UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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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
March 31, 2010
or
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o
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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:
000-51314
Winston Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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30-0132755
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(State or other Jurisdiction of
Incorporation)
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(IRS Employer Identification No.)
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100 North Fairway Drive,
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Suite 134
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Vernon Hills, Illinois
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60061
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(Address of Principal Executive Offices)
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(Zip Code)
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(847) 362-8200
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
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
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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) (the Registrant is not yet required to submit
Interactive Data). Yes
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No
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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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Accelerated
Filer
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Non-accelerated Filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes
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No
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As of May 10, 2010, 77,408,893 shares of the registrants Common Stock were issued
and outstanding.
WINSTON PHARMACEUTICALS, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Winston Pharmaceuticals, Inc. and Subsidiaries
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
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March 31,
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December 31,
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2010
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2009
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ASSETS
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CURRENT ASSETS
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Cash
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$
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677,522
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$
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1,562,848
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Accounts receivable
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15,653
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Related party receivables
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59,440
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22,395
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Inventory
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28,925
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Prepaid and other current assets
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45,414
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43,944
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Total current assets
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811,301
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1,644,840
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EQUIPMENT, net of accumulated depreciation of
$142,817 at March 31, 2010 and $141,433 at
December 31, 2009
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12,376
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13,760
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INTANGIBLE ASSETS, NET
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18,597
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17,455
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TOTAL ASSETS
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$
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842,274
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$
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1,676,055
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LIABILITIES AND STOCKHOLDERS EQUITY
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CURRENT LIABILITIES
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Accounts payable
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$
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715,248
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$
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724,140
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Accrued expenses and other current liabilities
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61,793
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146,638
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Unearned revenue
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316,706
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Total liabilities
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777,041
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1,187,484
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Commitments and Contingencies
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Stockholders equity
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Common stock, $.001 par value, 900,000,000
shares authorized, 77,408,893 shares issued
and outstanding at March 31, 2010 and at
December 31, 2009
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77,409
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77,409
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Additional paid-in capital
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49,831,613
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49,794,260
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Accumulated deficit
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(49,843,789
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(49,383,098
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Total stockholders equity
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65,233
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488,571
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TOTAL LIABILITIES AND STOCKHOLDERS EQUITY
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$
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842,274
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$
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1,676,055
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See notes to unaudited condensed consolidated financial statements
3
Winston Pharmaceuticals, Inc. and Subsidiaries
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months ended March 31
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2010
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2009
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REVENUES
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License revenues
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$
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316,706
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$
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316,706
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Royalty revenues
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23,280
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316,706
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339,986
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EXPENSES
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Research and development
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326,340
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545,966
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General and administrative
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449,765
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580,309
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Depreciation and amortization
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2,141
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2,318
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Total operating expenses
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778,246
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1,128,593
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Loss from operations
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(461,540
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(788,607
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Interest income
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159
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9,727
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Other income
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690
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96
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849
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9,823
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Loss before income taxes
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(460,691
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(778,784
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Income Taxes
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Current
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Deferred
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NET LOSS
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$
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(460,691
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$
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(778,784
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Loss per share, basic and diluted
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$
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(0.01
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$
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(0.01
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Weighted average number of shares outstanding, basic and diluted
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77,408,893
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55,307,145
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See notes to unaudited condensed consolidated financial statements
4
Winston Pharmaceuticals, Inc. and Subsidiaries
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended March 31, 2010 and 2009
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2010
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2009
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Cash flows from operating activities
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Net loss
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$
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(460,691
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$
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(778,784
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Depreciation and amortization
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2,141
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2,318
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Stock Option expense for non-employee directors and employees
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37,353
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Changes in:
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Accounts receivable
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(21,392
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14,645
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Inventory
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(28,925
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Prepaid and other current assets
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(1,470
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11,373
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Other assets
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1,154
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Unearned revenue
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(316,706
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(316,706
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Accounts payable
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(8,892
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(429,800
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Accrued expenses and other current liabilities
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(84,845
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(43,537
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Net cash used in operating activities
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(883,427
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(1,539,337
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Cash flows from investing activities
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Purchases of equipment
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(738
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Purchases of intangibles
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(1,899
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Net cash used in investing activities
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(1,899
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(738
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Cash flows from financing activities
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Proceeds from exercise of stock options
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82,950
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Net cash provided by financing activities
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82,950
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NET DECREASE IN CASH AND CASH EQUIVALENTS
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(885,326
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(1,457,125
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Cash and cash equivalents at beginning of period
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1,562,848
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5,626,913
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Cash and cash equivalents at end of period
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$
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677,522
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$
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4,169,788
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Supplemental disclosures of cash flow information
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Interest paid
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$
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$
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Income taxes paid
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$
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$
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See notes to unaudited condensed consolidated financial statements
5
Winston Pharmaceuticals, Inc. and Subsidiaries
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 BASIS OF PRESENTATION
Winston Pharmaceuticals, Inc. (Winston or the Company) is a research-based
specialty pharmaceutical company engaged in the discovery, development and
commercialization of pain-management products.
The accompanying financial statements are unaudited but in the opinion of management
contain all the adjustments (consisting of those of a normal recurring nature) considered
necessary to present fairly the financial position and the results of operations and cash
flow for the periods presented in conformity with generally accepted accounting
principles for interim financial information and the instructions to Form 10-Q and
Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information
and footnotes required by United States generally accepted accounting principles for
complete financial statements.
The Company has incurred significant losses from operations since its inception and
expects losses to continue for the foreseeable future. The Companys success depends
primarily on the development and regulatory approval of its product candidates. From
inception through March 31, 2010, the Company has incurred cumulative net losses of $49.8
million. Net losses may continue for at least the next several years as the Company
proceeds with the development of its product candidates and programs. The size of these
losses will depend on the receipt of revenue from its products candidates and programs,
if any, and on the level of the Companys expenses. To achieve profitable operations, the
Company must successfully identify, develop, partner and/or commercialize its product
candidates and programs. Product candidates developed by the Company will require
approval of the U.S. Food and Drug Administration (FDA) or a foreign regulatory authority
prior to commercial sales. The regulatory approval process is expensive, time consuming
and uncertain, and any denial or delay of approval could have a material adverse effect
on the Companys ability to become profitable or continue operations. Even if approved,
the Companys product candidates may not achieve market acceptance and could face
competition.
