Full Press Release Details
LIPOCINE ANNOUNCES FINANCIAL AND
OPERATIONAL RESULTS FOR THE THIRD QUARTER OF 2015
SALT LAKE CITY (November 12, 2015)
- Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today announced financial
results for the quarter ended September 30, 2015, as well as recent operational highlights.
Quarterly and Recent Highlights
"The highlight of the quarter
was the filing of our NDA for LPCN 1021, a significant milestone for the company. We remain focused on bringing this oral testosterone
replacement product candidate to patients, which we believe has the potential both to improve the ease of use compared to the available
formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and
partners," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "In addition, we made significant progress on the
development of LPCN 1107, one of our novel pipeline products."
Third Quarter 2015 Financial Results
Lipocine reported a net loss of $6.4 million,
or $0.35 per diluted share, for the third quarter of 2015, compared with a net loss of $4.1 million, or $0.32 per diluted share,
for the third quarter of 2014.
For the third quarter of 2015, research
and development expenses were $4.7 million, compared with $3.2 million for the third quarter of 2014. The increase was largely
attributable to a one-time payment of $2.3 million to the FDA for the NDA filing, partially offset by decreased clinical research,
consultant and manufacturing costs related as Phase 3 study for LPCN 1021 was completed.
For the third quarter of 2015, general
and administrative expenses were $1.7 million, compared with $872,000 for the same period in 2014. The increase was primarily due
to increased personnel costs and costs related to market research and pre-commercialization activities.
As of September 30, 2015, Lipocine had cash,
cash equivalents, and marketable investment securities of $47.8 million, compared with cash and cash equivalents of $27.7 million
as of December 31, 2014.
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. A New
Drug Application was filed with the FDA for Lipocine's lead product candidate, LPCN 1021. LPCN 1021 demonstrated positive efficacy
and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA.
Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement 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 with orphan drug designation, that is currently in Phase
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, product development and commercialization efforts and the projected timing of regulatory filings and actions.
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
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, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,733,889 | $ | 3,246,526 | $ | 9,814,492 | $ | 12,589,355 | ||||||||
| General and administrative | 1,700,099 | 871,825 | 3,871,478 | 3,831,181 | ||||||||||||
| Total operating expenses | 6,433,988 | 4,118,351 | 13,685,970 | 16,420,536 | ||||||||||||
| Operating loss | (6,433,988 | ) | (4,118,351 | ) | (13,685,970 | ) | (16,420,536 | ) | ||||||||
| Other income, net | 61,560 | 24,299 | 111,490 | 87,700 | ||||||||||||
| Loss before income tax expense | (6,372,428 | ) | (4,094,052 | ) | (13,574,480 | ) | (16,332,836 | ) | ||||||||
| Income tax expense | - | - | (200 | ) | - | |||||||||||
| Net loss | $ | (6,372,428 | ) | $ | (4,094,052 | ) | $ | (13,574,680 | ) | $ | (16,332,836 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.35 | ) | $ | (0.32 | ) | $ | (0.86 | ) | $ | (1.28 | ) | ||||
| Weighted average common shares outstanding, | 18,238,632 | 12,775,324 | 15,871,252 | 12,757,144 | ||||||||||||
| basic | ||||||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.35 | ) | $ | (0.32 | ) | $ | (0.86 | ) | $ | (1.28 | ) | ||||
| Weighted average common shares outstanding, diluted | 18,238,632 | 12,775,324 | 15,871,252 | 12,757,144 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (6,372,428 | ) | $ | (4,094,052 | ) | $ | (13,574,680 | ) | $ | (16,332,836 | ) | ||||
| Unrealized gain on available-for-sale securities | 15,887 | - | 5,802 | - | ||||||||||||
| Comprehensive loss | $ | (6,356,541 | ) | $ | (4,094,052 | ) | $ | (13,568,878 | ) | $ | (16,332,836 | ) |
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Balance Sheets |
| (Unaudited) |
| September 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 23,925,531 | $ | 27,666,055 | ||||
| Marketable investment securities | 17,868,989 | - | ||||||
| Accrued interest income | 146,844 | - | ||||||
| Prepaid and other current assets | 347,755 | 229,912 | ||||||
| Total current assets | 42,289,119 | 27,895,967 | ||||||
| Property and equipment, net of accumulated depreciation of | ||||||||
| $1,053,595 and $1,034,029, respectively | 82,906 | 73,782 | ||||||
| Long-term marketable investment securities | 6,032,439 | - | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 48,428,217 | $ | 27,993,502 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 456,830 | $ | 306,276 | ||||
| Accrued expenses | 1,722,146 | 1,327,256 | ||||||
| Total current liabilities | 2,178,976 | 1,633,532 | ||||||
| Total liabilities | 2,178,976 | 1,633,532 | ||||||
| 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; 18,249,456 and 12,800,382 issued | ||||||||
| and 18,243,746 and 12,794,672 outstanding | 1,825 | 1,280 | ||||||
| Additional paid-in capital | 128,094,083 | 94,636,479 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive income | 5,802 | - | ||||||
| Accumulated deficit | (81,811,757 | ) | (68,237,077 | ) | ||||
| Total stockholders' equity | 46,249,241 | 26,359,970 | ||||||
| Total liabilities and stockholders' equity | $ | 48,428,217 | $ | 27,993,502 |