TENAX THERAPEUTICS, INC. - Quarter Report: 2013 January (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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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FOR THE QUARTERLY PERIOD ENDED January 31, 2013
OR
¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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FOR THE TRANSITION PERIOD FROM TO
Commission File Number 001-34600
OXYGEN BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
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26-2593535
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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ONE Copley Parkway, Suite 490, Morrisville, North Carolina
(Address of principal executive offices)
27560
(Zip Code)
(919) 855-2120
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
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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Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). Yes ¨ No þ
As of March 15, 2013, the registrant had outstanding 38,305,765 shares of Common Stock.
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ITEM 1.
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FINANCIAL STATEMENTS
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OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
January 31,
2013
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April 30,
2012
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(Unaudited)
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ASSETS
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Current assets
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Cash and cash equivalents
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$ | 828,811 | $ | 1,879,872 | ||||
Accounts receivable
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13,642 | 13,385 | ||||||
Government grant receivable
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87,185 | 35,650 | ||||||
Inventory
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107,938 | 83,370 | ||||||
Prepaid expenses
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341,884 | 455,946 | ||||||
Other current assets
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272,713 | 162,809 | ||||||
Total current assets
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1,652,173 | 2,631,032 | ||||||
Property and equipment, net
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226,808 | 293,606 | ||||||
Debt issuance costs, net
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182,197 | 278,659 | ||||||
Intangible assets, net
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923,397 | 872,971 | ||||||
Other assets
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58,262 | 65,666 | ||||||
Total assets
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$ | 3,042,837 | $ | 4,141,934 | ||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT
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Current liabilities
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Accounts payable
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$ | 807,679 | $ | 542,809 | ||||
Accrued liabilities
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1,085,373 | 1,273,837 | ||||||
Convertible preferred stock
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- | 1,247,266 | ||||||
Current portion of notes payable, net
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98,657 | 62,958 | ||||||
Total current liabilities
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1,991,709 | 3,126,870 | ||||||
Other liabilities
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65,592 | - | ||||||
Long-term portion of notes payable, net
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2,586,109 | 1,361,110 | ||||||
Total liabilities
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4,643,410 | 4,487,980 | ||||||
Commitments and contingencies; see Note 7.
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Stockholders' deficit
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||||||||
Preferred stock, undesignated, authorized 9,992,500 shares; see Note 5.
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- | - | ||||||
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 33,650,499 and 29,417,718, respectively
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3,365 | 2,942 | ||||||
Additional paid-in capital
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113,581,120 | 107,279,296 | ||||||
Deficit accumulated during the development stage
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(115,185,058 | ) | (107,628,284 | ) | ||||
Total stockholders’ deficit
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(1,600,573 | ) | (346,046 | ) | ||||
Total liabilities and stockholders' deficit
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$ | 3,042,837 | $ | 4,141,934 |
The accompanying notes are an integral part of these Financial Statements.
Period from May 26, 1967
(Inception)
to January 31,
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Three months ended January 31, | Nine months ended January 31, | ||||||||||||||||||
2013 | 2013 | 2012 | 2013 | 2012 | ||||||||||||||||
(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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$ | 499,153 | $ | 2,871 | $ | 4,673 | $ | 28,899 | $ | 91,565 | ||||||||||
Cost of sales
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326,046 | 1,534 | 2,512 | 16,578 | 47,616 | |||||||||||||||
Net product revenue
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173,107 | 1,337 | 2,161 | 12,321 | 43,949 | |||||||||||||||
Government grant revenue
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1,311,550 | 221,051 | 146,101 | 997,035 | 224,345 | |||||||||||||||
Total net revenue
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1,484,657 | 222,388 | 148,262 | 1,009,356 | 268,294 | |||||||||||||||
Operating expenses
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||||||||||||||||||||
Selling, general, and administrative
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50,036,200 | 1,441,500 | 1,422,103 | 3,127,133 | 4,883,903 | |||||||||||||||
Research and development
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23,686,605 | 369,447 | 599,935 | 1,611,293 | 1,740,473 | |||||||||||||||
Restructuring expense
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220,715 | 2,941 | - | 220,715 | - | |||||||||||||||
Loss on impairment of long-lived assets
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363,691 | - | - | - | - | |||||||||||||||
Total operating expenses
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74,307,211 | 1,813,888 | 2,022,038 | 4,959,141 | 6,624,376 | |||||||||||||||
Net operating loss
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72,822,554 | 1,591,500 | 1,873,776 | 3,949,785 | 6,356,082 | |||||||||||||||
Interest expense
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43,338,767 | 821,777 | 5,341,988 | 3,615,204 | 6,649,554 | |||||||||||||||
Loss on extinguishment of debt
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250,097 | - | - | - | - | |||||||||||||||
Other (income) expense
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(1,226,360 | ) | (323 | ) | 82,850 | (8,215 | ) | 91,970 | ||||||||||||
Net loss
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$ | 115,185,058 | $ | 2,412,954 | $ | 7,298,614 | $ | 7,556,774 | $ | 13,097,606 | ||||||||||
Net loss per share, basic
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$ | (0.07 | ) | $ | (0.26 | ) | $ | (0.24 | ) | $ | (0.53 | ) | ||||||||
Weighted average number of common shares outstanding, basic
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33,177,893 | 27,558,532 | 31,828,750 | 24,922,512 | ||||||||||||||||
Net loss per share, diluted
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$ | (0.14 | ) | $ | (0.39 | ) | $ | (0.30 | ) | $ | (0.65 | ) | ||||||||
Weighted average number of common shares outstanding, diluted
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35,352,784 | 29,731,481 | 34,003,641 | 26,630,311 |
The accompanying notes are an integral part of these Financial Statements.
Period from May 26, 1967 (Inception) to January 31, | Nine months ended January 31, | |||||||||||
2013
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2013
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2012
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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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$ | (115,185,058 | ) | $ | (7,556,774 | ) | $ | (13,097,606 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities
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Depreciation and amortization
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2,181,552 | 110,744 | 166,134 | |||||||||
Amortization of deferred compensation
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336,750 | - | - | |||||||||
Interest on debt instruments
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42,930,131 | 3,614,137 | 6,635,979 | |||||||||
Loss on debt settlement and extinguishment
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163,097 | - | - | |||||||||
Loss on impairment, disposal and write down of long-lived assets
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802,736 | 11,563 | 95,760 | |||||||||
Issuance and vesting of compensatory stock options and warrants
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8,364,235 | 73,574 | 53,292 | |||||||||
Issuance of common stock below market value
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695,248 | - | - | |||||||||
Issuance of common stock as compensation
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851,820 | 169,294 | 106,190 | |||||||||
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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(795,191 | ) | (1,654 | ) | (341,637 | ) | ||||||
Inventory
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201,784 | (28,962 | ) | (40,616 | ) | |||||||
Accounts payable and accrued liabilities
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2,069,389 | 127,253 | (434,954 | ) | ||||||||
Net cash used in operating activities
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(55,781,377 | ) | (3,480,825 | ) | (6,857,458 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES
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Purchase of property and equipment
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(1,776,675 | ) | (14,932 | ) | (11,371 | ) | ||||||
Proceeds from the sale of property and equipment
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4,243 | - | - | |||||||||
Capitalization of patent costs and license rights
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(1,853,079 | ) | (91,003 | ) | (195,829 | ) | ||||||
Net cash used in investing activities
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(3,625,511 | ) | (105,935 | ) | (207,200 | ) | ||||||
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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44,478,293 | - | 8,619,181 | |||||||||
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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7,621,192 | 102,671 | 837,692 | |||||||||
Proceeds from convertible notes, net of issuance costs
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13,321,447 | - | 4,514,162 | |||||||||
Proceeds for issuance of convertible preferred stock
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6,000,000 | 2,500,000 | 3,500,000 | |||||||||
Payments on notes - short-term
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(1,326,405 | ) | (66,972 | ) | (76,819 | ) | ||||||
Payments on notes - long-term
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(8,000,000 | ) | - | (8,000,000 | ) | |||||||
Net cash provided by financing activities
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60,235,699 | 2,535,699 | 9,394,216 | |||||||||
Net change in cash and cash equivalents
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828,811 | (1,051,061 | ) | 2,329,558 | ||||||||
Cash and cash equivalents, beginning of period
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- | 1,879,872 | 951,944 | |||||||||
Cash and cash equivalents, end of period
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$ | 828,811 | $ | 828,811 | $ | 3,281,502 | ||||||
Cash paid for:
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Interest
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$ | 266,370 | $ | 1,067 | $ | 13,574 | ||||||
Income taxes
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$ | 27,528 | $ | - | $ | - |
The accompanying notes are an integral part of these Financial Statements.
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
STATEMENT OF CASH FLOWS, Continued
Non-cash financing activities during the nine months ended January 31, 2013:
(1)
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The Company issued 248,986 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 $561,458 interest payable on convertible notes with a gross carrying value of $4,900,000.
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(2)
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The Company issued 3,838,675 shares of its common stock upon the conversion of 3,668 shares of Series A Preferred Stock with a fair value of $4,509,987.
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Non-cash financing activities during the nine months ended January 31, 2012:
(1)
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The Company issued 161,438 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 $364,042 interest payable on convertible notes with a gross carrying value of $4,900,000.
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(2)
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The Company issued 446,496 shares of its common stock upon the conversion of 583 shares of Series A Preferred Stock with a gross carrying value of $583,000.
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The accompanying notes are an integral part of these Financial Statements.
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
(Unaudited)
NOTE 1. DESCRIPTION OF BUSINESS
Oxygen Biotherapeutics, Inc. (the “Company”) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Oxygen Biotherapeutics was formed on April 17, 2008, by Synthetic Blood International to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware and the merger was effective June 30, 2008. Under the Plan of Merger, Oxygen Biotherapeutics is the surviving corporation and each share of Synthetic Blood International common stock outstanding on June 30, 2008 was converted to one share of Oxygen Biotherapeutics common stock.
Going Concern
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has an accumulated deficit during the development stage of $115.2 million as of January 31, 2013, and stockholders’ deficit of $1,600,573 and $346,046 as of January 31, 2013 and April 30, 2012, respectively. The Company requires substantial additional funds to complete clinical trials and pursue regulatory approvals. Management is actively seeking additional sources of equity and/or debt financing; however, there is no assurance that any additional funding will be available on commercially acceptable terms, or at all.
In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying January 31, 2013 balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financing requirements on a continuing basis, to maintain present financing, and to generate cash from future operations. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The Company has prepared the accompanying interim financial statements in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, these financial statements and accompanying notes do not include all of the information and disclosures required by GAAP for complete financial statements. The financial statements include all adjustments (consisting of normal recurring adjustments) that management believes are necessary for the fair statement of the balances and results for the periods presented. These interim financial statement results are not necessarily indicative of the results to be expected for the full fiscal year or any future interim period.
Use of Estimates
In preparing the unaudited financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the unaudited financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full year.
On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.
Net Loss per Share
Basic loss per share, which excludes antidilutive securities, is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, warrants, preferred stock and convertible notes. A reconciliation of the numerator and denominator used in the calculation of basic and diluted net loss per share follows:
Three months ended Janaury 31,
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Nine months ended January 31,
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2013
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2012
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2013
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2012
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Historical net loss per share:
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Numerator
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Net loss, as reported
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$ | (2,412,954 | ) | $ | (7,298,614 | ) | $ | (7,556,774 | ) | $ | (13,097,606 | ) | ||||
Less: Effect of amortization of interest expense on convertible notes
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(2,496,089 | ) | (4,258,037 | ) | (2,496,089 | ) | (4,258,037 | ) | ||||||||
Net loss attributed to common stockholders (diluted)
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(4,909,043 | ) | (11,556,651 | ) | (10,052,863 | ) | (17,355,643 | ) | ||||||||
Denominator
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Weighted-average common shares outstanding
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33,177,893 | 27,558,532 | 31,828,750 | 24,922,512 | ||||||||||||
Effect of dilutive securities
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2,174,891 | 2,172,949 | 2,174,891 | 1,707,799 | ||||||||||||
Denominator for diluted net loss per share
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35,352,784 | 29,731,481 | 34,003,641 | 26,630,311 | ||||||||||||
Basic net loss per share
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$ | (0.07 | ) | $ | (0.26 | ) | $ | (0.24 | ) | $ | (0.53 | ) | ||||
Diluted net loss per share
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$ | (0.14 | ) | $ | (0.39 | ) | $ | (0.30 | ) | $ | (0.65 | ) |
The following outstanding options, warrants, preferred stock and convertible note shares were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.