The Companys cash has decreased from $1.6 million as of
December 31, 2009 to $0.7 million as of March 31, 2010. The Company believes that its
existing cash will be sufficient to fund its activities through the
end of June, 2010. The Company seeks additional sources of financing through
collaborations with third parties, or public or private debt or equity financings. There
can be no assurance that additional funds will be available on satisfactory terms, or at
all. If the Company is unsuccessful in its efforts to raise additional outside capital in
the near term, the Company will be required to significantly reduce its research,
development, and administrative operations, including further reduction of its employee
base, or it may be required to cease operations completely, or liquidate in order to
offset the lack of available funding.
The accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern, which contemplates the realization of
assets and the settlement of liabilities and commitments in the normal course of
business. The financial statements for the three months ended March 31, 2010 do not
include any adjustments to reflect the possible future effects on the recoverability and
classification of assets or the amounts and classification of liabilities that may result
from uncertainty related to the Companys ability to continue as a going concern.
Principles of Consolidation
The consolidated financial statements of the Company include the accounts of Winston
Laboratories, Inc., the Companys wholly-owned subsidiary (Winston Labs) and its
subsidiaries, Winston Laboratories Limited (UK Ltd.) and Rodlen Laboratories, Inc.
(Rodlen), as of March 31, 2010 and December 31, 2009 and for the three months ended
March 31, 2010 and 2009. All intercompany balances and transactions have been eliminated.
6
Inventories
Inventories are valued at the lower of cost or market (net realizable value). Cost
is determined by the first-in, first-out method.
Fair Value of Financial Instruments
The carrying amounts of financial instruments, including cash, accounts receivable,
accounts payable and accrued expenses approximate fair value due to the short term
maturity of these instruments.
Accounting Standards Codification (ASC) Topic 820,
Fair Value Measurements and
Disclosures,
provides a framework for measuring fair value of assets and liabilities in
accordance with GAAP, and establishes a three-tier fair value hierarchy, which
prioritizes the inputs used in measuring fair value. These tiers include: Level 1,
defined as observable inputs such as quoted prices in active markets; Level 2, defined as
inputs other than quoted prices in active markets that are either directly or indirectly
observable; and Level 3, defined as unobservable inputs in which little or no market data
exists, therefore requiring an entity to develop its own assumptions.
The Company did not have any financial assets measured at fair value on a recurring
basis, subject to the disclosure requirements of ASC Topic 820 as of March 31, 2010.
Revenue Recognition
The Company has historically generated revenues from product sales, collaborative
research and development arrangements, and other commercial arrangements such as,
royalties, and sales of technology rights. Payments received under such arrangements may
include non-refundable fees at the inception of the arrangements, milestone payments for
specific achievements designated in the agreements, royalties on sales of products
resulting from collaborative arrangements, and payments for the sale of rights to future
royalties.
The Company recognizes revenue in accordance with the SECs Staff Accounting
Bulletin Topic 13 (Topic 13), Revenue Recognition. Revenue is recognized when all of
the following criteria are met: (1) persuasive evidence of an arrangement exists; (2)
delivery has occurred or services have been rendered; (3) the sellers price to the buyer
is fixed and determinable; and (4) collectability is reasonably assured.
Certain sales transactions include multiple deliverables. The Company allocates
amounts to separate elements in multiple element arrangements in accordance with ASC
Topic 605,
Revenue Recognition
. Revenues are allocated to a delivered product or service
when all of the following criteria are met: (1) the delivered item has value to the
customer on a standalone basis; (2) there is objective and reliable evidence of the fair
value of the undelivered item; and (3) if the arrangement includes a general right of
return relative to the delivered item, delivery or performance of the undelivered item is
considered probable and substantially in the Companys control. The Company uses the
relative fair values of the separate deliverables to allocate revenue. For arrangements
with multiple elements that are separated, the Company recognizes revenues in accordance
with Topic 13.
Multiple Element Arrangements
The Company has arrangements whereby it delivers to the customer multiple elements
including technology and/or services. Such arrangements have generally included some
combination of the following: licensed rights to technology, patented products,
compounds, data and other intellectual property; and research and development services.
The Company analyzes its multiple element arrangements to determine whether the elements
can be separated. The Company performs its analysis at the inception of the arrangement
and as each product or service is delivered. If a product or service is not separable,
the combined deliverables will be accounted for as a single unit of accounting.
When a delivered element meets the criteria for separation, the Company allocates
amounts based upon the relative fair values of each element. The Company determines the
fair value of a separate deliverable using the price it charges other customers when it
sells that product or service separately; however, if the Company does not sell the
product or service separately, it uses third-party evidence of fair value. The Company
considers licensed rights or technology to have standalone value to its customers if it
or others have sold such rights or technology separately or its customers can sell such
rights or technology separately without the need for the Companys continuing
involvement.
7
License Arrangements.
License arrangements may consist of non-refundable upfront
license fees, data transfer fees, research reimbursement payments, exclusive licensed
rights to patented or patent pending compounds, technology access fees, various
performance or sales milestones. These arrangements are often multiple element
arrangements.
Non-refundable, up-front fees that are not contingent on any future performance by
the Company, and require no consequential continuing involvement on its part, are
recognized as revenue when the license term commences and the licensed data, technology
and/or compound is delivered. Such deliverables may include physical quantities of
compounds, design of the compounds and structure-activity relationships, the conceptual
framework and mechanism of action, and rights to the patents or patents pending for such
compounds. The Company defers recognition of non-refundable upfront fees if it has
continuing performance obligations without which the technology, right, product or
service conveyed in conjunction with the non-refundable fee has no utility to the
licensee that is separate and independent of the Companys performance under the other
elements of the arrangement. In addition, if the Company has required continuing
involvement through research and development services that are related to its proprietary
know-how and expertise of the delivered technology, or can only be performed by the
Company, then such up-front fees are deferred and recognized over the period of
continuing involvement. Under the license agreement with sanofi-aventis Canada, Inc.
(Note 3), the obligation period was not contractually defined in relation to the upfront
fee. Under the circumstances, management exercised judgment in estimating the period of
time over which certain deliverables will be provided to enable the licensee to utilize
the license, which was determined to be 18 months. The estimated period of 18 months was
primarily determined based on managements estimate of the maximum amount of time it
would take the Canadian regulatory authorities to approve the Companys new drug
submission (NDS).
Payments related to substantive, performance-based milestones in a research and
development arrangement are recognized as revenues upon the achievement of the milestones
as specified in the underlying agreements when they represent the culmination of the
earnings process.
