Lipocine (LPCN)
Market Price (8/8/2026): $2.13 | Market Cap: $17.5 MilSector: Health Care | Industry: Biotechnology
Lipocine (LPCN)
Market Price (8/8/2026): $2.13Market Cap: $17.5 MilSector: Health CareIndustry: Biotechnology
Investment Highlights Why It Matters Detailed financial logic regarding cash flow yields vs trend-riding momentum.
Cash is significant % of market capNet D/ENet Debt/Equity. Debt net of cash. Negative indicates net cash. Equity is taken as the Market Capitalization is -133% Valuation becoming less expensiveP/S 6M Chg %Price/Sales change over 6 months. Declining P/S indicates valuation has become less expensive. is -59% Megatrend and thematic driversMegatrends include Precision Medicine, and Aging Population & Chronic Disease. Themes include Biopharmaceutical R&D, Geriatric Care, Show more. | Weak multi-year price returns2Y Excs Rtn is -102%, 3Y Excs Rtn is -129% | Not profitable at operating income levelOp Inc LTMOperating Income, Last Twelve Months is -13 Mil, Op Mgn LTMOperating Margin = Operating Income / Revenue Reflects profitability before taxes and before impact of capital structure (interest payments). is -801% Weak revenue growthRev Chg LTMRevenue Change % Last Twelve Months (LTM) is -63%, Rev Chg QQuarterly Revenue Change % is -69% Significant share based compensationSBC/Rev LTMShare Based Compensation / Revenue (Sales), Last Twelve Months (LTM) is 15% Not cash flow generativeCFO/Rev LTMCash Flow from Operations / Revenue (Sales), Last Twelve Months (LTM) is -713%, FCF/Rev LTMFree Cash Flow / Revenue (Sales), Last Twelve Months (LTM) is -713% Yield minus risk free rate is negativeERPEquity Risk Premium (ERP) = Total Yield - Risk Free Rate, Reflects the premium above risk free assets offered by the investment. is -72% High stock price volatilityVol 12M is 108% Key risksLPCN key risks include [1] potential clinical trial failure or FDA rejection of its primary drug candidate, Show more. |
| Cash is significant % of market capNet D/ENet Debt/Equity. Debt net of cash. Negative indicates net cash. Equity is taken as the Market Capitalization is -133% |
| Valuation becoming less expensiveP/S 6M Chg %Price/Sales change over 6 months. Declining P/S indicates valuation has become less expensive. is -59% |
| Megatrend and thematic driversMegatrends include Precision Medicine, and Aging Population & Chronic Disease. Themes include Biopharmaceutical R&D, Geriatric Care, Show more. |
| Weak multi-year price returns2Y Excs Rtn is -102%, 3Y Excs Rtn is -129% |
| Not profitable at operating income levelOp Inc LTMOperating Income, Last Twelve Months is -13 Mil, Op Mgn LTMOperating Margin = Operating Income / Revenue Reflects profitability before taxes and before impact of capital structure (interest payments). is -801% |
| Weak revenue growthRev Chg LTMRevenue Change % Last Twelve Months (LTM) is -63%, Rev Chg QQuarterly Revenue Change % is -69% |
| Significant share based compensationSBC/Rev LTMShare Based Compensation / Revenue (Sales), Last Twelve Months (LTM) is 15% |
| Not cash flow generativeCFO/Rev LTMCash Flow from Operations / Revenue (Sales), Last Twelve Months (LTM) is -713%, FCF/Rev LTMFree Cash Flow / Revenue (Sales), Last Twelve Months (LTM) is -713% |
| Yield minus risk free rate is negativeERPEquity Risk Premium (ERP) = Total Yield - Risk Free Rate, Reflects the premium above risk free assets offered by the investment. is -72% |
| High stock price volatilityVol 12M is 108% |
| Key risksLPCN key risks include [1] potential clinical trial failure or FDA rejection of its primary drug candidate, Show more. |
Qualitative Assessment
AI Analysis | Feedback
Lipocine (LPCN) stock has lost about 10% since 4/30/2026 because of the following key factors:
1. Failure of the LPCN 1154 Phase 3 Trial for Postpartum Depression. Lipocine announced in April 2026 that its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for postpartum depression did not meet its primary endpoint, failing to show a statistically significant reduction in HAM-D total score compared to placebo. This significant clinical setback for a key pipeline candidate immediately preceded and impacted the stock's performance during the specified period.
2. Wider-than-Anticipated Fiscal Q1 2026 Loss and Increased Research & Development Expenses. For fiscal Q1 2026, which ended in March 2026, Lipocine reported a net loss of -$0.54 per diluted share, missing the Zacks Consensus Estimate of -$0.51 per share by 5.88% and another consensus estimate of -$0.4947 by 9.16%. This wider loss was partly due to an increase in research and development expenses, which rose to $2.8 million in fiscal Q1 2026 from $1.1 million in fiscal Q1 2025, largely attributed to the LPCN 1154 clinical study that subsequently failed. The stock declined by 0.8% the day following the May 7, 2026, earnings announcement.
Show more
Lipocine (LPCN) stock has lost about 10% since 4/30/2026 because of the following key factors:
1. Failure of the LPCN 1154 Phase 3 Trial for Postpartum Depression. Lipocine announced in April 2026 that its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for postpartum depression did not meet its primary endpoint, failing to show a statistically significant reduction in HAM-D total score compared to placebo. This significant clinical setback for a key pipeline candidate immediately preceded and impacted the stock's performance during the specified period.
