10-K 1 a12-30248_110k.htm 10-K

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-K

 

(Mark one)

 

x      ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2012

 

o         TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                  to                  .

 

Commission file number 001-31812

 


 

BIOSANTE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

58-2301143

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

 

 

111 Barclay Boulevard

 

 

Lincolnshire, Illinois

 

60069

(Address of principal executive offices)

 

(Zip Code)

 

(847) 478-0500

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

The NASDAQ Stock Market

 

Securities registered pursuant to Section 12(g) of the Act:
None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  YES o   NO x

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  YES o NO x

 

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 x   NO o

 

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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  YES x   NO o

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x

 

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 definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.  (Check one):

 

Large accelerated filer o

 

Accelerated filer x

 

 

 

Non-accelerated filer o
(Do not check if a smaller reporting company)

 

Smaller reporting company o

 

Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Act). YES o   NO x

 

The aggregate market value of the registrant’s common stock, excluding shares beneficially owned by affiliates, computed by reference to the closing sale price at which the common stock was last sold as of June 30, 2012 (the last business day of the registrant’s second fiscal quarter) as reported by The NASDAQ Global Market on that date was approximately $50.1 million.

 

As of February 28, 2013, 24,422,240 shares of common stock of the registrant were outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

None.

 

 

 



Table of Contents

 

TABLE OF CONTENTS

 


 

 

 

Page

 

 

 

PART I

 

1

 

 

 

ITEM 1.

BUSINESS

1

 

 

 

ITEM 1A.

RISK FACTORS

19

 

 

 

ITEM 1B.

UNRESOLVED STAFF COMMENTS

54

 

 

 

ITEM 2.

PROPERTIES

54

 

 

 

ITEM 3.

LEGAL PROCEEDINGS

54

 

 

 

ITEM 4.

MINE SAFETY DISCLOSURES

55

 

 

 

PART II

 

56

 

 

 

ITEM 5.

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

56

 

 

 

ITEM 6.

SELECTED FINANCIAL DATA

58

 

 

 

ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

59

 

 

 

ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

74

 

 

 

ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

75

 

 

 

ITEM 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

107

 

 

 

ITEM 9A.

CONTROLS AND PROCEDURES

107

 

 

 

ITEM 9B.

OTHER INFORMATION

107

 

 

 

PART III

 

109

 

 

 

ITEM 10.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

109

 

 

 

ITEM 11.

EXECUTIVE COMPENSATION

119

 

 

 

ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

148

 

 

 

ITEM 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

151

 

 

 

ITEM 14.

PRINCIPAL ACCOUNTING FEES AND SERVICES

153

 

 

 

PART IV

 

154

 

 

 

ITEM 15.

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

154

 

 

 

EXHIBIT INDEX TO ANNUAL REPORT ON FORM 10-K

157

 

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This annual report on Form 10-K contains or incorporates by reference forward-looking statements.  For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements.  You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “believe,” “may,” “could,” “would,” “might,” “possible,” “potential,” “project,” “will,” “should,” “expect,” “intend,” “plan,” “predict,” “anticipate,” “estimate,” “approximate,” “contemplate” and “continue”, the negative of these words, other words and terms of similar meaning and the use of future dates.  In evaluating these forward-looking statements, you should consider various factors, including those listed in this report under the headings “Part I.  Item I. Business — Forward-Looking Statements” and “Part I.  Item 1A. Risk Factors.”  These factors may cause BioSante’s actual results to differ materially from any forward-looking statement.  BioSante assume no obligation to update forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements.

 

As used in this report, references to “BioSante,” the “company,” “we,” “BioSante’s” or “us,” unless the context otherwise requires, refer to BioSante Pharmaceuticals, Inc.  References to “ANI” in this report refer to ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc.  References to the “merger agreement” refer to that certain agreement and plan of merger dated as of October 3, 2012 between BioSante and ANI, as amended from time to time.  References to the “combined company” refer to BioSante, as the surviving entity after the merger and incorporating the merged business of ANI.

 

Except as otherwise noted, references to “BioSante common stock” refer to shares of common stock, par value $0.0001 per share, of BioSante, and references to “BioSante class C special stock” refer to shares of class C special stock, par value of $0.0001 per share, of BioSante.  Except as otherwise noted, references to “BioSante capital stock” refer to shares of BioSante common stock and BioSante class C special stock.  References to the BioSante stockholders refer to holders of shares of BioSante common stock and/or shares of BioSante class C special stock.  All BioSante share and per share numbers have been adjusted retroactively to reflect the one-for-six reverse stock split effected on June 1, 2012.

 

Except as otherwise noted, references to “ANI series D preferred stock,” “ANI series C preferred stock,” “ANI series B preferred stock,” “ANI series A preferred stock”  and “ANI common stock” refer to shares of series D convertible preferred stock, par value $0.10 per share, of ANI, series C convertible preferred stock, par value $0.10 per share, of ANI, series B convertible preferred stock, par value $0.10 per share, of ANI, series A convertible preferred stock, par value $0.10 per share, of ANI, and common stock, par value $0.10 per share, of ANI, respectively, and references to “ANI preferred stock” refer to shares of ANI series D preferred stock, ANI series C preferred stock, ANI series B preferred stock and ANI series A preferred stock, collectively.  Except as otherwise noted, references to “ANI capital stock” refer to shares of ANI preferred stock and ANI common stock.   References to the ANI stockholders refer to holders of shares of ANI capital stock.

 

BioSante owns or has rights to various trademarks, trade names or service marks, including BioSante®, LibiGel®, The Pill-Plus™ and Elestrin™.

 

This report also contains trademarks, trade names and service marks that are owned by other persons or entities.

 

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PART I

 


 

ITEM 1.                                                BUSINESS

 

Overview

 

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism.   BioSante’s corporate strategy is to develop high value medically-needed pharmaceutical products.  As a part of BioSante’s corporate strategy, BioSante seeks to implement strategic alternatives with respect to its products and its company, including licenses, business collaborations and other business combinations or transactions with other pharmaceutical and biotechnology companies.  Therefore, as a matter of course, from time to time, BioSante may engage in discussions with third parties regarding the licensure, sale or acquisition of its products and technologies, with the goal of maximizing stockholder value.

 

On October 3, 2012, BioSante entered into an agreement and plan of merger with ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. (ANI).   The merger agreement provides that, subject to the terms and conditions set forth in the merger agreement, ANI will merge with and into BioSante, with BioSante continuing as the surviving company.  BioSante believes that the merger of the two companies will be able to create more value than BioSante could achieve individually.  The combined company that will result from the merger will be a fully integrated specialty branded and generic pharmaceutical company focused on developing, manufacturing and marketing branded and generic prescription pharmaceuticals.  Although the exact timing of completion of the merger cannot be predicted with certainty, each company has scheduled a special meeting of its stockholders for March 15, 2013 to consider and vote on certain matters in connection with the merger.  If the merger is approved by BioSante’s and ANI’s stockholders and the other conditions to closing are satisfied, it is anticipated that the merger will be completed as soon as reasonably practicable after the special meetings of stockholders.  The proposed merger with ANI is described in more detail below under the heading “—BioSante’s Proposed Merger with ANI” and elsewhere in this report.

 

BioSante’s products, either approved or in clinical development, include:

 

·                  LibiGel - once daily transdermal testosterone gel in Phase III development for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD).

 

·                  Male testosterone gel - 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, Inc. (Teva).

 

·                  The Pill-Plus (triple component contraceptive) - once daily use of various combinations of estrogens, progestogens and androgens in Phase II development.

 

·                  Elestrin - once daily transdermal estradiol (estrogen) gel approved by the FDA indicated for the treatment of hot flashes associated with menopause and marketed in the U.S. by Meda Pharmaceuticals, Inc. (Meda), BioSante’s licensee.

 

BioSante’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.  For the past several years, BioSante has focused its efforts on two Phase III LibiGel efficacy trials and a LibiGel Phase III cardiovascular and breast cancer safety study.  In December 2011, BioSante announced results from its two Phase III LibiGel efficacy trials, which showed that the trials did not meet the co-primary or secondary endpoints.  Although LibiGel performed as predicted, increasing satisfying sexual events and sexual desire and

 

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decreasing distress associated with low desire, the placebo response in the two efficacy trials was greater than expected, and LibiGel’s results were not shown to be statistically different from the placebo.

 

Beginning in December 2011, BioSante 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.  As a result of this process, in June 2012, BioSante announced a plan to initiate two new LibiGel Phase III efficacy trials.  BioSante is in 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. BioSante expects that any potential new LibiGel Phase III efficacy trials would include the same FDA-required efficacy endpoints as its prior Phase III efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire.  BioSante estimates that the cost of the two new LibiGel Phase III efficacy trials would be similar to the cost of the previous trials, approximately $15 to $18 million each, or a combined $30 to $36 million spread over approximately 18 months.  No assurance can be provided that these cost estimates will be correct or that BioSante, if it decides to pursue the trials, will be able to obtain the necessary working capital to fund the trials.  In addition, no assurance can be provided that BioSante will be able to design the two new efficacy trials to the FDA’s satisfaction or to minimize sufficiently the placebo effect and meet the co-primary and secondary endpoints for the trials.

 

With respect to BioSante’s LibiGel Phase III safety study, in September 2012, BioSante 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. Given this latest review during which no specific or general safety issues were raised, and after extensive consideration, BioSante announced in September 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 had advised BioSante 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 24.8 months; more than 3,200 subjects had been in the study for more than one year and over 1,850 subjects had been enrolled for more than two years. With this ninth unblinded review of the study by the DMC, and over 7,400 women-years of exposure, BioSante believes that adequate safety data of LibiGel use in menopausal women has been obtained.

 

Elestrin is BioSante’s first FDA approved product and is one of BioSante’s two FDA approved products.  Meda (which acquired Jazz Pharmaceuticals, Inc.’s women’s health business and which in turn acquired Azur Pharma International II Limited (Azur), BioSante’s prior original licensee), is marketing Elestrin in the U.S.  In December 2009, BioSante entered into an amendment to its original licensing agreement with Azur pursuant to which BioSante received $3.16 million in non-refundable payments in exchange for the elimination of all remaining future royalty payments and certain milestone payments that could have been paid to BioSante related to sales of Elestrin.  BioSante maintains the right to receive up to $140 million in sales-based milestone payments from Meda if Elestrin reaches certain predefined sales per calendar year; although, based on current sales levels, BioSante believes its receipt of such payments unlikely in the near term, if at all.

 

BioSante’s male testosterone gel is its second FDA approved product.  This product initially was developed by BioSante, and then licensed by BioSante to Teva for late stage clinical development.  Teva submitted an NDA to the FDA in the beginning of 2011, which was approved by the FDA in February 2012.  Subsequent to Teva submitting the NDA, in April 2011, AbbVie Inc., a marketer of a testosterone gel for men, filed a complaint against Teva alleging patent infringement.  This litigation was settled in December 2011; however, the terms of the settlement agreement are confidential and have not been disclosed publicly.  No launch date for this product has been announced by Teva.

 

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On January 31, 2013, BioSante entered into an asset purchase agreement with Aduro BioTech, Inc., a clinical-stage immunotherapy company (Aduro), pursuant to which BioSante sold all of its assets related to its GVAX cancer vaccine portfolio in exchange for a $1.0 million up front cash payment plus the potential for future royalty, milestone and sublicense payments.

 

BioSante’s Primary Product Portfolio

 

Product

 

Indication

 

Early
Human
Clinical

 

Late
Human
Clinical

 

FDA
Approval

 

Collaborations

LibiGel®
(testosterone gel)

 

Female sexual
dysfunction (FSD)

 

 

Non-partnered

 

 

 

 

 

 

 

Male
Testosterone Gel

 

Male
hypogonadism

 

 

Teva

 

 

 

 

 

 

 

The Pill Plus™
(birth control
with androgen)

 

Contraception

 

 

Pantarhei for
oral use

 

 

 

 

 

 

 

Elestrin™
(estradiol gel)

 

Menopausal
symptoms

 

 

Meda

 

BioSante’s Proposed Merger with ANI

 

On October 3, 2012, BioSante entered into a merger agreement with ANI, which provides that, subject to the terms and conditions set forth in the merger agreement, ANI will merge with and into BioSante, with BioSante continuing as the surviving company.  BioSante believes that the merger of the two companies will be able to create more value than BioSante could achieve individually.  The combined company that will result from the merger will be a fully integrated specialty branded and generic pharmaceutical company focused on developing, manufacturing and marketing branded and generic prescription pharmaceuticals.  Although the exact timing of completion of the merger cannot be predicted with certainty, each company has scheduled a special meeting of its stockholders on March 15, 2013 to consider and vote on certain matters in connection with the merger.  If the merger is approved by BioSante’s and ANI’s stockholders and the other conditions to closing are satisfied, it is anticipated that the merger will be completed as soon as reasonably practicable after the special meetings of stockholders.

 

At the effective time of the merger, each outstanding share of capital stock of ANI will be converted into the right to receive that number of shares of BioSante common stock, if any, as determined pursuant to the exchange ratios described in the merger agreement and the provisions of ANI’s certificate of incorporation.  All options, warrants or other rights to purchase shares of capital stock of ANI, will be canceled at the effective time of the merger without any consideration in exchange, except for certain warrants which although not cancelled will not represent the right to acquire any equity or other interest in the combined company after the merger.  No fractional shares of BioSante common stock will be issued in connection with the merger, and holders of ANI capital stock will be entitled to receive cash in lieu thereof.  Following completion of the transactions contemplated by the merger agreement, the current ANI stockholders are expected to own approximately 53 percent of the outstanding shares of common stock of the combined company, and current BioSante stockholders are expected to own approximately 47 percent of the outstanding shares of common stock of the combined company, assuming BioSante’s net cash as of the determination date is $18.0 million.  The exchange ratios are subject to potential adjustment as described in the merger agreement depending upon the amount of BioSante’s “net cash,” as defined in the merger agreement and generally consisting of BioSante’s cash and cash equivalents less certain expenses and liabilities, as of a determination date prior to

 

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the closing date of the merger, but in no event will the current ANI stockholders own less than 50.1 percent (or the current BioSante stockholders own more than 49.9 percent) of the outstanding shares of common stock of the combined company.  The merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended.

 

The merger agreement provides that, immediately following the effective time of the merger, the board of directors of the combined company will consist of five directors of ANI and two directors of BioSante, and ANI’s current executive officers are expected to serve as executive officers of the combined company.  In connection with the merger, BioSante has sought to amend its certificate of incorporation to: (i) effect a reverse split of BioSante common stock at a ratio of either one-for-two, one-for-three, one-for-four or one-for-five, as determined by BioSante and ANI, which is intended to ensure that the listing requirements of The NASDAQ Global Market or The NASDAQ Capital Market are satisfied; and (ii) change the name of the company to “ANI Pharmaceuticals, Inc.” or another name as designated by ANI (together, the charter amendments).

 

Completion of the merger is subject to a number of conditions, including, but not limited to (i) the adoption and approval of the merger agreement and the transactions contemplated thereby by both the BioSante and ANI stockholders and the approval of the two charter amendments described above by the BioSante stockholders; (ii) approval for the listing of shares of BioSante common stock to be issued in the merger on The NASDAQ Global Market or The NASDAQ Capital Market; (iii) written opinions of counsel that the merger will qualify as a reorganization within the meaning of Section 368(a) of the Code; and (iv) other customary closing conditions.  In addition, the obligation of ANI to effect the merger is subject to a condition that BioSante’s net cash, after deducting all remaining liabilities, as calculated and as adjusted pursuant to the terms of the merger agreement, be no less than $17.0 million immediately prior to the effective time of the merger. No fractional shares of BioSante common stock will be issued in connection with the reverse split and holders of BioSante common stock will be entitled to receive cash in lieu thereof.

 

Important Merger Information and Additional Information and Where to Find It

 

This report does not constitute an offer to sell or the solicitation of an offer to buy any securities of BioSante or ANI or the solicitation of any vote or approval. In connection with the proposed merger, BioSante filed with the Securities and Exchange Commission (SEC), and the SEC has declared effective, a registration statement on Form S-4 that includes a joint proxy statement/prospectus of BioSante and ANI and that also constitutes a prospectus of BioSante. The definitive joint proxy statement/prospectus of BioSante and ANI has been sent to the stockholders of BioSante and the stockholders of ANI. Investors are strongly urged to read the definitive joint proxy statement/prospectus regarding the proposed merger and other documents filed with the SEC by BioSante, because they contain important information about BioSante, ANI and the proposed merger.

 

Investors and security holders of BioSante and ANI may obtain free copies of the definitive joint proxy statement/prospectus for the proposed merger and other documents filed with the SEC by BioSante through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders of BioSante will be able to obtain free copies of the joint proxy statement/prospectus for the proposed merger by directing a request for such filing to (i) BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, Illinois 60069, Attention: Investor Relations or (ii) BioSante’s proxy solicitor, AST Phoenix Advisors, 110 Wall Street, 27th Floor, New York, New York 10005, or by calling AST Phoenix Advisors at (877) 478-5038.  Investors and security holders of ANI will be able to obtain free copies of the joint proxy statement/prospectus for the merger by contacting ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc., 210 Main Street West, Baudette, Minnesota 56623, Attention:  Investor Relations or by calling (218) 634-3500.

 

BioSante and ANI, and their respective directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the agreement between BioSante and ANI. Information regarding BioSante’s directors and executive officers is contained in this report.  Information regarding ANI’s directors and officers and a more complete description

 

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of the interests of BioSante’s and ANI’s respective directors and officers in the proposed transaction is available in the definitive joint proxy statement/prospectus of BioSante and ANI as filed by BioSante with the SEC on January 22, 2013.

 

Description of BioSante’s Female Sexual Health, Menopause, Contraception and Male Hypogonadism Products

 

Overview.  BioSante’s products for female sexual health, menopause, contraception and male hypogonadism include its gel formulations of estradiol or testosterone and combinations of estrogen, progestogen and androgen.

 

BioSante’s gel products are designed to be absorbed quickly through the skin after application on the upper arm for the women’s products, delivering the active component to the bloodstream evenly and in a non-invasive, painless manner.  The gels are formulated to be applied once per day and to be absorbed into the skin without a trace of residue and to dry in under one to two minutes.  BioSante believes its gel products have a number of benefits over competitive products, including the following:

 

·                  BioSante’s transdermal gels can be spread over areas of skin where they dry rapidly and decrease the chance for skin irritation versus transdermal patches;

 

·                  BioSante’s transdermal gels have been shown to be well absorbed, thus allowing effective therapeutic levels to reach the systemic circulation;

 

·                  transdermal gels may allow for better dose adjustment than either transdermal patches or oral tablets or capsules; and

 

·                  transdermal gels may be more appealing to patients since they are less conspicuous than transdermal patches, which may be aesthetically unattractive.

 

BioSante licenses the technology underlying LibiGel and Elestrin, but not its male testosterone gel, from Antares Pharma, Inc. (Antares).  BioSante’s male testosterone gel was developed initially by BioSante and licensed to Teva.  BioSante licenses the technology underlying The Pill Plus from Wake Forest University Health Sciences and Cedars-Sinai Medical Center.

 

LibiGel.  BioSante’s lead product in development is LibiGel, a once daily transdermal testosterone gel designed to treat FSD, specifically HSDD in postmenopausal women.

 

Although generally thought of as being limited to men, testosterone also is important to women and its deficiency has been found to cause low libido or sex drive.  Studies have shown that testosterone therapy in women can boost sexual desire, sexual activity and pleasure, increase bone density, raise energy levels and improve mood.  According to a study published in the Journal of the American Medical Association, 43 percent of American women between the ages of 18 to 59, or about 40 million women, experience some degree of impaired sexual function.  Among the more than 1,400 women surveyed, 32 percent lacked interest in sex (low sexual desire).  Furthermore, according to a study published in the New England Journal of Medicine, 43 percent of American women between the ages of 57 to 85 experience low sexual desire.  Importantly, according to IMS data, approximately two million testosterone prescriptions were written off-label for women in the U.S. in 2010.  In addition, according to independent primary market research, approximately two million additional prescriptions of compounded testosterone were written for women in the U.S. in 2010.  Female sexual dysfunction is defined as a consistent lack of sexual desire, arousal or pleasure.  The majority of women with FSD are postmenopausal, experiencing symptoms due to hormonal changes that occur with aging or following surgical menopause.

 

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Although treatment with LibiGel in BioSante’s Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD, the Phase III efficacy trials did not meet the co-primary endpoints of increase in satisfying sexual events or increase in sexual desire or the secondary endpoint of decrease in sexual distress.  The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline; this increase also was significant versus placebo.  In this trial, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group.  In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel.  The Phase II clinical trial was a double-blind, placebo-controlled trial, in surgically menopausal women distressed by their low sexual desire and activity.

 

The Phase III safety and efficacy trials were randomized, double-blind, placebo-controlled, multi-center trials of a total of 1,172 menopausal women, exposed to LibiGel or placebo for six months.  Subjects in the first trial, called BLOOM-1, who were treated with LibiGel showed an increase of 1.47 days with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.26 days with a satisfying sexual event compared to baseline.  The difference between these increases demonstrated a p value of 0.463.  (The smaller the p value, the stronger the statistical significance.   A p-value of .05 or less is typically used to represent statistical significance of trial results.)  In BLOOM 1, there was an increase in the total number of satisfying sexual events of 3.87 from baseline (an increase of 83 percent) in the LibiGel group and in the placebo group there was an increase of 3.52 satisfying sexual events from baseline (an increase of 65 percent) for a p value of 0.698.  Subjects in BLOOM-2 who were treated with LibiGel showed an increase of 1.0 day with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.28 days with a satisfying sexual event compared to baseline.  The difference between these increases demonstrated a p value of 0.214.  Subjects in BLOOM-1 showed an increase in mean sexual desire of 0.03 over placebo, a p value of 0.672, while subjects in BLOOM-2 demonstrated an increase in mean sexual desire of 0.03 compared to placebo, a p value of 0.48.  Subjects in both trials demonstrated a decrease in sexual distress when treated with LibiGel (p=0.569 and p=0.26) compared to baseline.

 

As seen in previous pharmacokinetic data, the LibiGel groups in both Phase III efficacy trials showed an increase in free testosterone levels compared to baseline and placebo.  In BLOOM-1, mean free testosterone at baseline was approximately 1.19 picograms per milliliter (pg/ml) and 1.10 pg/ml in the placebo and LibiGel groups, respectively.  In month six of the trial, free testosterone levels were approximately 1.35 pg/ml and 4.01 pg/ml in the placebo and LibiGel groups, respectively.  In BLOOM-2, mean free testosterone at baseline was approximately 1.06 pg/ml and 1.19 pg/ml in the placebo and LibiGel group, respectively.  In month six of the trial, free testosterone levels were approximately 1.09 pg/ml and 3.70 pg/ml in the placebo and LibiGel groups, respectively.

 

Results of the two Phase III efficacy trials were announced on December 14, 2011.  Subsequently, BioSante continued to analyze the data from the 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.  As a result of this process, in June 2012, BioSante announced a plan to initiate two new LibiGel Phase III efficacy trials.

 

In September 2012, BioSante announced that the independent 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 CV 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, BioSante announced in September 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 had advised

 

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BioSante that subjects in the 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, 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 24.8 months; more than 3,200 subjects had been in the study for more than one year and over 1,850 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, BioSante believes that adequate safety data of LibiGel use in menopausal women has been obtained.  BioSante remains blinded as to whether the CV events and breast cancers are experienced by subjects in the LibiGel arm or the placebo arm of the study.

 

BioSante is continuing to develop a protocol for the two new LibiGel efficacy trials and will seek an FDA Special Protocol Assessment agreement covering aspects of the two new efficacy trials.

 

Male Testosterone Gel.  BioSante’s once daily transdermal testosterone gel indicated for the treatment of hypogonadism, or testosterone deficiency, in men is BioSante’s second FDA approved product.

 

Testosterone deficiency in men is known as hypogonadism.  Low levels of testosterone may result in lethargy, depression, decreased sex drive, impotence, low sperm count and increased irritability.  Men with severe and prolonged reduction of testosterone also may experience loss of body hair, reduced muscle mass, osteoporosis and bone fractures due to osteoporosis.  Testosterone therapy has been shown to restore levels of testosterone with minimal side effects.

 

There are currently several products on the market for the treatment of low testosterone levels in men.  As opposed to estrogen therapy products, oral administration of testosterone is currently not possible as the hormone is, for the most part, rendered inactive in the liver making it difficult to achieve adequate levels of the compound in the bloodstream.  Current methods of administration include testosterone injections, patches and gels.  Testosterone injections require large needles, are often painful and not effective for maintaining adequate testosterone blood levels throughout the day.  Delivery of testosterone through transdermal patches was developed primarily to promote the therapeutic effects of testosterone therapy without the often painful side effects associated with testosterone injections.  Transdermal patches, however, similar to estrogen patches, have a physical presence, can fall off and can result in skin irritation.  Testosterone gel formulated products for men are designed to deliver testosterone without the pain of injections and the physical presence, skin irritation and discomfort associated with transdermal patches.  BioSante is aware of four gel testosterone products for men currently on the market in the United States.

 

Unlike LibiGel and Elestrin, BioSante’s male testosterone gel was developed initially by BioSante and therefore BioSante has no royalty or milestone obligations to any other party.  BioSante’s male testosterone gel is subject to a development and license agreement with Teva Pharmaceuticals USA, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.  Under the development and license agreement, Teva has agreed to market the male testosterone gel for the U.S. market and is responsible for any and all manufacturing and marketing associated with the product.  The financial terms of the development and license agreement included a $1.5 million upfront payment by Teva, which was paid to BioSante in December 2002, and an obligation by Teva to pay BioSante certain milestones and royalties on sales of the product in exchange for rights to develop and market the product, as described in more detail below. Teva is entitled to deduct the amount of any legal expenses incurred by Teva in connection with associated patent litigation against Teva from the net sales of the product.  The term of the development and license agreement will expire 10 years from the date on which Teva makes its first commercial sale of the male testosterone gel to an unrelated third party in an arms-length transaction in the United States.  The parties may terminate the development and license agreement upon the occurrence of certain events, including a material breach of the agreement by the other party.  BioSante may terminate the agreement if Teva files a petition in bankruptcy, enters into an arrangement with its creditors or makes an assignment for the benefit of creditors or a receiver or trustee is appointed or if Teva suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent.  Teva may terminate the agreement if Teva determines that the continued development and/or marketing of the male testosterone gel is no longer commercially viable.

 

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In October 2012, BioSante and Teva entered into an amendment to the development and license pursuant to which Teva made a non-refundable $1.0 million payment to BioSante upon the signing of the amendment and a non-refundable $750,000 payment in December 2012. Teva also agreed to make the following milestone based payments to BioSante:  (1) $500,000 if the FDA authorizes marketing of the licensed male testosterone gel as an “AB-rated” equivalent to AndroGel®; (2) $500,000 upon the earlier to occur of (a) December 31, 2013 and (b) five business days after Teva’s commencement of commercial manufacture of the licensed product for sale in the United States.  In addition, Teva has agreed to pay BioSante $4.0 million in the event Teva is the sole marketer in the United States of a generic 1% testosterone gel AB-rated to AndroGel® for at least 180 days immediately following the launch date of the licensed product in the United States.  The royalty rate to be paid by Teva to BioSante under the agreement is five percent of net sales; provided, however, that during the period of time that Teva markets the licensed product and is the sole marketer of a generic 1% testosterone gel that is AB-rated to AndroGel® in the United States, the royalty rate will be seven and one half percent of net sales.  Additionally, pursuant to the terms of the October 2012 amendment, the parties agreed to release each other from certain liabilities.

 

Teva submitted an NDA to the FDA in the beginning of 2011, which was approved by the FDA in February 2012.  Subsequent to Teva submitting the NDA, in April 2011, a subsidiary of Abbott Laboratories (now known as AbbVie Inc.), a marketer of a testosterone gel for men, filed a complaint against Teva alleging patent infringement.  This litigation was settled in December 2011; however, the terms of the settlement agreement are confidential and have not been disclosed publicly.   No launch date for this product has been announced by Teva.

 

The Pill-Plus.  The Pill-Plus is based on three issued U.S. patents claiming triple component therapy via any route of administration (the combination use of estrogen plus progestogen plus androgen, e.g. testosterone).  The Pill-Plus adds a third component, an androgen, to the normal two component (estrogen and progestogen) oral contraceptive to prevent testosterone deficiency which can result from the estrogen and progestogen components and which often leads to a decrease in sexual desire, sexual activity and mood changes.  In a completed Phase II double-blind randomized clinical trial, the addition of an oral androgen resulted in restoration of testosterone levels to the normal and physiological range for healthy women.  Paradoxically, many women who use oral contraceptives have reduced sexual desire, arousability and activity due to the estrogen and progestogen in normal oral contraceptives.  The Pill-Plus is designed to avoid or to improve the symptoms of female sexual dysfunction in oral contraceptive users.

