þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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26-2593535
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(State of incorporation)
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(I.R.S. Employer Identification No.)
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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¨
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Smaller reporting company
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þ
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(Do not check if a smaller reporting company)
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PAGE
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|||||
PART I. FINANCIAL INFORMATION
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|||||
Item 1.
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Unaudited Financial Statements
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3 | |||
Balance Sheets as of October 31, 2011 and as of April 30, 2011
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3 | ||||
Statements of Operations for the Three and Six months Ended October 31, 2011 and 2010
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4 | ||||
Statements of Cash Flows for the Six Months Ended October 31, 2011 and 2010
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5 | ||||
Notes to Financial Statements
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7 | ||||
Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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20 | |||
Item 3.
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Quantitative and Qualitative Disclosures About Market Risk
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29 | |||
Item 4.
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Controls and Procedures
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29 | |||
PART II. OTHER INFORMATION
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|||||
Item 1.
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Legal Proceedings
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30 | |||
Item 1A.
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Risk Factors
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30 | |||
Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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30 | |||
Item 3.
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Defaults Upon Senior Securities
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30 | |||
Item 4.
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(Removed and Reserved)
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30 | |||
Item 5.
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Other Information
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30 | |||
Item 6.
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Exhibits
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31 |
Period from May 26, 1967 (Inception) to
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Three months ended October 31,
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Six months ended October 31,
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||||||||||||||||||
October 31, 2011 |
2011
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2010
|
2011
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2010
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||||||||||||||||
(Unaudited)
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(Unaudited)
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(Unaudited)
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(Unaudited)
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(Unaudited)
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||||||||||||||||
Product revenue
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$ | 456,627 | $ | 27,415 | $ | 36,083 | $ | 86,892 | $ | 42,981 | ||||||||||
Cost of sales
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303,319 | 10,500 | 8,957 | 45,104 | 10,745 | |||||||||||||||
Net product revenue
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153,308 | 16,915 | 27,126 | 41,788 | 32,236 | |||||||||||||||
Government grant revenue
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78,244 | 78,244 | - | 78,244 | - | |||||||||||||||
Total net revenue
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231,552 | 95,159 | 27,126 | 120,032 | 32,236 | |||||||||||||||
Operating expenses
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||||||||||||||||||||
Selling, general, and administrative
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44,279,060 | 1,660,810 | 1,511,214 | 3,461,799 | 3,394,282 | |||||||||||||||
Research and development
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20,753,212 | 488,577 | 572,649 | 1,140,538 | 1,717,892 | |||||||||||||||
Loss on impairment of long-lived assets
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334,157 | - | - | - | - | |||||||||||||||
Total operating expenses
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65,366,429 | 2,149,387 | 2,083,863 | 4,602,337 | 5,112,174 | |||||||||||||||
Net operating loss
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65,134,877 | 2,054,228 | 2,056,737 | 4,482,305 | 5,079,938 | |||||||||||||||
Interest expense
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33,619,075 | 871,768 | 5,383 | 1,307,566 | 6,589 | |||||||||||||||
Loss on extinguishment of debt
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250,097 | - | - | - | - | |||||||||||||||
Other (income) expense
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(1,289,183 | ) | 3,927 | (10,183 | ) | 9,121 | (32,291 | ) | ||||||||||||
Net loss
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$ | 97,714,866 | $ | 2,929,923 | $ | 2,051,937 | $ | 5,798,992 | $ | 5,054,236 | ||||||||||
Net loss per share, basic
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$ | (0.12 | ) | $ | (0.09 | ) | $ | (0.25 | ) | $ | (0.22 | ) | ||||||||
Weighted average number of common shares outstanding, basic
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23,805,323 | 23,387,979 | 23,604,502 | 23,301,844 | ||||||||||||||||
Net loss per share, diluted
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$ | (0.29 | ) | $ | (0.09 | ) | $ | (0.42 | ) | $ | (0.22 | ) | ||||||||
