2011 Form 8-K Financial Statement

#000104746913000481 Filed on January 28, 2013

View on sec.gov

Income Statement

Concept 2011 2010 Q4 2010 Q3
Revenue $435.2K $143.0K $51.33K
YoY Change -82.41% -86.63% 413.31%
Cost Of Revenue $100.0K $0.00 $0.00
YoY Change -66.67% -100.0%
Gross Profit $400.0K $140.0K $50.00K
YoY Change -81.82% -81.82% 400.0%
Gross Profit Margin 91.92% 97.88% 97.41%
Selling, General & Admin $7.000M $1.370M $1.530M
YoY Change 18.64% -15.95% 1.32%
% of Gross Profit 1750.0% 978.57% 3060.0%
Research & Development $44.18M $11.90M $9.716M
YoY Change 11.27% 218.31% 188.31%
% of Gross Profit 11045.57% 8503.53% 19432.18%
Depreciation & Amortization $148.2K $40.00K $41.00K
YoY Change -11.75% 0.0% 2.5%
% of Gross Profit 37.06% 28.57% 82.0%
Operating Expenses $44.18M $11.90M $9.716M
YoY Change 11.27% -53.5% 97.88%
Operating Profit -$43.78M -$13.17M -$11.24M
YoY Change 16.74% -46.97% 129.39%
Interest Expense $681.6K -$350.0K $172.0K
YoY Change -0.95% 191.67%
% of Operating Profit
Other Income/Expense, Net $240.0K $0.00
YoY Change
Pretax Income -$51.61M -$13.27M -$11.59M
YoY Change 11.72% -59.16% 81.95%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$51.60M -$13.27M -$11.59M
YoY Change 11.69% -59.16% 81.95%
Net Earnings / Revenue -11857.71% -9277.64% -22578.95%
Basic Earnings Per Share -$3.15
Diluted Earnings Per Share -$3.15 -$6.668M -$5.854M
COMMON SHARES
Basic Shares Outstanding 16.40M shares 71.19M shares
Diluted Shares Outstanding 16.40M shares

Balance Sheet

Concept 2011 2010 Q4 2010 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $57.20M $38.20M $35.50M
YoY Change 49.74% 27.76% 168.94%
Cash & Equivalents $57.20M $38.16M $35.53M
Short-Term Investments
Other Short-Term Assets $800.0K $2.500M $1.200M
YoY Change -68.0% 66.67% 20.0%
Inventory
Prepaid Expenses
Receivables $0.00 $0.00
Other Receivables $0.00 $0.00
Total Short-Term Assets $58.00M $40.63M $36.70M
YoY Change 42.86% 29.38% 158.45%
LONG-TERM ASSETS
Property, Plant & Equipment $900.0K $635.8K $600.0K
YoY Change 50.0% -9.17% -14.29%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $3.400M $3.400M $3.300M
YoY Change 0.0% -5.56% 3200.0%
Other Assets $100.0K $100.0K $100.0K
YoY Change 0.0% -85.71% -88.89%
Total Long-Term Assets $4.400M $4.142M $4.100M
YoY Change 4.76% -17.17% 127.78%
TOTAL ASSETS
Total Short-Term Assets $58.00M $40.63M $36.70M
Total Long-Term Assets $4.400M $4.142M $4.100M
Total Assets $62.40M $44.77M $40.80M
YoY Change 39.29% 22.99% 155.0%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.200M $4.864M $4.500M
YoY Change -34.69% 102.68% 28.57%
Accrued Expenses $4.100M $2.200M $2.600M
YoY Change 86.36% 46.67% 116.67%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00 $1.100M
YoY Change -100.0%
Total Short-Term Liabilities $7.200M $8.183M $7.100M
YoY Change -12.2% 109.83% 47.92%
LONG-TERM LIABILITIES
Long-Term Debt $17.30M $17.40M $18.40M
YoY Change -0.57% 4.19%
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $17.30M $17.40M $18.40M
YoY Change -0.57% 4.19%
TOTAL LIABILITIES
Total Short-Term Liabilities $7.200M $8.183M $7.100M
Total Long-Term Liabilities $17.30M $17.40M $18.40M
Total Liabilities $24.60M $25.62M $25.50M
YoY Change -3.91% 24.37% 431.25%
SHAREHOLDERS EQUITY
Retained Earnings -$165.6M
YoY Change
Common Stock
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $37.80M $19.15M $15.30M
YoY Change
Total Liabilities & Shareholders Equity $62.40M $44.77M $40.80M
YoY Change 39.29% 22.99% 155.0%

