Full Press Release Details
Second Quarter 2020 Financial and Operational Results
SALT LAKE CITY, August 6, 2020 -
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today
announced financial results for the second quarter ended June 30, 2020, and provided a corporate update.
Second Quarter and Recent Corporate
Ongoing Activities and Upcoming
Second Quarter Ended June 30, 2020
Lipocine reported a net loss of $6.4
million, or ($0.13) per diluted share, for the quarter ended June 30, 2020, compared with a net loss of $3.4 million, or ($0.14)
per diluted share, in the quarter ended June 30, 2019.
Research and development expenses were $2.3 million for the
quarter ended June 30, 2020, compared with $2.0 million for the quarter ended June 30, 2019. The increase in research and development
expenses during the three months ended June 30, 2020 was primarily due to increased contract research organization and outside
consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects of $965,000, as
well as a $213,000 increase in personnel expense. These increases were offset by a $727,000 decrease in costs incurred in conjunction
with TLANDO with the completion of the ABPM study in the first half of 2019, a $96,000 decrease in costs for TLANDO XR, a $25,000
decrease in contract manufacturing costs for LPCN 1107 and a $25,000 decrease in other research and development expenses.
General and administrative expenses
were $2.0 million for the quarter ended June 30, 2020, compared with $1.4 million for the quarter ended June 30, 2019. The increase
in general and administrative expenses during the three months ended June 30, 2020 was primarily due to a $613,000 increase in
legal costs associated with the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent infringement in
April 2019, interference cases filed against Clarus and the on-going class action lawsuit defense. In addition, there was a $48,000
increase in personnel costs, offset by a $41,000 decrease marketing expense, a $34,000 decrease in administrative travel expenses
and a $19,000 decrease in other general and administrative expenses.
As of June 30, 2020, we had $18.3 million
of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019. Additionally,
as of June 30, 2020 and December 31, 2019 we 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.
Six Months Ended June 30, 2020 Financial
Lipocine reported a net loss of
$12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020, compared with a net loss of $6.7
million, or ($0.28) per diluted share, for the six months ended June 30, 2019.
Research and development expenses were $4.8 million for
the six months ended June 30, 2020, compared with $3.9 million for the six months ended June 30, 2019. The increase in
research and development expenses during the six months ended June 30, 2020 was primarily due to increased contract
research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical
study in NASH subjects of $2.6 million and a $270,000 increase in personnel expense. These increases were offset by a $1.9
million decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study in the first half of
2019, a $46,000 decrease in costs for TLANDO XR, a $37,000 decrease in contract manufacturing costs for LPCN 1107 and a
$20,000 decrease in other research and development expenses.
General and administrative expenses were $4.0 million for
the six months ended June 30, 2020, compared with $2.6 million for the six months ended June 30, 2019. The increase in
general and administrative expenses during the six months ended June 30, 2020 was primarily due to a $1.6 million increase
in legal costs associated with the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent
infringement in April 2019, interference cases filed against Clarus and the on-going class action lawsuit defense, offset by
a $11,000 decrease in personnel costs, a $60,000 decrease in administrative travel expense, a $41,000 decrease in marketing
expense and a $112,000 decrease in other general and administrative expenses.
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 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 non-cirrhotic NASH. LPCN 1144
is currently being studied in a Phase 2 clinical study. 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 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 www.lipocine.com.
Forward-Looking Statements
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 clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our
product candidates, our product development efforts, 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, 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
For further information:
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (617) 535-7743
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,837,818 | $ | 9,728,523 | ||||
| Restricted cash | 5,000,000 | 5,000,000 | ||||||
| Marketable investment securities | 4,466,541 | 4,340,041 | ||||||
| Accrued interest income | 7,919 | 16,522 | ||||||
| Prepaid and other current assets | 147,308 | 545,887 | ||||||
| Total current assets | 23,459,586 | 19,630,973 | ||||||
| Property and equipment, net of accumulated depreciation of $1,141,741 and $1,140,143, respectively | 1,956 | 3,554 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 23,485,295 | $ | 19,658,280 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 906,826 | $ | 1,182,241 | ||||
| Accrued expenses | 993,258 | 449,303 | ||||||
| Debt - current portion | 2,331,710 | 3,333,333 | ||||||
| Total current liabilities | 4,231,794 | 4,964,877 | ||||||
| Debt - non-current portion | 4,002,221 | 3,814,407 | ||||||
| Warrant liability | 2,166,312 | 4,591,200 | ||||||
| Total liabilities | 10,400,327 | 13,370,484 | ||||||
| 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; 61,383,016 and 37,655,175 issued and 61,377,306 and 37,649,465 outstanding | 6,138 | 3,766 | ||||||
| Additional paid-in capital | 176,327,120 | 157,391,969 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (104 | ) | (38 | ) | ||||
| Accumulated deficit | (163,207,474 | ) | (151,067,189 | ) | ||||
| Total stockholders' equity | 13,084,968 | 6,287,796 | ||||||
| Total liabilities and stockholders' equity | $ | 23,485,295 | $ | 19,658,280 |
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements
of Operations and Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 2,268,984 | $ | 1,964,146 | $ | 4,780,739 | $ | 3,913,966 | ||||||||
| General and administrative | 1,953,535 | 1,386,457 | 4,038,795 | 2,562,385 | ||||||||||||
| Total operating expenses | 4,222,519 | 3,350,603 | 8,819,534 | 6,476,351 | ||||||||||||
| Operating loss | (4,222,519 | ) | (3,350,603 | ) | (8,819,534 | ) | (6,476,351 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 7,177 | 124,581 | 67,115 | 249,846 | ||||||||||||
| Interest expense | (87,847 | ) | (204,575 | ) | (221,192 | ) | (428,364 | ) | ||||||||
| Loss on warrant liability | (2,066,445 | ) | - | (3,166,474 | ) | - | ||||||||||
| Total other expense, net | (2,147,115 | ) | (79,994 | ) | (3,320,551 | ) | (178,518 | ) | ||||||||
| Loss before income tax expense | (6,369,634 | ) | (3,430,597 | ) | (12,140,085 | ) | (6,654,869 | ) | ||||||||
| Income tax expense | - | - | (200 | ) | (200 | ) | ||||||||||
| Net loss | $ | (6,369,634 | ) | $ | (3,430,597 | ) | $ | (12,140,285 | ) | $ | (6,655,069 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.13 | ) | $ | (0.14 | ) | $ | (0.27 | ) | $ | (0.28 | ) | ||||
| Weighted average common shares outstanding, basic | 49,769,253 | 24,591,419 | 45,558,442 | 23,990,552 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.13 | ) | $ | (0.14 | ) | $ | (0.27 | ) | $ | (0.28 | ) | ||||
| Weighted average common shares outstanding, diluted | 49,769,253 | 24,591,419 | 45,558,442 | 23,990,552 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (6,369,634 | ) | $ | (3,430,597 | ) | $ | (12,140,285 | ) | $ | (6,655,069 | ) | ||||
| Net unrealized gain (loss) on available-for-sale securities | (104 | ) | 1,528 | (66 | ) | 3,880 | ||||||||||
| Comprehensive loss | $ | (6,369,738 | ) | $ | (3,429,069 | ) | $ | (12,140,351 | ) | $ | (6,651,189 | ) |