Weighted average number of common shares outstanding, diluted
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25,980,214 | 23,387,979 | 25,081,668 | 23,301,844 |
Period from May 26, 1967 (Inception) to |
Six months ended October 31,
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|||||||||||
October 31, 2011
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2011
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2010
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||||||||||
(Unaudited)
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(Unaudited)
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(Unaudited)
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||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES
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||||||||||||
Net Loss
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$ | (97,714,866 | ) | $ | (5,798,992 | ) | $ | (5,054,236 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities
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||||||||||||
Depreciation and amortization
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1,982,995 | 118,864 | 190,738 | |||||||||
Amortization of deferred compensation
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336,750 | - | - | |||||||||
Interest on debt instruments
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33,214,178 | 1,295,541 | - | |||||||||
Loss (gain) on debt settlement and extinguishment
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163,097 | - | 6,588 | |||||||||
Loss on impairment, disposal and write down of long-lived assets
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670,326 | 2,671 | - | |||||||||
Issuance and vesting of compensatory stock options and warrants
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8,276,193 | 50,905 | 92,124 | |||||||||
Issuance of common stock below market value
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695,248 | - | - | |||||||||
Issuance of common stock as compensation
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606,339 | 51,338 | 53,250 | |||||||||
Issuance of common stock for services rendered
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1,265,279 | - | - | |||||||||
Issuance of note payable for services rendered
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120,000 | - | - | |||||||||
Contributions of capital through services rendered by stockholders
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216,851 | - | - | |||||||||
Changes in operating assets and liabilities
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||||||||||||
Accounts receivable, prepaid expenses and other assets
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(890,193 | ) | (171,416 | ) | 153,977 | |||||||
Inventory
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218,397 | (19,629 | ) | 52,364 | ||||||||
Accounts payable and accrued liabilities
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2,233,766 | (112,736 | ) | 115,399 | ||||||||
Net cash used in operating activities
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(48,605,640 | ) | (4,583,454 | ) | (4,389,796 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES
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||||||||||||
Purchase of property and equipment
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(1,752,960 | ) | (8,869 | ) | (138,798 | ) | ||||||
Capitalization of patent costs and license rights
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(1,666,945 | ) | (152,606 | ) | (118,504 | ) | ||||||
Net cash used in investing activities
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(3,419,905 | ) | (161,475 | ) | (257,302 | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES
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||||||||||||
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
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36,363,844 | 619,181 | 4,901,400 | |||||||||
Repurchase of outstanding warrants
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(2,836,520 | ) | - | - | ||||||||
Proceeds from stockholder notes payable
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977,692 | - | - | |||||||||
Proceeds from issuance of notes payable, net of issuance costs
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7,380,829 | 700,000 | - | |||||||||
Proceeds from convertible notes, net of issuance costs
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13,321,447 | 4,514,161 | - | |||||||||
Payments on notes - short-term
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(1,177,490 | ) | (36,100 | ) | (49,841 | ) | ||||||
Net cash provided by financing activities
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54,029,802 | 5,797,242 | 4,851,559 | |||||||||
Net change in cash and cash equivalents
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2,004,257 | 1,052,313 | 204,461 | |||||||||
Cash and cash equivalents, beginning of period
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- | 951,944 | 632,706 | |||||||||
Cash and cash equivalents, end of period
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$ | 2,004,257 | $ | 2,004,257 | $ | 837,167 | ||||||
Cash paid for:
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||||||||||||
Interest
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$ | 262,631 | $ | 12,025 | $ | 863 | ||||||
Income taxes
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$ | 27,528 | $ | - | $ | - |
(1)
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The Company issued 7,333 shares of common stock for the cashless exercise of 40,000 stock options with an exercise price of $1.96.
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(2)
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The Company issued 78,197 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $2.255 for the payment of $176,333 interest payable on convertible notes with a gross carrying value of $4,600,000.
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(1)
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The Company issued 2,350 shares of common stock for the conversion of notes payable with a gross carrying value of $8,707 at a conversion price of $3.705 per share. The notes included a discount totaling $5,206 that was recognized as interest expense upon conversion.
