Perspective Therapeutics, Inc. - Quarter Report: 2008 March (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 March 31, 2008
or
¨
|
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 May 2, 2008
|
|
Common
stock, $0.001 par value
|
22,942,088
|
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
|
12
|
Item
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
20
|
Item
4
|
Controls
and Procedures
|
20
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1A
|
Risk
Factors
|
21
|
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
21
|
Item
6
|
Exhibits
and Reports on Form 8-K
|
22
|
Signatures
|
23
|
PART
I – FINANCIAL INFORMATION
Consolidated
Balance Sheets
|
March 31,
|
|
|||||
|
2008
|
June 30,
|
|||||
|
(Unaudited)
|
2007
|
|||||
|
|||||||
ASSETS
|
|||||||
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,353,295
|
$
|
9,355,730
|
|||
Short-term
investments
|
6,506,859
|
9,942,840
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $39,780 and
$99,789,
respectively
|
808,673
|
1,092,925
|
|||||
Inventory
|
862,439
|
880,834
|
|||||
Prepaid
expenses
|
400,027
|
458,123
|
|||||
Total
current assets
|
11,931,293
|
21,730,452
|
|||||
Fixed
assets, net of accumulated depreciation
|
6,401,331
|
3,665,551
|
|||||
Deferred
financing costs, net of accumulated amortization
|
72,847
|
95,725
|
|||||
Licenses,
net of accumulated amortization
|
455,539
|
262,074
|
|||||
Restricted
cash
|
174,273
|
-
|
|||||
Other
assets, net of accumulated amortization
|
341,036
|
322,360
|
|||||
Total
assets
|
$
|
19,376,319
|
$
|
26,076,162
|
|||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,066,270
|
$
|
1,946,042
|
|||
Accrued
payroll and related taxes
|
242,234
|
459,068
|
|||||
Accrued
interest payable
|
1,111
|
1,938
|
|||||
Deferred
revenue
|
-
|
23,874
|
|||||
Notes
payable, due within one year
|
55,025
|
49,212
|
|||||
Capital
lease obligations, due within one year
|
61,390
|
194,855
|
|||||
Asset
retirement obligation, current portion
|
-
|
131,142
|
|||||
Total
current liabilities
|
1,426,030
|
2,806,131
|
|||||
Notes
payable, due after one year
|
404,019
|
528,246
|
|||||
Capital
lease obligations, due after one year
|
3,422
|
25,560
|
|||||
Asset
retirement obligation
|
494,788
|
-
|
|||||
Total
liabilities
|
2,328,259
|
3,359,937
|
|||||
Commitments
and contingencies (see Note 11)
|
|||||||
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
|
47,292,395
|
45,844,793
|
|||||
Accumulated
deficit
|
(30,267,484
|
)
|
(23,151,416
|
)
|
|||
Total
shareholders' equity
|
17,048,060
|
22,716,225
|
|||||
Total
liabilities and shareholders' equity
|
$
|
19,376,319
|
$
|
26,076,162
|
The
accompanying notes are an integral part of these financial
statements.
1
Consolidated
Statements of Operations
(Unaudited)
|
Three months ended March 31,
|
Nine months ended March 31,
|
|||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||
|
|||||||||||||
Product
sales
|
$
|
1,783,642
|
$
|
1,645,694
|
$
|
5,397,705
|
$
|
4,085,293
|
|||||
Cost
of product sales
|
1,682,981
|
1,456,978
|
5,930,278
|
4,132,518
|
|||||||||
Gross
margin (loss)
|
100,661
|
188,716
|
(532,573
|
)
|
(47,225
|
)
|
|||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
434,418
|
437,143
|
1,086,333
|
898,995
|
|||||||||
Sales
and marketing expenses
|
888,448
|
849,744
|
3,091,091
|
2,412,691
|
|||||||||
General
and administrative expenses
|
869,435
|
937,905
|
2,690,624
|
3,492,565
|
|||||||||
Total
operating expenses
|
2,192,301
|
2,224,792
|
6,868,048
|
6,804,251
|
|||||||||
Operating
loss
|
(2,091,640
|
)
|
(2,036,076
|
)
|
(7,400,621
|
)
|
(6,851,476
|
)
|
|||||
Non-operating
income (expense):
|
|||||||||||||
Interest
income
|
131,442
|
68,760
|
549,993
|
158,947
|
|||||||||
Unrealized
loss on short-term investments (see Note 4)
|
(187,300
|
)
|
-
|
(187,300
|
)
|
-
|
|||||||
Financing
expense
|
(22,826
|
)
|
(56,772
|
)
|
(78,140
|
)
|
(177,443
|
)
|
|||||
Non-operating
income (expense), net
|
(78,684
|
)
|
11,988
|
284,553
|
(18,496
|
)
|
|||||||
Net
loss
|
$
|
(2,170,324
|
)
|
$
|
(2,024,088
|
)
|
$
|
(7,116,068
|
)
|
$
|
(6,869,972
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.09
|
)
|
$
|
(0.12
|
)
|
$
|
(0.31
|
)
|
$
|
(0.42
|
)
|
|
Weighted
average shares used in computing net loss per share:
|
|||||||||||||
Basic
and diluted
|
23,090,200
|
17,400,355
|
23,054,375
|
16,198,067
|
The
accompanying notes are an integral part of these financial
statements.