2. Wider-than-Anticipated Fiscal Q1 2026 Loss and Increased Research & Development Expenses. For fiscal Q1 2026, which ended in March 2026, Lipocine reported a net loss of -$0.54 per diluted share, missing the Zacks Consensus Estimate of -$0.51 per share by 5.88% and another consensus estimate of -$0.4947 by 9.16%. This wider loss was partly due to an increase in research and development expenses, which rose to $2.8 million in fiscal Q1 2026 from $1.1 million in fiscal Q1 2025, largely attributed to the LPCN 1154 clinical study that subsequently failed. The stock declined by 0.8% the day following the May 7, 2026, earnings announcement.
3. Significant Share Dilution. Shareholders of Lipocine experienced substantial dilution in the past year, with total shares outstanding increasing by 54.1%. More recently, in fiscal Q1 2026, shares outstanding grew by 18.5% from the prior quarter. This ongoing dilution can put downward pressure on the stock price by increasing the number of shares in the market.
4. Lack of Near-Term Catalysts and Pre-Revenue Status. As a pre-commercialization biopharmaceutical company, Lipocine's financial performance relies heavily on its clinical pipeline. The failure of the LPCN 1154 Phase 3 trial removed a significant near-term catalyst and underscored the inherent risks associated with drug development. The company reported minimal revenue of $119,000 from TLANDO royalties in fiscal Q1 2026, emphasizing its dependence on successful pipeline progression for future growth.
Show less
Stock Movement Drivers
Fundamental Drivers
The -8.6% change in LPCN stock from 4/30/2026 to 8/7/2026 was primarily driven by a -30.9% change in the company's Shares Outstanding (Mil).| (LTM values as of) | 4302026 | 8072026 | Change |
|---|---|---|---|
| Stock Price ($) | 2.33 | 2.13 | -8.6% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 2 | 2 | -20.6% |
| P/S Multiple | 6.7 | 11.2 | 66.5% |
| Shares Outstanding (Mil) | 6 | 8 | -30.9% |
| Cumulative Contribution | -8.6% |
Market Drivers
4/30/2026 to 8/7/2026| Return | Correlation | |
|---|---|---|
| LPCN | -8.6% | |
| Market (SPY) | 7.6% | 41.5% |
| Sector (XLV) | 13.5% | 7.0% |
Fundamental Drivers
The -76.3% change in LPCN stock from 1/31/2026 to 8/7/2026 was primarily driven by a -63.7% change in the company's Total Revenues ($ Mil).| (LTM values as of) | 1312026 | 8072026 | Change |
|---|---|---|---|
| Stock Price ($) | 9.00 | 2.13 | -76.3% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 4 | 2 | -63.7% |
| P/S Multiple | 11.3 | 11.2 | -1.1% |
| Shares Outstanding (Mil) | 5 | 8 | -34.1% |
| Cumulative Contribution | -76.3% |
Market Drivers
1/31/2026 to 8/7/2026| Return | Correlation | |
|---|---|---|
| LPCN | -76.3% | |
| Market (SPY) | 12.1% | 22.4% |
| Sector (XLV) | 7.5% | 15.3% |
Fundamental Drivers
The -34.1% change in LPCN stock from 7/31/2025 to 8/7/2026 was primarily driven by a -57.3% change in the company's Total Revenues ($ Mil).| (LTM values as of) | 7312025 | 8072026 | Change |
|---|---|---|---|
| Stock Price ($) | 3.23 | 2.13 | -34.1% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 4 | 2 | -57.3% |
| P/S Multiple | 4.7 | 11.2 | 137.2% |
| Shares Outstanding (Mil) | 5 | 8 | -34.9% |
| Cumulative Contribution | -34.1% |
Market Drivers
7/31/2025 to 8/7/2026| Return | Correlation | |
|---|---|---|
| LPCN | -34.1% | |
| Market (SPY) | 23.4% | 16.6% |
| Sector (XLV) | 28.7% | 11.8% |
Fundamental Drivers
The -57.1% change in LPCN stock from 7/31/2023 to 8/7/2026 was primarily driven by a -76.2% change in the company's P/S Multiple.| (LTM values as of) | 7312023 | 8072026 | Change |
|---|---|---|---|
| Stock Price ($) | 4.97 | 2.13 | -57.1% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 1 | 2 | 182.8% |
| P/S Multiple | 46.9 | 11.2 | -76.2% |
| Shares Outstanding (Mil) | 5 | 8 | -36.3% |
| Cumulative Contribution | -57.1% |
Market Drivers
7/31/2023 to 8/7/2026| Return | Correlation | |
|---|---|---|
| LPCN | -57.1% | |
| Market (SPY) | 74.9% | 12.5% |
| Sector (XLV) | 29.3% | 9.0% |
Price Returns Compared
| 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | Total [1] | |
|---|---|---|---|---|---|---|---|
| Returns | |||||||
| LPCN Return | -27% | -60% | -59% | 75% | 65% | -73% | -91% |
| Peers Return | -35% | 86% | 13% | 132% | 120% | 3% | 613% |
| S&P 500 Return | 27% | -19% | 24% | 23% | 16% | 13% | 105% |
Monthly Win Rates [3] | |||||||
| LPCN Win Rate | 25% | 33% | 33% | 58% | 50% | 50% | |
| Peers Win Rate | 36% | 42% | 44% | 56% | 44% | 46% | |
| S&P 500 Win Rate | 75% | 42% | 67% | 75% | 67% | 50% | |
Max Drawdowns [4] | |||||||
| LPCN Max Drawdown | -57% | -80% | -76% | -67% | -52% | -83% | |
| Peers Max Drawdown | -59% | -64% | -69% | -44% | -49% | -29% | |
| S&P 500 Max Drawdown | -5% | -25% | -10% | -8% | -19% | -9% | |
[1] Cumulative total returns since the beginning of 2021
[2] Peers: MDGL, VKTX, PRAX.
