Full Press Release Details
Lipocine Announces Financial and Operational
Results for the Second Quarter of 2014
SALT LAKE CITY (August 13, 2014)
- Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today announced financial results
for the quarter ended June 30, 2014, as well as recent operational highlights.
Quarterly and Recent Highlights
"Lipocine continues to make significant
progress across our entire pipeline, achieving milestones in all of our programs in the last few months. Our next key milestone
will be the top-line results from our SOAR trial for LPCN 1021 in the third quarter," said Dr. Mahesh Patel, President and
CEO of Lipocine Inc. "We continue to believe a significant potential demand exists for a convenient, orally available testosterone
replacement therapy. In addition, we believe that the safety of testosterone replacement continues to be reinforced, including
the recent FDA response to a citizen's petition on the issue."
Second Quarter 2014 Financial Results
Research and development expenses were
$6.0 million in the second quarter of 2014, compared with $0.4 million in the second quarter of 2013. The increase was largely
attributable to costs associated with development of product candidates, primarily LPCN 1021. General and administrative expenses
were $1.0 million in the second quarter of 2014, compared with $0.7 million for the same period in 2013. The increase was primarily
the result of higher professional fees associated with being a public company as well as in increase in personnel costs.
Lipocine reported a net loss of $7.0
million, or $0.55 per diluted share, for the second quarter of 2014, compared with a net loss of $1.4 million, or $0.31 per diluted
share, for the second quarter of 2013.
As of June 30, 2014, Lipocine had cash
and cash equivalents of $34.2 million, compared with cash and cash equivalents of $45.3 million as of December 31, 2013.
Lipocine Inc. is a specialty pharmaceutical company developing
innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine's
lead product candidate, LPCN 1021, currently in Phase 3 and is targeted to treat symptoms of low testosterone for men in need of
testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy
product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the
prevention of recurrent preterm birth.
Forward-Looking Statements
This release contains "forward
looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of
1995 and such forward-looking statements include statements that are not historical facts relating to an expectation that top-line
efficacy data for our LPCN 1021 pivotal Phase 3 clinical study will be available in the third quarter of 2014 and an anticipation
of our NDA filing in the second half of 2015; an expectation regarding patent protection for LPCN 1021 through January 2029; expectations
relating to top-line results from our LPCN 1111 Phase 2a clinical study in the second half of 2014; statements regarding the potential
uses and benefits of Lipocine's product candidates and statements regarding our product development efforts. Investors are cautioned
that all such forward-looking statements may not be realized and are subject to and involve risks and uncertainties, including,
without limitation, the risks related to the receipt of regulatory approvals, the results of clinical trials, patient acceptance
of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's
filings with the U.S. Securities and Exchange Commission (the "SEC"), including, without limitation, its Form 10-K, its
Quarterly Reports on Form 10-Q and other reports on Form 8-K, all of which can be obtained on the Company's website at www.lipocine.com
or on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements
contained in this release, except as required by law.
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Email: mb@lipocine.com
Phone: (443) 213-0500
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Statements of Operations and Comprehensive Loss |
| (Unaudited) |
| Three Months Ending June 30, | Six Months Ending June 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,973,829 | $ | 443,857 | $ | 9,342,829 | $ | 1,088,967 | ||||||||
| General and administrative | 1,035,733 | 712,627 | 2,959,356 | 1,419,663 | ||||||||||||
| Reverse merger costs | - | 216,728 | - | 216,728 | ||||||||||||
| Total operating expenses | 7,009,562 | 1,373,212 | 12,302,185 | 2,725,358 | ||||||||||||
| Operating loss | (7,009,562 | ) | (1,373,212 | ) | (12,302,185 | ) | (2,725,358 | ) | ||||||||
| Other income, net | 37,935 | 687 | 63,401 | 1,211 | ||||||||||||
| Loss before income tax expense | (6,971,627 | ) | (1,372,525 | ) | (12,238,784 | ) | (2,724,147 | ) | ||||||||
| Income tax expense | - | (182 | ) | - | (294 | ) | ||||||||||
| Net loss | $ | (6,971,627 | ) | $ | (1,372,707 | ) | $ | (12,238,784 | ) | $ | (2,724,441 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.55 | ) | $ | (0.31 | ) | $ | (0.96 | ) | $ | (0.61 | ) | ||||
| Weighted average common shares outstanding, basic | 12,770,391 | 4,455,790 | 12,749,355 | 4,455,790 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.55 | ) | $ | (0.31 | ) | $ | (0.96 | ) | $ | (0.61 | ) | ||||
| Weighted average common shares outstanding, diluted | 12,770,391 | 4,455,790 | 12,749,355 | 4,455,790 | ||||||||||||
| Comprehensive loss | $ | (6,971,627 | ) | $ | (1,372,707 | ) | $ | (12,238,784 | ) | $ | (2,724,441 | ) |
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Balance Sheets |
| (Unaudited) |
| June 30, | December 31, | |||||||
| 2014 | 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 34,164,006 | $ | 45,263,698 | ||||
| Prepaid and other current assets | 1,273,163 | 770,030 | ||||||
| Total current assets | 35,437,169 | 46,033,728 | ||||||
| Property and equipment, net accumulated depreciation of | ||||||||
| $1,025,467 and $1,019,409, respectively | 24,602 | 28,794 | ||||||
| Other assets | 23,753 | 45,000 | ||||||
| Total assets | $ | 35,485,524 | $ | 46,107,522 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 641,801 | $ | 1,027,021 | ||||
| Accrued expenses | 1,028,570 | 256,754 | ||||||
| Total current liabilities | 1,670,371 | 1,283,775 | ||||||
| Total liabilities | 1,670,371 | 1,283,775 | ||||||
| Commitments and contingencies (notes 7 and 9) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, par value $0.0001 per share, 10,000,000 | ||||||||
| shares authorized; zero issued and outstanding | - | - | ||||||
| Common stock, par value $0.0001 per share, 100,000,000 | ||||||||
| shares authorized; 12,780,382 and 12,668,393 | ||||||||
| issued and 12,774,672 and 12,668,393 outstanding | 1,278 | 1,267 | ||||||
| Additional paid-in capital | 93,957,772 | 92,686,881 | ||||||
| Treasury stock at cost, 5,710 and zero shares | (40,712 | ) | - | |||||
| Accumulated deficit | (60,103,185 | ) | (47,864,401 | ) | ||||
| Total stockholders' equity | 33,815,153 | 44,823,747 | ||||||
| Total liabilities and stockholders' equity | $ | 35,485,524 | $ | 46,107,522 |