2
IsoRay,
Inc. and Subsidiaries
Consolidated
Statements of Cash Flows
(Unaudited)
Nine months ended March 31,
|
|||||||
|
2008
|
2007
|
|||||
|
|
|
|||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(7,116,068
|
)
|
$
|
(6,869,972
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating activities:
|
|||||||
Depreciation
and amortization of fixed assets
|
849,716
|
283,422
|
|||||
Amortization
of deferred financing costs and other assets
|
61,521
|
99,387
|
|||||
Amortization
of discount on short-term investments
|
(145,165
|
)
|
-
|
||||
Unrealized
loss on short-term investments
|
187,300
|
-
|
|||||
Loss
on settlement of ARO liability (Note 7)
|
(135,120
|
)
|
-
|
||||
Accretion
of asset retirement obligation
|
25,670
|
4,690
|
|||||
Noncash
share-based compensation
|
425,090
|
1,022,241
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable, net
|
284,252
|
(646,869
|
)
|
||||
Inventory
|
18,395
|
(109,401
|
)
|
||||
Prepaid
expenses
|
58,095
|
(244,364
|
)
|
||||
Accounts
payable and accrued expenses
|
(879,772
|
)
|
222,910
|
||||
Accrued
payroll and related taxes
|
(216,834
|
)
|
(56,700
|
)
|
|||
Accrued
interest payable
|
(827
|
)
|
1,470
|
||||
Deferred
revenue
|
(23,874
|
)
|
-
|
||||
|
|||||||
Net
cash used by operating activities
|
(6,607,621
|
)
|
(6,293,186
|
)
|
|||
|
|||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of fixed assets
|
(3,112,400
|
)
|
(786,614
|
)
|
|||
Additions
to licenses and other assets
|
(250,783
|
)
|
(27,657
|
)
|
|||
Change
in restricted cash
|
(174,273
|
)
|
-
|
||||
Purchases
of short-term investments
|
(13,273,653
|
)
|
-
|
||||
Proceeds
from the sale or maturity of short-term investments
|
16,667,499
|
-
|
|||||
|
|||||||
Net
cash used by investing activities
|
(143,610
|
)
|
(814,271
|
)
|
|||
|
|||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Principal
payments on notes payable
|
(118,414
|
)
|
(95,301
|
)
|
|||
Principal
payments on capital lease obligations
|
(155,603
|
)
|
(135,165
|
)
|
|||
Proceeds
from cash sales of common shares pursuant to private placement, net
of
offering costs
|
-
|
19,819,962
|
|||||
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
|
6,448,181
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of options
|
11,900
|
1,106,333
|
|||||
Payment
of dividend to preferred shareholders
|
-
|
(38,458
|
)
|
||||
|
|||||||
Net
cash provided by financing activities
|
748,796
|
27,114,261
|
|||||
|
|||||||
Net
(decrease) increase in cash and cash equivalents
|
(6,002,435
|
)
|
20,006,804
|
||||
Cash
and cash equivalents, beginning of period
|
9,355,730
|
2,207,452
|
|||||
|
|||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
3,353,295
|
$
|
22,214,256
|
|||
|
|||||||
Non-cash
investing and financing activities:
|
|||||||
Increase
in fixed assets related to asset retirement obligation
|
$
|
473,096
|
$
|
-
|
|||
Cashless
exercise of common stock options
|
-
|
145,000
|
|||||
Exchange
of convertible debentures payable for shares of common stock
|
-
|
49,999
|
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 nine-month periods ended March 31, 2008 and
2007
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 Statement of Financial Accounting Standard (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 are subject to examination of
their 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
nine
months ended March 31, 2008 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 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, are
excluded from the calculations when their effect is antidilutive. At March
31,
2008 and 2007, 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 March 31, 2008 and 2007 are as
follows:
March 31,
|
|||||||
2008
|
2007
|
||||||
Preferred
stock
|
59,065
|
59,065
|
|||||
Common
stock warrants
|
3,250,774
|
3,627,767
|
|||||
Common
stock options
|
2,831,728
|
3,088,439
|
|||||
Convertible
debentures
|
-
|
85,542
|
|||||
Total
potential dilutive securities
|
6,141,567
|
6,860,813
|
4. Short-Term
Investments
The
Company’s short-term investments are classified as available-for-sale and
recorded at fair market value. The Company’s short-term investments consisted of
the following at March 31, 2008 and June 30, 2007:
March 31,
|
June 30,
|
||||||
2008
|
2007
|
||||||
Municipal
debt securities
|
$
|
3,812,700
|
$
|
3,000,000
|
|||
Corporate
debt securities
|
2,694,159
|
6,942,840
|
|||||
$
|
6,506,859
|
$
|
9,942,840
|
The
Company’s municipal debt securities consist of auction rate securities (ARS)
that are generally long term debt instruments that provide liquidity through
a
modified Dutch auction process that resets the applicable interest rate at
predetermined intervals, usually every 28 days. ARS generally trade at par
and
are callable at par on any interest payment date at the option of the issuer.