Research Services Arrangements
. Revenues from research services are recognized
during the period in which the services are performed and are based upon the number of
full-time-equivalent personnel working on the specific project at the agreed-upon rate.
Reimbursements from collaborative partners for agreed upon direct costs including direct
materials and outsourced services, or subcontracted, pre-clinical studies are classified
as revenues in accordance with ASC Topic 605, and recognized in the period the
reimbursable expenses are incurred. Payments received in advance are deferred until the
research services are performed or costs are incurred.
Royalty Arrangements
. The Company recognizes royalty revenues from licensed products
when earned in accordance with the terms of the license agreements. Net sales amounts
generally required to be used for calculating royalties include deductions for returned
product, pricing allowances, cash discounts, freight and warehousing.
Certain royalty arrangements require that royalties are earned only if a sales
threshold is exceeded. Under these types of arrangements, the threshold is typically
based on annual sales. The Company recognizes royalty revenue in the period in which the
threshold is exceeded.
Research and Development Expenses
The guidance in ASC Topic 730,
Research and Development,
requires the Company to
defer and capitalize nonrefundable advance payments made for goods or services to be used
in research and development activities until the goods have been delivered or the related
services have been performed. If the goods are no longer expected to be delivered or the
services are no longer expected to be performed, the Company would be required to expense
the related capitalized advance payments.
Research and development expenses consist of expenses incurred in performing
research and development activities including salaries and benefits, facilities and other
overhead expenses, clinical trials, contract services and outsource contracts. Research
and development expenses are charged to operations as they are incurred.
Acquired contractual rights
. Payments to acquire contractual rights to a licensed
technology or drug candidate are expensed as incurred when there is uncertainty in
receiving future economic benefits from the acquired contractual rights. The Company
considers the future economic benefits from the acquired contractual rights to a drug
candidate to be uncertain until such drug candidate is approved by the FDA or when other
significant risk factors are abated.
Research and development costs totaled $326,340 and $545,966 for the three month
periods ended March 31, 2010 and 2009, respectively.
8
Income Taxes
The Company files a consolidated tax return that includes all subsidiaries. Deferred
income taxes are recognized for the tax consequences in future years of differences
between the tax bases of assets and liabilities and their financial reporting amounts at
each year-end, based on enacted tax laws and statutory tax rates applicable to the
periods in which the differences are expected to affect taxable income. Valuation
allowances are established when necessary to reduce deferred income tax assets to the
amount expected to be realized.
ASC Topic 740,
Income Taxes
, prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken
or expected to be taken in a tax return. ASC Topic 740 provides a two-step process to
evaluate a tax position and also provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosure, and transition. The
Company has not recorded a reserve for any tax positions for which the ultimate
deductibility is highly certain but for which there is uncertainty about the timing of
such deductibility. The Company files tax returns in all appropriate jurisdictions. The
open tax years are those years ending December 31, 2006 to December 31, 2009, which
statutes expire in 2010-2013. As of March 31, 2010 and March 31, 2009, the Company has no
liability for unrecognized tax benefits. The Company recognizes interest and penalties
related to uncertain tax positions as income tax expense as incurred. No expense for
interest and penalties was recognized for the three month period ended March 31, 2010 and
2009.
Segment Information
The Company is operated on the basis of a single reportable segment, which is the
business of discovery and development of products for pain management. The Companys
chief operating decision-maker is the Chief Executive Officer, who evaluates the Company
as a single operating segment.
Recent Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) issued a new
pronouncement relating to Amendments to variable interest entities (VIE), which changes
the approach to determining the primary beneficiary of a VIE and requires companies to
more frequently assess whether they must consolidate VIEs. This new standard is effective
for the Company beginning on January 1, 2010. The adoption of this new pronouncement did
not have a material impact on the Companys financial position, results of operations or
cash flows.
In October 2009, the FASB issued Accounting Standards Update (ASU) 2009-13,
Revenue
Recognition (Topic 605)- Multiple-Deliverable Revenue Arrangements
, which amends ASC
605,
Revenue Recognition
, to require companies to allocate revenue in multiple-element
arrangements based on an elements estimated selling price if vendor-specific or other
third-party evidence of value is not available. ASU 2009-13 is effective prospectively
for revenue arrangements entered into or materially modified in fiscal years beginning on
or after June 15, 2010. Earlier application is permitted. The Company is currently
evaluating both the timing and the impact of the pending adoption of the ASU on its
consolidated financial statements.
The FASB has issued ASU No. 2010-17,
Revenue Recognition Milestone Method (Topic
605): Milestone Method of Revenue Recognition
. The ASU codifies the consensus reached in
Emerging Issues Task Force Issue No. 08-9, Milestone Method of Revenue Recognition. The
amendments to the
FASB Accounting Standards Codification
provide guidance on defining a
milestone and determining when it may be appropriate to apply the milestone method of
revenue recognition for research or development transactions. Consideration that is
contingent on achievement of a milestone in its entirety may be recognized as revenue in
the period in which the milestone is achieved only if the milestone is judged to meet
certain criteria to be considered substantive. Milestones should be considered
substantive in their entirety and may not be bifurcated. An arrangement may contain both
substantive and nonsubstantive milestones, and each milestone should be evaluated
individually to determine if it is substantive.
The amendments in the ASU are effective on a prospective basis for milestones
achieved in fiscal years, and interim periods within those years, beginning on or after
June 15, 2010. Early adoption is permitted. If a vendor elects early adoption and the
period of adoption is not the beginning of the entitys fiscal year, the entity should
apply the amendments retrospectively from the beginning of the year of adoption. Vendors
may also elect to adopt the amendments in the ASU retrospectively for all prior periods.
9
NOTE 2 EARNINGS PER SHARE
Basic EPS is computed by dividing income (loss) attributable to common stockholders
by the weighted average number of common shares outstanding for the period. Diluted EPS
is computed giving effect to all dilutive potential common shares that were outstanding
during the period. Dilutive potential common shares consist of the incremental common shares issuable upon conversion of convertible preferred shares and the exercise of stock
options and warrants and unvested shares granted to employees and non-employee directors.
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31
|
|
|
|
2010
|
|
|
2009
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding basic and diluted
|
|
|
77,408,893
|
|
|
|
55,307,145
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share basic and diluted
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
|
|
|
|
|
|
The Companys Basic EPS and Diluted EPS is identical as inclusion of the
incremental common shares attributable upon conversion of convertible preferred shares
and the exercise of stock options and warrants and unvested shares granted to employees
and directors would have been anti-dilutive.