Cashflow Statement

Concept 2011 2010 Q4 2010 Q3
OPERATING ACTIVITIES
Net Income -$51.60M -$13.27M -$11.59M
YoY Change 11.69% -59.16% 81.95%
Depreciation, Depletion And Amortization $148.2K $40.00K $41.00K
YoY Change -11.75% 0.0% 2.5%
Cash From Operating Activities -$47.87M -$14.21M -$10.85M
YoY Change 19.38% 131.43% 191.67%
INVESTING ACTIVITIES
Capital Expenditures $719.9K -$30.00K -$10.00K
YoY Change 1034.79% 50.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00 $0.00
YoY Change
Cash From Investing Activities -$720.0K -$30.00K -$10.00K
YoY Change 1100.0% 200.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $23.88M
YoY Change -50.72%
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 67.66M 16.86M 0.000
YoY Change 39.65% -26.18% -100.0%
NET CHANGE
Cash From Operating Activities -47.87M -14.21M -10.85M
Cash From Investing Activities -720.0K -30.00K -10.00K
Cash From Financing Activities 67.66M 16.86M 0.000
Net Change In Cash 19.07M 2.620M -10.86M
YoY Change 130.04% -84.3% -251.04%
FREE CASH FLOW
Cash From Operating Activities -$47.87M -$14.21M -$10.85M
Capital Expenditures $719.9K -$30.00K -$10.00K
Free Cash Flow -$48.59M -$14.18M -$10.84M
YoY Change 20.98% 131.7% 191.4%

Facts In Submission

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<p style="FONT-FAMILY: times"><font size="2"><b>1. DESCRIPTION OF BUSINESS</b></font></p> <p style="FONT-FAMILY: times"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;BioSante Pharmaceuticals,&#160;Inc. (the Company) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. The Company's products, either approved or in human clinical development, include: (1)&#160;LibiGel, once daily transdermal testosterone gel in Phase&#160;III clinical 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;GVAX cancer vaccines, a portfolio of cancer vaccines, four of which have been granted FDA orphan drug designation, and are currently in 17 Phase&#160;I and Phase&#160;II clinical trials for the treatment of various cancers; (4)&#160;The Pill-Plus (triple component contraceptive), once daily use of various combinations of estrogens, progestogens and androgens in Phase&#160;II development; and (5)&#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 Jazz Pharmaceuticals,&#160;Inc. (Jazz Pharmaceuticals), our licensee.</font></p> <p style="FONT-FAMILY: times"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The Company's lead product in development has been LibiGel for the treatment of FSD, specifically HSDD, in postmenopausal women, for which there is no FDA-approved pharmaceutical product. The Company continues to analyze the data from the two pivotal LibiGel Phase&#160;III efficacy trials first reported on December&#160;14, 2011. Initial analysis of the efficacy data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences from placebo, results indicated that LibiGel performed as predicted based on previous experience with testosterone products for FSD. However, the placebo response in the two efficacy trials was overwhelming and unpredictable; and therefore, LibiGel's results were not shown to be statistically different from placebo. The LibiGel Phase&#160;III safety study, which completed enrollment in June 2011, continues and will continue during further analysis of the LibiGel efficacy data and until a final strategic decision has been made. It is the Company's objective to meet with the FDA to determine the best path forward, and to make a decision during the second quarter of 2012 whether to continue the LibiGel Phase&#160;III safety study.</font></p> <p style="FONT-FAMILY: times"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The Company's corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of recently announced top-line results from the Company's two pivotal LibiGel Phase&#160;III efficacy trials, the Company is assessing its corporate strategy. The Company is determining LibiGel's path forward and potential alternative strategies to utilize the continuing LibiGel Phase&#160;III cardiovascular events and breast cancer safety study. The Company also has expanded its efforts to explore new product development projects through in-licensing and mergers and acquisitions. In addition, a full review of the Company's GVAX cancer vaccine portfolio is underway.</font></p> <p style="FONT-FAMILY: times"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;On January&#160;31, 2012, the Company received a notice from the Listing Qualifications Department of The NASDAQ Stock Market indicating that, for the last 30 consecutive business days, the bid price for the Company's common stock had closed below the minimum $1.00 per share required for continued inclusion on The NASDAQ Global Market under NASDAQ Listing Rule&#160;5450(a)(1). The notification letter stated that pursuant to NASDAQ Listing Rule&#160;5810(c)(3)(A), the Company will be afforded 180 calendar days, or until July&#160;30, 2012, to regain compliance with the minimum bid price requirement. In order to regain compliance, shares of the Company's common stock must maintain a minimum bid closing price of at least $1.00 per share for a minimum of 10 consecutive business days. If the Company does not regain compliance by July&#160;30, 2012, the Company may transfer its common stock listing to The NASDAQ Capital Market and be eligible for an additional 180-day grace period if the Company meets the market value of publicly held shares requirement for continued listing and all other initial inclusion requirements for listing on The NASDAQ Capital Market, other than the minimum bid price requirement. In order to be afforded the additional 180-day compliance period, the Company also would need to provide NASDAQ written notice of its intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company does not indicate its intent to cure the deficiency or if it does not appear to NASDAQ that it is possible for the Company to cure the deficiency, the Company will not be eligible for the second 180-day grace period and its common stock will be subject to delisting, which delisting determination the Company may appeal to a hearings panel at that time.</font></p>
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