Full Press Release Details
Lipocine Announces Financial
Results for the Year Ended December 31, 2021
SALT LAKE CITY, March
9, 2022 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on neuroendocrine and metabolic disorders,
today announced financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update.
Clinical Program Highlights
Neuroactive Steroids
Year Ended December 31, 2021 Financial Results
Lipocine reported a net loss of $634,399, or ($0.01)
per diluted share, for the year ended December 31, 2021, compared with a net loss of $21 million, or ($0.38) per diluted share, in the
year ended December 31, 2020.
Lipocine recognized revenue of $16.1 million during
the year ended December 31, 2021, compared to no revenue during the year ended December 31, 2020. Revenue in 2021 primarily related to
licensing fees, minimum royalties and the sale of finished goods materials we received in accordance with the Antares Licensing Agreement
for TLANDO which was signed on October 14, 2021.
Research and development expenses were $7.7 million
for the year ended December 31, 2021, compared with $9.7 million for the year ended December 31, 2020. The decrease in research and development
expenses during the year ended December 31, 2021 was primarily due a decrease in contract research organization expense and outside consulting
costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease
in personnel expense, as well as decreases in other R&D expenses. These decreases were offset by increases in costs related to LPCN
1154, LPCN 1148 and LPCN 1107.
General and administrative expenses were $5.3
million for the year ended December 31, 2021, compared with $8.2 million for the year ended December 31, 2020. The decrease in general
and administrative expenses during the year ended December 31, 2021 was primarily due to decreases in legal costs and personnel costs,
offset by an increase in corporate insurance expenses and in other general and administrative expenses.
Lipocine recorded an expense of $4.0 million on
litigation settlement during 2021 related to the Global Agreement with Clarus to resolve all outstanding claims in the on-going intellectual
property litigation between the two companies as well as the on-going interference proceeding between the two companies. There was no
comparable litigation settlement expense in 2020.
As of December 31, 2021, Lipocine had $44.6 million
of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and
marketable investment securities as of December 31, 2020.
Lipocine Inc. is a clinical-stage biopharmaceutical
company focused on endocrine and metabolic disorders using its proprietary drug delivery technologies. Lipocine's clinical development
pipeline includes: LPCN 1154, LPCN 2021, LPCN 1148, LPCN 1111, LPCN 1144, and LPCN 1107. LPCN 1154 is an oral neuroactive steroid targeted
for the treatment of post-partum depression and LPCN 2101 is an oral neuroactive steroid targeted for the treatment of women of childbearing
age with epilepsy. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with
liver cirrhosis. 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 and has been
licensed for commercialization to Antares. 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. In a phase 2 clinical evaluation when administered
as once or twice daily, LPCN 1111 met the typical primary and secondary endpoints. LPCN 1144, an oral prodrug of bioidentical testosterone,
recently completed a Phase 2 clinical study demonstrating potential utility in the treatment of non-cirrhotic NASH. 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 timing and completion of regulatory reviews, 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 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 law.
For further information:
Principal Accounting Officer and Corporate Controller
Phone: (801) 994-7383
Phone: (617) 430-7875
LIPOCINE INC. AND SUBSIDIARIES
Consolidated Balance Sheets
December 31, 2021 and 2020
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,950,552 | $ | 19,217,382 | ||||
| Restricted cash | - | 5,000,000 | ||||||
| Marketable investment securities | 41,667,405 | 449,992 | ||||||
| Accrued interest income | 247,253 | 391 | ||||||
| Prepaid and other current assets | 1,514,465 | 661,258 | ||||||
| Total current assets | 46,379,675 | 25,329,023 | ||||||
| Marketable investment securities | 2,021,800 | - | ||||||
| Contract asset | 4,050,000 | - | ||||||
| Property and equipment, net of accumulated depreciation of $1,144,077 and $1,143,697 respectively | 7,211 | - | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 52,482,439 | $ | 25,352,776 | ||||
| Liabilities and Stockholder's Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,289,342 | $ | 1,597,220 | ||||
| Accrued expenses | 1,016,458 | 1,653,178 | ||||||
| Debt - current portion | 2,310,825 | 3,333,333 | ||||||
| Litigation settlement liability - current portion | 1,000,000 | - | ||||||
| Total current liabilities | 5,616,625 | 6,583,731 | ||||||
| Debt - non-current portion | - | 2,257,075 | ||||||
| Warrant liability | 795,796 | 1,170,051 | ||||||
| Litigation settlement liability - non-current portion | 500,000 | - | ||||||
| Total liabilities | 6,912,421 | 10,010,857 | ||||||
| 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; 88,296,360 and 70,041,967 issued and 88,290,650 and 70,036,257 outstanding | 8,830 | 7,005 | ||||||
| Additional paid-in capital | 218,286,323 | 187,407,634 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (18,016 | ) | - | |||||
| Accumulated deficit | (172,666,407 | ) | (172,032,008 | ) | ||||
| Total stockholders' equity | 45,570,018 | 15,341,919 | ||||||
| Total liabilities and stockholders' equity | $ | 52,482,439 | $ | 25,352,776 |
LIPOCINE INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive
Years Ended December 31, 2021 and 2020
| 2021 | 2020 | |||||||
| Revenues | $ | 16,140,838 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 7,665,559 | 9,748,469 | ||||||
| General and administrative | 5,329,776 | 8,247,795 | ||||||
| Total operating expenses | 12,995,335 | 17,996,264 | ||||||
| Operating income (loss) | 3,145,503 | (17,996,264 | ) | |||||
| Other income (expense) | ||||||||
| Interest and investment income | 67,700 | 75,650 | ||||||
| Interest expense | (203,292 | ) | (386,618 | ) | ||||
| Gain on extinguishment of debt | - | 234,802 | ||||||
| Unrealized gain (loss) on warrant liability | 355,890 | (2,892,189 | ) | |||||
| Litigation settlement | (4,000,000 | ) | - | |||||
| Total other expense, net | (3,779,702 | ) | (2,968,355 | ) | ||||
| Loss before income tax expense | (634,199 | ) | (20,964,619 | ) | ||||
| Income tax expense | (200 | ) | (200 | ) | ||||
| Net loss | $ | (634,399 | ) | $ | (20,964,819 | ) | ||
| Basic loss per share attributable to common stock | $ | (0.01 | ) | $ | (0.38 | ) | ||
| Weighted average common shares outstanding, basic | 86,934,618 | 55,688,085 | ||||||
| Diluted loss per share attributable to common stock | $ | (0.01 | ) | $ | (0.38 | ) | ||
| Weighted average common shares outstanding, diluted | 86,934,618 | 55,688,085 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (634,399 | ) | $ | (20,964,819 | ) | ||
| Unrealized net gain (loss) on available-for-sale securities | (18,016 | ) | 38 | |||||
| Comprehensive loss | $ | (652,415 | ) | $ | (20,964,781 | ) |