NOTE 3 TECHNOLOGY LICENSE AGREEMENTS
Under its technology license agreement with Hi-Tech Pharmacal Co.(Hi-Tech), the
Company recorded royalty revenues of $0 and $23,280 for the three months ended March 31,
2010 and 2009, respectively. On October 30, 2009, the Company received communication
from Hi-Tech that it has discontinued the sale of the product as defined in the license
agreement. As a result, the Company does not expect to receive any more royalties from
Hi-Tech in the future.
Under its licensing agreement with sanofi-aventis Canada Inc., the Company
recognized approximately $316,000 license revenue for the three months ended March 31,
2010, and 2009, respectively.
NOTE 4 RELATED-PARTY TRANSACTIONS
Elorac, Inc. (Elorac) is an entity controlled by Dr. Bernstein, CEO of the
Company. In addition, Robert Yolles, a director of the Company, is also a director of
Elorac. Since inception, Elorac has been located in the same offices as Winston and
therefore has shared in certain of Winstons expenses such as rent, utilities, internet
usage, etc. The amount of Eloracs share of such expenses is based on various allocation
factors related to a particular expense. The Company has received approximately $46,399
and $25,169 for such services for the three month periods ended March 31, 2010 and 2009,
respectively, which are included as a reduction of the Companys expenses on the
Consolidated Statements of Operations. Amounts due from Elorac of $40,188 and $2,106 as
of March 31, 2010 and December 31, 2009, respectively, are included in related party
receivables on the Companys Consolidated Balance Sheets. Subsequent to March 31, 2010,
Elorac paid the $40,188 balance.
10
Gideon Pharmaceuticals, Inc. (Gideon) is a corporation whose chairman and sole director is Joel E. Bernstein,
M.D., president and CEO of the Company. Gideon reimburses the Company for certain expenses that the Company incurs
on behalf of Gideon. As of March 31, 2010 and December 31, 2009, respectively, the Company had $12,675 of receivables
related to such expenses which are included in related party receivables on the Consolidated Balance Sheets.
On September 19, 2007, Winston Labs entered into an exclusive technology license agreement with OPKO Ophthalmologists,
LLC, (OPKO). The CEO and Chairman of OPKO is also the indirect beneficial owner of 26,574,659 shares of the Companys
capital stock on a fully diluted basis (29.7% of the total issued and outstanding shares), including 8,779,797 shares of
common stock underlying warrants. Furthermore, Subbarao Uppaluri, Ph.D., a director of the Company and the Senior Vice President Chief
Financial Officer of OPKO Health, is the beneficial owner of 326,538 shares of the Companys capital stock on a fully-diluted basis,
including 27,500 shares of common stock underlying options and 89,589 shares of common stock underlying warrants. The agreement calls
for OPKO to reimburse Winston Labs for certain legal expenses Winston Labs has incurred related to the use of the licensed products to
treat keratoconjunctivitis. During the three month period ended March 31, 2010, approximately $9,274 of legal
fees were billed to OPKO, $6,577 of which were outstanding as of March 31, 2010 and are included in related party receivables on the
Consolidated Balance Sheets at March 31, 2010. Subsequent to March 31, 2010, OPKO paid the $6,577 balance.
On February 24, 2010, the Company received communications from OPKO that it was terminating the license agreement
effective May 24, 2010. As a result, all of OPKOs rights to certain products, as defined in the agreement, will
revert back to the Company.
NOTE 5 INCOME TAXES
Due to the continuing operating losses, no tax benefit is being recorded. The
Company continues to provide a full valuation allowance for any future tax benefits
resulting from the Companys net operating losses.
The provision for income taxes differs from the amount computed by applying the
statutory federal income tax rate of 34.0% to pre-tax loss as follows:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
March 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
Tax benefit at U.S. federal statutory rate
|
|
$
|
(157,000
|
)
|
|
$
|
(265,000
|
)
|
State tax benefit, net of federal benefit
|
|
|
(22,000
|
)
|
|
|
(38,000
|
)
|
Change in valuation allowance
|
|
|
197,000
|
|
|
|
311,000
|
|
Permanent differences
|
|
|
1,000
|
|
|
|
1,000
|
|
Research and development credits
|
|
|
(18,000
|
)
|
|
|
(25,000
|
)
|
Other, net
|
|
|
(1,000
|
)
|
|
|
16,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit)
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
11
NOTE 6 STOCK OPTION PLANS
The following table summarizes stock option activity under the Companys Omnibus
Incentive Plan during the three-month period ended March 31, 2010:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Weighted-
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
Average
|
|
|
Average
|
|
|
Aggregate
|
|
|
Remaining
|
|
|
|
|
|
|
|
Exercise
|
|
|
Grant Date
|
|
|
Intrinsic
|
|
|
Contractual
|
|
|
|
Shares
|
|
|
Price
|
|
|
Fair Value
|
|
|
Value
|
|
|
Life
|
|
Options at December 31, 2009
|
|
|
3,041,985
|
|
|
$
|
0.50
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeitures
|
|
|
(3,000
|
)
|
|
$
|
1.53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options at
March 31, 2010
|
|
|
3,038,985
|
|
|
$
|
0.50
|
|
|
|
|
|
|
$
|
1,711,362
|
|
|
|
3.96
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total unrecognized compensation cost for stock options as of March 31, 2010 was
$634,722. The aggregate intrinsic value in the table above is before income taxes, based
on the fair value of a share of the Companys common stock of $1.00 at March 31, 2010.
The aggregate intrinsic value of options outstanding and exercisable as of March 31, 2010
is $1,711,362.
12
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
The following discussion should be read in conjunction with the Condensed
Consolidated Financial Statements of Winston Pharmaceuticals, Inc., related Notes, and
other financial information included elsewhere in this report and in our Annual Report on
Form 10-K for the year ended December 31, 2009. Certain defined terms used herein have
the meaning ascribed to them in such financial statements.
This discussion contains forward-looking statements, within the meaning of Section
27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act
of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, including
statements regarding our expected financial position and business and financing plans.
These statements involve risks and uncertainties. Our actual results could differ
materially from the results described in or implied by these forward-looking statements
as a result of various factors. These forward looking statements and other information
are based on our beliefs as well as assumptions made by us using information currently
available.
The words anticipate, believe, estimate, expect, intend, will, should
and similar expressions, as they relate to us, are intended to identify forward-looking
statements. Such statements reflect our current views with respect to future events and
are subject to certain risks, uncertainties and assumptions. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as anticipated, believed,
estimated, expected, intended or using other similar expressions.