As of January 31,
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2013
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2012
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Warrants to purchase common stock
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4,755,583 | 5,759,247 | ||||||
Options to purchase common stock
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230,713 | 397,823 | ||||||
Restricted stock grants
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55,537 | - | ||||||
Convertible note shares outstanding
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1,942 | 1,942 | ||||||
Convertible preferred shares outstanding
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- | 1,490,783 |
Fair Value
The Company records its financial assets and liabilities in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820 Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, short-term notes payable, convertible preferred stock and convertible notes. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments. The Company did not elect the fair value option and records the carrying value of its convertible notes at amortized cost in accordance with ASC 470-20.
Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” The fair value measurement hierarchy consists of three levels:
Level one
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Quoted market prices in active markets for identical assets or liabilities;
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Level two
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Inputs other than level one inputs that are either directly or indirectly observable, and
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Level three
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Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.
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The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s financial statements.
The following tables show information regarding assets and liabilities measured at fair value on a recurring basis as of January 31, 2013 and April 30, 2012:
Fair Value Measurements at Reporting Date Using
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||||||||||||||||
Balance as of
January 31, 2013 |
Quoted prices in Active Markets for Identical Securities (Level 1)
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Significant Other Observable Inputs (Level 2)
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Significant Unobservable Inputs (Level 3)
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Current Assets
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||||||||||||||||
Cash and cash equivalents
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$ | 828,811 | $ | 828,811 | $ | - | $ | - | ||||||||
Current Liabilities
|
||||||||||||||||
Series A convertible preferred stock
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$ | - | $ | - | $ | - | $ | - |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Balance as of
April 30, 2012 |
Quoted prices in Active Markets for Identical Securities (Level 1)
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Significant Other Observable Inputs (Level 2)
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Significant Unobservable Inputs (Level 3)
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|||||||||||||
Current Assets
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||||||||||||||||
Cash and cash equivalents
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$ | 1,879,872 | $ | 1,879,872 | $ | - | $ | - | ||||||||
Current Liabilities
|
||||||||||||||||
Series A convertible preferred stock
|
$ | 1,247,266 | $ | - | $ | - | $ | 1,247,266 |
There were no significant transfers between levels in the three months ended January 31, 2013.
The Series A Convertible Preferred Stock is recorded at fair value with changes in fair value recorded as gains or losses within non-cash interest expense. The estimate of the fair value of the securities noted above, as of the valuation date, is based on the rights and privileges afforded to the holders of the Series A Convertible Preferred Stock. The fair value of the Series A Convertible Preferred Stock is determined at each reporting period by calculating the number of conversion shares underlying the outstanding Series A Convertible Preferred Stock as described in the Series A Certificate of Designations at the average volume weighted average price of the Company’s common stock on the valuation date (unobservable inputs).
The following table provides a summary of the changes in fair value of the Company’s financial liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three months ended January 31, 2013:
Series A Convertible Preferred Stock
|
||||
Balance as of April 30, 2012
|
$ | 1,247,266 | ||
Issued on June 15, 2012
|
2,500,000 | |||
Conversions to Common Stock
|
(3,747,266 | ) | ||
Adjustments to fair value as of January 31, 2013
|
- | |||
Transfers in and/or out of Level 3
|
- | |||
Balance as of January 31, 2013
|
$ | - |
Recent Accounting Pronouncements
On May 1, 2012, the Company adopted FASB Accounting Standards Update (“ASU”) 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. Under the amendments to Topic 220, Comprehensive Income, an entity has the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In both choices, an entity is required to present each component of net income along with total net income, each component of other comprehensive income along with a total for other comprehensive income, and a total amount for comprehensive income. This update eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity. The amendments in this update do not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income. The adoption of ASU 2011-05 did not have a material impact on the Company’s financial statements.
On May 1, 2012, the Company adopted ASU 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. The amendments in this update result in common fair value measurement and disclosure requirements in GAAP and International Financial Reporting Standards (“IFRS”). Consequently, the amendments change the wording used to describe many of the requirements in GAAP for measuring fair value and for disclosing information about fair value measurements. The amendments in this update will not result in a change in the application of the requirements in Topic 820. The adoption of ASU 2011-04 did not have a material impact on the Company’s financial statements.
On July 27, 2012, the FASB issued ASU 2012-02, Testing Indefinite-Lived Intangible Assets for Impairment (the revised standard). The revised standard provides companies with an option to perform a “qualitative” assessment to determine whether further impairment testing is necessary. The qualitative assessment is not an accounting policy election and can be performed on none, some, or all of a company’s indefinite-lived intangible assets. ASU 2012-02 is effective on May 1, 2013 and early adoption is permitted. The Company does not believe adoption of ASU 2012-02 will have a material impact on its financial statements.
On February 5, 2013, the FASB issued ASU 2013-02, Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income, as an update to Comprehensive Income (Topic 220). The objective of this Update is to improve the reporting of reclassifications out of accumulated other comprehensive income. The amendments in this Update require an entity to report the effect of significant reclassifications out of accumulated other comprehensive income on the respective line items in net income if the amount being reclassified is required under U.S. generally accepted accounting principles (GAAP) to be reclassified in its entirety to net income. For other amounts that are not required under U.S. GAAP to be reclassified in their entirety to net income in the same reporting period, an entity is required to cross-reference other disclosures required under U.S. GAAP that provide additional detail about those amounts. The amendments do not change the current requirements for reporting net income or other comprehensive income in financial statements. ASU 2013-02 is effective on February 1, 2013. The Company does not believe adoption of ASU 2013-02 will have a material impact on its financial statements.
NOTE 3. BALANCE SHEET COMPONENTS
Inventory
The Company operates in an industry characterized by rapid improvements and changes to its technology and products. The introduction of new products by the Company or its competitors can result in its inventory being rendered obsolete or it being required to sell items at a discount. The Company evaluates the recoverability of its inventory by reference to its internal estimates of future demands and product life cycles. If the Company incorrectly forecasts demand for its products or inadequately manages the introduction of new product lines, the Company could materially impact its financial statements by having excess inventory on hand. The Company's future estimates are subjective and actual results may vary.
Inventories are recorded at cost using the First-In-First-Out (“FIFO”) method. Ending inventories are comprised of raw materials and direct costs of manufacturing and are valued at the lower of cost or market. Inventories consisted of the following as of January 31, 2013 and April 30, 2012:
January 31,
2013 |
April 30,
2012 |
|||||||
Raw materials
|
$ | 28,779 | $ | 25,579 | ||||
Finished goods
|
79,159 | 57,791 | ||||||
$ | 107,938 | $ | 83,370 |
Other current assets
Other current assets consist of the following as of January 31, 2013 and April 30, 2012:
January 31,
2013 |
April 30,
2012 |
|||||||
R&D materials
|
$ | 204,440 | $ | 116,936 | ||||
Unbilled government grant expenses
|
29,144 | 14,950 | ||||||
Deferred cost of sales
|
17,500 | - | ||||||
Dermacyte samples
|
14,539 | 19,529 | ||||||
Other
|
7,090 | 11,394 | ||||||
$ | 272,713 | $ | 162,809 |
Property and equipment, net
Property and equipment consist of the following as of January 31, 2013 and April 30, 2012:
January 31,
2013 |
April 30,
2012 |
|||||||
Laboratory equipment
|
$ | 959,401 | $ | 968,101 | ||||
Computer equipment and software
|
136,218 | 134,005 | ||||||
Office furniture and fixtures
|
130,192 | 140,255 | ||||||
Leasehold improvements
|
- | 4,810 | ||||||
1,225,811 | 1,247,171 | |||||||
Less: Accumulated depreciation and amortization
|
(999,003 | ) | (953,565 | ) | ||||
$ | 226,808 | $ | 293,606 |
Depreciation and amortization expense was approximately $23,000 and $36,000 for the three months ended January 31, 2013 and 2012, respectively; and $70,000 and $134,000 for the nine months ended January 31, 2013 and 2012, respectively.
Other assets
Other assets consist of the following as of January 31, 2013 and April 30, 2012:
January 31,
2013 |
April 30,
2012 |
|||||||
Prepaid royalty fee
|
$ | 50,000 | $ | 50,000 | ||||
Other
|
8,262 | 15,666 | ||||||
$ | 58,262 | $ | 65,666 |
Accrued liabilities
Accrued liabilities consist of the following as of January 31, 2013 and April 30, 2012:
January 31,
2013 |
April 30,
2012 |
|||||||
Contingent liability
|
$ | 600,000 | $ | 532,350 | ||||
Deferred government grant revenue
|
209,830 | 244,013 | ||||||
Other operating costs
|
92,871 | 64,012 | ||||||
Employee related
|
77,319 | 352,400 | ||||||
Convertible note interest payable
|
61,625 | 59,583 | ||||||
Restructuring liability
|
43,728 | - | ||||||
Preferred stock dividend payable
|
- | 21,479 | ||||||
$ | 1,085,373 | $ | 1,273,837 |
Other liabilities
As further discussed in Note 10 below, following the closing of the Company’s research and development facility in California, the Company entered into a long-term sublease agreement with an unrelated third party covering the vacated space which extends through the termination date. The Company recorded a liability for the remaining lease payments due under its long-term, non-cancelable operating lease for this facility, net of sublease payments, which expires in July 2015. The table below summarizes the net future minimum payments due under this lease agreement.
January 31,
2013 |
April 30,
2012 |
|||||||
Net non-cancelable operating lease obligation
|
$ | 109,320 | $ | - | ||||
Less: current portion
|
(43,728 | ) | - | |||||
Long-term portion of net non-cancelable operating lease obligation
|
$ | 65,592 | $ | - |
NOTE 4. INTANGIBLE ASSETS
The following table summarizes the Company’s intangible assets as of January 31, 2013:
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
Patents
|
$ | 616,344 | 11.5 | $ | - | $ | (253,473 | ) | $ | 362,871 | ||||||||||
License Rights
|
560,892 | 15.9 | - | (110,523 | ) | 450,369 | ||||||||||||||
Trademarks
|
110,157 | N/A | - | - | 110,157 | |||||||||||||||
Total
|
$ | 1,287,393 | $ | - | $ | (363,996 | ) | $ | 923,397 |
The following table summarizes the Company’s intangible assets as of April 30, 2012:
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
Patents
|
$ | 546,624 | 11.7 | $ | - | $ | (233,989 | ) | $ | 312,635 | ||||||||||
License Rights
|
540,668 | 16.6 | - | (89,429 | ) | 451,239 | ||||||||||||||
Trademarks
|
138,631 | N/A | (29,534 | ) | - | 109,097 | ||||||||||||||
Total
|
$ | 1,225,923 | $ | (29,534 | ) | $ | (323,418 | ) | $ | 872,971 |
The aggregate amortization expense on the above intangibles was approximately $14,000 and $11,000, for the three months ended January 31, 2013 and 2012, respectively; and $41,000 and $32,000, for the nine months ended January 31, 2013 and 2012, respectively.
Patents and License Rights
The Company currently holds, has filed for, or owns exclusive rights to, U.S. and worldwide patents covering 13 various methods and uses of its perfluorocarbon (“PFC”) technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its patent applications. These capitalized costs are amortized on a straight-line method over their useful life or legal life, whichever is shorter. The Company capitalized patent costs of approximately $32,900 and $ 34,700, for the three months ended January 31, 2013 and 2012, respectively; and $89,900 and $177,000, for the nine months ended January 31, 2013 and 2012, respectively.
Trademarks
The Company currently holds, or has filed for, trademarks to protect the use of names and descriptions of its products and technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its trademark applications. The Company capitalized trademark costs of approximately $0 and $8,600, for the three months ended January 31, 2013 and 2012, respectively; and $1,100 and $18,843, for the nine months ended January 31, 2013 and 2012 respectively.
NOTE 5. SERIES A CONVERTIBLE PREFERRED STOCK
Under the Company’s Certificate of Incorporation, the Board of Directors is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof.
On December 8, 2011, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 7,500 shares of its authorized but unissued shares of preferred stock as Series A Convertible Preferred Stock.
Series A Convertible Preferred Stock
On December 12, 2011, the Company sold 3,500 units for net proceeds of approximately $3.2 million. Each unit sold consisted of (i) one share of the Company’s Preferred Stock and (ii) a warrant representing the right to purchase 225.2 shares of Common Stock (the “2011 Warrants”), at a price of $1,000 per unit, less issuance costs. The shares of Preferred Stock were immediately convertible and the 2011 Warrants are exercisable on the one-year anniversary of the closing date.