Interest received during a given period is based upon the interest rate
determined through the auction process. Although these securities are issued
and
rated as long term bonds, they are priced and traded as short-term instruments
because of the liquidity provided through the interest rate reset. This
mechanism generally allows existing investors to rollover their holdings and
continue to own their respective securities or liquidate their holdings by
selling their securities at par value. The Company generally invests in these
securities for short periods of time as part of its cash management
program.
However,
the recent uncertainties in the credit markets have prevented the Company and
other investors from liquidating their holdings by selling their securities
at
par value as the amount of securities submitted for sale at recent ARS auctions
has exceeded the market demand. These securities continue to pay interest
according to their stated terms. For those securities that failed to auction,
the Company continues to hold these securities and accrues interest at a higher
rate than similar securities for which auctions have cleared. The Company's
ARS
are all AAA/Aaa rated investments and consist of various student loan portfolios
with the vast majority of the student loans guaranteed by the U.S. Government
under the Federal Family Education Loan Program. These securities were valued
using a model that takes into consideration the financial conditions of the
issuer and the bond insurers as well as the current illiquidity of the
securities. If the credit ratings of the issuers deteriorate, the Company may
adjust the carrying value of these investments. The Company is uncertain as
to
when the liquidity issues relating to these investments will
improve.
None
of
the ARS investments in our portfolio were backed by sub-prime mortgage
loans.
5
Although
insufficient demand for certain ARS may continue, we anticipate, based on
discussions with our investment advisors, that liquidity may possibly be
realized through the emergence of secondary markets in the near term,
particularly considering the high default interest rates, high credit ratings,
the backing of the Federal Family Education Loan Program, and the historically
low default rates of these securities. As such, we believe that the primary
impact of the failed auctions is reduced liquidity rather than impairment of
principal. In the event that we are unable to sell the investments at or above
our carrying value, these securities may not provide us with a liquid source
of
cash.
Unrealized
gains and temporary unrealized losses on these securities are recorded in other
comprehensive income/loss within Shareholders' Equity. Unrealized losses that
are considered other than temporary are recorded in the Consolidated Statements
of Operations in unrealized loss on short-term investments. The Company has
recognized the unrealized losses on the ARS as other than temporary and recorded
them in the statement of operations rather than in other comprehensive income
as
the Company may need access to these funds before the uncertainties in the
credit markets are fully resolved.
5. Inventory
Inventory
consists of the following at March 31, 2008 and June 30, 2007:
March 31,
|
June 30,
|
||||||
2008
|
2007
|
||||||
Raw
materials
|
$
|
702,210
|
$
|
682,327
|
|||
Work
in process
|
127,614
|
120,242
|
|||||
Finished
goods
|
32,615
|
78,265
|
|||||
$
|
862,439
|
$
|
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 funded 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.
Interest earned on the CDs is rolled-over at the maturity of each CD and becomes
part of the restricted cash balance. Interest earned and added to restricted
cash during the quarter ended March 31, 2008 was $1,773. These funds will be
used to settle a portion of the Company’s remaining asset retirement obligations
(Note 7).
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.
6
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 nine month periods ended March 31, 2008 and 2007, the asset retirement
obligation changed as follows:
Nine months
|
|||||||
ended March 31,
|
|||||||
2008
|
2007
|
||||||
Beginning
balance
|
$
|
131,142
|
$
|
67,425
|
|||
New
obligations
|
473,096
|
-
|
|||||
Settlement
of existing obligation
|
(135,120
|
)
|
-
|
||||
Accretion
of discount
|
25,670
|
4,690
|
|||||
Ending
balance
|
$
|
494,788
|
$
|
72,115
|
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 nine months ended March 31, 2008 and 2007:
Three months
|
Nine months
|
||||||||||||
ended March 31,
|
ended March 31,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Cost
of product sales
|
$
|
36,029
|
$
|
21,076
|
$
|
109,859
|
$
|
92,401
|
|||||
Research
and development
|
10,971
|
8,418
|
34,071
|
28,132
|
|||||||||
Sales
and marketing expenses
|
59,557
|
54,737
|
178,671
|
153,974
|
|||||||||
General
and administrative expenses
|
(36,080
|
)
|
40,123
|
102,489
|
747,734
|
||||||||
Total
share-based compensation
|
$
|
70,477
|
$
|
124,354
|
$
|
425,090
|
$
|
1,022,241
|
7
Each
quarter the Company reviews its forfeiture assumptions and adjusts its
compensation expense when the actual pre-vesting forfeiture rate differs
materially from the estimate. During the three months ended March 31, 2008,
the
Company recognized a credit to compensation expense due to a significant
variation between the estimated pre-vesting forfeiture rate and the actual
pre-vesting forfeiture rate.