[3] Win Rate = % of calendar months in which monthly returns were positive
[4] Max drawdown represents maximum peak-to-trough decline within a year
[5] 2026 data is for the year up to 8/7/2026 (YTD)
How Low Can It Go
| Event | LPCN | S&P 500 |
|---|---|---|
| 2025 US Tariff Shock | ||
| % Loss | -21.6% | -18.8% |
| % Gain to Breakeven | 27.6% | 23.1% |
| Time to Breakeven | 37 days | 79 days |
| 2024 Yen Carry Trade Unwind | ||
| % Loss | -51.5% | -7.8% |
| % Gain to Breakeven | 106.3% | 8.5% |
| Time to Breakeven | 503 days | 18 days |
| Summer-Fall 2023 Five Percent Yield Shock | ||
| % Loss | -45.0% | -9.5% |
| % Gain to Breakeven | 81.8% | 10.5% |
| Time to Breakeven | 135 days | 24 days |
| 2023 SVB Regional Banking Crisis | ||
| % Loss | -61.5% | -6.7% |
| % Gain to Breakeven | 160.1% | 7.1% |
| Time to Breakeven | 395 days | 31 days |
| 2020 COVID-19 Crash | ||
| % Loss | -32.7% | -33.7% |
| % Gain to Breakeven | 48.5% | 50.9% |
| Time to Breakeven | 14 days | 140 days |
| Q4 2018 Fed Policy Error / Growth Scare | ||
| % Loss | -22.5% | -19.2% |
| % Gain to Breakeven | 29.0% | 23.8% |
| Time to Breakeven | 5 days | 105 days |
In The Past
Lipocine's stock fell -21.6% during the 2025 US Tariff Shock. Such a loss loss requires a 27.6% gain to breakeven.
Preserve Wealth
Limiting losses and compounding gains is essential to preserving wealth.
Asset Allocation
Actively managed asset allocation strategies protect wealth. Learn more.
| Event | LPCN | S&P 500 |
|---|---|---|
| 2025 US Tariff Shock | ||
| % Loss | -21.6% | -18.8% |
| % Gain to Breakeven | 27.6% | 23.1% |
| Time to Breakeven | 37 days | 79 days |
| 2024 Yen Carry Trade Unwind | ||
| % Loss | -51.5% | -7.8% |
| % Gain to Breakeven | 106.3% | 8.5% |
| Time to Breakeven | 503 days | 18 days |
| Summer-Fall 2023 Five Percent Yield Shock | ||
| % Loss | -45.0% | -9.5% |
| % Gain to Breakeven | 81.8% | 10.5% |
| Time to Breakeven | 135 days | 24 days |
| 2023 SVB Regional Banking Crisis | ||
| % Loss | -61.5% | -6.7% |
| % Gain to Breakeven | 160.1% | 7.1% |
| Time to Breakeven | 395 days | 31 days |
| 2020 COVID-19 Crash | ||
| % Loss | -32.7% | -33.7% |
| % Gain to Breakeven | 48.5% | 50.9% |
| Time to Breakeven | 14 days | 140 days |
| Q4 2018 Fed Policy Error / Growth Scare | ||
| % Loss | -22.5% | -19.2% |
| % Gain to Breakeven | 29.0% | 23.8% |
| Time to Breakeven | 5 days | 105 days |
| 2016-2017 Trump Reflation Bond Selloff | ||
| % Loss | -30.6% | -3.7% |
| % Gain to Breakeven | 44.1% | 3.9% |
| Time to Breakeven | 130 days | 6 days |
| 2014-2016 Oil Price Collapse | ||
| % Loss | -59.0% | -6.8% |
| % Gain to Breakeven | 144.1% | 7.3% |
| Time to Breakeven | 251 days | 15 days |
| 2013 Taper Tantrum | ||
| % Loss | -25.6% | -0.2% |
| % Gain to Breakeven | 34.4% | 0.2% |
| Time to Breakeven | 482 days | 1 days |
In The Past
Lipocine's stock fell -21.6% during the 2025 US Tariff Shock. Such a loss loss requires a 27.6% gain to breakeven.
Preserve Wealth
Limiting losses and compounding gains is essential to preserving wealth.
Asset Allocation
Actively managed asset allocation strategies protect wealth. Learn more.
About Lipocine (LPCN)
Lipocine Inc. (LPCN) is a clinical-stage biopharmaceutical company focused on developing innovative pharmaceutical products. The company specializes in addressing neuroendocrine and metabolic disorders by creating oral delivery solutions for drugs that typically exhibit poor bioavailability. This core strategy aims to transform the administration of essential therapies, making them more convenient and effective for patients.