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Three months ended October 31,
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Six months ended October 31,
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|||||||||||||||
2011
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2010
|
2011
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2010
|
|||||||||||||
Historical net loss per share:
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||||||||||||||||
Numerator
|
||||||||||||||||
Net loss, as reported
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$ | (2,929,923 | ) | $ | (2,051,937 | ) | $ | (5,798,992 | ) | $ | (5,054,236 | ) | ||||
Less: Effect of amortization of interest expense on convertible notes
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(4,637,024 | ) | - | (4,637,024 | ) | - | ||||||||||
Net loss attributed to common stockholders (diluted)
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(7,566,947 | ) | (2,051,937 | ) | (10,436,016 | ) | (5,054,236 | ) | ||||||||
Denominator
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||||||||||||||||
Weighted-average common shares outstanding
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23,805,323 | 23,387,979 | 23,604,502 | 23,301,844 | ||||||||||||
Effect of dilutive securities
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2,174,891 | - | 1,477,166 | - | ||||||||||||
Denominator for diluted net loss per share
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25,980,214 | 23,387,979 | 25,081,668 | 23,301,844 | ||||||||||||
Basic net loss per share
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$ | (0.12 | ) | $ | (0.09 | ) | $ | (0.25 | ) | $ | (0.22 | ) | ||||
Diluted net loss per share
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$ | (0.29 | ) | $ | (0.09 | ) | $ | (0.42 | ) | $ | (0.22 | ) |
Six months ended October 31,
|
||||||||
2011
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2010
|
|||||||
Options to purchase common stock
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721,015 | 976,233 | ||||||
Convertible note shares outstanding
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- | 1,942 | ||||||
Warrants to purchase common stock
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4,983,855 | 4,199,466 |
October 31, 2011
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April 30, 2011
|
|||||||
Raw materials
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$ | 25,855 | $ | 107,271 | ||||
Work in process
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- | 124,308 | ||||||
Finished goods
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69,865 | 25,803 | ||||||
$ | 95,720 | $ | 257,382 |
October 31, 2011
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April 30, 2011
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|||||||
R&D materials
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$ | 145,714 | $ | - | ||||
Dermacyte samples
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53,957 | 1,052 | ||||||
Other
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83,609 | 7,090 | ||||||
$ | 283,280 | $ | 8,142 |
October 31, 2011
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April 30, 2011
|
|||||||
Laboratory equipment
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$ | 961,078 | $ | 970,463 | ||||
Office furniture and fixtures
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140,255 | 140,255 | ||||||
Computer equipment and software
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152,024 | 153,234 | ||||||
Leasehold improvements
|
4,810 | 4,810 | ||||||
1,258,167 | 1,268,762 | |||||||
Less: Accumulated depreciation and amortization
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(907,097 | ) | (826,176 | ) | ||||
$ | 351,070 | $ | 442,586 |
October 31, 2011
|
April 30, 2011
|
|||||||
Reimbursable patent expenses- Glucometrics
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$ | 88,087 | $ | 82,522 | ||||
Prepaid royalty fee
|
50,000 | 50,000 | ||||||
Other
|
11,565 | 15,086 | ||||||
$ | 149,652 | $ | 147,608 |
October 31, 2011
|
April 30, 2011
|
|||||||
Section 409A tax liability
|
$ | 532,350 | $ | 532,350 | ||||