We are making investors aware that such forward-looking statements, because they
relate to future events, are by their very nature subject to many important factors that
could cause actual results to differ materially from those contemplated by the
forward-looking statements contained in this Quarterly Report on Form 10-Q. For example,
we may encounter competitive, technological, pharmacological, financial and business
challenges making it more difficult than expected to continue to develop and market our
products; the market may not accept our existing and future products; we may not be able
to retain our customers; we may be unable to retain existing key management personnel;
and there may be other material adverse changes in our operations or business. In
addition, assumptions relating to budgeting, marketing, product development and other
management decisions are subjective in many respects and thus susceptible to
interpretations and periodic revisions based on actual experience and business
developments, the impact of which may cause us to alter our marketing, expenditure or
other budgets, which may in turn affect our financial position and results of operations.
For all of these reasons, the reader is cautioned
not to place undue reliance on
forward-looking statements contained herein, which speak only as of the date hereof. We
assume no responsibility to update any forward-looking statements as a result of new
information, future events, or otherwise, except as required by law.
Executive Overview
On September 25, 2008, the Company, formerly known as Getting Ready Corporation
completed its merger transaction (the Merger) with Winston Labs, by merging a
wholly-owned subsidiary of Getting Ready Corporation into Winston Labs. Effective
November 17, 2008, Getting Ready Corporation changed its name to Winston Pharmaceuticals,
Inc. (hereafter referred to as we, us, our or the Company). The Company has
carried on the business of Winston Labs as its sole line of business and it has retained
all of Winston Labss management.
13
On August 14, 2007, Winston Labs entered into an exclusive technology license
agreement with Elorac, formerly known as Exopharma, Inc. Dr. Bernstein is a majority
owner and President and Chief Executive Officer of Elorac. Robert
Yolles, a director of the Company, is also a director of Elorac. Under the terms of the license agreement, Winston Labs
granted Elorac an exclusive license to the proprietary rights of certain products (
£
0.025% civamide with the stated indication of psoriasis of the skin). In
exchange, Elorac paid Winston Labs a license fee of $100,000 and is required to pay a 9%
royalty on sales of the product. In addition, the agreement required Elorac to pay
Winston Labs a non-refundable payment of $250,000 upon approval of a marketing
authorization by Elorac on the product(s) described in the agreement. On October 27, 2008
Winston Labs and Elorac mutually terminated the above license agreement. As a result of
this mutual termination, Winston Labs agreed to pay Elorac the $105,000 in exchange for
Winston Labs retaining all the proprietary rights under the original agreement. Since
inception, Elorac has been located in the same offices as Winston Labs and therefore has
shared in certain of Winston Labs expenses such as rent, utilities, internet usage, etc.
The amount of Eloracs share of such expenses is based on various allocation factors
related to particular expense. Winston Labs has received approximately $46,399 and
$25,169 for such services for the three month periods ended March 31, 2010 and 2009,
respectively, which are included as a reduction of the Winston Labss expenses on the
Consolidated Statements of Operations. Amounts due from Elorac of $40,188 and $2,106 as
of March 31, 2010 and December 31, 2009, respectively, are included in related party
receivables on the Companys Consolidated Balance Sheets. Subsequent to March 31, 2010,
Elorac paid the $40,188 balance.
On September 19, 2007, Winston Labs entered into an exclusive technology license
agreement with OPKO Ophthalmologics, LLC, (OPKO). Under the terms of the license
agreement, Winston Labs granted OPKO an exclusive license to the proprietary rights of
certain products (pharmaceutical compositions or preparations containing the active
ingredient civamide in formulations suitable for use in the therapeutic or preventative
treatment of ophthalmic conditions in humans). In exchange, OPKO paid Winston Labs a
license fee of $100,000 and would have been required to pay a 10% royalty on sales of the
products. In addition, under the terms of the agreement, OPKO and the Company agreed to
equally share the cost related to manufacturing and clinical supplies of Civamide Nasal
solution. For the three month period ending March 31, 2010 and 2009, respectively, OPKOs
share of these costs was $0 and $112,221. Under the terms of the agreement OPKO agreed to
reimburse Winston Labs for certain legal expenses Winston Labs has incurred related to
the use of the licensed products to treat keratoconjunctivitis. During the period ended
March 31, 2010, approximately $9,274 of legal fees were billed to OPKO, $6,577 of which
were outstanding as of March 31, 2010 and are included in related party receivables on
the Consolidated Balance Sheets at March 31, 2010. Subsequent to March 31, 2010, OPKO
paid the $6,577 balance.
Phillip Frost, M.D. is the Chairman and Chief Executive Officer of OPKOs parent
company, OPKO Health, Inc. (OPKO Health), and the sole trustee of Frost Gamma
Investments Trust. As of April 15, 2010, Dr. Frost was the beneficial owner of more than
48% of OPKO Healths common stock. As of March 31, 2010, Frost Gamma Investments Trust
was the beneficial owner of 26,574,659 shares (29.7%) of the Company, including 8,779,797
shares of common stock underlying warrants. Furthermore, Subbarao Uppaluri, Ph.D., the
Senior Vice President Chief Financial Officer of OPKO Health, is the beneficial owner
of 326,538 shares (0.3%) of the Company, including 27,500 shares of common stock
underlying options and 89,589 shares of common stock underlying warrants.
On February 24, 2010, the Company received communications from OPKO that it was
terminating the license agreement effective May 24, 2010. As a result, all of OPKOs
rights to certain products, as defined in the agreement, will revert back to the Company.
On October 29, 2008, Winston Labs filed a new drug submission (NDS) in Canada, for
CIVANEX
®
Cream (civamide cream 0.075%) for the treatment of signs and
symptoms of osteoarthritis, the first product Winston Labs has developed under its
transient receptor potential vanilloid (TRPV) channel technology. On October 30, 2008,
Winston Labs entered into a License Agreement (the License Agreement) with
sanofi-aventis Canada Inc. (sanofi-aventis Canada) pursuant to which Winston Labs
granted sanofi-aventis an exclusive license to the Canadian rights to Winston Labs
proprietary transient receptor potential vanilloid (TRPV-1) modulator in formulations for
topical application. Under the terms of the License Agreement, sanofi-aventis Canada owns
the rights to manufacture, develop and commercialize civamide cream in Canada along with
a second generation cream that is currently in development. In return for granting
sanofi-aventis Canada the Canadian rights to civamide cream, Winston Labs received an
upfront payment of $1.9 million (US), and will receive an additional milestone payment
upon regulatory approval of civamide cream in Canada (see page 15 for further details),
certain milestone payments, and future royalties on net sales of civamide or the related
second generation cream in Canada.