The company's lead product candidate is TLANDO, an oral testosterone replacement therapy primarily targeting hypogonadal men. Beyond TLANDO, Lipocine boasts a robust pipeline of oral prodrugs, many based on testosterone. This includes LPCN 1144, which has completed Phase II trials for non-cirrhotic non-alcoholic steatohepatitis (NASH), and LPCN 1111, an oral testosterone prodrug for once-daily dosing in hypogonadal men. Other candidates like LPCN 1148 aim to manage decompensated cirrhosis.
Lipocine is also expanding its reach into other significant therapeutic areas, demonstrating its versatile platform. This includes LPCN 1154, an investigational new drug for Postpartum depression, and LPCN 1107, an oral hydroxyprogesterone caproate product for preventing recurrent preterm birth. The company's diverse product pipeline targets a broad patient base, including men requiring hormone replacement, individuals with liver and metabolic diseases, and women facing reproductive or neurological health challenges, leveraging its oral delivery technology to serve these distinct markets.
AI Analysis | Feedback
Think of them as a specialized Eli Lilly (a global pharmaceutical company with a strong focus on metabolic disorders) developing new, easy-to-take oral versions of hormone and metabolic treatments.
They're like a clinical-stage AbbVie (a major pharmaceutical company with a diverse portfolio including hormone-related therapies), but specifically dedicated to bringing novel oral testosterone and related hormone products to market.
AI Analysis | Feedback
- TLANDO: An oral testosterone replacement therapy.
- LPCN 1144: An oral prodrug of bioidentical testosterone for non-cirrhotic non-alcoholic steatohepatitis.
- LPCN 1111: An oral prodrug of testosterone tridecanoate for once daily dosing in hypogonadal men.
- LPCN 1148: A novel prodrug of testosterone for the management of decompensated cirrhosis.
- LPCN 1154: An investigational new drug application for Postpartum depression.
- LPCN 2101: A pre-clinical product designed for women with epilepsy.
- LPCN 1107: An oral hydroxyprogesterone caproate product for preventing recurrent preterm birth.
AI Analysis | Feedback
Lipocine Inc. (LPCN) is described as a clinical-stage biopharmaceutical company focused on the development of pharmaceutical products. As such, it does not primarily sell directly to individual consumers.
Instead, if and when its pharmaceutical products are approved and commercialized, Lipocine Inc.'s major customers would typically be other companies. These would be:
- Larger pharmaceutical companies that would license or acquire the rights to Lipocine's developed drugs for commercialization and distribution.
- Pharmaceutical wholesalers and distributors that purchase drugs for onward sale to pharmacies, hospitals, and healthcare providers.
The provided background information does not name any specific customer companies or licensing partners with their corresponding symbols.
AI Analysis | Feedback
AI Analysis | Feedback
Mahesh V. Patel, Ph.D., President and Chief Executive Officer
Dr. Patel co-founded Lipocine Inc. in 1997 and has served as its President and Chief Executive Officer since its inception. He has over 30 years of experience in strategic planning, technology assessment and development, technical management, and product research and development, particularly in drug discovery support, drug delivery, and product line extensions. Prior to co-founding Lipocine, he led drug delivery research and development at Pharmacia and Upjohn. Dr. Patel earned a B. Pharm from Karnataka University in India, an M.S. in physical pharmacy from the University of Cincinnati, and a Ph.D. in pharmaceutics from the University of Utah.
Krista Fogarty, Principal Accounting Officer and Corporate Controller
Ms. Fogarty has served as Lipocine's Corporate Controller since October 2018 and was appointed Principal Accounting Officer in January 2022. She previously held the position of Chief Financial Officer at Alternative Behavior Strategies. Her prior experience also includes serving as Controller and Associate VP Business Operations at Navigen, VP Finance at Lineagen, and Corporate Controller at NPS Pharmaceuticals. Ms. Fogarty holds a B.S. in Accounting and a MAcc from Utah State University.
George Nomikos, M.D., Ph.D., Chief Medical Officer
Dr. Nomikos joined Lipocine as Chief Medical Officer in November 2022, bringing a specialized skillset consistent with the company's focus on CNS disorders. He received his M.D. and Ph.D. from the University of Patras, School of Health Sciences, Faculty of Medicine in Greece.
Nachiappan Chidambaram, Ph.D., Senior Vice President, Research and Development
Dr. Chidambaram has over 20 years of experience in research and development, focusing on drug delivery, product development, and associated line extensions. Before joining Lipocine, he was involved in product development at Banner Pharmacaps Inc. (now Thermo Fisher), where he was responsible for advancing several products from research to commercialization. He obtained his master's in pharmacy from the Institute of Technology, Banaras Hindu University in India, and a Ph.D. in Pharmaceutics from the University of Connecticut.
AI Analysis | Feedback
The key risks to Lipocine's business include:
-
Clinical Trial and Regulatory Approval Risk: As a clinical-stage biopharmaceutical company, Lipocine's success is heavily dependent on the successful completion of clinical trials and subsequent regulatory approvals for its pipeline candidates. The failure of any of its investigational drugs, particularly its lead product candidate TLANDO, to demonstrate efficacy, safety, or to secure necessary regulatory approvals (e.g., FDA approval) at any stage of development, would significantly harm the company's business prospects. The company currently has multiple candidates in various stages, including those that have completed Phase II, an investigational new drug application to conduct a Phase 2 study, and a completed pre-clinical study, all of which still require successful navigation of further clinical and regulatory hurdles.
