Delaware
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75-1590407
|
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(State
or other jurisdiction of
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(I.R.S.
Employer
|
|
incorporation
or organization)
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Identification
No.)
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2188
West 2200 South
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||
Salt
Lake City, Utah 84119
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||
(Address
of principal executive offices, including zip code)
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||
(801)
972-5555
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||
(Registrant’s
telephone number, including area
code)
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Large
accelerated filer o
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Accelerated
filer ý
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Non-accelerated
filer o
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Smaller
reporting company ý
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Item
1.
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Financial
Statements (Unaudited)
|
|
Condensed
Balance Sheets
|
3
|
|
Condensed
Statements of Operations
|
4
|
|
Condensed
Statements of Cash Flows
|
5
|
|
Notes
to Condensed Financial Statements
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6
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|
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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14
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Item
4.
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Controls
and Procedures
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28
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PART
II - Other Information
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||
Item
1A.
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Risk
Factors
|
29
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Item
5.
|
Other
Information
|
29
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Item
6.
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Exhibits
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29
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Signatures
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30
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ASSETS
|
May
31,
2009
|
August
31,
2008
|
||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 9,003,163 | $ | 1,394,652 | ||||
Investments
|
- | 14,487,192 | ||||||
Accounts
receivable, net of allowance for doubtful accounts of
$20,000
|
89,194 | 439,739 | ||||||
Related
party trade accounts receivable
|
248,485 | 737,483 | ||||||
Income
tax receivable
|
1,466,014 | 1,409,996 | ||||||
Inventories,
net
|
1,800,885 | 1,425,153 | ||||||
Other
current assets
|
89,780 | 113,829 | ||||||
Total
current assets
|
12,997,521 | 20,008,044 | ||||||
Property
and equipment, net
|
1,379,265 | 1,441,524 | ||||||
Patents,
net
|
32,357 | 37,330 | ||||||
$ | 14,409,143 | $ | 21,486,898 | |||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 472,857 | $ | 221,605 | ||||
Accrued
liabilities
|
403,451 | 585,777 | ||||||
Customer
deposits
|
39,777 | 427,677 | ||||||
Deferred
revenue – current portion
|
43,596 | 41,885 | ||||||
Total
current liabilities
|
959,681 | 1,276,944 | ||||||
Deferred
revenue – net of current portion
|
91,574 | 54,094 | ||||||
Total
liabilities
|
1,051,255 | 1,331,038 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, $.001 par value; 10,000,000 shares authorized, no shares issued and
outstanding
|
- | - | ||||||
Common
stock; $.001 par value, 40,000,000 shares authorized, 22,039,301 and
21,388,958 shares issued
|
22,040 | 21,389 | ||||||
Additional
paid-in capital
|
28,309,130 | 27,565,373 | ||||||