As
of
March 31, 2008, total unrecognized compensation expense related to stock-based
options was $762,148 and the related weighted-average period over which it
is
expected to be recognized is approximately 0.89 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 nine months ended March 31, 2008 is as follows:
Weighted
|
|||||||||||||
Weighted
|
Average
|
||||||||||||
Average
|
Remaining
|
Aggregate
|
|||||||||||
Number of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Options
|
Price
|
Term
|
Value
|
||||||||||
Outstanding
at March 31, 2008
|
2,831,728
|
$
|
2.72
|
7.83
|
$
|
0.00
|
|||||||
Vested
and expected to vest at March 31, 2008
|
2,793,342
|
$
|
2.70
|
7.83
|
$
|
0.00
|
|||||||
Vested
and exercisable at March 31, 2008
|
2,294,642
|
$
|
2.42
|
7.65
|
$
|
0.00
|
The
aggregate intrinsic value of options exercised during the nine months ended
March 31, 2008 and 2007 was $25,300 and $2,065,450, respectively. The Company’s
current policy is to issue new shares to satisfy option exercises.
During
the three and nine months ended March 31, 2008, 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
|
Nine months
|
|||||||||||
ended March 31,
|
ended March 31,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Weighted
average fair value of options granted
|
$
|
-
|
$
|
2.68
|
$
|
-
|
$
|
2.18
|
|||||
Key
assumptions used in determining fair value:
|
|||||||||||||
Weighted
average risk-free interest rate
|
-
|
%
|
4.45
|
%
|
-
|
%
|
4.82
|
%
|
|||||
Weighted
average life of the option (in years)
|
-
|
4.97
|
-
|
5.5
|
|||||||||
-
|
%
|
80.00
|
%
|
-
|
%
|
75.65
|
%
|
||||||
Expected
dividend yield
|
-
|
%
|
0.00
|
%
|
-
|
%
|
0.00
|
%
|
8
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. Shareholders’
Equity
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.
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 would have allowed 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. Shareholder approval was not obtained
for the 2008 Plan at the Company’s annual meeting held on February 20, 2008, and
thus no grants have been or will be made under the 2008 Option
Plan.
10. 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 subsidiary, IsoRay International LLC. UNONA Holdings,
a
private holding company, has a 40% ownership interest and a 30% ownership
interest is 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.
9
11. 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 May 1, 2008, the
parties still have not reached a 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.
10
12. Management
and Other Corporate Changes
Resignation
of CEO
On
February 26, 2008, Roger Girard, Chairman, President and CEO of the Company,
resigned from all positions held with the Company and its subsidiaries,
including resigning from Board service. There was no disagreement, as defined
in
17 CFR 240.3b-7, between the Company and Mr. Girard at the time of Mr. Girard's
resignation from the Board of Directors.
In
connection with Mr. Girard's resignation, and in lieu of the severance
arrangements contained in his Employment Agreement with the Company dated
October 6, 2005, the Company made a one time payment to Mr. Girard of $250,000
(less payroll and withholding taxes) in March 2008. The Company has also agreed
to release Mr. Girard from certain personal guarantees of Company debt and
cancel 148,112 shares of common stock either issued in connection with the
guarantees or contingent on his employment through August 2008, continue
providing him with certain benefits for one year, and extend the exercise period
for Mr. Girard's vested options to purchase 547,173 shares of common stock
until
May 31, 2009. All unvested options held by Mr. Girard terminated upon his
resignation as provided in the Company's applicable stock option plans. Mr.
Girard has also agreed to provide consulting services on request through May
15,
2008.
Also
on
February 26, 2008, the Company's Board appointed Dwight Babcock, one of the
Company's directors, as interim CEO and as Chairman of the Board, and appointed
Lori Woods, who previously served as Vice President, as Chief Operating
Officer.
Mr.
Babcock does not have any employment agreement or other compensatory agreement
in place with the Company, although he is compensated $4,000 per month for
his
service as interim CEO and $3,000 per month for his service as Chairman in
addition to $3,000 per month for service on the Board. Ms. Woods' existing
Employment Agreement, dated February 14, 2007, was not modified or amended
in
connection with her promotion to Chief Operating Officer.
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, that was held on February 20, 2008, and he resigned
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.
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.
11
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 in the “Risk Factors” section of our Form 10-KSB for the fiscal year
ended June 30, 2007 and under Part II, Item 1A below 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 March 31, 2008, there have been no material
changes to any of the critical accounting policies contained
therein.
12
Results
of Operations
Three
months ended March 31, 2008 compared to three months ended March 31,
2007
Product
sales.
The
Company generated sales of $1,783,642 during the three months ended March 31,
2008, compared to sales of $1,645,694 for the three months ended March 31,
2007.
The increase of $137,948 or 8% is due to increased sales volume of the Company’s
Proxcelan Cs-131 brachytherapy seeds. During the three months ended March 31,
2008, the Company sold its Proxcelan seeds to 57 different medical centers
as
compared to 36 medical centers during the corresponding period of 2007. The
increase in the number of centers ordering was tempered by a lower average
invoice price due to the expanded use of the Company’s seeds in dual therapy
cases which typically use fewer seeds.