-
Commercialization and Market Acceptance Risk: Even if Lipocine's product candidates successfully complete clinical trials and receive regulatory approval, there is no guarantee of commercial success. Their ability to compete effectively in the market, gain physician adoption, secure favorable reimbursement, and achieve significant market penetration for products like TLANDO (an oral testosterone replacement therapy) will be critical. The market for many of its potential products may be competitive, impacting revenue generation and profitability.
AI Analysis | Feedback
AI Analysis | Feedback
Lipocine Inc. is a biopharmaceutical company focused on developing oral delivery solutions for various neuroendocrine and metabolic disorders. The addressable markets for their main product candidates are as follows:
- TLANDO (oral testosterone replacement therapy for hypogonadism): The global testosterone replacement therapy (TRT) market was valued at approximately $3.8 billion in 2021 and is projected to reach $5.7 billion by 2026, with a compound annual growth rate (CAGR) of 8.4%. North America is a dominant region, accounting for over 75% of this market. The global male hypogonadism market was estimated at USD 4 billion in 2024 and is expected to grow to USD 6.7 billion by 2034. The oral testosterone market specifically was valued at USD 124 million in 2024 and is projected to reach USD 153 million by 2031 globally.
- LPCN 1144 (oral prodrug of bioidentical testosterone for non-cirrhotic non-alcoholic steatohepatitis - NASH): The global Non-alcoholic steatohepatitis (NASH) market size was valued at USD 1.87 billion in 2024 and is expected to reach USD 11.08 billion by 2033, growing at a CAGR of 21.85%. Other sources estimate the global NASH treatment market at USD 5.5 billion in 2023, projected to reach USD 57.9 billion by 2032 with a CAGR of 29.9% from 2024. North America is a significant market, with the U.S. NASH treatment market expected to reach USD 23.2 billion by 2032.
- LPCN 1111 (oral prodrug of testosterone tridecanoate for once-daily dosing in hypogonadal men): This product targets the male hypogonadism market, which was estimated at USD 4 billion globally in 2024 and is expected to reach USD 6.7 billion by 2034. The global testosterone replacement therapy market, which LPCN 1111 falls under, was valued at USD 2.03 billion in 2024 and is expected to reach USD 2.73 billion by 2033.
- LPCN 1148 (novel prodrug of testosterone and testosterone laurate for the management of decompensated cirrhosis): The global liver cirrhosis treatment market was valued at USD 14.12 billion in 2024 and is projected to reach USD 23.77 billion by 2032, growing at a CAGR of 6.73%. The decompensated cirrhosis segment is a significant portion of this market, holding nearly 56% share in 2024. The U.S. market for liver cirrhosis treatment is projected to grow to approximately $15 billion by 2030.
- LPCN 1154 (investigational new drug for Postpartum depression - PPD): The global postpartum depression treatment market was valued at USD 8.68 billion in 2023 and is expected to reach USD 55.24 billion by 2031, growing at a CAGR of 30.25%. Another estimate places the global postpartum depression treatment market at USD 1 billion in 2024, projected to grow to USD 2.3 billion by 2034. The U.S. postpartum depression therapeutic market was valued at USD 370.7 million in 2024. Approximately 500,000 women are affected by PPD annually in the United States.
- LPCN 2101 (for women with epilepsy): The global epilepsy treatment market was valued at USD 4.61 billion in 2024 and is expected to reach nearly USD 8.10 billion by 2032, growing at a CAGR of 7.3%. The global epilepsy treatment drugs market was estimated at USD 8.3 billion in 2024 and is expected to reach USD 13 billion in 2034. The total Epilepsy Treatment Drugs Market Size in the US was approximately USD 4.3 billion in 2023.
- LPCN 1107 (oral hydroxyprogesterone caproate product for the prevention of recurrent preterm birth): The global preterm birth prevention and management market was valued at USD 1.8 billion in 2024 and is expected to reach USD 3.8 billion by 2034, growing at a CAGR of 7.7%. The U.S. preterm birth prevention and management market accounted for USD 671.6 million in 2024.
AI Analysis | Feedback
Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company, is anticipated to drive future revenue growth over the next 2-3 years through several key initiatives:
- Commercialization of LPCN 1154 for Postpartum Depression (PPD): Lipocine's lead CNS candidate, LPCN 1154 (oral brexanolone) for the treatment of postpartum depression, is a significant expected revenue driver. Enrollment and dosing in its Phase 3 clinical trial were completed as of January 20, 2026. Topline data for LPCN 1154 is expected in the second quarter of 2026, with a regulatory filing for a New Drug Application (NDA) to the FDA anticipated later in 2026. If approved, LPCN 1154 could become a first-line, rapid-acting oral treatment option for PPD, addressing a significant unmet medical need. The company may also explore partnerships for its commercialization.