Treasury
stock, 24,331 shares at cost
|
(234 | ) | (234 | ) | ||||
Other
comprehensive loss
|
- | (2,141,416 | ) | |||||
Accumulated
deficit
|
(14,973,048 | ) | (5,289,252 | ) | ||||
Total
stockholders’ equity
|
13,357,888 | 20,155,860 | ||||||
$ | 14,409,143 | $ | 21,486,898 |
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
May
31,
2009
|
May
31,
2008
|
May
31,
2009
|
May
31,
2008
|
|||||||||||||
Revenues:
|
||||||||||||||||
Sales
|
$ | 465,652 | $ | 725,810 | $ | 2,301,749 | $ | 1,846,052 | ||||||||
Sales
to related parties
|
460,423 | 189,207 | 585,919 | 1,932,345 | ||||||||||||
Total
revenues
|
926,075 | 915,017 | 2,887,668 | 3,778,397 | ||||||||||||
Operating
costs and expenses:
|
||||||||||||||||
Cost
of sales
|
270,629 | 309,276 | 1,259,739 | 713,724 | ||||||||||||
Cost
of related party sales
|
267,556 | 66,570 | 352,877 | 694,062 | ||||||||||||
Research
and development
|
509,422 | 481,692 | 1,443,563 | 1,252,914 | ||||||||||||
Selling,
general and administrative
|
1,653,363 | 1,368,451 | 4,663,942 | 4,196,516 | ||||||||||||
Total
operating costs and expenses
|
2,700,970 | 2,225,989 | 7,720,121 | 6,857,216 | ||||||||||||
Loss
from operations
|
(1,774,895 | ) | (1,310,972 | ) | (4,832,453 | ) | (3,078,819 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
and investment income
|
56,246 | 226,692 | 578,813 | 771,680 | ||||||||||||
Realized
loss on investments
|
(2,125,999 | ) | - | (6,501,586 | ) | - | ||||||||||
Other
expense
|
(21,796 | ) | (41,020 | ) | (85,570 | ) | (151,933 | ) | ||||||||
Total
other income (expense)
|
(2,091,549 | ) | 185,672 | (6,008,343 | ) | 619,747 | ||||||||||
Loss
before income taxes
|
(3,866,444 | ) | (1,125,300 | ) | (10,840,796 | ) | (2,459,072 | ) | ||||||||
Income
tax benefit
|
151,000 | 336,071 | 1,157,000 | 647,071 | ||||||||||||
Net
loss
|
(3,715,444 | ) | (789,229 | ) | (9,683,796 | ) | (1,812,001 | ) | ||||||||
Other
comprehensive income (loss) – (increase) decrease in unrealized loss on
investments, net of income tax
|
2,101,920 | 545,841 | 2,141,416 | (922,173 | ) | |||||||||||
Net
comprehensive loss
|
$ | (1,613,524 | ) | $ | (243,388 | ) | $ | (7,542,380 | ) | $ | (2,734,174 | ) | ||||
Net
loss per common share:
|
||||||||||||||||
Basic
|
$ | (0.17 | ) | $ | (0.04 | ) | $ | (0.44 | ) | $ | (0.09 | ) | ||||
Diluted
|
$ | (0.17 | ) | $ | (0.04 | ) | $ | (0.44 | ) | $ | (0.09 | ) | ||||
Weighted
average number of shares
outstanding:
|
||||||||||||||||
Basic
|
21,886,000 | 21,359,000 | 21,835,000 | 21,325,000 | ||||||||||||
Diluted
|
21,886,000 | 21,359,000 | 21,835,000 | 21,325,000 |
Nine
Months Ended
|
||||||||
May
31,
2009
|
May
31,
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (9,683,796 | ) | $ | (1,812,001 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
100,087 | 88,955 | ||||||
Stock-based
compensation
|
833,664 | 574,413 | ||||||
Stock
issued for services
|
105,180 | 61,195 | ||||||
Realized
loss on investments
|
6,501,586 | - | ||||||
Loss
on disposition of property and equipment
|
- | 1,153 | ||||||
Decrease
(increase) in:
|
||||||||
Receivables
|
539,543 | 28,029 | ||||||
Income
tax receivable
|
(250,454 | ) | (900,000 | ) | ||||
Inventories
|
(375,732 | ) | (51,856 | ) | ||||
Other
current assets
|
24,049 | 2,004 | ||||||
Deferred
tax assets
|
- | 244,000 | ||||||
Increase
(decrease) in:
|
||||||||
Accounts
payable
|
251,252 | 17,310 | ||||||
Accrued
liabilities
|
(182,326 | ) | (160,489 | ) | ||||
Customer
deposits
|
(387,900 | ) | (129,838 | ) | ||||
Deferred
revenue
|
39,191 | 23,045 | ||||||
Net
cash used in operating activities
|
(2,485,656 | ) | (2,014,080 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Sales
of investments
|
10,150,957 | 4,988,760 | ||||||
Purchases
of investments
|
(23,935 | ) | (1,925,808 | ) | ||||
Purchase
of property and equipment
|
(32,855 | ) | (1,273,449 | ) | ||||
Increase
in patents
|
- | (20,966 | ) | |||||
Net