Cost
of product sales.
Cost of
product sales was $1,682,981 for the three months ended March 31, 2008 compared
to cost of product sales of $1,456,978 during the three months ended March
31,
2007. The major components of the increase of $226,003 or 16% were depreciation,
materials, and occupancy costs. Depreciation expenses increased approximately
$163,000 as a result of moving operations into the new production facility
and
purchasing new equipment. This new production facility allowed the Company
to
increase its available capacity by approximately 300% using its current
production techniques and should fulfill the Company’s production needs for the
near future. Materials increased approximately $42,000 mainly due to ordering
and using more isotope in the three months ended March 31, 2008 compared to
the
corresponding period of 2007 due to higher production levels and a higher unit
price from our primary isotope supplier compared to the previous year. 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. The Company renegotiated with its main isotope
vendors and reached agreements that reduced the Company’s isotope costs
beginning in late March 2008. Occupancy costs increased approximately $75,000
due to the higher rent on our new production facility and associated increased
utility costs. In January 2008, the Company’s internal preload facility began
shipping preloaded strands on a limited basis and increased its activity during
the quarter. This led to a decrease in preload expenses of approximately
$12,000.
Gross
margin. Gross
margin was $100,661 for the three month period ended March 31, 2008. This
represents a decrease in the Company’s gross profit margin of $88,055 or 47%
over the corresponding period of 2007’s gross margin of $188,716. The decrease
in gross margin is due to the Company’s higher revenues being more than offset
by higher production costs.
Research
and development expenses.
Research
and development expenses for the three month period ended March 31, 2008 were
$434,418 which represents a decrease of $2,725 or 1% over research and
development expenses of $437,143 for the three month period ended March 31,
2007. Consulting expenses increased approximately $106,000 due to the Company’s
ongoing project to increase the efficiency of isotope production. This was
offset by a decrease of approximately $101,000 in legal expenses as the Company
has focused on its key patents and trademarks in significant countries and
deemphasized the protection of patents and trademarks in other
countries.
Sales
and marketing expenses.
Sales
and marketing expenses were $888,448 for the three months ended March 31, 2008.
This represents an increase of $38,704 or 5% compared to expenditures in the
three months ended March 31, 2007 of $849,744 for sales and marketing.
Consulting expenses increased approximately $54,000 related to a payment for
assistance with certain technical and clinical papers. Travel expenses increased
approximately $11,000 mainly due to the first annual national sales meeting
held
in January 2008 that was used to further train the sales force. These increases
were offset by decreases in hiring costs, marketing and advertising, and
personnel expenses. Hiring costs decreased approximately $21,000 as the Company
was actively building its direct sales force during the period ended March
31,
2007 but the sales force has remained constant during the three months ended
March 31, 2008. Marketing and advertising decreased approximately $17,000 due
to
new article reprints and other marketing materials purchased during the three
months ended March 31, 2007. Personnel expenses decreased approximately $15,000
due to a decrease in the sales force that occurred at the beginning of January
2008. The Company currently has a direct sales force of seven people in various
geographic regions.
13
General
and administrative expenses.
General
and administrative expenses for the three months ended March 31, 2008 were
$869,435 compared to general and administrative expenses of $937,905 for the
corresponding period of 2007. The decrease of $68,470 or 7% is mainly due to
reduced share-based compensation of approximately $76,000 as the Company
reversed the expense for unvested and forfeited options of Mr. Girard, reduced
bad debt expense of approximately $71,000 due to improved collections, reduced
consulting expenses of approximately $50,000 due to a payment in the previous
year related to design work for a potential new production facility, reduced
payroll expenses of approximately $48,000 due to a lower headcount, reduced
public company expenses of approximately $20,000 due to lower investor relations
cost partially offset by increased director compensation, and reduced travel
expenses of approximately $13,000. These decreases were partially offset by
a
one-time accrual paid upon Mr. Girard’s resignation of $250,000 plus payroll
taxes less previously accrued vacation of approximately $69,000.
Operating
loss.
The
Company continues to focus its resources on marketing and sales and retaining
the administrative infrastructure to increase the level of demand for the
Company’s product. These costs coupled with an increase in production costs, and
significant research and development expenditures has resulted in operating
losses since its inception. In the three months ended March 31, 2008, the
Company had an operating loss of $2,091,641 which is an increase of $55,565
or
3% over the operating loss of $2,036,076 for the three months ended March 31,
2007.
Interest
income.
Interest
income was $131,442 for the three months ended March 31, 2008. This represents
an increase of $62,682 or 91% compared to interest income of $68,760 for the
three months ended March 31, 2007. Interest income is mainly derived from excess
funds held in money market accounts and invested in short-term
investments.
Unrealized
loss on short-term investments.