 

BioSante has a fully paid-up right and exclusive license from Wake Forest University Health Sciences (formerly known as Wake Forest University) and Cedars-Sinai Medical Center for the three issued U.S. patents for triple component contraception.  The Pill-Plus is subject to a sublicense agreement with Pantarhei Bioscience B.V. (Pantarhei), a Netherlands-based pharmaceutical company.  Pantarhei is responsible under the agreement for all expenses to develop and market the product.  BioSante may receive certain development and regulatory milestones for the first product developed under the license.  In addition, BioSante will receive royalty payments on any sales of the product in the U.S., if and when approved and marketed.  If the product is sublicensed by Pantarhei to another company, BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party.  BioSante has retained all rights under its licensed patents to the transdermal delivery of triple component contraceptives.

 

Elestrin.  Elestrin is BioSante’s first FDA approved product.  Elestrin is a once daily transdermal gel that delivers estrogen without the skin irritation associated with, and the physical presence of, transdermal patches, and to avoid the effects of oral estrogen.  Elestrin contains estradiol versus conjugated equine estrogen contained in the most commonly prescribed oral estrogen.

 

Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.  Elestrin is administered using a metered dose applicator.  Two doses of Elestrin were approved by the FDA.

 

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Meda is marketing Elestrin in the U.S.  In December 2009, BioSante entered into an amendment to its original licensing agreement with Azur (which was acquired by Jazz Pharmaceuticals, Inc. which subsequently sold its women’s health business to Meda) pursuant to which BioSante received $3.16 million in non-refundable payments in exchange for the elimination of all remaining future royalty payments and certain milestone payments that could have been paid to BioSante related to sales of Elestrin.  BioSante maintains the right to receive up to $140 million in sales-based milestone payments from Meda if Elestrin reaches certain predefined sales per calendar year, although based on current sales levels, BioSante believes its receipt of such payments unlikely in the near term, if at all.

 

Elestrin also is subject to an exclusive agreement with Valeant Pharmaceuticals International, Inc. (which acquired PharmaSwiss SA) for the marketing of Elestrin in Israel.  Valeant Pharmaceuticals will be responsible for regulatory and marketing activities in Israel.  Israeli authorities have approved Elestrin, but the product has not been launched.

 

Other Products.  Marketing rights to BioSante’s gel products in Canada are subject to an agreement with Paladin Labs Inc.  In exchange for the sublicense, Paladin agreed to make an initial investment in BioSante, make future milestone payments and pay royalties on sales of the products in Canada.  The milestone payments are required to be in the form of a series of equity investments by Paladin in BioSante common stock at a 10 percent premium to the market price of its stock at the time the equity investment is made.  No recent investments have been made and none are expected in the foreseeable future.

 

Oncolytic Virus Technology.  In November 2010, BioSante entered into an assignment and technology transfer agreement with Cold Genesys, Inc. pursuant to which BioSante sold to Cold Genesys exclusive, worldwide rights to develop and commercialize its oncolytic virus technology.  The oncolytic virus technology uses replication-competent adenoviruses derived from Adenovirus type 5, a common “cold” virus that replicate in and selectively kill tumor cells.  The replication of the virus is controlled by replacing the promoter of a gene required for replication with a promoter that is preferentially expressed only in tumor cells.  Furthermore, the virus may optionally include a gene encoding a cytokine, which enhances immune stimulation to the tumor, thereby providing a dual mechanism of action for killing targeted cancer cells by direct cell lysis as well as via cellular and humoral immune responses to the tumor.  The oncolytic virus technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer.  In exchange for the technology, BioSante received an initial 19.9 percent ownership position in Cold Genesys and a $95,000 upfront cash payment and is eligible to receive future milestone and royalty payments.

 

Sales and Marketing

 

BioSante currently has no sales and marketing personnel to sell any of its products on a commercial basis.  Under BioSante’s license agreements, its licensees have agreed to market the products covered by the agreements in certain countries.  For example, under BioSante’s license agreement with Meda, Meda has agreed to use commercially reasonable efforts to manufacture, market, sell and distribute Elestrin for commercial sale and distribution throughout the United States, and under BioSante’s agreement with Teva, Teva has agreed to use commercially reasonable efforts to market its male testosterone gel in the United States.  If and when BioSante is ready to launch commercially a product not covered by its license agreements, BioSante will either contract with or hire qualified sales and marketing personnel or seek a joint marketing partner or licensee to assist BioSante with this function.

 

Research and Product Development

 

BioSante historically has spent a significant amount of its financial resources on product development activities, with the largest portion being spent on clinical studies for LibiGel.  BioSante spent approximately $16.9 million in 2012, $44.2 million in 2011 and $39.7 million in 2010 on research and product development activities.  BioSante anticipates that its research and development expenses for 2013 will consist primarily of

 

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expenses associated with the conclusion of the LibiGel Phase III cardiovascular events and breast cancer study and the planning for the two new LibiGel Phase III efficacy trials.  If BioSante’s pending merger with ANI is completed, BioSante anticipates that is research and development expense for 2013 also will consist of expenses associated with ANI’s targeted areas of product development including narcotics, anti-cancers and hormones (potent compounds) and extended release niche generic prescription product opportunities.

 

Manufacturing

 

BioSante does not have any facilities suitable for manufacturing on a commercial scale basis any of its products nor does it have any experience in volume manufacturing.  BioSante currently uses third-party current Good Manufacturing Practices (cGMP), manufacturers to manufacture its products in development in accordance with FDA and other appropriate regulations.

 

Patents, Licenses and Proprietary Rights

 

BioSante’s success depends and will continue to depend in part upon its ability to maintain its exclusive licenses, to obtain and maintain patent protection for its products and processes, to preserve its proprietary information, trademarks and trade secrets and to operate without infringing the proprietary rights of third parties.  BioSante’s policy is to attempt to protect its technology by, among other things, filing patent applications or obtaining license rights for technology that BioSante considers important to the development of its business.

 

License Agreements.  BioSante licensed the technology underlying LibiGel and Elestrin, but not its male testosterone gel, from Antares Pharma, Inc.  Under the agreement, Antares granted BioSante an exclusive license to certain patents and patent applications covering these gel products, including rights to sublicense, in order to develop and market the products in certain territories, including the U.S., Canada, New Zealand, South Africa, Israel, Mexico, China (including Hong Kong) and Indonesia.  BioSante is the exclusive licensee in certain territories for issued U.S. patents for these products and additional patent applications have been filed for this licensed technology in the U.S. and several foreign jurisdictions. Under the agreement, BioSante is required to pay Antares certain development and regulatory milestone payments and royalties based on net sales of any products BioSante or its sub-licensees sell incorporating the in-licensed technology. Specifically, BioSante is obligated to pay Antares 25 percent of all upfront and milestone payments related to a license and a 4.5 percent royalty on net sales of product by BioSante or a licensee.

 

BioSante and Antares may terminate the license agreement upon the occurrence of certain events, including a material breach of the agreement by the other party or if the other party goes into liquidation or bankruptcy or makes an assignment for the benefit of creditors or a receiver is appointed.  Antares may terminate the agreement with respect to certain products or territories if BioSante does not continue development, seeking regulatory approval or marketing of such products in the covered territories.  BioSante may terminate the agreement with respect to certain products or territories if, for technical, scientific or regulatory reasons, it is not likely that the product will gain required regulatory approvals in a territory, if regulatory approvals in a territory are not obtained or if BioSante determines that it is not economically viable to continue development or marketing of a product in a territory.

 

The patents covering the formulations used in these gel products are expected to expire in 2022, although with respect to LibiGel, a new U.S. patent covering the “method of use” of LibiGel for treating FSD and HSDD was issued, which will expire in December 2028.  In addition, BioSante has other patents pending, which, if issued, may expire later than 2028.  BioSante’s male testosterone gel was developed initially by BioSante and not covered under the Antares license.

 

BioSante has a fully-paid up right and exclusive license to the technology underlying its triple component contraceptives, or The Pill Plus, from Wake Forest University Health Sciences and Cedars-Sinai Medical Center.

 

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Trademarks and Trademark Applications/Registrations.  BioSante owns trademark registrations in the U.S. and/or in certain foreign jurisdictions for several marks, including BIOSANTE® and LIBIGEL®.  In addition, BioSante has filed trademark applications for several other marks including ELESTRIN™ (pursuant to a license agreement regarding Elestrin, the Elestrin trademark in the U.S. is now owned by Meda).  In addition, BioSante owns common law rights to several trademarks, including BIOSANTE®, LIBIGEL®, THE PILL-PLUS™ and ELESTRIN™.  For those trademarks for which registration has been sought, registrations have issued for some of those trademarks in certain jurisdictions and others currently are in the application/prosecution phase.

 

Confidentiality and Assignment of Inventions Agreements.  BioSante requires its employees, consultants and advisors having access to its confidential information to execute confidentiality agreements upon commencement of their employment or consulting relationships with BioSante.  These agreements generally provide that all confidential information BioSante develops or makes known to the individual during the course of the individual’s employment or consulting relationship with BioSante must be kept confidential by the individual and not disclosed to any third parties.  BioSante also requires all of its employees and consultants who perform research and development for BioSante to execute agreements that generally provide that all inventions and works-for-hire conceived by these individuals during their employment by BioSante will be BioSante’s property.

 

Competition

 

There is intense competition in the biopharmaceutical industry.  Potential competitors in the United States are numerous and include major pharmaceutical and specialized biotechnology companies, universities and other institutions.  In general, competition in the pharmaceutical industry can be divided into four categories:  (1) corporations with large research and developmental departments that develop and market products in many therapeutic areas; (2) companies that have moderate research and development capabilities and focus their product strategy on a small number of therapeutic areas; (3) small companies with limited development capabilities and only a few product offerings; and (4) university and other research institutions.  Many of BioSante’s competitors have longer operating histories, greater name recognition, substantially greater financial resources and larger research and development staffs than BioSante does, as well as substantially greater experience than BioSante in developing products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.  A significant amount of research is carried out at academic and government institutions.  These institutions are aware of the commercial value of their findings and are aggressive in pursuing patent protection and negotiating licensing arrangements to collect royalties for use of technology that they have developed.

 

There are several firms currently marketing or developing products that may be competitive with BioSante’s gel products.  They include Upsher-Smith Laboratories, Inc., Noven Pharmaceuticals, Inc. (a subsidiary of Hisamitsu Pharmaceutical Co., Inc.), Auxilium Pharmaceuticals, Inc., Ascend Therapeutics, Inc., Watson Pharmaceuticals, Inc. and AbbVie Inc.  Competitor products include oral tablets, transdermal patches, a spray and gels.  BioSante expects its FDA-approved products, Elestrin and its male testosterone gel, and its other products, if and when approved for sale, to compete primarily on the basis of product efficacy, safety, patient convenience, reliability and patent position and potentially on cost.  In addition, the first product to reach the market in a therapeutic or preventative area is often at a significant competitive advantage relative to later entrants in the market and may result in certain marketing exclusivity as per federal legislation.  Acceptance by physicians and other health care providers, including managed care groups, also is critical to the success of a product versus competitor products.

 

Governmental Regulation

 

Pharmaceutical companies are subject to extensive regulation by national, state and local agencies in countries in which they do business.  Pharmaceutical products intended for therapeutic use in humans are governed by extensive FDA regulations in the United States and by comparable regulations in foreign

 

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countries.  Any products developed by BioSante will require FDA approvals in the United States and comparable approvals in foreign markets before they can be marketed.

 

The U.S. Federal Food, Drug, and Cosmetic Act (FDCA) and other federal and state statutes and regulations govern or influence, among other things, the development, testing, manufacture, safety, labeling, storage, recordkeeping, approval, advertising, promotion, sale, import, export and distribution of pharmaceutical products in the United States.  Pharmaceutical manufacturers also are subject to certain record-keeping and reporting requirements, establishment registration and product listing, and FDA inspections.

 

Manufacturers of controlled substances also must comply with the federal Controlled Substances Act of 1970 (CSA) and regulations promulgated by the U.S. Drug Enforcement Administration (DEA), as well as similar state and local regulatory requirements for manufacturing, distributing, testing, importing, exporting and handling controlled substances.

 

Noncompliance with applicable legal and regulatory requirements can have a broad range of consequences, including warning letters, fines, seizure of products, product recalls, total or partial suspension of production and distribution, refusal to approve NDAs or other applications or revocation of approvals previously granted, withdrawal of product from marketing, injunction, withdrawal of licenses or registrations necessary to conduct business, disqualification from supply contracts with the government, and criminal prosecution.

 

Product development and approval within the FDA regulatory framework take a number of years, involve the expenditure of substantial resources, and are uncertain.  Many products ultimately do not reach the market because they are not found to be safe or effective or cannot meet the FDA’s other regulatory requirements. After a product is approved, the FDA may revoke or suspend the product approval if compliance with post-market regulatory standards is not maintained or if problems occur after the product reaches the marketplace.  In addition, the FDA may require post-marketing studies to monitor the effect of approved products, and may limit further marketing of the product based on the results of these post-market studies or evidence of safety concerns. Further, the current regulatory framework may change and additional regulatory or approval requirements may arise at any stage of BioSante’s product development that may affect approval, delay the submission or review of an application or require additional expenditures by BioSante.  BioSante may not be able to obtain necessary regulatory clearances or approvals on a timely basis, if at all, for any of its products under development.  Delays in receipt or failure to receive such clearances or approvals, the loss of previously received clearances or approvals, or failure to comply with existing or future regulatory requirements could have a material adverse effect on BioSante’s business.

 

New Product Development and Approval.  All applications for FDA approval must contain information relating to product formulation, raw material suppliers, stability, product testing, manufacturing processes, manufacturing facilities, packaging, labeling, quality control, and evidence of safety and effectiveness for intended uses. For a generic drug product, instead of safety and effectiveness data, an application must demonstrate that the proposed product is the same as the branded drug in several key characteristics. There are two types of applications used for obtaining FDA approval of new non-biological drug products, other than a generic product:

 

·                  An NDA, sometimes referred to as a “full NDA,” generally is submitted when approval is sought to market a drug with active ingredients that have not been previously approved by the FDA.  Full NDAs typically are submitted for newly developed branded products and, in certain instances, an applicant submits an NDA or NDA supplement for a change to one of its previously approved products, such as a new dosage form, a new delivery system or a new indication.

 

·                  Another form of an NDA is the “505(b)(2) NDA,” which typically is used to seek FDA approval of products that share characteristics (often, the active ingredient(s)) with a previously approved product of another company, but contain modifications to, or differences from, the approved

 

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product that preclude submission of an abbreviated new drug application.  A 505(b)(2) NDA is required where at least some of the information required for approval does not come from studies conducted by or for the applicant or for which the applicant has obtained a right of reference.  Usually, this means the application relies on the FDA’s previous approval of a similar product or reference listed drug, or published data in scientific literature that are not the applicant’s.

 

The process by which a product, other than a generic product, is approved for marketing in the United States can take from three to more than 10 years, and generally involves the following:

 

·                  laboratory and preclinical tests;

 

·                  submission of an Investigational New Drug (IND) application, which must become effective before clinical studies may begin;

 

·                  adequate and well-controlled human clinical studies to establish the safety and efficacy of the proposed product for its intended use;

 

·                  submission of a full NDA or 505(b)(2) NDA containing, to the extent required, the results of the preclinical tests and clinical studies establishing the safety and efficacy of the proposed product for its intended use, as well as extensive data addressing matters such as manufacturing and quality assurance;

 

·                  scale-up to commercial manufacturing;

 

·                  satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities; and

 

·                  FDA approval of the application.

 

To the extent that a 505(b)(2) NDA applicant can rely on a previously approved application or published literature, it may not be required to conduct some or all laboratory and preclinical tests or human clinical studies.

 

Pre-Clinical Studies and Clinical Trials.  Typically, preclinical studies are conducted in the laboratory and in animals to gain preliminary information on a product’s uses and physiological effects and harmful effects, if any, and to identify any potential safety problems that would preclude testing in humans.  The results of these studies, together with the general investigative plan, protocols for specific human studies and other information, are submitted to the FDA as part of the IND application.  The FDA regulations do not, by their terms, require FDA approval of an IND.  Rather, they allow a clinical investigation to commence if the FDA does not notify the sponsor to the contrary within 30 days of receipt of the IND.  As a practical matter, however, FDA approval is often sought before a company commences clinical investigations.  That approval may come within 30 days of IND receipt but may involve substantial delays if the FDA requests additional information.  BioSante’s submission of an IND, or those of its collaboration partners, may not result in FDA authorization to commence a clinical trial.

 

A separate submission to an existing IND also must be made for each successive clinical trial conducted during product development.  Depending on its significance, the FDA also must approve changes to an existing IND.  Further, an independent institutional review board (IRB) for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed.  Alternatively, a central IRB may be used instead of individual IRBs.  The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.  Clinical testing also must satisfy extensive Good Clinical Practice requirements and regulations for informed consent.

 

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The sponsor of a drug product typically conducts human clinical trials in three sequential phases, but the phases may overlap or not all phases may be necessary.  The initial phase of clinical testing, which is known as Phase I, is conducted to evaluate the metabolism, uses and physiological effects of the experimental product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of possible effectiveness.  Phase I studies can also evaluate various routes, dosages and schedules of product administration.  These studies generally involve a small number of healthy volunteer subjects, but may be conducted in people with the disease the product is intended to treat.  The total number of subjects is generally in the range of 20 to 80.  A demonstration of therapeutic benefit is not required in order to complete Phase I trials successfully.  If acceptable product safety is demonstrated, Phase II trials may be initiated.

 

Phase II trials are designed to evaluate the effectiveness of the product in the treatment of a given disease and involve people with the disease under study.  These trials often are well controlled, closely monitored studies involving a relatively small number of subjects, usually no more than several hundred.  The optimal routes, dosages and schedules of administration are determined in these studies.  If Phase II trials are completed successfully, Phase III trials are often commenced, although Phase III trials are not always required.

 

Phase III trials are expanded, controlled trials that are performed after preliminary evidence of the effectiveness of the experimental product has been obtained.  These trials are intended to gather the additional information about safety and effectiveness that is needed to evaluate the overall risk/benefit relationship of the experimental product and provide the substantial evidence of effectiveness and the evidence of safety necessary for product approval.  Phase III trials are usually conducted with several hundred to several thousand subjects.

 

A clinical trial may combine the elements of more than one phase and typically two or more Phase III studies are required.  A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the trial will be sufficient to satisfy the FDA requirements of that phase because this determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA.  In addition, a clinical trial may contain elements of more than one phase notwithstanding the designation of the trial as being of a particular phase.  The FDA closely monitors the progress of the phases of clinical testing and may, at its discretion, re-evaluate, alter, suspend or terminate the testing based on the data accumulated and its assessment of the risk/benefit ratio to patients.  It is not possible to estimate with any certainty the time required to complete Phase I, II and III studies with respect to a given product.

 

Success in early-stage clinical trials does not necessarily assure success in later-stage clinical trials.  Data obtained from clinical activities are not always conclusive and may be subject to alternative interpretations that could delay, limit or even prevent regulatory approval.  Regulations require the posting of certain details about active clinical trials on government (i.e., www.clinicaltrials.gov) or independent websites, and subsequently a limited posting of the results of those trials.  This helps prospective patients find out about trials they may wish to enroll in, but also provides some competitive intelligence to other companies working in the field.  Failure to post the trial or its results in a timely manner can result in civil penalties and the rejection of the drug application.

 

New Drug Applications.  The results of the product development, including preclinical studies, clinical studies, and product formulation and manufacturing information, are then submitted to the FDA as part of the NDA.

 

The FDA reviews each submitted application before accepting it for filing, and may refuse to file the application if it does not appear to meet the minimal standards for filing.  If the FDA refuses to file an application and requests additional information, the application must be resubmitted with the requested information.  Once the submission is accepted for filing, the FDA begins an in-depth review of the application to determine, among other things, whether a product is safe and effective for its intended use.  As part of this review, the FDA may refer the application to an appropriate FDA-advisory committee of outside experts, typically a panel of clinicians, for review, evaluation and a recommendation.  Under the policies agreed to by

 

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the FDA under the Prescription Drug User Fee Act (PDUFA), the FDA has 10 months in which to complete its initial review of a standard NDA and respond to the applicant.  The review process and the PDUFA goal date may be extended by three months if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding information already provided in the submission within the last three months of the PDUFA goal date.  Following its review of an NDA, the FDA invariably raises questions or requests additional information.  The NDA approval process can, accordingly, be very lengthy, and there is no assurance that the FDA will ultimately approve an NDA.

 

Acceptance for filing of an application does not assure FDA approval for marketing.  The FDA has substantial discretion in the approval process and may disagree with an applicant’s interpretation of the submitted data, which could delay, limit, or prevent regulatory approval.  If it concludes that the application does not satisfy the regulatory criteria for approval, the FDA typically issues a “complete response” letter communicating the agency’s decision not to approve the application and outlining the deficiencies in the submission.  The complete response letter may request additional information, including additional preclinical testing or clinical trials.  Even if such information and data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval.

 

If the FDA approves the application, the agency may require post-marketing studies, also known as Phase IV studies, as a condition to approval.  These studies may involve continued testing of a product and development of data, including clinical data, about the product’s effects in various populations and any side effects associated with long-term use.  After approval, the FDA also may require post-marketing studies or clinical trials if new safety information develops.

 

The FDA also may conclude that as part of the NDA or the 505(b)(2) NDA, the sponsor must develop a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the drug outweigh the risks.  A REMS may have different components, including a package insert directed to patients, a plan for communication with healthcare providers, restrictions on a drug’s distribution, or a medication guide to provide better information to consumers about the drug’s risks and benefits.

 

Special Protocol Assessments (SPA).  The special protocol assessment process generally involves FDA evaluation of a proposed Phase III clinical trial protocol and a commitment from the FDA that the design and analysis of the trial are adequate to support approval of an NDA, if the trial is performed according to the SPA and meets its endpoints.  The FDA’s guidance on the SPA process indicates that SPAs are designed to evaluate individual clinical trial protocols primarily in response to specific questions posed by the sponsors.  In practice, the sponsor of a product candidate may request an SPA for proposed Phase III trial objectives, designs, clinical endpoints and analyses.  A request for an SPA is submitted in the form of a separate amendment to an IND, and the FDA’s evaluation generally will be completed within a 45-day review period under applicable PDUFA goals, provided that the trials have been the subject of discussion at an end-of-Phase II and pre-Phase III meeting with the FDA, or in other limited cases.

 

If an agreement is reached, the FDA will reduce the agreement to writing and make it part of the administrative record.  While the FDA’s guidance on SPAs states that documented SPAs should be considered binding on the review division, the FDA has the latitude to change its assessment if certain exceptions apply.  Exceptions include identification of a substantial scientific issue essential to safety or efficacy testing that later comes to light, a sponsor’s failure to follow the protocol agreed upon, or the FDA’s reliance on data, assumptions or information that are determined to be wrong.

 

The Hatch-Waxman Act.  The Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act (Hatch-Waxman), established an abbreviated process for obtaining FDA approval for generic versions of approved branded drug products.  In addition to establishing a shorter, less expensive pathway for approval of generic drugs, Hatch-Waxman provides incentives for the development of new branded products and innovations to approved products by means of marketing exclusivities and extension of patent rights.  Under the Hatch-Waxman Act, newly-approved drugs and new conditions of use

 

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may benefit from a statutory period of non-patent marketing exclusivity.  The Hatch-Waxman Act provides five years of marketing exclusivity if the product’s active ingredient is a new chemical entity not previously approved.  The Hatch-Waxman Act provides three years of marketing exclusivity for the approval of new and supplemental NDAs for, among other things, new indications, dosages or strengths of a drug containing a previously approved active ingredient, if new clinical investigations that were conducted or sponsored by the applicant are essential to the approval of the application.  This three-year marketing exclusivity period protects against the approval of abbreviated new drug applications and 505(b)(2) NDAs for the innovation that required clinical data; it does not prohibit the FDA from accepting or approving abbreviated new drug application or 505(b)(2) applications for other products containing the same active ingredient.  The five- and three-year marketing exclusivity periods apply equally to patented and non-patented drug products.  It is under this provision that BioSante received three years marketing exclusivity for Elestrin.  .

 

Orphan Drug Exclusivity.  The Orphan Drug Act was enacted by Congress to provide financial incentives for the development of drugs for rare conditions (affecting less than 200,000 individuals per year) in the United States.  The orphan designation is granted for a combination of a drug entity and an indication and therefore it can be granted for an existing drug with a new (orphan) indication.  Applications are made to the Office of Orphan Products Development at the FDA and a decision or request for more information is rendered in 60 days.  NDAs for designated orphan drugs may be exempt from application fees, obtain additional clinical protocol assistance, are eligible for tax credits up to 50 percent of research and development costs, and are granted a seven-year period of exclusivity upon approval.  The FDA cannot approve the same drug for the same condition during this period of exclusivity, except in certain circumstances where a new product demonstrates superiority to the original treatment.

 

Other Regulatory Requirements.  Regulations continue to apply to pharmaceutical products after FDA approval occurs.  Post-marketing safety surveillance is required in order to continue to market an approved product.  The FDA also may, in its discretion, require post-marketing testing and surveillance to monitor the effects of approved products or place conditions on any approvals that could restrict the commercial applications of these products.

 

All facilities and manufacturing techniques used to manufacture products for clinical use or sale in the United States must be operated in conformity with “current good manufacturing practice” regulations, commonly referred to as “cGMP” regulations, which govern the production of pharmaceutical products.  BioSante currently does not have any manufacturing capability.

 

The FDA regulates and monitors all promotion advertising and of prescription drugs after approval.  All promotion must be consistent with the conditions of approval and submitted to the agency.  Failure to adhere to FDA promotional requirements can result in enforcement letters, warning letters, changes to existing promotional material, and corrective notices to healthcare professionals.  Promotion of a prescription drug for uses not approved by the FDA can have serious consequences and result in lawsuits by private parties, state governments and the federal government, significant civil and criminal penalties, and compliance agreements that require the company to change current practices and prevent unlawful activity in the future.

 

U.S. Drug Enforcement Administration.  The DEA regulates certain drug products containing controlled substances, such as testosterone, pursuant to the U.S. Controlled Substances Act.  The CSA and DEA regulations impose specific requirements on manufacturers and other entities that handle these substances including registration, recordkeeping, reporting, storage, security and distribution.  Recordkeeping requirements include accounting for the amount of product received, manufactured, stored and distributed. Companies handling controlled substances also are required to maintain adequate security and to report suspicious orders, thefts and significant losses.  The DEA periodically inspects facilities for compliance with the CSA and its regulations.  Failure to comply with current and future regulations of the DEA could lead to a variety of sanctions, including revocation or denial of renewal of DEA registrations, injunctions, or civil or criminal penalties.

 

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Foreign Regulation.  Products marketed outside of the United States are subject to regulatory approval requirements similar to those in the United States, although the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widely from country to country.  No action can be taken to market any product in a country until an appropriate application has been approved by the regulatory authorities in that country.  The current approval process varies from country to country, and the time spent in gaining approval varies from that required for FDA approval.  In certain European and other countries (i.e., Canada, Australia and Japan), the sales price of a product also must be approved.  The pricing review period often begins after market approval is granted.  BioSante intends to seek and utilize foreign partners to apply for foreign approvals of its products.

 

Employees

 

As of December 31, 2012, BioSante had 23 employees, including 12 in product development and 11 in management or administrative positions.  As of February 28, 2013, BioSante had 12 employees, including three in product development and nine in management or administrative positions. None of BioSante’s employees is covered by a collective bargaining agreement.  BioSante also engages independent contractors from time to time on an as needed, project by project, basis.

