Full Press Release Details
Announces Financial Results for the Year Ended December 31, 2020
LAKE CITY, March 11, 2021 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on
metabolic and endocrine disorders, today announced financial results for the fourth quarter and year ended December 31, 2020, and
provided a corporate update.
"Lipocine had a number of important
accomplishments in 2020, most notably the U.S. Food and Drug Administration ("FDA") decision to grant tentative approval
to TLANDO, the Company's oral testosterone product for testosterone replacement therapy ("TRT") in adult males
with hypogonadism. We are committed to taking action to receiving final approval to permit the launch of the product," said
Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We also made excellent progress advancing
LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH"). We were pleased with the top-line
results from our Phase 2 LiFT clinical study, announced in January 2021, which showed that treatment with LPCN
1144 resulted in significant liver fat reduction and improvement of key liver injury markers. The trial is on-going and we expect
36-week biopsy data in July/August 2021."
Fourth Quarter and Recent Corporate
Year Ended December 31, 2020 Financial
Lipocine reported a net loss of $21.0
million, or ($0.38) per diluted share, for the year ended December 31, 2020, compared with a net loss of $13.0 million, or ($0.50)
per diluted share, for the year ended December 31, 2019.
Research and development expenses were
$9.7 million for the year ended December 31, 2020, compared with $7.5 million for the year ended December 31, 2019. The increase
in research and development expenses compared with the prior year was primarily due increases in contract research organization
and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study, an increase in commercial
manufacturing costs related to TLANDO, an increase in personnel expense, as well as a net increase in other R&D programs and
expenses. Additionally, other costs related to TLANDO had a net decrease which was the result of a decrease in contract research
organization expenses, offset by increases in other TLANDO expenses.
General and administrative expenses
were $8.2 million for the year ended December 31, 2020, compared with $5.6 million for the year ended December 31, 2019. The increase
in general and administrative expenses compared with the prior year was primarily due to an increase in legal costs, an increase
in personnel costs, and an increase in other general and administrative expenses. These were offset by a decrease in administrative
travel expenses and marketing expense.
As of December 31, 2020, Lipocine had
$19.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million as of December
31, 2019. Additionally, as of December 31, 2020 and December 31, 2019 Lipocine had $5.0 million of restricted cash, which was required
to be maintained as cash collateral under the Silicon Valley Bank ("SVB") Loan and Security Agreement until TLANDO
is approved by the FDA. However, on February 16, 2021, Lipocine and SVB amended the Loan and Security Agreement to, among other
things, remove the cash collateral requirement.
Subsequent to the end of the year,
in January 2021, Lipocine raised gross proceeds of approximately $28.7 million in a public offering before deducting underwriting
discounts and commissions and other offering expenses payable by 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, has received tentative approval from the FDA for conditions
associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug
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 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
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 clinical trials, the timing of completion of
clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, 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, the risk 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
President & Chief Financial Officer
Phone: (801) 994-7383
Phone: (617) 535-7743
LIPOCINE INC. AND SUBSIDIARIES
Consolidated Balance Sheets
December 31, 2020 and 2019
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,217,382 | $ | 9,728,523 | ||||
| Restricted cash | 5,000,000 | 5,000,000 | ||||||
| Marketable investment securities | 449,992 | 4,340,041 | ||||||
| Accrued interest income | 391 | 16,522 | ||||||
| Prepaid and other current assets | 661,258 | 545,887 | ||||||
| Total current assets | 25,329,023 | 19,630,973 | ||||||
| Property and equipment, net of accumulated depreciation of $1,143,697 and $1,140,143, respectively | - | 3,554 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 25,352,776 | $ | 19,658,280 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,597,220 | $ | 1,182,241 | ||||
| Accrued expenses | 1,653,178 | 449,303 | ||||||
| Debt - current portion | 3,333,333 | 3,333,333 | ||||||
| Total current liabilities | 6,583,731 | 4,964,877 | ||||||
| Debt - non-current portion | 2,257,075 | 3,814,407 | ||||||
| Warrant liability | 1,170,051 | 4,591,200 | ||||||
| Total liabilities | 10,010,857 | 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; 70,041,967 and 37,655,175 issued and 70,036,257 and 37,649,465 outstanding | 7,005 | 3,766 | ||||||
| Additional paid-in capital | 187,407,634 | 157,391,969 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | - | (38 | ) | |||||
| Accumulated deficit | (172,032,008 | ) | (151,067,189 | ) | ||||
| Total stockholders' equity | 15,341,919 | 6,287,796 | ||||||
| Total liabilities and stockholders' equity | $ | 25,352,776 | $ | 19,658,280 |
LIPOCINE INC. AND SUBSIDIARIES
Statements of Operations and Comprehensive Loss
Years Ended December 31, 2020 and 2019
| 2020 | 2019 | |||||||
| Revenues: | ||||||||
| License revenue | $ | - | $ | 164,990 | ||||
| Total revenues | - | 164,990 | ||||||
| Operating expenses: | ||||||||
| Research and development | 9,748,469 | 7,468,210 | ||||||
| General and administrative | 8,247,795 | 5,597,070 | ||||||
| Total operating expenses | 17,996,264 | 13,065,280 | ||||||
| Operating loss | (17,996,264 | ) | (12,900,290 | ) | ||||
| Other income (expense) | ||||||||
| Interest and investment income | 75,650 | 423,491 | ||||||
| Interest expense | (386,618 | ) | (766,745 | ) | ||||
| Gain on extinguishment of debt | 234,802 | - | ||||||
| Unrealized gain (loss) on warrant liability | (2,892,189 | ) | 236,400 | |||||
| Total other expense, net | (2,968,355 | ) | (106,854 | ) | ||||
| Loss before income tax expense | (20,964,619 | ) | (13,007,144 | ) | ||||
| Income tax expense | (200 | ) | (200 | ) | ||||
| Net loss | $ | (20,964,819 | ) | $ | (13,007,344 | ) | ||
| Basic loss per share attributable to common stock | $ | (0.38 | ) | $ | (0.50 | ) | ||
| Weighted average common shares outstanding, basic | 55,688,085 | 25,882,273 | ||||||
| Diluted loss per share attributable to common stock | $ | (0.38 | ) | $ | (0.50 | ) | ||
| Weighted average common shares outstanding, diluted | 55,688,085 | 25,882,273 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (20,964,819 | ) | $ | (13,007,344 | ) | ||
| Unrealized net gain on available-for-sale securities | 38 | 925 | ||||||
| Comprehensive loss | $ | (20,964,781 | ) | $ | (13,006,419 | ) |