On December 15, 2008 the Company amended its Certificate of Incorporation to provide
for the reduction of the total number of issued and outstanding shares of the Companys
common stock, par value $.001 per share (Common Stock) and its preferred stock, par
value $.001 per share (Preferred Stock), by exchanging each eight (8) shares of such
issued and outstanding shares of Common Stock and Preferred Stock for one (1) share of
Common Stock or Preferred Stock, respectively.
14
Following a 1-for-8 reverse split of the Companys common and preferred stock on
December 15, 2008, 12,730 shares of its Series A Preferred Stock and 9,157 shares of its
Series B Preferred Stock were issued and outstanding. On September 24, 2009, each
outstanding share of Company Series A Preferred Stock and Series B Preferred Stock
automatically converted into 1,000 fully-paid, non-assessable shares of the Companys
Common Stock. In addition, in connection with such conversion, each outstanding warrant
to purchase shares of Series A Preferred Stock automatically converted into the right to
acquire 1,000 shares of Common Stock upon the exercise of such warrant, at an exercise
price of $0.39 per share of Common Stock.
Winston Labs submitted a Marketing Authorization Application (MAA) in Europe for
CIVANEX in January 2008. On July 10, 2009 the Company received a negative opinion letter
from the Swedish Medical Products Administration (MPA) as the Reference Member State on
behalf of the Concerned Member States, the United Kingdom and Spain on the Companys MAA
for CIVANEX in the decentralized procedure to obtain mutual recognition of CIVANEX by
such states. CIVANEX is an investigational therapy in development for the signs and
symptoms of, including the pain associated with, osteoarthritis. In its letter to the
Company, MPA cited lack of data relating to the full risk assessment of the carcinogenic
potential of CIVANEX. The Companys management disagrees with several of the conclusions
in the opinion letter and has filed an appeal of the negative opinion of the Swedish
review team with the MPA. On November 2, 2009, the Company filed a separate appeal of the
opinion with the Medicines and Healthcare products Regulatory Agency in the United
Kingdom. The Company believes that the current application containing safety and efficacy
data support the approval of CIVANEX for use under the proposed labeling. The Company is
currently considering whether to conduct another carcinogenesis study of CIVANEX.
In May 2009, the Company completed a Phase I pharmacokinetic and safety study of
oral civamide in an enteric coated soft gel capsule with no systemic absorption detected.
If the Company is able to raise sufficient funds, it intends to conduct a new study
designed to take advantage of this lack of systemic absorption in a proof of concept
study for the treatment of the inflammatory bowel disorder, Crohns Disease.
In
September, 2009, the Company completed Study WL-1001-04-03, a Phase II clinical trial
evaluating the efficacy and safety of Civamide Patch 0.015% in the treatment PHN.
Twenty-two patients with at least a 6 month history of PHN already on stable doses of
medication for PHN, but with recalcitrant pain of at least a 4 on a 0-10 categorical
scale during the week prior to enrollment, were enrolled in the study. Civamide Patch
0.015% was applied over a 4 week Treatment Period, for up to 24 hours daily. Daily Pain
and Sleep Scores were assessed as the primary efficacy variables. There was a 2 week
Post-Observation Treatment Period during which no patch was applied, but patients
continued to record efficacy and safety parameters. Results demonstrated that by Week 2
and continuing throughout the Treatment Period and Post Treatment Observation Period,
there was approximately up to a 40% improvement from Baseline in both Daily Pain Scores
and Sleep Scores.
On October 15, 2009, Winston Labs announced that it received a Notice of
Non-compliance (NON) from the Therapeutics Drug Directorate, Health Canada (the
Directorate) for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%)
for the treatment of the signs and symptoms of osteoarthritis. The Directorate remarked
that the analysis of the pivotal trial did not support the requested indication. Winston
Labs had a period of ninety days to submit a response to the Directorates NON, which it
did on January 29, 2010. In the event that Winston Labs is not able to obtain regulatory
approval in Canada by June 30, 2010, the sanofi-aventis payment due upon regulatory
approval will be reduced by $250,000 (CAD) to $1,750,000 (CAD).
On February 12, 2010, Pharmaceutical Financial Syndicate, LLC (PFS), whose members
include Dr. Joel Bernstein, the Companys President and Chief Executive Officer and
Robert A. Yolles and Neal S. Penneys, directors of the Company, executed a letter of
intent (LOI) with Frost Gamma Investments Trust, Subbarao Uppaluri, a director of the
company, and certain other shareholders of the Company (collectively, the Frost Group),
to acquire 100% of the Companys capital stock
(the Acquisition) beneficially owned by all of the members of the Frost Group
consisting of an aggregate of 18,399,271 outstanding shares of common stock and warrants
to purchase an aggregate of 8,958,975 shares of common stock (collectively, the Acquired
Securities).
15
As provided in the LOI, consummation of the Acquisition is subject to a number of
conditions, including the parties entering into a definitive acquisition agreement. The
LOI also provides that simultaneous with the completion of the Acquisition, three of the
Companys directors, namely Subbarao Uppaluri, Glenn Halpryn and Curtis Lockshin, shall
resign as directors of the Company, and each of Messrs. Uppaluri, Halpryn and Lockshin
have advised the Company that they have consented to resign upon completion of the
Acquisition. Upon completion of the Acquisition, as the manager of PFS, Dr. Bernstein
would be deemed to be the beneficial owner of all of the Acquired Securities, however Dr.
Bernstein intends to disclaim beneficial ownership of those Acquired Securities in which
he does not have a pecuniary interest through PFS.
Winston Labs does not currently market any products. In the past, Winston Labs
marketed certain products revenues from which were used to help fund its research
programs. Winston Labs is engaged in the development of innovative products for managing
and alleviating pain. After discontinuing the Zostrix
®
and Axsain
®
product lines, Winston Labs has devoted most of its resources to research
and development.
