Full Press Release Details
Condensed Balance Sheets
| June 30, 2013 | December 31, 2012 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,606,499 | $ | 5,377,114 | ||||
| Accounts receivable | 92,732 | |||||||
| Prepaid and other current assets | 123,317 | 90,934 | ||||||
| Related-party receivable | 3,815 | |||||||
| Total current assets | 3,822,548 | 5,471,863 | ||||||
| Property and equipment, net | 40,078 | 49,355 | ||||||
| Other assets | 45,000 | 45,000 | ||||||
| Total assets | $ | 3,907,626 | $ | 5,566,218 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 590,295 | $ | 87,027 | ||||
| Accrued expenses | 124,851 | 107,950 | ||||||
| Income taxes payable | 17,886 | 17,836 | ||||||
| Total current liabilities | 733,032 | 212,813 | ||||||
| Income taxes payable, noncurrent | 37,456 | 37,212 | ||||||
| Total liabilities | 770,488 | 250,025 | ||||||
| Commitments and contingencies (notes 8 and 10) | ||||||||
| Stockholders equity: | ||||||||
| Series B convertible preferred stock, $0.001 par value; 4,100,000 shares authorized and issuable in series; 250,000 shares designated in series, 250,000 issued and outstanding | 250 | 250 | ||||||
| Series A common stock, $0.001 par value; 32,000,000 shares authorized; 10,351,334 issued and outstanding | 10,351 | 10,351 | ||||||
| Series B common stock, $0.001 par value; 11,000,000 shares authorized; 4,637,347 issued, 4,607,847 and 4,637,347 outstanding | 4,638 | 4,638 | ||||||
| Additional paid-in capital | 43,173,735 | 42,575,249 | ||||||
| Treasury stock at cost, 29,500 and zero shares | (53,100 | ) | ||||||
| Accumulated deficit | (39,998,736 | ) | (37,274,295 | ) | ||||
| Total stockholders equity | 3,137,138 | 5,316,193 | ||||||
| Total liabilities and stockholders equity | $ | 3,907,626 | $ | 5,566,218 |
See notes to condensed financial statements
Condensed Statements of Operations
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Revenues: | ||||||||||||||||
| License and milestone revenue | $ | $ | $ | $ | 7,523,437 | |||||||||||
| Research revenue | 186,233 | |||||||||||||||
| Total revenues | 7,709,670 | |||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 443,857 | 545,403 | 1,088,967 | 1,148,607 | ||||||||||||
| General and administrative | 929,355 | 343,356 | 1,636,391 | 789,511 | ||||||||||||
| Operating income (loss) | (1,373,212 | ) | (888,759 | ) | (2,725,358 | ) | 5,771,552 | |||||||||
| Other income, net | 687 | 2,849 | 1,211 | 6,141 | ||||||||||||
| Income (loss) before income tax expense | (1,372,525 | ) | (885,910 | ) | (2,724,147 | ) | 5,777,693 | |||||||||
| Income tax expense | (182 | ) | (171 | ) | (294 | ) | (1,410 | ) | ||||||||
| Net income (loss) | $ | (1,372,707 | ) | $ | (886,081 | ) | $ | (2,724,441 | ) | $ | 5,776,283 | |||||
| Basic earnings (loss) per share attributable to Series A and B common stock | $ | (0.09 | ) | $ | (0.06 | ) | $ | (0.18 | ) | $ | 0.37 | |||||
| Weighted average common shares outstanding | 14,988,681 | 14,988,681 | 14,988,681 | 14,988,681 | ||||||||||||
| Diluted earnings (loss) per share attributable to Series A and B common stock | $ | (0.09 | ) | $ | (0.06 | ) | $ | (0.18 | ) | $ | 0.37 | |||||
| Weighted average common shares outstanding, diluted | 14,988,681 | 14,988,681 | 14,988,681 | 15,238,681 |
See notes to condensed financial statements
Condensed Statements of Cash Flows
| Six months ended June 30, | ||||||||
| 2013 | 2012 | |||||||
| Cash from operating activities: | ||||||||
| Net income (loss) | $ | (2,724,441 | ) | $ | 5,776,283 | |||
| Adjustments to reconcile net income (loss) to cash used in operating activities: | ||||||||
| Depreciation and amortization | 10,483 | 20,950 | ||||||
| Forgiveness of related party receivable | 3,815 | |||||||
| Stock-based compensation expense | 598,486 | 79,948 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (92,732 | ) | 235,638 | |||||
| Prepaid and other current assets | 12,306 | 54,398 | ||||||
| Accounts payable | 458,579 | (71,249 | ) | |||||
