Full Press Release Details
2019 Year End Financial and Operational Results
SALT LAKE CITY, March 13, 2020 -
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, today
announced financial results for the year ended December 31, 2019, and provided a corporate update.
Fourth Quarter and Recent Corporate
"We are pleased that the FDA has assigned a new PDUFA date
for TLANDO and are committed to working with the Agency towards the goal of achieving approval of TLANDO," said Dr. Mahesh
Patel, Chairman, President and Chief Executive Officer of Lipocine. "Based on the recent Post Action Meeting and subsequent
written feedback, the FDA has indicated our approach to addressing the deficiency from the most recent CRL appears
to be a reasonable path forward. In parallel, we continue to develop LPCN 1144 for the treatment of NASH and look forward to announcing
top line liver fat data from the ongoing LiFT clinical study in the second half of 2020."
Year Ended December 31, 2019 Financial
Lipocine reported a net loss of $13.0
million, or ($0.50) per diluted share, for the year ended December 31, 2019, compared with a net loss of $11.7 million, or ($0.55)
per diluted share, for the year ended December 31, 2018.
Research and development expenses were
$7.5 million for the year ended December 31, 2019, compared with $6.5 million for the year ended December 31, 2018. The increase
in research and development expenses during the year ended December 31, 2019 was primarily due to increases in contract research
organization and outside consulting and manufacturing costs for LPCN 1144 and an increase in costs for TLANDO XR (LPCN 1111), offset
by a decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study and the filing of the NDA in the
first half of 2019, a decrease in contract manufacturing costs for LPCN 1107 and a decrease in personnel expense.
General and administrative expenses
were $5.6 million for the year ended December 31, 2019, compared with $5.3 million for the year ended December 31, 2018. The increase
in general and administrative expenses was primarily due to increases in legal and corporate insurance costs offset by a decrease
As of December 31, 2019, the Company
had $14.1 million of unrestricted cash, cash equivalents and marketable investment securities compared to $15.3 million at December
31, 2018. Additionally, as of December 31, 2019 and December 31, 2018 the Company had $5.0 million of restricted cash, which is
required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA. In
February 2020, the Company raised an additional $6.0 million in gross proceeds from a registered direct offering of common stock
Lipocine Inc. is a clinical-stage
biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's
clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR ("LPCN 1111"), LPCN 1148 and LPCN 1107. TLANDO,
a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels
in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN
1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential
utility in the treatment of pre-cirrhotic NASH. TLANDO XR, 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. In a phase 2 clinical
evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148
is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first
oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent
preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit please visit www.lipocine.com.
Forward-Looking Statements
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 clinical trials, the timing of completion of clinical trials, enrollment of patients in the LiFT
study, the completion of and timing of data from the LiFT study, the potential uses and benefits of our product
candidates, our product development efforts, and future discussions and potential future actions by the FDA related to TLANDO
including the PDUFA date. Investors are cautioned that all such forward-looking statements involve risks and uncertainties,
including, without limitation, the risks that the FDA will not approve any of our products, 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, risk related to on-going litigation, competition including from companies with
approved competing drugs, 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
For further information contact:
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (617) 535-7743
LIPOCINE INC. AND SUBSIDIARIES
Consolidated Balance Sheets
December 31, 2019 and 2018
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,728,523 | $ | 8,077,539 | ||||
| Restricted cash | 5,000,000 | 5,000,000 | ||||||
| Marketable investment securities | 4,340,041 | 7,173,037 | ||||||
| Accrued interest income | 16,522 | 38,514 | ||||||
| Prepaid and other current assets | 545,887 | 520,113 | ||||||
| Total current assets | 19,630,973 | 20,809,203 | ||||||
| Property and equipment, net of accumulated depreciation of $1,140,143 and $1,124,700, respectively | 3,554 | 18,997 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 19,658,280 | $ | 20,851,953 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,182,241 | $ | 671,280 | ||||
| Accrued expenses | 449,303 | 487,135 | ||||||
| Debt - current portion | 3,333,333 | 3,333,333 | ||||||
| Total current liabilities | 4,964,877 | 4,491,748 | ||||||
| Debt - non-current portion | 3,814,407 | 6,926,532 | ||||||
| Warrant liability | 4,591,200 | - | ||||||
| Total liabilities | 13,370,484 | 11,418,280 | ||||||
| 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; 37,655,175 and 21,737,196 issued and 37,649,465 and 21,731,486 outstanding | 3,766 | 2,174 | ||||||
| Additional paid-in capital | 157,391,969 | 147,533,019 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (38 | ) | (963 | ) | ||||
| Accumulated deficit | (151,067,189 | ) | (138,059,845 | ) | ||||
| Total stockholders' equity | 6,287,796 | 9,433,673 | ||||||
| Total liabilities and stockholders' equity | $ | 19,658,280 | $ | 20,851,953 |
LIPOCINE INC. AND SUBSIDIARIES
Consolidated Statements of Operations
and Comprehensive Loss
Years Ended December 31, 2019
| 2019 | 2018 | |||||||
| Revenues: | ||||||||
| License revenue | $ | 164,990 | $ | 428,031 | ||||
| Total revenues | 164,990 | 428,031 | ||||||
| Operating expenses: | ||||||||
| Research and development | 7,468,210 | 6,464,708 | ||||||
| General and administrative | 5,597,070 | 5,289,142 | ||||||
| Total operating expenses | 13,065,280 | 11,753,850 | ||||||
| Operating loss | (12,900,290 | ) | (11,325,819 | ) | ||||
| Other expense, net | (343,254 | ) | (333,503 | ) | ||||
| Unrealized gain on warrant liability | 236,400 | - | ||||||
| Loss before income tax expense | (13,007,144 | ) | (11,659,322 | ) | ||||
| Income tax expense | (200 | ) | (700 | ) | ||||
| Net loss | $ | (13,007,344 | ) | $ | (11,660,022 | ) | ||
| Basic loss per share attributable to common stock | $ | (0.50 | ) | $ | (0.55 | ) | ||
| Weighted average common shares outstanding, basic | 25,882,273 | 21,352,339 | ||||||
| Diluted loss per share attributable to common stock | $ | (0.50 | ) | $ | (0.55 | ) | ||
| Weighted average common shares outstanding, diluted | 25,882,273 | 21,352,339 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (13,007,344 | ) | $ | (11,660,022 | ) | ||
| Unrealized net gain on available-for-sale securities | 925 | 3,653 | ||||||
| Comprehensive loss | $ | (13,006,419 | ) | $ | (11,656,369 | ) |