initial draw of $418,670 (see Note 9). The
loan bears interest at nine percent and the principal balance owed as of
December 31, 2007 was $377,142. This loan is secured by receivables, equipment,
materials and inventory, and certain life insurance policies and also required
personal guarantees.
The
Company has certain capital leases for production and office equipment that
expire at various times from March 2008 to April 2009. These leases currently
call for total monthly payments of $19,361. The total of all capital lease
obligations at December 31, 2007 was $118,258.
Other
Commitments and Contingencies
On
October 12, 2007, the Company entered into Amendment No. 1 (the Amendment)
to
its License Agreement dated February 2, 2006 with IBt. The original License
Agreement provided the Company with access to IBt’s proprietary polymer based
seed encapsulation technology for use in brachytherapy procedures using
Cesium-131 in the United States for a fifteen year term. A payment of $225,000
was made on October 12, 2007 pursuant to the Amendment. As the parties agreed
that the ink jet technology was not viable for Cesium-131 seeds, the Amendment
eliminated the previously required royalty payments based on net sales revenue,
and the parties intend to negotiate terms for future payments by the Company
for
polymer seed components to be purchased from IBt at IBt's cost plus a
to-be-determined profit percentage. No agreement has been reached on these
terms
and there is no assurance that the parties will consummate an agreement pursuant
to such terms.
17
The
Company is subject to various local, state, and federal environmental
regulations and laws due to the isotopes used to produce the Company’s product.
As part of normal operations, amounts are expended to ensure that the Company
is
in compliance with these laws and regulations. While there have been no
reportable incidents or compliance issues, the Company incurred certain
decommissioning expenses as part of vacating its old production facility. The
Company has asset retirement obligations which represent the discounted cost
of
cleanup that the Company anticipates it will incur at the end of its equipment
and property leases. This amount was determined based on discussions with
qualified production personnel and on historical evidence. During the quarter
ended December 31, 2007, the Company incurred $274,163 of expenses to complete
the decommissioning of its old production facility. These expenses were offset
by the asset retirement obligation of $135,120 resulting in a net expense of
$139,043 that was recorded in cost of products sales. Another asset retirement
obligation of $473,096 was established in the first quarter of fiscal year
2008
representing obligations at its new production facility. This new asset
retirement obligation is for obligations to remove any residual radioactive
materials and to remove any unwanted leasehold improvements at the end of the
lease term.
The
industry that the Company operates in is subject to product liability
litigation. Through its production and quality assurance procedures, the Company
works to mitigate the risk of any lawsuits concerning its product. The Company
also carries product liability insurance to help protect it from this
risk.
The
Company has no off-balance sheet arrangements.
New
Accounting Standards
In
September 2006, the FASB issued statement No. 157, Fair
Value Measurements,
(SFAS 157). SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with accounting principles generally accepted
in the United States, and expands disclosures about fair value measurements.
SFAS 157 is effective for fiscal years beginning after November 15,
2007, with earlier application encouraged. Any amounts recognized upon adoption
as a cumulative effect adjustment will be recorded to the opening balance of
retained earnings in the year of adoption. The Company does not believe the
adoption of SFAS 157 will have a material effect on its consolidated financial
statements.
In
February 2007, the FASB issued statement No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities Including
an
Amendment of FASB Statement No. 115
(SFAS
159). The statement allows entities to value financial instruments and certain
other items at fair value. The statement provides guidance over the election
of
the fair value option, including the timing of the election and specific items
eligible for the fair value accounting. Changes in fair values would be recorded
in earnings. The statement is effective for fiscal years beginning after
November 15, 2007. The Company does not believe the adoption of SFAS 159
will have a material effect on its consolidated financial
statements.
ITEM
3 - QUANITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
As
a
smaller reporting company, the Company is not required to provide Part I, Item
3
disclosure in this Quarterly Report.
18
ITEM
4 - CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Under
the
supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we conducted an
evaluation of the design and operation of our disclosure controls and
procedures, as such term is defined under Rules 13a-14(c) and 15d-14(c)
promulgated under the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), as of December 31, 2007. Based on that evaluation, our principal
executive officer and our principal financial officer concluded that the design
and operation of our disclosure controls and procedures were effective in timely
alerting them to material information required to be included in the Company's
periodic reports filed with the SEC under the Exchange Act. The design of any
system of controls is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design
will
succeed in achieving its stated goals under all potential future conditions,
regardless of how remote. However, management believes that our system of
disclosure controls and procedures is designed to provide a reasonable level
of
assurance that the objectives of the system will be met.
Changes
in Internal Control over Financial Reporting
There
have not been any changes in our internal control over financial reporting
(as
such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act)
during the most recent fiscal quarter that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
ITEM
1A - RISK FACTORS
There
have been no material changes to the risk factors disclosed in the “Risk
Factors” section of our Annual Report on Form 10-KSB for the year ended June 30,
2007.
ITEM
6. EXHIBITS AND REPORTS ON FORM 8-K
(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 Section
1350 Certifications
(b) Reports
on Form 8-K:
On
October 16, 2007, the Company filed a Current Report on Form 8-K announcing
its
entry into a Lease Agreement for its prior production facility.
On
October 17, 2007, the Company filed a Current Report on Form 8-K announcing
its
subsidiary's entry into Amendment No. 1 to its License Agreement with
International Brachytherapy, SA.
On
November 8, 2007, the Company filed a Current Report on Form 8-K announcing
its
financial results for the first quarter of fiscal 2008.
On
January 14, 2008, the Company filed a Current Report on Form 8-K announcing
certain amendments to its Bylaws and the decision by a director not to stand
for
re-election at the February 20, 2008 annual meeting of
shareholders.
19
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused
this
report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Dated:
February 11, 2008
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ISORAY,
INC., a Minnesota corporation
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By
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/s/ Roger
E. Girard
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Roger
E. Girard, Chief Executive Officer
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By
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/s/ Jonathan
R. Hunt
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Jonathan
R. Hunt, Chief Financial Officer
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20