x
|
Annual
Report of Small Business Issuers under Section 13 or 15(d) of the
Securities Exchange Act of
1934
|
¨
|
Transition
Report of Small Business Issuers under Section 13 or 15(d) of the
Securities Exchange Act of
1934
|
Minnesota
|
41-1458152
|
|
(State
of incorporation)
|
(I.R.S.
Employer Identification No.)
|
|
350
Hills St., Suite 106
Richland,
Washington 99354
|
(509)
375-1202
|
|
(Address
of principal executive offices)
|
(Registrant’s
telephone number)
|
|
Issuer's
telephone number, including area code: (509)
375-1202
|
||
Securities
registered under Section 12 (b) of the Exchange Act –
Common
Stock – $0.001 par value
(American
Stock Exchange)
Securities
registered under Section 12(g) of the Exchange Act – Series C Preferred
Share Purchase
Rights |
||
Number
of shares outstanding of each of the issuer's classes of common
equity:
|
Class
|
Outstanding
as of September 12, 2007
|
|
Common
stock, $0.001 par value
|
23,033,108
|
Page
|
||
PART
I
|
||
ITEM
1 – DESCRIPTION OF BUSINESS
|
1
|
|
ITEM
2 – DESCRIPTION OF PROPERTY
|
28
|
|
ITEM
3 – LEGAL PROCEEDINGS
|
29
|
|
ITEM
4 – SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
29
|
|
PART
II
|
||
ITEM
5 – MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
|
29
|
|
ITEM
6 – MANAGEMENT’S DISCUSSION AND ANALYSIS
|
31
|
|
ITEM
7 – FINANCIAL STATEMENTS
|
44
|
|
ITEM
8 – CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
|
44
|
|
ITEM
8A – CONTROLS AND PROCEDURES
|
45
|
|
ITEM
8B – OTHER INFORMATION
|
46
|
|
PART
III
|
||
ITEM
9 – DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS, CONTROL PERSONS AND
CORPORATE GOVERNANCE; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE
ACT
|
46
|
|
ITEM
10 – EXECUTIVE COMPENSATION
|
50
|
|
ITEM
11 – SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
|
54
|
|
ITEM
12 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
|
56
|
|
ITEM
13 – EXHIBITS AND REPORTS ON FORM 8-K
|
57
|
|
ITEM
14 – PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
62
|
|
SIGNATURES
|
63 |
§
|
Opened
a new manufacturing and production facility at the Applied Process
Engineering Laboratory to replace the PEcoS-IsoRay
Radioisotope Laboratory (PIRL)
facility (September 2007);
|
§
|
Treated
over 1,600 patients with Proxcelan Cs-131 seeds (October 2004 to
September
2007);
|
§
|
Deployed
and grew the direct sales force to 11 people in the market (July
2007);
|
§
|
Branded
Cs-131 seeds as Proxcelan Cesium-131 brachytherapy seeds (July
2007);
|
§
|
Developed
a dual therapy treatment protocol with 9 centers participating
(June
2007);
|
§
|
Raised
over $42 million in debt and equity funding (September 2003 - June
2007);
|
§
|
Filed
additional patent applications for the production of purified Cs-131
(November 2003 – February 2007);
|
§
|
Completed
the monotherapy treatment protocol for prostate cancer (February
2007);
|
§
|
Obtained
FDA 510(k) clearance to market preloaded brachytherapy seeds (preloaded
Mick cartridges, strands, and needles) (November
2006);
|
§
|
Opened
a manufacturing and production facility at PIRL (October
2005);
|
§
|
Treated
the first patient with Cs-131 seeds (October
2004);
|
§
|
Commenced
production of the Cs-131 seed (August
2004);
|
§
|
Obtained
a Nuclear Regulatory Commission Sealed Source and Device Registration
required by the Washington State Department of Health and the FDA
(September 2004);
|
§
|
Received
a Radioactive Materials License from the Washington State Department
of
Health (July 2004);
|
§
|
Signed
a Commercial Work for Others Agreement between Battelle (manager
of the
Pacific Northwest National Laboratory or PNNL) and IsoRay, allowing
initial production of seeds through 2006 at PNNL (April
2004);
|
§
|
Obtained
Medicare reimbursement codes for the Cs-131 brachytherapy seed
(November
2003);
|
§
|
Obtained
FDA 510(k) clearance to market the first product: the Cs-131 brachytherapy
seed (March 2003);
|
§
|
Implemented
a quality management system and production operating procedures
that are
compliant with the FDA’s Quality System Regulation (QSR) (January
2003);
|
§
|
Completed
prototype radioactive seed production, design verification, computer
modeling of the radiation profile, and actual dosimetric data compiled
by
the National Institute of Standards and Technology and PNNL (October
2002); and
|
§
|
Obtained
the initial patent for Cs-131 isotope separation and purification
(May
2000).
|
§
|
Age
– about 2 out of every 3 prostate cancers are found in men over the
age of
65;
|
§
|
Race
– prostate cancer is more prevalent in African-American men who are
also
twice as likely to die of the
disease;
|
§
|
Nationality
– prostate cancer is most common in North America and northwestern
Europe;
|
§
|
Family
history – men are more likely to have prostate cancer if a close relative
had the disease and especially if the relatives were young at the
time of
diagnosis;
|
§
|
Diet
– men who eat more red meat or high-fat dairy products seem to have
a
greater chance of getting prostate cancer;
and
|
§
|
Exercise
– men over the age of 65 who exercised vigorously had a lower rate
of
prostate cancer.
|
§
|
In
September 2006, a 5-year prospective study to assess the impact
of
interstitial brachytherapy on the quality of life of patients with
localized prostate cancer was published. The results of the study
confirm
the low impact of interstitial brachytherapy on the patients’ quality of
life despite its transient negative effects on some functions (Caffo,
O.,
et al. International
Journal of Radiation Oncology; Volume 66; 1;31-37).
|
§
|
Results
of a trial published in 2007 in the International Journal of Radiation
Oncology looking at 15-year survival in 223 patients with stage
T1-T3
prostate cancer and treated with brachytherapy in combination with
external beam and demonstrated excellent long-term biochemical
control.
Fifteen-year biochemical relapse free survival (BRFS) for the entire
treatment group was 74%. BRFS using the Memorial Sloan-Kettering
risk
cohort analysis (95% confidence interval) were as follows: low
risk 88%,
intermediate risk 80%, and high risk 53% (Sylvester J. et al. “15-year
biochemical relapse free survival in clinical stage T1-T3 prostate
cancer
following combined external beam radiotherapy and brachytherapy;
Seattle
experience”, Int. J. Rad. Onc. Biol., Vol. 67, 2007,
57-64.).
|
§
|
A
study of 367 patients with localized prostate cancer treated using
real-time intraoperative planning technique with median follow
up of 63
months demonstrated this technique consistently achieved optimal
coverage
of the prostate with concomitant low doses delivered to the urethra
and
rectum. Biochemical control outcomes were excellent at 5 years
(Zelefsky
M, et al. “Five-year outcome of intraoperative conformal permanent I-125
interstitial implantation for patient with clinically localized
prostate
cancer’, Int. J. Rad. Onc. Biol., Vol. 67, 2007,
65-70.).
|
§
|
A
1700 patient case review over 12 years was conducted by J. Sharkey
and
published in the August 2004 edition of Brachytherapy. The review
of
patients diagnosed with T1 or T2 adenocarcinoma of the prostate
and
treated with either radical prostatectomy or brachytherapy showed
superiority of brachytherapy over prostatectomy. Low risk brachytherapy
resulted in 99% freedom from PSA failure while surgery showed results
of
97% (Sharkey J, et al. “Pd-103 brachytherapy versus radical prostatectomy
in patient with clinically localized prostate cancer: a 12-year
experience
from a single group practice”. Brachytherapy, 4,
2005.).
|
§
|
Patient
reported symptoms (IPSS Scores) were mild to moderate with relatively
rapid resolution within 4-6 months.
|
§
|
Prostate
Specific Antigen, or PSA, response over 12 months was very encouraging,
i.e. low levels with no failures per the nadir definition. (Prestidge
BR,
Bice WS, “Clinical
outcomes
of
a
Phase II, multi-institutional
Cesium-131 permanent prostate brachytherapy trial”. Brachytherapy, Volume
6, Issue 2, April-June
2007, Page
78) (Moran BJ, Braccioforte MH, “Cesium-131
prostate brachytherapy:
An
early experience”. Brachytherapy, Volume
6, Issue 2, April-June
2007, Page
80).
|
§
|
The
resolution of acute side effects proved to be much quicker with
Cs-131
compared to I-125 thus validating the theoretical argument that
dose
related side effects dissipate faster with shorter lived isotopes.
(Prestidge BR, “Cesium-131; the isotope of choice in permanent prostate
brachytherapy”. Oral Presentation at the American Brachytherapy Society
annual conference, April 2007.).
|
§
|
The
dosimetric observations of the trial demonstrated that it was possible
to
deliver adequate dose to the prostate while maintaining dose uniformity
across the gland. The dose delivered to critical structures was
well
within acceptable limits. (Bice WS, Prestidge BR, “Cesium-131 permanent
prostate brachytherapy: The dosimetric analysis of a multi-institutional
Phase II trial”. Brachytherapy 2007(6);
88-89.).
|
§
|
Continue
to introduce the Proxcelan Cs-131 brachytherapy seed into the U.S.
market.
Utilizing our direct sales organization and selected channel partners,
IsoRay intends to continue expanding the use of Proxcelan Cs-131
seeds in
brachytherapy procedures for prostate cancer, by increasing the
number of
treatment centers offering Cs-131 and increasing the number of
patients
treated at each center using Cs-131. IsoRay hopes to capture much
of the
incremental market growth in seed implant brachytherapy and take
market
share from existing competitors.
|
§
|
Move
our state-of-the-art manufacturing process to a new
facility.
IsoRay has completed construction of a new manufacturing facility
in
Richland, Washington in its recently leased facility at the Applied
Process Engineering Laboratory (APEL facility). This facility replaces
our
currently leased production facility (PIRL facility). The new facility
is
four times larger than the size of our former facility and will
allow
production to expand as sales orders
increase.
|
§
|
Develop
an enriched barium manufacturing process.
Working
with leading scientists, IsoRay is working to design and create
a
proprietary process for manufacturing enriched barium, a key source
material for Cs-131. This will ensure adequate future supply of
Cs-131 and
greater efficiencies in producing the
isotope.
|
§
|
Introduce
Cs-131 therapies for other cancers.