16
Results of Operations
For the three months ended March 31, 2010 compared to the three months ended March
31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
$ Change
|
|
|
% Change
|
|
REVENUES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
revenues
|
|
$
|
316,706
|
|
|
$
|
316,706
|
|
|
$
|
|
|
|
|
|
|
Royalty
revenues
|
|
|
|
|
|
|
23,280
|
|
|
|
(23,280
|
)
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
316,706
|
|
|
|
339,986
|
|
|
|
(23,280
|
)
|
|
|
(7
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
326,340
|
|
|
|
545,966
|
|
|
|
(219,626
|
)
|
|
|
(40
|
)%
|
General and administrative
|
|
|
449,765
|
|
|
|
580,309
|
|
|
|
(130,544
|
)
|
|
|
(22
|
)%
|
Depreciation and amortization
|
|
|
2,141
|
|
|
|
2,318
|
|
|
|
(177
|
)
|
|
|
(8
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
778,246
|
|
|
|
1,128,593
|
|
|
|
(350,347
|
)
|
|
|
(31
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(461,540
|
)
|
|
|
(788,607
|
)
|
|
|
327,067
|
|
|
|
(41
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
159
|
|
|
|
9,727
|
|
|
|
(9,568
|
)
|
|
|
(98
|
)%
|
Other income
|
|
|
690
|
|
|
|
96
|
|
|
|
594
|
|
|
|
619
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
|
849
|
|
|
|
9,823
|
|
|
|
(8,974
|
)
|
|
|
(91
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(460,691
|
)
|
|
|
(778,784
|
)
|
|
|
318,093
|
|
|
|
(41
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(460,691
|
)
|
|
$
|
(778,784
|
)
|
|
$
|
318,093
|
|
|
|
(41
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
Revenues from licenses remained the same at $316,706 for the three months ended
March 31, 2010 compared to the same period in 2009. The $316,706 license revenue in 2010
and in 2009 represents 3 months of revenue recognition related to a $1.9 million upfront
cash payment received by Winston Labs from sanofi-aventis Canada Inc. in accordance with
a license agreement entered into by Winston Labs in the fourth quarter of 2008.
Revenues from royalties declined to $0 for the three months ended March 31, 2010
compared to $23,280 for the same period in 2009. The $23,280 royalty revenue for the
three month period ending March 31, 2009 is comprised entirely of royalties earned from
Hi-Tech. On October 30, 2009, the Company received communication from Hi-Tech that it has
discontinued the sale of the product as defined in the license agreement. As a result,
the Company does not expect to receive any more royalties from Hi-Tech in the future.
17
Research & Development Expenses
Research and development expenses declined to $326,340 for the three months ended
March 31, 2010 compared to $545,966 for the same period in 2009. The decline was
primarily due to decreased spending on various European and Canadian filing fees and
other decreased spending on R&D projects as well as decrease in payroll due to reduction
of R&D staff.
General and Administrative Expenses
General and administrative expenses decreased to $449,765 for the three months ended
March 31, 2010 compared to $580,309 for the same period in 2009. The decrease is due
largely to decreased spending on legal and accounting fees as well as decrease in payroll
due to reduction of administrative staff.
Interest Income
Interest income decreased by $9,568 to $159 for the three month period ended March
31, 2010 from $9,727 for the same period in 2009 due to less cash on hand at March 31,
2010 compared to the same period in 2009.
Net Loss
Net loss was $460,691, or $(0.01) per share, for the three months ended March 31,
2010, compared to a net loss of $778,784, or $(0.01) per share for the same period in
2009. The decrease in net loss is primarily attributed to a decrease in operating
expenses totaling $.3 million, consisting of a decrease in research and development
totaling $.2 million and a decrease in general and administrative expenses totaling $.1
million.
Liquidity and Capital Resources
Since Winston Labss inception, it has financed its operations through the private
placement of equity securities and, to a lesser extent, through licensing revenues and
product sales. Through March 31, 2010, Winston Labs has raised approximately $54 million
from the private placement of Winston Labs and Rodlen common shares.
While the focus going forward is to improve our financial performance, we expect
operating losses and negative cash flow to continue for the foreseeable future and, as
described below we will need to raise additional capital to fund these losses. We
anticipate that our losses may increase from current levels because we expect to incur
significant costs and expenses related to being a public company, continuing our research
and development activities, filing with regulatory agencies (e.g. FDA) as well as
developing new compounds and products, advertising, marketing and promotional activities,
all of which will involve employing additional personnel as our business expands. Our
ability to become profitable depends on our ability to develop products and to generate
and sustain substantial revenue related to those products through new license and
distribution agreements while maintaining reasonable expense levels.
The bulk of our expenditures are for operating activities. Our net cash used in
operating activities was $3.1 million for the year ended December 31, 2008, $4.2 million
for the year ended December 31, 2009 and $0.9 million for the three months ended March
31, 2010. These amounts were used to fund our operating losses for the periods, adjusted
for non-cash expenses and changes in operating assets and liabilities.
On November 13, 2007, Winston issued 5,815,851 shares of Winston Series A Preferred
Stock and warrants to purchase 4,092,636 shares of Winston Labs Series A Preferred Stock
in a private placement for an aggregate purchase price of $5.1 million. Immediately prior
to consummation of the Merger, Winston Labs issued 4,187,413 shares of Winston Labs
Series B Preferred Stock in a private placement for an aggregate purchase price of $4.0
million. All of the Winston Labs shares and warrants issued in these transactions were
exchanged for shares of the Companys Series A and B Preferred Stock and warrants to
purchase the Companys Series A Preferred Stock upon consummation of the Merger.
On October 30, 2008, Winston Labs and sanofi-aventis Canada Inc. entered into a
licensing agreement for the Canadian rights to Winston Labss transient receptor
potential vanilloid (TRPV-1) modulator in formulations for topical application. Under the
terms of the agreement, sanofi-aventis Canada Inc. owns the rights to develop,
manufacture and commercialize civamide cream in Canada along with a second generation
cream that is currently in development. In return for granting sanofi-aventis Canada Inc.
the Canadian rights, Winston Labs received an upfront payment of $1.9 million (US) and
will receive an additional $2 million (CAD) upon regulatory approval of civamide cream in
Canada, certain milestone payments and future royalties on net sales of civamide or the
related second generation cream in Canada. In connection with this agreement, Winston
Labs is recognizing the upfront payment of $1.9 million over 18 months. As such,
approximately $316,000 has been recognized as revenue for the three month periods ended
March 31, 2010 and March 31, 2009, respectively.