Deferred government grant revenue
|
310,000 | - | ||||||
Employee related
|
303,237 | 493,640 | ||||||
Legal
|
27,248 | - | ||||||
Clinical trial related
|
41,908 | 150,000 | ||||||
Other
|
92,460 | 74,583 | ||||||
$ | 1,307,203 | $ | 1,250,573 |
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
Patents
|
$ | 471,918 | 11.4 | $ | - | $ | (223,221 | ) | $ | 248,697 | ||||||||||
License Rights
|
523,970 | 17.1 | - | (76,164 | ) | 447,806 | ||||||||||||||
Trademarks
|
134,904 | N/A | - | - | 134,904 | |||||||||||||||
Total
|
$ | 1,130,792 | $ | - | $ | (299,385 | ) | $ | 831,407 |
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
Patents
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$ | 566,564 | 10.1 | $ | (202,934 | ) | $ | (214,840 | ) | $ | 148,790 | |||||||||
License Rights
|
558,532 | 17.6 | (68,602 | ) | (63,395 | ) | 426,535 | |||||||||||||
Trademarks
|
155,134 | N/A | (30,508 | ) | - | 124,626 | ||||||||||||||
Total
|
$ | 1,280,230 | $ | (302,044 | ) | $ | (278,235 | ) | $ | 699,951 |
October 31, 2011
|
April 30, 2011
|
|||||||
Current portion of notes payable
|
$ | - | $ | 36,100 | ||||
Current portion of convertible notes payable
|
7,195 | 7,195 | ||||||
Current portion of notes payable, net
|
$ | 7,195 | $ | 43,295 | ||||
Long-term portion of notes payable
|
$ | 8,001,600 | $ | 6,881,600 | ||||
Less: Unaccreted premium
|
(2,367,574 | ) | (2,417,965 | ) | ||||
5,634,026 | 4,463,635 | |||||||
Long-term portion of convertible notes payable
|
$ | 4,900,001 | $ | - | ||||
Less: Unamortized discount
|
(4,355,557 | ) | - | |||||
544,444 | - | |||||||
Long-term portion of notes payable, net
|
$ | 6,178,470 | $ | 4,463,635 |
Date issued
|
Note principal
|
Accumulated Accretion
|
Unaccreted premium
|
Effective interest rate
|
||||||||||||
Balance at April 30, 2011
|
$ | 4,301,000 | $ | 568,360 | $ | 2,012,240 | 17.17 | % | ||||||||
May 9, 2011
|
400,000 | 37,959 | 202,041 | 18.83 | % | |||||||||||
May 20, 2011
|
100,000 | 8,996 | 51,004 | 19.06 | % | |||||||||||
May 23, 2011
|
200,000 | 17,711 | 102,289 | 19.12 | % | |||||||||||
$ | 5,001,000 | $ | 633,026 | $ | 2,367,574 |
For the three months ending October 31,
|
For the six months ending October 31,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Product revenue
|
||||||||||||||||
United States
|
$ | 27,415 | $ | 36,083 | $ | 60,892 | $ | 42,981 | ||||||||
Latin America
|
- | - | 26,000 | - | ||||||||||||
Europe
|
- | - | - | - | ||||||||||||
Total product revenue
|
$ | 27,415 | $ | 36,083 | $ | 86,892 | $ | 42,981 | ||||||||
Segment loss (income)
|
||||||||||||||||
United States
|
$ | 117,120 | $ | 133,077 | $ | 332,165 | $ | 233,043 | ||||||||
Latin America
|
- | - | (10,585 | ) | - | |||||||||||
Europe
|
- | - | - | - | ||||||||||||
Unallocated revenues
|
||||||||||||||||
Government grant revenue
|
(78,244 | ) | - | (78,244 | ) | - | ||||||||||
Unallocated expenses
|
||||||||||||||||
General and administrative
|
1,526,775 | 1,351,011 | 3,098,431 | 3,129,003 | ||||||||||||
Research and development
|
488,577 | 572,649 | 1,140,538 | 1,717,892 | ||||||||||||
Net interest and other expense (income)
|
875,695 | (4,800 | ) | 1,316,687 | (25,702 | ) | ||||||||||
Net loss
|
$ | 2,929,923 | $ | 2,051,937 | $ | 5,798,992 | $ | 5,054,236 |
(1)
|
The Company received $4,401,400 (net of closing costs) from the issuance of 1,724,138 shares of common stock as part of the registered direct offering in May 2010.
|
(2)
|
The Company recorded $22,398 for the fair value of restricted stock grants issued to nonemployee directors.
|
(3)
|
The Company issued 7,333 shares of common stock from the cashless exercise of 40,000 stock options.
|
(4)
|
The Company issued 366,379 shares of common stock from the exercise of warrants. The shares were issued at an exercise price of $1.69 for a payment of $619,181.
|
(5)
|
As further discussed below, the company recorded $50,905 for the computed fair value of options issued to employees, nonemployee directors, and consultants.
|
(6)
|
The Company issued 78,197 shares of common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $2.255 for the payment of $176,333 interest payable on convertible notes with a gross carrying value of $4,600,000.
