2012 Q4 Form 10-K Financial Statement

#000110465913016148 Filed on February 28, 2013

View on sec.gov

Income Statement

Concept 2012 Q4 2012 Q3 2012 Q2
Revenue $1.968M $5.036M $5.187M
YoY Change 1620.31% 2655.18% 6303.21%
Cost Of Revenue $2.322M $2.119M
YoY Change
Gross Profit $2.714M $3.068M
YoY Change
Gross Profit Margin 53.9% 59.15%
Selling, General & Admin $4.190M $1.257M $914.0K
YoY Change 143.6% -25.19% -54.07%
% of Gross Profit 46.3% 29.79%
Research & Development $2.515M $148.7K $209.9K
YoY Change -62.48% -98.71% -98.11%
% of Gross Profit 5.48% 6.84%
Depreciation & Amortization $480.0K $144.0K $140.6K
YoY Change 1500.0% 303.59% 251.6%
% of Gross Profit 5.3% 4.58%
Operating Expenses $2.515M $1.405M $1.124M
YoY Change -62.48% -87.78% -89.89%
Operating Profit -$3.635M -$207.4K $586.4K
YoY Change -56.42% -98.41% -104.49%
Interest Expense $81.23K $501.0K
YoY Change -52.78% -126.09%
% of Operating Profit 85.43%
Other Income/Expense, Net -$91.21K -$50.00K
YoY Change -600.0%
Pretax Income $22.24M -$379.8K $35.42K
YoY Change -434.44% -97.02% -100.24%
Income Tax $90.00K $866.00 $0.00
% Of Pretax Income 0.4% 0.0%
Net Earnings $22.22M -$377.3K $35.42K
YoY Change -434.14% -97.04% -100.24%
Net Earnings / Revenue 1129.31% -7.49% 0.68%
Basic Earnings Per Share
Diluted Earnings Per Share -$1.602M -$2.178M
COMMON SHARES
Basic Shares Outstanding 22.92M shares
Diluted Shares Outstanding 22.92M shares

Balance Sheet

Concept 2012 Q4 2012 Q3 2012 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $0.00 $38.00M $42.40M
YoY Change -100.0% -45.4% 14.29%
Cash & Equivalents $11.00K $148.3K $119.6K
Short-Term Investments
Other Short-Term Assets $300.0K $500.0K $500.0K
YoY Change -62.5% -44.44% -50.0%
Inventory $2.810M
Prepaid Expenses $313.0K
Receivables $5.432M
Other Receivables $0.00
Total Short-Term Assets $8.566M $38.58M $42.90M
YoY Change -85.24% -45.27% 12.6%
LONG-TERM ASSETS
Property, Plant & Equipment $4.880M $1.185M $900.0K
YoY Change 466.54% 31.64% -18.18%
Goodwill $0.00
YoY Change
Intangibles $85.00K
YoY Change
Long-Term Investments $3.400M $3.400M
YoY Change 0.0% 0.0%
Other Assets $302.3K $0.00 $100.0K
YoY Change 202.29% -100.0% 0.0%
Total Long-Term Assets $5.182M $4.629M $4.400M
YoY Change 19.03% 5.2% -6.38%
TOTAL ASSETS
Total Short-Term Assets $8.566M $38.58M $42.90M
Total Long-Term Assets $5.182M $4.629M $4.400M
Total Assets $13.75M $43.21M $47.30M
YoY Change -77.96% -42.31% 10.51%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.994M $2.005M $3.800M
YoY Change -36.71% -66.59% -39.68%
Accrued Expenses $927.0K $1.300M $2.100M
YoY Change -77.39% -69.05% -46.15%
Deferred Revenue
YoY Change
Short-Term Debt $4.100M $0.00 $0.00
YoY Change
Long-Term Debt Due $7.600M $10.50M
YoY Change 533.33% 775.0%
Total Short-Term Liabilities $7.712M $10.92M $16.40M
YoY Change 6.7% -5.03% 42.61%
LONG-TERM LIABILITIES
Long-Term Debt $48.80M $0.00 $0.00
YoY Change 182.08% -100.0% -100.0%
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $48.80M $0.00 $0.00
YoY Change 182.08% -100.0% -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $7.712M $10.92M $16.40M
Total Long-Term Liabilities $48.80M $0.00 $0.00
Total Liabilities $10.59M $10.92M $16.40M
YoY Change -56.87% -64.42% -47.44%
SHAREHOLDERS EQUITY
Retained Earnings -$43.80M -$241.0M
YoY Change -79.84% 14.43%
Common Stock
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost) $0.00
YoY Change
Treasury Stock Shares
Shareholders Equity -$42.72M $32.30M $30.90M
YoY Change
Total Liabilities & Shareholders Equity $13.75M $43.21M $47.30M
YoY Change -77.96% -42.31% 10.51%