IsoRay intends to partner with other companies to develop the appropriate
technologies and therapeutic delivery systems for treatment of
other solid
tumors such as breast, lung, liver, ocular, pancreas, neck, and
brain
cancers. IsoRay’s management believes that the first major opportunities
may be for the use of Cs-131 for ocular melanoma and as adjunct
therapy
for lung cancer (treating the surgical
margins).
|
§
|
Support
clinical research and sustained product development.
The Company plans to structure and support clinical studies on
the
therapeutic benefits of Cs-131 for the treatment of solid tumors
and other
patient benefits. We are and will continue to support clinical
studies
with several leading radiation oncologists to clinically document
patient
outcomes, provide support for our product claims, and compare the
performance of our seeds to competing seeds. IsoRay plans to sustain
long-term growth by implementing research and development programs
with
leading medical institutions in the U.S. and other countries to
identify
and develop other applications for IsoRay’s core radioisotope
technology.
|
§
|
Diversify
our supply of Cs-131.
Currently, the Company relies heavily on Cs-131 from its primary
Russian
supplier. This supplier has significant capacity for producing
Cs-131 with
higher quality than currently available from other sources. The
Company is
actively developing the capability to produce multi-curie quantities
of
Cs-131 from several reactor sources located both abroad and
domestically.
|
§
|
Introduce
Proxcelan Cesium-131 brachytherapy seeds to the European and Russian
markets.
The Company is currently working to obtain the European CE Mark
and
certification to ISO 13485 to enable the sale of our product in
the
European Union. If the proposed strategic alliance with IBt, SA,
a Belgian
company, is ultimately consummated, it will allow the Company to
obtain
access to various foreign countries through IBt distribution channels
and
leverage IBt's international regulatory
expertise.
|
Cesium-131
|
Palladium-103
|
Iodine-125
|
||||
Half
Life
|
9.7
Days
|
17.5
days
|
60
days
|
|||
Avg.
Energy
|
30.4
keV+
|
20.8
keV+
|
28.5
keV+
|
|||
Dose
Delivery
|
90%
in 33 days
|
90%
in 58 days
|
90%
in 204 days
|
|||
Total
Dose
|
115
Gy
|
125
Gy
|
145
Gy
|
|||
Anisotropy
Factor*
|
0.969
|
0.877
(TheraSeed® 200)
|
0.930
(OncoSeed® 6711)
|
§
|
Loose
seeds
|
§
|
Pre-loaded
needles
(loaded with 3 to 5 seeds and
spacers)
|
§
|
Strands
of seeds
(consists of seeds and spacers in a biocompatible “shrink wrap”)
|
§
|
Pre-loaded
Mick cartridges
(fits the Mick applicator)
|
§
|
American
Brachytherapy Society (ABS),
|
§
|
American
Society for Therapeutic Radiation and Oncology
(ASTRO),
|
§
|
American
Urological Association (AUA),
|
§
|
Association
of American Physicists in Medicine (AAPM),
and
|
§
|
various
other professional society
meetings.
|
1.
|
Urinary
Morbidity Following Cs-131 Brachytherapy for Localized Prostate
Cancer
|
2.
|
Results
of a Multi-Institutional Trial Using Cesium-131 Permanent Prostate
Brachytherapy
|
3.
|
BED
as a Predictive Tool for the Outcome of a Permanent Prostate Brachytherapy
Trial Using Cesium-131 as
Monotherapy
|
4.
|
Dosimetric
Comparison of Cesium-131 and Palladium-103 for Permanent Prostate
Brachytherapy
|
Community Hospital of Los Gatos | Los Gatos, CA | 24.5% of revenue |
Chicago Prostate Cancer Center | Westmont, IL | 13.2% of revenue |
§
|
our
achievement of product development objectives and
milestones;
|
§
|
demand
and pricing for the Company’s
products;
|
§
|
effects
of aggressive competitors;
|
§
|
hospital,
clinic and physician buying
decisions;
|
§
|
research
and development and manufacturing
expenses;
|
§
|
patient
outcomes from our therapy;
|
§
|
physician
acceptance of our products;
|
§
|
government
or private healthcare reimbursement
policies;
|
§
|
our
manufacturing performance and
capacity;
|
§
|
incidents,
if any, that could cause temporary shutdown of our manufacturing
facility;
|
§
|
the
amount and timing of sales orders;
|
§
|
rate
and success of future product
approvals;
|
§
|
timing
of FDA clearance, if any, of competitive products and the rate of
market
penetration of competing products;
|
§
|
seasonality
of purchasing behavior in our
market;
|
§
|
overall
economic conditions; and
|
§
|
the
successful introduction or market penetration of alternative
therapies.
|
Year
ended June 30, 2007
|
High
|
Low
|
|||||
First
quarter
|
$
|
3.50
|
$
|
2.75
|
|||
Second
quarter
|
6.00
|
3.00
|
|||||
Third
quarter
|
4.90
|
3.80
|
|||||
Fourth
quarter
|
5.18
|
3.51
|
High
|
Low
|
||||||
First
quarter
|
$
|
5.95
|
$
|
1.00
|
|||
Second
quarter
|
8.25
|
4.50
|
|||||
Third
quarter
|
7.25
|
6.20
|
|||||
6.40
|
3.25
|
Plan
Category
|
Number
of
securities to be issued on exercise of outstanding options, warrants and rights #
|
Weighted-
average exercise price of outstanding options, warrants, and rights $
|
Number
of
securities remaining available for future issuance under equity compensation plans |
|||||||
Equity
compensation plans approved by shareholders
|
N/A
|
N/A
|
N/A
|
|||||||
Equity
compensation plans not approved by shareholders
|
3,683,439
|
$
|
2.86
|
259,778
|
||||||
Total
|
3,683,439
|
$
|
2.86
|
259,778
|
2006
|
|||||||
Municipal
debt securities
|
$
|
3,000,000
|
$
|
–
|
|||
6,942.840
|
–
|
||||||
$
|
9,942,840
|
$
|
–
|
3
to 7 years
|
||
Office
equipment
|
2
to 5 years
|
|
Furniture
and fixtures
|
2
to 5 years
|
2007
|
2006
|
||||||
Value
of shares issued to guarantors:
|
|||||||
Benton-Franklin
Economic Development District (83,640 shares)
|
$
|
138,006
|
$
|
138,006
|
|||
Columbia
River Bank line of credit (127,500 shares)
|
–
|
210,375
|
|||||
Benton-Franklin
Economic Development
|
|||||||
District
loan fees
|
3,450
|
3,450
|
|||||
Columbia
River Bank line of credit loan fees
|
–
|
500
|
|||||
Convertible
debentures issuance costs
|
–
|
30,047
|
|||||
Hanford
Area Economic Investment Fund Committee loan fees
|
22,128
|
22,128
|
|||||
Less
amortization
|
(67,859
|
)
|
(130,148
|
)
|
|||
$
|
95,725
|
$
|
274,358
|
2007
|
2006
|
||||||
Beginning
balance
|
$
|
67,425
|
$
|
–
|
|||
New
obligations
|
–
|
63,040
|
|||||
Changes
in estimates of existing obligations
|
56,120
|
–
|
|||||
Accretion
of discount
|
7,597
|
4,385
|
|||||
$
|
131,142
|
$
|
67,425
|
Year
ended June 30,
|
|||||||
2007
|
2006
|
||||||
Cost
of product sales
|
$
|
120,710
|
$
|
–
|
|||
Research
and development
|
41,481
|
–
|
|||||
Sales
and marketing
|
216,432
|
–
|
|||||
General
and administrative
|
1,449,491
|
–
|
|||||
$
|
1,828,114
|
$
|
–
|
2007
|
2006
|
||||||
Preferred
stock
|
59,065
|
144,759
|
|||||
Preferred
stock warrants
|
–
|
179,512
|
|||||
Common
stock warrants
|
3,627,764
|
2,502,769
|
|||||
Common
stock options
|
3,683,439
|
3,129,692
|
|||||
Convertible
debentures
|
–
|
109,639
|
|||||
7,370,268
|
6,066,371
|
Year
ending June 30,
|
||||
2008
|
$
|
49,212
|
||
2009
|
53,609
|
|||
2010
|
182,566
|
|||
2011
|
38,436
|
|||
2012
|
41,983
|
|||
Thereafter
|
211,652
|
|||
|
$
|
577,458
|
Year
ending June 30,
|
||||
2008
|
$
|
214,269
|
||
2009
|
27,626
|
|||
Total
future minimum lease payments
|
241,895
|
|||
Less
amounts representing interest
|
(21,480
|
)
|
||
Present
value of net minimum lease payments
|
220,415
|
|||
Less
amounts due in one year
|
(194,855
|
)
|
||
Amounts
due after one year
|
$
|
25,560
|
Year
ending June 30,
|
||||
2008
|
$
|
372,118
|
||
2009
|
338,496
|
|||
2010
|
338,354
|
|||
2011
|
337,925
|
|||
2012
|
328,749
|
|||
Thereafter
|
1,260,206
|
|||
$
|
2,975,848
|
§
|
An
amendment to IsoRay’s license agreement with IBt for use of its polymer
seed technology whereby IsoRay would pay the remaining $225,000 license
fee but would not be subject to ongoing royalty payments. IsoRay
would
purchase polymer seed components at cost plus a profit margin to
be
determined.
|
§
|
The
Company would grant IBt an exclusive license to distribute Cs-131
brachytherapy seeds in certain markets outside of North and South
America,
including the European Union.
|
§
|
The
Company would receive the exclusive right to manufacture and distribute
polymer I-125 brachytherapy seeds in North and South
America.
|
§
|
The
Company would also receive IBt’s US subsidiary’s customer list and the
right to offer employment to certain IBt US
employees.
|
§
|
Reviewed
the duties of all accounting personnel and reassigned any conflicting
duties to other personnel;
|
§
|
Established
daily management reviews of cash and accounts receivable activities
and
positions;
|
§
|
Distributed
monthly operating results for review by management in an appropriate
time
frame; and
|
§
|
Established
monthly reconciliation procedures including review by the appropriate
supervisor.
|
§
|
Established
monthly reconciliation procedures including review by the appropriate
supervisor;
|
§
|
Established
and implemented various accounting policies and procedures;
and
|
§
|
Distributed
monthly operating results for review by management in an appropriate
time
frame.