 

Forward-Looking Statements

 

This annual report on Form 10-K contains or incorporates by reference not only historical information, but also forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created by those sections.  In addition, BioSante or others on its behalf may make forward-looking statements from time to time in oral presentations, including telephone conferences and/or web casts open to the public, in news releases or reports, on its Internet web site or otherwise.  All statements other than statements of historical facts included in this report that address activities, events or developments that BioSante expects, believes or anticipates will or may occur in the future are forward-looking statements including, in particular, the statements about BioSante’s plans, objectives, strategies and prospects regarding, among other things, its financial condition, results of operations, business and proposed merger with ANI.  BioSante has identified some of these forward-looking statements with words like “believe,” “may,” “could,” “would,” “might,” “possible,” “potential,” “project,” “will,” “should,” “expect,” “intend,” “plan,” “predict,” “anticipate,” “estimate,” “approximate,” “contemplate” and “continue”, the negative of these words, other words and terms of similar meaning and the use of future dates.  These forward-looking statements may be contained in this section, the notes to BioSante’s financial statements and elsewhere in this report, including under the heading “Part II.  Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.”  Forward-looking statements generally relate to:

 

·                  the timing and anticipated completion of the proposed merger between BioSante and ANI;

 

·                  the expected benefits of and potential value created by the proposed merger for the stockholders of BioSante and ANI;

 

·                  the likelihood of the satisfaction of certain conditions to completion of the merger and whether and when the merger will be completed;

 

·                  the amount of shares of BioSante common stock that BioSante expects to issue in the proposed merger and the post-capitalization of the combined company after the merger;

 

·                  the status of BioSante’s LibiGel Phase III development program;

 

·                  BioSante’s future operating expenses, anticipated burn rate and whether and how long its existing cash and cash equivalents will be sufficient to fund its operations;

 

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·                  the amount of cash and cash equivalents that will be available to fund the combined company’s business after the merger and the length of time that the combined company anticipates such cash and cash equivalents will be available to fund the combined company’s operating plan after the merger;

 

·                  the market size and market acceptance of BioSante’s approved products and products in development;

 

·                  the effect of new accounting pronouncements and future health care, tax and other legislation; and

 

·                  BioSante’s substantial and continuing losses.

 

Forward-looking statements involve risks and uncertainties.  These uncertainties include factors that affect all businesses as well as matters specific to BioSante.  Some of the factors known to BioSante that could cause its actual results to differ materially from what it has anticipated in its forward-looking statements are described under the heading “Part I.  Item 1A. Risk Factors” below.  BioSante cautions readers not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward-looking statements are predictions of future results, which may not occur as anticipated.  Actual results could differ materially from those anticipated in the forward-looking statements and from historical results, due to the risks and uncertainties described under the heading “Part I.  Item 1A. Risk Factors” below, as well as others that BioSante may consider immaterial or does not anticipate at this time.  Although BioSante believes that the expectations reflected in its forward-looking statements are reasonable, BioSante does not know whether its expectations will prove correct.  BioSante’s expectations reflected in its forward-looking statements can be affected by inaccurate assumptions BioSante might make or by known or unknown risks and uncertainties, including those described below under the heading “Part I. Item 1A. Risk Factors.”  The risks and uncertainties described under the heading “Item 1A. Risk Factors” below are not exclusive and further information concerning BioSante and its business, including factors that potentially could materially affect its financial results or condition, may emerge from time to time.  BioSante assumes no obligation to update forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements.  BioSante advises you, however, to consult any further disclosures BioSante makes on related subjects in its quarterly reports on Form 10-Q and current reports on Form 8-K that BioSante files with or furnishes to the Securities and Exchange Commission.

 

Available Information

 

BioSante is a Delaware corporation that was initially formed as a corporation organized under the laws of the Province of Ontario in August 1996.  BioSante continued as a corporation under the laws of the State of Wyoming in December 1996 and reincorporated under the laws of the State of Delaware in June 2001.  In October 2009, Cell Genesys, Inc. was merged with and into BioSante, and BioSante was the surviving corporation.

 

On October 3, 2012, BioSante entered into a merger agreement with ANI pursuant to which, subject to the terms and conditions set forth in the merger agreement, ANI will merge with and into BioSante, with BioSante continuing as the surviving company.  Although the exact timing of completion of the merger cannot be predicted with certainty, each company has scheduled a special meeting of its stockholders for March 15, 2013 to consider and vote on certain matters in connection with the merger.  If the merger is approved by BioSante’s and ANI’s stockholders and the other conditions to closing are satisfied, it is anticipated that the merger will be completed as soon as reasonably practicable after the special meetings of stockholders.  The proposed merger with ANI is described in more detail below under the heading “—BioSante’s Proposed Merger with ANI” and elsewhere in this report.

 

BioSante’s principal executive offices are located at 111 Barclay Boulevard, Lincolnshire, Illinois 60069.  Its telephone number is (847) 478-0500, and its Internet web site address is www.biosantepharma.com.

 

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The information contained on BioSante’s web site or connected to its web site is not incorporated by reference into and should not be considered part of this annual report on Form 10-K.

 

BioSante makes available, free of charge and through its Internet web site, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after BioSante electronically files such material with, or furnish it to, the SEC.  BioSante also makes available, free of charge and through its Internet web site, to any stockholder who requests, its corporate governance guidelines, the charters of its board committees and its Code of Conduct and Ethics.  Requests for copies can be directed to Investor Relations at (847) 478-0500, extension 120.

 

ITEM 1A.                                       RISK FACTORS

 

The following are significant factors known to BioSante that could materially harm its business, financial condition or operating results or could cause its actual results to differ materially from its anticipated results or other expectations, including those expressed in any forward-looking statement made in this report:

 

Risks Related to the Merger Between BioSante and ANI

 

The issuance of shares of BioSante common stock to ANI stockholders in connection with the merger will dilute substantially the voting power of current BioSante stockholders.

 

Pursuant to the terms of the merger agreement, it is anticipated that BioSante will issue shares of BioSante common stock to ANI stockholders representing approximately 53 percent of the outstanding shares of common stock of the combined company as of immediately following completion of the merger, assuming BioSante’s net cash is $18.0 million as of the determination date. After such issuance, the shares of BioSante common stock outstanding immediately prior to completion of the merger will represent approximately 47 percent of the outstanding shares of common stock of the combined company as of immediately following completion of the merger. These ownership percentages may change depending upon the amount of BioSante’s net cash as of a determination date prior to completion of the merger.  Accordingly, the issuance of shares of BioSante common stock to ANI stockholders in connection with the merger will reduce significantly the relative voting power of each share of BioSante common stock held by current BioSante stockholders. Consequently, the BioSante stockholders as a group will have significantly less influence over the management and policies of the combined company after the merger than prior to the merger.

 

The exchange ratios in the merger agreement are subject to adjustment based on BioSante’s net cash as of a determination date prior to completion of the merger, which could dilute further the ownership of the BioSante stockholders in the combined company.

 

Subject to the terms and conditions of the merger agreement, at the effective time of and as a result of the merger, each share of ANI capital stock issued and outstanding immediately prior to the effective time of the merger will be converted into the right to receive that number of shares of BioSante common stock, if any, as determined pursuant to the exchange ratios described in the merger agreement and the provisions of ANI’s certificate of incorporation.  The exchange ratios are subject to potential adjustment as described in the merger agreement depending upon the amount of “net cash” of BioSante, as defined in the merger agreement and generally consisting of BioSante’s cash and cash equivalents less certain expenses and liabilities, as of a determination date prior to the closing date of the merger. If BioSante has more than $18.0 million of net cash as of the determination date, then the percentage ownership of the current BioSante stockholders will be increased on a pro rata basis by 0.6 percent for each $1.0 million of net cash excess, which would dilute further the ownership of the current ANI stockholders in the combined company.  If BioSante has less than $18.0 million of net cash as of the determination date, then the percentage ownership of current BioSante stockholders will be decreased on a pro rata basis by 0.6 percent for each $1.0 million of net cash shortfall, which would dilute further the ownership of the current BioSante stockholders in the combined company.  In

 

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no event, however, will the current ANI stockholders own less than 50.1 percent (or the current BioSante stockholders own more than 49.9 percent) of the outstanding shares of common stock of the combined company.  In addition, one of the conditions to ANI’s obligations to complete the merger is BioSante’s net cash as of the closing date being no less than $17.0 million as calculated and as adjusted pursuant to the provisions of the merger agreement.  The items that will constitute BioSante’s net cash at the determination date set forth in the merger agreement are subject to a number of factors, some of which are outside the control of BioSante and many of which are outside the control of ANI.

 

The exchange ratios are not adjustable based on issuances by BioSante of additional shares of BioSante common stock either upon the exercise of options or warrants or the conversion of convertible securities or otherwise, which issuances would result in additional dilution to the BioSante stockholders.

 

As of December 31, 2012, BioSante had outstanding options to purchase an aggregate of approximately 1.1 million shares of BioSante common stock, warrants to purchase an aggregate of approximately 4.7 million shares of BioSante common stock, an aggregate of 65,211 shares of BioSante class C special stock that are convertible into 65,211 shares of BioSante common stock and an aggregate of $8.3 million in aggregate principal amount of 3.125% convertible senior notes due May 1, 2013 that are convertible into an aggregate of 370,871 shares of BioSante common stock.  BioSante is not prohibited under the terms of the merger agreement from issuing additional equity securities under certain circumstances, including securities issued pursuant to the exercise of outstanding options or warrants or the conversion or exchange of outstanding convertible senior notes.  It is possible that prior to completion of the merger BioSante may issue additional equity securities.  The exchange ratios in the merger agreement, which are designed to result in the issuance by BioSante of shares of BioSante common stock to ANI stockholders representing approximately 53 percent of the outstanding shares of common stock of the combined company as of immediately following completion of the merger, assuming BioSante’s net cash is $18.0 million as of the determination date, are not adjustable based on issuances by BioSante of additional shares of BioSante common stock.  Therefore, any such issuances by BioSante would result in additional dilution to the BioSante stockholders.

 

The announcement and pendency of the merger could have an adverse effect on the trading price of BioSante common stock and/or the business, financial condition, results of operations or business prospects for BioSante.

 

While there have been no significant adverse effects to date, the announcement and pendency of the merger could disrupt BioSante’s business in the following ways, among others:

 

·                  third parties may seek to terminate and/or renegotiate their relationships with BioSante as a result of the merger, whether pursuant to the terms of their existing agreements with BioSante or otherwise; and

 

·                  the attention of BioSante management may be directed toward completion of the merger and related matters and may be diverted from the day-to-day business operations, including from other opportunities that otherwise might be beneficial to BioSante.

 

Should they occur, any of these matters could adversely affect the trading price of BioSante common stock or harm the financial condition, results of operations or business prospects of BioSante and/or the combined company.

 

Failure to complete the merger could negatively impact BioSante’s business, financial condition or results of operations or the trading price of BioSante common stock.

 

The completion of the merger is subject to a number of conditions and there can be no assurance that the conditions to the completion of the merger will be satisfied. If the merger is not completed, BioSante will be subject to several risks, including:

 

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·                  the current trading price of BioSante common stock may reflect a market assumption that the merger will occur, meaning that a failure to complete the merger could result in a decline in the trading price of BioSante common stock;

 

·                  certain executive officers and/or directors of BioSante may seek other employment opportunities, and the departure of any of BioSante’s executive officers and the possibility that the company would be unable to recruit and hire an executive could impact negatively BioSante’s business and operating results;

 

·                  the BioSante board of directors will need to reevaluate BioSante’s strategic alternatives, which alternatives may include a sale of the company, liquidation of the company or other strategic transaction;

 

·                  BioSante may be required to reimburse ANI for expenses of up to $500,000 or pay a termination fee of $1.0 million to ANI if the merger agreement is terminated by ANI or BioSante under certain circumstances;

 

·                  BioSante has incurred and is expected to continue to incur substantial transaction costs in connection with the merger whether or not the merger is completed;

 

·                  BioSante would not realize any of the anticipated benefits of having completed the merger; and

 

·                  under the merger agreement, BioSante is subject to certain restrictions on the conduct of its business prior to completion of the merger, which restrictions could adversely affect its ability to realize certain of its business strategies or take advantage of certain business opportunities.

 

If the merger is not completed, these risks may materialize and affect materially and adversely BioSante’s business, financial condition, results of operations, or the trading price of BioSante common stock.

 

BioSante has incurred and will continue to incur significant transaction costs in connection with the merger, some of which will be required to be paid even if the merger is not completed.

 

BioSante has incurred and will continue to incur significant transaction costs in connection with the merger.  These costs are primarily associated with the fees of its attorneys, accountants and financial advisor.  Most of these costs will be paid by BioSante even if the merger is not completed.  In addition, if the merger agreement is terminated due to certain triggering events specified in the merger agreement, BioSante may be required to pay ANI a termination fee of $1.0 million.  The merger agreement also provides that under specified circumstances, BioSante may be required to reimburse ANI up to $500,000 for its expenses in connection with the transaction.  If the merger is completed, the combined company will bear the transaction costs of both BioSante and ANI in connection with the merger, including financial advisor, legal and accounting fees and expenses.

 

Because the merger will be completed after the date of the BioSante special meeting of stockholders, it is possible under certain limited circumstances described below that at the time of the special meeting, BioSante stockholders will not know the exact number of shares of BioSante common stock that the ANI stockholders will receive upon completion of the merger.

 

Subject to the terms of the merger agreement, at the effective time of the merger, each share of ANI capital stock issued and outstanding immediately prior to the merger will be canceled, extinguished and automatically converted into the right to receive that number of shares of BioSante common stock as determined pursuant to the exchange ratios described in the merger agreement. The exchange ratios depend on the net cash of BioSante as of a determination date prior to completion of the merger.  The determination date is defined as the date that is 14 days prior to the date of the special meeting of BioSante stockholders, subject

 

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to extension for adjournment of the special meeting and subject to a dispute resolution provisions in the event there is a dispute between BioSante and ANI as to the amount of net cash of BioSante as of the determination date.  Under the merger agreement, BioSante’s “net cash” is defined as generally consisting of BioSante’s cash and cash equivalents less certain expenses and liabilities, as of a determination date prior to the closing date of the merger.  In the event of a dispute regarding the amount of net cash of BioSante as of the determination date, it is possible that the exact number of shares of BioSante common stock that the ANI stockholders will receive upon completion of the merger may not be available at the time of the special meeting of BioSante stockholders.

 

Some of the directors and executive officers of BioSante have interests in the merger that are different from, or in addition to, those of the other BioSante stockholders.

 

When considering the recommendation by the BioSante board of directors that the BioSante stockholders vote “for” each of the proposals being submitted to the BioSante stockholders at the special meeting of BioSante stockholders, the BioSante stockholders should be aware that certain of the directors and executive officers of BioSante have arrangements that provide them with interests in the merger that are different from, or in addition to, those of the stockholders of BioSante.   For instance, in connection with the merger, Fred Holubow and Ross Mangano, each a current member of the BioSante board of directors, will continue to serve as a director of the combined company following completion of the merger and will receive cash and equity compensation in consideration for such service.  The employment of BioSante’s three executive officers will terminate immediately following completion of the merger and they will be entitled to receive severance cash payments ranging from $526,400 to $1,490,100, and other severance benefits such as continuing health insurance, in connection with such termination. The directors and executive officers of BioSante also have certain rights to indemnification and to directors’ and officers’ liability insurance that will be provided by the combined company following completion of the merger.  The board of directors of BioSante was aware of these potential interests and considered them in making its recommendations to approve the proposals being submitted to the BioSante stockholders at the special meeting of BioSante stockholders.

 

The merger agreement and voting agreements contain provisions that could discourage or make it difficult for a third party to acquire BioSante prior to completion of the merger.

 

The merger agreement contains provisions that make it difficult for BioSante to entertain a third-party proposal for an acquisition of BioSante. These provisions include:

 

·                  the general prohibition on BioSante’s soliciting or engaging in discussions or negotiations regarding any alternative acquisition proposal;

 

·                  the requirement that BioSante reimburse ANI for expenses of up to $500,000 or pay a termination fee of $1.0 million to ANI if the merger agreement is terminated by ANI or BioSante under certain circumstances; and

 

·                  the requirement that BioSante submit the merger-related proposals to a vote of the BioSante stockholders even if the BioSante board of directors changes its recommendations with respect to such proposals.

 

Pursuant to voting agreements entered into between (i) BioSante and certain stockholders of ANI and (ii) ANI and the directors, executive officers and certain stockholders of BioSante, each such director, executive officer and applicable stockholder has agreed not to take any actions that BioSante or ANI, as applicable, is prohibited from taking pursuant to the no-solicitation restrictions contained in the merger agreement. In addition, holders of shares representing approximately 85 percent of the shares of the outstanding ANI capital stock, calculated on an as-converted basis, and approximately 86 percent of the outstanding shares of the ANI series D preferred stock, as of October 3, 2012 are subject to a voting

 

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agreement, pursuant to which the holders of such shares have agreed to vote in favor of the approval and adoption of the merger agreement and the transactions contemplated thereby, including the merger, and ANI is required under the terms of the merger agreement to convene and hold the ANI special meeting regardless of any change in the recommendation of the ANI board of directors. Likewise, holders of shares representing approximately two percent of the outstanding capital stock of BioSante as of October 3, 2012 are subject to a voting agreement, pursuant to which the holders of such shares have agreed to vote in favor of the approval and adoption of the merger agreement and the transactions contemplated thereby, including the merger and the issuance of the shares of BioSante common stock, and the approval of the BioSante charter amendments, and BioSante is required under the terms of the merger agreement to convene and hold the BioSante special meeting regardless of any change in the recommendation of the BioSante board of directors.  These provisions might discourage an otherwise interested third party from considering or proposing an acquisition of BioSante, even one that may be deemed of greater value than the merger to BioSante stockholders. Furthermore, even if a third party elects to propose an acquisition, the concept of a termination fee or payment of the other party’s expenses may result in that third party offering a lower value to BioSante stockholders than such third party might otherwise have offered.

 

Because the lack of a public market for shares of ANI capital stock makes it difficult to evaluate the fairness of the merger, ANI stockholders may receive consideration in the merger that is greater than the fair value of the shares of capital stock of ANI.

 

ANI is privately held and its outstanding capital stock is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair value of ANI or its shares of capital stock. Since the percentage of BioSante’s equity to be issued to the ANI stockholders was determined based on negotiations between the parties, it is possible that the value of the BioSante common stock to be issued in connection with the merger will be greater than the fair value of ANI.

 

BioSante may not issue contingent value rights (CVRs) to holders of BioSante common stock prior to the merger and, even if issued, the CVRs will not be certificated or transferable and may not result in any cash payments to holders of CVRs.

 

Although BioSante currently plans to enter into the contingent value rights agreement and issue CVRs to holders of BioSante common stock as of March 15, 2013, there is no assurance that the CVRs will be issued at all or based on the terms currently set forth in the form of the contingent value rights agreement.  BioSante currently has not entered into the contingent value rights agreement and the BioSante board of directors may determine in its sole discretion not to issue the CVRs based on, among other things, the anticipated tax impact of the distribution and issuance of the CVRs to the holders of BioSante common stock.  Furthermore, if BioSante and ANI agree, the terms of the contingent value rights agreement as contemplated currently may be changed prior to BioSante entering into the contingent value rights agreement. Even if CVRs are issued, they will not be certificated or transferable and may not result in any cash payments to holders of CVRs.  Under the contingent value rights agreement, the combined company will not have any obligation, other than an obligation to act in good faith to pursue, engage in, negotiate, enter into or consummate an actual or potential LibiGel transaction (as such term is defined in the contingent value rights agreement).

 

BioSante may waive one or more of the conditions to the merger without resoliciting stockholder approval for the merger.

 

Certain conditions to BioSante’s obligations to complete the merger may be waived, in whole or in part, to the extent legally allowed, either unilaterally or by agreement of BioSante and ANI. In the event of a waiver of a condition, the board of directors of BioSante will evaluate the materiality of any such waiver to determine whether amendment of the joint proxy statement/prospectus and resolicitation of proxies is necessary. In the event that the board of directors of BioSante determines any such waiver is not significant enough to require resolicitation of stockholders, it will have the discretion to complete the merger without

 

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seeking further stockholder approval.  The conditions requiring the approval of each company’s stockholders cannot, however, be waived.

 

Risks Related to the Combined Company if the Merger is Completed

 

The success of the merger will depend, in large part, on the ability of the combined company following completion of the merger to realize the anticipated benefits from combining the businesses of BioSante and ANI.

 

The merger involves the integration of two companies that previously have operated independently with principal offices in two distinct locations. Due to legal restrictions, BioSante and ANI are able to conduct only limited planning regarding the integration of the two companies prior to completion of the merger. Significant management attention and resources will be required to integrate the two companies after completion of the merger. The failure to integrate successfully and to manage successfully the challenges presented by the integration process may result in the combined company’s failure to achieve some or all of the anticipated benefits of the merger.

 

Potential difficulties that may be encountered in the integration process include the following:

 

·                  using the combined company’s cash and other assets efficiently to develop the business of the combined company;

 

·                  appropriately managing the liabilities of the combined company;

 

·                  potential unknown or currently unquantifiable liabilities associated with the merger and the operations of the combined company;

 

·                  potential unknown and unforeseen expenses, delays or regulatory conditions associated with the merger; and

 

·                  performance shortfalls at one or both of the companies as a result of the diversion of management’s attention caused by completing the merger and integrating the companies’ operations.

 

Delays in the integration process could adversely affect the combined company’s business, financial results, financial condition and stock price following the merger. Even if the combined company were able to integrate the business operations successfully, there can be no assurance that this integration will result in the realization of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that these benefits will be achieved within a reasonable period of time.

 

The merger will result in changes to the BioSante board of directors and the combined company may pursue different strategies than BioSante may have pursued independently.

 

If BioSante and ANI complete the merger, the composition of the BioSante board of directors will change in accordance with the merger agreement. Following completion of the merger, the combined company’s board of directors will consist of seven members, including two of the current directors of BioSante and five of the current directors of ANI. Currently, it is anticipated that the combined company will continue to advance the product development efforts and business strategies of ANI primarily. However, because the composition of the board of directors of the combined company will consist of directors from both BioSante and ANI, the combined company may determine to pursue certain business strategies that BioSante would not have pursued independently.

 

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Ownership of the combined company’s common stock may be highly concentrated, and it may prevent the BioSante stockholders from influencing significant corporate decisions and may result in conflicts of interest that could cause the combined company’s stock price to decline.

 

Upon completion of the merger, ANI’s directors and executive officers continuing with the combined company, together with their respective affiliates, are expected to beneficially own or control approximately 41 percent of the combined company.  Accordingly, these directors, executive officers and their affiliates, acting individually or as a group, will have substantial influence over the outcome of a corporate action of the combined company requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of the combined company’s assets or any other significant corporate transaction.  These stockholders also may exert influence in delaying or preventing a change in control of the combined company, even if such change in control would benefit the other stockholders of the combined company.  In addition, the significant concentration of stock ownership may affect adversely the market value of the combined company’s common stock due to investors’ perception that conflicts of interest may exist or arise.

 

Future results of the combined company may differ materially from the unaudited pro forma financial statements presented in the joint proxy statement/prospectus and the financial forecasts prepared by ANI in connection with discussions concerning the merger.

 

The future results of the combined company may be materially different from those shown in the unaudited pro forma condensed combined financial statements presented in the joint proxy statement/prospectus, which show only a combination of the historical results of BioSante and ANI, and the financial forecasts prepared by ANI in connection with discussions concerning the merger. BioSante and ANI expect to incur significant costs associated with completion of the merger and combining the operations of the two companies.  The exact magnitude of these costs is not yet known, but is estimated to be approximately $3.1 million.  Furthermore, these costs may decrease the capital that the combined company could use for continued development of the combined company’s business in the future or may cause the combined company to seek to raise new capital sooner than expected.

 

The combined company’s ability to utilize BioSante’s or ANI’s net operating loss and tax credit carryforwards in the future is subject to substantial limitations and may be further limited as a result of the merger.

 

Under Section 382 of the Internal Revenue Code of 1986, as amended (the Code), if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percent change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited.  Further, if the historic business of BioSante is not treated as being continued by the combined entity for the two-year period beginning on the date of the merger (referred to as the “continuity of business requirement”), the pre-transaction net operating loss carryforward deductions become substantially reduced or unavailable for use by the surviving corporation in the transaction. In 2009, an “ownership change” occurred with respect to BioSante, and it is expected that the merger with ANI will result in another “ownership change” of BioSante.  Accordingly, the combined company’s ability to utilize BioSante’s net operating loss and tax credit carryforwards may be substantially limited.  These limitations, in turn, could result in increased future tax payments for the combined company, which could have a material adverse effect on the business, financial condition or results of operations of the combined company.

 

Under Section 384 of the Code, available net operating loss carryovers of BioSante or ANI may not be available to offset certain gains arising after the merger from assets held by the other corporation at the effective time of the merger.  This limitation will apply to the extent that the gain is attributable to an unrealized built-in-gain in the assets of BioSante or ANI existing at the effective time of the merger.  To the extent that any such gains are recognized in the five year period after the merger upon the disposition of any

 

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such assets, the net operating loss carryovers of the other corporation will not be available to offset such gains (but the net operating loss carryovers of the corporation that owned such assets will not be limited by Section 384 although they may be subject to other limitations under Section 382 as described above).

 

The price of BioSante common stock after the merger is completed may be affected by factors different from those currently affecting the price of BioSante common stock.

 

The business of BioSante differs significantly from the business of ANI; and, accordingly, the results of operations of the combined company and the trading price of BioSante common stock following completion of the merger may be affected significantly by factors different from those currently affecting the independent results of operations of BioSante.

 

The NASDAQ Global Market considers the anticipated merger of BioSante and ANI to be a business combination with a non-NASDAQ entity, resulting in a change in control of BioSante; and therefore, has required that BioSante submit a new initial listing application, which requires certain actions on the part of the combined company which may not be successful and, if unsuccessful, could make it more difficult for holders of shares of the combined company to sell their shares.

 

The NASDAQ Global Market considers the merger between BioSante and ANI to be a business combination with a non-NASDAQ entity, resulting in a change in control of BioSante and has required that BioSante submit a new initial listing application.  The NASDAQ Global Market may not approve BioSante’s new initial listing application for The NASDAQ Global Market on a timely basis, or at all. If this occurs and the merger is still completed, stockholders may have difficulty converting their investments into cash effectively.   Additionally, as part of the new initial listing application, BioSante will be required to submit, among other things, a plan for the combined company to effect a reverse stock split.  A reverse stock split likely would increase the per share trading price by an as yet undetermined multiple.  The change in share price may affect the volatility and liquidity of the combined company’s stock, as well as the marketplace’s perception of the stock.  As a result, the relative price of the combined company’s stock may decline and/or fluctuate more than in the past, and stockholders may have trouble converting their investments in the combined company into cash effectively.

 

The combined company’s management will be required to devote substantial time to comply with public company regulations.

 

As a public company, the combined company will incur significant legal, accounting and other expenses that ANI did not incur as a private company.  The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act as well as rules implemented by the SEC and The NASDAQ Global Market, impose various requirements on public companies, including those related to corporate governance practices.  The combined company’s management and other personnel will need to devote a substantial amount of time to these requirements.  Certain members of ANI’s management, which will continue as the management of the combined company, do not have significant experience in addressing these requirements.  Moreover, these rules and regulations will increase the combined company’s legal and financial compliance costs relative to those of ANI and will make some activities more time consuming and costly.

 

The Sarbanes-Oxley Act requires, among other things, that the combined company maintain effective internal control for financial reporting and disclosure controls and procedures.  In particular, the combined company must perform system and process evaluation and testing of its internal control over financial reporting to allow management and the combined company’s independent registered public accounting firm to report on the effectiveness of its internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act.  The combined company’s compliance with these requirements will require that it incur substantial accounting and related expenses and expend significant management efforts.  The combined company will need to hire additional accounting and financial staff to satisfy the ongoing requirements of Section 404 of the Sarbanes-Oxley Act.  The costs of hiring such staff may be material and there can be no

 

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assurance that such staff will be immediately available to the combined company.  Moreover, if the combined company is not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if the combined company or its independent registered public accounting firm identifies deficiencies in its internal control over financial reporting that are deemed to be material weaknesses, investors could lose confidence in the accuracy and completeness of the combined company’s financial reports, the market price of the combined company’s common stock could decline and the combined company could be subject to sanctions or investigations by The NASDAQ Global Market, the SEC or other regulatory authorities.

 

After completion of the merger, the combined company will possess not only all of the assets but also all of the liabilities of both BioSante and ANI. Discovery of previously undisclosed or unknown liabilities could have an adverse effect on the combined company’s business, operating results and financial condition.

 

Acquisitions involve risks, including inaccurate assessment of undisclosed, contingent or other liabilities or problems.  After completion of the merger, the combined company will possess not only all of the assets, but also all of the liabilities of both BioSante and ANI.  Although BioSante conducted a due diligence investigation of ANI and its known and potential liabilities and obligations, and ANI conducted a due diligence investigation of BioSante and its known and potential liabilities and obligations, it is possible that undisclosed, contingent or other liabilities or problems may arise after completion of the merger, which could have an adverse effect on the combined company’s business, operating results and financial condition.

 

BioSante and ANI do not expect the combined company to pay cash dividends.

 

BioSante and ANI anticipate that the combined company will retain its earnings, if any, for future growth and therefore not pay any cash dividends in the foreseeable future.  Investors seeking cash dividends should not invest in the combined company’s common stock for that purpose.