| Accrued expenses | 16,901 | 22,430 | ||||||
| Income taxes payable | 294 | 342 | ||||||
| Deferred revenues | (7,523,437 | ) | ||||||
| Cash used in operating activities | (1,716,309 | ) | (1,404,697 | ) | ||||
| Cash used in investing activities: | ||||||||
| Purchases of property and equipment | (1,206 | ) | (2,610 | ) | ||||
| Cash used in investing activities | (1,206 | ) | (2,610 | ) | ||||
| Cash used in financing activities: | ||||||||
| Purchase of treasury stock | (53,100 | ) | ||||||
| Cash used in financing activities | (53,100 | ) | ||||||
| Net decrease in cash and cash equivalents | (1,770,615 | ) | (1,407,307 | ) | ||||
| Cash and equivalents at beginning of period | 5,377,114 | 8,567,823 | ||||||
| Cash and equivalents at end of period | $ | 3,606,499 | $ | 7,160,516 | ||||
| Supplemental disclosure of non-cash financing activities: | ||||||||
| Accrued deferred offering costs | $ | 44,689 |
See notes to condensed financial statements
Notes to Condensed Financial Statements
The accompanying unaudited financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange
Commission ( SEC ) regarding interim financial reporting. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements and should be read in
conjunction with the audited Lipocine Inc. financial statements for the year ended December 31, 2012. The accompanying unaudited financial statements reflect all adjustments necessary for a fair presentation of results for the interim periods
presented. Preparing financial statements requires the Company to make estimates and assumptions that affect the amounts that are reported in the financial statements and accompanying footnotes. Although these estimates are based upon the
Company s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from the estimates. The results of operations for the three and six months ended June 30, 2013 are not
necessarily indicative of the results to be expected for any future period or for the full year.
Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average
number of common shares outstanding during the period. Net income (loss) available to common shareholders for the three and six months ended June 30, 2013 and 2012 was calculated using the two-class method, which is an earnings (loss)
allocation method for computing earnings (loss) per share when an entity s capital structure includes common stock and participating securities. The two-class method determines earnings (losses) per share based on dividends declared on common
stock and participating securities (i.e., distributed earnings) and participation rights of participating securities in any undistributed earnings (loss). The application of the two-class method was required since the Company s Series B
preferred stock and the unvested restricted stock each contain nonforfeitable rights to dividends or dividend equivalents. However, unvested restricted stock grants and Series B convertible preferred stock are not included in computing basic
earnings (loss) per share for periods where the Company has losses as these securities are not contractually obligated to share in losses of the Company.
Diluted earnings (loss) per share is based on the weighted average number of common shares outstanding plus, where applicable, the additional potential common shares that would have been outstanding
related to dilutive options, warrants, convertible preferred stock and unvested restricted stock to the extent such shares are dilutive.
The following table sets forth the computation of basic and diluted earnings (loss) per share of Series A and Series B common stock for the three and six months ended June 30, 2013 and 2012. The
allocation of undistributed earnings (losses) to Series A and Series B common stock in the table below excludes zero net income (loss) allocated to the participating securities for the three months ended June 30, 2013 and 2012, and zero and
$221,232 for the six months ended June 30, 2013 and 2012.