|
Name
|
Age
|
Position
Held
|
Term*
|
|||
|
|
|||||
Roger
Girard
|
64
|
Chairman,
President, CEO
|
Annual
|
|||
Jonathan
Hunt
|
40
|
Chief
Financial Officer –
Treasurer
|
||||
David
Swanberg
|
51
|
Executive
Vice President – Operations and Corporate Secretary,
Director
|
Annual
|
|||
Lori
Woods
|
45
|
Vice
President
|
||||
Dwight
Babcock
|
59
|
Director
|
Annual
|
|||
Stephen
Boatwright
|
43
|
Director
|
Annual
|
|||
Robert
Kauffman
|
66
|
Director
|
Annual
|
|||
Thomas
LaVoy
|
47
|
Director
|
Annual
|
|||
Albert
Smith
|
63
|
Director
|
Annual
|
Name
|
Age
|
Position
Held and Tenure
|
||
Fredric
Swindler
|
59
|
VP,
Regulatory Affairs and Quality Assurance
|
||
Lane
Bray
|
79
|
Chemist
|
||
Oleg
Egorov
|
37
|
Director
of Research and Development
|
Name and principal position
|
Year
|
Salary ($)
|
Bonus ($)
|
Stock
awards ($)
|
Option
awards ($)
(1)
|
Nonequity
incentive
plan
compensation
($)
|
Nonqualified
deferred
compensation
earnings
($)
|
All other
compensation
($)
|
Total ($)
|
|||||||||||||||||||
Roger
Girard, Chairman and CEO (2)
|
2007
|
298,042
|
-
|
-
|
600,500
|
-
|
-
|
-
|
898,542
|
|||||||||||||||||||
2006
|
199,231
|
-
|
-
|
-
|
-
|
-
|
-
|
199,231
|
||||||||||||||||||||
David
Swanberg, Executive Vice President - Operations (2) (3)
|
2007
|
161,539
|
-
|
-
|
372,228
|
-
|
-
|
-
|
533,767
|
|||||||||||||||||||
2006
|
120,000
|
25,000
|
-
|
79,500
|
-
|
-
|
-
|
224,500
|
||||||||||||||||||||
Lori
Woods, Vice President (4)
|
2007
|
155,692
|
-
|
-
|
327,150
|
-
|
-
|
-
|
482,842
|
|||||||||||||||||||
2006
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||
Jonathan
Hunt, Chief Financial Officer (5)
|
2007
|
120,000
|
-
|
-
|
205,650
|
-
|
-
|
24,266
|
349,916
|
|||||||||||||||||||
2006
|
60,000
|
-
|
-
|
58,512
|
-
|
-
|
-
|
118,512
|
||||||||||||||||||||
Michael
Dunlop, former Chief Financial Officer (6)
|
2007
|
30,660
|
-
|
-
|
-
|
-
|
-
|
288,000
|
318,660
|
|||||||||||||||||||
2006
|
80,167
|
-
|
-
|
79,500
|
-
|
-
|
-
|
159,667
|
(1)
|
Amounts
represent the FAS 123R valuation for the fiscal year ended June 30,
2007
and 2006, respectively. All such options were awarded under one of
the
Company’s stock option plans. All options awarded (with the exception of
Mr. Swanberg’s and Mr. Dunlop’s fiscal year 2006 stock option grants that
were immediately vested on the grant date) vest in three equal annual
installments beginning with the first anniversary from the date of
grant
and expire ten years after the date of grant. All options were granted
at
the fair market value of the Company’s stock on the date of grant and the
Company used a Black-Scholes methodology as discussed in the footnotes
to
the financial statements to value the
options.
|
(2)
|
Mr.
Girard and Mr. Swanberg were granted 150,000 and 100,000 options,
respectively, on June 1, 2007. These options have an exercise price
of
$4.14 and vest over 3 years. On July 25, 2007, the Board discussed
the
issue of director compensation and each director (including Mr. Girard
and
Mr. Swanberg) elected to cancel 50,000 of their options from the
June 1,
2007 grant. After the cancellation, Mr. Girard and Mr. Swanberg had
100,000 and 50,000 options, respectively, from the June 1, 2007 grant.
The
terms of these options were not changed as part of the cancellation.
Under
FAS 123R, the value of the cancelled options to Mr. Girard and Mr.
Swanberg were $128,500 each. The value of these options has been
included
in the table above.
|
(3)
|
The
value of Mr. Swanberg’s options includes $7,728 relating to options
granted to his wife who is also an employee of the
Company.
|
(4)
|
Ms.
Woods became an employee of the Company on July 5,
2006.
|
(5)
|
Mr.
Hunt became an employee of the Company on May 1, 2006. The Company
reimbursed Mr. Hunt for certain of his relocation costs and this
amount is
included in the “All other compensation” column for fiscal year
2007.
|
(6)
|
Mr.
Dunlop left the Company in September 2006. As part of his employment
agreement, Mr. Dunlop was entitled to a severance payment of $288,000
and
this amount is included in the “All other compensation”
column.
|
Option
awards
|
||||||||||||||||
Name
|
Number of
securities
underlying
unexercised
options (#)
exercisable
|
Number of
securities
underlying
unexercised
options (#)
unexercisable
|
Equity
incentive
plan
awards:
Number of
securities
underlying
unexercised
unearned
options (#)
|
Option
exercise
price ($)
|
Option
expiration
date
|
|||||||||||
Roger
Girard, Chief Executive Officer (Principal Executive
Officer)
|
513,840
|
-
|
-
|
1.19
|
8/1/2015
|
|||||||||||
|
- |
100,000
|
(1)
|
-
|
3.11
|
8/15/2016
|
||||||||||
|
- |
150,000
|
(2)
|
-
|
4.14
|
6/1/2017
|
||||||||||
David
Swanberg, Executive Vice President - Operations
|
150,000
|
-
|
-
|
1.00
|
8/18/2015
|
|||||||||||
|
- |
50,000
|
(1)
|
-
|
3.11
|
8/15/2016
|
||||||||||
|
- |
100,000
|
(2)
|
-
|
4.14
|
6/1/2017
|
||||||||||
Lori
Woods, Vice President
|
-
|
50,000
|
(3)
|
-
|
3.50
|
7/5/2016
|
||||||||||
|
- |
50,000
|
(4)
|
-
|
3.10
|
10/17/2016
|
||||||||||
|
- |
15,000
|
(5)
|
-
|
4.40
|
3/2/2017
|
||||||||||
|
- |
20,000
|
(6)
|
-
|
4.14
|
6/1/2017
|
||||||||||
Jonathan
Hunt, Chief Financial Officer
|
10,000
|
20,000
|
(7)
|
-
|
5.50
|
5/1/2016
|
||||||||||
|
- |
50,000
|
(4)
|
-
|
3.10
|
10/17/2016
|
||||||||||
|
- |
15,000
|
(5)
|
-
|
4.40
|
3/2/2017
|
||||||||||
|
- |
20,000
|
(6)
|
-
|
4.14
|
6/1/2017
|
||||||||||
Michael
Dunlop, former Chief Financial Officer
|
-
|
-
|
-
|
-
|
-
|
(1)
|
Represents
the August 15, 2006 grant, one-third of which became exercisable
on August
15, 2007, one-third of which will become exercisable on August 15,
2008,
and the final third will become exercisable on August 15,
2009.
|
(2)
|
Mr.
Girard and Mr. Swanberg were granted 150,000 and 100,000 options,
respectively, on June 1, 2007. These options have an exercise price
of
$4.14 and vest over 3 years. On July 25, 2007, the Board discussed
the
issue of director compensation and each director (including Mr. Girard
and
Mr. Swanberg) elected to cancel 50,000 of their options from the
June 1,
2007 grant. After the cancellation, Mr. Girard and Mr. Swanberg had
100,000 and 50,000 options, respectively, from the June 1, 2007 grant.
The
terms of these options was not changed as part of the cancellation.
These
cancelled options have been included in the table above as they were
outstanding on June 30, 2007.
|
(3)
|
Represents
a July 5, 2006 grant, one-third of which became exercisable on July
1,
2007, one-third of which will become exercisable on July 1, 2008,
and the
final third will become exercisable on July 1,
2009.
|
(4)
|
Represents
the October 17, 2006 grant, one-third of which will become exercisable
on
October 17, 2007, one-third of which will become exercisable on October
17, 2008, and the final third will become exercisable on October
17,
2009.
|
(5)
|
Represents
the March 2, 2007 grant, one-third of which will become exercisable
on
March 2, 2008, one-third of which will become exercisable on March
2,
2009, and the final third will become exercisable on March 2,
2010.
|
(6)
|
Represents
the June 1, 2007 grant, one-third of which will become exercisable
on June
1, 2008, one-third of which will become exercisable on June 1, 2009,
and
the final third will become exercisable on June 1,
2010.
|
(7)
|
Represents
the final two-thirds vesting of a May 1, 2006 grant, half of which
will
become exercisable on May 1, 2008 and the other half will become
exercisable on May 1, 2009.
|
Name
|
Fees
earned or
paid in
cash ($)
(1)
|
Stock
awards ($)
|
Option
awards ($)
(2) (3)
|
Non-equity
incentive
plan
compensation
($)
|
Non-qualified
deferred
compensation
earnings
($)
|
All other
compensation
($)
|
Total ($)
|
|||||||||||||||
Dwight
Babcock
|
8,000
|
-
|
236,000
|
-
|
-
|
-
|
244,000
|
|||||||||||||||
Stephen
Boatwright
|
8,000
|
-
|
236,000
|
-
|
-
|
-
|
244,000
|
|||||||||||||||
Robert
Kauffman
|
8,000
|
-
|
236,000
|
-
|
-
|
-
|
244,000
|
|||||||||||||||
Thomas
LaVoy
|
7,000
|
-
|
236,000
|
-
|
-
|
-
|
243,000
|
|||||||||||||||
Albert
Smith
|
7,000
|
-
|
236,000
|
-
|
-
|
-
|
243,000
|
(1)
|
In
fiscal year 2007, each non-employee director received cash compensation
of
$1,000 per meeting attended. Beginning in fiscal year 2008, each
non-employee director will receive cash compensation of $3,000 per
month,
except for Mr. Boatwright who will receive $1,000 per month. In addition,
each non-employee director will receive $1,000 per Board meeting
attended
in person or $500 per Board meeting attended via telephone and $500
per
committee meeting attended.