 

Anti-takeover provisions in the combined company’s charter and bylaws may prevent or frustrate attempts by stockholders to change the board of directors or management and could make a third-party acquisition of the combined company difficult.

 

The combined company’s certificate of incorporation and bylaws, as amended, will contain provisions that may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.  These provisions could limit the price that investors might be willing to pay in the future for shares of the combined company’s common stock.

 

The sale or availability for sale of a substantial number of shares of common stock of the combined company after the merger and after expiration of the lock-up period could adversely affect the market price of such shares after the merger.

 

Sales of a substantial number of shares of common stock of the combined company in the public market after the merger or after expiration of the lock-up period that will apply to certain of ANI’s stockholders and executive officers, or the perception that these sales could occur, could adversely affect the market price of such shares and could materially impair the combined company’s ability to raise capital through equity offerings in the future.  BioSante is unable to predict what effect, if any, market sales of securities held by significant stockholders, directors or officers of the combined company or the availability of these securities for future sale will have on the market price of the combined company’s common stock after the merger.

 

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Risks Related to BioSante

 

Risks Related to BioSante’s Financial Condition and Future Capital Requirements

 

BioSante has not generated significant revenues and does not expect to in the near future.  BioSante has a history of operating losses, expects continuing losses and may never become profitable.

 

Substantially all of BioSante’s revenue to date has been derived from upfront and milestone payments earned on licensing transactions, revenue earned from subcontracts and royalty revenue.  In order to generate new and significant revenues, BioSante must develop and commercialize successfully its own products or enter into strategic partnering agreements with others who can develop and commercialize them successfully, or acquire additional new products that generate or have the potential to generate revenues.  Because of the numerous risks and uncertainties associated with BioSante’s and its strategic partners’ product development programs and BioSante’s ability to acquire additional new products, BioSante is unable to predict when it will be able to generate significant revenue or become profitable, if at all.  BioSante incurred a net loss of $27.7 million for the year ended December 31, 2012.  As of December 31, 2012, BioSante’s accumulated deficit was $245.0 million.  BioSante expects to continue to incur substantial and continuing losses for the foreseeable future.  These losses will increase if BioSante decides to pursue the two new LibiGel Phase III efficacy trials or in-license additional new products that require further development.  Even if BioSante’s approved products, products in development or any additional new products BioSante may acquire or in-license are introduced commercially, BioSante may never achieve market acceptance and it may never generate sufficient revenues or receive sufficient license fees or royalties on its licensed products and technologies in order to achieve or sustain future profitability.

 

Because BioSante has no source of significant recurring revenue, BioSante must depend on financing or partnering to sustain its operations.  BioSante likely will need to raise substantial additional capital or enter into strategic partnering agreements to fund its operations and BioSante may be unable to raise such funds or enter into strategic partnering agreements when needed and on acceptable terms.

 

Developing products requires substantial amounts of capital. BioSante estimates that the cost of the two new LibiGel Phase III efficacy trials will be approximately $15 to $18 million each, or a combined $30 to $36 million spread over 18 months.  No assurance can be provided, however, that BioSante’s cost estimates will be correct.  It is possible that the two new LibiGel Phase III efficacy trials will cost more than BioSante anticipates.  If BioSante decides to pursue the two new LibiGel Phase III efficacy trials or in-license additional new products that require further development, BioSante will need to raise substantial additional capital or enter into strategic partnering agreements to fund its operations and it may be unable to raise such funds or enter into strategic partnering agreements when needed and on acceptable terms.

 

BioSante’s future capital requirements will depend upon numerous factors, including:

 

·                  the progress, timing, cost and results of its clinical development programs, including the two new LibiGel Phase III efficacy trials if BioSante decides to pursue them and if BioSante in-licenses additional new products that require further development;

 

·                  the cost, timing and outcome of regulatory actions with respect to BioSante’s products;

 

·                  the success, progress, timing and costs of BioSante’s business development efforts to implement business collaborations, licenses and other business combinations or transactions, and its efforts to evaluate various strategic alternatives available with respect to its products and its company.

 

·                  BioSante’s ability to obtain value from its current products and technologies and its ability to out-license its products and technologies to third parties for development and commercialization and the terms of such out-licenses;

 

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·                  BioSante’s ability to acquire or in-license additional new products and technologies and the costs and expenses of such acquisitions or licenses;

 

·                  the timing and amount of any royalties, milestone or other payments BioSante may receive from or be obligated to pay to current and potential licensors, licensees and other third parties;

 

·                  the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other intellectual property rights;

 

·                  the emergence of competing products and technologies, and other adverse market developments;

 

·                  the perceived, potential and actual commercial success of BioSante’s products;

 

·                  the outstanding principal amount of BioSante’s 3.125% convertible senior notes due May 1, 2013 (convertible senior notes) that are scheduled to mature and become due and payable on May 1, 2013 and BioSante’s ability to avoid a “fundamental change” or an “event of default” under the indenture governing such notes, which may cause such notes to become due and payable prior to their maturity date on May 1, 2013;

 

·                  BioSante’s operating expenses; and

 

·                  the resolution of BioSante’s pending purported class action and shareholder derivative litigation and any amount it may be required to pay in excess of its directors’ and officers’ liability insurance.

 

BioSante’s future capital requirements and projected expenditures are based upon numerous assumptions and subject to many uncertainties, and actual requirements and expenditures may differ significantly from its projections.  To date, BioSante has relied primarily upon proceeds from sales of its equity securities to finance its business and operations.  BioSante likely will need to raise additional capital to fund its operations.  As of December 31, 2012, BioSante had $34.8 million of cash and cash equivalents.  BioSante does not have any existing credit facilities under which it may borrow funds.  Absent the receipt of any additional licensing income or financing, BioSante expects its cash and cash equivalents balance to decrease as it continues to use cash to fund its operations, including in particular the two new LibiGel Phase III efficacy trials if BioSante decides to pursue them.  As of December 31, 2012, BioSante has $8.3 million in principal amount of convertible senior notes outstanding that mature on May 1, 2013.  Assuming the merger is completed during the first quarter of 2013 and BioSante decides not to commence the two new efficacy trials for LibiGel, BioSante expects its cash equivalents as of December 31, 2012 to meet its liquidity requirements through at least its anticipated closing of the merger, including the closing condition under the merger agreement to have at least $17.0 million of “net cash,” as defined in the merger agreement, available upon the closing of the merger.  If the merger is not completed, BioSante will need to reevaluate its strategic alternatives, which may include continuing to operate its business as an independent, stand-alone company, a sale of the company, liquidation of the company or other strategic transaction.  BioSante’s liquidity position will be dependent upon the strategic alternative selected; however, assuming BioSante does not enter into another strategic transaction, and assuming BioSante decides not to commence the two new efficacy trials for LibiGel, BioSante expects its cash and cash equivalents as of December 31, 2012 will be sufficient to meet its liquidity requirements for at least the next three to five years.  Additional financing would be required should BioSante decide to commence the two new efficacy trials for LibiGel.  These estimates may prove incorrect or BioSante, nonetheless, may choose to raise additional financing earlier in order to create a “cash cushion” and take advantage of favorable financing conditions.

 

The December 2011 announcement of the results of BioSante’s prior completed LibiGel Phase III efficacy trials has significantly depressed the trading price of BioSante common stock and harmed BioSante’s ability to raise additional capital.  BioSante can provide no assurance that additional financing, if needed, will

 

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be available on terms favorable to BioSante, or at all.  This is particularly true if investors are not confident in BioSante’s LibiGel Phase III development program, the future value of the company and/or if economic and market conditions deteriorate. BioSante has on file effective shelf registration statements that allow it to raise up to an aggregate of $102.4 million from the sale of common stock, preferred stock, warrants or units comprised of the foregoing. However, under applicable SEC rules, if BioSante has a public float of less than $75.0 million, it can only offer to sell under the registration statement up to one-third of its public float during any 12-month period. BioSante can provide no assurance that additional financing, if needed, will be available on terms favorable to it, or at all. If adequate funds are not available or are not available on acceptable terms when BioSante needs them, BioSante may need to make changes to its operations to reduce costs. As an alternative to raising additional financing, BioSante may choose to license LibiGel, Elestrin (outside the territories already licensed) or another product, to a third party who may finance a portion or all of the continued development and, if approved, commercialization of that licensed product, sell certain assets or rights BioSante has under its existing license agreements or decide or be forced to explore other strategic alternatives, such as selling or merging the company or winding down its operations and liquidating the company.  In such case, the BioSante stockholders could lose some or all of their investment.

 

Raising additional funds by issuing additional equity securities may cause dilution to existing BioSante stockholders, raising additional funds by issuing additional debt financing may restrict BioSante’s operations and raising additional funds through licensing arrangements may require BioSante to relinquish proprietary rights.

 

If BioSante raises additional funds through the issuance of additional equity or convertible debt securities, the percentage ownership of its stockholders could be diluted significantly, and these newly issued securities may have rights, preferences or privileges senior to those of its existing stockholders.  In addition, the issuance of any equity securities could be at a discount to the market price.

 

If BioSante incurs additional debt financing, the payment of principal and interest on such indebtedness may limit funds available for its business activities, and BioSante could be subject to covenants that restrict its ability to operate its business and make distributions to its stockholders.  These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of BioSante’s assets, as well as prohibitions on the ability of BioSante to create liens, pay dividends, redeem its stock or make investments.  There is no assurance that any equity or debt financing transaction will be available on terms acceptable to BioSante, or at all.

 

As an alternative to raising additional financing by issuing additional equity or debt securities, BioSante may choose to license one or more of its products or technologies to a third party who may finance a portion or all of the continued development and, if approved, commercialization of that licensed product, sell certain assets or rights under BioSante’s existing license agreements or enter into other business collaborations or combinations, including a possible sale or merger of its company.  If BioSante raises additional funds through licensing arrangements, BioSante may be required to relinquish greater or all rights to BioSante’s products at an earlier stage of development or on less favorable terms than BioSante otherwise would choose.

 

BioSante has substantial indebtedness, in the form of convertible senior notes, which notes BioSante may not be able to pay when they become due and payable on May 1, 2013, or earlier if BioSante experiences a “fundamental change” or an “event of default” under the indenture governing such notes.

 

As of December 31, 2012, BioSante had $8.3 million in aggregate principal amount of convertible senior notes outstanding.  The annual interest payment on these notes is approximately $259,000.  At maturity, on May 1, 2013, the entire then remaining aggregate outstanding principal amount of the convertible senior notes will become due and payable. In addition, upon the occurrence of a “fundamental change”, holders of the convertible senior notes may require BioSante to purchase their notes prior to the May 1, 2013 maturity date. A fundamental change includes a significant change in BioSante’s ownership; the first day the majority of its board of directors does not consist of continuing directors; the consummation of certain recapitalizations,

 

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reclassifications, or changes of common stock, share exchanges or consolidations or mergers; or the termination of trading of BioSante common stock (which will be deemed to have occurred if BioSante common stock is neither listed for trading on a United States national securities exchange nor any United States system of automated dissemination of quotations of securities prices or traded in over-the-counter securities markets). The proposed merger between BioSante and ANI will not amount to a “fundamental change” under the indenture. Additionally, the aggregate principal amount of the outstanding convertible senior notes will become due and payable upon an uncured or unwaived event of default.  Although BioSante believes it will be able to pay the aggregate outstanding principal amount of its convertible senior notes plus accrued interest when the notes mature on May 1, 2013, it is possible that BioSante may not have sufficient funds to pay the aggregate principal amount of its then outstanding convertible senior notes when they mature on May 1, 2013, or become due and payable earlier if BioSante were to experience a “fundamental change” or an “event of default” under the indenture governing such notes.

 

The indentures governing BioSante’s convertible senior notes contains covenants, which if not complied with, could result in an event of default and the acceleration of all amounts due under the notes.

 

The indenture governing BioSante’s convertible senior notes contains covenants, such as the requirement to pay accrued interest on May 1 and November 1 of each year, the requirement to repurchase the notes upon a “fundamental change,” as defined in the indenture, if a note holder so elects and the requirement to file periodic reports electronically with the SEC.  If BioSante does not comply with the covenants in the indenture, an event of default could occur and all amounts due under the notes could become immediately due and payable.  Upon the occurrence of an event of default under the indenture, the trustee has available a range of remedies customary in these circumstances, including declaring all such indebtedness, together with accrued and unpaid interest thereon, to be due and payable.  Although it is possible BioSante could negotiate a waiver with the trustee and the holders of the notes, such a waiver likely would involve significant costs.  It also is possible that BioSante could refinance or restructure its obligations under the notes; however, such a refinancing or restructuring also likely would involve significant costs and likely would result in higher interest rates than the current 3.125% annual interest rate on the notes.

 

Future purchases, exchanges or restructurings of BioSante’s outstanding convertible senior notes could dilute the percentage ownership of the BioSante stockholders, result in the issuance of securities at a discount to market price or that may have rights, preferences or privileges senior to those of BioSante’s existing stockholders and/or decrease its cash balance.

 

In February 2012, BioSante entered into privately-negotiated securities exchange agreements with one of the holders of its convertible senior notes pursuant to which BioSante issued an aggregate of 1,868,055 shares of its common stock, as adjusted to reflect its one-for-six reverse stock split effected on June 1, 2012, to the note holder in exchange for the cancellation of an aggregate of $9.0 million principal amount of BioSante’s convertible senior notes, including accrued and unpaid interest of $79,024.  In July 2012, BioSante entered into a privately-negotiated securities exchange agreement with two of the holders of its convertible senior notes pursuant to which BioSante issued an aggregate of 1,784,070 shares of its common stock to the note holder in exchange for the cancellation of an aggregate of $3.5 million principal amount of BioSante’s convertible senior notes and accrued and unpaid interest of $20,686.  An aggregate of $8.3 million principal amount of the convertible senior notes remained outstanding as of September 30, 2012.  From time-to-time, BioSante again may purchase, exchange or restructure its outstanding convertible senior notes through cash purchases and/or exchanges for other equity securities of its company, in open market purchases, privately negotiated transactions and/or a tender offer.  Such additional purchases, exchanges or restructurings, if any, will depend on prevailing market conditions, the trading price and volume of BioSante common stock, the willingness of the note holders to sell, exchange or restructure their notes, BioSante’s available cash and cash equivalents, its liquidity requirements, regulatory limitations, contractual restrictions and other factors.  Such future purchases, exchanges or restructurings could dilute the percentage ownership of the BioSante stockholders, result in the issuance of securities at a discount to market price or that may have rights, preferences or privileges senior to those of existing BioSante stockholders and/or decrease BioSante’s cash balance.  A significant decrease in

 

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BioSante’s cash balance may impair its ability to execute strategic alternatives, including the proposed merger with ANI, or leave BioSante without sufficient cash remaining for operations.

 

BioSante is subject to pending purported securities class action and shareholder derivative litigation, which could divert management’s attention, harm its business and/or reputation and result in significant liabilities, as well as harm its ability to raise additional financing and execute certain strategic alternatives.

 

BioSante is subject to pending purported securities class action and shareholder derivative litigation.

 

On February 3, 2012, a purported class action lawsuit was filed in the United States District Court for the Northern District of Illinois under the caption Thomas Lauria, on behalf of himself and all others similarly situated v. BioSante Pharmaceuticals, Inc. and Stephen M. Simes naming BioSante and its President and Chief Executive Officer, Stephen M. Simes, as defendants.  The complaint alleges that certain of BioSante’s disclosures relating to the efficacy of LibiGel and its commercial potential were false and/or misleading and that such false and/or misleading statements had the effect of artificially inflating the price of BioSante’s securities resulting in violations of Section 10(b) of the Securities Exchange Act of 1934, as amended, Rule 10b-5 and Section 20(a) of the Exchange Act.  Although a substantially similar complaint was filed in the same court on February 21, 2012, such complaint was voluntarily dismissed by the plaintiff in April 2012.  The plaintiff seeks to represent a class of persons who purchased BioSante’s securities between February 12, 2010 and December 15, 2011, and seeks unspecified compensatory damages, equitable and/or injunctive relief, and reasonable costs, expert fees and attorneys’ fees on behalf of such purchasers.  BioSante believes the action is without merit and intends to defend the action vigorously.  On November 6, 2012, the plaintiff filed a consolidated amended complaint.  On December 28, 2012, BioSante and Mr. Simes filed motions to dismiss the consolidated amended complaint.  Briefing on the motion to dismiss is ongoing and is expected to be completed during the first quarter of 2013.

 

On May 7, 2012, Jerome W. Weinstein, a purported stockholder of BioSante filed a shareholder derivative action in the United States District Court for the Northern District of Illinois under the caption Weinstein v. BioSante Pharmaceuticals, Inc. et al., naming BioSante’s directors as defendants and BioSante as a nominal defendant.  A substantially similar complaint was filed in the same court on May 22, 2012 and another substantially similar complaint was filed in the Circuit Court for Cook County, Illinois, County Department, Chancery Division, on June 27, 2012.  The suits generally related to the same events that are the subject of the class action litigation described above.  The complaints allege breaches of fiduciary duty, abuse of control, gross mismanagement and unjust enrichment as causes of action occurring from at least February 2010 through December 2011.  The complaints seek unspecified damages, punitive damages, costs and disbursements and unspecified reform and improvements in BioSante’s corporate governance and internal control procedures.  On September 24, 2012, the District Court consolidated the two cases before it and on November 20, 2012 plaintiffs filed their consolidated amended complaint.  On November 27, 2012, the plaintiff in the action pending in Illinois state court filed an amended complaint.  On January 11, 2013, the defendants filed a motion to dismiss the amended complaint in the action pending in District Court, and on January 18, 2013, the defendants filed a motion to dismiss the amended complaint in the action pending in Illinois state court. Briefing on these motions is ongoing and is expected to be completed during the first quarter of 2013.

 

The lawsuits are in their early stages; and, therefore, BioSante is unable to predict the outcome of the lawsuits and the possible loss or range of loss, if any, associated with their resolution or any potential effect the lawsuits may have on BioSante’s operations.  Depending on the outcome or resolution of these lawsuits, they could have a material effect on BioSante’s operations, including its financial condition, results of operations, or cash flows.

 

BioSante is not involved in any other legal actions, however, from time to time may be subject to various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of

 

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its business.  Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time.

 

Risks Related to BioSante’s Business

 

BioSante’s two pivotal LibiGel Phase III efficacy trials did not meet the co-primary and secondary endpoints, and it is possible that the two new LibiGel Phase III efficacy trials, if BioSante decides to pursue them, will not meet the co-primary and secondary endpoints, which could harm BioSante’s business and further disappoint BioSante stockholders and cause the trading price of BioSante common stock to decrease.

 

BioSante’s lead near term product in development is LibiGel for the treatment of FSD, specifically HSDD, in postmenopausal women, for which there is no FDA-approved product.  In June 2012, BioSante announced a plan to initiate two new LibiGel Phase III efficacy trials.  This decision was based on an extensive analysis of previous efficacy data, consultation with key opinion leaders in FSD, testosterone therapy and placebo effects, as well as a meeting with the FDA. The protocol for the two new efficacy trials is in development.  BioSante intends to apply for an FDA Special Protocol Assessment (SPA) agreement prior to initiating the two new efficacy trials.  Currently, it is expected that the efficacy trials will include the same FDA-required efficacy endpoints as prior Phase III efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire.

 

The initiation of the two new LibiGel Phase III efficacy trials involves risk, especially since BioSante’s prior LibiGel Phase III efficacy trials failed to meet the co-primary or secondary endpoints.  Although the results indicated that LibiGel performed as predicted based on previous experience with testosterone products for female sexual dysfunction, the placebo response in the two efficacy trials was greater than expected; and therefore, LibiGel’s results were not shown to be statistically different from placebo.  No assurance can be provided that BioSante will be able to design the two new LibiGel Phase III efficacy trials to minimize sufficiently the placebo effect and meet the co-primary and secondary endpoints for the trials.  In addition, BioSante can provide no assurance that it will be able to obtain an FDA SPA agreement for such trials or that BioSante will initiate or complete the trials on a timely basis, or ever.  Any of these possible results could harm BioSante’s business and further disappoint BioSante stockholders and cause the trading price of BioSante common stock to decrease.

 

Although BioSante’s male testosterone gel is approved by the FDA, BioSante is uncertain as to when Teva will begin to market and sell the male testosterone gel and thus when or if BioSante would begin to receive royalties from such sales in light of Teva’s settlement agreement with AbbVie Inc.

 

BioSante’s male testosterone gel was developed initially by BioSante, and then licensed by BioSante to Teva for late stage clinical development.  Teva submitted a New Drug Application, which NDA was approved by the FDA in February 2012.  Subsequent to Teva submitting the NDA, in April 2011, AbbVie Inc., a marketer of a testosterone gel for men, filed a complaint against Teva alleging patent infringement.  The Teva/AbbVie patent infringement litigation was settled in December 2011; however, the terms of the settlement agreement are confidential and have not been publicly disclosed.  In light of the settlement agreement, BioSante is uncertain as to when or if Teva will begin to market and sell its male testosterone gel and thus when or if BioSante would begin to receive royalties from such sales.

 

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Several of BioSante’s products are in the clinical development stages and, depending on the product, likely will not be approved by regulatory authorities or introduced commercially for at least several years and likely more, if at all.

 

Several of BioSante’s products are in the clinical development stages and will require further development, preclinical and clinical testing and investment prior to obtaining required regulatory approvals and commercialization in the United States and abroad.  Other than Elestrin and BioSante’s male testosterone gel, none of BioSante’s products have been approved by the FDA or other regulatory authorities; and accordingly, none of BioSante’s products have been introduced commercially and most are not expected to be for several years and likely more, if at all.  BioSante cannot assure you that any of its products in clinical development will:

 

·                  be developed successfully;

 

·                  prove to be safe and effective in clinical studies;

 

·                  meet applicable regulatory standards or obtain required regulatory approvals;

 

·                  demonstrate substantial protective or therapeutic benefits in the prevention or treatment of any disease;

 

·                  be capable of being produced in commercial quantities at reasonable costs;

 

·                  obtain coverage and favorable reimbursement rates from insurers and other third-party payors; or

 

·                  be marketed successfully or achieve market acceptance by physicians and patients.

 

If BioSante fails to obtain regulatory approval to manufacture commercially or sell any of its future products, or if approval is delayed or withdrawn, BioSante will be unable to generate revenue from the sale of its products.

 

BioSante must obtain regulatory approval to sell any of its products in the United States and abroad.  In the United States, BioSante must obtain the approval of the FDA for each product or drug that BioSante intends to commercialize.  The FDA approval process typically is very lengthy and expensive, and approval never is certain. Products to be commercialized abroad are subject to similar foreign government regulation.

 

Generally, only a very small percentage of newly discovered pharmaceutical products that enter preclinical development eventually are approved for sale.  Because of the risks and uncertainties in biopharmaceutical development, BioSante’s products could take a significantly longer time to gain regulatory approval than BioSante expects or may never gain approval.  If regulatory approval is delayed or never obtained, the credibility of BioSante’s management, the value of BioSante and its operating results and liquidity would be affected adversely.  Even if a product gains regulatory approval, the product and the manufacturer of the product may be subject to continuing regulatory review and BioSante may be restricted or prohibited from marketing or manufacturing a product if previously unknown problems with the product or its manufacture of the product subsequently are discovered.  The FDA also may require BioSante to commit to perform lengthy post-approval studies, for which BioSante would have to expend significant additional resources, which could have an adverse effect on its operating results and financial condition.

 

To obtain regulatory approval to market many of BioSante’s products, costly and lengthy human clinical trials are required, and the results of the studies and trials are highly uncertain.  As part of the FDA approval process, BioSante must conduct, at its own expense or the expense of current or potential licensees or other entities, clinical trials in human subjects on each of BioSante’s products.  BioSante expects the number of human clinical trials that the FDA will require will vary depending on the product, the disease or condition

 

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the product is being developed to address and regulations applicable to the particular product.  Depending on the stage of development, BioSante may need to perform multiple pre-clinical studies using various doses and formulations before BioSante can begin human clinical trials, which could result in delays in BioSante’s ability to market its products.  Furthermore, even if BioSante obtains favorable results in pre-clinical studies on animals, the results in humans may be different.

 

In order to receive regulatory approval for commercial sale, BioSante must demonstrate that its products are safe and effective for use in the target human population.  The data obtained from pre-clinical and human clinical testing are subject to varying interpretations that could delay, limit or prevent regulatory approval.  BioSante faces the risk that the results of its clinical trials in later phases of clinical trials may be inconsistent with those obtained in earlier phases.  As an example, BioSante’s prior two pivotal LibiGel Phase III efficacy trials did not meet the co-primary endpoints of an increase in satisfying sexual events and an increase in desire and the secondary endpoint of a decrease in distress compared to placebo even though treatment with LibiGel in BioSante’s Phase II clinical trial significantly increased satisfying sexual events compared to placebo.  A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after experiencing promising results in early animal or human testing.  Adverse or inconclusive human clinical results would prevent BioSante from submitting for regulatory approval of its products.

 

Additional factors that can cause delay or termination of BioSante’s human clinical trials include:

 

·                  slow subject enrollment;

 

·                  timely completion of clinical site protocol approval and obtaining informed consent from subjects;

 

·                  longer treatment time required to demonstrate efficacy or safety;

 

·                  new or additional trials or studies that are designed differently in order to increase the chances of demonstrating efficacy or safety;

 

·                  adverse medical events or side effects in treated subjects;

 

·                  lack of effectiveness of the product being tested; and

 

·                  lack of funding.

 

Delays in BioSante’s clinical trials could allow its competitors additional time to develop or market competing products and thus can be extremely costly in terms of lost sales opportunities and increased clinical trial costs.

 

The process for obtaining FDA approval of an NDA is time consuming, subject to unanticipated delays and costs, and requires the commitment of substantial resources.

 

BioSante’s products in development will require the submission and approval of an NDA in order to obtain required approval by the FDA to commercially market the product.  The FDA conducts in-depth reviews of NDAs to determine whether to approve products for commercial marketing for the indications proposed.  If the FDA is not satisfied with the information provided, the FDA may refuse to approve an NDA or may require a company to perform additional studies or provide other information in order to secure approval.  The FDA may delay, limit or refuse to approve an NDA for many reasons, including:

 

·                  the information submitted may be insufficient to demonstrate that a product is safe and effective;

 

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·                  the FDA might not approve the processes or facilities of a company, or those of its vendors, that will be used for the commercial manufacture of a product; or

 

·                  the FDA’s interpretation of the nonclinical, clinical or manufacturing data provided in an NDA may differ from a company’s interpretation of such data.

 

If the FDA determines that the clinical studies submitted for a product candidate in support of an NDA are not conducted in full compliance with the applicable protocols for these studies, as well as with applicable regulations and standards, or if the FDA does not agree with a company’s interpretation of the results of such studies, the FDA may reject the data that resulted from such studies.  The rejection of data from clinical studies required to support an NDA could affect negatively a company’s ability to obtain marketing authorization for a product and would have a material adverse effect on a company’s business and financial condition.  In addition, an NDA may not be approved, or approval may be delayed, as a result of changes in FDA policies for drug approval during development or the review period.

 

BioSante may not achieve projected goals and objectives in the time periods that BioSante anticipates or announce publicly, which could have an adverse effect on its business and could cause the price of BioSante common stock to decline.

 

BioSante sets goals and objectives for, and makes public statements regarding, the timing of certain accomplishments and milestones regarding its business, such as the initiation and completion of clinical studies, the completion of enrollment for clinical studies, the submission of applications for regulatory approvals, the receipt of regulatory approvals and other developments and milestones.  The actual timing of these events can vary dramatically due to a number of factors including without limitation delays or failures in BioSante’s current clinical studies, the amount of time, effort and resources committed to its programs by BioSante and its current and potential future strategic partners and the uncertainties inherent in the clinical studies and regulatory approval process.  As a result, there can be no assurance that clinical studies involving BioSante’s products in development will advance or be completed in the time periods that BioSante or its strategic partners announce or expect, that BioSante or its current and potential future strategic partners will make regulatory submissions or receive regulatory approvals as planned or that BioSante or its current and potential future strategic partners will be able to adhere to its current schedule for the achievement of key milestones under any of its development programs.  If BioSante or any of its strategic partners fail to achieve one or more of these milestones as planned, BioSante’s business could be affected adversely and materially and the trading price of BioSante common stock could decline.  BioSante also discloses from time-to-time projected financial information, including its cash position and anticipated cash burn rate and other expenditures, for future periods.  These financial projections are based on management’s current expectations and may not contain any margin of error or cushion for any specific uncertainties, or for the uncertainties inherent in all financial forecasting.

 

If the market opportunities for BioSante’s products are smaller than BioSante anticipates, then its future revenues and business may be affected adversely.