Cashflow Statement

Concept 2012 Q4 2012 Q3 2012 Q2
OPERATING ACTIVITIES
Net Income $22.22M -$377.3K $35.42K
YoY Change -434.14% -97.04% -100.24%
Depreciation, Depletion And Amortization $480.0K $144.0K $140.6K
YoY Change 1500.0% 303.59% 251.6%
Cash From Operating Activities $21.98M -$7.380M -$7.050M
YoY Change -301.1% -41.34% -49.24%
INVESTING ACTIVITIES
Capital Expenditures $240.0K -$470.0K -$10.00K
YoY Change -442.86% 327.27% -96.88%
Acquisitions
YoY Change
Other Investing Activities $10.00K $0.00 $0.00
YoY Change
Cash From Investing Activities $250.0K -$470.0K -$10.00K
YoY Change -457.14% 327.27% -96.88%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -3.040M 3.480M 0.000
YoY Change 120.29% -92.29% -100.0%
NET CHANGE
Cash From Operating Activities 21.98M -7.380M -7.050M
Cash From Investing Activities 250.0K -470.0K -10.00K
Cash From Financing Activities -3.040M 3.480M 0.000
Net Change In Cash 19.19M -4.370M -7.060M
YoY Change -255.01% -113.46% -50.35%
FREE CASH FLOW
Cash From Operating Activities $21.98M -$7.380M -$7.050M
Capital Expenditures $240.0K -$470.0K -$10.00K
Free Cash Flow $21.74M -$6.910M -$7.040M
YoY Change -300.18% -44.59% -48.12%