On June 15, 2012, the Company sold an additional 2,500 units for net proceeds of approximately $2.3 million. Each unit sold consisted of (i) one share of the Company’s Preferred Stock and (ii) a 2011 Warrant, at a price of $1,000 per unit, less issuance costs. The shares of Preferred Stock were immediately convertible and the 2011 Warrants are exercisable beginning on the one-year anniversary of the closing date.
The table below sets forth a summary of the designation, powers, preferences and rights of the Preferred Stock.
Maturity
|
The shares of Preferred Stock will mature on the one year anniversary of issuance of such shares.
|
Amortization
|
On each one month anniversary of issuance of the Preferred Stock, the Company will redeem, subject to certain exceptions (i) with respect to shares issued in the first closing, one-sixth of the initial stated value of the Preferred Stock, and (ii) with respect to shares issued in the additional closings, 667 shares of Preferred Stock.
|
Amortization Payments
|
The Company may elect to pay the monthly amortization payments in cash or, subject to certain conditions, in shares of Common Stock by delivering that number of shares of Common Stock equal to the amount of the monthly amortization payment divided by a per share amortization price, which shall be the lesser of (i) the then-existing conversion price, which is initially $2.22 per share of common stock and (ii) 90% of the calculated market price per share of Common Stock.
|
Dividends
|
The shares of Preferred Stock will carry a dividend equal to 7% per annum, paid monthly in arrears. The Company may elect to pay dividends in cash or, subject to certain conditions, in shares of Common Stock. If the Company pays dividends in shares of Common Stock, the shares will be valued at a calculated per share market price. Dividends shall be subject to a make-whole through maturity upon any earlier conversion, redemption or amortization.
|
Market Price
|
For purposes of the amortization or dividend payments on the Preferred Stock as described above, the market price shall be equal to the average of the volume weighted average prices (the “VWAP”) for the five lowest trading days, excluding the two lowest trading days of such period, ending on the 23rd trading day prior to the applicable payment date, subject to a “true up” based on the five lowest trading days during the twenty consecutive trading days ending on the trading day immediately prior to the applicable payment date.
|
Conversion
|
Holders may elect to convert shares of Preferred Stock into shares of Common Stock at the then-existing conversion price at any time. The initial conversion price is $2.22 per share of Common Stock, and is subject to certain adjustments, including an anti-dilution provision that reduces the conversion price upon the issuance of any Common Stock or securities convertible into Common Stock at an effective price per share less than the conversion price.
|
Redemption
|
If any shares of Preferred Stock remain outstanding on the maturity date after giving effect to any conversions on such date, the Company is required to redeem such preferred shares in cash in an amount equal to the then-existing conversion amount for each preferred share.
Additionally, after a triggering event, the holders of the shares of Preferred Stock have the right, at their option, to require the Company to redeem all or a portion of the then outstanding preferred shares in cash at the triggering event redemption price.
Triggering events include, among other events, certain breaches by the Company of its agreements, failures to pay amounts when due, failures to maintain any registration statement as required, failure to keep its Common Stock listed on any of the specified eligible markets (including the OTC Bulletin Board), and failure to keep a sufficient number of authorized shares reserved for issuance on conversion of the Preferred Stock or exercise of the 2011 Warrants.
The triggering event redemption price will be the greater of (i) 125% of the then-existing conversion amount, or (ii) the product of the then-existing conversion amount and the greatest closing sales price of the Company’s Common Stock beginning on the last trading day prior to the triggering event and ending on the date the holder of the Preferred Stock delivers a notice of redemption. In addition, the Company is required to pay to the holders of the Preferred Stock any additional make-whole amounts accrued at the date of the triggering event.
|
Liquidation preference
|
In the event of the Company’s voluntary or involuntary dissolution, liquidation or winding up, each holder of Preferred Stock will be entitled to be paid a liquidation preference equal to the initial stated value of such holder’s Preferred Stock of $2.22 per share, plus accrued and unpaid dividends and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Preferred Stock.
|
Voting rights
|
Shares of Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding. Preferred Stock will be required to amend the terms of the Preferred Stock.
|
Equity Conditions
|
The “Equity Conditions” will be satisfied on any date if: (i) on each day during the 30 trading days prior to such measurement date, all shares of Common Stock issued and issuable upon conversion of the Preferred Stock , as dividends on the Preferred Stock and upon exercise of the 2011 Warrants will have been issued or, to the extent not yet issued will be eligible for sale without restriction and without the need for registration under the securities laws; (ii) on each such day, the Common Stock is listed on The NASDAQ Capital Market, on one of several named alternative markets and, if subject to certain delisting proceedings or a failure to meet the maintenance standards of such an exchange, the Company must meet the minimum listing conditions of one of the other permitted markets (including the OTC Bulletin Board); (iii) on each such day, the Company has delivered Common Stock upon conversion by holders of Preferred Stock on a timely basis, as and if required; (iv) any applicable shares to be issued in connection with the determination may be issued in full without violating the ownership limitations described below or the rules of the Company’s principal market (except that the ownership limitations will not prevent the Company from delivering Common Stock in amounts up to such limits); (v) during such period, the Company has made timely payments as required; (vi) there has been no triggering event or potential triggering event under the certificate of designations; (vii) the Company has no knowledge of any fact that would cause the shares of Common Stock issuable in connection with the Preferred Stock or Preferred Warrants not to be eligible for sale without restriction; (viii) the Company meets certain minimum average trading volume qualifications on its principal market (i.e., a $375,000 aggregate dollar volume over the applicable 20 trading days); and (ix) the Company is otherwise in material compliance with its covenants and representations in the related Preferred Stock transaction documents, including the certificate of designations.
|
The Company will not affect any conversion of the Preferred Stock, nor shall a holder convert its shares of Preferred Stock, to the extent that such conversion would cause the holder to have acquired, through conversion of the Preferred Stock or otherwise, beneficial ownership of a number shares of Common Stock in excess of 4.99% of the Common Stock outstanding immediately preceding the conversion.
While the Preferred Stock is outstanding, the Company may not incur any additional indebtedness, with the exception of ordinary course equipment leases, obligations to vendors and similar exceptions. The Company is also prohibited from issuing additional or other capital stock or from issuing variable rate securities, without the consent of holders of the Preferred Stock then outstanding.
The scheduled conversions and actual activity for the Preferred Stock for the nine months ended January 31, 2013 is as follows:
Installement Date
|
Pre-delivery Date
|
Preferred Shares
Redeemedable
|
Less: Preferred Shares Redeemed / Converted
at 01/31/13 |
Balance of
Preferred Shares at 01/31/13 |
Fair Value of
Preferred Stock
at 01/31/13
|
||||||||||
5/12/2012
|
4/10/2012
|
583 | (583 | ) | - | $ | - | ||||||||
6/12/2012
|
5/10/2012
|
583 | (583 | ) | - | - | |||||||||
7/12/2012
|
6/8/2012
|
2 | (2 | ) | - | - | |||||||||
7/16/2012
|
6/15/2012
|
667 | (667 | ) | - | - | |||||||||
8/15/2012
|
7/13/2012
|
667 | (667 | ) | - | - | |||||||||
9/17/2012
|
8/14/2012
|
667 | (667 | ) | - | - | |||||||||
10/15/2012
|
9/12/2012
|
112 | (112 | ) | - | - | |||||||||
11/15/2012
|
10/12/2012
|
112 | (112 | ) | - | - | |||||||||
12/17/2012
|
11/12/2012
|
110 | (110 | ) | - | - | |||||||||
1/15/2013
|
12/14/2012
|
28 | (28 | ) | - | - | |||||||||
1/31/2013
|
1/31/2013
|
138 | (138 | ) | - | - | |||||||||
Convertible preferred stock
|
$ | - |
During the nine months ended January 31, 2013, 3,668 shares of Preferred Stock were converted into 3,838,675 shares of Common Stock. The Company recorded interest expense of $762,738 related to these conversions. The interest expense was calculated as the difference between the fair value of the shares of Preferred Stock converted and the fair value of the Common Stock on the date of the conversion.
The following summarizes the non-cash interest expense related to the Preferred Stock for the nine months ended January 31, 2013:
Amount
|
||||
Dividends paid in common stock
|
$ | 309,938 | ||
Fair value of warrants issued with preferred shares
|
656,535 | |||
Interest expense on conversion of preferred stock
|
762,738 | |||
Non-cash interest expense
|
$ | 1,729,211 |
NOTE 6. NOTES PAYABLE
The following table summarizes the Company’s outstanding notes payable as of January 31, 2013 and April 30, 2012:
January 31,
2013 |
April 30,
2012 |
|||||||
Current portion of convertible notes payable
|
$ | 7,195 | $ | 7,195 | ||||
Current portion of notes payable
|
91,462 | 55,763 | ||||||
Current portion of notes payable, net
|
$ | 98,657 | $ | 62,958 | ||||
Long-term portion of convertible notes payable
|
$ | 4,900,001 | $ | 4,900,001 | ||||
Less: Unamortized discount
|
(2,313,892 | ) | (3,538,891 | ) | ||||
Long-term portion of notes payable, net
|
$ | 2,586,109 | $ | 1,361,110 |
Convertible Note
On June 29, 2011, the Company issued a note (the “June Note”) with a principal amount of approximately $300,000 and Warrants to purchase 133,038 shares of Common Stock. On July 1, 2011, the Company issued a separate note (together with the June Note, the “Notes”) with a principal amount of $4,600,000 and warrants to purchase 2,039,911 shares of Common Stock. The aggregate gross proceeds to the Company from the offering were approximately $4.9 million, excluding any proceeds from the exercise of any warrants. The aggregate placement agent fees were $297,000 and legal fees associated with the offering were $88,839. These costs have been capitalized as debt issue costs and will be amortized as interest expense over the life of the Notes. The Company recorded amortization of debt issue costs of $32,154 and $96,462 for each of the three and nine months ended January 31, 2013 and 2012, respectively.
Interest on the Notes accrues at a rate of 15% annually and will be paid in quarterly installments commencing on the third month anniversary of issuance. The Notes will mature 36 months from the date of issuance. The Notes may be converted into shares of Common Stock at a conversion price of $2.255 per share (subject to adjustment for stock splits, dividends and combinations, recapitalizations and the like) (the “Conversion Price”) at any time, in whole or in part, at any time at the option of the holders of the Notes. The Notes also will automatically convert into shares of Common Stock at the Conversion Price at the election of a majority-in-interest of the holders of notes issued under the purchase agreement or upon the acquisition or sale of all or substantially all of the assets of the Company. The Company may make each applicable interest payment or payment of principal in cash, shares of Common Stock at the Conversion Price, or any combination thereof. The Company may elect to prepay all or any portion of the Notes without prepayment penalties only with the approval of a majority-in-interest of the note holders under the purchase agreement at the time of the election. The Notes contain various events of default such as failing to timely make any payment under the Note when due, which may result in all outstanding obligations under the Note becoming immediately due and payable.
The Company recorded interest expense of $628,321 for the three months ended January 31, 2013 and 2012, respectively; and $1,884,962 and $1,464,968 for the nine months ended January 31, 2013 and 2012, respectively.
The total value allocated to the warrants was approximately $1,960,497 and was recorded as a debt discount against the proceeds of the notes. In addition, the beneficial conversion features related to the notes were determined to be approximately $2,939,503. As a result, the aggregate discount on the notes totaled $4,900,000, and is being amortized over term of the notes. The Company recorded interest expense for the amortization of the debt discount of approximately $408,000 and $1,225,000 for each of the three and nine months ended January 31, 2013 and 2012, respectively.
NOTE 7. COMMITMENTS AND CONTINGENCIES
Agreement with Virginia Commonwealth University
In May 2008 the Company entered into a license agreement with Virginia Commonwealth University (“VCU”) whereby it obtained a worldwide, exclusive license to valid claims under three of the VCU's patent applications that relate to methods for non-pulmonary delivery of oxygen to tissue and the products based on those valid claims used or useful for therapeutic and diagnostic applications in humans and animals. The license includes the right to sub-license to third parties. The term of the agreement is the life of the patents covered by the patent applications unless the Company elects to terminate the agreement prior to patent expiration. Under the agreement the Company has an obligation to diligently pursue product development and pursue, at its own expense, prosecution of the patent applications covered by the agreement. As part of the agreement, the Company is required to pay to VCU nonrefundable payments upon achieving development and regulatory milestones. As of January 31, 2013, the Company has not met any of the developmental milestones.