The
unrealized loss for the three months ended March 31, 2008 is due to the recent
uncertainties in the credit markets particularly for certain auction rate
securities held by the Company. The loss represents the amount to write-down
these securities to their estimated fair market value. The Company has elected
to recognize these losses as other than temporary and record them in the
statement of operations rather than in other comprehensive income as the Company
may need access to these funds before the uncertainties in the credit markets
are fully resolved.
Financing
expense.
Financing expense for the three months ended March 31, 2008 was $22,826 or
a
decrease of $33,946 or 60% from financing expense of $56,772 for the
corresponding period in 2007. Included in financing expense is interest expense
of approximately $15,000 and $35,000 for the three months ended March 31, 2008
and 2007, 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.
14
Nine
months ended March 31, 2008 compared to nine months ended March 31,
2007
Product
sales.
Sales
for the nine months ended March 31, 2008 were $5,397,705 compared to sales
of
$4,085,293 for the nine months ended March 31, 2007. The increase of $1,312,412
or 32% was due to increased sales volume of the Company’s Proxcelan Cs-131
brachytherapy seeds. During the nine months ended March 31, 2008 the Company
sold its Cs-131 seeds to 79 different medical centers as compared to 44 centers
during the corresponding period of 2007. The increase in the number of centers
ordering was tempered by a lower average invoice price due to the expanded
use
of the Company’s seeds in dual therapy cases which typically use less
seeds.
Cost
of product sales.
Cost of
product sales was $5,930,278 for the nine months ended March 31, 2008 which
represents an increase of $1,797,760 or 44% compared to cost of product sales
of
$4,132,518 during the nine months ended March 31, 2007. Materials expense
increased approximately $528,000 mainly due to ordering and using more isotope
in the nine months ended March 31, 2008 compared to the corresponding period
of
2007 and a higher unit price from our main supplier in 2008 compared to 2007.
The Company renegotiated with its main isotope vendors and reached agreements
that reduced the Company’s isotope costs beginning in late March 2008.
Depreciation expense increased approximately $568,000 as a result of moving
operations into a new production facility and purchasing new production
equipment in the past nine months. This new production facility allowed the
Company to increase its available capacity by approximately 300% using its
current production techniques and should fulfill the Company’s production needs
for the near future. Preload expenses increased approximately $184,000 due
to
higher sales volumes and due to the start-up costs of the Company’s internal
preload facility. The Company began shipping preloaded strands during January
2008 and has slowly increased the amount of preload activity completed in-house.
Personnel expenses, including payroll, benefits, and related taxes, increased
approximately $149,000 due to the hiring of additional production personnel
to
support higher production levels. Occupancy costs increased approximately
$169,000 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 experienced increases in cost of product sales expenditures
directly related to the new facility that was opened in September 2007. 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.
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 $532,573 for the nine month period ended March 31, 2008. This
represents an increase of $485,348 or 1,028% over the corresponding period
of
2007’s gross loss of $47,225. The increase is due to the increase in production
costs more than offsetting the increase in revenues as discussed
above.
15
Research
and development expenses.
Research
and development expenses for the nine months ended March 31, 2008 were
$1,086,333 which represents an increase of $187,338 or 21% over the research
and
development expenses of $898,995 for the corresponding period of 2007. The
major
components of the increase were consulting, personnel, protocol, and travel
expenses. Consulting expenses increased approximately $172,000 which is mainly
due to the Company’s ongoing project to increase the efficiency of isotope
production. Personnel expenses, including payroll, benefits, and related taxes,
increased approximately $25,000 due to higher salaries for research and
development personnel, which was partially offset by a decrease in headcount
during the third quarter ended March 31, 2008. Protocol expenses increased
approximately $24,000 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. Travel expenses increased approximately
$30,000 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. These increases were partially offset by a
decrease in legal expenses of approximately $96,000 as the Company has focused
on its key patents and trademarks in significant countries and deemphasized
the
protection of patents and trademarks in other countries.
Sales
and marketing expenses.
Sales
and marketing expenses were $3,091,091 for the nine months ended March 31,
2008.
This represents an increase of $678,400 or 28% compared to expenditures in
the
nine months ended March 31, 2007 of $2,412,691 for sales and marketing.
Personnel expenses, including payroll, benefits, and related taxes, increased
approximately $439,000 due to higher commissions paid due to higher revenues
and
an increase in average headcount. Travel expenses increased approximately
$81,000 due to the increase in average headcount. Consulting expenses increased
approximately $151,000, 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 $35,000
mainly due to the purchase of market research reports and the purchase of
subscriptions for US medical residents. Marketing and advertising increased
approximately $66,000 as the Company created new brochures and other marketing
aids. These increases were partially offset by a decrease of approximately
$112,000 in convention and tradeshow expenses as the Company reduced its overall
budget for ASTRO and the smaller tradeshows and a decrease of approximately
$26,000 in hiring costs.
General
and administrative expenses.