Notes to Condensed Financial Statements
| Three Months Ended June 30, | ||||||||||||||||
| 2013 | 2012 | |||||||||||||||
| Series A | Series B | Series A | Series B | |||||||||||||
| Basic net loss per share attributable to Series A and Series B common stock: | ||||||||||||||||
| Numerator | ||||||||||||||||
| Allocation of undistributed losses to Series A and Series B common stock | $ | (947,991 | ) | $ | (424,716 | ) | $ | (611,928 | ) | $ | (274,153 | ) | ||||
| Denominator | ||||||||||||||||
| Weighted avg. common shares outstanding | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Number of shares used in per share computation | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Basic losses per share attributable to Series A and Series B common stock | $ | (0.09 | ) | $ | (0.09 | ) | $ | (0.06 | ) | $ | (0.06 | ) | ||||
| Diluted net loss per share attributable to Series A and Series B common stock: | ||||||||||||||||
| Numerator | ||||||||||||||||
| Allocation of undistributed losses to Series A and | ||||||||||||||||
| Series B common stock in basic earnings per share | $ | (947,991 | ) | $ | (424,716 | ) | $ | (611,928 | ) | $ | (274,153 | ) | ||||
| Plus: Undistributed losses allocated to Series B convertible preferred stock | ||||||||||||||||
| Total losses used in per share computation | $ | (947,991 | ) | $ | (424,716 | ) | $ | (611,928 | ) | $ | (274,153 | ) | ||||
| Denominator | ||||||||||||||||
| Weighted avg. common shares used in basic per share computation | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Plus: Weighted avg. Series B convertible preferred stock | ||||||||||||||||
| Number of shares used in per share computation | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Diluted losses per share attributable to Series A and Series B common stock | $ | (0.09 | ) | $ | (0.09 | ) | $ | (0.06 | ) | $ | (0.06 | ) |
Notes to Condensed Financial Statements
| Six Months Ended June 30, | ||||||||||||||||
| 2013 | 2012 | |||||||||||||||
| Series A | Series B | Series A | Series B | |||||||||||||
| Basic net income (loss) per share attributable to Series A and Series B common stock: | ||||||||||||||||
| Numerator | ||||||||||||||||
| Allocation of undistributed earnings (losses) to Series A and Series B common stock | $ | (1,881,499 | ) | $ | (842,942 | ) | $ | 3,836,607 | $ | 1,718,444 | ||||||
| Denominator | ||||||||||||||||
| Weighted avg. common shares outstanding | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Number of shares used in per share computation | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Basic earnings (losses) per share attributable to Series A and Series B common stock | $ | (0.18 | ) | $ | (0.18 | ) | $ | 0.37 | $ | 0.37 | ||||||
| Diluted net income (loss) per share attributable to Series A and Series B common stock: | ||||||||||||||||
| Numerator | ||||||||||||||||
| A and Series B common stock in basic earnings per share | $ | (1,881,499 | ) | $ | (842,942 | ) | $ | 3,836,607 | $ | 1,718,444 | ||||||
| Plus: Undistributed earnings allocated to Series B convertible preferred stock | 92,421 | |||||||||||||||
| Total earnings (losses) used in per share computation | $ | (1,881,499 | ) | $ | (842,942 | ) | $ | 3,929,028 | $ | 1,718,444 | ||||||
| Denominator | ||||||||||||||||
| Weighted avg. common shares used in basic per share computation | 10,351,334 | 4,637,347 | 10,351,334 | 4,637,347 | ||||||||||||
| Plus: Weighted avg. Series B convertible preferred stock | 250,000 | |||||||||||||||
| Number of shares used in per share computation | 10,351,334 | 4,637,347 | 10,601,334 | 4,637,347 | ||||||||||||
| Diluted earnings (losses) per share attributable to Series A and Series B common stock | $ | (0.18 | ) | $ | (0.18 | ) | $ | 0.37 | $ | 0.37 |
Notes to Condensed Financial Statements
The computation of diluted earnings (loss) per share for the three and six months ended
June 30, 2013 and 2012 does not include the following unvested restricted stock, stock options and warrants to purchase shares in the computation of diluted earnings (loss) per share because these instruments were antidilutive:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Stock Options | 4,201,684 | 3,419,201 | 4,201,684 | 3,419,201 | ||||||||||||
| Unvested Restricted Stock | 310,250 | 346,050 | 310,250 | 346,050 | ||||||||||||
| Warrants | 70,000 | 70,000 | 70,000 | 70,000 |
accounts receivable, prepaid and other current assets, related-party receivable, trade accounts payable, and accrued expenses the carrying amounts approximate fair value because of the short maturity of these instruments.