The agreement with VCU also requires the Company to pay royalties to VCU at specified rates based on annual net sales derived from the licensed technology. Pursuant to the agreement, the Company must make minimum annual royalty payments to VCU totaling $70,000 as long as the agreement is in force. These payments are fully creditable against royalty payments due for sales and sublicense revenue earned during the fiscal year as described above. This fee is recorded as an other current asset and is amortized over the fiscal year. Amortization expense was $17,500 and $52,500 for each of the three and nine months ended January 31, 2013 and 2012, respectively.
Litigation
The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s financial statements.
On August 30, 2011, Tenor Opportunity Master Fund Ltd., Aria Opportunity Fund, Ltd., and Parsoon Opportunity Fund, Ltd. (collectively, “Tenor”) filed a lawsuit in the United States District Court for the Southern District of New York alleging that a right of first offer held by Tenor was breached in connection with our June 2011 financing. The complaint sought compensatory damages, attorneys’ fees and costs. Discovery was completed and motions for summary judgment from both sides were filed, Plaintiffs filed on the matter of breach and we filed on the matter of damages. On July 11, 2012 the court entered an order on both summary judgment motions. The court found in favor of Plaintiff’s motion, holding that we did breach the agreement. The court did not find in favor of our motion regarding damages. The matter was then set to move to trial for a jury to determine what, if any, damages Plaintiff’s suffered from our breach of the agreement. The trial was scheduled to begin on October, 10, 2012. On October 3, 2012 the court granted a motion from Tenor to continue the trial until March 7, 2013.
However, on February 19, 2013, the Company and Tenor reached a tentative oral settlement of this litigation, and executed a written settlement agreement, effective March 14, 2013, under which the litigation was dismissed with prejudice. The settlement agreement provided that the parties will settle the matter for the Company’s payment of $600,000 in cash, plus interest accrued thereon from the date of the executed settlement agreement at the rate of fifteen percent (15%) per year, payable in six quarterly installments commencing on the date the parties executed the written settlement agreement. The settlement agreement also provides that upon the Company completing financings in certain amounts, if the settlement amount is not fully paid at such time, a portion of the settlement payment schedule will be accelerated.
The Company has accrued $600,000 as a liability related to this claim as of January 31, 2013.
Registration Requirement
During the fiscal year ended April 30, 2008, the Company issued warrants as part of a convertible note offering. These warrants were issued with a requirement that the Company file a registration statement with the Securities and Exchange Commission (“SEC”) to register the underlying shares, and that it be declared effective on or before January 9, 2009. In the event that the Company does not have an effective registration statement as of that date, or if at some future date the registration ceases to be effective, then the Company is obligated to pay liquidated damages to each holder in the amount of 1% of the aggregate market value of the stock, as measured on January 9, 2009 or at the date the registration statement ceases to be effective. As an additional remedy for non-registration of the shares, the holders would also receive the option of a cashless exercise of their warrant or conversion shares. As of January 31, 2013, approximately 70,000 of these warrants are subject to the registration requirement.
ASC 825-20, Financial Instruments, Registration Payment Arrangements, provides guidance to proper recognition, measurement, and classification of certain freestanding financial instruments that are indexed to, and potentially settled in, any entity's own stock. ASC 825-20-25 specifies that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement, should be separately recognized and measured in accordance with ASC 450, Accounting for Contingencies. The Company has accounted for these warrants as equity instruments in the accompanying financial statements. The Company does not believe the registration payments are probable, and as such, has not recorded any amounts with respect to the separately measured registration rights agreement.
Contingent Liabilities Related to Internal Revenue Code Section 409A
In November, 2010, management conducted an independent review of certain option grants made by the Company between February 1998 and April 2009. This voluntary review was not in response to any governmental investigation. During the course of the Company’s review, management identified certain options granted in prior years that may have been non-compliant with Section 409A (“Section 409A”) of the Internal Revenue Code of 1986, as amended, including options granted with an exercise price below fair market value on the date of grant and options that were modified such that they may have become non-compliant with Section 409A.
In February 2011, after management conducted a preliminary, limited scope review of certain of the Company’s stock option granting practices, the Audit Committee commenced a voluntary, independent investigation of the Company’s historical stock option granting practices and related accounting during the period from February 1998 through April 2009. The Company’s outside legal counsel assisted the Audit Committee in this investigation.
The primary adverse tax consequence of Section 409A non-compliance is that the holders of non-compliant options are taxed on the value of such options as they vest, and annually thereafter until they are exercised. In addition to ordinary income taxes, holders of non-compliant options are subject to a 20% penalty tax under Section 409A (and, as applicable, similar excise taxes under state laws). Because virtually all holders of stock options granted by the Company were not involved in or aware that the pricing and/or modification of their options raised these issues, the Company intends to take actions to address certain of the adverse tax consequences that may apply to these holders. In addition, on March 17, 2011 the Company entered into indemnification agreements with its executive officers that indemnify those officers from potential Section 409A tax liabilities arising from their prior option awards.
As of January 31, 2013, all of the potentially non-compliant options were either cancelled or expired unexercised. The Company evaluated the contingent liability and concluded that the likelihood of an asserted claim is no longer probable and fails to satisfy the accrual criteria in accordance with ASC 450. During the nine months ended January 31, 2013, the Company recorded a credit of approximately $532,500 against general and administrative expense in the statement of operations and reduced its accrual for the potential liability to $0.
NOTE 8. STOCKHOLDERS’ EQUITY
Common Stock
The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of January 31, 2013, there were 33,650,499 shares of common stock issued and outstanding.
Warrants
The following table summarizes the Company’s warrant activity for the nine months ended January 31, 2013:
Warrants
|
Weighted Average Exercise Price
|
|||||||
Outstanding at April 30, 2012
|
5,239,964 | $ | 2.08 | |||||
Issued
|
563,064 | 2.22 | ||||||
Forfeited
|
(1,047,445 | ) | 2.39 | |||||
Outstanding at January 31, 2013
|
4,755,583 | $ | 2.03 |
As further discussed in Note 5 above, on June 15, 2012, the Company issued 563,064 warrants as part of the second closing of the Series A Convertible Preferred Stock. The warrants were issued with an exercise price of $2.22 and a six-year term. The warrants become exercisable on the one-year anniversary of the issue date. The Company recorded non-cash interest expense of $656,535 during the nine months ended January 31, 2013 for the calculated fair value of the warrants.
1999 Amended Stock Plan
In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “Plan”). Under the Plan, with the approval of the Compensation Committee of the Board of Directors, the Company may grant stock options, restricted stock, stock appreciation rights and new shares of Common Stock upon exercise of stock options. On September 30, 2011, the Company’s stockholders approved an amendment to the Plan which increased the amount of shares authorized for issuance under the Plan to 6,000,000, up from 800,000 previously authorized. As of January 31, 2013 the Company had 5,559,822 shares of Common Stock available for grant under the Plan.
The following table summarizes the shares available for grant under the Plan for the nine months ended January 31, 2013:
Shares Available for Grant
|
||||
Balance, at April 30, 2012
|
5,531,630 | |||
Options granted
|
(30,891 | ) | ||
Options cancelled/forfeited
|
152,001 | |||
Restricted stock granted
|
(106,359 | ) | ||
Restricted stock cancelled/forfeited
|
13,441 | |||
Balance, at January 31, 2013
|
5,559,822 |
Plan Stock Options
Stock options granted under the Plan may be either incentive stock options (“ISOs”), or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the Plan may be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to three years.
The following table summarizes the outstanding stock options under the Plan for the nine months ended January 31, 2013:
Outstanding Options
|
||||||||
Number of Shares
|
Weighted Average Exercise Price
|
|||||||
Balance, at April 30, 2012
|
351,823 | $ | 4.06 | |||||
Options granted
|
30,891 | $ | 1.67 | |||||
Options cancelled
|
(152,001 | ) | $ | 5.42 | ||||
Balance, at January 31, 2013
|
230,713 | $ | 2.84 |
The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.
The Company used the following assumptions to estimate the fair value of options granted under its stock option plans for the nine months ended January 31, 2013 and 2012, respectively:
For the the nine months ended Janaury 31,
|
||||||||
2013
|
2012
|
|||||||
Risk-free interest rate (weighted average)
|
1.29 | % | 2.16 | % | ||||
Expected volatility (weighted average)
|
79.30 | % | 78.65 | % | ||||
Expected term (in years)
|
7 | 7 | ||||||
Expected dividend yield
|
0.00 | % | 0.00 | % |
Risk-Free Interest Rate
|
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
|
Expected Volatility
|
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
|
Expected Term
|
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the Company’s historical experience.
|
Expected Dividend Yield
|
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future.
|
Forfeitures
|
Stock compensation expense recognized in the statements of operations for the three and nine months ended January 31, 2013 and 2012 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.
|
As of January 31, 2013, there were unrecognized compensation costs of approximately $25,000 related to non-vested stock option grants that will be recognized on a straight-line basis over the weighted average remaining vesting period of 1.7 years.
Restricted Stock Grants
The following table summarizes the restricted stock grants under the Plan for the nine months ended January 31, 2013.
Outstanding Restricted Stock Grants
|
||||||||
Number of Shares
|
Weighted Average Grant Date Fair Value
|
|||||||
Balance, at April 30, 2012
|
36,095 | $ | 2.19 | |||||
Restricted stock granted
|
106,359 | $ | 1.75 | |||||
Restricted stock vested
|
(73,476 | ) | $ | 1.94 | ||||
Restricted stock cancelled
|
(13,441 | ) | $ | 1.83 | ||||
Balance, at January 31, 2013
|
55,537 | $ | 1.77 |
The Company chose the “straight-line” attribution method for allocating compensation costs of each restricted stock grant over the requisite service period using fair value of the underlying common stock at the grant date. The Company recorded compensation expense for these restricted stock grants of $24,420 and $146,466 for the three and nine months ended January 31, 2013, respectively.
As of January 31, 2013, there were unrecognized compensation costs of approximately $22,400 related to the non-vested restricted stock grants that will be recognized on a straight-line basis over the remaining vesting period.
NOTE 9. SEGMENT REPORTING
In the Company’s operation of its business, management, including its chief operating decision maker, the Chief Executive Officer, reviews certain financial information, including segmented internal profit and loss statements prepared on a basis not consistent with GAAP.
The Company operates in a single commercial market consisting of the design, development, marketing, sales and support of its Dermacyte® cosmetic segment. The Company’s commercial revenues are derived from sales of the Dermacyte line of topical cosmetic products in the United States and Latin America. The Company does not engage in intercompany revenue transfers between segments.
The Company’s management evaluates performance based primarily on revenues in the geographic locations in which the Company operates. Segment profit or loss for each segment includes certain sales and marketing expenses directly attributable to the segment and excludes certain expenses that are managed outside the reportable segments.
Costs that are identifiable are allocated to the segments that benefit. Allocated costs may include those relating to development and marketing of products and services from which multiple segments benefit, or those costs relating to services performed by one segment on behalf of other segments. Each allocation is measured differently based on the specific facts and circumstances of the costs being allocated. Certain other corporate-level activity is not allocated to the Company’s segments, including costs of human resources; legal; finance; information technology; corporate development and procurement activities; and research and development.
Net revenues and segment profit, classified by the Company’s reportable segments are as follows:
For the three months ending January 31,
|
For the nine months ending January 31,
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Product revenue
|
||||||||||||||||
United States
|
$ | 2,871 | $ | 4,673 | $ | 28,899 | $ | 65,565 | ||||||||
Latin America
|
- | - | - | 26,000 | ||||||||||||
Total product revenue
|
$ | 2,871 | $ | 4,673 | $ | 28,899 | $ | 91,565 |
For the three months ending January 31,
|
For the nine months ending January 31,
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Segment loss (income)
|
||||||||||||||||
United States
|
$ | 12,784 | $ | (1,335 | ) | $ | 93,698 | $ | 330,830 | |||||||
Latin America
|
- | - | - | (10,585 | ) | |||||||||||
Unallocated revenues
|
||||||||||||||||
Government grant revenue
|
(221,051 | ) | (146,101 | ) | (997,035 | ) | (224,345 | ) | ||||||||
Unallocated expenses
|
||||||||||||||||
General and administrative
|
1,427,379 | 1,421,277 | 3,021,114 | 4,519,709 | ||||||||||||
Research and development
|
369,447 | 599,935 | 1,611,293 | 1,740,473 | ||||||||||||
Restructuring expense
|
2,941 | - | 220,715 | - | ||||||||||||
Net interest and other expense
|
821,454 | 5,424,838 | 3,606,989 | 6,741,524 | ||||||||||||
Net loss
|
$ | 2,412,954 | $ | 7,298,614 | $ | 7,556,774 | $ | 13,097,606 |
Assets are not allocated to segments for internal reporting presentations. It is impracticable for the Company to separately identify the amount of amortization and depreciation by segment in the measure of segment profit or loss.