General
and administrative expenses for the nine months ended March 31, 2008 were
$2,690,624 compared to general and administrative expenses of $3,492,565 for
the
corresponding period of 2007. The decrease of $801,941 or 23% is primarily
due
to a decrease in share-based compensation of approximately $645,000. Components
of this decrease were comprised of no option grants in 2008 and the reversal
of
the expense for unvested and forfeited options of Mr. Girard, reduced bad debt
expense of approximately $86,000, reduced consulting expenses of approximately
$46,000, and reduced travel expenses of approximately $79,000. Personnel costs
also decreased approximately $77,000 primarily as a result of a lower severance
accrual of approximately $187,000 in the nine months ended March 31, 2008
compared to a severance accrual of approximately $288,000 in the nine months
ended March 31, 2007. These decreases were partially offset by increases in
legal expenses and public company expenses. Legal expenses increased by
approximately $87,000 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 $150,000.
Public company expenses increased approximately $95,000 owing to the new
director compensation plan instituted in fiscal year 2008.
16
Operating
loss.
The
Company continues to focus its resources on marketing and sales and retaining
the administrative infrastructure to increase the level of demand for the
Company’s product. These costs coupled with product revenues not covering
production costs, and significant research and development expenditures, has
resulted in operating losses since its inception. In the nine months ended
March
31, 2008, the Company had an operating loss of $7,400,622 which is an increase
of $549,146 or 8% over the operating loss of $6,851,476 for the nine months
ended March 31, 2007.
Interest
income.
Interest
income was $549,993 for the nine months ended March 31, 2008. This represents
an
increase of $391,046 or 246% compared to interest income of $158,947 for the
nine months ended March 31, 2007. Interest income is mainly derived from excess
funds held in money market accounts and invested in short-term
investments.
Unrealized
loss on short-term investments.
The
unrealized loss for the three months ended March 31, 2008 is due to the recent
uncertainties in the credit markets particularly for certain auction rate
securities held by the Company. The loss represents the amount to write-down
these securities to their estimated fair market value. The Company has elected
to recognize these losses as other than temporary and record them in the
statement of operations rather than in other comprehensive income as the Company
may need access to these funds before the uncertainties in the credit markets
are fully resolved.
Financing
expense.
Financing expense for the nine months ended March 31, 2008 was $78,140 or a
decrease of $99,303 or 56% from financing expense of $177,443 for the
corresponding period in 2007. Included in financing expense is interest expense
of approximately $55,000 and $112,000 for the nine months ended March 31, 2008
and 2007, 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 nine months ended March 31, 2008, the Company’s primary
source of cash was the exercise of common stock warrants and options for
$1,022,813 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 $6.6 million for the nine months ended March 31,
2008 compared to $6.3 million for the nine months ended March 31, 2007. Cash
used by operating activities is net loss adjusted for non-cash items and changes
in operating assets and liabilities. The year-to-date increase in cash usage
is
mainly due to an increased net loss.
Cash
flows from investing activities
Cash
used
in investing activities was approximately $142,000 and $814,000 for the nine
months ended March 31, 2008 and 2007, respectively. Cash expenditures for fixed
assets were approximately $3.1 million and $787,000 during the nine months
ended
March 31, 2008 and 2007, respectively. The large increase is mainly due to
construction of our new facility and equipment purchases for the new facility.
The Company also established restricted cash accounts of $172,500 during the
nine months ended March 31, 2008 and these restricted cash accounts have earned
interest of $1,773 (see Note 6). These decreases were partially offset by net
proceeds of approximately $3.4 million from the sale of short-term
securities.
17
Cash
flows from financing activities
During
the nine months ended March 31, 2008, 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
March
31, 2008, cash and cash equivalents amounted to $3,353,295 and short-term
investments amounted to $6,506,859 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 $3.7 million of cash and $5.6 million of short-term
investments as of May 8, 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 nine months ended
March 31, 2008 but this was mainly due to the additional expenditures necessary
to make the new facility operational while maintaining operations at the
previous facility and a one-time severance payment. Our new interim CEO has
reemphasized certain initiatives to focus on the Company’s core business and
strategy of increasing revenues and reducing costs of production. Based on
these
initiatives, the Company has implemented a short-term target of reducing its
monthly cash burn rate to $400,000 but there can be no assurance that the
Company will be able to achieve this level. For the month of April 2008,
management believes that the Company’s cash expenditures decreased to
approximately $450,000, a significant improvement from the monthly rate of
the
prior quarter.
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. Because the quarter ended
March 31, 2008 was relatively flat when compared to the prior quarter, our
interim CEO has instituted greater levels of cost reductions than prior
management had undertaken. 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.
The
Company has continued its focus on reducing its production costs and making
its
sales force more efficient. The Company has recently begun a review of our
production process and the possibility of automating a portion of the process
in
order to reduce labor costs and gain better efficiencies. The Company also
reviewed and revised its sales compensation policy. The new compensation policy
places increased emphasis on generating new customers and organic growth from
existing customers.
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.
18
Long-Term
Debt and Capital Lease Agreements
IsoRay
had two loan facilities in place as of March 31, 2008. 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
March 31, 2008, the principal balance owed was $149,433. 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. The loan bears
interest at nine percent and the principal balance owed as of March 31, 2008
was
$309,612. 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 March 31, 2008 was $64,813.