|
(7)
|
As further discussed in note 5 above, the Company recorded $1,960,497 for the computed fair value of 2,172,949 warrants issued with convertible notes issued on June 29, 2011 and July 1, 2011. In addition, the Company recorded $2,939,504 for the computed beneficial conversion features for the intrinsic value of the notes at the commitment date. The total value allocated to the warrants and beneficial conversion features was approximately $4.9 million and was recorded as additional paid in capital.
|
(1)
|
The Company received $4,401,400 (net of closing costs) from the issuance of 1,724,138 shares of common stock as part of the registered direct offering (the "Offering") described below.
|
(2)
|
The Company received $500,000 (net of closing costs), from the issuance of 133,334 shares of restricted common stock in accordance with the Securities Purchase Agreement with Vatea Fund. An additional 53,334 shares of common stock were issued as compensation for services provided in closing the Securities Purchase Agreement.
|
(3)
|
The Company issued 2,018 shares of common stock from the cashless exercise of 6,333 stock options.
|
(4)
|
The Company issued 2,350 shares of common stock for the conversion of notes payable with a gross carrying value of $8,707, at a conversion price of $3.705 per share. These notes included a discount totaling $868, and thus had a net carrying value of $7,839. The unamortized discount of $868 was recognized as interest expense upon conversion. The remaining unamortized discount of $4,859 was also recognized as interest expense.
|
(5)
|
The Company issued 17,782 shares of its common stock as compensation. These shares had a fair value at the grant date of $53,250.
|
(6)
|
The company recorded $91,931 for the computed fair value of options issued to employees, nonemployee directors, and consultants.
|
Warrants
|
Weighted Average Exercise Price
|
|||||||
Outstanding at April 30, 2011
|
3,581,347 | $ | 3.90 | |||||
Granted
|
2,172,949 | 2.53 | ||||||
Exercised
|
(366,379 | ) | 1.69 | |||||
Forfeited
|
(636,144 | ) | 3.68 | |||||
Other
|
232,082 | (1) | 2.15 | (1) | ||||
Outstanding at October 31, 2011
|
4,983,855 | $ | 2.82 | (2) |
(1)
|
The Company has a class of warrants outstanding that contain an anti-dilution clause requiring a repricing in the event of a capital raise whereby the equity shares sold were priced below the exercise price of the outstanding warrants. Subsequent to the convertible note issuance in June 2011, the repricing of these warrants resulted in an increase of 232,082 potentially issuable shares. The exercise price of these warrants was $2.90 prior to the issuance.
|
(2)
|
The Company has a class of warrants outstanding that contain a price protection clause requiring a repricing in the event of a capital raise whereby the equity shares sold were priced below the exercise price of the outstanding warrants. Subsequent to the convertible note issuance in June 2011, resulted in repricing these warrants to $2.15. The exercise price of these warrants was $5.32 prior to the issuance.
|
Outstanding Options
|
||||||||||||
Shares Available for Grant
|
Number of Shares
|
Weighted Average Exercise Price
|
||||||||||
Balances, at April 30, 2011
|
243,832 | 515,071 | $ | 4.54 | ||||||||
Options granted
|
(43,000 | ) | 43,000 | $ | 2.03 | |||||||
Options cancelled
|
3,556 | (3,556 | ) | $ | 5.81 | |||||||
Restricted stock granted
|
(132,900 | ) | ||||||||||
Restricted stock cancelled
|
7,322 | |||||||||||
Balances, at July 31, 2011
|
78,810 | 554,515 | $ | 4.33 | ||||||||
Additional shares reserved
|
5,200,000 | |||||||||||
Options granted
|
(2,500 | ) | 2,500 | $ | 2.50 | |||||||
Options exercised
|
(7,333 | ) | $ | 1.96 | ||||||||
Options cancelled
|
95,334 | (95,334 | ) | $ | 3.62 | |||||||
Restricted stock granted
|
(35,412 | ) | ||||||||||
