Full Press Release Details
Lipocine Announces Financial and Operational
Results for the Third Quarter of 2014
SALT LAKE CITY (November 10, 2014)
- Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today announced financial results
for the quarter ended September 30, 2014, as well as recent operational highlights.
Quarterly and Recent Highlights
"The highlight of the quarter
were the positive top-line efficacy results from our SOAR trial for LPCN 1021," said Dr. Mahesh Patel, President and CEO of
Lipocine Inc. "Based on the data, we continue to believe that LPCN 1021 represents a significant opportunity, given the product's
profile to-date and the need for a convenient, orally available testosterone replacement therapy."
Third Quarter 2014 Financial Results
Research and development expenses were
$3.2 million in the third quarter of 2014, compared with $1.6 million in the third quarter of 2013. The increase was largely attributable
to costs associated with development of product candidates, primarily LPCN 1021, partially offset by a reduction in manufacturing
and drug purchase costs. General and administrative expenses were $872,000 in the third quarter of 2014, compared with $1.2 million
for the same period in 2013. The decrease was primarily the result of higher professional fees associated with preparing to be
a public company in 2013.
Lipocine reported a net loss of $4.1
million, or $0.32 per diluted share, for the third quarter of 2014, compared with a net loss of $3.5 million, or $0.39 per diluted
share, for the third quarter of 2013.
As of September 30, 2014, Lipocine
had cash and cash equivalents of $31.7 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, demonstrated positive top-line efficacy results in Phase 3 testing and is targeted for testosterone
replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product with
once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone
caproate product indicated for the prevention of recurrent preterm birth, is currently in Phase 1 testing.
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 includes statements
that are not historical facts relating to expectations regarding clinical trials, the potential uses and benefits of Lipocine's
product candidates, and product development efforts. Investors are cautioned that all such forward-looking statements involve risks
and uncertainties, including, without limitation, the risks related to products, product benefits, clinical and regulatory expectations
and plans, the receipt of regulatory approvals, pre-clinical and clinical development timelines, the results of clinical trials,
patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, anticipated financial
performance, future revenues or earnings, business prospects, projected ventures, new products and services, anticipated market
performance, future expectations for liquidity and capital resources needs, 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 and other reports
on Forms 8-K and 10-Q, 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
| Three Months Ending September 30, | Nine Months Ending September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,246,526 | $ | 1,568,969 | $ | 12,589,355 | $ | 2,657,936 | ||||||||
| General and administrative | 871,825 | 1,181,894 | 3,831,181 | 2,601,557 | ||||||||||||
| Reverse merger costs | - | 794,902 | - | 1,011,630 | ||||||||||||
| Total operating expenses | 4,118,351 | 3,545,765 | 16,420,536 | 6,271,123 | ||||||||||||
| Operating loss | (4,118,351 | ) | (3,545,765 | ) | (16,420,536 | ) | (6,271,123 | ) | ||||||||
| Other income, net | 24,299 | 15,084 | 87,700 | 16,295 | ||||||||||||
| Loss before income tax expense | (4,094,052 | ) | (3,530,681 | ) | (16,332,836 | ) | (6,254,828 | ) | ||||||||
| Income tax benefit | - | 55,342 | - | 55,048 | ||||||||||||
| Net loss | $ | (4,094,052 | ) | $ | (3,475,339 | ) | $ | (16,332,836 | ) | $ | (6,199,780 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.32 | ) | $ | (0.39 | ) | $ | (1.28 | ) | $ | (1.04 | ) | ||||
| Weighted average common shares outstanding, basic | 12,775,324 | 8,914,666 | 12,757,144 | 5,958,415 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.32 | ) | $ | (0.39 | ) | $ | (1.28 | ) | $ | (1.04 | ) | ||||
| Weighted average common shares outstanding, diluted | 12,775,324 | 8,914,666 | 12,757,144 | 5,958,415 | ||||||||||||
| Comprehensive loss | $ | (4,094,052 | ) | $ | (3,475,339 | ) | $ | (16,332,836 | ) | $ | (6,199,780 | ) |
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2014 | 2013 | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 31,667,417 | $ | 45,263,698 | ||||
| Prepaid and other current assets | 285,916 | 770,030 | ||||||
| Total current assets | 31,953,333 | 46,033,728 | ||||||
| Property and equipment, net accumulated depreciation of $1,028,796 and $1,019,409, respectively | 40,687 | 28,794 | ||||||
| Other assets | 23,753 | 45,000 | ||||||
| Total assets | $ | 32,017,773 | $ | 46,107,522 | ||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 399,113 | $ | 1,027,021 | ||||
| Accrued expenses | 1,657,788 | 256,754 | ||||||
| Total current liabilities | 2,056,901 | 1,283,775 | ||||||
| Total liabilities | 2,056,901 | 1,283,775 | ||||||
| Commitments and contingencies | ||||||||
| 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; 12,784,382 and 12,668,393 issued and 12,778,672 and 12,668,393 outstanding | 1,278 | 1,267 | ||||||
| Additional paid-in capital | 94,197,543 | 92,686,881 | ||||||
| Treasury stock at cost, 5,710 and zero shares | (40,712 | ) | - | |||||
| Accumulated deficit | (64,197,237 | ) | (47,864,401 | ) | ||||
| Total stockholders' equity | 29,960,872 | 44,823,747 | ||||||
| Total liabilities and stockholders' equity | $ | 32,017,773 | $ | 46,107,522 |