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.
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.
19
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 SFAS No. 157, Fair
Value Measurements.
SFAS No. 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 No. 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 No. 157 will have a material effect on its consolidated financial
statements.
In
February 2007, the FASB issued statement SFAS No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities Including
an
Amendment of FASB Statement No. 115.
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 No.
159 will have a material effect on its consolidated financial
statements.
ITEM
3 – QUANTITATIVE 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.
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 March 31, 2008. 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.
20
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
Except
as
set forth below, 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.
We
Rely Heavily On A Limited Number Of Suppliers. Some
materials used in our products are currently available only from a limited
number of suppliers. Approximately (50%) of our cesium was supplied by two
suppliers located in Russia, with the remaining fifty percent (50%) being
supplied by a single U.S. supplier, during the quarter ended March 31, 2008.
In
certain prior quarters, nearly eighty percent (80%) of our cesium was supplied
by a single Russian supplier, but the Company has begun taking steps to reduce
its reliance on a single source for cesium.
With
the
development of barium enrichment capabilities, the Company plans to expand
Cs-131 manufacturing capability at the MURR reactor in the United States. This
strategy may increase the risk associated with concentrating isotope production
at a single reactor facility unless the Company can continue to obtain cesium
from multiple suppliers. Failure to obtain deliveries of cesium from multiple
sources could have a material adverse effect on seed production and there may
be
a delay before we could locate alternative suppliers beyond the three currently
used.
We
may
not be able to locate additional suppliers outside of Russia capable of
producing the level of output of cesium at the quality standards we require.
Additional factors that could cause interruptions or delays in our source of
materials include limitations on the availability of raw materials or
manufacturing performance experienced by our suppliers and a breakdown in our
commercial relations with one or more suppliers. Some of these factors may
be
completely out of our and our suppliers’ control.
Virtually
all titanium tubing used in brachytherapy seed manufacture comes from a single
source, Accellant Corporation. We currently obtain a key component of our seed
core from a single supplier. We do not have formal written agreements with
either this key supplier or with Accellant Corporation. Any interruption or
delay in the supply of materials required to produce our products could harm
our
business if we were unable to obtain an alternative supplier or substitute
equivalent materials in a cost-effective and timely manner. To mitigate any
potential interruptions, the Company continually evaluates its inventory levels
and management believes that the Company maintains a sufficient quantity on
hand
to alleviate any potential disruptions.
ITEM
4 – SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On
February 20, 2008, the Company held its Annual Meeting of Shareholders at which
our shareholders elected six Directors, voted on the 2008 Employee Stock Option
Plan, and ratified the appointment of our independent registered public
accounting firm for the fiscal year ending June 30, 2008.
(a)
|
Election
of Directors.
All nominees for election as Directors were unopposed and elected
as
follows:
|
21
Director
|
For
|
Withhold
|
|||||
Dwight
Babcock
|
14,449,758
|
2,726,725
|
|||||
Roger
E. Girard
|
15,552,855
|
1,623,628
|
|||||
Robert
R. Kauffman
|
14,312,149
|
2,864,334
|
|||||
Thomas
C. LaVoy
|
14,554,589
|
2,621,894
|
|||||
Albert
Smith
|
14,554,589
|
2,621,894
|
|||||
David
J. Swanberg
|
15,816,620
|
1,359,863
|
(b)
|
IsoRay,
Inc. 2008 Employee Stock Option Plan. Shareholder
approval was not obtained due to a lack of shareholder votes for
the 2008
Plan at the Company’s annual meeting held on February 20, 2008, and thus
no grants have been or will be made under the 2008 Option Plan. The
voting
totals were as follows:
|
For
|
Against
|
Abstain
|
Non-votes
|
|||||||
6,787,570
|
3,288,004
|
393,202
|
167,601
|
(c)
|
Appointment
of our independent registered public accounting firm.
Proposal to ratify the appointment of DeCoria, Maichel & Teague, P.S.
as independent registered public accounting firm of the Company for
the
fiscal year ending June 30, 2008 was approved as
follows:
|
For
|
Against
|
Abstain
|
|||||
16,483,868
|
525,014
|
167,601
|
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
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.
On
February 11, 2008, the Company filed a Current Report on Form 8-K announcing
its
financial results for the second quarter of fiscal year 2008.
On
February 27, 2008, the Company filed a Current Report on Form 8-K announcing
the
resignation of Roger Girard, Chairman, President, and CEO of the Company, from
all positions held with the Company and its subsidiaries, the appointment of
Dwight Babcock as interim CEO and as Chairman, and the appointment of Lori
Woods
as Chief Operating Officer.
22
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:
May 13, 2008
ISORAY,
INC., a Minnesota corporation
|
|
By
|
/s/ Dwight
Babcock
|
Dwight
Babcock, Interim Chief Executive Officer
|
|
|
|
By
|
/s/ Jonathan
R. Hunt
|
Jonathan
R. Hunt, Chief Financial
Officer
|
23