NOTE 10. RESTRUCTURING EXPENSE
In May 2012, the Company decided to consolidate its operations and relocate its research and development function to North Carolina from Costa Mesa, California. To allow for this transition period, all existing development work had been completed and all of the manufacturing of the Company’s PFC-based products had been transferred to contract manufacturers. As part of these initiatives, the Company terminated all related research and development activities and a workforce reduction was implemented. In September 2012, the Company entered into a sublease agreement with an unrelated third party that extends throughout the remaining term of the existing lease for the vacated facility.
The Company incurred a restructuring expense of $220,715 related to the closing during the nine months ended January 31, 2013. The Company may incur additional costs as a result of the restructuring, but it does not expect these costs to be significant beyond January 31, 2013. The following table summarizes the impact of the work force reductions and other associated costs on operating expenses and payments for the nine months ended January 31, 2013, and the liability remaining on the balance sheet as of January 31, 2013.
Charges Incurred During the Nine Months Ended January 31, 2013
|
Amounts Paid Through
January 31, 2013
|
Amounts Accrued at January 31, 2013
|
||||||||||
Future lease obligations, net of sublease revenue
|
$ | 134,984 | $ | 32,564 | $ | 109,320 | ||||||
Employee severance, benefits and related costs for work force reductions
|
53,991 | 53,991 | - | |||||||||
Other exit costs
|
31,740 | 31,740 | - |
The Company recorded all restructuring expenses as operating expenses on the statement of operations. All restructuring costs were paid by January 31, 2013, with the exception of approximately $109,000 of future lease obligations, net of sublease revenue.
During the nine months ended January 31, 2013, the Company recognized an impairment loss of approximately $12,000 related to the disposal lab equipment as a result of the decision to discontinue internal manufacturing and development activities which is not recorded in the table above.
NOTE 11. SUBSEQUENT EVENTS
Dermacyte Cosmetic License and Supply Agreement
On February 5, 2013, the Company entered into a License and Supply Agreement (the “Dermacyte License”) with the Cosmetics Division of Valor SA (“Valor”) with respect to Dermacyte, a perfluorocarbon based cosmetic product currently manufactured and distributed by the Company. The Dermacyte License grants Valor the exclusive right to sell, import, export, distribute, package, label and otherwise commercialize Dermacyte worldwide for a five year term. Valor is also authorized to sublicense the license granted under the Dermacyte License provided that such sublicenses are consistent with the terms of the Dermacyte License.
Under the Dermacyte License, Valor will purchase bulk Dermacyte from the Company for 125% of the Company’s actual manufacturing cost, and must pay the Company an annual, non-refundable license fee of $140,000, payable on a quarterly basis, with the first year’s payment creditable against Dermacyte purchased by Valor during the first 12 months following the effective date of the Dermacyte License. Valor must also pay the Company royalties of 5% of net sales of Dermacyte once Valor’s aggregate net sales of Dermacyte equals or exceeds $10,000,000.
Warrant Exchange Agreement
On February 21, 2013, the Company entered into Warrant Exchange Agreements (the “Warrant Exchange Agreements”) with the institutional investors party to that certain Securities Purchase Agreement by and among the Company and certain institutional investors, dated December 8, 2011 as subsequently amended (the “Prior SPA”). Under the Warrant Exchange Agreements, all warrants issued pursuant to the Prior SPA were exchanged for an aggregate of 400,000 shares of the Company’s common stock and $380,000 in cash pursuant to Section 3(a)(9) under the Securities Act. In addition, the Warrant Exchange Agreements provide that the investors party thereto may not sell, offer to sell or contract to sell the shares of common stock issued thereunder prior to and including May 21, 2013.
Series B Convertible Preferred Stock
On February 22, 2013, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) providing for the issuance and sale by the Company (the “Offering”) of $1.6 million of shares of the Company’s Series B-1 convertible preferred stock (the “Series B-1 Stock”) and $0.5 million of shares of the Company's Series B-2 convertible preferred stock (the “Series B-2 Stock” and, together with the Series B-1 Stock, the “Series B Preferred Stock”) which are convertible into a combined total of 8,400,000 shares of common stock (the “Conversion Shares”). In connection with the purchase of shares of Series B Preferred Stock in the Offering, the Investor will receive warrants to purchase a number of shares of common stock equal to 150% of the number of Conversion Shares at an exercise price equal to $0.50 (the “Warrants”). Each Warrant was immediately exercisable upon issuance, with one-half exercisable for six years and the other half exercisable for two years.
On February 27, 2013, the Company sold 2,100 units for net proceeds of approximately $1.9 million. Each unit sold consisted of (i) one share of the Company’s Series B Preferred Stock and (ii) a Warrant representing the right to purchase 6,000 shares of Common Stock at a price of $1,000 per unit, less issuance costs. The shares of Series B Preferred Stock were immediately convertible and the Warrants were immediately exercisable upon issuance.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to them. In some cases you can identify forward-looking statements by words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. Examples of these statements include, but are not limited to, statements regarding: the implications of interim or final results of our clinical trials, the progress of our research programs, including clinical testing, the extent to which our issued and pending patents may protect our products and technology, our ability to identify new product candidates, the potential of such product candidates to lead to the development of commercial products, our anticipated timing for initiation or completion of our clinical trials for any of our product candidates, our future operating expenses, our future losses, our future expenditures for research and development, and the sufficiency of our cash resources. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us and described in Part II, Item 1A of this Quarterly Report on Form 10-Q, Part I, Item IA of our Annual Report on Form 10-K and our other filings with the Securities and Exchange Commission, or SEC. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from those we expect. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise.
The following discussion and analysis should be read in conjunction with the unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with the audited financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended April 30, 2012.
All references in this Quarterly Report to “Oxygen Biotherapeutics”, “we”, “our” and “us” means Oxygen Biotherapeutics, Inc.
Overview
Strategy
We are a development stage biomedical company focused on developing oxygen-carrying intravenous and topical products. Our principal business objective is to discover, develop, and commercialize novel therapeutic products for disease indications that represent significant areas of clinical need and commercial opportunity.
Our current strategy is to:
●
|
Efficiently conduct clinical development to establish clinical proof of concept with our lead product candidates;
|
●
|
Advance the development of the perfluorocarbon, or PFC, therapeutic modality and supporting capabilities;
|
●
|
Efficiently explore new high-potential therapeutic applications, leveraging third-party research collaborations and our results from related areas;
|
●
|
Continue to expand our intellectual property portfolio; and
|
●
|
Enter into licensing or product co-development arrangements in certain areas, while out-licensing opportunities in non-core areas.
|
We believe that this strategy will allow us to develop a portfolio of high quality product development opportunities, expand our clinical development and commercialization capabilities, and enhance our ability to generate value from our proprietary technologies.
Third Quarter 2013 Highlights
The following summarizes certain key financial measures for the three months ended January 31, 2013:
●
|
Cash and cash equivalents were $829,000 at January 31, 2013.
|
●
|
Net product sales from Dermacyte® were $2,900 for the third quarter of 2013 compared to $4,700 for the three months ended January 31, 2012.
|
●
|
Revenue earned under our research grant was $221,100 for the third quarter of 2013 compared to $146,000 for the three months ended January 31, 2012.
|
●
|
Our loss from operations was $1.6 million for the third quarter of 2013 compared to $1.9 million for the three months ended January 31, 2012.
|
●
|
Net cash used in operating activities was $0.7 million for the third quarter of 2013 compared to $2.3 million for the three months ended January 31, 2012.
|
Consistent with our strategy, during the three months ended January 31, 2013, we (i) completed the first phase of our preclinical studies designed to determine the effects of Oxycyte using an intercranial hemorrhage model, (ii) enrolled the first patient in the in vitro platelet function studies using TBI subjects, (iii) completed three of the four in-life portions of the preclinical studies to evaluate the impact of Oxycyte on the immune system and (iv) obtained approval from the ethics committee in Israel to initiate the second cohort of our Phase II-B TBI clinical trials, which are expected to resume enrollment during the fourth fiscal quarter.
Opportunities and Trends
We continue to execute on our strategic plan, which calls for resuming our STOP-TBI (Safety and Tolerability of Oxycyte in Patients with Severe non-Penetrating Traumatic Brain Injury) Phase II-B clinical trials; supporting our collaborations to gather proof-of-concept data for additional therapeutic areas with unmet medical needs; and continuing our business development efforts to expand our product portfolio. We also continue to progress Oxycyte® through the regulatory approval process by conducting a comprehensive group of preclinical studies to confirm the safety profile of our product. These studies are particularly focused on platelet activity and immunocompetence. We believe these actions position us well to drive future growth and create stockholder value.
As we focus on the development of our existing products and product candidates, we also continue to position ourselves to execute upon licensing and other partnering opportunities. In order to do so, we will need to continue to maintain our strategic direction, manage and deploy our available cash efficiently and strengthen our collaborative research development and partner relationships.
During fiscal year 2013 we are focused on the following four key initiatives:
●
|
conducting well-designed studies early in the clinical development process to establish a robust foundation for subsequent development, partnership and expansion into complementary areas;
|
●
|
working with collaborators and partners to accelerate product development, reduce our development costs, and broaden our commercialization capabilities;
|
●
|
gaining regulatory approval for the continued development and commercialization of Oxycyte in the United States; and
|
●
|
developing new intellectual property will enable us to file patent applications that cover new applications of our existing technologies and product candidates.
|
Critical Accounting Policies and Significant Judgments and Estimates
Critical accounting policies and estimates are those policies and estimates that are most important and material to the preparation of our financial statements, and which require management’s most subjective and complex judgment due to the need to select policies from among alternatives available, and to make estimates about matters that are inherently uncertain.
As further discussed in Note 7, Commitments and Contingencies, of our Notes to Financial Statements of this quarterly report on Form 10-Q, during the three months ended January 31, 2013, management recorded a significant change to its estimate of the accrued liability relating to our litigation with Tenor, as compared to the critical accounting policies and estimates described in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2012.
Financial Overview
Results of Operations- Comparison of the Three Months Ended January 31, 2013 and 2012
Revenue
Product Revenue and Gross Profit
We generate revenue through the sale of Dermacyte® through on-line retailers and physician and medical spa facilities. Product revenue and percentage changes for the three months ended January 31, 2013 and 2012, respectively, are as follows:
Three months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Product revenue
|
$ | 2,871 | $ | 4,673 | $ | (1,802 | ) | (39 | ) % | |||||||
Cost of sales
|
1,534 | 2,512 | (978 | ) | (39 | ) % | ||||||||||
Gross profit
|
$ | 1,337 | $ | 2,161 | $ | (824 | ) | (38 | ) % |
The decrease in product revenue for the three months ended January 31, 2013 was primarily due to the elimination of our internal sales force and the suspension of our direct marketing and advertising programs in the current year.
Government Grant Revenue
We earn revenues through a cost-reimbursement grant sponsored by the United States Army, or Grant Revenue. Grant Revenue is recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party contract research organizations, or CROs.
Three months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Government grant revenue
|
$ | 221,051 | $ | 146,101 | $ | 74,950 | 51 | % |
For the three months ended January 31, 2013, we recorded an increase of approximately $75,000 in revenue under the grant program as compared to the same period in the prior year. This increase is due to the progress of the underlying studies and the achievement of contractual milestones under the grant.