|
(2)
|
This
represents the value determined in accordance with FAS 123R for the
option
grant of August 15, 2006. Each non-employee director also received
a grant
of 50,000 options with an exercise price of $4.14 per share on June
1,
2007. After a discussion of director compensation with the entire
Board,
each Board member elected to cancel their June 1, 2007 option grant
on
July 25, 2007 in exchange for the additional cash compensation discussed
in (1) above. Under FAS 123R, these options were valued at $128,500
per
director. The value of these options has been included in the table
above
and in the financial statements as they were fully vested on the
day of
grant.
|
(3)
|
Each
director had stock options to purchase 200,000 shares of the Company’s
common stock outstanding as of June 30, 2007 including the June 1,
2007
grant (for 50,000 shares per director) that was subsequently cancelled
on
July 25, 2007.
|
Common
Stock Share Ownership
|
|||||||||||||
Name of Beneficial Owner
|
Common Shares
Owned
|
Common Stock
Options
Exercisable
Within 60 Days
|
Common
Warrants
|
Percent of
Class (1)
|
|||||||||
Roger
Girard
|
368,534
|
547,173
|
-
|
3.98
|
%
|
||||||||
David
Swanberg (2)
|
324,327
|
179,999
|
5,500
|
2.21
|
%
|
||||||||
Lori
Woods
|
3,000
|
33,332
|
-
|
—
|
%
|
||||||||
Jonathan
Hunt
|
-
|
26,666
|
-
|
—
|
%
|
||||||||
Michael
Dunlop
|
195,050
|
-
|
-
|
—
|
%
|
||||||||
Dwight
Babcock (3)
|
61,002
|
150,000
|
12,500
|
—
|
%
|
||||||||
Stephen
Boatwright (4)
|
60,000
|
150,000
|
-
|
—
|
%
|
||||||||
Robert
Kauffman
|
43,802
|
150,000
|
-
|
—
|
%
|
||||||||
Thomas
LaVoy
|
8,423
|
150,000
|
-
|
—
|
%
|
||||||||
Albert
Smith
|
108,947
|
150,000
|
12,500
|
1.18
|
%
|
||||||||
Directors
and Executive Officers as a group
|
1,173,085
|
1,537,170
|
30,500
|
11.90
|
%
|
Percentage
ownership is based on 23,033,108 shares of Common Stock outstanding
on
September 12, 2007. Shares of Common Stock subject to stock options
which
are currently exercisable or will become exercisable within 60
days after
September 12, 2007 are deemed outstanding for computing the percentage
ownership of the person or group holding such options, but are
not deemed
outstanding for computing the percentage ownership of any other
person or
group.
|
||
Mr.
Swanberg’s options include 13,333 options granted to his
spouse.
|
||
(3)
|
Mr.
Babcock’s common shares owned include 2,695 shares owned by his
spouse.
|
|
(4)
|
Mr.
Boatwright’s common shares owned are held by an entity controlled by Mr.
Boatwright.
|
Name of Beneficial Owner
|
Preferred
Shares
Owned
|
Percent
of
Class (1)
|
|||||
Aissata
Sidibe (2)
|
20,000
|
33.86
|
%
|
||||
William
and Karen Thompson Trust (3)
|
14,218
|
24.07
|
%
|
||||
Jamie
Granger (4)
|
10,529
|
17.83
|
%
|
||||
Hostetler
Living Trust (5)
|
9,479
|
16.05
|
%
|
||||
Leslie
Fernandez (6)
|
3,688
|
6.24
|
%
|
Percentage
ownership is based on 59,065 shares of Preferred Stock outstanding
on
September 12, 2007.
|
||
(2)
|
The
address of Ms. Sidibe is 229 Lasiandra Ct, Richland, WA
99352.
|
|
(3)
|
The
address of the William and Karen Thompson Trust is 285 Dondero
Way, San
Jose, CA 95119.
|
|
(4)
|
The
address of Jamie Granger is 53709 South Nine Canyon Road, Kennewick,
WA
99337.
|
|
The
address of the Hostetler Living Trust is 9257 NE 175th Street,
Bothell, WA
98011.
|
||
(6)
|
The
address of Leslie Fernandez is 2615 Scottsdale Place, Richland,
WA
99352.
|
Exhibit #
|
Description
|
|
2.1
|
Merger
Agreement dated as of May 27, 2005, by and among Century Park Pictures
Corporation, Century Park Transitory Subsidiary, Inc., certain
shareholders and IsoRay Medical, Inc. incorporated by reference
to the
Form 8-K filed on August 3, 2005.
|
|
2.2
|
Certificate
of Merger, filed with the Delaware Secretary of State on July 28,
2005
incorporated by reference to the Form 8-K filed on August 3, 2005.
|
|
3.1
|
Articles
of Incorporation and By-Laws are incorporated by reference to the
Exhibits
to the Company's Registration Statement of September 15,
1983.
|
|
3.2
|
Certificate
of Designation of Rights, Preferences and Privileges of Series
A and B
Convertible Preferred Stock, filed with the Minnesota Secretary
of State
on June 29, 2005 incorporated by reference to the Form 8-K filed
on August
3, 2005.
|
|
3.3
|
Restated
and Amended Articles of Incorporation incorporated by reference
to the
Form 10-KSB filed on October 11, 2005.
|
|
3.4
|
Text
of Amendments to the Amended and Restated By-Laws of the Company,
incorporated by reference to the Form 8-K filed on February 7,
2007.
|
|
4.2
|
Form
of Lock-Up Agreement for Certain IsoRay Medical, Inc. Shareholders
incorporated by reference to the Form 8-K filed on August 3,
2005.
|
|
4.3
|
Form
of Lock-Up Agreement for Anthony Silverman incorporated by reference
to
the Form 8-K filed on August 3, 2005.
|
|
4.4
|
Form
of Registration Rights Agreement among IsoRay Medical, Inc., Century
Park
Pictures Corporation and the other signatories thereto incorporated
by
reference to the Form 8-K filed on August 3, 2005.
|
|
4.5
|
Form
of Escrow Agreement among Century Park Pictures Corporation, IsoRay
Medical, Inc. and Anthony Silverman incorporated by reference to
the Form
8-K filed on August 3, 2005.
|
4.6
|
Form
of Escrow Agreement among Century Park Pictures Corporation, IsoRay
Medical, Inc. and Thomas Scallen incorporated by reference to the
Form 8-K
filed on August 3, 2005.
|
|
4.7
|
Amended
and Restated 2005 Stock Option Plan incorporated by reference to
the Form
S-8 filed on August 19, 2005.
|
|
4.8
|
Amended
and Restated 2005 Employee Stock Option Plan incorporated by reference
to
the Form S-8 filed on August 19, 2005.
|
|
4.9
|
Form
of Registration Right Agreement among IsoRay Medical, Inc., Meyers
Associates, L.P. and the other signatories thereto, dated October
15,
2004, incorporated by reference to the Form SB-2 filed on November
10,
2005.
|
|
4.10
|
Form
of Registration Rights Agreement among IsoRay, Inc., Meyers Associates,
L.P. and the other signatories thereto, dated February 1, 2006,
incorporated by reference to the Form SB-2/A1 filed on March 24,
2006.
|
|
4.11
|
Form
of IsoRay, Inc. Common Stock Purchase Warrant, incorporated by
reference
to the Form SB-2/A1 filed on March 24, 2006.
|
|
4.12
|
2006
Director Stock Option Plan, incorporated by reference to the Form
S-8
filed on August 18, 2006.
|
|
4.13
|
Form
of Registration Rights Agreement among IsoRay, Inc. and the other
signatories thereto, dated August 9, 2006, incorporated by reference
to
the Form 8-K filed on August 18, 2006.
|
|
4.14
|
Form
of IsoRay, Inc. Common Stock Purchase Warrant, dated August 9,
2006,
incorporated by reference to the Form 8-K filed on August 18,
2006.
|
|
4.15
|
Form
of Registration Rights Agreement among IsoRay, Inc., Meyers Associates,
L.P. and the other signatories thereto, dated October 17, 2005,
incorporated by reference to the Form SB-2 filed on October 16,
2006.
|
|
4.16
|
Amended
and Restated 2006 Director Stock Option Plan, incorporated by reference
to
the Form S-8/A1 filed on December 18, 2006.
|
|
4.17
|
Amended
and Restated 2005 Stock Option Plan, incorporated by reference
to the Form
S-8/A1 filed on December 18, 2006.
|
|
4.18
|
Intentionally
omitted.
|
|
4.19
|
Rights
Agreement, dated as of February 1, 2007, between the Computershare
Trust
Company N.A., as Rights Agent, incorporated by reference to Exhibit
1 to
the Company’s Registration Statement on Form 8-A filed on February 7,
2007.
|
|
4.20
|
Certificate
of Designation of Rights, Preferences and Privileges of Series
C Junior
Participating Preferred Stock, incorporated by reference to Exhibit
1 to
the Company’s Registration Statement on Form 8-A filed February 7,
2007.
|
|
10.2
|
Universal
License Agreement, dated November 26, 1997 between Donald C. Lawrence
and
William J. Stokes of Pacific Management Associates Corporation,
incorporated by reference to the Form SB-2 filed on November 10,
2005.
|
|
10.3
|
Royalty
Agreement of Invention and Patent Application, dated July 12, 1999
between
Lane A. Bray and IsoRay LLC, incorporated by reference to the Form
SB-2
filed on November 10, 2005.
|
|
10.4
|
Tri-City
Industrial Development Council Promissory Note, dated July 22,
2002,
incorporated by reference to the Form SB-2/A2 filed on April 27,
2006.
|
|
10.5
|
Section
510(k) Clearance from the Food and Drug Administration to market
Lawrence
CSERION Model CS-1, dated March 28, 2003, incorporated by reference
to the
Form SB-2 filed on November 10, 2005.
|
|
10.6
|
Battelle
Project No. 45836 dated June 20, 2003, incorporated by reference
to the
Form SB-2/A2 filed on April 27, 2006.
|
|
10.7
|
Applied
Process Engineering Laboratory APEL Tenant Lease Agreement, dated
April
23, 2001 between Energy Northwest and IsoRay, LLC, incorporated
by
reference to the Form SB-2/A2 filed on April 27, 2006.