cash provided by investing activities
|
10,094,167 | 1,768,537 | ||||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from the sale of common stock
|
- | 106,506 | ||||||
Net
increase (decrease) in cash and cash equivalents
|
7,608,511 | (139,037 | ) | |||||
Cash
and cash equivalents, beginning of period
|
1,394,652 | 416,540 | ||||||
Cash
and cash equivalents, end of period
|
$ | 9,003,163 | $ | 277,503 |
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
May
31,
|
May
31,
|
May
31,
|
May
31,
|
|||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Weighted
average number of shares outstanding – basic
|
21,886,000 | 21,359,000 | 21,835,000 | 21,325,000 | ||||||||||||
Dilutive
effect of stock options
|
- | - | - | - | ||||||||||||
Weighted
average number of shares outstanding – diluted
|
21,886,000 | 21,359,000 | 21,835,000 | 21,325,000 |
Gross
|
Gross
|
|||||||||||||||
Amortized
|
Unrealized
|
Unrealized
|
Fair
|
|||||||||||||
Type
of Security
|
Cost
|
Gains
|
(Losses)
|
Value
|
||||||||||||
Corporate
debt funds
|
$ | 11,518,134 | $ | - | $ | (1,158,692 | ) | $ | 10,359,442 | |||||||
Equity
income funds
|
5,031,467 | - | (982,724 | ) | 4,048,743 | |||||||||||
Other
short-term interest-bearing securities
|
79,007 | - | - | 79,007 | ||||||||||||
Total
|
$ | 16,628,608 | $ | - | $ | (2,141,416 | ) | $ | 14,487,192 |
May
31,
2009
|
August
31,
2008
|
|||||||
Parts
and supplies
|
$ | 1,108,465 | $ | 802,956 | ||||
Work-in-process
|
621,157 | 608,391 | ||||||
Finished
goods
|
111,263 | 53,806 | ||||||
Reserve
for obsolete inventory
|
(40,000 | ) | (40,000 | ) | ||||
Inventories,
net
|
$ | 1,800,885 | $ | 1,425,153 |
May
31,
2009
|
August
31,
2008
|
|||||||
Equipment
|
$ | 1,074,116 | $ | 1,048,061 | ||||
Furniture
and fixtures
|
298,576 | 298,576 | ||||||
Leasehold
improvements
|
24,220 | 17,420 | ||||||
Building
|
956,000 | 956,000 | ||||||
Land
|
244,000 | 244,000 | ||||||
2,596,912 | 2,564,057 | |||||||
Less
accumulated depreciation
|
(1,217,647 | ) | (1,122,533 | ) | ||||
Property
and equipment, net
|
$ | 1,379,265 | $ | 1,441,524 |
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
May
31,
|
May
31,
|
May
31,
|
May
31,
|
|||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Cost
of sales
|
$ | 18,009 | $ | 21,148 | $ | 54,867 | $ | 63,444 | ||||||||
Research
and development
|
48,042 | 35,125 | 138,648 | 95,745 | ||||||||||||
Selling,
general and administrative
|
218,254 | 153,046 | 640,149 | 415,224 | ||||||||||||
Total
|
$ | 284,305 | $ | 209,319 | $ | 833,664 | $ | 574,413 |
Expected
volatility
|
66.30%
|
Expected
dividends
|
0.00%
|
Expected
term
|
6.0 Years
|
Risk-free interest
rate
|
2.70%
|
Shares
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contract Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||
Outstanding at August 31,
2008
|
2,182,629 | $ | 3.02 | |||||||||||
Granted
|
990,760 | 3.10 | ||||||||||||
Exercised
|
(815,102 | ) | 1.04 | |||||||||||
Forfeited or
expired
|
(81,000 | ) | 6.35 | |||||||||||
Outstanding at May 31,
2009
|
2,277,287 | $ | 3.69 | 8.26 | ||||||||||
Exercisable at May 31,
2009
|
858,335 | $ | 3.61 | 6.76 | $331,477 |
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
May
31,
|
May
31,
|
May
31,
|
May
31,
|
|||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Current
|
$ | 151,000 | $ | 336,071 | $ | 1,386,000 | $ | 815,071 | ||||||||
Deferred
|
- | - | (229,000 | ) | (168,000 | ) | ||||||||||
Total
|
$ | 151,000 | $ | 336,071 | $ | 1,157,000 | $ | 647,071 |
|
·
|
Increased other comprehensive loss
and decreased investments by
$4,360,170.
|
|
·
|
Increased common stock and
decreased additional paid-in capital by
$618.
|
|
·
|
Decreased income tax receivable
and additional paid-in capital by
$194,436.
|
|
·
|
Recorded an increase in additional
paid-in capital of $173,961 and an increase in income tax receivable of
$173,961 related to the tax benefit from the exercise of stock
options.