Restricted stock cancelled
|
126,252 | |||||||||||
Balances, at October 31, 2011
|
5,462,484 | 454,348 | $ | 4.51 |
For the the six months ended October 31
|
||||||||
2011
|
2010
|
|||||||
Research and development
|
$ | 63,532 | $ | 19,428 | ||||
Marketing and sales
|
2,174 | - | ||||||
General and administrative
|
2,024 | 47,566 | ||||||
$ | 67,730 | $ | 66,994 |
For the the six months ended October 31
|
||||||||
2011
|
2010
|
|||||||
Risk-free interest rate (weighted average)
|
2.38 | % | 1.83 | % | ||||
Expected volatility (weighted average)
|
78.47 | % | 86.44 | % | ||||
Expected term (in years)
|
7 | 6 | ||||||
Expected dividend yield
|
0.00 | % | 0.00 | % |
Three months ended October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Six months ended October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
Wholesale & retail revenue
|
$ | 27,415 | $ | 36,083 | $ | (8,668 | ) | -24 | % | $ | 60,892 | $ | 42,981 | $ | 17,911 | 42 | % | |||||||||||||||
Distibutor revenue
|
- | - | - | 0 | % | 26,000 | - | 26,000 | 0 | % | ||||||||||||||||||||||
Product revenue
|
27,415 | 36,083 | (8,668 | ) | -24 | % | 86,892 | 42,981 | 43,911 | 102 | % | |||||||||||||||||||||
Cost of sales
|
10,500 | 8,957 | 1,543 | 17 | % | 45,104 | 10,745 | 34,359 | 320 | % | ||||||||||||||||||||||
Gross profit
|
16,915 | 27,126 | (10,211 | ) | -38 | % | 41,788 | 32,236 | 9,552 | 30 | % | |||||||||||||||||||||
Government grant revenue
|
78,244 | - | 78,244 | - | % | 78,244 | - | 78,244 | - | % | ||||||||||||||||||||||
Total net revenue
|
95,159 | 27,126 | 68,033 | 251 | % | 120,032 | 32,236 | 87,796 | 272 | % | ||||||||||||||||||||||
Operating expenses:
|
||||||||||||||||||||||||||||||||
Sales and Marketing
|
134,035 | 160,203 | (26,168 | ) | -16 | % | 363,368 | 265,279 | 98,089 | 37 | % | |||||||||||||||||||||
General and administrative
|
1,526,775 | 1,351,011 | 175,764 | 13 | % | 3,098,431 | 3,129,003 | (30,572 | ) | -1 | % | |||||||||||||||||||||
Research and development
|
488,577 | 572,649 | (84,072 | ) | -15 | % | 1,140,538 | 1,717,892 | (577,354 | ) | -34 | % | ||||||||||||||||||||
Total Operating expenses
|
2,149,387 | 2,083,863 | 65,524 | 3 | % | 4,602,337 | 5,112,174 | (509,837 | ) | -10 | % | |||||||||||||||||||||
Net operating loss
|
2,054,228 | 2,056,737 | (2,509 | ) | 0 | % | 4,482,305 | 5,079,938 | (597,633 | ) | -12 | % | ||||||||||||||||||||
Interest expense
|
871,768 | 5,383 | 866,385 | 16095 | % | 1,307,566 | 6,589 | 1,300,977 | 19745 | % | ||||||||||||||||||||||
Other (income) expense
|
3,927 | (10,183 | ) | 14,110 | -139 | % | 9,121 | (32,291 | ) | 41,412 | -128 | % | ||||||||||||||||||||
Net loss
|
$ | 2,929,923 | $ | 2,051,937 | $ | 877,986 | 43 | % | $ | 5,798,992 | $ | 5,054,236 | $ | 744,756 | 15 | % |
Three months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Six months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
Product revenue
|
$ | 27,415 | $ | 36,083 | $ | (8,668 | ) | -24 | % | $ | 86,892 | $ | 42,981 | $ | 43,911 | 102 | % | |||||||||||||||
Government grant revenue
|
$ | 78,244 | $ | - | $ | 78,244 | 100 | % | $ | 78,244 | $ | - | $ | 78,244 | 100 | % |
Three months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Six months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
Marketing and sales expense
|
$ | 134,035 | $ | 160,203 | $ | (26,168 | ) | -16 | % | $ | 363,368 | $ | 265,279 | $ | 98,089 | 37 | % |
-
|
We reduced the costs associated with direct marketing and advertising approximately $60,000. These costs include attendance at trade shows and conferences, fees paid to a third party public relations firm, the costs of product samples distributed to potential customers, and the costs of direct print and online advertisements
topical product line Dermacyte. These costs include salaries, commissions, and employee benefits.
