Full Press Release Details
Announces Financial and Operational Results for the Year Ended December 31, 2018
SALT LAKE CITY, March 6, 2019 -
Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the year ended December
Fourth Quarter 2019 and Recent Corporate
Year Ended December 31, 2018 Financial
Lipocine reported a net loss of $11.7
million, or ($0.55) per diluted share, for the year ended December 31, 2018, compared with a net loss of $21.0 million, or ($1.05)
per diluted share, in the year ended December 31, 2017.
Research and development expenses were
$6.5 million for the year ended December 31, 2018, compared with $11.0 million for the year ended December 31, 2017. The decrease
in research and development expenses year over year was primarily due to reduced costs associated with TLANDO which include decreased
contract research organization expenses, decreased contract manufacturing expenses and decreased outside services and consulting
costs. Additionally, there were significant decreases in contract manufacturing expenses associated with LPCN 1107.
General and administrative expenses
were $5.3 million for the year ended December 31, 2018, compared with $10.2 million for the year ended December 31, 2017. The decrease
in general and administrative expenses year over year was primarily due to decreased personnel costs related to an overall reduction
in headcount resulting in lower stock compensation expense, bonus expense, and salary and related benefit costs in 2018. Additionally,
expenses for pre-commercialization marketing and sales activities related to TLANDO decreased significantly.
As of December 31, 2018, the Company
had unrestricted cash, cash equivalents and marketable securities aggregating $15.3 million, compared to $21.4 million at December
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 clinical development pipeline includes four development programs TLANDO, LPCN 1144, LPCN 1111 and LPCN
1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone
levels in hypogonadal men. TLANDO received a Complete Response Letter from the FDA on May 8, 2018. LPCN 1144, an oral prodrug
of bioidentical testosterone, is being developed as a treatment of non-alcoholic steatohepatitis ("NASH") and is currently
being studied in a proof-of-concept clinical study. LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed
by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.
LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent
preterm birth and has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed.
For more information, please visit www.lipocine.com.
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 regarding Lipocine's product candidates and related current and future clinical
trials, the timing of completion and related expectations of clinical trials including the ongoing ABPM clinical trial with TLANDO
and the Liver Fat Imaging study with LPCN 1144, the timing of resubmission of the NDA for TLANDO, the potential uses and benefits
of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements
involve risks and uncertainties, including, without limitation, risks related to potential delays in filing and acceptance of our
NDA for TLANDO, the risks that the FDA will not approve any of our products, including TLANDO, risks related to our products, expected
product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments
and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing
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 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 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.
For further information:
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (617) 535-7743
INC. AND SUBSIDIARIES
Consolidated Balance Sheets
December 31, 2018 and 2017
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,077,539 | $ | 3,210,749 | ||||
| Restricted cash | 5,000,000 | - | ||||||
| Marketable investment securities | 7,173,037 | 18,257,321 | ||||||
| Accrued interest income | 38,514 | 23,067 | ||||||
| Litigation insurance recovery | - | 3,319,927 | ||||||
| Prepaid and other current assets | 520,113 | 408,227 | ||||||
| Total current assets | 20,809,203 | 25,219,291 | ||||||
| Property and equipment, net of accumulated depreciation | ||||||||
| of $1,124,700 and $1,121,080, respectively | 18,997 | 75,070 | ||||||
| Other assets | 23,753 | 30,753 | ||||||
| Total assets | $ | 20,851,953 | $ | 25,325,114 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 671,280 | $ | 598,070 | ||||
| Litigation settlement payable | - | 4,250,000 | ||||||
| Accrued expenses | 487,135 | 1,497,056 | ||||||
| Debt - current portion | 3,333,333 | - | ||||||
| Total current liabilities | 4,491,748 | 6,345,126 | ||||||
| Debt - non-current portion | 6,926,532 | - | ||||||
| Total liabilities | 11,418,280 | 6,345,126 | ||||||
| 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; 21,737,196 and 21,270,249 | ||||||||
| issued and 21,731,486 and 21,264,539 outstanding | 2,174 | 2,127 | ||||||
| Additional paid-in capital | 147,533,019 | 145,423,012 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (963 | ) | (4,616 | ) | ||||
| Accumulated deficit | (138,059,845 | ) | (126,399,823 | ) | ||||
| Total stockholders' equity | 9,433,673 | 18,979,988 | ||||||
| Total liabilities and stockholders' equity | $ | 20,851,953 | $ | 25,325,114 |
LIPOCINE INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
Years Ending December 31, 2018, 2017, and 2016
| 2018 | 2017 | 2016 | ||||||||||
| Revenues: | ||||||||||||
| License revenue | $ | 428,031 | $ | - | $ | - | ||||||
| Total revenues | 428,031 | - | - | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | 6,464,708 | 11,004,281 | 8,076,053 | |||||||||
| General and administrative | 5,289,142 | 10,213,695 | 10,382,146 | |||||||||
| Restructuring costs | - | - | 728,635 | |||||||||
| Total operating expenses | 11,753,850 | 21,217,976 | 19,186,834 | |||||||||
| Operating loss | (11,325,819 | ) | (21,217,976 | ) | (19,186,834 | ) | ||||||
| Other income (expense), net | (333,503 | ) | 235,816 | 216,078 | ||||||||
| Loss before income tax expense | (11,659,322 | ) | (20,982,160 | ) | (18,970,756 | ) | ||||||
| Income tax expense | (700 | ) | (700 | ) | (752 | ) | ||||||
| Net loss | $ | (11,660,022 | ) | $ | (20,982,860 | ) | $ | (18,971,508 | ) | |||
| Basic loss per share attributable to common stock | $ | (0.55 | ) | $ | (1.05 | ) | $ | (1.04 | ) | |||
| Weighted average common shares outstanding, basic | 21,352,339 | 20,051,934 | 18,258,149 | |||||||||
| Diluted loss per share attributable to common stock | $ | (0.55 | ) | $ | (1.05 | ) | $ | (1.04 | ) | |||
| Weighted average common shares outstanding, diluted | 21,352,339 | 20,051,934 | 18,258,149 | |||||||||
| Comprehensive loss: | ||||||||||||
| Net loss | $ | (11,660,022 | ) | $ | (20,982,860 | ) | $ | (18,971,508 | ) | |||
| Unrealized net gain on available-for-sale securities | 3,653 | 3,877 | 24,407 | |||||||||
| Comprehensive loss | $ | (11,656,369 | ) | $ | (20,978,983 | ) | $ | (18,947,101 | ) |