On October 15, 2009, Winston Labs announced that it received a Notice of
Non-compliance (NON) from the Therapeutics Drug Directorate, Health Canada (the
Directorate) for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%)
for the treatment of the signs and symptoms of osteoarthritis. The Directorate remarked
that the analysis of the pivotal trial did not support the requested indication. Winston
Labs had a period of ninety days to submit a response to the Directorates
NON, which it did on January 29, 2010. In the event that the Company is not be able
to obtain regulatory approval in Canada by June 30, 2010, the sanofi-aventis payment due
upon regulatory approval will be reduced by $250,000 (CAD) to $1,750,000 (CAD).
18
The Company has incurred significant losses from operations since its inception and
expects losses to continue for the foreseeable future. The Companys success depends
primarily on the development and regulatory approval of its product candidates. From
inception through March 31, 2010, the Company has incurred cumulative net losses of $49.8
million. Net losses may continue for at least the next several years as the Company
proceeds with the development of its product candidates and programs. The size of these
losses will depend on the receipt of revenue from its products candidates and programs,
if any, and on the level of the Companys expenses. To achieve profitable operations, the
Company must successfully identify, develop, partner and/or commercialize its product
candidates and programs. Product candidates developed by the Company will require
approval of the U.S. Food and Drug Administration (FDA) or a foreign regulatory authority
prior to commercial sales. The regulatory approval process is expensive, time consuming
and uncertain, and any denial or delay of approval could have a material adverse effect
on the Companys ability to become profitable or continue operations. Even if approved,
the Companys product candidates may not achieve market acceptance and could face
competition.
The Companys cash has decreased from $1.6 million as of
December 31, 2009 to $0.7 million as of March 31,
2010. The Company believes that its existing cash will be sufficient to fund its activities through the end of June,
2010. The Company seeks additional sources of financing through collaborations with
third parties, or public or private debt or equity financings. There can be no assurance
that additional funds will be available on satisfactory terms, or at all. If the Company
is unsuccessful in its efforts to raise additional outside capital in the near term, it
will be required to significantly reduce its research, development, and administrative
operations, including further reduction of its employee base, or it may be required to
cease operations completely, or liquidate in order to offset the lack of available
funding.
Contractual Obligations
We lease our facilities on a month-to-month basis and certain equipment under
operating leases that expire through 2013 and require monthly payments of $1,166.
Rental expense for the three months ended March 31, 2010 and 2009 was $16,510 and
$22,078, respectively.
We enter into contracts in the normal course of business with clinical research
organizations and clinical investigators, for third party manufacturing and formulation
development. These contracts generally provide for termination with notice, and
therefore, our management believes that our non-cancelable obligations under these
agreements are not material.
19
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, with the exception of the above
noted operating leases.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as such term is defined in Rule 12b-2 of the
Exchange Act and are exempt from making the disclosures required by this item pursuant to
paragraph (e) of Item 305 of Regulation S-K.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
. Our management, with the participation of our
chief executive officer and chief financial officer, has evaluated the effectiveness of
our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act) as of the end of the period covered by this report.
Based on such evaluation, our chief executive officer and chief financial officer have
concluded that, as of the end of such period, our disclosure controls and procedures are
effective in recording, processing, summarizing and reporting, on a timely basis,
information required to be disclosed by us in the reports that we file or submit under
the Exchange Act, including, without limitation, controls and procedures designed to
ensure that information required to be disclosed by us in the reports that we file or
submit under the Exchange Act is accumulated and communicated to our management,
including our chief executive officer and chief financial officer, to allow timely
decisions regarding required disclosure.
Internal Control Over Financial Reporting
. There have not been any changes in our
internal control over financial reporting (as such term is defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) during the fiscal quarter to which this report relates
that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
20
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
We are not a party to any legal proceedings, other than ordinary routine litigation
incidental to our business, which we believe will not have a material effect on our
financial position, results of operations, or cash flows.
Item 1A. Risk Factors
We are a smaller reporting company as such term is defined in Rule 12b-2 of the
Exchange Act and are exempt from making the disclosures required by this item pursuant to
the instructions to Item 1A to Part II of Form 10-Q.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Removed and Reserved
Item 5. Other Information
None.
Item 6. Exhibits
|
|
|
Exhibit No.
|
|
|
|
|
|
10.1
|
|
Letter of Intent Between Pharmaceutical Financial
Syndicate, LLC, Frost Gamma Investments Trust, Subbarao
Uppaluri, Steven D. Rubin and Jane Hsiao, Ph.D. (filed
as Exhibit 10.1 to the Companys Current Report on Form
8-K dated February 12, 2010 and incorporated herein by
reference).
|
|
|
|
31.1
|
|
Certification of the President and Chief Executive
Officer of Winston Pharmaceuticals, Inc., Joel E.
Bernstein, M.D., pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of the Vice President and Chief Financial
Officer of Winston Pharmaceuticals, Inc., David Starr,
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
|
|
|
32.1
|
|
Certification of the President and Chief Executive
Officer of Winston Pharmaceuticals, Inc., Joel E.
Bernstein, M.D., and the Vice President and Chief
Financial Officer of Winston Pharmaceuticals, Inc.,
David Starr, pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
21
SIGNATURES
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.
|
|
|
|
|
|
WINSTON PHARMACEUTICALS, INC.
(Registrant)
|
|
Dated: May 13, 2010
|
By:
|
/s/ Joel E. Bernstein
|
|
|
|
Joel E. Bernstein, M.D.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
Dated: May 13, 2010
|
By:
|
/s/ David Starr
|
|
|
|
David Starr
|
|
|
|
Vice President, Chief Financial Officer
|
|
22
EXHIBIT INDEX
|
|
|
Exhibit
|
|
|
No.
|
|
Description
|
|
|
|
10.1
|
|
Letter of Intent Between Pharmaceutical Financial
Syndicate, LLC, Frost Gamma Investments Trust, Subbarao
Uppaluri, Steven D. Rubin and Jane Hsiao, Ph.D. (filed as
Exhibit 10.1 to the Companys Current Report on Form 8-K
dated February 12, 2010 and incorporated herein by
reference).
|
|
|
|
31.1
|
|
Certification of the President and Chief Executive Officer
of Winston Pharmaceuticals, Inc., Joel E. Bernstein, M.D.,
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of the Vice President and Chief Financial
Officer of Winston Pharmaceuticals, Inc., David Starr,
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification of the President and Chief Executive Officer
of Winston Pharmaceuticals, Inc., Joel E. Bernstein, M.D.,
and the Vice President and Chief Financial Officer of
Winston Pharmaceuticals, Inc., David Starr, pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.
|
23
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