Marketing and Sales Expenses
Marketing and sales expenses consist primarily of personnel-related costs, including salaries, commissions, and the costs of marketing programs aimed at increasing revenue, such as advertising, trade shows, public relations and other market development programs. Marketing and sales expenses and percentage changes for the three months ended January 31, 2013 and 2012, respectively, are as follows:
Three months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Marketing and sales expense
|
$ | 14,121 | $ | 826 | $ | 13,295 | 1610 | % |
The increase in marketing and sales expenses for the three months ended January 31, 2013 was driven primarily by the cost associated with website maintenance and direct marketing.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, other professional services, and consulting fees. General and administrative expenses and percentage changes for the three months ended January 31, 2013 and 2012, respectively, are as follows:
Three months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Legal and professional fees
|
$ | 916,623 | $ | 850,267 | $ | 66,356 | 8 | % | ||||||||
Personnel costs
|
371,027 | 343,252 | 27,775 | 8 | % | |||||||||||
Other costs
|
75,409 | 127,266 | (51,857 | ) | (41 | ) % | ||||||||||
Facilities
|
36,496 | 63,128 | (26,632 | ) | (42 | ) % | ||||||||||
Depreciation and amortization
|
27,824 | 37,364 | (9,540 | ) | (26 | ) % |
Personnel costs:
Personnel costs increased approximately $28,000 for the three months ended January 31, 2013 compared to the same period in the prior year. The increase was due primarily to an increase in the recognized costs associated with outstanding stock options and the vesting of restricted stock grants.
Legal and professional fees:
Legal and professional fees include the costs of external audit and tax preparation fees, external legal counsel, banking fees, investor relations and NASDAQ Stock Market, LLC, or NASDAQ, listing fees, payments to our board of directors and recruiting and other consulting fees incurred. Legal and professional fees increased approximately $66,000 for the three months ended January 31, 2013 compared to the same period in the prior year. This increase was primarily due to increases in legal fees, investor relations costs and NASDAQ listing fees partially offset by decreases in consulting costs and fees paid to our board of directors.
-
|
Legal expenses increased approximately $100,000 due primarily to the $600,000 accrual for settlement of the Tenor matter discussed at Note 7 to the financial statements above, partially offset by the costs incurred for the initial closing of the Series A Preferred Stock offering in the prior year.
|
-
|
Investor relations and NASDAQ listing costs increased approximately $36,000 due primarily to the costs incurred to attend and present at conferences in the current period and the costs related to our continued listing on the NASDAQ.
|
-
|
Consulting costs decreased approximately $57,000 due to a reduction in the costs associated with Board of Director and executive recruiting fees incurred in the prior year.
|
-
|
Fees paid to the board of directors decreased approximately $13,000 due primarily to the recognition of stock based compensation compared to the same period in the prior year.
|
Facilities:
Facilities include costs paid for rent and utilities at our corporate headquarters in North Carolina, the allocation of lease costs not otherwise included in Research and Development expenses, and the costs incurred for third party Information Technology, or IT, support services. The $27,000 reduction in facilities costs during the three months ended January 31, 2013 as compared to the same period in the prior year was primarily the result of the elimination of the allocated lease costs related to the closure of our California facility.
Depreciation and Amortization:
The $10,000 decrease in depreciation and amortization costs for the three months ended January 31, 2013 compared to the same period in the prior year was primarily due to the disposal of fixed assets related to the closure of the California facility.
Other costs:
Other costs include costs incurred for travel, supplies, insurance and other miscellaneous charges. The $52,000 reduction in other costs was due primarily to a $20,000 reduction in travel costs and an overall decrease in administrative and office expenses as a result of headcount reductions compared to the same period in the prior year.
Research and Development Expenses
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the three months ended January 31, 2013 and 2012, respectively, are as follows:
Three months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Clinical and preclinical development
|
$ | 204,091 | $ | 209,609 | $ | (5,518 | ) | (3 | ) % | |||||||
Personnel costs
|
143,333 | 213,240 | (69,907 | ) | (33 | ) % | ||||||||||
Consulting
|
5,790 | 87,750 | (81,960 | ) | (93 | ) % | ||||||||||
Depreciation
|
9,939 | 15,104 | (5,165 | ) | (34 | ) % | ||||||||||
Other costs
|
3,697 | 37,293 | (33,596 | ) | (90 | ) % | ||||||||||
Facilities
|
2,597 | 36,939 | (34,342 | ) | (93 | ) % |
Clinical and preclinical development:
Clinical and preclinical development costs include the costs associated with our pre-clinical safety studies and current Good Manufacturing Practices, or cGMP, development for Oxycyte, costs incurred to resume our Phase II-b clinical trials, and development costs for Dermacyte. During the three months ended January 31, 2013, as compared to the same period in the prior year, we incurred an increase of approximately $185,000 in pre-clinical study costs due to CRO fees recognized for the completion of milestones under the Grant-funded preclinical program to assess the safety of Oxycyte for the treatment of patients with TBI; partially offset by a decrease of approximately $183,000 in costs incurred related to the development of cGMP supply and manufacturing capabilities and validated release methods for Oxycyte.
Personnel costs:
Personnel costs decreased approximately $70,000 for the three months ended January 31, 2013 compared to the same period in the prior year, primarily due to headcount reductions related to the closure of our California lab facility and the resignation of our Chief Medical Officer in the prior year.
Consulting fees:
Consulting fees decreased approximately $82,000 for the three months ended January 31, 2013 compared to the same period in the prior year, primarily due to charges under the consulting and separation agreement for our former President and Chief Operating Officer that were not incurred in the current period.
Depreciation:
Depreciation expense decreased approximately $5,000 for the three months ended January 31, 2013 compared to the same period in the prior year due to the disposal of fixed assets related to the closure of our California facility.
Other costs:
Other costs decreased approximately $34,000 for the three months ended January 31, 2013 as compared to the same period in the prior year, due primarily to a decrease in cost of lab supplies as a result of closing our California facility.
Facilities:
Facilities expense decreased approximately $34,000 for the three months ended January 31, 2013 as compared to the same period in the prior year, primarily due to the closing our California facility.
Restructuring expense
Three months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Restructuring expense
|
$ | 2,941 | $ | - | $ | 2,941 | — | % |
During the three months ended January 31, 2013, the Company did not incur any additional significant restructuring costs related to the closure of our California facility.
Interest expense
Interest expense includes the interest payments due under our long-term debt, amortization of debt issuance costs and accretion of discounts recorded against our outstanding convertible notes. Interest expense also includes dividends and fair-value adjustments to the carrying value of our Series A Convertible Preferred Stock. Interest expense and percentage changes for the three months ended January 31, 2013 and 2012, respectively, are as follows:
Three months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Interest expense
|
$ | 821,777 | $ | 5,341,988 | $ | (4,520,211 | ) | (85 | )% |
Long-term notes payable:
Interest expense for our long-term notes payable was $0 and approximately $2.4 million for the three months ended January 31, 2013 and 2012, respectively. These notes were repaid in full in November 2011.
Convertible notes payable:
Interest expense on our outstanding convertible notes was approximately $628,000 for the three months ended January 31, 2013 and 2012, respectively. The recorded interest for the three months ended January 31, 2013 was comprised of approximately $188,000 for quarterly interest payments, $408,000 for amortization of debt discounts and $32,000 for amortization of debt issue costs.
Series A Convertible Preferred Stock:
Interest expense on our outstanding Series A Convertible Preferred Stock was approximately $193,000 and $2.3 million for the three months ended January 31, 2013 and 2012, respectively. The recorded interest for the three months ended January 31, 2013 was comprised of approximately $98,000 for the excess of the fair-value of the shares issued upon conversion over the fair value of the Series A Convertible Preferred Stock. The Series A Convertible Preferred Stock matured on January 31, 2013 and all of the outstanding shares were redeemed by conversion into common stock at maturity.
Preferred Stock Dividends:
Interest expense recorded for the payment of dividends on the Series A Convertible Preferred Stock Preferred Stock was approximately $95,000 and $42,000 for the three months ended January 31, 2013 and 2012, respectively.
Other income and expense
Other income and expense includes non-operating income and expense items not otherwise recorded in our statement of operations. These items include, but are not limited to, revenue earned under sublease agreements for our California facility, recognized gains and losses on foreign currency translations, interest income earned and fixed asset disposals. Other expense for the three months ended January 31, 2013 and 2012, respectively, is as follows:
Three months ended January 31,
|
Increase/ (Decrease)
|
|||||||||||
2013
|
2012
|
|||||||||||
Other (income) expense, net
|
$ | (323 | ) | $ | 82,850 | $ | (83,173 | ) |
During the three months ended January 31, 2013 compared to the prior year, we recorded income from sublease agreements and interest of approximately $300 and $10,000, respectively.
For the three months ended January 31, 2012, we recorded other non-operating expenses of approximately $93,000 for the write off of receivables from Glucometrics, Inc., the company that previously held license rights for the use of our patents related to glucose monitoring technology, which was determined to be uncollectible during the third quarter of fiscal 2012.
Results of Operations- Comparison of the Nine Months Ended January 31, 2013 and 2012
Revenue
Product Revenue and Gross Profit
We generate revenue through the sale of Dermacyte® through on-line retailers and physician and medical spa facilities. Product revenue and percentage changes for the nine months ended January 31, 2013 and 2012, respectively, are as follows:
Nine months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Product revenue
|
$ | 28,899 | $ | 91,565 | $ | (62,666 | ) | (68 | ) % | |||||||
Cost of sales
|
16,578 | 47,616 | (31,038 | ) | (65 | ) % | ||||||||||
Gross profit
|
$ | 12,321 | $ | 43,949 | $ | (31,628 | ) | (72 | ) % |
The decrease in product revenue for the nine months ended January 31, 2013 was primarily due to the elimination of our internal sales force and the suspension of our direct marketing and advertising programs in the current year and the termination of existing distribution agreements in the prior year. During the nine months ended January 31, 2012, we recorded $26,000 in revenue from sales to our distributer that did not occur in the current year. During the current year, we employed only one internal salesperson compared to six during the same period in the prior year.
Government Grant Revenue
Grant Revenue is recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party CROs.
Nine months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Government grant revenue
|
$ | 997,035 | $ | 224,345 | $ | 772,690 | 344 | % |
For the nine months ended January 31, 2013, we recorded an increase of approximately $773,000 in revenue under the grant program as compared to the same period in the prior year. This increase is due to the progress of the underlying studies and the achievement of contractual milestones under the grant.
In addition to the revenue earned, we have recorded approximately $210,000 in deferred revenue associated with the grant. Deferred revenue under the grant represents pass-through costs that have been reimbursed in advance of performing the studies underlying the subcontracts.
Marketing and Sales Expenses
Marketing and sales expenses consisted primarily of personnel-related costs, including salaries, commissions, and the costs of marketing programs aimed at increasing revenue, such as advertising, trade shows, public relations and other market development programs. Marketing and sales expenses and percentage changes for the nine months ended January 31, 2013 and 2012, respectively, are as follows:
Nine months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Marketing and sales expense
|
$ | 106,019 | $ | 364,194 | $ | (258,175 | ) | (71 | ) % |
The decrease in marketing and sales expenses for the nine months ended January 31, 2013 was driven primarily by a decrease in the costs incurred for compensation and direct marketing.
-
|
We reduced compensation costs related to marketing and selling the cosmetic topical product line Dermacyte by approximately $146,000 compared to the same period in the prior year. These costs include salaries, commissions, and employee benefits.
|
-
|
Costs related to direct marketing and advertising decreased by approximately $70,000 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.
|
-
|
We reduced our travel and marketing sample expenses by approximately $42,000 during the nine months ended January 31, 2013 as compared to the same period in the prior year. This decrease was a result of our regional market focus and our reduction in overall headcount.
|
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, other professional services, and consulting fees. General and administrative expenses and percentage changes for the nine months ended January 31, 2013 and 2012, respectively, are as follows:
Nine months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Legal and professional fees
|
$ | 1,965,200 | $ | 2,591,639 | $ | (626,439 | ) | (24 | ) % | |||||||
Personnel costs
|
1,121,660 | 1,220,121 | (98,461 | ) | (8 | ) % | ||||||||||
Facilities
|
127,312 | 218,818 | (91,506 | ) | (42 | ) % | ||||||||||
Depreciation and amortization
|
81,988 | 134,835 | (52,847 | ) | (39 | ) % | ||||||||||
Other costs
|
(275,046 | ) | 354,296 | (629,342 | ) | (178 | ) % |
Legal and professional fees:
Legal and professional fees include the costs of external audit and tax preparation fees, external legal counsel, banking fees, investor relations and NASDAQ listing fees, payments to our board of directors and recruiting and other consulting fees incurred. Legal and professional fees decreased approximately $626,000 for the nine months ended January 31, 2013 compared to the same period in the prior year. This decrease was primarily due to decreases of approximately $132,000 in legal fees, $217,000 in consulting fees, $171,000 in costs related to our board of directors, $55,000 in investor relations and NASDAQ listing fees and $50,000 in auditing and tax preparation costs.
