Lipocine (LPCN) AI Stock Analysis

• Market Cap: $15.66M
• Dividend Yield: N/A
• Average Volume (3M): 24.55K
• Price to Earnings (P/E): 650.6
• Beta (1Y): 1.08
• Revenue Growth: -45.78%
• EPS Growth: 47.33%
• Country: US
• Employees: 16
• Sector: Healthcare
• Sector Strength: 51
• Industry: Biotechnology
• EPS (TTM): -0.41
• Shares Outstanding: 5,419,047
• 10 Day Avg. Volume: 17,059
• 30 Day Avg. Volume: 24,547
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: -0.07
• Enterprise Value/Revenue: -0.24
• Enterprise Value/Gross Profit: 0.30
• Enterprise Value/Ebitda: 0.19
• 1Y Price Target: $7.38
• Price Target Upside: 155.36% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 2

• Rating: 52 Neutral
• Price Target: $3.00 ▲(3.81% Upside)

Lipocine's overall stock score is driven by a strong balance sheet and positive corporate developments, which are offset by ongoing profitability challenges and bearish technical indicators. The company's active pipeline and strategic initiatives offer potential upside, but financial and valuation concerns remain significant.

Positive Factors

Efficacy and Safety

LPCN 1154, Lipocine’s oral formulation of brexanolone, further improves the efficacy and safety profile compared to zuranolone, with rapid onset of action and a treatment duration of 48 hours.

Market Need

Perinatal depression is under-diagnosed and under-treated, which may lead to adverse outcomes for the mother and the child, indicating a significant market need for effective treatments like LPCN 1154.

Regulatory Progress

Phase 3 PPD trial underway with topline results expected, which could support a NDA submission for LPCN 1154 in PPD.

Negative Factors

Clinical Trials

Risks include, but are not limited to: failure of LPCN 1154 in clinical trials and failure to obtain regulatory approval.

Commercial Risks

Risks include failure of LPCN 1154 in clinical trials and failure to achieve commercial success due to reimbursement, penetration rate, and/or competition.

Financial Performance

Net loss was $2.2M, or ($0.41) per share, in line with the estimated loss.

Lipocine Business Overview & Revenue Model

Company Description

Lipocine Inc., a clinical-stage biopharmaceutical company, focuses on the development of pharmaceutical products for the treatment of neuroendocrine and metabolic disorders. The company's primary development programs are based on oral delivery solutions for poorly bioavailable drugs. Its lead product candidate is TLANDO, an oral testosterone replacement therapy. The company's pipeline candidates also include LPCN 1144, an oral prodrug of bioidentical testosterone that has completed Phase II clinical trial for the treatment of non-cirrhotic non-alcoholic steatohepatitis; LPCN 1111, an oral prodrug of testosterone tridecanoate for once daily dosing, which has completed Phase II clinical trial in hypogonadal men; LPCN 1148, a novel prodrug of testosterone and testosterone laurate for the management of decompensated cirrhosis; LPCN 1154, an investigational new drug application to conduct a Phase 2 study in Postpartum depression; LPCN 2101 for women with epilepsy, which has completed pre-clinical study; and LPCN 1107, an oral hydroxyprogesterone caproate product that has completed dose finding Phase II clinical trial for the prevention of recurrent preterm birth. The company is headquartered in Salt Lake City, Utah.

How the Company Makes Money

Lipocine generates revenue primarily through the development and commercialization of its pharmaceutical products. The company may earn revenue from product sales once its therapeutics receive regulatory approval and are launched in the market. Additionally, Lipocine could potentially generate revenue through licensing agreements or partnerships with larger pharmaceutical companies seeking to leverage its proprietary technology for their own product development. Research grants and funding from governmental or private entities may also contribute to its earnings, especially during the clinical trial phases of its products. The successful advancement of its product pipeline and strategic collaborations are critical for enhancing Lipocine's revenue prospects.

Lipocine Financial Statement Overview

Summary

Lipocine's financial performance shows signs of recovery with a positive net income in 2024, but profitability and cash flow generation remain challenges. The balance sheet is strong with no debt, providing a buffer against operational volatility. Consistent revenue and profit growth are needed to enhance financial stability.

Income Statement

Lipocine's financial performance shows some improvement with a positive net income in the latest year, but historical profitability has been weak. Revenue growth is volatile, with a significant increase in 2024 after a decline in 2023. EBIT and EBITDA margins are negative, reflecting operational challenges.

Balance Sheet

The company's balance sheet is relatively strong with no debt in the latest year and an increasing equity base. The equity ratio is high, indicating financial stability. However, the return on equity remains low due to historically negative net income.