|
|
10.8
|
Work
for Others Agreement No. 45658, R2, dated April 27, 2004 between
Battelle
Memorial Institute, Pacific Northwest Division and IsoRay Products
LLC,
incorporated by reference to the Form SB-2/A2 filed on April 27,
2006.
|
|
10.9
|
Development
Loan Agreement for $230,000, dated September 15, 2004 between
Benton-Franklin Economic Development District and IsoRay Medical,
Inc.,
incorporated by reference to the Form SB-2/A2 filed on April 27,
2006.
|
10.10
|
Registry
of Radioactive Sealed Sources and Devices Safety Evaluation of
Sealed
Source, dated September 17, 2004, incorporated by reference to
the Form
SB-2/A2 filed on April 27, 2006.
|
|
10.11
|
CRADA
PNNL/245, "Y-90 Process Testing for IsoRay", dated December 22,
2004
between Pacific Northwest National Laboratory and IsoRay Medical
Inc.,
including Amendment No. 1, incorporated by reference to the Form
SB-2/A2
filed on April 27, 2006.
|
|
10.12
|
Intentionally
Omitted
|
|
10.13
|
Amendment
1 to Agreement 45658, dated February 23, 2005 between Battelle
Memorial
Institute Pacific Northwest Division and IsoRay Medical, Inc.,
incorporated by reference to the Form SB-2/A2 filed on April 27,
2006.
|
|
10.14
|
Equipment
Lease Agreement dated April 14, 2005 between IsoRay Medical, Inc.
and
Nationwide Funding, LLC, incorporated by reference to the Form
SB-2/A2
filed on April 27, 2006.
|
|
10.15
|
Lease
Agreement, Rev. 2, dated November 1, 2005 between Pacific EcoSolutions,
Inc. and IsoRay Medical, Inc., incorporated by reference to the
Form
SB-2/A2 filed on April 27, 2006.
|
|
10.16
|
Master
Lease Agreement Number 5209, dated May 7, 2005 between VenCore
Solutions
LLC and IsoRay Medical, Inc., incorporated by reference to the
Form
SB-2/A2 filed on April 27, 2006.
|
|
10.17
|
Contract
#840/08624332/04031 dated August 25, 2005 between IsoRay, Inc.
and the
Federal State Unitary Enterprise << Institute of Nuclear Materials
>>, Russia, incorporated by reference to the Form SB-2 filed on
November 10, 2005.
|
|
10.18
|
State
of Washington Radioactive Materials License dated October 6, 2005,
incorporated by reference to the Form SB-2 filed on November 10,
2005.
|
|
10.19
|
Express
Pricing Agreement Number 219889, dated October 5, 2005 between
FedEx and
IsoRay Medical, Inc., incorporated by reference to the Form 10-QSB
filed
on November 21, 2005.
|
|
10.20
|
Girard
Employment Agreement, dated October 6, 2005 between Roger E. Girard
and
IsoRay, Inc., incorporated by reference to the Form 10-QSB filed
on
November 21, 2005.
|
|
10.21
|
Contract
Modification Quality Class G, dated October 25, 2005 to Contract
Number
X40224 between Energy Northwest and IsoRay, Inc., incorporated
by
reference to the Form 10-QSB filed on November 21,
2005.
|
|
10.22
|
Agreement
dated August 9, 2005 between the Curators of the University of
Missouri
and IsoRay Medical, Inc., incorporated by reference to the Form
SB-2/A2
filed on April 27, 2006 (confidential treatment
requested).
|
|
10.23
|
SICAV
ONE Securities Purchase Agreement, dated December 7, 2005, by and
between
IsoRay, Inc. and Mercatus & Partners, Ltd., incorporated by reference
to the Form 8-K filed on December 12, 2005.
|
|
10.24
|
SICAV
TWO Securities Purchase Agreement, dated December 7, 2005, by and
between
IsoRay, Inc. and Mercatus & Partners, Ltd., incorporated by reference
to the Form 8-K filed on December 12, 2005.
|
|
10.25
|
Economic
Development Agreement, dated December 14, 2005, by and between
IsoRay,
Inc. and the Pocatello Development Authority, incorporated by reference
to
the Form 8-K filed on December 20, 2005.
|
|
10.26
|
License
Agreement, dated February 2, 2006, by and between IsoRay Medical,
Inc. and
IBt SA, incorporated by reference to the Form 8-K filed on March
24, 2006
(confidential treatment requested).
|
|
10.27
|
Benton
Franklin Economic Development District Loan Covenant Waiver Letter,
dated
as of March 31, 2005, incorporated by reference to the Form SB-2/A3
filed
on May 12, 2006.
|
|
10.28
|
Service
Agreement between IsoRay, Inc. and Advanced Care Medical, Inc.,
dated
March 1, 2006, incorporated by reference to the Form SB-2/A2 filed
on
April 27, 2006.
|
|
10.29
|
Business
Loan Agreement between IsoRay Medical, Inc. and Columbia River
Bank, dated
March 1, 2006, incorporated by reference to the Form SB-2/A4 filed
on May
26, 2006.
|
|
10.30
|
Letter
from HAEIFC to IsoRay Medical, Inc. dated April 26, 2006, incorporated
by
reference to the Form SB-2/A5 filed on June 6,
2006.
|
10.31
|
Loan
Agreement, dated June 15, 2006, by and between IsoRay Medical,
Inc. and
the Hanford Area Economic Investment Fund Committee, incorporated
by
reference to the Form 8-K filed on June 21, 2006.
|
|
10.32
|
Commercial
Security Agreement, dated June 15, 2006, by and between IsoRay
Medical,
Inc. and the Hanford Area Economic Investment Fund Committee, incorporated
by reference to the Form 8-K filed on June 21, 2006.
|
|
10.33
|
Common
Stock and Warrant Purchase Agreement among IsoRay, Inc. and the
other
signatories thereto, dated August 9, 2006, incorporated by reference
to
the Form 8-K filed on August 18, 2006.
|
|
10.34
|
Benton
Franklin Economic Development District Loan Covenant Waiver Letter,
dated
September 26, 2006, filed herewith.
|
|
10.35
|
Form
of Officer and Director Indemnification Agreement, incorporated
by
reference to the Form SB-2 Post Effective Amendment No. 2 filed
on October
13, 2006.
|
|
10.36
|
Contract
No. 840/20553876/11806-32, dated October 6, 2006, by and between
IsoRay
Medical, Inc. and FSUE “SSC-Research Institute of Atomic Reactors,”
incorporated by reference to the Form 8-K filed on November 6,
2006
(confidential treatment requested for redacted
portions).
|
|
10.37
|
Agreement
for Exclusive Right to Buy, dated October 6, 2006, by and between
IsoRay
Medical, Inc. and FSUE “SSC-Research Institute of Atomic Reactors,”
incorporated by reference to the Form 8-K filed on November 6,
2006
(confidential treatment requested for redacted
portions).
|
|
10.38
|
Form
of Securities Purchase Agreement by and among IsoRay, Inc. and the
Buyers dated March 22, 2007, incorporated by reference to the Form
8-K filed on March 23, 2007.
|
|
10.39
|
Form
of Common Stock Purchase Warrant dated March 21, 2007, incorporated
by
reference to the Form 8-K filed on March 23, 2007.
|
|
10.40
|
Placement
Agent Agreement by and between the Company and Punk, Ziegel & Company,
L.P. dated March 14, 2007, incorporated by reference to the Form
8-K filed
on March 23, 2007.
|
|
10.41
|
Placement
Agent Agreement by and between the Company and Maxim Group LLC
dated
February 2, 2006, incorporated by reference to the Form 8-K filed
on March
23, 2007.
|
|
10.42
|
APEL
- Tenant Lease Agreement Revision No. 11 dated as of May 2, 2007
with an
effective date of May 1, 2007 between Energy Northwest and IsoRay
Medical,
Inc., incorporated by reference to the Form 8-K filed on May 8,
2007.
|
|
10.43
|
Loan
Covenant Waiver Letter dated September 24, 2007 from the Hanford
Area
Economic Investment Fund Committee, filed herewith.
|
|
10.44
|
Loan
Covenant Waiver Letter dated September 26, 2007 from the Benton-Franklin
Economic Development District, filed herewith.
|
|
16.1
|
Letter
from S.W. Hatfield, CPA to the SEC dated December 13, 2005, incorporated
by reference to the Form 8-K filed on December 14,
2005.
|
|
21.1
|
Subsidiaries
of the Company, incorporated by reference to the Form 10-KSB filed
on
October 11, 2005.
|
|
23.1
|
Consent of DeCoria, Maichel & Teague, P.S., filed herewith. | |
31.1
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief
Executive Officer, filed herewith.
|
|
31.2
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief
Financial Officer, filed herewith.
|
|
32.1
|
Certifications
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, filed
herewith.
|
|
Year ended
June 30,
2007
|
Year ended
June 30,
2006
|
|||||
|
|
|
|||||
1.
Audit
fees(1)
|
$
|
41,016
|
$
|
72,292
|
|||
2.
Audit-related
fees
|
1,800
|
1,150
|
|||||
3.
Tax
fees
|
4,250
|
2,750
|
|||||
4.