- Growth in TLANDO Revenue from US Sales and International Expansion: TLANDO, an FDA-approved oral testosterone replacement therapy, continues to be a source of revenue. Lipocine has licensed the exclusive U.S. rights to its commercialization partner, Verity Pharmaceuticals. The company has also executed multiple territorial licenses for TLANDO with partners, including Verity, SPC, Pharmalink, and Aché, to support commercialization outside the U.S. Royalty revenue from TLANDO sales increased in 2025 to $480,000 from $298,000 in 2024. A New Drug Submission (NDS) for TLANDO in Canada, filed by its partner Verity Pharma in June 2025, represents a potential new market and further growth in royalty revenue from international sales.
- Advancement and Potential Partnering of Other Pipeline Candidates, Particularly in CNS: Lipocine has strategically focused on developing differentiated products for central nervous system (CNS) disorders, leveraging its oral drug delivery technology for neuroactive steroids. Beyond LPCN 1154, the company's pipeline includes other CNS-focused candidates such as LPCN 2201 for major depressive disorder, LPCN 2202 for treatment-resistant depression, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor. While these candidates are earlier stage, the company is actively exploring partnerships for these and other pipeline programs, including LPCN 1144 for NASH, LPCN 1107 for preterm birth, LPCN 1148 for cirrhosis, and LPCN 2401 for obesity management. Successful advancement of these programs or new licensing deals, milestone payments, and royalties from partnerships could contribute to future revenue streams.
AI Analysis | Feedback
Share Issuance
- In January 2021, Lipocine completed an underwritten public offering, generating approximately $25.0 million in gross proceeds from the sale of 14,285,714 shares of common stock at $1.75 per share.
- The company established an "At the Market ("ATM") Offering" program in April 2024 to sell common stock through A.G.P./Alliance Global Partners.
- In February 2026, Lipocine authorized the sale of up to $50,000,000 in common stock under the ATM program, contributing to an increase in cash and equivalents to approximately $24.7 million by March 6, 2026, from $14.9 million at the end of 2025.
Inbound Investments
- In 2024, Lipocine generated $10.9 million in license revenue from agreements with partners including Verity, SPC, and Pharmalink.
- In 2025, the company received $1.5 million in license revenue from agreements with Verity and Aché.
Capital Expenditures
- Capital expenditures amounted to $10K in Q3 2024.
- Research and development expenses, which support pipeline advancement, increased to $8.6 million in 2025 from $7.4 million in 2024, primarily for clinical and personnel spending related to programs such as LPCN 1154 Phase 3.
- Cumulative research and development spending reached $163.2 million through 2025.
Latest Trefis Analyses
| Title | Date | |
|---|---|---|
| DASHBOARDS | ||
| Lipocine Earnings Notes | 12/16/2025 | |
| Lipocine Stock Jump Looks Great, But How Secure Is That Gain? | 10/17/2025 |
| Title | |
|---|---|
| ARTICLES |
Research & Analysis
Invest in Strategies
Wealth Management
Peer Comparisons
| Peers to compare with: |
Financials
| Median | |
|---|---|
| Name | |
| Mkt Price | 197.51 |
| Mkt Cap | 7.2 |
| Rev LTM | 1 |
| Op Inc LTM | -340 |
| FCF LTM | -244 |
| FCF 3Y Avg | -198 |
| CFO LTM | -240 |
| CFO 3Y Avg | -198 |
Growth & Margins
| Median | |
|---|---|
| Name | |
| Rev Chg LTM | -62.7% |
| Rev Chg 3Y Avg | 1,491.2% |
| Rev Chg Q | 0.8% |
| QoQ Delta Rev Chg LTM | -4.1% |
| Op Inc Chg LTM | -89.3% |
| Op Inc Chg 3Y Avg | -26.1% |
| Op Mgn LTM | -413.0% |
| Op Mgn 3Y Avg | -807.2% |
| QoQ Delta Op Mgn LTM | -96.2% |
| CFO/Rev LTM | -364.2% |
| CFO/Rev 3Y Avg | -678.6% |
| FCF/Rev LTM | -364.5% |
| FCF/Rev 3Y Avg | -686.7% |
Segment Financials
Revenue by Segment| $ Mil | 2025 | 2024 | 2023 | 2022 | 2021 |