 

From time-to-time, BioSante discloses estimated market opportunity data for its products and products in development.  Although BioSante believes it has a reasonable basis for its market opportunity estimates, BioSante estimates may prove to be incorrect.  If the market opportunities for BioSante’s products are smaller than BioSante anticipates, its anticipated revenues from the sales or licensure of such products will be lower than BioSante anticipates.

 

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Uncertainties associated with the impact of published studies regarding the adverse health effects of certain forms of hormone therapy could adversely affect the market for BioSante’s hormone therapy products and the trading price of BioSante common stock.

 

The market for hormone therapy products has been affected negatively by the Women’s Health Initiative (WHI) study and other studies that have found that the overall health risks from the use of certain hormone therapy products may exceed the benefits from the use of those products among postmenopausal women.  In July 2002, the National Institutes of Health (NIH) released data from its WHI study on the risks and benefits associated with long-term use of oral hormone therapy by women.  The NIH announced that it was discontinuing the arm of the study investigating the use of oral estrogen/progestin combination hormone therapy products after an average follow-up period of 5.2 years because the product used in the study was shown to cause an increase in the risk of invasive breast cancer.  The study also found an increased risk of stroke, heart attacks and blood clots and concluded that overall health risks exceeded benefits from use of combined estrogen plus progestin for an average of 5.2 year follow-up among postmenopausal women.  Also, in July 2002, results of an observational study sponsored by the National Cancer Institute on the effects of estrogen therapy were announced.  The main finding of the study was that postmenopausal women who used estrogen therapy for 10 or more years had a higher risk of developing ovarian cancer than women who never used hormone therapy.  In October 2002, a significant hormone therapy study being conducted in the United Kingdom also was halted.  BioSante’s products differ from the products used in the WHI study and the primary products observed in the National Cancer Institute and United Kingdom studies.  In March 2004, the NIH announced that the estrogen-alone study was discontinued after nearly seven years because the NIH concluded that estrogen alone does not affect (either increase or decrease) heart disease, the major question being evaluated in the study.  The findings indicated a slightly increased risk of stroke as well as a decreased risk of hip fracture and breast cancer.  Preliminary data from the memory portion of the WHI study suggested that estrogen alone may possibly be associated with a slight increase in the risk of dementia or mild cognitive impairment.

 

Researchers continue to analyze data from both arms of the WHI study and other studies.  Some reports indicate that the safety of estrogen products may be affected by the age of the woman at initiation of therapy.  There currently are no studies published comparing the safety of BioSante’s products against other hormone therapies.  The markets for female hormone therapies for menopausal symptoms declined as a result of these published studies, although the market now seems to have stabilized.  The release of any follow-up or other studies that show adverse effects from hormone therapy, including in particular, hormone therapies similar to BioSante’s products, also could adversely affect BioSante’s business and decrease the trading price of BioSante common stock.

 

If clinical studies for BioSante’s products are terminated, prolonged or delayed, it may be difficult for BioSante to find a strategic partner to assist it in the development and commercialization of its non-partnered products or commercialize such products on a timely basis, which would require BioSante to incur additional costs and delay or prevent its receipt of any revenue from potential product sales or licenses.

 

BioSante may encounter problems with its completed, ongoing or planned clinical studies for its products that may cause it or the FDA to delay, suspend or terminate those studies or delay the analysis of data derived from them.  A number of events, including any of the following, could delay the completion of, or cause BioSante to suspend or terminate its ongoing and planned clinical studies for its products and negatively impact BioSante’s ability to obtain regulatory approval or enter into strategic partnerships for, or market or sell, a particular product:

 

·                  conditions imposed on BioSante by the FDA or any foreign regulatory authority regarding the scope or design of its clinical studies;

 

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·                  delay in developing, or BioSante’s inability to obtain, a clinical dosage form, insufficient supply or deficient quality of its products or other materials necessary to conduct its clinical studies;

 

·                  negative or inconclusive results from clinical studies, or results that are inconsistent with earlier results, that necessitate additional clinical study or termination of a clinical program;

 

·                  serious and/or unexpected product-related side effects experienced by subjects in BioSante’s clinical studies; or

 

·                  failure of BioSante’s third-party contractors or its investigators to comply with regulatory requirements or otherwise meet their contractual obligations to BioSante in a timely manner.

 

Regulatory authorities, clinical investigators, institutional review boards, data safety monitoring boards and the sites at which BioSante’s clinical studies are conducted all have the power to stop or recommend stopping its clinical studies prior to completion.  BioSante’s clinical studies for its products in development may not begin as planned, may need to be amended, suspended or terminated and may not be completed on schedule, if at all.  This is particularly true if BioSante no longer believes it can obtain regulatory approval for a particular product or if BioSante no longer has the financial resources to dedicate to a clinical development program for a particular product.

 

BioSante relies on third parties to assist it in certain aspects of its clinical studies.  If these third parties do not perform as required contractually or expected, BioSante’s clinical studies may be extended, delayed or terminated or may need to be repeated, and BioSante may not be able to obtain regulatory approval for or commercialize the product being tested in such studies.

 

BioSante relies on third parties, such as medical institutions, academic institutions, clinical investigators and contract laboratories, to assist it in certain aspect of its clinical studies.  BioSante is responsible for confirming that BioSante’s studies are conducted in accordance with applicable regulations and that each of its clinical trials is conducted in accordance with its general investigational plan and protocol.  The FDA requires BioSante to comply with regulations and standards, commonly referred to as good clinical practices for conducting, monitoring, recording and reporting the results of clinical trials, to assure that data and reported results are accurate and that the clinical trial participants are adequately protected.  BioSante’s reliance on these few third parties does not relieve it of these responsibilities.  If the third parties assisting BioSante with certain aspects of its clinical studies do not perform their contractual duties or obligations, do not meet expected deadlines, fail to comply with the FDA’s good clinical practice regulations, do not adhere to BioSante’s protocols or otherwise fail to generate reliable clinical data, BioSante may need to enter into new arrangements with alternative third parties and its clinical studies may be extended, delayed or terminated or may need to be repeated, and BioSante may not be able to obtain regulatory approval for or commercialize the product being tested in such studies.  In addition, if a third party fails to perform as agreed, BioSante’s ability to collect damages may be limited contractually.

 

BioSante’s products will remain subject to ongoing regulatory review even if BioSante receives marketing approval.  If BioSante fails to comply with continuing regulations, BioSante could lose these approvals, and the sale of any future products could be suspended.

 

Even if BioSante receives regulatory approval to market a particular product in development, the FDA or a foreign regulatory authority could condition approval on conducting additional costly post-approval studies or could limit the scope of BioSante’s approved labeling or could impose burdensome post-approval obligations under a Risk Evaluation and Mitigation Strategy (REMS).  If required, a REMS may include various elements, such as publication of a medication guide, a patient package insert, a communication plan to educate healthcare providers of the drug’s risks, limitations on who may prescribe or dispense the drug or other measures that the FDA deems necessary to assure the safe use of the drug.  Moreover, the product may later cause adverse effects that limit or prevent its widespread use, result in more restrictive labeling than originally

 

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approved, force BioSante to withdraw it from the market, cause the FDA to impose additional REMS obligations or impede or delay BioSante’s ability to obtain regulatory approvals in additional countries.  In addition, BioSante will continue to be subject to FDA review and periodic inspections to ensure adherence to applicable regulations.  After receiving marketing approval, the FDA imposes extensive regulatory requirements on the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping related to the product.

 

If BioSante fails to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities or previously unknown problems with any future products, suppliers or manufacturing processes are discovered, BioSante could be subject to administrative or judicially imposed sanctions, including:

 

·                  restrictions on the products, suppliers or manufacturing processes;

 

·                  warning letters or untitled letters;

 

·                  civil or criminal penalties or fines;

 

·                  injunctions;

 

·                  product seizures, detentions or import bans;

 

·                  voluntary or mandatory product recalls and publicity requirements;

 

·                  suspension or withdrawal of regulatory approvals;

 

·                  total or partial suspension of production; and

 

·                  refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications.

 

BioSante may enter into additional strategic relationships with third parties to help develop and commercialize its products in development.  If BioSante does not enter into such relationships, BioSante will need to undertake development and commercialization efforts on its own, which would be costly and could delay BioSante’s ability to obtain required approvals for and commercialize its future products.

 

A key element of BioSante’s business strategy is BioSante’s intent to partner selectively with pharmaceutical, biotechnology and other companies to obtain assistance for commercialization and, in some cases, development of its products.  For example, BioSante has a strategic relationship with Meda with respect to Elestrin, with Teva with respect to BioSante’s male testosterone gel and with Pantarhei Science with respect to The Pill Plus.  BioSante currently does not have a strategic partner for LibiGel.

 

BioSante may enter into additional strategic relationships with third parties to develop, and if regulatory approval is obtained commercialize, its products in development, including LibiGel, and any additional new products BioSante may acquire or in-license.  BioSante faces significant competition in seeking appropriate strategic partners, and these strategic relationships can be intricate and time consuming to negotiate and document.  BioSante may not be able to negotiate additional strategic relationships on acceptable terms, or at all.  BioSante is unable to predict when, if ever, it will enter into any additional strategic relationships because of the numerous risks and uncertainties associated with establishing such relationships.  If BioSante is unable to negotiate additional strategic relationships for its products, BioSante may be forced to curtail the development of a particular product, reduce, delay or terminate its development program or one or more of its other development programs, delay its potential commercialization, reduce the scope of anticipated sales or marketing activities or undertake development or commercialization activities at BioSante’s own expense.  In

 

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addition, BioSante would then bear all the risk related to the development and commercialization of that product.  If BioSante elects to increase its expenditures to fund development or commercialization activities on its own, BioSante may need to obtain additional capital, which may not be available to BioSante on acceptable terms, or at all.  If BioSante does not have sufficient funds, BioSante will not be able to bring its products in development and any additional new products BioSante may acquire or in-license if they receive regulatory approvals to market and generate product revenue.

 

If BioSante is unable to partner with a third party and obtain assistance for the potential commercialization of its products, if approved for commercial sale, BioSante would need to establish its own sales and marketing capabilities, which involves risk.

 

BioSante does not have an internal sales and marketing organization and has limited experience in the sales, marketing and distribution of pharmaceutical products.  There are risks involved with establishing BioSante’s own sales capabilities and increasing its marketing capabilities, as well as entering into arrangements with third parties to perform these services.  Developing an internal sales force is expensive and time consuming and could delay any product launch.  On the other hand, if BioSante enters into arrangements with third parties to perform sales, marketing and distribution services, revenues from sales of the product or the profitability of these product revenues are likely to be lower than if BioSante markets and sells any products that BioSante develops itself.

 

Although BioSante’s preferred alternative would be to engage a pharmaceutical or other healthcare company with an existing sales and marketing organization and distribution systems to sell, market and distribute its products, if approved for commercial sale, if BioSante is unable to engage such a sales and marketing partner, BioSante may need to establish its own specialty sales force.  Factors that may inhibit BioSante’s efforts to commercialize any future products without strategic partners or licensees include:

 

·                  BioSante’s inability to recruit and retain adequate numbers of effective sales and marketing personnel;

 

·                  the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any future products;

 

·                  the lack of complementary products to be offered by sales personnel, which may put BioSante at a competitive disadvantage relative to companies with more extensive product lines; and

 

·                  unforeseen costs and expenses associated with creating an independent sales and marketing organization.

 

Because the establishment of sales and marketing capabilities depends on the progress towards commercialization of BioSante’s products and because of the numerous risks and uncertainties involved with establishing its own sales and marketing capabilities, BioSante is unable to predict when, if ever, BioSante will establish its own sales and marketing capabilities.  If BioSante is not able to partner with additional third parties and are unsuccessful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure, BioSante will have difficulty commercializing its products, which would harm its business and financial condition.

 

BioSante’s current strategic relationships and any future additional strategic relationships it may enter into involve risks with respect to the development and commercialization of its products.

 

A key element of BioSante’s business strategy is to selectively partner with pharmaceutical, biotechnology and other companies to obtain assistance for commercialization and, in some cases, development of BioSante’s products.  For example, BioSante has strategic relationships with Meda with

 

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respect to Elestrin, with Teva with respect to its male testosterone gel and with Pantarhei Science with respect to The Pill Plus.

 

BioSante’s current strategic relationships and any future additional strategic relationships BioSante may enter into involve a number of risks, including:

 

·                  business combinations or significant changes in a strategic partner’s business strategy may affect adversely a strategic partner’s willingness or ability to complete its obligations under any arrangement;

 

·                  BioSante may not be able to control the amount and timing of resources that its strategic partners devote to the development or commercialization of its partnered products;

 

·                  strategic partners may delay clinical trials, provide insufficient funding, terminate a clinical trial or abandon a partnered product, repeat or conduct new clinical trials or require a new version of a product for clinical testing;

 

·                  strategic partners may not pursue further development and commercialization of partnered products resulting from the strategic partnering arrangement or may elect to delay research and development programs or commercialization of a partnered product;

 

·                  strategic partners may not commit adequate resources to the marketing and distribution of BioSante’s partnered products, limiting BioSante’s potential revenues from these products;

 

·                  disputes may arise between BioSante and its strategic partners that result in the delay or termination of the research, development or commercialization of its partnered products or that result in costly litigation or arbitration that diverts management’s attention and consumes resources;

 

·                  strategic partners may experience financial difficulties;

 

·                  strategic partners may not maintain properly or defend BioSante’s intellectual property rights or may use its proprietary information in a manner that could jeopardize or invalidate its proprietary information or expose BioSante to potential litigation;

 

·                  strategic partners independently could move forward with competing products developed either independently or in collaboration with others, including BioSante’s competitors; and

 

·                  strategic partners could terminate or delay the arrangement or allow it to expire, which would delay the development or commercialization of the partnered product and may increase the cost of developing or commercializing the partnered product.

 

Although BioSante maintains the right to receive sales-based milestones of up to $140 million, its ability to receive these milestones is dependent upon Meda’s ability to market and sell Elestrin, and based on Elestrin sales to date, BioSante believes it is unlikely that it will receive any sales-based milestone payments from Meda in the foreseeable future, or at all.

 

Meda (which acquired Jazz Pharmaceuticals, Inc.’s women’s health business, and which in turn had acquired BioSante’s original licensee, Azur Pharma International II Limited (Azur)), is marketing Elestrin in the U.S.  In December 2009, BioSante entered into an amendment to its original licensing agreement with Azur pursuant to which BioSante received $3.16 million in non-refundable payments in exchange for the elimination of all remaining future royalty payments and certain milestone payments that could have been paid to BioSante related to sales of Elestrin.  BioSante continues to recognize certain royalty revenue from sales of

 

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Elestrin; however, such revenue is offset by its corresponding obligation to pay royalties to Antares, from whom BioSante licensed the technology underlying its Elestrin product.  BioSante maintains the right to receive up to $140 million in sales-based milestone payments from Meda if Elestrin reaches certain predefined sales per calendar year.  BioSante can provide no assurance that Meda will be successful in marketing Elestrin, Elestrin will be accepted widely in the marketplace or that Meda will remain focused on the commercialization of Elestrin, especially if Meda does not experience significant Elestrin sales.  Based on current sales of Elestrin, BioSante believes it is unlikely that BioSante will receive any sales-based milestone payments from Meda in the near term, if at all.

 

If BioSante’s products in development receive FDA approval and are introduced commercially, they may not achieve expected levels of market acceptance, which could harm BioSante’s business, financial position and operating results and could cause the trading price of BioSante common stock to decline.

 

The commercial success of BioSante’s products in development, if BioSante receives the required FDA or other regulatory approvals, and the commercial success of its male testosterone gel, which is FDA approved, but not yet commercially launched, are dependent upon acceptance by physicians, patients, third-party payors and the medical community.  Levels of market acceptance for such products, if approved for commercial sale with respect to BioSante’s products in development, could be affected by several factors, including:

 

·                  demonstration of efficacy and safety in clinical trials with respect to BioSante’s products in development;

 

·                  the existence, prevalence and severity of any side effects;

 

·                  the availability of competitive or alternative treatments and potential or perceived advantages or disadvantages compared to competitive or alternative treatments;

 

·                  the timing of market entry relative to competitive treatments;

 

·                  relative convenience, product dependability and ease of administration;

 

·                  the strength of marketing and distribution support;

 

·                  the sufficiency of coverage and reimbursement of BioSante’s products by third-party payors and governmental and other payors; and

 

·                  the product labeling or product insert required by the FDA or regulatory authorities in other countries.

 

Some of these factors are not within BioSante’s control, especially if BioSante has transferred all of the marketing rights associated with the product, as BioSante has with the U.S. marketing rights to Elestrin to Meda, and the U.S. development and marketing rights to its male testosterone gel to Teva.  BioSante’s products may not achieve expected levels of market acceptance.

 

Additionally, continuing studies of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by other companies, government agencies and others.  Such studies, which increasingly employ sophisticated methods and techniques, can call into question the use, safety and efficacy of previously marketed products.  In some cases, these studies have resulted, and in the future may result, in the discontinuance of product marketing.  These situations, should they occur, could harm BioSante’s business, financial position and results of operations, and the trading price of BioSante common stock could decline.

 

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Even if BioSante or its strategic partners successfully develop, obtain required regulatory approvals and commercialize any of its products under development, BioSante faces uncertainty with respect to pricing, third-party reimbursement and healthcare reform, all of which could affect adversely the commercial success of BioSante’s products.

 

BioSante’s ability to collect significant revenues from sales of its products, if approved and commercialized, may depend on its ability, and the ability of any current or potential future strategic partners or customers, to obtain adequate levels of coverage and reimbursement for such products from third-party payers such as:

 

·                  private health insurers;

 

·                  health maintenance organizations;

 

·                  pharmacy benefit management companies;

 

·                  government health administration authorities; and

 

·                  other healthcare-related organizations.

 

Third-party payers increasingly are challenging the prices charged for medical products and services.  For example, third-party payers may deny coverage or offer inadequate levels of reimbursement if they determine that a prescribed product has not received appropriate clearances from the FDA, or foreign equivalent, or other government regulators, is not used in accordance with cost-effective treatment methods as determined by the third-party payer, or is experimental, unnecessary or inappropriate.  Prices also could be driven down by health maintenance organizations that control or significantly influence purchases of healthcare services and products.  If third-party payers deny coverage or offer inadequate levels of reimbursement, BioSante or any of its strategic partners may not be able to market its products effectively or it may be required to offer its products at prices lower than anticipated.

 

In both the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory proposals and initiatives to change the health care system in ways that could affect BioSante’s ability to sell its products profitably.  Some of these proposed and implemented reforms could result in reduced reimbursement rates for BioSante’s products, which could affect adversely its business strategy, operations and financial results.  For example, in March 2010, President Obama signed into law a legislative overhaul of the U.S. healthcare system, known as the Patient Protection and Affordable Care Act of 2010, as amended by the Healthcare and Education Affordability Reconciliation Act of 2010, which is referred to as the PPACA.  This legislation may have far reaching consequences for life science companies like BioSante.  As a result of this new legislation, substantial changes could be made to the current system for paying for healthcare in the United States, including changes made in order to extend medical benefits to those who currently lack insurance coverage.  Extending coverage to a large population could substantially change the structure of the health insurance system and the methodology for reimbursing medical services, drugs and devices.  These structural changes could entail modifications to the existing system of private payors and government programs, such as Medicare and Medicaid, creation of a government-sponsored healthcare insurance source, or some combination of both, as well as other changes.  Restructuring the coverage of medical care in the United States could impact the reimbursement for prescribed drugs, biopharmaceuticals and medical devices.  If reimbursement for BioSante’s products, if approved, is substantially less that BioSante expects in the future, its business could be affected materially and adversely.

 

The cost-containment measures that healthcare providers are instituting and the results of healthcare reforms such as the PPACA may prevent BioSante from maintaining prices for its products that are sufficient for BioSante to realize profits and may otherwise significantly harm its business, financial condition and operating results.  In addition, to the extent that BioSante’s approved products are marketed outside of the

 

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United States, foreign government pricing controls and other regulations may prevent BioSante from maintaining prices for such products that are sufficient for BioSante to realize profits and may otherwise significantly harm its business, financial condition and operating results.

 

BioSante and its licensees depend on third-party manufacturers to produce its products and if these third parties do not manufacture successfully these products BioSante’s business would be harmed.

 

BioSante has no manufacturing experience or manufacturing capabilities for the production of its products for its clinical studies or, if approved, commercial sale.  In order to continue to develop products, apply for regulatory approvals and commercialize BioSante’s products following approval, if obtained, BioSante or its licensees must be able to manufacture or contract with third parties to manufacture its products in clinical and commercial quantities, in compliance with regulatory requirements, at acceptable costs and in a timely manner.  The manufacture of BioSante’s products may be complex, difficult to accomplish and difficult to scale-up when large-scale production is required.  Manufacture may be subject to delays, inefficiencies and poor or low yields of quality products.  The cost of manufacturing BioSante’s products may make them prohibitively expensive.  If supplies of any of BioSante’s products become unavailable on a timely basis or at all or are contaminated or otherwise lost, BioSante’s clinical studies could be seriously delayed or compromised, and with respect to its approved products, its future revenue from royalties and milestone payments could be affected adversely.

 

To the extent that BioSante or its licensees enter into manufacturing arrangements with third parties, BioSante and such licensees will depend upon these third parties to perform its obligations in a timely and effective manner and in accordance with government regulations.  Contract manufacturers may breach their manufacturing agreements because of factors beyond BioSante’s control or may terminate or fail to renew a manufacturing agreement based on their own business priorities at a time that is costly or inconvenient for BioSante.

 

BioSante’s existing and future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store and distribute BioSante’s products.  If a natural disaster, business failure, strike or other difficulty occurs, BioSante may be unable to replace these contract manufacturers in a timely or cost-effective manner and the production of its products would be interrupted, resulting in delays and additional costs.  Switching manufacturers or manufacturing sites would be difficult and time-consuming because the number of potential manufacturers is limited.  In addition, before a product from any replacement manufacturer or manufacturing site can be commercialized, the FDA must approve that site.  This approval would require regulatory testing and compliance inspections.  A new manufacturer or manufacturing site also would have to be educated in, or develop substantially equivalent processes for, production of BioSante’s products.  It may be difficult or impossible to transfer certain elements of a manufacturing process to a new manufacturer or for BioSante to find a replacement manufacturer on acceptable terms quickly, or at all, either of which would delay or prevent its ability to develop and commercialize its products.

 

If third-party manufacturers fail to perform their obligations, BioSante’s competitive position and ability to generate revenue may be affected adversely in a number of ways, including:

 

·                  BioSante and its strategic partners may be unable to initiate or continue clinical studies of its products that are under development;

 

·                  BioSante and its strategic partners may be delayed in submitting applications for regulatory approvals for its products that are under development; and

 

·                  BioSante and its strategic partners may be unable to meet commercial demands for any approved products.

 

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In addition, if a third-party manufacturer fails to perform as agreed, BioSante’s ability to collect damages may be contractually limited.

 

If BioSante reallocates its resources to other products and technologies in its current product portfolio or any additional new products and technologies that BioSante may acquire or in-license, BioSante may not be successful in developing such products and technologies and BioSante will be subject to all the risks and uncertainties associated with research and development of products and technologies.

 

BioSante has explored the possibility of reallocating its resources towards other products and technologies in its current product portfolio or any additional new products and technologies that BioSante may acquire or in-license.  It BioSante decides to reallocate its resources towards other products and technologies in its current product portfolio or any additional new products and technologies that BioSante may acquire or in-license, BioSante cannot guarantee that any such allocation would result in the identification and successful development of one or more approved and commercially viable products. The development of products and technologies is subject to a number of risks and uncertainties, including:

 

·                  the time, costs and uncertainty associated with the clinical testing required to demonstrate the safety and effectiveness of BioSante’s products and obtain regulatory approvals;

 

·                  the ability to raise sufficient funds to fund the research and development of BioSante’s products;

 

·                  the ability to find third party strategic partners to assist or share in the costs of product development, and potential dependence on such strategic partners, to the extent BioSante relies on them for future sales, marketing or distribution;

 

·                  the ability to protect the intellectual property rights associated with BioSante’s products;

 

·                  litigation;

 

·                  competition;

 

·                  ability to comply with ongoing regulatory requirements;

 

·                  government restrictions on the pricing and profitability of products in the United States and elsewhere; and

 

·                  the extent to which third-party payers, including government agencies, private health care insurers and other health care payers, such as health maintenance organizations, and self-insured employee plans, will cover and pay for newly approved therapies.

 

BioSante has very limited staffing and is dependent upon key employees and the limited use of independent contractors, the loss of some of which could affect adversely its operations.

 

BioSante’s success is dependent upon the efforts of a relatively small management team and staff.  BioSante also has engaged independent contractors from time-to-time on an as needed, project by project, basis.  During 2012, in order to reduce BioSante’s operating expenses, BioSante terminated all of its independent contractor arrangements and reduced its total employee headcount.  Such reductions in force, combined with BioSante’s future business prospects and financial condition, put BioSante at risk of losing key personnel who BioSante will need going forward to implement its business strategies.  BioSante has no redundancy of personnel in key development areas, including clinical, regulatory, strategic planning and finance.  BioSante has employment arrangements in place with its executive and other officers, but none of these executive and other officers is bound legally to remain employed with BioSante for any specific term.  BioSante does not have key man life insurance policies covering its executive and other officers or any of its

 

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other employees.  If key individuals leave BioSante, its business could be affected adversely if suitable replacement personnel are not recruited quickly.  There is competition for qualified personnel in the biotechnology and biopharmaceutical industry in the suburban Chicago, Illinois area in all functional areas, which makes it difficult to retain and attract the qualified personnel necessary for the development and growth of BioSante’s business.  BioSante’s financial condition and recent reductions in force and expense reductions may make it difficult for BioSante to retain current personnel and attract qualified employees and independent contractors in the future.

 

If plaintiffs bring product liability lawsuits against BioSante, BioSante may incur substantial liabilities and may be required to delay development or limit commercialization of any of BioSante’s products approved for commercial sale.

 

BioSante faces an inherent risk of product liability as a result of the clinical testing of its products in development and the commercial sale of its products that have been or will be approved for commercial sale.  BioSante may be held liable if any product it develops causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale.  Regardless of merit or eventual outcome, liability claims may result in decreased demand for BioSante’s products, injury to its reputation, withdrawal of clinical studies, costs to defend litigation, substantial monetary awards to clinical study participants or patients, loss of revenue and the inability to commercialize any products that BioSante develops.

 

BioSante currently maintains limited product liability insurance.  BioSante may not have sufficient resources to pay for any liabilities resulting from a personal injury or other claim excluded from, or beyond the limit of, BioSante’s insurance coverage.  BioSante’s insurance does not cover third parties’ negligence or malpractice, and its clinical investigators and sites may have inadequate insurance or none at all.  In addition, in order to conduct BioSante’s clinical studies or otherwise carry out its business, BioSante may have to assume liabilities contractually for which it may not be insured.  If BioSante is unable to look to its own or a third party’s insurance to pay claims against them, BioSante may have to pay any arising costs and damages themselves, which may be substantial.  Even if BioSante ultimately is successful in product liability litigation, the litigation likely would consume substantial amounts of its financial and managerial resources and may create adverse publicity, all of which likely would impair BioSante’s ability to generate sales of the affected product and its other products.  Moreover, product recalls may be issued at BioSante’s discretion or at the direction of the FDA, other governmental agencies or other companies having regulatory control for its product sales.  Product recalls generally are expensive and often have an adverse effect on the reputation of the products being recalled and of the product’s developer or manufacturer.

 

BioSante may be required to indemnify third parties against damages and other liabilities arising out of its development, commercialization and other business activities, which could be costly and time-consuming and distract management.  If third parties that have agreed to indemnify BioSante against damages and other liabilities arising from their activities do not fulfill their obligations, then BioSante may be held responsible for those damages and other liabilities.

 

Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on the trading price of BioSante common stock.

 

Section 404 of the Sarbanes-Oxley Act of 2002 requires BioSante’s management to assess the effectiveness of its internal control over financial reporting and to provide a report by its registered independent public accounting firm addressing the effectiveness of BioSante’s internal control over financial reporting.  The Committee of Sponsoring Organizations of the Treadway Commission (COSO) provides a framework for companies to assess and improve their internal control systems.  If BioSante is unable to assert that its internal control over financial reporting is effective or if BioSante’s registered independent public accounting firm is unable to express an opinion on the effectiveness of the internal controls or identifies one or more material weaknesses in BioSante’s internal control over financial reporting, BioSante could lose investor confidence in the accuracy and completeness of its financial reports, which in turn could have an adverse effect

 

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on the trading price of BioSante common stock.  If BioSante fails to maintain the adequacy of its internal controls, BioSante may not be able to ensure that it can conclude on an ongoing basis that BioSante has effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act.  Failure to achieve and maintain effective internal control over financial reporting could have an adverse effect on the trading price of BioSante common stock.