Cash Flow

Cash flow management appears stable, with reduced negative free cash flow in recent years. However, there is no operating cash flow in 2024, which raises concerns about cash generation from core operations. The company has managed to improve its cash position through investing and financing activities.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	4.21M	11.20M	-2.85M	500.00K	16.14M	0.00
Gross Profit	-3.41M	3.85M	-13.03M	500.00K	16.14M	0.00
EBITDA	-5.52M	-1.11M	-17.90M	-10.72M	-430.53K	-17.99M
Net Income	-4.51M	8.35K	-16.35M	-10.76M	-634.40K	-20.96M
Balance Sheet
Total Assets	18.58M	22.51M	23.00M	37.54M	52.48M	25.35M
Cash, Cash Equivalents and Short-Term Investments	17.94M	21.63M	22.04M	32.53M	44.62M	19.67M
Total Debt	0.00	438.63K	17.17K	0.00	2.31M	5.59M
Total Liabilities	1.45M	1.51M	2.63M	1.91M	6.91M	10.01M
Stockholders Equity	17.13M	21.00M	20.37M	35.63M	45.57M	15.34M
Cash Flow
Free Cash Flow	-1.22M	-1.31M	-11.88M	-12.10M	-4.42M	-15.30M
Operating Cash Flow	-1.13M	-1.22M	-11.87M	-11.97M	-4.41M	-15.30M
Investing Cash Flow	5.40M	2.45M	13.08M	14.29M	-43.78M	3.89M
Financing Cash Flow	75.62K	209.34K	404.57K	-2.13M	26.92M	20.90M

Lipocine Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 2.89
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For LPCN, the sentiment is Negative. The current price of 2.89 is below the 20-day moving average (MA) of 2.99, below the 50-day MA of 3.12, and below the 200-day MA of 3.66, indicating a bearish trend. The MACD of -0.06 indicates Positive momentum. The RSI at 39.04 is Neutral, neither overbought nor oversold. The STOCH value of 13.80 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for LPCN.

Lipocine Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
EQ	56 Neutral	$104.13M	―	-146.92%	―	-61.16%	-139.15%
LPCN	52 Neutral	$15.66M	650.59	-23.51%	―	-45.78%	47.33%
Sector *	51 Neutral	$7.92B	-0.43	-41.67%	2.21%	22.29%	-1.85%
CING	47 Neutral	$20.51M	―	-417.77%	―	―	96.32%
CLDI	37 Underperform	$7.69M	―	354.78%	―	―	91.46%
EDSA	35 Underperform	$17.81M	―	-69.64%	―	―	22.63%
UNBX	31 Underperform	$1.07M	―	-231.27%	―	―	35.08%

Lipocine Corporate Events

Lipocine to Present at Global Investment Conference

On September 5, 2025, Lipocine Inc. announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference held from September 8-10, 2025, in New York City. The event provides Lipocine an opportunity to present its innovative oral delivery products and engage with investors, potentially impacting its market presence and stakeholder relationships.

Lipocine Participates in H.C. Wainwright Investor Conference

Lipocine announced its participation in the H.C. Wainwright 27th Annual Global Investor Conference held from September 8-10, 2025, in New York City. The event provided Lipocine an opportunity to present and meet with investors, potentially impacting its market visibility and investor relations.

Lipocine’s LPCN 2101 Accepted for AES Presentation

On August 26, 2025, Lipocine announced that two abstracts related to LPCN 2101, a drug candidate for epilepsy treatment, were accepted for presentation at the 2025 American Epilepsy Society annual meeting in December. This acceptance highlights Lipocine’s ongoing efforts to advance its epilepsy treatment pipeline, potentially enhancing its positioning in the biopharmaceutical industry and offering new opportunities for stakeholders.

Lipocine Hosts Virtual Event on LPCN 1154

On July 9, 2025, Lipocine hosted a virtual key opinion leader event to discuss LPCN 1154 (BRLIZIO™), a treatment for postpartum depression. This event highlights Lipocine’s ongoing efforts to address mental health issues, potentially enhancing its market position in the pharmaceutical industry.

Lipocine Updates Corporate Presentation for Investors

Lipocine has updated its corporate presentation used for meetings with investors and analysts. This update may impact how the company communicates its strategies and performance, potentially influencing stakeholder perceptions and market positioning.

Lipocine Begins Phase 3 Trial for LPCN 1154

On June 26, 2025, Lipocine Inc. announced the dosing of the first patient in its Phase 3 clinical trial for LPCN 1154, an investigational oral treatment for postpartum depression. This trial, conducted in an outpatient setting without medical monitoring, aims to support an NDA submission in mid-2026. The study involves a two-arm, randomized, blinded design comparing LPCN 1154 to a placebo, with primary and secondary endpoints focusing on depression and anxiety severity. The trial’s results could position LPCN 1154 as a rapid relief, standard-of-care treatment for postpartum depression, addressing a significant unmet need in the market.

Lipocine to Host R&D Event on July 9

Lipocine Inc. announced it will host a virtual R&D investor event on July 9, 2025, to discuss LPCN 1154 (BRLIZIO™) as a treatment for postpartum depression. The event will feature clinical, regulatory, and development updates, including the Phase 3 registrational study expected to conclude in Q2-2026. LPCN 1154 is being developed as a rapid-acting oral treatment for postpartum depression, aimed at providing symptom relief within 48 hours. This initiative highlights Lipocine’s commitment to addressing unmet needs in postpartum depression treatment and could strengthen its position in the biopharmaceutical industry.

Lipocine’s Partner Files New Drug Submission in Canada

On June 9, 2025, Lipocine announced that its licensing partner, Verity Pharma, filed a New Drug Submission for TLANDO® in Canada. TLANDO is the first oral testosterone replacement therapy approved by the FDA that does not require dose titration, representing a significant commercial opportunity in Canada, where over 700,000 prescriptions for testosterone replacement therapy are written annually. The filing marks an important step in expanding TLANDO’s market presence, potentially capturing a significant share of the Canadian market due to limited promotional activities for existing therapies.