All
other fees
|
-
|
-
|
|||||
Totals
|
$
|
47,066
|
$
|
76,192
|
(1)
|
Fees
for the year ended June 30, 2006 were as follows: $49,125 paid to
DeCoria,
Maichel & Teague, P.S. and $23,167 paid to S. W. Hatfield,
CPA.
|
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
Financial
Statements:
|
||
Consolidated
Balance Sheets as of June 30, 2007 and 2006
|
F-3
|
|
Consolidated
Statements of Operations for the years ended June 30, 2007 and 2006
|
F-4
|
|
Consolidated
Statement of Changes in Shareholders’ Equity for the years ended
June 30, 2007 and 2006
|
F-5
|
|
Consolidated
Statements of Cash Flows for the years ended June 30, 2007 and 2006
|
F-6
|
|
Notes
to Consolidated Financial Statements
|
F-7
|
June 30,
|
|||||||
2007
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
9,355,730
|
$
|
2,207,452
|
|||
Short-term
investments
|
9,942,840
|
-
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $99,789 and
$85,183,
respectively
|
1,092,925
|
596,447
|
|||||
Inventory
|
880,834
|
161,381
|
|||||
Prepaid
expenses and other current assets
|
458,123
|
161,546
|
|||||
Total
current assets
|
21,730,452
|
3,126,826
|
|||||
Fixed
assets, net of accumulated depreciation
|
3,665,551
|
1,642,293
|
|||||
Deferred
financing costs, net of accumulated amortization
|
95,725
|
274,358
|
|||||
Licenses,
net of accumulated amortization
|
262,074
|
273,475
|
|||||
Other
assets, net of accumulated amortization
|
322,360
|
338,987
|
|||||
Total
assets
|
$
|
26,076,162
|
$
|
5,655,939
|
|||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,946,042
|
$
|
584,296
|
|||
Accrued
payroll and related taxes
|
459,068
|
614,645
|
|||||
Accrued
interest payable
|
1,938
|
11,986
|
|||||
Deferred
revenue
|
23,874
|
-
|
|||||
Notes
payable, due within one year
|
49,212
|
51,351
|
|||||
Capital
lease obligations, due within one year
|
194,855
|
183,554
|
|||||
Convertible
debentures payable, due within one year
|
-
|
455,000
|
|||||
Asset
retirement obligation, current portion
|
131,142
|
-
|
|||||
Total
current liabilities
|
2,806,131
|
1,900,832
|
|||||
Notes
payable, due after one year
|
528,246
|
581,557
|
|||||
Capital
lease obligations, due after one year
|
25,560
|
220,415
|
|||||
Asset
retirement obligation
|
-
|
67,425
|
|||||
Total
liabilities
|
3,359,937
|
2,770,229
|
|||||
Commitments and contingencies (Note 16) | |||||||
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 and 144,759 shares issued
and
outstanding
|
59
|
145
|
|||||
Common
stock, $.001 par value; 194,000,000 shares authorized; 22,789,324
and
15,157,901 shares issued and outstanding
|
22,789
|
15,158
|
|||||
Subscriptions
receivable
|
-
|
(6,122,007
|
)
|
||||
Additional
paid-in capital
|
45,844,793
|
22,538,675
|
|||||
Accumulated
deficit
|
(23,151,416
|
)
|
(13,546,261
|
)
|
|||
Total
shareholders' equity
|
22,716,225
|
2,885,710
|
|||||
|
|||||||
Total
liabilities and shareholders' equity
|
$
|
26,076,162
|
$
|
5,655,939
|
Year
ended June 30,
|
|||||||
2007
|
2006
|
||||||
Product
sales
|
$
|
5,738,033
|
$
|
1,994,306
|
|||
Cost
of product sales
|
5,792,630
|
3,815,122
|
|||||
Gross
loss
|
(54,597
|
)
|
(1,820,816
|
)
|
|||
Operating
expenses:
|
|||||||
Research
and development
|
1,345,163
|
450,425
|
|||||
Sales
and marketing expenses
|
3,384,472
|
1,420,500
|
|||||
General
and administrative expenses
|
4,915,598
|
3,503,522
|
|||||
Total
operating expenses
|
9,645,233
|
5,374,447
|
|||||
Operating
loss
|
(9,699,830
|
)
|
(7,195,263
|
)
|
|||
Non-operating
income (expense):
|
|||||||
Interest
income
|
406,921
|
51,744
|
|||||
Financing
expense
|
(312,246
|
)
|
(689,100
|
)
|
|||
Debt
conversion expense (Note 10)
|
-
|
(385,511
|
)
|
||||
Non-operating
income (expense), net
|
94,675
|
(1,022,867
|
)
|
||||
Net
loss
|
$
|
(9,605,155
|
)
|
$
|
(8,218,130
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.54
|
)
|
$
|
(0.68
|
)
|
|
Weighted
average shares used in computing net loss per share:
|
|||||||
Basic
and diluted
|
17,827,522
|
12,051,964
|
IsoRay, Inc. (MN)
|
IsoRay Medical, Inc.
|
||||||||||||||||||||||||||||||||||||
Series B Preferred Stock
|
Common Stock
|
Series B Preferred Stock
|
Common Stock
|
||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Subscriptions
Receivable
|
Additional
Paid-in Capital
|
Accumulated
Deficit
|
Total
|
||||||||||||||||||||||||||
Balances
at June 30, 2005
|
-
|
$
|
-
|
-
|
$
|
-
|
1,338,167
|
$
|
1,338
|
6,163,623
|
$
|
6,164
|
$
|
-
|
$
|
3,805,773
|
$
|
(5,328,131
|
)
|
$
|
(1,514,856
|
)
|
|||||||||||||||
Merger
of IsoRay, Inc. (formerly Century Park Pictures Corporation)
and IsoRay
Medical, Inc., net of fractional shares paid in cash (see Note
1)
|
1,338,132
|
1,338
|
6,163,518
|
6,164
|
(1,338,167
|
)
|
(1,338
|
)
|
(6,163,623
|
)
|
(6,164
|
)
|
-
|
||||||||||||||||||||||||
Common
stock held by shareholders of Century Park Picture Corporation
after the
reverse acquisition
|
2,498,534
|
2,499
|
8,733
|
11,232
|
|||||||||||||||||||||||||||||||||
Issuance
of common shares as payment for merger consulting services
|
168,472
|
169
|
329,831
|
330,000
|
|||||||||||||||||||||||||||||||||
Payments
to shareholders in lieu of issuing fractional shares
|
(734
|
)
|
(734
|
)
|
|||||||||||||||||||||||||||||||||
Issuance
of preferred stock pursuant to exercise of warrants
|
8,708
|
8
|
6,977
|
6,985
|
|||||||||||||||||||||||||||||||||
Issuance
of preferred stock pursuant to exercise of warrants paid by surrending
a
partial note payable
|
44,788
|
45
|
48,268
|
48,313
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to exercise of warrants
|
84,147
|
84
|
49,866
|
49,950
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to exercise of options
|
101,284
|
101
|
119,476
|
119,577
|
|||||||||||||||||||||||||||||||||
Conversion
of preferred stock to common stock
|
(1,246,869
|
)
|
(1,246
|
)
|
1,246,869
|
1,246
|
-
|
||||||||||||||||||||||||||||||
Exchange
of convertible debentures payable to common stock
|
911,271
|
911
|
3,681,964
|
3,682,875
|
|||||||||||||||||||||||||||||||||
Issuance
of warrants pursuant to short-term inducement to convert
debentures
|
385,511
|
385,511
|
|||||||||||||||||||||||||||||||||||
Issuance
of warrants as inducement for note payable from shareholder (see
Note
8)
|
60,000
|
60,000
|
|||||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to the October 2005 private placement,
net of
offering costs
|
1,500,000
|
1,500
|
5,406,626
|
5,408,126
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to the February 2006 private placement,
net of
offering costs
|
268,889
|
269
|
1,107,955
|
1,108,224
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock to Mercatus subject to a subscription receivable
agreement
|
1,748,146
|
1,748
|
(6,122,007
|
)
|
6,120,259
|
-
|
|||||||||||||||||||||||||||||||
Issuance
of common stock for payment of invoices
|
39,007
|
39
|
184,996
|
185,035
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to the June 2006 warrant exercise solicitation,
net of offering costs
|
427,764
|
428
|
1,223,174
|
1,223,602
|
|||||||||||||||||||||||||||||||||
Net
loss
|
(8,218,130
|
)
|
(8,218,130
|
)
|
|||||||||||||||||||||||||||||||||
Balances
at June 30, 2006
|
144,759
|
145
|
15,157,901
|
15,158
|
-
|
-
|
-
|
-
|
(6,122,007
|
)
|
22,538,675
|
(13,546,261
|
)
|
2,885,710
|
|||||||||||||||||||||||
Issuance
of preferred stock pursuant to exercise of warrants
|
37,322
|
37
|
41,642
|
41,679
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to exercise of warrants
|
2,295,506
|
2,295
|
6,857,385
|
6,859,680
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to exercise of options
|
755,499
|
755
|
873,937
|
874,692
|
|||||||||||||||||||||||||||||||||
Conversion
of preferred stock to common stock
|
(123,016
|
)
|
(123
|
)
|
123,016
|
123
|
-
|
||||||||||||||||||||||||||||||
Issuance
of common stock to Mercatus subject to a subscription receivable
agreement
|
(1,748,146
|
)
|
(1,748
|
)
|
6,122,007
|
(6,120,259
|
)
|
-
|
|||||||||||||||||||||||||||||
Exchange
of convertible debentures payable for common stock
|
12,048
|
12
|
49,987
|
49,999
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to the August 2006 Stock Purchase Agreement,
net of offering costs (see Note 12)
|
2,063,000
|
2,063
|
4,700,870
|
4,702,933
|
|||||||||||||||||||||||||||||||||
Issuance
of common stock pursuant to the Public Equity Offering, net of
offering costs (see Note 12)
|
4,130,500
|
4,131
|
15,112,900
|
15,117,031
|
|||||||||||||||||||||||||||||||||
Payment
of dividend to Preferred shareholders
|
(38,458
|
)
|
(38,458
|
)
|
|||||||||||||||||||||||||||||||||
Share-based
compensation
|
1,828,114
|
1,828,114
|
|||||||||||||||||||||||||||||||||||
Net
loss
|
(9,605,155
|
)
|
(9,605,155
|
)
|
|||||||||||||||||||||||||||||||||
