Full Press Release Details
Announces Financial Results for the Full Year Ended December 31, 2024
LAKE CITY, March 13, 2025 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform
to augment therapeutics through effective oral delivery, today announced financial results for the year ended December 31, 2024, and
provided a corporate update.
2401 for Obesity Management
February 28, 2025, the FDA informed sponsors of testosterone products about new labeling changes following the agency's review
of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal
Men (TRAVERSE) clinical trial and the results from required post-market ambulatory blood pressure (ABPM) studies. The changes include
adding the TRAVERSE trial results to testosterone products, retaining "Limitation of Use" language for age-related hypogonadism,
and removal of language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products,
in addition to other changes led by results of the ABPM studies.
Ended December 31, 2024 Financial Results
of December 31, 2024, Lipocine had $21.6 million of unrestricted cash, cash equivalents and marketable investment securities compared
to $22.0 million as of December 31, 2023.
reported a net income of approximately $8,400 for the year ended December 31, 2024, compared with a net loss of $16.4 million, or ($3.14)
per diluted share, for the year ended December 31, 2023.
Company recognized revenue of $11.2 million during the year ended December 31, 2024, compared to a net reversal of variable consideration
revenue of $2.9 million during the year ended December 31, 2023. Revenue in 2024 primarily consisted of license revenue from the Company's
licensees, Verity Pharma, SPC Korea and Pharmalink and royalty revenue from TLANDO sales.
and development expenses were $7.4 million and $10.2 million, respectively, for the years ended December 31, 2024 and 2023. The decrease
in research and development expenses in 2024 compared with the prior year was primarily due to completion of patient dosing expenses
in the LPCN 1148 Phase 2 POC study in male patients with cirrhosis in 2023, a decrease in TLANDO related costs, and a decrease in personnel
related costs. These decreases were offset by an increase in LPCN 1154 clinical studies, an increase in other lab supplies and research
costs, and an increase in LPCN 2401 costs.
and administrative expenses were $5.0 million and $4.9 million, respectively, for the years ended December 31, 2024 and 2023.
and investment income was $1.2 million and $1.4 million, respectively, for the years ended December 31, 2024 and 2023.
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring
partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit
to risk profile which target large addressable markets with significant unmet medical needs.
clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101
for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral
proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in
obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms
associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm
birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated
cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral
prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with
a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.
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 our product candidates and related clinical
trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our current
intention to conduct a safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study
relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our
product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without
limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete
the development processes for our product candidates or we may decide to allocate our available capital to other product candidates,
we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies,
including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the
FDA may 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 and our ability to utilize a streamlined approval pathway for LPCN 1154, 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.
further information:
INC. AND SUBSIDIARIES
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,205,926 | $ | 4,771,758 | ||||
| Marketable investment securities | 15,427,385 | 17,263,788 | ||||||
| Accrued interest income | 120,447 | 52,254 | ||||||
| Prepaid and other current assets | 567,915 | 773,424 | ||||||
| Total current assets | 22,321,673 | 22,861,224 | ||||||
| Property and equipment, net of accumulated depreciation of $1,223,297 and $1,182,191 respectively | 165,075 | 116,095 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 22,510,501 | $ | 23,001,072 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 271,696 | $ | 1,395,977 | ||||
| Accrued expenses | 921,240 | 1,218,486 | ||||||
| Deferred revenue | 320,000 | - | ||||||
| Warrant liability | - | 17,166 | ||||||
| Total current liabilities | 1,512,936 | 2,631,629 | ||||||
| Total liabilities | 1,512,936 | 2,631,629 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,348,276 and 5,316,166 issued and 5,347,940 and 5,315,830 outstanding, respectively | 8,863 | 8,860 | ||||||
| Additional paid-in capital | 220,789,138 | 220,171,250 | ||||||
| Treasury stock at cost, 336 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive gain | 9,138 | 7,259 | ||||||
| Accumulated deficit | (199,768,862 | ) | (199,777,214 | ) | ||||
| Total stockholders' equity | 20,997,565 | 20,369,443 | ||||||
| Total liabilities and stockholders' equity | $ | 22,510,501 | $ | 23,001,072 |
INC. AND SUBSIDIARIES
Statements of Operations and Comprehensive Income (Loss)
| Years Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| License and royalty revenue | $ | 11,198,144 | $ | 109,987 | ||||
| Minimum guaranteed royalties revenue (reversal of variable consideration) | - | (2,960,805 | ) | |||||
| Total revenues (reversal of variable consideration), net | 11,198,144 | (2,850,818 | ) | |||||
| Operating expenses: | ||||||||
| Research and development | 7,351,753 | 10,175,251 | ||||||
| General and administrative | 5,001,426 | 4,904,888 | ||||||
| Total operating expenses | 12,353,179 | 15,080,139 | ||||||
| Operating loss | (1,155,035 | ) | (17,930,957 | ) | ||||
| Other income: | ||||||||
| Interest and investment income | 1,146,902 | 1,366,940 | ||||||
| Unrealized gain on warrant liability | 17,166 | 212,690 | ||||||
| Total other income | 1,164,068 | 1,579,630 | ||||||
| Income (loss) before income tax expense | 9,033 | (16,351,327 | ) | |||||
| Income tax expense | (681 | ) | (755 | ) | ||||
| Net income (loss) | 8,352 | (16,352,082 | ) | |||||
| Issuance of Series B preferred stock dividend | - | (89 | ) | |||||
| Net gain (loss) attributable to common shareholders | $ | 8,352 | $ | (16,352,171 | ) | |||
| Basic income (loss) per share attributable to common stock | $ | - | $ | (3.10 | ) | |||
| Weighted average common shares outstanding, basic | 5,338,957 | 5,269,671 | ||||||
| Diluted income (loss) per share attributable to common stock | $ | - | $ | (3.14 | ) | |||
| Weighted average common shares outstanding, diluted | 5,422,604 | 5,269,671 | ||||||
| Comprehensive income (loss): | ||||||||
| Net income (loss) | $ | 8,352 | $ | (16,352,082 | ) | |||
| Net unrealized gain on available-for-sale securities | 1,879 | 27,580 | ||||||
| Comprehensive gain (loss) | $ | 10,231 | $ | (16,324,502 | ) |