 

BioSante’s business is subject to increasingly complex corporate governance, public disclosure and accounting requirements that could affect adversely its business and financial results.

 

BioSante is subject to changing rules and regulations of federal and state governments as well as the stock exchange on which BioSante common stock is listed.  These entities, including the SEC and The NASDAQ Stock Market, continue to issue new requirements and regulations in response to laws enacted by Congress.  In July 2010, the Dodd-Frank Wall Street Reform and Protection Act (the Dodd-Frank Act) was enacted.  There are significant corporate governance and executive compensation-related provisions in the Dodd-Frank Act that require the SEC and The NASDAQ Stock Market to adopt additional rules and regulations in these areas.  BioSante’s efforts to comply with these requirements have resulted in, and are likely to continue to result in, an increase in expenses and a diversion of management’s time from its other business activities.

 

BioSante’s operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.

 

BioSante’s principal executive office and its only business location is in Lincolnshire, Illinois, which is a suburb of Chicago. Natural disasters or other catastrophic events could disrupt BioSante’s operations or those of its strategic partners, contractors and vendors. Even though BioSante believes it carries commercially reasonable business interruption and liability insurance, and its contractors may carry liability insurance that protect BioSante in certain events, BioSante might suffer losses as a result of business interruptions that exceed the coverage available under its and its contractors’ insurance policies or for which it or its contractors do not have coverage. Any natural disaster or catastrophic event could have a significant negative impact on BioSante’s operations and financial results, and could delay its efforts to identify and execute any strategic opportunities.

 

Risks Related to BioSante’s Industry

 

Because BioSante’s industry is very competitive, BioSante may not succeed in bringing certain of its products to market and any products BioSante or its strategic partners introduce commercially may not be successful.

 

Competition in the pharmaceutical industry is intense.  Potential competitors in the United States and abroad are numerous and include pharmaceutical and biotechnology companies, most of which have substantially greater capital resources and more experience in research and development, manufacturing and marketing than BioSante.  Academic institutions, hospitals, governmental agencies and other public and private research organizations also are conducting research and seeking patent protection and may develop and commercially introduce competing products or technologies on their own or through joint ventures.  BioSante cannot assure you that its potential competitors, some of whom are BioSante’s strategic partners, will not succeed in developing similar technologies and products more rapidly than it does, commercially introducing such technologies and products to the marketplace prior to BioSante, or that these competing technologies and products will not be more effective or successful than any of those that BioSante currently is developing or will develop.

 

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Because the pharmaceutical industry is heavily regulated, BioSante faces significant costs and uncertainties associated with its efforts to comply with applicable regulations.  Should BioSante fail to comply, it could experience material adverse effects on its business, operating results and financial position, and the trading price of BioSante common stock could decline.

 

The pharmaceutical industry is subject to regulation by various federal authorities, including principally the FDA and, to a lesser extent, the U.S. Drug Enforcement Administration, and state governmental authorities.  The U.S. Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act of 1970 and other federal statutes and regulations govern or influence the testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and distribution of BioSante’s products.  Noncompliance with applicable legal and regulatory requirements can have a broad range of consequences, including warning letters, fines, seizure of products, product recalls, total or partial suspension of production and distribution, refusal to approve NDAs or other applications or revocation of approvals previously granted, withdrawal of product from marketing, injunction, withdrawal of licenses or registrations necessary to conduct business, disqualification from supply contracts with the government, civil penalties, debarment and criminal prosecution.

 

In addition to compliance with “current good manufacturing practice” regulations, commonly referred to as “cGMP” regulations and requirements, drug manufacturers must register each manufacturing facility with the FDA and list their drugs with the FDA.  Manufacturers and distributors of prescription drug products also are required to be registered in the states where they are located and in certain states that require registration by out-of-state manufacturers and distributors.  Manufacturers also must be registered with the U.S. Drug Enforcement Administration and similar applicable state and local regulatory authorities if they handle controlled substances, and also must comply with other applicable U.S. Drug Enforcement Administration and state requirements.

 

Despite BioSante’s efforts at compliance, there is no guarantee that BioSante may not be deemed to be deficient in some manner in the future.  If BioSante was deemed to be deficient in any significant way, its business, financial position and results of operations could be materially affected and the trading price of BioSante common stock could decline.

 

The trend towards consolidation in the pharmaceutical and biotechnology industries may affect BioSante adversely.

 

There is a trend towards consolidation in the pharmaceutical and biotechnology industries.  This consolidation trend may result in the remaining companies in these industries having greater financial resources and technological capabilities, thus intensifying competition in these industries.  This trend also may result in fewer potential strategic partners or licensees for BioSante’s products and technology.  Also, if a consolidating company is already doing business with its competitors, BioSante may lose existing licensees or strategic partners as a result of such consolidation.  This trend may affect adversely BioSante’s ability to enter into strategic arrangements for the development and commercialization of its products, and as a result may harm its business.

 

Risks Related to BioSante’s Intellectual Property

 

BioSante licenses rights to the technology underlying LibiGel and many of its other products and technologies from third parties.  The loss of these rights, including in particular, BioSante’s rights underlying LibiGel, could have an adverse effect on its business and future prospects and could cause the trading price of BioSante common stock to decline.

 

BioSante licenses rights to certain technology underlying its gel products, including LibiGel, but not its male testosterone gel, from Antares Pharma, Inc. and The Pill Plus from Wake Forest University Health Sciences.  BioSante may lose its rights to these technologies if BioSante breaches its obligations under the

 

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license agreements.  Although BioSante intends to use commercially reasonable efforts to meet these obligations and to cause its sublicensees to meet these obligations, if BioSante violates or fails to perform any term or covenant of the license agreements, the other party to these agreements under certain circumstances may terminate these agreements or certain projects contained in these agreements.  The termination of these agreements, however, will not relieve BioSante of its obligation to pay any royalty or license fees owed at the time of termination.  In addition, it is possible that the licensors of the technology licensed by BioSante will not continue to maintain certain patents and other intellectual property rights, breach the agreements or take actions inconsistent with BioSante’s license rights, which could harm BioSante’s business.

 

BioSante has licensed some of its products to third parties and any breach by these parties of their obligations under these license agreements or a termination of these license agreements by these parties could affect adversely the development and marketing of its licensed products.  In addition, these third parties also may compete with BioSante with respect to some of its products.

 

BioSante has licensed some of its products to third parties, including Meda, Teva Pharmaceuticals USA, Inc., Pantarhei Bioscience B.V. and Valeant Pharmaceuticals.  All of these parties, except for Meda, have agreed to be responsible for continued development, regulatory filings and manufacturing and marketing associated with the products, except for Valeant Pharmaceuticals, which has not agreed to be responsible for manufacturing the products.  In addition, in the future BioSante may enter into additional similar license agreements.  BioSante’s products that it has licensed to others thus are subject to not only customary and inevitable uncertainties associated with the drug development process, regulatory approvals and market acceptance of products, but also depend on the respective licensees for timely development, obtaining required regulatory approvals, commercialization and otherwise continued commitment to the products.  BioSante’s current and future licensees may have different and, sometimes, competing priorities.  BioSante cannot assure you that its strategic partners or any future third party to whom it may license its products will remain focused on the development and commercialization of its partnered products or will not otherwise breach the terms of its agreements with them, especially since these third parties also may compete with BioSante with respect to some of its products.  Any breach of BioSante’s agreements by its strategic partners or any other third party of their obligations under these agreements or a termination of these agreements by these parties could harm development of the partnered products in these agreements if BioSante is unable to license the products to another party on substantially the same or better terms or continue the development and future commercialization of the products itself.  As an example, BioSante’s male testosterone gel was developed initially by BioSante, and then licensed to Teva for late stage clinical development and commercialization.  Teva submitted an NDA for BioSante’s male testosterone gel that was approved by the FDA in February 2012.  Subsequent to Teva’s NDA submission, in April 2011, AbbVie Inc., a marketer of a testosterone gel for men, filed a complaint against Teva alleging patent infringement.  The Teva/AbbVie patent infringement litigation was settled in December 2011; however, the terms of the settlement agreement are confidential and have not been disclosed publicly.  In light of the settlement agreement, BioSante is uncertain as to when or if Teva will begin to market and sell its male testosterone gel and thus when or if BioSante would begin to receive royalties from such sales.

 

If BioSante is unable to protect its proprietary technology, it may not be able to compete as effectively.

 

The pharmaceutical industry places considerable importance on obtaining patent and trade secret protection for new technologies, products and processes.  BioSante’s success will depend, in part, upon its ability to obtain, enjoy and enforce protection for any products it develops or acquires under United States and foreign patent laws and other intellectual property laws, preserve the confidentiality of its trade secrets and operate without infringing the proprietary rights of third parties.  BioSante relies on patent protection, as well as a combination of copyright and trademark laws and nondisclosure, confidentiality and other contractual arrangements to protect its proprietary technology.  These legal means, however, afford only limited protection and may not adequately protect BioSante’s rights or permit BioSante to gain or keep any competitive advantage.

 

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Where appropriate, BioSante seeks patent protection for certain aspects of its technology.  BioSante owned and licensed patents and patent applications, however, may not ensure the protection of its intellectual property for a number of other reasons:

 

·                  BioSante does not know whether its licensor’s patent applications will result in issued patents.

 

·                  Competitors may interfere with BioSante’s patents and patent process in a variety of ways.  BioSante issued patents and those that may be issued in the future may be challenged, invalidated or circumvented, which could limit its ability to stop competitors from marketing related products. Competitors also may have BioSante’s patents reexamined by demonstrating to the U.S. Patent and Trademark Office examiner that the invention was not novel or was obvious.

 

·                  BioSante is engaged in the process of developing products.  Even if BioSante receives a patent, it may not provide much practical protection.  There is no assurance that third parties will not be able to design around BioSante’s patents.  If BioSante receives a patent with a narrow scope, then it will be easier for competitors to design products that do not infringe on BioSante’s patent.  Even if the development of BioSante’s products is successful and approval for sale is obtained, there can be no assurance that applicable patent coverage, if any, will not have expired or will not expire shortly after this approval.  Though patent term extension may be possible for particular products, any expiration of the applicable patent could have a material adverse effect on the sales and profitability of BioSante’s products.

 

·                  Litigation also may be necessary to enforce patent rights BioSante holds or to protect trade secrets or techniques it owns.  Intellectual property litigation is costly and may affect adversely BioSante’s operating results.  Such litigation also may require significant time by BioSante’s management.  In litigation, a competitor could claim that BioSante’s issued patents are not valid or unenforceable for a number of reasons.  If the court agrees, BioSante would lose protection on products covered by those patents.

 

·                  BioSante also may support and collaborate in research conducted by government organizations or universities.  BioSante cannot guarantee that it will be able to acquire any rights to technology or products derived from these collaborations.  If BioSante does not obtain required licenses or rights, it could encounter delays in product development while it attempts to design around other patents or it may be prohibited from developing, manufacturing or selling products requiring these licenses.  There also is a risk that disputes may arise as to the rights to technology or products developed in collaboration with other parties.

 

BioSante also relies on unpatented proprietary technology.  It is unclear whether efforts to secure BioSante’s trade secrets will provide useful protection.  BioSante relies on the use of registered trademarks with respect to the branded names of some of its products.  BioSante also relies on common law trademark protection for some branded names, which are not protected to the same extent as its rights in the use of its registered trademarks.  BioSante cannot assure you that it will be able to meaningfully protect all of its rights in its unpatented proprietary technology or that others will not independently develop and obtain patent protection substantially equivalent proprietary products or processes or otherwise gain access to its unpatented proprietary technology.  BioSante seeks to protect its know-how and other unpatented proprietary technology, in part with confidentiality agreements and intellectual property assignment agreements with BioSante’s employees and consultants.  Such agreements, however, may not be enforceable or may not provide meaningful protection for BioSante’s proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements or in the event that its competitors discover or independently develop similar or identical designs or other proprietary information.  Enforcing a claim that someone else illegally obtained and is using BioSante’s trade secrets, like patent litigation, is expensive and time consuming, and the outcome is unpredictable.  In addition, courts outside the United States are sometimes less willing to protect trade secrets.

 

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The patent protection for BioSante’s products may expire before BioSante is able to maximize their commercial value which may subject BioSante to increased competition, inhibit its ability to find strategic partners and reduce or eliminate its opportunity to generate product revenue.

 

The patents for BioSante’s commercialized products and products in development have varying expiration dates and, when these patents expire, BioSante may be subject to increased competition and it may not be able to recover its development costs.  For example, the U.S. patents covering the formulations used in Elestrin and LibiGel which BioSante licenses from Antares Pharma are scheduled to expire in June 2022 and the U.S. patent covering the “method of use” of LibiGel for treating FSD and HSDD will expire in December 2028.  Although BioSante has filed additional U.S. patent applications covering LibiGel, it can provide no assurance that such applications will be granted and that the patent applications will issue.  In addition to patents, BioSante may receive three years of marketing exclusivity in the United States for LibiGel under the Hatch-Waxman Act and an additional six months of pediatric exclusivity, if BioSante decides to pursue regulatory approval for LibiGel.  Depending upon if and when BioSante receives regulatory approval for LibiGel and its other products in development and the then expiration dates of the patents underlying LibiGel and such other products, BioSante may not have sufficient time to recover its development costs prior to the expiration of such patents and consequently it may be difficult to find a strategic partner for such products.

 

Claims by others that BioSante’s products infringe their patents or other intellectual property rights could adversely affect BioSante’s operating results and financial condition.

 

The pharmaceutical industry has been characterized by frequent litigation regarding patent and other intellectual property rights.  Patent applications are maintained in secrecy in the United States and outside the United States until the application is published.  Accordingly, BioSante cannot determine whether its technology would infringe on patents arising from these unpublished patent applications of others.  Any claims of patent infringement asserted by third parties would be time-consuming and could likely:

 

·                  result in costly litigation;

 

·                  divert the time and attention of BioSante’s technical personnel and management;

 

·                  cause product development delays;

 

·                  require BioSante to develop non-infringing technology; or

 

·                  require BioSante to enter into royalty or licensing agreements.

 

Although patent and intellectual property disputes in the pharmaceutical industry often have been settled through licensing or similar arrangements, costs associated with these arrangements may be substantial and often require the payment of ongoing royalties, which could hurt BioSante’s potential gross margins.  In addition, BioSante cannot be sure that the necessary licenses would be available to BioSante on satisfactory terms, or that it could redesign its products or processes to avoid patent infringement, if necessary.  Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent BioSante from developing, manufacturing and selling some of its products, which could harm its business, financial condition and operating results. With respect to products which BioSante has licensed to others, BioSante’s licensees may be responsible for the defense of any patent infringement claims, which would result in its dependence upon them to defend its intellectual property rights.

 

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Risks Related to BioSante Common Stock

 

The trading price of BioSante common stock has been volatile, and your investment in BioSante common stock or convertible senior notes could decline in value.

 

The price of BioSante common stock has fluctuated in the past and it is likely that the price of BioSante common stock will continue to fluctuate in the future.  Since January 1, 2011 through December 31, 2012, the sale price of BioSante common stock ranged from $1.08 per share to $24.12 per share.  These prices reflect the one-for-six reverse stock split of BioSante common stock that was effective at the close of business on June 1, 2012. The securities of small capitalization, biopharmaceutical companies, including BioSante, from time-to- time experience significant price fluctuations, often unrelated to the operating performance of these companies.  In addition, as BioSante’s convertible senior notes are convertible into shares of BioSante common stock, volatility or depressed prices of BioSante common stock could have a similar effect on the trading price of the notes.  Interest rate fluctuations also can affect the price of BioSante’s convertible senior notes. In particular, the market price of BioSante common stock and its convertible senior notes may fluctuate significantly due to a variety of factors, including:

 

·                  general stock market and general economic conditions in the United States and abroad, not directly related to BioSante or its business;

 

·                  actual or anticipated governmental agency actions, including in particular decisions or actions by the FDA or FDA advisory committee panels with respect to BioSante’s products in development or its competitors’ products;

 

·                  actual or anticipated results of BioSante’s clinical studies or those of its competitors;

 

·                  changes in anticipated or actual timing of BioSante’s development programs, including delays or cancellations of clinical studies for its products;

 

·                  announcements of technological innovations or new products by BioSante or its competitors;

 

·                  announcements by licensors or licensees of BioSante’s technology;

 

·                  entering into new strategic partnering arrangements or termination of existing strategic partnering arrangements;

 

·                  developments concerning BioSante’s efforts to identify and implement strategic opportunities and the terms and timing of any resulting transactions;

 

·                  public concern as to the safety or efficacy of or market acceptance of products developed by BioSante or its competitors;

 

·                  BioSante’s cash and cash equivalents and its need and ability to obtain additional financing;

 

·                  equity sales by BioSante to fund its operations or restructure its outstanding convertible senior notes;

 

·                  changes in laws or regulations applicable to BioSante’s products;

 

·                  the resolution of BioSante’s pending purported class action and shareholder derivative litigation;

 

·                  developments or disputes concerning patents or other proprietary rights;

 

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·                  period-to-period fluctuations in BioSante’s financial results, including its cash and cash equivalents, operating expenses, cash burn rate or revenues;

 

·                  loss of key management;

 

·                  common stock sales and purchases in the public market by one or more of BioSante’s larger stockholders, officers or directors;

 

·                  reports issued by securities analysts regarding BioSante common stock and articles published regarding its business and/or products;

 

·                  changes in the market valuations of other life science or biotechnology companies; and

 

·                  other financial announcements, including delisting of BioSante common stock from The NASDAQ Global Market, review of any of its filings by the SEC, changes in accounting treatment or restatement of previously reported financial results, delays in its filings with the SEC or its failure to maintain effective internal control over financial reporting.

 

In addition, the occurrence of any of the risks described in this report or in subsequent reports BioSante files with or submits to the SEC from time to time could have a material and adverse impact on the market price of BioSante common stock.  Securities class action litigation is sometimes brought against a company following periods of volatility in the market price of its securities or for other reasons.  BioSante currently is subject to such litigation.  Securities litigation, whether with or without merit, could result in substantial costs and divert management’s attention and resources, which could harm BioSante’s business and financial condition, as well as the market price of BioSante common stock.

 

Provisions in BioSante’s charter documents and Delaware law could discourage or prevent a takeover, even if an acquisition would be beneficial to BioSante stockholders.

 

Provisions of BioSante’s certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire BioSante, even if doing so would be beneficial to its stockholders.  These provisions include:

 

·                  authorizing the issuance of “blank check” preferred shares that could be issued by the BioSante board of directors to increase the number of outstanding shares and thwart a takeover attempt;

 

·                  prohibiting cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates; and

 

·                  advance notice provisions in connection with stockholder proposals and director nominations that may prevent or hinder any attempt by BioSante stockholders to bring business to be considered by its stockholders at a meeting or replace its board of directors.

 

BioSante does not intend to pay any cash dividends in the foreseeable future; and, therefore, any return on an investment in BioSante common stock must come from increases in the fair market value and trading price of BioSante common stock.

 

BioSante does not intend to pay any cash dividends in the foreseeable future; and, therefore, any return on an investment in BioSante common stock must come from increases in the fair market value and trading price of BioSante common stock.

 

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ITEM 1B.                                       UNRESOLVED STAFF COMMENTS

 

None.

 

ITEM 2.                                                PROPERTIES

 

BioSante’s principal executive office is located in a leased facility in Lincolnshire, Illinois, where BioSante leases approximately 20,000 square feet of office space for approximately $21,000 per month.  BioSante’s lease for this space expires in February 2014.  Management of BioSante considers its leased properties suitable and adequate for its current and foreseeable needs.

 

ITEM 3.                                                LEGAL PROCEEDINGS

 

On February 3, 2012, a purported class action lawsuit was filed in the United States District Court for the Northern District of Illinois under the caption Thomas Lauria, on behalf of himself and all others similarly situated v. BioSante Pharmaceuticals, Inc. and Stephen M. Simes naming BioSante and its President and Chief Executive Officer, Stephen M. Simes, as defendants.  The complaint alleges that certain of BioSante’s disclosures relating to the efficacy of LibiGel and its commercial potential were false and/or misleading and that such false and/or misleading statements had the effect of artificially inflating the price of BioSante’s securities resulting in violations of Section 10(b) of the Securities Exchange Act of 1934, as amended, Rule 10b-5 and Section 20(a) of the Exchange Act.  Although a substantially similar complaint was filed in the same court on February 21, 2012, such complaint was voluntarily dismissed by the plaintiff in April 2012.  The plaintiff seeks to represent a class of persons who purchased BioSante’s securities between February 12, 2010 and December 15, 2011, and seeks unspecified compensatory damages, equitable and/or injunctive relief, and reasonable costs, expert fees and attorneys’ fees on behalf of such purchasers.  BioSante believes the action is without merit and intends to defend the action vigorously.  On November 6, 2012, the plaintiff filed a consolidated amended complaint.  On December 28, 2012, BioSante and Mr. Simes filed motions to dismiss the consolidated amended complaint.  Briefing on the motion to dismiss is ongoing and is expected to be completed during the first quarter of 2013.

 

On May 7, 2012, Jerome W. Weinstein, a purported stockholder of BioSante filed a shareholder derivative action in the United States District Court for the Northern District of Illinois under the caption Weinstein v. BioSante Pharmaceuticals, Inc. et al., naming BioSante’s directors as defendants and BioSante as a nominal defendant.  A substantially similar complaint was filed in the same court on May 22, 2012 and another substantially similar complaint was filed in the Circuit Court for Cook County, Illinois, County Department, Chancery Division, on June 27, 2012.  The suits generally related to the same events that are the subject of the class action litigation described above.  The complaints allege breaches of fiduciary duty, abuse of control, gross mismanagement and unjust enrichment as causes of action occurring from at least February 2010 through December 2011.  The complaints seek unspecified damages, punitive damages, costs and disbursements and unspecified reform and improvements in BioSante’s corporate governance and internal control procedures.  On September 24, 2012, the District Court consolidated the two cases before it and on November 20, 2012, the plaintiffs filed their consolidated amended complaint.  On November 27, 2012, the plaintiff in the action pending in Illinois state court filed an amended complaint.  On January 11, 2013, the defendants filed a motion to dismiss the amended complaint in the action pending in District Court, and on January 18, 2013, the defendants filed a motion to dismiss the amended complaint in the action pending in Illinois state court.  Briefing on these motions is ongoing and is expected to be completed during the first quarter of 2013.

 

The lawsuits are in their early stages; and, therefore, BioSante is unable to predict the outcome of the lawsuits and the possible loss or range of loss, if any, associated with their resolution or any potential effect the lawsuits may have on BioSante’s operations.  Depending on the outcome or resolution of these lawsuits, they could have a material effect on BioSante’s operations, including its financial condition, results of operations, or cash flows.

 

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BioSante is not involved in any other legal actions, however, from time to time may be subject to various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of its business.  Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time.

 

ITEM 4.                                                MINE SAFETY DISCLOSURES

 

Not applicable.

 

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PART II

 


 

ITEM 5.                                                MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Price

 

BioSante common stock is listed for trading on The NASDAQ Global Market, under the symbol “BPAX.”  The following table sets forth the high and low daily sale prices for BioSante common stock, as reported by The NASDAQ Global Market, for each calendar quarter during 2012 and 2011.

 

2012

 

High

 

Low

 

 

 

 

 

 

 

First Quarter

 

$

7.38

 

$

2.64

 

Second Quarter

 

$

4.56

 

$

2.00

 

Third Quarter

 

$

2.62

 

$

1.21

 

Fourth Quarter

 

$

1.97

 

$

1.08

 

 

2011

 

High

 

Low

 

 

 

 

 

 

 

First Quarter

 

$

15.24

 

$

9.72

 

Second Quarter

 

$

19.20

 

$

11.58

 

Third Quarter

 

$

24.12

 

$

12.12

 

Fourth Quarter

 

$

16.56

 

$

2.28

 

 

Number of Record Holders; Dividends

 

As of February 15, 2013, there were 453 record holders of BioSante common stock and six record holders of BioSante class C stock.  To date, BioSante has not declared or paid any cash dividends on BioSante common stock and BioSante class C stock is not eligible to receive dividends.

 

Recent Sales of Unregistered Equity Securities

 

During the fourth quarter ended December 31, 2012, BioSante did not issue or sell any equity securities without registration under the Securities Act of 1933, as amended.

 

Issuer Purchases of Equity Securities

 

BioSante did not purchase any shares of its common stock or other equity securities of BioSante during the fourth quarter ended December 31, 2012.  The Board of Directors has not authorized any repurchase plan or program for the purchase of shares of BioSante common stock or other securities on the open market or otherwise, other than in connection with the cashless exercise of outstanding warrants and stock options.

 

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Stock Performance Graph

 

The following graph compares the annual cumulative total stockholder return on BioSante common stock from December 31, 2007 until December 31, 2012, with the annual cumulative total return over the same period of The NASDAQ Stock Market (U.S.) Index and Russell 3000 Index.

 

The comparison assumes the investment of $100 in each of BioSante common stock, The NASDAQ Stock Market (U.S.) Index and Russell 3000 Index on December 31, 2007, and the reinvestment of all dividends.

 

GRAPHIC

 

The foregoing Stock Performance Graph shall not be deemed to be “filed” with the Securities and Exchange Commission or subject to the liabilities of Section 18 of the Securities Exchange Act of 1934, as amended.   Notwithstanding anything to the contrary set forth in any of BioSante’s previous filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, that might incorporate future filings, including this annual report on Form 10-K, in whole or in part, the foregoing Stock Performance Graph shall not be incorporated by reference into any such filings.

 

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ITEM 6.                SELECTED FINANCIAL DATA

 

The following selected financial information has been derived from BioSante’s audited financial statements.  The information below is not necessarily indicative of results of future operations, and should be read together with “Part II. Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements and related notes included in “Part II. Item 8.  Financial Statements and Supplementary Data” of this report in order to fully understand factors that may affect the comparability of the information presented below:

 

 

 

Year Ended December 31,

 

 

 

2012

 

2011

 

2010

 

2009

 

2008

 

 

 

(in thousands, except per share data)

 

Statement of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

2,301

 

$

435

 

$

2,474

 

$

1,258

 

$

3,781

 

Expenses

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

16,889

 

44,182

 

39,706

 

13,681

 

15,790

 

General and administration

 

8,230

 

6,982

 

5,940

 

5,374

 

5,125

 

Acquired in-process research and development

 

 

 

 

9,000

 

 

Excess consideration paid over fair value

 

 

 

 

20,192

 

 

Licensing expense

 

95

 

50

 

269

 

300

 

836

 

Depreciation and amortization

 

259

 

148

 

168

 

137

 

43

 

Total expenses

 

25,473

 

51,362

 

46,083

 

48,684

 

21,794

 

Other (expense) income — Convertible note fair value adjustment

 

(4,328

)

(23

)

(1,871

)

33

 

 

Other expense — Investment impairment charge

 

 

 

(286

)

 

 

Other interest (expense) income

 

(340

)

(674

)

(675

)

(135

)

588

 

Other income

 

 

15

 

245

 

 

 

Income tax benefit

 

122

 

 

 

 

 

Net loss

 

$

(27,718

)

$

(51,609

)

$

(46,196

)

$

(47,528

)

$

(17,425

)

Basic and diluted net loss per common share(1)

 

$

(1.27

)

$

(3.15

)

$

(4.21

)

$

(8.40

)

$

(3.83

)

Weighted average number of common shares and common equivalent shares outstanding(1)

 

21,758

 

16,398

 

10,985

 

5,659

 

4,551

 

 

 

 

As of December 31,

 

 

 

2012

 

2011

 

2010

 

2009

 

2008

 

 

 

(in thousands, except per share data)

 

Balance Sheet Data:

 

 

 

 

 

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

 

$

34,794

 

$

57,225

 

$

38,155

 

$

29,858

 

$

14,787

 

Total assets

 

38,769

 

62,380

 

44,767

 

36,437

 

17,679

 

Total current liabilities (includes short-term convertible senior notes in 2010 and 2012)

 

10,594

 

7,228

 

8,183

 

3,930

 

3,853

 

Convertible senior notes, total long-term

 

 

17,337

 

17,436

 

16,676

 

 

Stockholders’ equity

 

28,176

 

37,815

 

19,147

 

15,830

 

13,826

 

 


(1)         All share and per share numbers have been adjusted retroactively to reflect the one-for-six reverse stock split effected on June 1, 2012.

