SALT LAKE CITY , March 9, 2022 /PRNewswire/ --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.

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.

About Lipocine 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.

$             2,950,552

Prepaid and other current assets

Property and equipment, net of accumulated depreciation

   of $1,144,077 and $1,143,697 respectively

$           52,482,439

$             1,289,342

Litigation settlement liability - current portion

Litigation settlement liability - non-current portion

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 

Treasury stock at cost, 5,710 shares

Total liabilities and stockholders' equity

$           52,482,439

Consolidated Statements of Operations and Comprehensive Loss

$                  -

Gain on extinguishment of debt

Unrealized gain (loss) on warrant liability

Loss before income tax expense

Basic loss per share attributable to common stock

$            (0.01)

$            (0.38)

Weighted average common shares outstanding, 

Diluted loss per share attributable to common stock 

$            (0.01)

$            (0.38)

Weighted average common shares outstanding, diluted

Unrealized net gain (loss) on available-for-sale securities

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