Assets and liabilities that are measured at fair value on a recurring basis using quoted prices in active markets for identical
instruments (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) consist of the following at June 30, 2013 and December 31, 2012:
| Fair value measurements at reporting date using | ||||||||||||||||
| June 30, 2013 | Level 1 inputs | Level 2 inputs | Level 3 inputs | |||||||||||||
| Assets: | ||||||||||||||||
| Cash equivalents-money market funds | $ | 2,433,188 | $ | 2,433,188 | $ | $ | ||||||||||
| $ | 2,433,188 | $ | 2,433,188 | $ | $ | |||||||||||
| Fair value measurements at reporting date using | ||||||||||||||||
| December 31, 2012 | Level 1 inputs | Level 2 inputs | Level 3 inputs | |||||||||||||
| Assets: | ||||||||||||||||
| Cash equivalents-money market funds | $ | 2,686,727 | $ | 2,686,727 | $ | $ | ||||||||||
| $ | 2,686,727 | $ | 2,686,727 | $ | $ |
The following methods and assumptions were used to determine the fair value of each class of assets
recorded at fair value in the balance sheets:
Cash equivalents: Cash equivalents primarily consist of highly rated money
market funds with original maturities to the Company of three months or less, and are purchased daily at par value with specified yield rates. Due to the high ratings and short-term nature of the funds, the Company considers all cash equivalents as
Notes to Condensed Financial Statements
provision for interim periods is determined using an estimate of the Company s effective tax rate for the full year adjusted for discrete items, if any, that are taken into account in the relevant period. Each quarter the Company updates its
estimate of the annual effective tax rate, and if the estimated tax rate changes, the Company makes a cumulative adjustment.
At June 30, 2013 and December 31, 2012, the Company has a full valuation allowance against its deferred tax assets, net of
expected reversals of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized.
On January 2, 2013, an extension of the research and development credit in the U.S. was signed into law. While the Company fully intends to take advantage of the research and development credit for
the 2012 and 2013 tax years, no benefit has been recorded in the financial statements due to the full valuation allowance position in the U.S.
Company recognizes stock-based compensation expense for grants of stock option awards and restricted stock under the Company s Incentive Plan to employees and nonemployee members of the Company s board of directors based on the grant-date
fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award s requisite service period. In addition, the Company has granted performance-based stock option awards and
restricted stock grants which vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options will be recognized only if, and when, the Company
estimates that these options will vest, which is based on whether the Company considers the options performance conditions to be probable of attainment. The Company s estimates of the number of performance-based options that will vest
will be revised, if necessary, in subsequent periods. In addition, the Company grants stock options to nonemployee consultants from time to time in exchange for services performed for the Company. Equity instruments granted to nonemployees are
subject to periodic revaluation over their vesting terms.
On January 31, 2013, the Company modified 3,262,948 existing
time-vested and performance stock options by lowering the exercise price to $0.782. Additionally, the Company modified the vesting terms for its unvested performance stock options and unvested restricted stock to vest on the earlier of the first
dosing in the pivotal clinical study for its lead drug candidate, or 50% on January 31, 2014 and 50% on January 31, 2015. Compensation expense of $421,950 was recorded as a result of the modifications.
Stock-based compensation cost that has been expensed in the statements of operations amounted to
$118,180 and $33,915 for the three months ended June 30, 2013 and 2012 and $598,486 and $79,948 for the six months ended June 30, 2013 and 2012, allocated as follows:
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Research and development | $ | 37,463 | $ | 10,751 | $ | 189,720 | $ | 25,344 | ||||||||
| General and administrative | 80,717 | 23,164 | 408,766 | 54,604 | ||||||||||||
| $ | 118,180 | $ | 33,915 | $ | 598,486 | $ | 79,948 |
Notes to Condensed Financial Statements
As of June 30, 2013, there was approximately $718,299 of total unrecognized
compensation cost related to unvested share-based compensation arrangements granted under the Company s Incentive Plan. The cost will be expensed pro-rata over the service period. The cumulative amount of
compensation expense recognized at any point in time is at least equal to the portion of the award that is vested at that date. No stock options were issued during the three months ended June 30, 2013. The weighted average fair value of stock
options granted during the six months ended June 30, 2013, was approximately $0.48.