|---|---|---|---|---|---|
| Leveraging its proprietary technology platform to augment therapeutics through effective oral | 2 | 11 | -3 | 0 | 16 |
| Total | 2 | 11 | -3 | 0 | 16 |
| $ Mil | 2025 | 2024 | 2023 |
|---|---|---|---|
| Leveraging its proprietary technology platform to augment therapeutics through effective oral | -10 | -1 | -18 |
| Total | -10 | -1 | -18 |
| $ Mil | 2025 | 2024 | 2023 |
|---|---|---|---|
| Leveraging its proprietary technology platform to augment therapeutics through effective oral | -10 | 0 | -16 |
| Total | -10 | 0 | -16 |
| $ Mil | 2020 | 2017 | 2016 |
|---|---|---|---|
| Leveraging its proprietary technology platform to augment therapeutics through effective oral | 25 | 25 | 27 |
| Total | 25 | 25 | 27 |
Price Behavior
| Market Price | $2.13 | |
| Market Cap ($ Bil) | 0.0 | |
| First Trading Date | 06/15/2012 | |
| Distance from 52W High | -81.1% | |
| 50 Days | 200 Days | |
| DMA Price | $2.29 | $4.57 |
| DMA Trend | down | down |
| Distance from DMA | -6.8% | -53.4% |
| 3M | 1YR | |
| Volatility | 47.4% | 108.3% |
| Downside Capture | 159.51 | 19.23 |
| Upside Capture | 81.36 | -23.45 |
| Correlation (SPY) | 38.3% | 16.8% |
| 1M | 2M | 3M | 6M | 1Y | 3Y | |
|---|---|---|---|---|---|---|
| Beta | 1.88 | 1.50 | 1.53 | 2.03 | 1.42 | 0.73 |
| Up Beta | 2.29 | 3.15 | 3.25 | 5.23 | 3.66 | 0.85 |
| Down Beta | 0.70 | 0.39 | 0.54 | 1.95 | 2.03 | 1.36 |
| Up Capture | 67% | 133% | 104% | -83% | -15% | -0% |
| Bmk +ve Days | 11 | 22 | 35 | 67 | 138 | 427 |
| Stock +ve Days | 8 | 20 | 27 | 57 | 116 | 351 |
| Down Capture | 333% | 150% | 164% | 157% | 38% | 62% |
| Bmk -ve Days | 11 | 21 | 28 | 59 | 114 | 326 |
| Stock -ve Days | 12 | 21 | 32 | 64 | 125 | 374 |
[1] Upside and downside betas calculated using positive and negative benchmark daily returns respectively
Based On 1-Year Data
| Annualized Return | Annualized Volatility | Sharpe Ratio | Correlation with LPCN | |
|---|---|---|---|---|
| LPCN | -29.6% | 108.1% | 0.56 | - |
| Sector ETF (XLV) | 28.7% | 15.5% | 1.42 | 11.8% |
| Equity (SPY) | 23.3% | 12.8% | 1.36 | 16.6% |
| Gold (GLD) | 28.5% | 28.4% | 0.87 | 9.5% |
| Commodities (DBC) | 32.9% | 19.8% | 1.32 | -17.1% |
| Real Estate (VNQ) | 14.2% | 13.8% | 0.72 | -1.0% |
| Bitcoin (BTCUSD) | -44.2% | 42.9% | -1.23 | 16.7% |
Smart multi-asset allocation framework can stack odds in your favor. Learn How
Based On 5-Year Data
| Annualized Return | Annualized Volatility | Sharpe Ratio | Correlation with LPCN | |
|---|---|---|---|---|
| LPCN | -37.6% | 83.2% | -0.09 | - |
| Sector ETF (XLV) | 6.2% | 15.0% | 0.23 | 12.2% |
| Equity (SPY) | 13.5% | 17.2% | 0.61 | 16.5% |
| Gold (GLD) | 18.6% | 18.6% | 0.81 | 3.9% |
| Commodities (DBC) | 8.2% | 19.6% | 0.31 | -1.6% |
| Real Estate (VNQ) | 2.3% | 18.9% | 0.02 | 11.2% |
| Bitcoin (BTCUSD) | 8.8% | 53.0% | 0.35 | 14.8% |
Smart multi-asset allocation framework can stack odds in your favor. Learn How
Based On 10-Year Data
| Annualized Return | Annualized Volatility | Sharpe Ratio | Correlation with LPCN | |
|---|---|---|---|---|
| LPCN | -28.5% | 88.1% | 0.11 | - |
| Sector ETF (XLV) | 10.1% | 16.6% | 0.49 | 10.9% |
| Equity (SPY) | 15.4% | 17.9% | 0.73 | 14.1% |
| Gold (GLD) | 12.1% | 16.2% | 0.61 | 4.8% |
| Commodities (DBC) | 7.4% | 18.0% | 0.33 | 3.7% |
| Real Estate (VNQ) | 4.8% | 20.7% | 0.20 | 10.0% |
| Bitcoin (BTCUSD) | 58.2% | 66.2% | 0.98 | 8.9% |
Smart multi-asset allocation framework can stack odds in your favor. Learn How
Returns Analyses
Earnings Returns History
Updated 8/3/2026| Forward Returns | |||
|---|---|---|---|
| Earnings Date | 1D Returns | 5D Returns | 21D Returns |
| 5/7/2026 | -1.6% | -4.5% | -15.6% |
| 3/10/2026 | 2.9% | -7.5% | -73.0% |
| 11/6/2025 | 3.1% | 14.1% | 27.7% |
| 8/5/2025 | -1.6% | -5.8% | -7.3% |
| 3/7/2024 | 1.4% | 33.8% | 34.1% |
| 1/25/2021 | -10.0% | -22.3% | -25.5% |
| SUMMARY STATS | |||
| # Positive | 3 | 2 | 2 |