|
-
|
We incurred an increase of approximately $30,000 in compensation costs related to marketing and selling the cosmetic topical product line Dermacyte. These costs include salaries, commissions, and employee benefits.
|
-
|
We incurred an increase of approximately $95,000 in compensation costs and $10,000 in travel costs related to marketing and selling the cosmetic topical product line Dermacyte. These costs include salaries, commissions, employee benefits, and entertainment.
|
-
|
We reduced the costs related to direct marketing and advertising approximately $6,000 compared to the same period in the prior year. These costs include attendance at trade shows and conferences, fees paid to a third party public relations firm, the costs of product samples distributed to potential customers, and the costs of direct print and online advertisements.
|
Three months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Six months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
General and administrative expense
|
$ | 1,526,775 | $ | 1,351,011 | $ | 175,764 | 13 | % | $ | 3,098,431 | $ | 3,129,003 | $ | (30,572 | ) | -1 | % |
-
|
We reduced compensation expenses approximately $195,000 compared to the same period in the prior year due to a reduction in headcount.
|
-
|
We reduced administrative travel costs by approximately $51,000 compared to the same period in the prior year due to a reduction in headcount and international travel.
|
-
|
We reduced depreciation and amortization costs approximately $27,000 compared to the same period in the prior year due to impairments to intangible assets recorded in the prior year.
|
-
|
We incurred an increase of approximately $213,000 in legal and accounting fees associated with our filings and other corporate matters compared to the same period in the prior year.
|
-
|
We incurred and increase in consulting and Board of Director fees of approximately $230,000 compared to the same period in the prior year due to the accrual of severance payments due to a retired Director and fees paid to a third-party recruiter.
|
-
|
We reduced compensation expenses approximately $474,000 compared to the same period in the prior year due to a reduction in headcount.
|
-
|
We reduced depreciation and amortization costs approximately $67,000 compared to the same period in the prior year due to impairments to intangible assets recorded in the prior year.
|
-
|
We reduced investor relations costs by approximately $108,000 compared to the same period in the prior year due to a reduction in presentations and costs associated with international marketing firms.
|
-
|
We incurred an increase of approximately $422,000 in legal and accounting fees associated with our filings and other corporate matters compared to the same period in the prior year.
|
-
|
We incurred and increase in consulting and Board of Director fees of approximately $275,000 compared to the same period in the prior year due to the accrual of severance payments due to a retired Director and fees paid to a third-party recruiter.
|
Three months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Six months October 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
Research and development expense
|
$ | 488,577 | $ | 572,649 | $ | (84,072 | ) | -15 | % | $ | 1,140,538 | $ | 1,717,892 | $ | (577,354 | ) | -34 | % |
-
|
We reduced compensation expenses approximately $43,000 compared to the same period in the prior year due to a reduction in headcount.
|
-
|
We reduced travel costs by approximately $10,000 compared to the same period in the prior year due to a reduction in headcount and international travel.
|
-
|
We reduced CRO costs approximately $104,000 compared to the same period in the prior year due to the completion of the first cohort of the TBI trials in the prior year.
|
-
|
We incurred an increase of approximately $32,000 in consulting costs compared to the same period in the prior year primarily due to the consulting agreement with our retired Chief Operating Officer entered into in the fourth quarter of the prior year.
|
-
|
We incurred an increase of approximately $52,000 in Oxycyte development costs compared to the same period in the prior year due to costs incurred for manufacturing and preclinical studies.
|
-
|
We reduced compensation expenses approximately $16,000 compared to the same period in the prior year due to a reduction in headcount.
|
-
|
We reduced travel costs by approximately $35,000 compared to the same period in the prior year due to a reduction in headcount, conferences and seminars, and international travel.
|
-
|
We reduced CRO costs approximately $487,000 compared to the same period in the prior year due to the completion of the first cohort of the TBI trials in the prior year.