 

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ITEM 7.                                                MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Management’s Discussion and Analysis provides material historical and prospective disclosures intended to enable investors and other users to assess BioSante’s financial condition and results of operations. Statements that are not historical are forward-looking and involve risks and uncertainties discussed under the headings “Part I.  Item 1. Business—Forward-Looking Statements” and “Part I.  Item 1A. Risk Factors” of this report.  The following discussion of BioSante’s results of operations and financial condition should be read in conjunction with BioSante’s financial statements and the related notes thereto included elsewhere in this report.  This Management’s Discussion and Analysis is organized in the following major sections:

 

·                  Business Overview.  This section provides a brief overview description of BioSante’s business, focusing in particular on developments during the most recent fiscal year.

 

·                  Summary of 2012 Financial Results and Outlook for 2013.  This section provides a brief summary of BioSante’s financial results and financial condition for 2012 and BioSante’s outlook for 2013.

 

·                  Critical Accounting Policies and Estimates.  This section discusses the accounting estimates that are considered important to BioSante’s financial condition and results of operations and require BioSante to exercise subjective or complex judgments in their application.  All of BioSante’s significant accounting policies, including BioSante’s critical accounting estimates, are summarized in Note 2 to BioSante’s financial statements.

 

·                  Results of Operations.  This section provides BioSante’s analysis of the significant line items in BioSante’s statements of operations.

 

·                  Liquidity and Capital Resources.  This section provides an analysis of BioSante’s liquidity and cash flows and a discussion of BioSante’s outstanding indebtedness and commitments.

 

·                  Recent Accounting Pronouncements.  This section discusses recently issued accounting pronouncements that have had or may affect BioSante’s results of operations and financial condition.

 

Overview

 

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism.  BioSante’s corporate strategy is to develop high value medically-needed pharmaceutical products.  As a part of its corporate strategy, BioSante seeks to implement strategic alternatives with respect to its products and company, including licenses, business collaborations and other business combinations or transactions with other pharmaceutical and biotechnology companies.  Therefore, as a matter of course, from time to time, BioSante may engage in discussions with third parties regarding the licensure, sale or acquisition of its products and technologies or a merger or sale of BioSante, with the goal of maximizing stockholder value.

 

On October 3, 2012, BioSante entered into an agreement and plan of merger with ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc.  The merger agreement provides that, subject to the terms and conditions set forth in the merger agreement, ANI will merge with and into BioSante, with BioSante continuing as the surviving company.  BioSante believes that the merger of the two companies will be able to create more value than BioSante could achieve individually.  The combined company that will result from the merger will be a fully integrated specialty branded and generic pharmaceutical company focused on developing, manufacturing and marketing branded and generic prescription pharmaceuticals.  Although the exact timing of completion of the merger cannot be predicted with certainty, each company has scheduled a

 

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special meeting of its stockholders for March 15, 2013 to consider and vote on certain matters in connection with the merger.  If the merger is approved by BioSante’s and ANI’s stockholders and the other conditions to closing are satisfied, it is anticipated that the merger will be completed as soon as reasonably practicable after the special meetings of stockholders.  The proposed merger with ANI is described in more detail below under the heading “—Proposed Merger with ANI” and elsewhere in this report.

 

BioSante’s products, either approved or in clinical development, include:

 

·                  LibiGel — once daily transdermal testosterone gel in Phase III development for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD).

 

·                  Male testosterone gel — 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, Inc. (Teva).

 

·                  The Pill-Plus (triple component contraceptive) — once daily use of various combinations of estrogens, progestogens and androgens in Phase II development.

 

·                  Elestrin — once daily transdermal estradiol (estrogen) gel approved by the FDA indicated for the treatment of hot flashes associated with menopause and marketed in the U.S. by Meda, BioSante’s licensee.

 

Proposed Merger with ANI

 

Agreement and Plan of Merger

 

On October 3, 2012, BioSante entered into an agreement and plan of merger with ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc.  The merger agreement provides that, subject to the terms and conditions set forth in the merger agreement, ANI will merge with and into BioSante, with BioSante continuing as the surviving company.  BioSante believes that the merger of the two companies will be able to create more value than BioSante could achieve individually.  The combined company that will result from the merger will be a fully integrated specialty branded and generic pharmaceutical company focused on developing, manufacturing and marketing branded and generic prescription pharmaceuticals.  Although the exact timing of completion of the merger cannot be predicted with certainty, each company has scheduled a special meeting of its stockholders for March 15, 2013 to consider and vote on certain matters in connection with the merger.  If the merger is approved by BioSante’s and ANI’s stockholders and the other conditions to closing are satisfied, it is anticipated that the merger will be completed as soon as reasonably practicable after the special meetings of stockholders.

 

At the effective time of the merger, each outstanding share of capital stock of ANI will be converted into the right to receive that number of shares of BioSante common stock, if any, as determined pursuant to the exchange ratios described in the merger agreement and the provisions of ANI’s certificate of incorporation.  All options, warrants or other rights to purchase shares of capital stock of ANI, will be canceled at the effective time of the merger without any consideration in exchange, except for certain warrants which although not cancelled will not represent the right to acquire any equity or other interest in the combined company after the merger.  No fractional shares of BioSante common stock will be issued in connection with the merger, and holders of ANI capital stock will be entitled to receive cash in lieu thereof.  Following completion of the transactions contemplated by the merger agreement, the current ANI stockholders are expected to own approximately 53 percent of the outstanding shares of common stock of the combined company, and current BioSante stockholders are expected to own approximately 47 percent of the outstanding shares of common stock of the combined company, assuming BioSante’s net cash as of the determination date is $18.0 million.  The exchange ratios are subject to potential adjustment as described in the merger agreement depending upon the amount of BioSante’s “net cash,” as defined in and as calculated pursuant to the merger agreement and

 

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generally consisting of BioSante’s cash and cash equivalents less certain expenses and liabilities, 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 BioSante stockholders own more than 49.9 percent) of the outstanding shares of common stock of the combined company.  The merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended.

 

The merger agreement provides that, immediately following the effective time of the merger, the board of directors of the combined company will consist of five former directors of ANI and two former directors of BioSante, and ANI’s current executive officers are expected to serve as executive officers of the combined company.  In connection with the merger, BioSante will seek to amend its certificate of incorporation to: (i) effect a reverse split of BioSante common stock at a ratio of either one-for-two, one-for-three, one-for-four or one-for-five, as determined by BioSante and ANI, which is intended to ensure that the listing requirements of The NASDAQ Global Market or The NASDAQ Capital Market are satisfied; and (ii) change the name of the company to “ANI Pharmaceuticals, Inc.” or another name as designated by ANI (together, the charter amendments).

 

Completion of the merger is subject to a number of conditions, including, but not limited to (i) the adoption and approval of the merger agreement and the transactions contemplated thereby by both the BioSante and ANI stockholders and the approval of the charter amendments by the BioSante stockholders; (ii) approval for the listing of shares of BioSante common stock to be issued in the merger on The NASDAQ Global Market or The NASDAQ Capital Market; (iii) written opinions of counsel that the merger will qualify as a reorganization within the meaning of Section 368(a) of the Code; and (iv) other customary closing conditions.  In addition, the obligation of ANI to effect the merger is subject to a condition that BioSante’s net cash, after deducting all remaining liabilities, as calculated and as adjusted pursuant to the terms of the merger agreement, be no less than $17.0 million immediately prior to the effective time of the merger. No fractional shares of BioSante common stock will be issued in connection with the reverse split and holders of BioSante common stock will be entitled to receive cash in lieu thereof.

 

Each of BioSante and ANI have made customary representations, warranties and covenants in the merger agreement, including among others, covenants that (i) each party will conduct its business in the ordinary course consistent with past practice during the interim period between the execution of the merger agreement and the consummation of the merger; (ii) each party will not engage in certain kinds of transactions or take certain actions during such period; (iii) ANI will convene and hold a meeting of its stockholders for the purpose of considering the adoption and approval of the merger agreement and the transactions contemplated thereby and the board of directors of ANI will recommend that the ANI stockholders adopt and approve the merger agreement, subject to certain exceptions; and (iv) BioSante will convene and hold a meeting of the BioSante stockholders for the purpose of considering the adoption and approval of the merger agreement and the transactions contemplated thereby and the approval of the charter amendments and the BioSante board of directors will recommend that the BioSante stockholders adopt and approve the merger agreement and approve the charter amendments, subject to certain exceptions.  Each of BioSante and ANI also has agreed not to solicit proposals relating to alternative business combination transactions or enter into discussions or an agreement concerning any proposals for alternative business combination transactions, subject to exceptions for BioSante in the event of its receipt of a “superior proposal.”

 

The merger agreement contains certain termination rights in favor of each of ANI and BioSante in certain circumstances. If the merger agreement is terminated due to certain triggering events specified in the merger agreement, BioSante will be required to pay ANI a termination fee of up to $1.0 million or ANI will be required to pay BioSante a termination fee of up to $750,000. The merger agreement also provides that under specified circumstances, BioSante may be required to reimburse ANI up to $500,000 for ANI’s expenses in connection with the transaction. Any expenses paid by BioSante will be credited against the $1.0 million termination fee if the termination fee subsequently becomes payable by BioSante.

 

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Voting Agreements

 

Concurrently and in connection with the execution of the merger agreement, certain ANI stockholders, who collectively held approximately 90 percent of the outstanding shares of ANI common stock on an as-converted basis and approximately 86 percent of the outstanding shares of ANI series D preferred stock as of October 3, 2012, entered into voting agreements with BioSante, pursuant to which each ANI stockholder agreed to vote its shares of ANI capital stock in favor of the merger, the merger agreement and the transactions contemplated by the merger agreement and against certain transactions or certain actions that would delay, prevent or nullify the merger or the transaction contemplated by the merger agreement.  In addition, one of the ANI stockholders, who held approximately 57 percent of the outstanding shares of ANI capital stock as of October 3, 2012, has agreed to vote in favor of the election of the two directors designated by BioSante at the first annual meeting of BioSante stockholders following completion of the merger.

 

In addition, all of BioSante’s directors and officers, who collectively held approximately two percent of the outstanding shares of BioSante capital stock as of October 3, 2012, entered into voting agreements with ANI, pursuant to which each BioSante stockholder agreed to vote its shares of BioSante capital stock in favor of the merger, the merger agreement and the transactions contemplated by the merger agreement and the charter amendments, and against certain transactions or certain actions that would delay, prevent or nullify the merger or the transaction contemplated by the merger agreement.

 

Lock-Up Agreements

 

Concurrently and in connection with the execution of the merger agreement, ANI’s chief executive officer and chief financial officer and certain ANI stockholders, who collectively held approximately 85 percent of the outstanding shares of ANI common stock, on an as-converted basis, as of October 3, 2012, entered into lock-up agreements with BioSante, pursuant to which each ANI stockholder will be subject to a six-month lock-up on the sale of shares of BioSante common stock received in the merger.

 

Contingent Value Rights Agreement

 

BioSante has the right in its sole discretion to issue contingent value rights (each, a CVR and collectively, the CVRs) to holders of BioSante common stock as of immediately prior to completion of the merger.  BioSante expects that one CVR will be issued for each share of BioSante common stock outstanding as of the record date, which has been set as March 15, 2013.  However, the CVRs will not be certificated and will not be attached to the shares of BioSante common stock.  Each CVR will be a non-transferable (subject to certain limited exceptions) right to potentially receive certain cash payments in the event BioSante receives net cash payments during the ten-year period after the distribution of the rights as a result of the sale, transfer, license or similar transaction relating to BioSante’s LibiGel program, upon the terms and subject to the conditions set forth in a contingent value rights agreement to be entered into between BioSante and its transfer agent, as rights agent.  The aggregate cash payments to be distributed to the holders of the CVRs, if any, will be equal to 66 percent of the net cash payments received by the combined company as a result of the sale, transfer, license or similar transaction relating to BioSante’s LibiGel program, as determined pursuant to the CVR agreement, and will not exceed $40 million in the aggregate.

 

Business Overview

 

BioSante’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.  For the past several years, BioSante has focused its efforts on two Phase III LibiGel efficacy trials and its LibiGel Phase III cardiovascular and breast cancer safety study.  In December 2011, BioSante announced results from its two Phase III LibiGel efficacy trials, which showed that the trials did not meet the co-primary or secondary endpoints.  Although LibiGel performed as predicted, increasing satisfying sexual events and sexual desire and

 

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decreasing distress associated with low desire, the placebo response in the two efficacy trials was greater than expected, and LibiGel’s results were not shown to be statistically different from the placebo.

 

Beginning in December 2011, BioSante 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.  As a result of this process, in June 2012 BioSante announced a plan to initiate two new LibiGel Phase III efficacy trials.

 

In September 2012, BioSante 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 CV 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, BioSante also announced in September 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 BioSante 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, BioSante believes that adequate safety data of LibiGel use in menopausal women has been obtained.

 

BioSante is continuing to develop a protocol for the two new LibiGel efficacy trials and plans to seek an FDA SPA agreement covering aspects of the two new efficacy trials.

 

Elestrin was BioSante’s first FDA approved product and now is one of BioSante’s two FDA approved products.  Meda (which acquired Jazz Pharmaceuticals, Inc.’s women’s health business and which in turn had acquired Azur Pharma International II Limited (Azur), BioSante’s prior licensee), is marketing Elestrin in the U.S.  In December 2009, BioSante entered into an amendment to its original licensing agreement with Azur pursuant to which BioSante received $3.16 million in non-refundable payments in exchange for the elimination of all remaining future royalty payments and certain milestone payments that could have been paid to BioSante related to sales of Elestrin.  BioSante maintains the right to receive up to $140 million in sales-based milestone payments from Meda if Elestrin reaches certain predefined sales per calendar year; although, based on current sales levels, BioSante believes its receipt of such payments unlikely in the near term, if at all.

 

BioSante’s male testosterone gel is its second FDA approved product.  This product was developed initially by BioSante, and then licensed by BioSante to Teva for late stage clinical development.  Teva submitted an NDA to the FDA in the beginning of 2011, which was approved by the FDA in February 2012.  Subsequent to Teva submitting the NDA, in April 2011, AbbVie Inc., a marketer of a testosterone gel for men, filed a complaint against Teva alleging patent infringement.  This litigation was settled in December 2011; however, the terms of the settlement agreement are confidential and have not been disclosed publicly.  No launch date for this product has been announced by Teva.

 

Under BioSante’s development and license agreement with Teva, Teva has agreed to market the male testosterone gel for the U.S. market and is responsible for any and all manufacturing and marketing associated with the product.  The financial terms of the development and license agreement included a $1.5 million upfront payment by Teva, which was paid to BioSante in December 2002, and an obligation by Teva to pay BioSante certain milestones and royalties on sales of the product in exchange for rights to develop and market the product, as described in more detail below. Teva is entitled to deduct the amount of any legal expenses

 

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incurred by Teva in connection with associated patent litigation against Teva from the net sales of the product.  The term of the development and license agreement will expire 10 years from the date on which Teva makes its first commercial sale of the male testosterone gel to an unrelated third party in an arms-length transaction in the United States.  The parties may terminate the development and license agreement upon the occurrence of certain events, including a material breach of the agreement by the other party.  BioSante may terminate the agreement if Teva files a petition in bankruptcy, enters into an arrangement with its creditors or makes an assignment for the benefit of creditors or a receiver or trustee is appointed or if Teva suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent.  Teva may terminate the agreement if Teva determines that the continued development and/or marketing of the male testosterone gel is no longer commercially viable.

 

In October 2012, BioSante entered into an amendment to its agreement with Teva pursuant to which Teva made a non-refundable $1.0 million payment to BioSante upon the signing of the amendment and a non-refundable $750,000 payment in December 2012.  Teva also agreed to make the following milestone based payments to BioSante:  (1) $500,000 if the FDA authorizes marketing of the licensed male testosterone gel as an “AB-rated” equivalent to AndroGel®; and (2) $500,000 upon the earlier to occur of (a) December 31, 2013 and (b) five business days after Teva’s commencement of commercial manufacture of the licensed product for sale in the United States.  In addition, Teva has agreed to pay BioSante $4.0 million in the event Teva is the sole marketer in the United States of a generic 1% testosterone gel AB-rated to AndroGel® for at least 180 days immediately following the launch date of the licensed product in the United States.  The royalty rate to be paid by Teva to BioSante under the agreement is five percent of net sales; provided, however, that during the period of time that Teva markets the licensed product and is the sole marketer of a generic 1% testosterone gel that is AB-rated to AndroGel® in the United States, the royalty rate will be seven and one half percent of net sales.  Additionally, pursuant to the terms of the October 2012 amendment, the parties agreed to release each other from certain liabilities.

 

BioSante licenses the technology underlying certain of its gel products, including LibiGel and Elestrin, but not the male testosterone gel, from Antares Pharma, Inc.  The patents covering the formulations used in the gel products covered under the license agreement are expected to expire in 2022, although with respect to LibiGel, a new U.S. patent covering the “method of use” of LibiGel for treating FSD and HSDD was issued, which will expire in December 2028.  BioSante’s license agreement with Antares requires BioSante to pay Antares certain development and regulatory milestone payments and royalties based on net sales of any products BioSante or its licensees sell incorporating the licensed technology.  Specifically, BioSante is obligated to pay Antares 25 percent of all upfront and milestone payments related to a license and a 4.5 percent royalty on net sales of product by BioSante or a licensee.  Since entering into the agreement and through December 31, 2012, BioSante has paid Antares an upfront payment of $1.0 million, an aggregate of $5.1 million in milestone payments and an aggregate of $100,000 in royalties.  Aggregate potential milestone payments to be paid by BioSante to Antares under the agreement include 25 percent of the potential $140 million in sales-based milestone payments, or $35 million from Meda if Elestrin reaches certain predefined sales per calendar year; although, based on current sales levels, BioSante believes its receipt of such payments unlikely in the near term, if at all.

 

The term of BioSante’s license agreement with Antares will expire on a country-by-country and product-by-product basis when the royalties expire (at patent expiration), at which time BioSante will have a fully paid-up exclusive license regarding the applicable product in such country.  BioSante and Antares may terminate the license agreement upon the occurrence of certain events, including a material breach of the agreement by the other party or if the other party goes into liquidation or bankruptcy or makes an assignment for the benefit of creditors or a receiver is appointed.  Antares may terminate the agreement with respect to certain products or territories if BioSante does not continue development, seeking regulatory approval or marketing of such products in the covered territories.  BioSante may terminate the agreement with respect to certain products or territories if, for technical, scientific or regulatory reasons, it is not likely that the product will gain required regulatory approvals in a territory, if regulatory approvals in a territory are not obtained or if

 

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BioSante determines that it is not economically viable to continue development or marketing of a product in a territory.

 

On January 31, 2013, BioSante entered into an asset purchase agreement with Aduro BioTech, Inc. pursuant to which BioSante sold all of its assets related to its GVAX cancer vaccine portfolio in exchange for a $1.0 million up front cash payment plus the potential for future royalty, milestone and sublicense payments.

 

Summary of 2012 Financial Results and Outlook for 2013

 

Substantially all of BioSante’s revenue to date has been derived from upfront, milestone and royalty payments earned on licensing and sublicensing transactions and from subcontracts.  BioSante’s business operations to date have consisted primarily of licensing and research and development activities and if BioSante does not complete its proposed merger with ANI, BioSante would expect this to continue for the immediate future.  To date, BioSante has used primarily equity financings, and to a lesser extent, licensing income, interest income and the cash received from its 2009 merger with Cell Genesys, Inc., to fund its ongoing business operations and short-term liquidity needs.

 

As of December 31, 2012, BioSante had $34.8 million of cash and cash equivalents and had outstanding $8.3 million in aggregate principal amount of its 3.125% convertible senior notes due May 1, 2013.  Absent the receipt of any additional licensing income or financing, BioSante expects its cash and cash equivalents balance to decrease as it continues to use cash to fund its operations.  Assuming the proposed merger between BioSante and ANI is completed, BioSante expects its cash and cash equivalents as of December 31, 2012 to meet its liquidity requirements through at least its anticipated closing of the merger, including the requirement under the merger agreement to have at least $17 million of “net cash,” as defined in and as calculated under the merger agreement, available upon the closing of the merger.  If the proposed merger between BioSante and ANI is not completed, BioSante will need to reevaluate its strategic alternatives, which may include continuing as an independent, stand-alone business, a sale of the company, liquidation of the company or other strategic transaction.  BioSante’s liquidity position will be dependent upon the strategic alternative selected; however, assuming BioSante does not enter into another strategic transaction, and assuming BioSante decides not to commence the two new efficacy trials for LibiGel, BioSante expects its cash and cash equivalents as of December 31, 2012 will be sufficient to meet its liquidity requirements for at least the next three to five years.  Additional financing would be required should BioSante decide to commence the two new efficacy trials for LibiGel.  These estimates may prove incorrect or BioSante, nonetheless, may choose to raise additional financing earlier.

 

BioSante incurred expenses of $16.9 million on research and development activities during the year ended December 31, 2012, which is a 62 percent decrease compared to 2011, primarily as a result of the conclusion of the two LibiGel Phase III efficacy trials at the end of 2011.  BioSante anticipates that its research and development expenses for 2013 will be approximately $2.5 million and will consist primarily of expenses associated with the conclusion of the safety study.  This estimate assumes no further development of LibiGel and completion of the merger with ANI, but does not include research and development expenses to be incurred by the combined company after completion of the merger.

 

General and administrative expenses for the year ended December 31, 2012 increased 18 percent compared to 2011 due primarily to an increase in professional fees and other administrative expenses.  BioSante’s general and administrative expenses generally fluctuate from year-to-year and quarter-to-quarter depending upon the amount of non-cash, stock-based compensation expense and the amount of legal, public and investor relations, accounting, corporate governance and other general and administrative fees and expenses incurred.

 

BioSante recognized an income tax benefit based on the receipt of an income tax credit for the year ended December 31, 2012 of $121,791 compared to the recognition of no income tax benefit or expense for the year ended December 31, 2011.  The income tax benefit was a result of an election to accelerate research and

 

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development credits in lieu of receiving bonus depreciation on certain property under Section 168(k)(4) of the Internal Revenue Code of 1986, as amended.

 

BioSante recognized a net loss for the year ended December 31, 2012 of $27.7 million compared to a net loss of $51.6 million for the year ended December 31, 2011.  This decrease was primarily a result of the conclusion of the prior two LibiGel Phase III efficacy trials at the end of 2011 and in September 2012 the conclusion of the LibiGel Phase III safety study, and was offset in part by an increase in the non-cash fair value adjustment relating to the cancellation of $12.5 million in aggregate principal amount of BioSante’s convertible senior notes.  BioSante recognized a net loss per share for the year ended December 31, 2012 of $1.27 compared to a net loss per share of $3.15 for the year ended December 31, 2011.  This decrease in net loss per share was the result of the significantly higher weighted average number of shares outstanding, partially offset by the lower net loss described above.

 

Critical Accounting Policies and Estimates

 

BioSante’s significant accounting policies are described in Note 2 to BioSante’s financial statements included under the heading “Part II.  Item 8.  Financial Statements and Supplementary Data” of this report.  The discussion and analysis of BioSante’s financial statements and results of operations are based upon BioSante’s financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America.  The discussion and analysis of BioSante’s financial statements and results of operations are based upon BioSante’s financial statements, which have been prepared in accordance with GAAP.  The preparation of BioSante’s financial statements requires management to make estimates and judgments that affect the reported amount of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.  The SEC has defined a company’s most critical accounting policies as those that are most important to the portrayal of its financial condition and results of operations, and which requires BioSante to make its most difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain.  Based on this definition, BioSante has identified the critical accounting policy described below.  Although BioSante believes that its estimates and assumptions are reasonable, they are based upon information available when they are made.  Actual results may differ significantly from these estimates under different assumptions or conditions.

 

Accounting for Convertible Senior Notes Assumed in Connection with the Cell Genesys Acquisition

 

On October 14, 2009, BioSante completed a legal merger with Cell Genesys, as a result of which BioSante acquired all of the assets and liabilities of Cell Genesys.  Concurrently with the merger, the common stock of Cell Genesys was converted into common stock of BioSante, and Cell Genesys ceased to exist.  The primary reason BioSante merged with Cell Genesys was BioSante’s need at that time for additional funding to continue its then Phase III clinical studies for LibiGel and the lack of other available acceptable alternatives for BioSante to access capital prior to and at the time the merger agreement was entered into by BioSante and Cell Genesys in June 2009, especially in light of the then state of the markets for equity offerings, which historically had been BioSante’s primary method for raising additional financing.  BioSante has accounted for this transaction with Cell Genesys under GAAP as an acquisition of the net assets of Cell Genesys, whereby BioSante has recorded the individual assets and liabilities of Cell Genesys as of the completion of the merger based on their estimated fair values.  As Cell Genesys had ceased operations, the acquisition was not considered to be a business combination, and the allocation of the purchase price did not result in recognition of goodwill.  As a result of this treatment, during the fourth quarter of 2009, BioSante recognized a non-cash expense of approximately $20.2 million representing the excess of the consideration and costs of the transaction over the fair value of assets and liabilities received.

 

BioSante assumed $22.0 million in aggregate principal amount of convertible senior notes in connection with the Cell Genesys acquisition, including $1.2 million in aggregate principal amount of 3.125% convertible senior notes due November 1, 2011, which were repaid prior to the November 1, 2011 maturity date, and $20.8 million in aggregate principal amount of 3.125% convertible senior notes due May 1, 2013,

 

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$8.3 million in aggregate principal amount of which were outstanding as of December 31, 2012. As of December 31, 2012, $8.3 million in aggregate principal amount of convertible senior notes remained outstanding.

 

BioSante elected to apply the fair value option to the debt at the time of the acquisition, with recognition of subsequent changes in the fair value of the convertible senior notes recognized in BioSante’s statements of operations immediately.  As a result of this election, BioSante periodically must estimate the fair value of its convertible senior notes, which requires BioSante to make certain judgments and estimates about appropriate discount rates, BioSante’s creditworthiness, and assumptions regarding potential conversion of the notes.  BioSante believes that its estimates and assumptions are reasonable; however, changes in these estimates and assumptions could result in significant differences in the carrying value of the convertible senior notes.  The most sensitive of these assumptions is the discount rate used in the fair value estimate, which was 19.4 percent at December 31, 2012, and is based on the median yield to maturity of Ca and Caa3 rated debt instruments as of December 31, 2012.  A one percentage point increase or decrease in the discount rate would cause the recorded value of the convertible senior notes to decrease or increase by approximately $22,000.

 

Results of Operations

 

The following table sets forth, for the periods indicated, BioSante’s results of operations.

 

 

 

Year Ended December 31,

 

 

 

2012

 

2011

 

2010

 

Revenue

 

$

2,300,736

 

$

435,160

 

$

2,474,237

 

Expenses

 

 

 

 

 

 

 

Research and development

 

16,888,849

 

44,182,260

 

39,705,502

 

General and administrative

 

8,229,523

 

6,981,490

 

5,940,360

 

Licensing expense

 

95,000

 

50,000

 

268,750

 

Total expenses

 

25,472,318

 

51,361,990

 

46,082,598

 

Other (expense) income — Convertible note fair value adjustment

 

(4,328,468

)

(23,427

)

(1,870,916

)

Other expense — Investment impairment charge

 

 

 

(286,000

)

Other expense — Interest expense

 

(348,019

)

(681,573

)

(688,083

)

Other income

 

 

15,000

 

244,479

 

Other income — Interest income

 

8,539

 

8,326

 

12,665

 

Income tax benefit

 

121,791

 

 

 

Net loss

 

$

(27,717,739

)

$

(51,608,504

)

$

(46,196,216

)

Net loss per common share (basic and diluted)

 

$

(1.27

)

$

(3.15

)

$

(4.21

)

Weighted average number of common shares and common equivalent shares outstanding

 

21,757,906

 

16,397,618

 

10,985,291

 

 

Year Ended December 31, 2012 Compared to Year Ended December 31, 2011

 

Revenue recognized during 2012 consisted primarily of licensing revenue from Teva under the terms of the license agreement amendment executed in October 2012 pursuant to which Teva made a $1.0 million payment to BioSante upon signing of the amendment in October 2012 and a $750,000 milestone payment in December 2012.  Additionally, BioSante recognized royalty revenue from Meda for Elestrin sales, which royalty revenue is offset by BioSante’s corresponding obligation to pay Antares royalties representing the same amount.  BioSante’s corresponding obligation to pay Antares a portion of the royalties received, which equaled $550,736 during 2012 and $335,160 during 2011, is recorded within general and administrative expenses in BioSante’s statements of operations.  In addition, during 2011, BioSante recognized $100,000 in revenue from its receipt of an upfront non-refundable licensing fee from The John P. Hussman Foundation associated with BioSante’s former GVAX cancer vaccine portfolio.

 

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Research and development expenses for 2012 decreased 62 percent compared to 2011 primarily as a result of the completion of BioSante’s two LibiGel Phase III efficacy trials at the end of 2011 and the conclusion of the safety study in September 2012.