On May 15, 2009, the Company granted an exclusive license to Solvay Pharmaceuticals, Inc. (later acquired by Abbott Products, Inc.) to certain rights to its intellectual property in exchange for an
up-front license fee of $4,000,000, certain specified payments upon achievement of various development and commercial milestones or the passage of time and also a royalty on related net sales. The Company also received research revenue for services
rendered during the development period and reimbursement of out-of-pocket expenses.
The Company received the up-front fee of
$4,000,000 in 2009 and milestone payments, related solely to the passing of time and not the achievement of any of the development or commercial milestones, totaling $3,000,000 and $2,000,000 in 2011 and 2010. The up-front license fee and milestone
payments were recorded as a single unit of account, as the delivered technology does not have stand-alone value. Total consideration was recorded using cumulative catch-up method as payments were deemed collectible over the estimated term of the
contract for which the Company has continuing performance obligations. The agreement was terminated effective March 29, 2012, and the balance of deferred revenue of $7,523,438 was recognized as licensing and milestone revenue during the six
months ended June 30, 2012. The Company also earned research revenue under the agreement of zero and $186,233 during the three and six months ended June 30, 2012. No amounts were recorded for the three or six months ended June 30,
As part of the termination we reacquired the rights to the intellectual property from Abbott in March 2012. All
obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1.5% royalty on net sales should Lipocine decide to use certain Solvay/Abbott formulations or a perpetual 1% royalty on net sales
should Lipocine use data generated during the term of the Solvay/Abbott agreement in any regulatory filings for a product. Such royalties are limited to $1 million in the first two calendar years following product launch, after which period there is
not a cap on royalties and no maximum aggregate amount. If generic versions of any such product are introduced, then royalties are reduced by 50%.
On May 21, 2011, the Company entered into a collaborative product development agreement with Nexgen Pharma, Inc.
( Nexgen ). Under the agreement, the parties agreed to jointly develop certain products for the treatment of coughs and colds and to share future revenues from those products. Nexgen agreed to reimburse the Company at cost for all future
clinical costs incurred in the development of the products. A total of $92,732 and $55,560 for the three months ended June 30, 2013 and 2012 and $468,348 and $397,852 during the six months ended June 30, 2013 and 2012 was reimbursed for
related expenses under the agreement and recorded net in research and development expense. The Company is responsible for certain new drug application ( NDA ) filing costs with the Food and Drug Administration ( FDA ) under terms
of this contract and, additionally, will participate on a joint steering committee with Nexgen for the development, regulatory, and manufacturing strategy of product candidates. On July 23, 2013, the Company transferred all rights and
obligations under this agreement to Spriaso, LLC (see note 11).
The Company has entered into agreements with a number of independent contractors, primarily clinical researchers, who serve as advisors to the Company and various contract organizations that conduct
preclinical and clinical development work on behalf of the Company. The Company incurred expenses of $123,905 and $131,373 for the three months ended June 30, 2013 and 2012, and $538,395 and $578,074 for the six months ended June 30, 2013
and 2012 under these agreements.
Notes to Condensed Financial Statements
lease payments under noncancelable operating leases (with initial or remaining lease terms in excess of one year) as of June 30, 2013 are:
| Operating leases | ||||
| Year ending December 31: | ||||
| 2013 | $ | 131,907 | ||
| 2014 | 247,841 | |||
| Total minimum lease payments | $ | 379,748 |
The Company s rent expense was $90,864 and $84,952 for the three months ended June 30, 2013 and
2012 and $177,727 and $169,905 for the six months ended June 30, 2013 and 2012.
Series B convertible preferred stock may be converted any time after three years after issuance and at the option of the holder
into Series A common stock on a one-to-one basis. Series B preferred stockholders are not entitled to vote. Series B convertible preferred stock has
liquidation rights consistent with common stockholders based on the number of common shares into which Series B preferred is convertible. At June 30, 2013, all outstanding Series B preferred shares are convertible.
Preferred stockholders are entitled to receive dividends when and if declared by the board of directors with respect to Series A voting
common stock. The Company may not pay or declare any form of dividend to Series A common stockholders without at the same time paying or declaring the same per share dividend to the preferred stockholders as if all preferred shares were converted to
common stock at the date of declaration.
Common stock consists of two series; Series A common stock and Series B common stock. Both series bear the same rights except Series B