-
|
The decrease in legal expenses was due to a reduction in the costs incurred for securities matters and SEC filings, general employment matters, intellectual property and our SIX listing, partially offset by the costs incurred to defend the Tenor matter, the accrual for the settlement of the Tenor matter described in Note 7 to the financial statements above and fees associated with the closing of the Series A Preferred Stock offering.
|
-
|
The decrease in consulting fees was due to a reduction in executive recruiting fees and the elimination of other executive consulting expenses in the current period.
|
-
|
The decrease in fees paid to our directors was due to approximately $200,000 in severance costs related to our former President’s resignation from our Board of Directors in the prior year, partially offset by an increase of $44,000 in fees and travel costs associated with directors’ retainers and meetings
|
-
|
The decrease in accounting and filing fees was due primarily to a reduction in audit fees associated with the closing of the Series A Preferred Stock offering and other filings made with the SEC in the prior year.
|
-
|
The decrease in investor relations and listing fees was due primarily to the fees incurred for public and investor relations services and other costs related to our SIX listing in the prior year.
|
Personnel costs:
Personnel costs decreased approximately $98,000 for the nine months ended January 31, 2013 compared to the same period in the prior year. The decrease was due primarily to reductions in executive and management headcount and the recorded cost of outstanding stock options and restricted stock.
Facilities:
Facilities include costs paid for rent and utilities at our corporate headquarters in North Carolina, the allocation of lease costs not otherwise included in Research and Development expenses, and the costs incurred for third party IT support services. Facilities expense decreased approximately $92,000 due to reductions of $68,000 in allocated lease costs related to the closure of our California facility, and $23,000 in costs for utilities and fees paid to outside service providers for network and computer maintenance services in the prior year.
Depreciation and Amortization:
Depreciation and amortization expense decreased approximately $53,000 for the nine months ended January 31, 2013 compared to the same period in the prior year due to the disposal of fixed assets related to the closure of the California facility and assets becoming fully depreciated in the current period.
Other costs:
Other costs include costs incurred for travel, supplies, insurance and other miscellaneous charges. The $629,000 reduction in other costs was due primarily to a $532,000 reduction in our estimate of the accrued liability related to potential 409A violations, a $50,000 reduction in travel costs and an overall decrease of $86,000 in administrative and office expenses as a result of headcount reductions, partially offset by an increase of $37,000 in insurance premiums as compared to the same period in the prior year.
Research and Development Expenses
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the nine months ended January 31, 2013 and 2012, respectively, are as follows:
Nine months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Clinical and preclinical development
|
$ | 925,795 | $ | 531,499 | $ | 394,296 | 74 | % | ||||||||
Personnel costs
|
478,120 | 680,161 | (202,041 | ) | (30 | ) % | ||||||||||
Consulting
|
93,249 | 298,379 | (205,130 | ) | (69 | ) % | ||||||||||
Other costs
|
27,373 | 73,999 | (46,626 | ) | (63 | ) % | ||||||||||
Depreciation
|
33,461 | 45,618 | (12,157 | ) | (27 | ) % | ||||||||||
Facilities
|
53,295 | 110,817 | (57,522 | ) | (52 | ) % |
Clinical and preclinical development:
Clinical and preclinical development costs include the costs associated with our pre-clinical safety studies and current Good Manufacturing Practices, or cGMP, development for Oxycyte, costs incurred to resume our Phase II-b clinical trials, and development costs for Dermacyte. The increase of approximately $394,000 in clinical and preclinical development costs for the nine months ended January 31, 2013 as compared to the prior year was primarily due to increases in costs associated with our pre-clinical studies and quality assurance for Oxycyte, partially offset by a reduction in costs associated with Dermacyte development.
-
|
We incurred an increase of approximately $529,000 in pre-clinical study costs. These costs are the result of CRO fees for the completion of milestones under the Grant-funded preclinical program to assess the safety of Oxycyte for the treatment of patients with TBI.
|
-
|
We incurred an increase of approximately $37,000 in Oxycyte development costs. These costs are the result of developing cGMP supply and manufacturing capabilities, validated release methods for our clinical drug product and other costs associated with resuming the phase II-b clinical trials for TBI.
|
-
|
We decreased Dermacyte development costs by approximately $169,000. This decrease was primarily related to the development of additional cosmetic formulations, proof of concept preclinical trials, and other development activities in the prior year.
|
Personnel costs:
Personnel costs decreased approximately $202,000 for the nine months ended January 31, 2013 compared to the same period in the prior year, primarily due to headcount reductions related to the closure of our California lab facility during the current period and the resignation of our Chief Medical Officer in the prior year.
Consulting fees:
Consulting fees decreased approximately $205,000 for the nine months ended January 31, 2013 compared to the same period in the prior year, primarily due to charges under the consulting and separation agreement for our former President and Chief Operating Officer that were not incurred in the current period; partially offset by an increase in costs paid to regulatory consultants.
Other costs:
Other costs decreased approximately $47,000 for the nine months ended January 31, 2013 as compared to the same period in the prior year, due primarily to a decreases of $13,000 in travel cost and $32,000 in the cost of lab supplies related to the closure our California facility.
Depreciation:
Depreciation expense decreased approximately $12,000 for the nine months ended January 31, 2013 compared to the same period in the prior year due to the disposal of fixed assets related to the closure of our California facility.
Facilities:
Facilities expense decreased approximately $58,000 for the nine months ended January 31, 2013 as compared to the same period in the prior year primarily due to the closure of our California facility.
Restructuring expense
Nine months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Restructuring expense
|
$ | 220,715 | $ | - | $ | 220,715 | — | % |
During the nine months ended January 31, 2013, the Company recorded one-time charges of approximately $54,000 for severance and benefits related charges, $135,000 for net future lease obligations and $29,000 for other exit costs.
Interest expense
Interest expense includes the interest payments due under our long-term debt, amortization of debt issuance costs and accretion of discounts recorded against our outstanding convertible notes. Interest expense also includes dividends and fair-value adjustments to the carrying value of our Series A Convertible Preferred Stock. Interest expense and percentage changes for the nine months ended January 31, 2013 and 2012, respectively, are as follows:
Nine months ended January 31,
|
Increase/
(Decrease)
|
% Increase/
(Decrease)
|
||||||||||||||
2013
|
2012
|
|||||||||||||||
Interest expense
|
$ | 3,615,204 | $ | 6,649,554 | $ | (3,034,350 | ) | (46 | ) % |
Long-term notes payable:
Interest expense for our long-term notes payable was $0 and approximately $2.8 million for the nine months ended January 31, 2013 and 2012, respectively. These notes were repaid in full in November 2011.
Convertible notes payable:
Interest expense on our outstanding convertible notes was approximately $1.9 million and $1.5 million for the nine months ended January 31, 2013 and 2012, respectively. The recorded interest for the nine months ended January 31, 2013 was comprised of approximately $562,000 for quarterly interest payments, $1,225,000 for amortization of debt discounts and $97,000 for amortization of debt issue costs.
Series A Convertible Preferred Stock:
Interest expense on our outstanding Series A Convertible Preferred Stock was approximately $1.7 million and $2.3 million for the nine months ended January 31, 2013 and 2012, respectively. The recorded interest for the nine months ended January 31, 2013 was comprised of approximately $656,000 for the calculated fair value of the warrants issued with the Series A Convertible Preferred Stock, $559,000 for the excess of the fair-value of the shares issued upon conversion over the fair value of the Series A Convertible Preferred Stock and $204,000 for the fair value adjustment to the remaining Preferred Stock outstanding at January 31, 2013. The Series A Convertible Preferred Stock matured on January 31, 2013 and all of the outstanding shares were redeemed by conversion into common stock at maturity.
Preferred Stock Dividends:
Interest expense recorded for the payment of dividends on the Series A Convertible Preferred Stock was approximately $310,000 and $42,000 for the nine months ended January 31, 2013 and 2012, respectively.
Other income and expense
Other income and expense includes non-operating income and expense items not otherwise recorded in our statement of operations. These items include, but are not limited to, revenue earned under sublease agreements for our California facility, prior to exiting the facility on September 1, 2012, recognized gains and losses on foreign currency translations, interest income earned and fixed asset disposals. Other (income) expense for the nine months ended January 31, 2013 and 2012, respectively, is as follows:
Nine months ended January 31,
|
Increase/
(Decrease)
|
|||||||||||
2013
|
2012
|
|||||||||||
Other (income) expense, net
|
$ | (8,215 | ) | $ | 91,970 | $ | (100,185 | ) |
Other (income) expense increased approximately $100,000 for the nine months ended January 31, 2013 compared to the same period in the prior year, primarily due to the write off of receivables from Glucometrics, Inc. The company previously held license rights for the use of our patents related to glucose monitoring technology. The receivable was determined to be uncollectible during the third quarter of 2012 and we recognized approximately $100,000 as a non-operating expense.
During the nine months ended January 31, 2013 compared to the prior year, we recorded income from sublease agreements and interest of approximately $20,000 and $15,000, respectively. We recorded losses of approximately $12,000 and $6,000 from the disposal of fixed assets and recognized losses on foreign currency translations.
Liquidity, Capital Resources and Plan of Operation
We have incurred losses since our inception and as of January 31, 2013 we had an accumulated deficit of $115.2 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur increased expenses related to our development and potential commercialization of Oxycyte and other product candidates and, as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
Liquidity
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had $1,652,173 and $2,631,032 of total current assets and a working capital deficit of $(339,536) and $(495,838) as of January 31, 2013 and April 30, 2012, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments.
We are in the preclinical and clinical trial stages in the development of our product candidates. We are currently conducting Phase II-b clinical trials for the use of Oxycyte in the treatment of severe traumatic brain injury. Even if we are successful with our Phase II-b study, we must then conduct a Phase III clinical study and, if that is successful, file with the FDA and obtain approval of a Biologics License Application to begin commercial distribution, all of which will take more time and funding to complete. Our other product candidates must undergo further development and testing prior to submission to the FDA for approval to initiate clinical trials, which also requires additional funding. Management is actively pursuing private and institutional financing, as well as strategic alliances and/or joint venture agreements to obtain the necessary additional financing and reduce the cost burden related to the development and commercialization of our products though we can give no assurance that any such initiative will be successful. We expect our primary focus will be on funding the continued testing of Oxycyte, since this product is the furthest along in the regulatory review process. Our ability to continue to pursue testing and development of our products beyond January 31, 2013 depends on obtaining license income or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining the necessary resources.
In December 2011, we entered into a Securities Purchase Agreement with certain institutional investors that provided for the sale and issuance of units (“Units”) consisting of Series A Convertible Preferred Stock and warrants in aggregate amount of up to $7.5 million in two installments (the “2011 Offering”). The first installment of $3.5 million closed on December 12, 2011, and the second installment of $4.0 million was scheduled to have occurred in June 2012, subject to certain closing conditions. Because certain closing conditions for the second installment were not satisfied, on June 14, 2012, we entered into an Amendment Agreement with each of the institutional investors that, among other things, divided the remaining installment into two installments, the first additional installment to occur in June 2012 in the amount of $2.5 million and the second additional installment to occur in September 2012 in the amount of $1.5 million.
On June 15, 2012, we sold 2,500 Units for net proceeds of approximately $2.3 million upon the closing of the first additional installment. The remainder of the 2011 Offering, which may be up to $1.5 million, was scheduled to be completed in an additional closing in September 2012. However, as our stock was trading at a level below the minimum price, the additional closing did not occur.
As further discussed in Note 11 Subsequent Events, in February 2013, we entered into a Securities Purchase Agreement with an institutional investor that provided for the sale and issuance of units (“Units”) consisting of Series B-1 and Series B-2 Convertible Preferred Stock and associated warrants in aggregate amount of up to $2.1 million (the “2013 Offering”). On February 27, 2013, we sold 2,100 shares of Series B-1 and Series B-2 Convertible Preferred Stock and associated warrants for net proceeds of approximately $1.9 million upon the closing of the 2013 Offering.
Based on our working capital at January 31, 2013, combined with the proceeds from the 2013 Offering, we believe we have sufficient capital on hand to continue to fund operations through July 31, 2013.
We will need to find alternative sources of capital to continue as a going concern, and there can be no assurance that such funding will be available on favorable terms or at all.