|
-
|
We incurred a decrease of approximately $148,000 in product development costs compared to the same period in the prior year due to impairment costs recognized in the prior year for expired clinical drug material offset by development costs associated with Dermacyte and Oxycyte manufacturing and preclinical studies incurred in the current year.
|
-
|
We incurred an increase of approximately $112,000 in consulting costs compared to the same period in the prior year primarily due to the consulting agreement with our retired Chief Operating Officer entered into in the fourth quarter of the prior year.
|
For the six months ended October 31,
|
||||||||
2011
|
2010
|
|||||||
Net cash used in operating activities
|
(4,583,454 | ) | (4,389,796 | ) | ||||
Net cash used in investing activities
|
(161,475 | ) | (257,302 | ) | ||||
Net cash provided by financing activities
|
5,797,242 | 4,851,559 |
·
|
the initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
|
·
|
the outcome, timing and cost of regulatory approvals and the regulatory approval process;
|
·
|
delays that may be caused by changing regulatory requirements;
|
·
|
the number of product candidates that we pursue;
|
·
|
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
|
·
|
the timing and terms of future in-licensing and out-licensing transactions;
|
·
|
the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
|
·
|
the cost of procuring clinical and commercial supplies of our product candidates;
|
·
|
the extent to which we acquire or invest in businesses, products or technologies; and
|
·
|
the possible costs of litigation.
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
ITEM 1.
|
LEGAL PROCEEDINGS
|
ITEM 1A.
|
RISK FACTORS
|
·
|
the incurrence of additional indebtedness without the consent of the holders of the Preferred Stock;
|
·
|
the issuance of additional securities, subject to standard exceptions; and
|
·
|
the payment of cash dividends on shares of capital stock outstanding.
|
ITEM 2.
|
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
ITEM 3.
|
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4.
|
(REMOVED AND RESERVED)
|
ITEM 5.
|
OTHER INFORMATION
|
ITEM 6.
|
EXHIBITS
|
No.
|
Description
|
|
3.1 | Amended and Restated Bylaws | |
10.1
|
Amendment No. 3 to Securities Purchase Agreement between the Company and Vatea Fund, dated November 14, 2011 (1)
|
|
10.2
|
Task Order between the Company and NextPharma, dated November 15, 2011 (1)
|
|
10.3
|
Termination Agreement between the Company and Hospira, dated August 30, 2011 (1)
|
|
10.4
|
Placement Agency Agreement, dated December 8, 2011, between Oxygen Biotherapeutics, Inc. and William Blair & Company, L.L.C., as placement agent (2)
|
|
10.5
|
Form of Warrant (2)
|
|
10.6
|
Form of Certificate of Designations (2)
|
|
10.7
|
Form of Securities Purchase Agreement (2)
|
|
10.8
|
Form of Lock-up Agreement (2)
|
|
10.9 | Restricted Stock Award Agreement | |
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
|
||
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
101.INS
|
XBRL Instance Document (3)
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document (3)
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document (3)
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document (3)
|
(1)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 16, 2011, and is incorporated herein by reference.
|
(2)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 9, 2011, and is incorporated herein by reference.
|
(3)
|
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
|
OXYGEN BIOTHERAPEUTICS, INC. | |||
Date: December 15, 2011
|
By:
|
/s/ Michael B. Jebsen | |
Michael B. Jebsen, | |||
Interim Chief Executive Officer, President and Chief Financial Officer | |||
(Principal Executive Officer) |
Name of Recipient:
|
|
Number of shares of restricted common stock awarded:
|
|
Grant Date:
|
OXYGEN BIOTHERAPEUTICS, INC.
|
|||
|
By:
|
||
Name: | |||
Title: | |||
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Oxygen Biotherapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: December 15, 2011
|
/ s/ Michael B. Jebsen | ||
Michael B. Jebsen | |||
Interim Chief Executive Officer, President and Chief Financial Officer | |||
(Principal Executive Officer) |
Date: December 15, 2011
|
|
/s/ Michael B. Jebsen | |
Michael B. Jebsen, | |||
Interim Chief Executive Officer, President and Chief Financial Officer | |||
(Principal Executive Officer) |