Facts In Submission

Frame Concept Type Concept / XBRL Key Value Unit
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CY2012 us-gaap Nature Of Operations
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<div style='font-size:10.0pt;FONT-FAMILY: Times New Roman;'> <p style="MARGIN: 0in 0in 0pt 36.4pt; TEXT-INDENT: -29.9pt"><b><font style="FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">1.</font></b><b><font style="FONT-WEIGHT: bold; FONT-SIZE: 3pt" size="1">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</font></b> <b><font style="FONT-WEIGHT: bold; FONT-SIZE: 10pt" size="2">DESCRIPTION OF BUSINESS</font></b></p> <p style="MARGIN: 0in 0in 0pt 36.4pt; TEXT-INDENT: -29.9pt"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">&#160;</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">BioSante Pharmaceuticals,&#160;Inc. (the Company) is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism.&#160; The Company&#8217;s products, either approved or in human clinical development, include: (1)&#160;LibiGel, once daily transdermal testosterone gel in Phase III development for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD); (2)&#160;a once daily transdermal testosterone gel approved by the U.S. Food and Drug Administration (FDA) indicated for the treatment of hypogonadism, or testosterone deficiency in men, and licensed to Teva Pharmaceuticals USA,&#160;Inc. (Teva); (3)&#160;The Pill-Plus (triple component contraceptive), once daily use of various combinations of estrogens, progestogens and androgens in Phase II development; and (4)&#160;Elestrin, once daily transdermal estradiol (estrogen) gel approved by the FDA indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause and marketed in the U.S. by Meda, the Company&#8217;s licensee.</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">&#160;</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">The Company&#8217;s lead product in development is LibiGel for the treatment of FSD, specifically HSDD, in postmenopausal women, for which there is no FDA-approved pharmaceutical product.&#160; For the past several years, the Company focused its efforts on two Phase III LibiGel efficacy trials and a LibiGel Phase III cardiovascular and breast cancer safety study.&#160; In December&#160;2011, the Company announced results from its two Phase III LibiGel efficacy trials, which showed that the trials did not meet the co-primary or secondary endpoints.&#160; Although LibiGel performed as predicted, increasing satisfying sexual events and sexual desire and decreasing distress associated with low desire, the placebo response in the two efficacy trials was greater than expected, and LibiGel&#8217;s results were not shown to be statistically different from the placebo.</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">&#160;</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">Beginning in December&#160;2011, the Company analyzed the data from its Phase III LibiGel efficacy trials, consulted with key opinion leaders in female sexual dysfunction, testosterone therapy and placebo effects, and met with representatives of the FDA.&#160; As a result of this process, in June&#160;2012 the Company announced a plan to initiate two new LibiGel Phase III efficacy trials.&#160; The Company subsequently began the process of developing a protocol for the two new efficacy trials and applying for an FDA Special Protocol Assessment (SPA) agreement covering aspects of the two new efficacy trials.</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">&#160;</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">In September&#160;2012, the Company announced that the independent Data Monitoring Committee (DMC) completed its ninth unblinded review of the LibiGel Phase III cardiovascular events and breast cancer safety study and recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. At the time of the DMC review, there were 53 adjudicated cardiovascular events, with a lower than anticipated event rate of approximately 0.72 percent. In the same population of subjects, there were 27 breast cancers reported, a rate of approximately 0.37 percent, which is in line with the expected rate based on the ages of the subjects enrolled in the study. Given this latest review during which no specific or general safety issues were raised, and after extensive consideration, the Company also announced in September&#160;2012 the conclusion of the LibiGel Phase III safety study effective immediately. Prior to the initiation of the LibiGel safety study in 2008, the FDA advised the Company that subjects in the cardiovascular event and breast cancer safety study were required to have a minimum average exposure in the safety study of 12 months prior to submitting a LibiGel new drug application (NDA), and prior to a potential FDA approval of LibiGel. As of the date of the conclusion of the safety study, subjects had been in the study for an average time of 24.5 months; more than 3,200 subjects had been in the study for more than one year and over 1,700 subjects had been enrolled for more than two years. With this ninth positive unblinded review of the study by the DMC, and over 7,400 women-years of exposure, the Company believes that adequate safety data of LibiGel use in menopausal women has been obtained.</font></p> <p style="MARGIN: 0in 0in 0pt"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">&#160;</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">The Company is continuing to develop a protocol for the two new LibiGel efficacy trials and intends to seek an FDA SPA agreement covering aspects of the two new efficacy trials.</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">&#160;</font></p> <p style="MARGIN: 0in 0in 0pt 0.5in"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" size="2">On October&#160;3, 2012, the Company entered into an agreement and plan of merger (the Merger Agreement) with ANIP Acquisition Company d/b/a ANI Pharmaceuticals,&#160;Inc. (ANI).&#160; The Merger Agreement provides that, subject to the terms and conditions set forth in the Merger Agreement, ANI will merge with and into the Company, with the Company continuing as the surviving company (the Merger).&#160; Following completion of the Merger, the current stockholders of ANI are expected to own approximately 53 percent of the outstanding shares of common stock of the combined company, and current stockholders of the Company are expected to own approximately 47 percent of the outstanding shares of common stock of the combined company, assuming the Company&#8217;s &#8220;net cash&#8221; as defined in the Merger Agreement and generally consisting of the Company&#8217;s cash and cash equivalents less certain expenses and liabilities, as of a determination date prior to the closing date of the Merger, is $18.0 million.&#160; The exchange ratios in the Merger are subject to potential adjustment as described in the Merger Agreement depending upon the amount of the Company&#8217;s net cash as of a determination date prior to the closing date of the Merger, but in no event will the current ANI stockholders own less than 50.1 percent (or the current Company stockholders own more than 49.9 percent) of the outstanding shares of common stock of the combined company.&#160; The pending Merger with ANI is more fully described in Note 3, &#8220;Pending Merger with ANI.&#8221;</font></p></div>
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CY2012 dei Entity Voluntary Filers
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CY2012Q3 bpax Number Of Breast Cancers Reported In Sampling Population Under Data Monitoring Committee Review
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CY2012Q3 bpax Breast Cancer Rate Reported In Sampling Population Under Data Monitoring Committee Review
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CY2012Q3 bpax Period Of Average Exposure In Safety Study Prior To Submission Of Nda And Potential Fda Approval
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CY2012Q3 bpax Average Time For Which Subjects Has Been In Study
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CY2012 bpax Term Of Arrangement From Date Of First Commercial Sale Of Product By Counterparty To Unrelated Party On Arms Length Price
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9 item
CY2011 bpax Stock Issued During Period Common Shares And Warrants
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CY2010 bpax Stock Issued During Period Common Shares And Warrants
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CY2012 us-gaap Research And Development Asset Acquired Other Than Through Business Combination Written Off
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