Cash Flows
The following table shows a summary of our cash flows for the nine months ended January 31, 2013 and 2012:
For the nine months ended January 31,
|
||||||||
2013
|
2012
|
|||||||
Net cash used in operating activities
|
$ | (3,480,825 | ) | $ | (6,857,458 | ) | ||
Net cash used in investing activities
|
(105,935 | ) | (207,200 | ) | ||||
Net cash provided by financing activities
|
2,535,699 | 9,394,216 |
Net cash used in operating activities. Net cash used in operating activities was $3.5 million for the nine months ended January 31, 2013 compared to net cash used in operating activities of $6.9 million for the nine months ended January 31, 2012. The decrease in cash used for operating activities was due primarily to decreases in our overall administrative expenses, our costs associated with marketing and selling our cosmetic products and revenue received under the Army Grant; partially offset by an increase in costs incurred for research and development activities.
Net cash used in investing activities. Net cash used in investing activities was $105,935 for the nine months ended January 31, 2013 compared to net cash used in investing activities of $207,200 for the nine months ended January 31, 2012. The decrease in cash used for investing activities was due to a reduction in capitalized legal fees incurred for filing and maintaining our patent portfolio.
Net cash provided by financing activities. Net cash provided by financing activities was $2.5 million for the nine months ended January 31, 2013 compared to net cash provided by financing activities of $9.4 million for the nine months ended January 31, 2012. The decrease of net cash provided by financing activities was due primarily to net proceeds of $2.3 million received from the issuance of Preferred Stock on June 15, 2012 as compared to the $4.5 million received from the issuance of the convertible notes and the $0.7 million proceeds from the issuance of notes payable under the Note Purchase Agreement with Vatea Fund during the nine months ended January 31, 2012.
Plan of Operation
Conducting a significant amount of research and development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of clinical trials. We plan to incur substantial research and development expenses for the foreseeable future in order to complete development of our most advanced product candidate, Oxycyte, and to conduct earlier-stage research and development on our topical applications.
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the U.S. Food and Drug Administration, or the FDA, is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our most advanced product candidate, Oxycyte, and our topical dermatologic indications; however, we will need substantial additional capital in the future in order to complete the development and potential commercialization of Oxycyte and other product candidates.
Operating Capital and Capital Expenditure Requirements
Our future capital requirements will depend on many factors that include, but are not limited to the following:
●
|
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.
|
We believe that our existing cash and cash equivalents will be sufficient to fund our projected operating requirements through July 31, 2013. We will need substantial additional capital in the future in order to complete the development and commercialization of Oxycyte and to fund the development and commercialization of our future product candidates. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding, if needed, may not be available on favorable terms, if at all. In the event we are unable to obtain additional capital, we may delay or reduce the scope of our current research and development programs and other expenses.
To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
Recent Accounting Pronouncements
On May 1, 2012, we adopted FASB Accounting Standards Update (“ASU”) 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. Under the amendments to Topic 220, Comprehensive Income, an entity has the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In both choices, an entity is required to present each component of net income along with total net income, each component of other comprehensive income along with a total for other comprehensive income, and a total amount for comprehensive income. This update eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholders' equity. The amendments in this update do not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income. The adoption of ASU 2011-05 did not have a material impact on our financial statements.
On May 1, 2012, we adopted ASU 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. The amendments in this update result in common fair value measurement and disclosure requirements in GAAP and International Financial Reporting Standards (“IFRS”). Consequently, the amendments change the wording used to describe many of the requirements in GAAP for measuring fair value and for disclosing information about fair value measurements. The amendments in this update will not result in a change in the application of the requirements in Topic 820. The adoption of ASU 2011-04 did not have a material impact on its financial statements.
On July 27, 2012, the FASB issued ASU 2012-02, Testing Indefinite-Lived Intangible Assets for Impairment (the revised standard). The revised standard provides companies with an option to perform a “qualitative” assessment to determine whether further impairment testing is necessary. The qualitative assessment is not an accounting policy election and can be performed on none, some, or all of a company’s indefinite-lived intangible assets. ASU 2012-02 is effective on May 1, 2013 and early adoption is permitted. We do not believe adoption of ASU 2012-02 will have a material impact on our financial statements.
On February 5, 2013, the FASB issued ASU 2013-02, Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income, as an update to Comprehensive Income (Topic 220). The objective of this Update is to improve the reporting of reclassifications out of accumulated other comprehensive income. The amendments in this Update require an entity to report the effect of significant reclassifications out of accumulated other comprehensive income on the respective line items in net income if the amount being reclassified is required under U.S. generally accepted accounting principles (GAAP) to be reclassified in its entirety to net income. For other amounts that are not required under U.S. GAAP to be reclassified in their entirety to net income in the same reporting period, an entity is required to cross-reference other disclosures required under U.S. GAAP that provide additional detail about those amounts. The amendments do not change the current requirements for reporting net income or other comprehensive income in financial statements. ASU 2013-02 is effective on February 1, 2013. We do not believe adoption of ASU 2013-02 will have a material impact on its financial statements.
Off-Balance Sheet Arrangements
Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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Management does not believe that we possess any instruments that are sensitive to market risk. Our debt instruments bear interest at fixed interest rates.
We believe that there have been no significant changes in our market risk exposures for the three months ended January 31, 2013.
CONTROLS AND PROCEDURES
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Evaluation of Disclosure Controls and Procedures
As required by paragraph (b) of Rules 13a-15 and 15d-15 promulgated under the Exchange Act, our management, including our Interim Chief Executive Officer and Chief Financial Officer, conducted an evaluation as of the end of the period covered by this report, of the effectiveness of our disclosure controls and procedures as defined in Exchange Act Rule 13a-15(e) and 15d-15(e). Based on that evaluation, our Interim Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of January 31, 2013, the end of the period covered by this report in that they provide reasonable assurance that the information we are required to disclose in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods required by the SEC and is accumulated and communicated to our management, including the Interim Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no significant changes in our internal control over financial reporting during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We routinely review our internal controls over financial reporting and from time to time make changes intended to enhance the effectiveness of our internal control over financial reporting. We will continue to evaluate the effectiveness of our disclosure controls and procedures and internal controls over financial reporting on an ongoing basis and will take action as appropriate.
LEGAL PROCEEDINGS
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On August 30, 2011, Tenor Opportunity Master Fund Ltd., Aria Opportunity Fund, Ltd., and Parsoon Opportunity Fund, Ltd (collectively, “Tenor”) filed a lawsuit in the United States District Court for the Southern District of New York alleging that a right of first offer held by Tenor was breached in connection with our June 2011 financing. The complaint sought compensatory damages, attorneys’ fees and costs. Discovery was completed and motions for summary judgment from both sides were filed, Plaintiffs filed on the matter of breach and we filed on the matter of damages. On July 11, 2012 the court entered an order on both summary judgment motions. The court found in favor of Plaintiff’s motion, holding that we did breach the agreement. The court did not find in favor of our motion regarding damages. The matter was then set to move to trial for a jury to determine what, if any, damages Plaintiff’s suffered from our breach of the agreement. The trial was scheduled to begin on October, 10, 2012. On October 3, 2012 the court granted a motion from Tenor to continue the trial until March 7, 2013.
However, on February 19, 2013, we and Tenor reached a tentative oral settlement of this litigation, and executed a written settlement agreement, effective March 14, 2013, under which the litigation was dismissed with prejudice. The settlement agreement provides that the parties will settle the matter for our payment of $600,000 in cash, plus interest accrued thereon from the date of the executed settlement agreement at the rate of fifteen percent (15%) per year, payable in six quarterly installments commencing on the date the parties executed the written settlement agreement. The settlement agreement also provides that upon the Company completing financings in certain amounts, if the settlement amount is not fully paid at such time, a portion of the settlement payment schedule will be accelerated.
RISK FACTORS
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We are supplementing the risk factors disclosed in our Annual Report on Form 10-K for the year ended April 30, 2012 with the risk factors below.
If we cannot meet the NASDAQ Capital Market continued listing requirements, our common stock may be delisted which could have an adverse impact on the liquidity and market price of our common stock.
Our common stock is currently listed on the NASDAQ Capital Market, or NASDAQ. Continued listing of a security on NASDAQ is conditioned upon compliance with various continued listing standards, which require, among other things, that for 30 consecutive trading days (i) the closing minimum bid price for our listed securities not be lower than $1.00 per share and (ii) our market capitalization not be lower than $35 million. The closing bid price for our shares has been less than $1.00 per share since August 21, 2012 and our market capitalization has been less than $35 million since August 8, 2012.
On September 20, 2012 we received a deficiency notice from NASDAQ due to our market capitalization falling below $35 million for 30 consecutive days. We are required to regain compliance with continued listing standards before March 19, 2013. On October 3, 2012 we received a deficiency notice from NASDAQ due to the closing bid price for our shares falling below $1.00 per share for 30 consecutive days. We are required to regain compliance with continued listing standards before April 1, 2013.
There can be no assurance made that we will be able to regain compliance during that period, and, if we do not, our common stock will be subject to delisting from the NASDAQ. We would then be entitled to appeal the NASDAQ’s Staff determination to a NASDAQ Listing Qualifications Panel and request a hearing, though there can be no assurance that any such appeal would be successful. During the appeal process, our common stock would continue to trade on NASDAQ. Delisting from NASDAQ would negatively impact us and our stockholders by, among other things, reducing the liquidity and market price of our common stock and adversely affecting our ability to raise additional capital.
The second additional closing of our December 2011 registered direct offering did not occur.
While our 2011 Offering provided for an aggregate amount of up to $7.5 million, only $3.5 million of the offered securities were purchased initially. In June 2012, an additional $2.5 million of the offered securities were purchased.
The remainder of the 2011 Offering, which may be up to $1.5 million, was scheduled to be completed in an additional closing in September 2012. The final closing was subject to various conditions, including conditions that are outside of our control, including, but not limited to, a minimum stock price prior to the final closing and a minimum trading volume limitation. As of September 14, 2012, our stock was trading at a level below the minimum price and the final closing did not occur. We will need to find alternative sources of capital to continue as a going concern, and there can be no assurance that such funding would be available on favorable terms or at all.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
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Repurchases of Common Stock
The following table lists all repurchases during the third quarter of fiscal 2013 of any of our securities registered under Section 12 of the Exchange Act by or on behalf of us or any affiliated purchaser.
Issuer Purchases of Equity Securities
Period
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Total Number of Shares Purchased (1)
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Average Price Paid per Share (2)
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Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
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Approximate Dollar Value of Shares that August Yet Be Purchased Under the Plans or Programs
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November 1, 2012 - November 30, 2012
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438 | $ | 1.05 | - | $ | - | ||||||||||
December 1, 2012 - December 31, 2012
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438 | 0.69 | - | - | ||||||||||||
January 1, 2013 - January 31, 2013
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393 | 0.64 | - | - | ||||||||||||
Total
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1,269 | $ | 0.80 | - | $ | - |
(1)
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Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
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(2)
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Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
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Unregistered Sales of Equity Securities
On December 19, 2012, we issued 83,242 shares of unregistered common stock as payment of $187,708 of interest due on our outstanding convertible notes.
All of the securities described above were issued in reliance on the exemption from registration set forth in Section 4(2) of the Securities Act.
DEFAULTS UPON SENIOR SECURITIES
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None.
MINE SAFETY DISCLOSURES
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Not applicable.
OTHER INFORMATION
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On August 30, 2011, Tenor filed a lawsuit in the United States District Court for the Southern District of New York alleging that a right of first offer held by Tenor was breached in connection with our June 2011 financing. Subsequently, the Company and Tenor executed a written settlement agreement, effective March 14, 2013, under which the litigation was dismissed with prejudice. The settlement agreement provides that the parties will settle the matter for the Company’s payment of $600,000 in cash, plus interest accrued thereon from the date of the executed settlement agreement at the rate of fifteen percent (15%) per year, payable in six quarterly installments commencing on March 15, 2013. The settlement agreement also provides that upon the Company completing financings in certain amounts, if the settlement amount is not fully paid at such time, a portion of the settlement payment schedule will be accelerated.
EXHIBITS
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No.
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Description
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Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
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Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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101.INS
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XBRL Instance Document (1)
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101.SCH
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XBRL Taxonomy Extension Schema Document (1)
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document (1)
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document (1)
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101.LAB
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XBRL Taxonomy Extension Label Linkbase Document (1)
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase Document (1)
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(1)
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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 Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
OXYGEN BIOTHERAPEUTICS, INC.
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Date: March 18, 2013 |
By:
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/s/ Michael B. Jebsen
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Michael B. Jebsen
Chief Financial Officer and Interim Chief Executive Officer
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