Balances
at June 30, 2007
|
59,065
|
$
|
59
|
22,789,324
|
$
|
22,789
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
-
|
$
|
45,844,793
|
$
|
(23,151,416
|
)
|
$
|
22,716,225
|
Year
ended June 30,
|
|||||||
2007
|
2006
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(9,605,155
|
)
|
$
|
(8,218,130
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
|||||||
Depreciation
and amortization of fixed assets
|
491,643
|
271,060
|
|||||
Amortization
of deferred financing costs and other assets
|
223,604
|
384,266
|
|||||
Accretion
of asset retirement obligation
|
7,597
|
4,385
|
|||||
Share-based
compensation (Note 11)
|
1,828,114
|
-
|
|||||
Merger
consulting fees paid by issuance of common stock
|
-
|
330,000
|
|||||
Consulting
and repair fees paid by issuance of common stock
|
-
|
39,750
|
|||||
Rent
expense paid by issuance of common stock
|
-
|
90,026
|
|||||
Debt
conversion expense (Note 10)
|
-
|
385,511
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable, net
|
(496,478
|
)
|
(546,478
|
)
|
|||
Inventory
|
(719,453
|
)
|
(79,455
|
)
|
|||
Prepaid
expenses
|
(296,577
|
)
|
41,252
|
||||
Accounts
payable and accrued expenses
|
1,361,746
|
(132,646
|
)
|
||||
Accrued
payroll and related taxes
|
(10,577
|
)
|
456,721
|
||||
Accrued
interest payable
|
(10,048
|
)
|
(29,339
|
)
|
|||
Deferred
revenue
|
23,874
|
-
|
|||||
Net
cash used by operating activities
|
(7,201,710
|
)
|
(7,003,077
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of fixed assets
|
(2,445,850
|
)
|
(474,795
|
)
|
|||
Additions
to licenses and other assets
|
(29,874
|
)
|
(395,201
|
)
|
|||
Purchase
of short-term investments
|
(10,931,920
|
)
|
-
|
||||
Proceeds
from the sale or maturity of short-term investments
|
989,080
|
-
|
|||||
Cash
acquired in reverse acquisition (Note 1)
|
-
|
32,587
|
|||||
Net
cash used by investing activities
|
(12,418,564
|
)
|
(837,409
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of notes payable, net of financing costs
|
-
|
646,542
|
|||||
Proceeds
from sales of convertible debentures payable
|
-
|
550,000
|
|||||
Repayment
of convertible debentures payable
|
(405,001
|
)
|
-
|
||||
Principal
payments on notes payable
|
(55,450
|
)
|
(592,790
|
)
|
|||
Principal
payments on capital lease obligations
|
(183,554
|
)
|
(124,688
|
)
|
|||
Proceeds
from cash sales of common shares, net of offering costs
|
19,819,964
|
6,516,350
|
|||||
Proceeds
from cash sales of preferred stock, pursuant to exercise of
warrants
|
41,679
|
6,985
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of
warrants
|
6,859,680
|
49,950
|
|||||
Proceeds
from cash sales of common stock, pursuant to exercise of
options
|
729,692
|
119,577
|
|||||
Proceeds
from cash sales of common stock, pursuant to June 2006 warrant
exercises
|
-
|
1,223,602
|
|||||
Payments
of dividends to preferred shareholders
|
(38,458
|
)
|
-
|
||||
Payments
to common shareholders in lieu of issuing fractional
shares
|
-
|
(734
|
)
|
||||
Net
cash provided by financing activities
|
26,768,552
|
8,394,794
|
|||||
Net
increase in cash and cash equivalents
|
7,148,278
|
554,308
|
|||||
Cash
and cash equivalents, beginning of period
|
2,207,452
|
1,653,144
|
|||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
9,355,730
|
$
|
2,207,452
|
|||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
143,662
|
$
|
361,832
|
|||
Non-cash
investing and financing activities:
|
|||||||
Cashless
exercise of common stock options in lieu of severance pay
|
$
|
145,000
|
$
|
-
|
|||
Exchange
of convertible debentures payable for shares of common
stock
|
49,999
|
3,682,875
|
|||||
Fixed
assets acquired by capital lease obligations
|
-
|
507,947
|
|||||
Increase
in PP&E related to asset retirement obligation
|
56,120
|
63,040
|
|||||
Issuance
of common shares as partial payment for production
equipment
|
-
|
25,248
|
|||||
Issuance
of common shares as partial payment of notes payable
|
-
|
48,313
|
|||||
Liabilities
acquired in acquisition
|
-
|
21,355
|
|||||
Prepaid
rent paid by issuance of common stock
|
-
|
120,036
|
|||||
Issuance
of warrants as an inducement for a note payable
|
-
|
60,000
|
1. |
Organization
|
2. |
Summary
of Significant Accounting
Policies
|
2007
|
2006
|
||||||
Municipal
debt securities
|
$
|
3,000,000
|
$
|
–
|
|||
Corporate
debt securities
|
6,942.840
|
–
|
|||||
$
|
9,942,840
|
$
|
–
|
Production
equipment
|
3
to 7 years
|
Office
equipment
|
2
to 5 years
|
Furniture
and fixtures
|
2
to 5 years
|
2007
|
2006
|
||||||
Value
of shares issued to guarantors:
|
|||||||
Benton-Franklin
Economic Development District (83,640 shares)
|
$
|
138,006
|
$
|
138,006
|
|||
Columbia
River Bank line of credit (127,500 shares)
|
–
|
210,375
|
|||||
Benton-Franklin
Economic Development District loan fees
|
3,450
|
3,450
|
|||||
Columbia
River Bank line of credit loan fees
|
–
|
500
|
|||||
Convertible
debentures issuance costs
|
–
|
30,047
|
|||||
Hanford
Area Economic Investment Fund Committee loan fees
|
22,128
|
22,128
|
|||||
Less
amortization
|
(67,859
|
)
|
(130,148
|
)
|
|||
$
|
95,725
|
$
|
274,358
|
2007
|
2006
|
||||||
Beginning
balance
|
$
|
67,425
|
$
|
–
|
|||
New
obligations
|
–
|
63,040
|
|||||
Changes
in estimates of existing obligations
|
56,120
|
–
|
|||||
Accretion
of discount
|
7,597
|
4,385
|
|||||
Ending
balance
|
$
|
131,142
|
$
|
67,425
|
2007
|
2006
|
||||||
Preferred
stock
|
59,065
|
144,759
|
|||||
Preferred
stock warrants
|
–
|
179,512
|
|||||
Common
stock warrants
|
3,627,764
|
2,502,769
|
|||||
Common
stock options
|
3,683,439
|
3,129,692
|
|||||
Convertible
debentures
|
–
|
109,639
|
|||||
Total
potential dilutive securities
|
7,370,268
|
6,066,371
|
3. |
Inventory
|
2007
|
2006
|
||||||
Raw
materials
|
$
|
682,327
|
$
|
61,531
|
|||
Work
in process
|
120,242
|
67,906
|
|||||
Finished
goods
|
78,265
|
31,944
|
|||||
$
|
880,834
|
$
|
161,381
|
4. |
Prepaid
Expenses
|
2007
|
2006
|
||||||
Prepaid
contract work
|
$
|
-
|
$
|
7,913
|
|||
Prepaid
insurance
|
37,001
|
21,340
|
|||||
Prepaid
rent
|
26,693
|
30,009
|
|||||
Other
prepaid expenses
|
249,184
|
21,200
|
|||||
Other
current assets
|
145,245
|
81,084
|
|||||
$
|
458,123
|
$
|
161,546
|
5. |
Fixed
Assets
|
2007
|
2006
|
||||||
Production
equipment
|
$
|
807,838
|
$
|
590,908
|
|||
Office
equipment
|
111,218
|
70,060
|
|||||
Furniture
and fixtures
|
118,227
|
100,653
|
|||||
Leasehold
improvements
|
522,951
|
652,404
|
|||||
Capital
lease assets (a)
|
655,858
|
599,738
|
|||||
Construction
in progress
|
2,217,372
|
34,254
|
|||||
4,433,464
|
2,048,017
|
||||||
Less
accumulated depreciation
|
(767,913
|
)
|
(405,724
|
)
|
|||
$
|
3,665,551
|
$
|
1,642,293
|
6. |
Other
Assets
|
2007
|
2006
|
||||||
Deferred
charges
|
$
|
297,008
|
$
|
318,885
|
|||
Patents
and trademarks, net of accumulated amortization of $16,463 and
$13,831
|
25,352
|
20,102
|
|||||
$
|
322,360
|
$
|
338,987
|
7. |
Bank
Line of Credit
|
8. |
Notes
Payable
|
2007
|
2006
|
||||||
Tri-City
Industrial Development Council (TRIDEC) note payable (a)
|
$
|
-
|
$
|
10,000
|
|||
Benton-Franklin
Economic Development District (BFEDD) note payable (b)
|
185,848
|
204,237
|
|||||
Hanford
Area Economic Investment Fund Committee (HAEIFC) note payable
(c)
|
391,610
|
418,671
|
|||||
577,458
|
632,908
|
||||||
Less
amounts due within one year
|
(49,212
|
)
|
(51,351
|
)
|
|||
Amounts
due after one year
|
$
|
528,246
|
$
|
581,557
|
(a)
|
This
is a non-interest bearing note, due in annual installments of $10,000
that
matured in August 2006. The note payable to TRIDEC did not bear interest,
but was not discounted because the note was exchanged solely for
cash.
|
(b)
|
The
note payable to BFEDD, which is collateralized by substantially all
of the
Company’s assets, and guaranteed by certain shareholders, was executed
pursuant to a Development Loan Agreement. The note contains certain
restrictive covenants relating to: working capital; levels of long-term
debt to equity; incurrence of additional indebtedness; payment of
compensation to officers and directors; and payment of dividends.
The note
is payable in monthly installments including interest at 8.0% per
annum
with a final balloon payment due in October 2009. At June 30, 2007,
the
Company was not in compliance with certain of the covenants. The
Company
has obtained a waiver from BFEDD, relating to these covenants, through
June 30, 2008.
|
(c)
|
In
June 2006, the Company entered into a note payable with HAEIFC, which
is
collateralized by receivables, inventory, equipment, and certain
life
insurance policies. The total note payable facility is for $1.4 million
and is to be used to purchase production equipment. In June 2006,
the
Company requested an initial disbursement of approximately $400,000.
