Full Press Release Details
Lipocine Announces Financial And Operational
Results For The Full Year 2014
SALT LAKE CITY (March 11, 2015)
- Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today announced
financial results for the full year ended December 31, 2014, as well as recent operational highlights.
Quarterly and Recent Highlights
"We continue to make progress
with LPCN 1021, both progressing the SOAR Phase 3 study and receiving confirmation from the FDA regarding our ability to file an
NDA based on the SOAR Phase 3 design," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "In addition, we also
made important strides with our other two clinical candidates, delivering positive clinical data for LPCN 1107 and LPCN 1111."
Full Year 2014 Financial Results
For the full year of 2014, research
and development expenses were $15.5 million, compared with $5.1 million for the full year of 2013. The increase was largely attributable
to external service provider costs associated with development of product candidates, primarily LPCN 1021, partially offset by
a reduction in manufacturing and drug purchase costs.
For the full year of 2014, general
and administrative expenses were $5.0 million, compared with $3.6 million for the same period in 2013. The increase was primarily
due to increased compensation expense, including increases in equity compensation due primarily to accelerated vesting and/or extension
of exercise dates for retiring directors and a terminated officer; as well as increased compensation expense for new administrative
personnel and severance payments to a terminated officer.
Lipocine reported a net loss of $20.4
million, or $1.60 per diluted share, for the full year of 2014, compared with a net loss of $10.6 million, or $1.44 per diluted
share, for the full year of 2013.
As of December 31, 2014, Lipocine had
cash and cash equivalents of $27.7 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, and is currently in Phase 1
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 include 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 and commercialization efforts. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product
benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, 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 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 |
| Consolidated Statements of Operations and Comprehensive Loss |
| Years Ending December 31, 2014 and 2013 |
| 2014 | 2013 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 15,479,446 | $ | 5,122,864 | ||||
| General and administrative | 5,001,368 | 3,635,690 | ||||||
| Reverse merger costs | - | 1,011,630 | ||||||
| Settlement for termination of certain | ||||||||
| rights in stock purchase agreement | - | 913,446 | ||||||
| Total operating expenses | 20,480,814 | 10,683,630 | ||||||
| Operating loss | (20,480,814 | ) | (10,683,630 | ) | ||||
| Other income, net | 108,338 | 38,476 | ||||||
| Loss before income tax expense | (20,372,476 | ) | (10,645,154 | ) | ||||
| Income tax benefit (expense) | (200 | ) | 55,048 | |||||
| Net loss | $ | (20,372,676 | ) | $ | (10,590,106 | ) | ||
| Basic loss per share attributable to common stock | $ | (1.60 | ) | $ | (1.44 | ) | ||
| Weighted average common shares outstanding, basic | 12,766,295 | 7,363,076 | ||||||
| Diluted loss per share attributable to common stock | $ | (1.60 | ) | $ | (1.44 | ) | ||
| Weighted average common shares outstanding, diluted | 12,766,295 | 7,363,076 | ||||||
| Comprehensive loss | $ | (20,372,676 | ) | $ | (10,590,106 | ) |
| LIPOCINE INC. AND SUBSIDIARIES |
| Consolidated Balance Sheets |
| December 31, 2014 and 2013 |
| 2014 | 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 27,666,055 | $ | 45,263,698 | ||||
| Prepaid and other current assets | 229,912 | 770,030 | ||||||
| Total current assets | 27,895,967 | 46,033,728 | ||||||
| Property and equipment, net accumulated depreciation of | ||||||||
| $1,034,029 and $1,019,409, respectively | 73,782 | 28,794 | ||||||
| Other assets | 23,753 | 45,000 | ||||||
| Total assets | $ | 27,993,502 | $ | 46,107,522 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 306,276 | $ | 1,027,021 | ||||
| Accrued expenses | 1,327,256 | 256,754 | ||||||
| Total current liabilities | 1,633,532 | 1,283,775 | ||||||
| Total liabilities | 1,633,532 | 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; 12,800,382 and 12,668,393 | ||||||||
| issued and 12,794,672 and 12,668,393 outstanding | 1,280 | 1,267 | ||||||
| Additional paid-in capital | 94,636,479 | 92,686,881 | ||||||
| Treasury stock at cost, 5,710 and zero shares | (40,712 | ) | - | |||||
| Accumulated deficit | (68,237,077 | ) | (47,864,401 | ) | ||||
| Total stockholders' equity | 26,359,970 | 44,823,747 | ||||||
| Total liabilities and stockholders' equity | $ | 27,993,502 | $ | 46,107,522 |