 

General and administrative expenses for 2012 increased 18 percent compared to 2011 primarily as a result of an increase in professional fees and other administrative expenses primarily due to BioSante’s efforts to seek strategic alternatives, including in particular expenses incurred in connection with BioSante’s pending merger with ANI.

 

The fair value adjustment on BioSante’s convertible senior notes for 2012 was $4.3 million compared to $23,427 for 2011.  The increase in the expense for 2012 was primarily as a result of $3.2 million non-cash fair value adjustment (expense) recorded upon cancellation of $12.5 million in aggregate principal amount of BioSante’s convertible senior notes in February and July 2012 in exchange for the issuance of 3,652,125 shares of BioSante common stock.  The convertible fair value adjustment for 2011 increased the recorded liability and corresponding expense by $23,427 and included BioSante’s 3.125% convertible senior notes due November 1, 2011 and 3.125% convertible senior notes due May 1, 2013.

 

Interest expense was $348,019 and $681,573 for 2012 and 2011, respectively, as a result of BioSante’s convertible senior notes.  Interest expense decreased during 2012 as a result of the repayment of BioSante’s 3.125% convertible senior notes due November 1, 2011 during the fourth quarter of 2011 and the cancellation of $12.5 million in aggregate principal amount of BioSante’s 3.125% convertible senior notes due May 1, 2013, including accrued and unpaid interest, during the first and third quarters of 2012 in exchange for the issuance of 3,652,125 shares of BioSante common stock.

 

Interest income increased $213 for 2012 compared to 2011 as a result of higher average interest rates despite lower average cash balances during 2012.

 

BioSante recognized an income tax benefit based on the receipt of an income tax credit for 2012 of $121,791 compared to the recognition of no income tax benefit or expense for 2011.  The income tax benefit was a result of an election to accelerate research and development credits in lieu of receiving bonus depreciation on certain property under Section 168(k)(4) of the Internal Revenue Code of 1986, as amended.

 

Year Ended December 31, 2011 Compared to Year Ended December 31, 2010

 

Revenue decreased $2.0 million, or 82.4 percent in 2011 compared to 2010, primarily as a result of the recognition of royalty revenue during 2010 resulting primarily from the receipt of $2.3 million in non-refundable upfront payments from Azur, partially offset by BioSante’s receipt during 2011 of $100,000 in a non-refundable upfront licensing fee from The John P. Hussman Foundation relating to an exclusive worldwide license of BioSante’s former melanoma vaccine.  The $2.3 million payment from Azur in 2010 was in exchange for the elimination of all remaining future royalty payments that BioSante is not required to pay Antares under a separate agreement and certain future milestone payments due BioSante under the terms of the original license, as permitted by the amendment to BioSante’s license agreement signed in December 2009. The only other revenue recognized during 2011 consisted of royalty revenue from Jazz Pharmaceuticals for Elestrin sales, which royalty revenue is offset by BioSante’s corresponding obligation to pay Antares royalties representing the same amount.

 

Research and development expenses for 2011 increased 11.3 percent compared to 2010 primarily as a result of the conduct of the three LibiGel Phase III clinical studies, particularly the safety study.

 

General and administrative expenses for 2011 increased 17.5 percent compared to 2010 primarily as a result of an increase in personnel-related costs and, to a lesser extent, increases in professional fees and other administrative expenses during 2011.

 

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The fair value adjustment on BioSante’s convertible senior notes for 2011 was $23,427 compared to $1.9 million for 2010 as the fair value of the debt did not change significantly between December 31, 2010 and 2011.

 

Interest expense for 2011 was $681,573 compared to $688,083 for 2010.

 

During 2010, BioSante recorded an investment impairment loss of $286,000 based on BioSante’s determination that an other-than-temporary loss had occurred with respect to BioSante’s investment in Ceregene, Inc. based on a third-party investment in Ceregene in 2010.

 

Liquidity and Capital Resources

 

The following table highlights several items from BioSante’s balance sheets:

 

Balance Sheet Data

 

December 31, 2012

 

December 31, 2011

 

Cash and cash equivalents

 

$

34,794,341

 

$

57,225,234

 

Total current assets

 

35,173,144

 

58,026,381

 

Investments

 

3,413,762

 

3,405,807

 

Total assets

 

38,769,170

 

62,379,755

 

Total current liabilities

 

10,593,665

 

7,227,703

 

Convertible senior notes due May 1, 2013, non-current

 

0

 

17,336,760

 

Total liabilities

 

10,593,665

 

24,564,463

 

Total stockholders’ equity

 

28,175,505

 

37,815,292

 

 

Working Capital

 

Since its inception, BioSante has incurred significant operating losses resulting in an accumulated deficit of $245.0 million as of December 31, 2012.  To date, BioSante has used primarily equity financings, and to a lesser extent, licensing income, interest income and the cash received from its 2009 merger with Cell Genesys, to fund its ongoing business operations and short-term liquidity needs.

 

As of December 31, 2012, BioSante had $34.8 million of cash and cash equivalents and $8.3 million in aggregate principal amount of its 3.125% convertible senior notes due May 1, 2013 outstanding.  Absent the receipt of any additional licensing income or financing, BioSante expects its cash and cash equivalents balance to decrease as it continues to use cash to fund its operations.  Assuming the proposed merger between BioSante and ANI is completed during the first quarter of 2013, BioSante expects its cash and cash equivalents as of December 31, 2012 to meet its liquidity requirements through at least the anticipated closing of the merger, including the requirement under the merger agreement to have at least $17 million of “net cash” as defined in and as calculated pursuant to the merger agreement available upon closing of the merger.  If the proposed merger between BioSante and ANI is not completed, BioSante will need to reevaluate its strategic alternatives, which may include continuing as an independent, stand-alone company, a sale of the company, liquidation of the company or other strategic transaction.  BioSante’s liquidity position will be dependent upon the strategic alternative selected; however, assuming BioSante does not enter into another strategic transaction, and assuming BioSante decides not to commence the two new efficacy trials for LibiGel, BioSante expects its cash and cash equivalents as of December 31, 2012 will be sufficient to meet its liquidity requirements for at least the next three to five years.  Substantial additional financing would be required should BioSante decide to commence the two new efficacy trials for LibiGel.  These estimates may prove incorrect or BioSante, nonetheless, may choose to raise additional financing earlier.

 

BioSante’s future capital requirements will depend upon numerous factors, including:

 

·                  the timing, cost and successful completion of the proposed merger between BioSante and ANI;

 

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·                  the progress, timing, cost and results of BioSante’s clinical development programs, including in particular the conclusion of the LibiGel Phase III safety study, and if BioSante has not completed the proposed merger between BioSante and ANI, beginning in mid-2013, the two new LibiGel Phase III efficacy trials if BioSante decides to commence such trials, and if BioSante in-licenses additional new products that require further development;

 

·                  the cost, timing and outcome of regulatory actions with respect to BioSante’s products;

 

·                  the success, progress, timing and costs of BioSante’s business development efforts to implement business collaborations, licenses and other business combinations or transactions, and BioSante’s efforts to evaluate various strategic alternatives available with respect to its products and company.

 

·                  BioSante’s ability to obtain value from its current products and technologies and its ability to out-license its products and technologies to third parties for development and commercialization and the terms of such out-licenses;

 

·                  BioSante’s ability to acquire or in-license additional new products and technologies and the costs and expenses of such acquisitions or licenses;

 

·                  the timing and amount of any royalties, milestone or other payments BioSante may receive from or be obligated to pay to current and potential licensors, licensees and other third parties;

 

·                  the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other intellectual property rights;

 

·                  the emergence of competing products and technologies, and other adverse market developments;

 

·                  the perceived, potential and actual commercial success of BioSante’s products;

 

·                  the outstanding principal amount of BioSante’s 3.125% convertible senior notes due May 1, 2013 that are scheduled to mature and become due and payable on May 1, 2013 and BioSante’s ability to avoid a “fundamental change” or an “event of default” under the indenture governing such notes, which may cause such notes to become due and payable prior to their maturity date on May 1, 2013;

 

·                  BioSante’s operating expenses; and

 

·                  the resolution of BioSante’s pending purported class action and shareholder derivative litigation and any amount BioSante may be required to pay in excess of its directors’ and officers’ liability insurance.

 

BioSante does not have any existing credit facilities under which it could borrow funds.  In the event that BioSante would require additional working capital to fund future operations, it could seek to acquire such funds through additional equity or debt financing arrangements.  If BioSante raises additional funds by issuing equity securities, its stockholders may experience dilution. Debt financing, if available, may involve covenants restricting BioSante’s operations or its ability to incur additional debt.  There is no assurance that any financing transaction will be available on terms acceptable to BioSante, or at all.  As an alternative to raising additional financing, BioSante may choose to license one or more of its products or technologies to a third party who may finance a portion or all of the continued development and, if approved, commercialization of that licensed product, or sell certain assets or rights under its existing license agreements.  In addition, from time to time, BioSante may purchase, exchange or restructure its outstanding convertible senior notes through

 

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cash purchases and/or exchanges for other equity securities of BioSante, in open market purchases, privately negotiated transactions and/or a tender offer.  In February 2012, BioSante issued an aggregate of 1,868,055 shares of its common stock to one of the holders of its convertible senior notes in exchange for the cancellation of $9.0 million in aggregate principal amount of such notes, including accrued and unpaid interest of $79,024, and in July 2012, BioSante issued an aggregate of 1,784,070 shares of its common stock to two of the holders of BioSante’s convertible senior notes in exchange for the cancellation of $3.5 million in aggregate principal amount of such notes and accrued and unpaid interest of $20,686.  Such additional purchases, exchanges or restructurings, if any, will depend on prevailing market conditions, the trading price and volume of BioSante common stock, the willingness of the note holders to sell, exchange or restructure their notes, BioSante’s available cash and cash equivalents, its liquidity requirements, regulatory limitations, contractual restrictions and other factors.  Such future purchases, exchanges or restructurings could dilute the percentage ownership of the BioSante stockholders, result in the issuance of securities at a discount to market price or that may have rights, preferences or privileges senior to those of existing BioSante stockholders and/or decrease BioSante’s cash balance.  A significant decrease in BioSante’s cash balance, together with an inability to raise additional financing when needed, may impair BioSante’s ability to execute strategic alternatives or leave it without sufficient cash remaining for operations.

 

BioSante is subject to pending purported class action and shareholder derivative litigation, which litigation is described elsewhere in this report.  Such litigation could divert management’s attention, harm BioSante’s business and/or reputation and result in significant liabilities, as well as harm BioSante’s ability to raise additional financing and execute certain strategic alternatives.

 

BioSante can provide no assurance that additional financing, if needed, will be available on terms favorable to BioSante, or at all.  This is particularly true if investors are not confident in the success of the proposed merger between BioSante and ANI, BioSante’s LibiGel development program, the future value of BioSante and/or economic and market conditions deteriorate.  If BioSante does not complete the proposed merger between BioSante and ANI and if adequate funds are not available or are not available on acceptable terms when BioSante needs them, BioSante may need to reduce its operating costs further or it may be forced to explore other strategic alternatives, such as other business combination transactions or winding down its operations and liquidating the company.  In such case, BioSante stockholders could lose some or all of their investment.

 

Uses of Cash and Cash Flow

 

Years Ended December 31, 2012, 2011 and 2010

 

Net cash used in operating activities was $25.3 million for the year ended December 31, 2012 compared to $47.9 million for the year ended December 31, 2011 and $40.1 million for the year ended December 31, 2010.  Net cash used in operating activities for 2012 was primarily the result of the net loss for that period which was lower compared to the prior year period due to lower clinical trial related expenses primarily as a result of the completion of BioSante’s two LibiGel Phase III efficacy trials at the end of 2011 and the conclusion of the safety study in September 2012.  Net cash used in operating activities for 2011 was primarily the result of the net loss for that period which was higher compared to 2010 due to higher LibiGel Phase III clinical study related expenses, partially offset by a decrease in prepaid expenses and other assets and an increase in accounts payable and accrued liabilities and the non-cash mark-to-market expense for BioSante’s convertible senior notes.  Net cash used in operating activities for 2010 was primarily the result of the net loss for that period, which was slightly higher compared to the prior year period due primarily to higher LibiGel Phase III clinical study related expenses, partially offset by an increase in accounts payable and accrued liabilities and a decrease in prepaid expenses and other assets.

 

Net cash used in investing activities was $619,148 for the year ended December 31, 2012 compared to net cash used in investing activities of $719,925 for the year ended December 31, 2011 and net cash used in investing activities of $60,366 for the year ended December 31, 2010.  Net cash used in investing activities for

 

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2012 was due primarily to the purchase of fixed assets.  The increase in net cash used in investing activities for 2011 compared to 2010 was due to a significant increase in the purchase of fixed assets, including in particular machinery, computers and furniture.  The machinery purchased during 2011 related to BioSante-owned machinery for LibiGel product manufacturing at its contract manufacturer and the increased amounts spent on computers and furniture during 2011 was due primarily to its increased number of personnel in 2011 compared to 2010.

 

Net cash provided by financing activities was $3.5 million for the year ended December 31, 2012 compared to $67.7 million for the year ended December 31, 2011 and $48.5 million for the year ended December 31, 2010.  Net cash provided by financing activities in 2012 was the result of BioSante’s August 2012 registered direct offering, which resulted in net proceeds of $3.3 million, after deduction of placement agent fees and offering expenses.  Net cash provided by financing activities in 2011 resulted from the net proceeds to BioSante, after deducting placement agent fees, underwriters’ discounts, commissions and other offering expenses, from the completion of BioSante’s March 2011 registered direct offering and August 2011 underwritten public offering, partially offset by the repayment of the 3.125% convertible senior notes due November 1, 2011 of $1.2 million.  Net cash provided by financing activities in 2010 resulted from the net proceeds to BioSante, after deducting placement agent fees and offering expenses, from the completion of BioSante’s March, June and December 2010 registered direct offerings.

 

3.125% Convertible Senior Notes Due May 1, 2013

 

As a result of BioSante’s merger with Cell Genesys in 2009, BioSante assumed $1.2 million in aggregate principal amount of 3.125% convertible senior notes due November 1, 2011 and $20.8 million in aggregate principal amount of 3.125% convertible senior notes due May 1, 2013 issued by Cell Genesys.  Prior to the November 1, 2011 maturity date, BioSante repaid in its entirety the outstanding aggregate principal amount of the 3.125% convertible senior notes due November 1, 2011 and all accrued and unpaid interest thereon through such date.  During the year ended December 31, 2012, BioSante issued an aggregate of approximately 3.7 million shares of BioSante common stock to holders of the 3.125% convertible senior notes due May 1, 2013 in exchange for cancellation of $12.5 million in aggregate principal amount of such notes, including accrued and unpaid interest.

 

Contractual interest payments on the convertible senior notes are due on May 1 and November 1 of each year through maturity.  Annual interest on the remaining convertible senior notes is approximately $259,000.

 

The remaining outstanding convertible senior notes are convertible into an aggregate of approximately 370,871 shares of BioSante common stock at a conversion price of $22.32 per share, subject to adjustments for stock dividends, stock splits and other similar events.  The convertible senior notes are general, unsecured obligations of BioSante, ranking equally with all of BioSante’s existing and future unsubordinated, unsecured indebtedness and senior in right of payment to any subordinated indebtedness, but are effectively subordinated to all of BioSante’s existing and future secured indebtedness to the extent of the value of the related collateral, and structurally subordinated to all existing and future liabilities and other indebtedness of any subsidiaries of BioSante.  The convertible senior notes are subject to repurchase by BioSante at each holder’s option, if a fundamental change (as defined in the indenture) occurs, at a repurchase price equal to 100 percent of the principal amount of the convertible senior notes, plus accrued and unpaid interest on the repurchase date and are subject to redemption for cash by BioSante, in whole or in part, at a redemption price equal to 100 percent of the principal amount of such notes plus accrued and unpaid interest to the redemption date, if the closing price of BioSante common stock has exceeded 150 percent of the conversion price then in effect with respect to such notes for at least 20 trading days in any period of 30 consecutive trading days ending on the trading day prior to the mailing of the notice of redemption.  As of December 31, 2012, the convertible senior notes were not eligible for redemption.  The indenture governing the convertible senior notes, as supplemented by the supplemental indenture, does not contain any financial covenants and does not restrict BioSante from paying dividends, incurring additional debt or issuing or repurchasing other securities of BioSante.  In

 

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addition, the indenture, as supplemented by the supplemental indenture, does not protect the holders of the convertible senior notes in the event of a highly leveraged transaction or a fundamental change of BioSante except in certain circumstances specified in the indenture.

 

From time to time, BioSante may purchase, exchange or restructure its outstanding convertible senior notes through cash purchases and/or exchanges for other equity securities of BioSante, in open market purchases, privately negotiated transactions and/or a tender offer.  The amounts involved may be material.  Such additional purchases, exchanges or restructurings, if any, will depend on prevailing market conditions, BioSante’s available cash and cash equivalents, its liquidity requirements, contractual restrictions and other factors.  Such future purchases, exchanges or restructurings could dilute the percentage ownership of the BioSante stockholders, result in the issuance of securities at a discount to market price or that may have rights, preferences or privileges senior to those of the existing BioSante stockholders and/or decrease BioSante’s cash balance.  A significant decrease in BioSante’s cash balance may impair its ability to execute strategic alternatives or leave it without sufficient cash remaining for operations.

 

BioSante has elected to record the convertible senior notes at fair value in order to simplify the accounting for the convertible debt, inclusive of the redemption, repurchase and conversion adjustment features which otherwise would require specialized valuation, bifurcation and recognition.  Accordingly, BioSante has adjusted the carrying value of the convertible senior notes to their fair value as of December 31, 2012, with changes in the fair value of the convertible senior notes occurring since December 31, 2011 reflected in convertible note fair value adjustment in BioSante’s statement of operations for the year ended December 31, 2012.  The fair value of the convertible senior notes are based on Level 2 inputs according to the fair value hierarchy required under GAAP, which means fair value of the convertible senior notes is based on observable prices that are based on inputs not quoted on active markets, but corroborated by market data.  The aggregate recorded fair value of the convertible senior notes of $7.9 million as of December 31, 2012 differs from their total stated principal amount of $8.3 million as of such date by $0.4 million.  The aggregate recorded fair value of the convertible senior notes of $17.3 million as of December 31, 2011 differs from their total stated principal amount of $20.8 million as of such date by $3.5 million.

 

Commitments and Contractual Obligations

 

The following table summarizes the timing of these future contractual obligations and commitments as of December 31, 2012:

 

 

 

Payments Due by Period

 

 

 

Total

 

Less than
1 Year

 

1-3 Years

 

3-5 Years

 

More than
5 Years

 

Convertible senior notes

 

$

8,277,850

 

$

8,277,850

 

$

0

 

$

0

 

$

0

 

Interest payment obligations related to convertible senior notes

 

129,500

 

129,500

 

0

 

0

 

0

 

Operating lease

 

290,350

 

248,632

 

41,718

 

0

 

0

 

Commitment under license agreement with Wake Forest

 

300,000

 

300,000

 

0

 

0

 

0

 

Total contractual cash obligations

 

$

8,997,700

 

$

8,955,982

 

$

41,718

 

$

0

 

$

0

 

 

On January 31, 2013, BioSante entered into an asset purchase agreement with Aduro pursuant to which BioSante sold all of its assets related to its GVAX cancer vaccine portfolio in exchange for a $1.0 million up front cash payment plus the potential for future royalty, milestone and sublicense payments.  As a result of such agreement, Aduro is responsible for future contractual obligations relating to the GVAX cancer vaccine portfolio. As such, all future contractual obligations related to the GVAX cancer vaccine portfolio of BioSante as of December 31, 2012 have been omitted from the above table. In February 2013, the Wake Forest University commitment was paid in full.

 

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Off-Balance Sheet Arrangements

 

BioSante does not have any off-balance sheet arrangements that have or reasonably are likely to have a material effect on BioSante’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.  As a result, BioSante is not exposed materially to any financing, liquidity, market or credit risk that could arise if BioSante had engaged in these arrangements.

 

Recent Accounting Pronouncements

 

BioSante does not expect the adoption of any recent accounting pronouncements to have a material effect on its financial position, results of operations or cash flows.

 

ITEM 7A.                                       QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

BioSante is exposed to interest rate sensitivity on its cash equivalents in money market funds and its outstanding fixed rate debt.  The objective of BioSante’s investment activities is to preserve principal, while at the same time maximizing yields without significantly increasing risk.  To achieve this objective, BioSante invests in highly liquid U.S. Treasury money market funds.  BioSante’s investments in U.S. Treasury money market funds are subject to interest rate risk.  To minimize the exposure due to an adverse shift in interest rates, BioSante invests in short-term securities and its goal is to maintain an average maturity of less than one year.  As of the date of this report, all of BioSante’s cash equivalents are only invested in a U.S. Treasury money market fund and a certificate of deposit.

 

The following table provides information about BioSante’s financial instruments that are sensitive to changes in interest rates.

 

Interest Rate Sensitivity

Principal Amount by Expected Maturity and Average Interest Rate

 

 

As of December 31, 2012

 

2012

 

2013

 

Total

 

Fair Value
December 31, 2012

 

Total cash equivalents

 

$

34,210,555

 

 

 

$

34,210,555

 

Average interest rate

 

0.01

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Fixed interest rate convertible senior notes

 

 

$

8,277,850

 

$

8,277,850

 

$

7,883,886

 

Average interest rate

 

3.125

%

3.125

%

3.125

%

 

 

 

 

As of December 31, 2011

 

2012

 

2013

 

Total

 

Fair Value
December 31, 2011

 

Total cash equivalents

 

$

55,465,507

 

 

 

$

55,465,507

 

Average interest rate

 

0.02

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Fixed interest rate convertible senior notes

 

 

$

20,782,000

 

$

20,782,000

 

$

17,336,760

 

Average interest rate

 

3.125

%

3.125

%

3.125

%

 

 

 

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ITEM 8.                                                FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

 

Description

 

Page

 

 

Management’s Report on Internal Control Over Financial Reporting

76

 

 

Report of Independent Registered Public Accounting Firm

77

 

 

Report of Independent Registered Public Accounting Firm

78

 

 

Balance Sheets as of December 31, 2012 and 2011

79

 

 

Statements of Operations for the years ended December 31, 2012, 2011 and 2010

80

 

 

Statements of Stockholders’ Equity for the years ended December 31, 2012, 2011 and 2010

81

 

 

Statements of Cash Flows for the years ended December 31, 2012, 2011 and 2010

82

 

 

Notes to the Financial Statements for the years ended December 31, 2012, 2011 and 2010

83-106

 

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MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

 

As management of BioSante Pharmaceuticals, Inc., we are responsible for establishing and maintaining an adequate system of internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended, for BioSante Pharmaceuticals, Inc.  This system is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.

 

BioSante’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of BioSante; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of BioSante are being made only in accordance with authorizations of management and directors of BioSante; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of BioSante’s assets that could have a material effect on the financial statements.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements and even when determined to be effective, can only provide reasonable assurance with respect to financial statement preparation and presentation.  Also, projection of any evaluation of the effectiveness of internal control over financial reporting to future periods is subject to the risk that controls may become inadequate because of changes in conditions, or that the degree or compliance with the policies or procedures may deteriorate.

 

With our participation, management evaluated the effectiveness of BioSante’s internal control over financial reporting as of December 31, 2012. In making this evaluation, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework. Based on this assessment, management concluded that BioSante’s internal control over financial reporting was effective as of December 31, 2012.

 

 

/s/ Stephen M. Simes

 

/s/ Phillip B. Donenberg

Stephen M. Simes

 

Phillip B. Donenberg

Vice Chairman, President and Chief Executive Officer

 

Senior Vice President of Finance, Chief Financial

Officer and Secretary

 

 

 

February 28, 2013

 

 

 

Further discussion of BioSante’s internal controls and procedures is included under the heading “Part II. Item 9A. Controls and Procedures” of this report.

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of

BioSante Pharmaceuticals, Inc.

Lincolnshire, Illinois

 

We have audited the internal control over financial reporting of BioSante Pharmaceuticals, Inc. (the “Company”) as of December 31, 2012, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.  The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control Over Financial Reporting.  Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

 

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.  Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.  We believe that our audit provides a reasonable basis for our opinion.

 

A company’s internal control over financial reporting is a process designed by, or under the supervision of, the company’s principal executive and principal financial officers, or persons performing similar functions, and effected by the company’s board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.  A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis.  Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2012, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the financial statements as of and for the year ended December 31, 2012 of the Company and our report dated February 28, 2013 expressed an unqualified opinion on those financial statements.

 

/s/ DELOITTE & TOUCHE LLP

 

 

 

Chicago, Illinois

 

February 28, 2013

 

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of

BioSante Pharmaceuticals, Inc.

Lincolnshire, Illinois

 

We have audited the accompanying balance sheets of BioSante Pharmaceuticals, Inc. (the “Company”) as of December 31, 2012 and 2011, and the related statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2012.  These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, such financial statements present fairly, in all material respects, the financial position of BioSante Pharmaceuticals, Inc. as of December 31, 2012 and 2011, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2012, in conformity with accounting principles generally accepted in the United States of America.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2012, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 28, 2013 expressed an unqualified opinion on the Company’s internal control over financial reporting.

 

/s/ DELOITTE & TOUCHE LLP

 

 

 

Chicago, Illinois

 

February 28, 2013

 

 

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BIOSANTE PHARMACEUTICALS, INC.

Balance Sheets

December 31, 2012 and 2011

 

 

 

December 31,

 

December 31,

 

 

 

2012

 

2011

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

Cash and cash equivalents

 

$

34,794,341

 

$

57,225,234

 

Prepaid expenses and other assets

 

378,803

 

801,147

 

 

 

35,173,144

 

58,026,381

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, NET

 

166,386

 

861,364

 

 

 

 

 

 

 

OTHER ASSETS

 

 

 

 

 

Investments

 

3,413,762

 

3,405,807

 

Deposits

 

15,878

 

86,203

 

 

 

$

38,769,170

 

$

62,379,755

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

Accounts payable

 

$

1,128,644

 

$

3,150,677

 

Accrued compensation

 

1,078,683

 

1,597,329

 

Other accrued expenses

 

502,452

 

2,479,697

 

Current portion of Convertible Senior Notes

 

7,883,886

 

 

 

 

10,593,665

 

7,227,703

 

 

 

 

 

 

 

Long-term Convertible Senior Notes

 

 

17,336,760

 

TOTAL LIABILITIES

 

10,593,665

 

24,564,463

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

Capital stock

 

 

 

 

 

Issued and outstanding

 

 

 

 

 

2012 - 65,211; 2011 - 65,214 Class C special stock

 

391

 

391

 

2012 - 24,422,240; 2011 - 18,269,754 Common stock

 

273,132,001

 

255,054,049

 

 

 

273,132,392

 

255,054,440

 

 

 

 

 

 

 

Accumulated deficit

 

(244,956,887

)

(217,239,148

)

 

 

28,175,505

 

37,815,292

 

 

 

$

38,769,170

 

$

62,379,755

 

 

See accompanying notes to the financial statements.

 

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BIOSANTE PHARMACEUTICALS, INC.

Statements of Operations

Years ended December 31, 2012, 2011 and 2010

 

 

 

Year Ended December 31,

 

 

 

2012

 

2011

 

2010

 

 

 

 

 

 

 

 

 

REVENUE

 

 

 

 

 

 

 

Licensing revenue

 

$

1,750,000

 

$

100,000

 

$

115,807

 

Grant revenue

 

 

 

51,870

 

Royalty revenue

 

550,736

 

335,160

 

2,306,560

 

 

 

 

 

 

 

 

 

 

 

2,300,736

 

435,160

 

2,474,237

 

 

 

 

 

 

 

 

 

EXPENSES

 

 

 

 

 

 

 

Research and development

 

16,888,849

 

44,182,260

 

39,705,502

 

General and administration

 

8,229,523

 

6,981,490

 

5,940,360

 

 

 

 

 

 

 

 

 

Licensing expense

 

95,000

 

50,000

 

268,750

 

Depreciation and amortization

 

258,946

 

148,240

 

167,986

 

 

 

 

 

 

 

 

 

 

 

25,472,318

 

51,361,990

 

46,082,598

 

OTHER

 

 

 

 

 

 

 

Convertible note fair value adjustment

 

(4,328,468

)

(23,427

)

(1,870,916

)

Investment impairment charge

 

 

 

(286,000

)

Interest expense

 

(348,019

)

(681,573

)

(688,083

)

Other income

 

 

15,000

 

244,479

 

Interest income

 

8,539

 

8,326

 

12,665

 

 

 

 

 

 

 

 

 

LOSS BEFORE INCOME TAX BENEFIT

 

(27,839,530

)

(51,608,504