| # Negative | 3 | 4 | 4 |
| Median Positive | 2.9% | 23.9% | 30.9% |
| Median Negative | -1.6% | -6.6% | -20.5% |
| Max Positive | 3.1% | 33.8% | 34.1% |
| Max Negative | -10.0% | -22.3% | -73.0% |
| Forward Returns | |||
|---|---|---|---|
| Earnings Date | 1D Returns | 5D Returns | 21D Returns |
| 5/7/2026 | -1.6% | -4.5% | -15.6% |
| 3/10/2026 | 2.9% | -7.5% | -73.0% |
| 11/6/2025 | 3.1% | 14.1% | 27.7% |
| 8/5/2025 | -1.6% | -5.8% | -7.3% |
| 3/7/2024 | 1.4% | 33.8% | 34.1% |
| 1/25/2021 | -10.0% | -22.3% | -25.5% |
| SUMMARY STATS | |||
| # Positive | 3 | 2 | 2 |
| # Negative | 3 | 4 | 4 |
| Median Positive | 2.9% | 23.9% | 30.9% |
| Median Negative | -1.6% | -6.6% | -20.5% |
| Max Positive | 3.1% | 33.8% | 34.1% |
| Max Negative | -10.0% | -22.3% | -73.0% |
SEC Filings
Expand for More| Report Date | Filing Date | Filing |
|---|---|---|
| 06/30/2026 | 08/04/2026 | 10-Q |
| 03/31/2026 | 05/07/2026 | 10-Q |
| 12/31/2025 | 03/10/2026 | 10-K |
| 09/30/2025 | 11/06/2025 | 10-Q |
| 06/30/2025 | 08/05/2025 | 10-Q |
| 03/31/2025 | 05/08/2025 | 10-Q |
| 12/31/2024 | 03/13/2025 | 10-K |
| 09/30/2024 | 11/07/2024 | 10-Q |
| 06/30/2024 | 08/08/2024 | 10-Q |
| 03/31/2024 | 05/09/2024 | 10-Q |
| 12/31/2023 | 03/07/2024 | 10-K |
| 09/30/2023 | 11/08/2023 | 10-Q |
| 06/30/2023 | 08/10/2023 | 10-Q |
| 03/31/2023 | 05/11/2023 | 10-Q |
| 12/31/2022 | 03/10/2023 | 10-K |
| 09/30/2022 | 11/09/2022 | 10-Q |
| Report Date | Filing Date | Filing |
|---|---|---|
| 06/30/2026 | 08/04/2026 | 10-Q |
| 03/31/2026 | 05/07/2026 | 10-Q |
| 12/31/2025 | 03/10/2026 | 10-K |
| 09/30/2025 | 11/06/2025 | 10-Q |
| 06/30/2025 | 08/05/2025 | 10-Q |
| 03/31/2025 | 05/08/2025 | 10-Q |
| 12/31/2024 | 03/13/2025 | 10-K |
| 09/30/2024 | 11/07/2024 | 10-Q |
| 06/30/2024 | 08/08/2024 | 10-Q |
| 03/31/2024 | 05/09/2024 | 10-Q |
| 12/31/2023 | 03/07/2024 | 10-K |
| 09/30/2023 | 11/08/2023 | 10-Q |
| 06/30/2023 | 08/10/2023 | 10-Q |
| 03/31/2023 | 05/11/2023 | 10-Q |
| 12/31/2022 | 03/10/2023 | 10-K |
| 09/30/2022 | 11/09/2022 | 10-Q |
| 06/30/2022 | 08/08/2022 | 10-Q |
| 03/31/2022 | 05/09/2022 | 10-Q |
| 12/31/2021 | 03/09/2022 | 10-K |
| 09/30/2021 | 11/10/2021 | 10-Q |
| 06/30/2021 | 08/05/2021 | 10-Q |
| 03/31/2021 | 05/06/2021 | 10-Q |
| 12/31/2020 | 03/11/2021 | 10-K |
| 09/30/2020 | 11/10/2020 | 10-Q |
| 06/30/2020 | 08/06/2020 | 10-Q |
| 03/31/2020 | 05/07/2020 | 10-Q |
| 12/31/2019 | 03/13/2020 | 10-K |
| 09/30/2019 | 11/12/2019 | 10-Q |
Insider Activity
Updated 8/7/2026| # | Owner | Title | Holding | Action | Filing Date | Price | Shares | Transacted Value | Value of Held Shares | Form |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Higuchi, John W | Direct | Buy | 4072026 | 2.03 | 40,000 | 81,200 | 413,708 | Form | |
| 2 | Higuchi, John W | Direct | Buy | 4062026 | 2.05 | 123,000 | 252,150 | 335,784 | Form | |
| 3 | Patel, Mahesh V | Chief Executive Officer | Direct | Buy | 4062026 | 2.03 | 25,000 | 50,750 | 326,178 | Form |
| 4 | Patel, Mahesh V | Chief Executive Officer | Direct | Buy | 4022026 | 2.02 | 25,000 | 50,500 | 274,072 | Form |
| # | Owner | Title | Holding | Action | Filing Date | Price | Shares | Transacted Value | Value of Held Shares | Form |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Higuchi, John W | Direct | Buy | 4072026 | 2.03 | 40,000 | 81,200 | 413,708 | Form | |
| 2 | Higuchi, John W | Direct | Buy | 4062026 | 2.05 | 123,000 | 252,150 | 335,784 | Form | |
| 3 | Patel, Mahesh V | Chief Executive Officer | Direct | Buy | 4062026 | 2.03 | 25,000 | 50,750 | 326,178 | Form |
| 4 | Patel, Mahesh V | Chief Executive Officer | Direct | Buy | 4022026 | 2.02 | 25,000 | 50,500 | 274,072 | Form |
Industry Resources
External Quote Links
| Y Finance | Barrons |
| TradingView | Morningstar |
| SeekingAlpha | ValueLine |
| Motley Fool | Robinhood |
| CNBC | Etrade |
| MarketWatch | Unusual Whales |
| YCharts | Perplexity Finance |
| FinViz |
Prefer one of these to Trefis? Tell us why.