The
note contains certain restrictive covenants relating to: financial
ratios;
payment of compensation to officers and directors; and payment of
dividends. The note accrues interest at 9% and is payable in monthly
installments with the final installment due in July 2016. At June 30,
2007, the Company was not in compliance with certain of the
covenants. The Company has obtained a waiver from HAEIFC, relating to
these covenants, through June 30,
2008.
|
Year
ending June 30,
|
||||
2008
|
$
|
49,212
|
||
2009
|
53,609
|
|||
2010
|
182,566
|
|||
2011
|
38,436
|
|||
2012
|
41,983
|
|||
Thereafter
|
211,652
|
|||
$
|
577,458
|
9. |
Capital
Lease Obligations
|
Year
ending June 30,
|
||||
2008
|
$
|
214,269
|
||
2009
|
27,626
|
|||
Total
future minimum lease payments
|
241,895
|
|||
Less
amounts representing interest
|
(21,480
|
)
|
||
Present
value of net minimum lease payments
|
220,415
|
|||
Less
amounts due within one year
|
(194,855
|
)
|
||
Amounts
due after one year
|
$
|
25,560
|
10. |
Convertible
Debentures Payable
|
11. |
Share-Based
Compensation
|
Year
ended June 30,
|
|||||||
2007
|
2006
|
||||||
Cost
of product sales
|
$
|
120,710
|
$
|
–
|
|||
Research
and development
|
41,481
|
–
|
|||||
Sales
and marketing expenses
|
216,432
|
–
|
|||||
General
and administrative expenses
|
1,449,491
|
–
|
|||||
Total
share-based compensation
|
$
|
1,828,114
|
$
|
–
|
|
Shares
|
|
Price
(a)
|
|
Life
(b)
|
|
Value
(c)
|
|
|||||
Outstanding
at June 30, 2007
|
3,683,439
|
$
|
2.86
|
8.67
|
$
|
8,259,814
|
|||||||
Vested
and expected to vest at June 30, 2007
|
3,270,441
|
$
|
2.85
|
8.68
|
$
|
8,150,622
|
|||||||
Vested
and exercisable at June 30, 2007
|
2,278,172
|
$
|
2.45
|
8.42
|
$
|
6,726,822
|
(a)
|
Weighted
average price per share.
|
(b)
|
Weighted
average remaining contractual life.
|
(c)
|
Aggregate
intrinsic value.
|
|
|
Year
ended June 30,
|
|
||||
|
|
2007
|
|
2006
|
|||
Weighted
average fair value of options granted
|
$
|
2.29
|
$
|
1.38
|
|||
Key
assumptions used in determining fair value:
|
|||||||
Weighted
average risk-free interest rate
|
4.86
|
%
|
4.67
|
%
|
|||
Weighted
average life of the option (in years)
|
5.58
|
7.31
|
|||||
Weighted
average historical stock price volatility
|
69.87
|
%
|
31.24
|
%
|
|||
Expected
dividend yield
|
0.00
|
%
|
0.00
|
%
|
2006
|
||||
Net
loss, as reported
|
$
|
8,218,130
|
||
SFAS
No. 123 stock option expense
|
1,167,086
|
|||
Pro
forma net loss
|
$
|
9,385,216
|
||
Net
loss per share:
|
||||
Basic
and Diluted, as reported
|
$
|
0.68
|
||
Basic
and Diluted, pro forma
|
$
|
0.77
|
12. |
Shareholders’
Equity
|
2007
|
2006 (a)
|
||||||||||||
Warrants
|
Price (b)
|
Warrants
|
Price (b)
|
||||||||||
Beginning
balance outstanding
|
179,512
|
$
|
0.79
|
233,008
|
$
|
0.84
|
|||||||
Converted
to common warrants (c)
|
(142,190
|
)
|
0.70
|
–
|
–
|
||||||||
Exercised
|
(37,322
|
)
|
1.12
|
(53,496
|
)
|
1.03
|
|||||||
Ending
balance outstanding
|
–
|
$
|
–
|
179,512
|
$
|
0.79
|
(a)
|
The
2006 beginning balance has been adjusted to reflect the 0.842362
conversion ration (see Note 1).
|
(b)
|
Weighted
average price per share.
|
(c)
|
During
fiscal year 2007, one preferred warrant holder requested the Board
of
Directors to extend the expiration date of his warrants and to convert
them to common warrants. The Board granted this request and set new
expiration dates as noted below. The exercise price was not changed.
The
change in expiration date and the conversion to common warrants was
a
modification of the original warrant based on market conditions and
was
accounted for as a financing transaction similar to a modification
of the
offering price 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.
|
Number of Warrants
|
Price
|
New
Expiration Date
|
Old
Expiration Date
|
||||
56,876
|
$ 0.70
|
October
30, 2007
|
October
30, 2006
|
||||
28,438
|
0.70
|
January
31, 2009
|
January
31, 2007
|
||||
56,876
|
0.70
|
March
30, 2010
|
March
30, 2007
|
||||
142,190
|
2007
|
2006
(a)
|
||||||||||||
Warrants
|
Price
(b)
|
Warrants
|
Price
(b)
|
||||||||||
Beginning
balance outstanding
|
2,502,769
|
$
|
5.73
|
136,158
|
$
|
1.20
|
|||||||
Warrants
issued
|
3,301,926
|
3.59
|
2,878,522
|
5.85
|
|||||||||
Converted
from preferred (c)
|
142,190
|
0.70
|
-
|
-
|
|||||||||
Cancelled/expired
|
(23,615
|
)
|
2.54
|
-
|
-
|
||||||||
Exercised
|
(2,295,506
|
)
|
2.99
|
(511,911
|
)
|
2.49
|
|||||||
Ending
balance outstanding
|
3,627,764
|
$
|
5.31
|
2,502,769
|
$
|
5.73
|
(a)
|
The
2006 beginning balance has been adjusted to reflect the 0.842362
conversion ratio (see Note 1).
|
(b)
|
Weighted
average price per share.
|
(c)
|
During
fiscal year 2007, one preferred warrant holder requested the Board
of
Directors to extend the expiration date of his warrants and to convert
them to common warrants. The Board granted this request and set new
expiration dates as noted in the Preferred Warrants section of this
footnote.
|
Number
of Warrants
|
Range
of Exercise Prices
|
Expiration
Date
|
||
277,614
|
$4.15
|
July
2007
|
||
12,500
|
$0.0008
|
October
2007
|
||
56,876
|
$0.70
|
October
2007
|
||
53,000
|
$6.00
|
October
2007
|
||
162,500
|
$6.00
|
November
2007
|
||
934,469
|
$5.75
to $6.00
|
December
2007
|
||
700,250
|
$6.00
|
January
2008
|
||
276,923
|
$6.00
to $6.50
|
February
2008
|
||
5,000
|
$7.00
|
March
2008
|
||
5,692
|
$4.15
|
May
2008
|
||
28,438
|
$0.70
|
January
2009
|
||
56,876
|
$0.70
|
March
2010
|
||
826,100
|
$5.00
|
March
2011
|
||
206,526
|
$4.40
|
March
2012
|
||
25,000
|
$2.00
|
July
2015
|
||
3,627,764
|
2007
|
2006
(a)
|
||||||||||||
Shares
|
Price
(b)
|
Shares
|
Price
(b)
|
||||||||||
Beginning
balance outstanding
|
3,129,692
|
$
|
2.05
|
2,237,802
|
$
|
1.31
|
|||||||
Granted
(c) (d)
|
1,488,700
|
3.67
|
1,189,722
|
3.23
|
|||||||||
Cancelled
|
(179,454
|
)
|
2.68
|
(196,548
|
)
|
1.19
|
|||||||
Exercised
|
(755,499
|
)
|
1.16
|
(101,284
|
)
|
1.18
|
|||||||
Ending
balance outstanding
|
3,683,439
|
$
|
2.86
|
3,129,692
|
$
|
2.05
|
|||||||
Exercisable
at end of year
|
2,528,172
|
$
|
2.45
|
2,649,576
|
$
|
1.79
|
(a)
|
The
2006 beginning balances have been adjusted to reflect the 0.842362
conversion ratio (see Note 1).
|
(b)
|
Weighted
average price per share.
|
(c)
|
All
options granted had exercise prices equal to the ending market price
of
the Company’s common stock on the grant
date.
|
(d)
|
Included
in options granted are 350,000 options granted with an exercise price
of
$4.14 to members of the Board of Directors that were subsequently
cancelled on July 25, 2007. 100,000 of these options were granted
to the
Company’s CEO and Executive Vice-President Operations and were to vest
over three years. The remaining 250,000 options were granted to
non-employee Directors and were immediately vested. See Note 11 for
a
further discussion of these cancelled
options.
|
Options
Outstanding
|
Options
Exercisable
|
||||||||||
Range of Exercise Prices
|
Shares
|
Price
(a)
|
Life
(b)
|
Shares
|
Price
(a)
|
||||||
$1.00
to $1.19
|
1,002,892
|
$ 1.16
|
7.85
yrs
|
934,322
|
$ 1.16
|
||||||
$1.96
to $2.00
|
653,791
|
1.98
|
8.09
yrs
|
653,791
|
1.98
|
||||||
$3.10
to $3.20
|
676,234
|
3.12
|
9.16
yrs
|
342,075
|
3.12
|
||||||
$3.50
to $3.85
|
200,000
|
3.74
|
9.00
yrs
|
116,666
|
3.81
|
||||||
$4.14
to $4.15
|
820,472
|
4.14
|
9.54
yrs
|
334,235
|
4.14
|
||||||
$4.40
|
108,800
|
4.40
|
9.68
yrs
|
-
|
-
|
||||||
$5.50
to $6.50
|
221,250
|
6.06
|
8.65
yrs
|
147,083
|
6.18
|
||||||
Total
options
|
3,333,439
|
2,278,172
|
(a)
|
Weighted
average exercise price.
|
(b) |
Weighted
average remaining contractual life.
|
13. |
Income
Taxes
|
14. |
401(k)
and Profit Sharing Plan
|
15. |
Related
Party Transactions
|
16. |
Commitments
and Contingencies
|
2008
|
$
|
372,118
|
||
2009
|
338,496
|
|||
2010
|
338,354
|
|||
2011
|
337,925
|
|||
2012
|
328,749
|
|||
Thereafter
|
1,260,206
|
|||
$
|
2,975,848
|
17. |
Concentrations
of Credit and Other Risks
|
18. |
New
Accounting Standards
|
19. |
Subsequent
Events
|
§
|
An
amendment to the IsoRay’s license agreement with IBt for the use of its
polymer seed technology whereby IsoRay would pay the remaining $225,000
license fee but would not be subject to ongoing royalty payments.
IsoRay
would purchase polymer seed components at cost plus a profit margin
to be
determined.
|
§
|
The
Company would grant IBt an exclusive license to distribute Cs-131
brachytherapy seeds in certain markets outside of North and South
America,
including the European Union.
|
§
|
The
Company would receive the exclusive right to manufacture and distribute
polymer I-125 brachytherapy seeds in North and South
America.
|
§
|
The
Company would also receive IBt’s US subsidiary’s customer list and the
right to offer employment to certain IBt US
employees.
|
ISORAY,
INC., a Minnesota corporation
|
|
By /s/
Roger E. Girard
|
|
Roger
E. Girard, Chief Executive Officer
|
|
By
/s/
Jonathan R. Hunt
|
|
Jonathan
R. Hunt, Chief Financial Officer
|