|
|
·
|
Increased other comprehensive loss
by $922,173, decreased investments by $710,173 and decreased short-term
deferred tax asset by
$212,000.
|
|
·
|
Increased common stock and
decreased additional paid-in capital by
$24.
|
|
·
|
Thermal
ablation ablates soft tissues at high temperatures through focused
microwave energy.
|
|
·
|
Superficial
hyperthermia non-invasively treats cancerous tumors located within a few
centimeters of the surface of the body, such as melanoma and recurrent
breast cancer.
|
|
·
|
Internal
or interstitial hyperthermia treats tumors in combination with internal
radiation therapy by inserting tiny microwave antennae that deliver
hyperthermic microwave energy to tumors through the same catheters used to
deliver radioactive materials, or “seeds,” to tumors for radiation
therapy. This technique can be employed in treating prostate
cancer, breast cancer, head and neck cancer and a variety of other cancer
sites.
|
|
·
|
Deep
hyperthermia non-invasively treats tumors located deep within the body,
including many problematic cancer sites located in the
pelvis.
|
Three
Months Ended
|
Nine
Months Ended
|
|||
May
31,
|
May
31,
|
May
31,
|
May
31,
|
|
2009
|
2008
|
2009
|
2008
|
|
BSD-500
|
1
|
3
|
5
|
8
|
BSD-2000
|
1
|
-
|
4
|
-
|
BSD-2000/3D
|
1
|
-
|
1
|
-
|
BSD-2000/3D/MR
|
-
|
-
|
-
|
2
|
Total
|
3
|
3
|
10
|
10
|
|
·
|
our
belief about the market opportunities for our
products;
|
|
·
|
our
anticipated financial performance and business
plan;
|
|
·
|
our
expectations regarding the commercialization of, and the potential revenue
from, the BSD-2000, BSD 500 and MicroThermX-100
systems;
|
|
·
|
our
expectations to further expand our developments to treat other diseases
and medical conditions;
|
|
·
|
our
belief that the implementation of recent accounting pronouncements will
not have a material impact on our financial
statements;
|
|
·
|
our
belief concerning the market potential for developed cancer therapy
systems;
|
|
·
|
our
expectation that our interest and investment income for the foreseeable
future will be substantially less than previously earned on our mutual
funds.
|
|
·
|
our
expectations that we will incur increased expenses related to seeking
governmental and regulatory approvals for our
products;
|
|
·
|
our
expectations regarding FDA approvals relating to the BSD-2000
system;
|
|
·
|
our
expectations related to the amount of expenses we will incur for the
commercial introduction of our
systems;
|
|
·
|
our
expectation that we will continue to incur expenses related to our
corporate governance and compliance with the Sarbanes-Oxley Act of 2002;
and
|
|
·
|
our
belief that our current working capital, investments and cash from
operations will be sufficient to finance our operations through working
capital and capital resources needs for the next twelve
months.
|
Exhibit
No.
|
Description
of Exhibit
|
|
10.1
|
Exclusive
Distribution Agreement with Sennewald/Medizin-Technik GmbH dated May 13,
2009
|
|
10.2
|
Separation
Agreement, dated April 7, 2009, between BSD Medical Corporation and Hyrum
A. Mead. Incorporated by reference to Exhibit 10.1 of Current
Report on Form 8-K filed on April 8, 2009
|
|
10.3
|
Offer
Letter, dated April 7, 2009, between BSD Medical Corporation and Harold R.
Wolcott. Incorporated by reference to Exhibit 10.2 of Current
Report on Form 8-K filed on April 8, 2009
|
|
31.1
|
Certification
of the Principal Executive Officer Required Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2
|
Certification
of the Principal Accounting Officer Required Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
32.1
|
Certification
of Principal Executive Officer Required Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
32.2
|
Certification
of Principal Accounting Officer Required Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
BSD
MEDICAL CORPORATION
|
|
Date: July
10, 2009
|
/s/
Harold R. Wolcott
|
Harold
R. Wolcott
|
|
President
(Principal Executive Officer)
|
|
Date: July
10, 2009
|
/s/
Dennis P. Gauger
|
Dennis
P. Gauger
|
|
Chief
Financial Officer (Principal Accounting
Officer)
|