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1. Company Snapshot

1.a. 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.

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1.b. Last Insights on LPCN

Lipocine's recent performance was driven by several positive developments. The company's Q3 financial results, announced on November 6, 2025, showcased progress in its pipeline, particularly with LPCN 1154 for postpartum depression (PPD) and LPCN 2401 for obesity. The presentation of LPCN 2401 clinical data at ObesityWeek on November 4, 2025, highlighted the treatment's potential in rapidly improving body composition in men with obesity. Additionally, the promising interim safety profile of LPCN 1154 in its Phase 3 trial, announced on November 18, 2025, supports the study's continuation as planned.

1.c. Company Highlights

2. Transcript Summary

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3. NewsRoom

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Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Nov -18

Source: prnewswire.com

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Lipocine (LPCN) Reports Q3 Loss, Tops Revenue Estimates

Nov -06

Source: zacks.com

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Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025

Nov -06

Source: prnewswire.com

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Lipocine Presents LPCN 2401 Clinical Data at ObesityWeek®

Nov -04

Source: prnewswire.com

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Lipocine Provides Progress Update on LPCN 1154 Phase 3 Clinical Trial in Postpartum Depression (PPD)

Sep -30

Source: prnewswire.com

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Lipocine to Present at H.C. Wainwright 27th Annual Global Investment Conference

Sep -05

Source: prnewswire.com

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Lipocine Announces LPCN 2101 Abstracts Accepted for Presentation at AES 2025

Aug -26

Source: prnewswire.com

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Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2025

Aug -05

Source: prnewswire.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (8.90%)

6. Segments

Oral Delivery Solutions

Expected Growth: 8.9%

Lipocine Inc.'s Oral Delivery Solutions exhibit 8.9% growth driven by increasing demand for convenient, patient-centric treatments, advancements in lipid-based formulations, and strategic partnerships expanding market reach. Additionally, growing prevalence of chronic diseases, such as hypogonadism and thyroid disorders, fuels adoption of oral delivery solutions.

7. Detailed Products

TLANDO

TLANDO is an oral testosterone replacement therapy (TRT) for the treatment of hypogonadism in adult males.

LPCN 1021

LPCN 1021 is an oral hydrocortisone (cortisol) replacement therapy for the treatment of congenital adrenal hyperplasia (CAH) and adrenal insufficiency.

LPCN 1111

LPCN 1111 is an oral testosterone therapy for the treatment of vasomotor symptoms in men, including hot flashes and night sweats.

LPCN 1107

LPCN 1107 is an oral therapy for the treatment of non-alcoholic steatohepatitis (NASH).

8. Lipocine Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Lipocine Inc. has a moderate threat of substitutes due to the presence of alternative treatments for hypogonadism, such as testosterone gels and patches. However, the company's oral testosterone replacement therapy has a unique advantage in terms of convenience and patient compliance.

Bargaining Power Of Customers

Lipocine Inc.'s customers, primarily healthcare providers and patients, have limited bargaining power due to the company's specialized product offerings and limited competition in the oral testosterone replacement therapy market.

Bargaining Power Of Suppliers

Lipocine Inc. relies on a limited number of suppliers for its raw materials and manufacturing services, which gives them some bargaining power. However, the company's strong relationships with its suppliers and its ability to negotiate contracts mitigate this risk.

Threat Of New Entrants

The threat of new entrants in the oral testosterone replacement therapy market is high due to the attractiveness of the market and the potential for new companies to enter with innovative products or technologies.

Intensity Of Rivalry

The intensity of rivalry in the oral testosterone replacement therapy market is moderate, with a few established players competing for market share. However, Lipocine Inc.'s unique product offerings and strong relationships with healthcare providers give it a competitive advantage.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 0.08%
Debt Cost 3.95%
Equity Weight 99.92%
Equity Cost 9.39%
WACC 9.39%
Leverage 0.08%

11. Quality Control: Lipocine Inc. passed 5 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

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Rigel Pharma

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Value: 6.1

Growth: 8.0

Quality: 9.1

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Momentum: 9.5

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Fulcrum Therapeutics

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Quality: 6.4

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Arbutus Biopharma

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Value: 6.0

Growth: 4.0

Quality: 3.9

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EyePoint Pharmaceuticals

A-Score: 3.7/10

Value: 6.6

Growth: 2.3

Quality: 4.9

Yield: 0.0

Momentum: 7.5

Volatility: 1.0

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Lipocine

A-Score: 3.6/10

Value: 8.2

Growth: 6.9

Quality: 3.0

Yield: 0.0

Momentum: 1.0

Volatility: 2.7

1-Year Total Return ->

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Clearside Biomedical

A-Score: 3.3/10

Value: 8.4

Growth: 3.6

Quality: 6.1

Yield: 0.0

Momentum: 0.5

Volatility: 1.0

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

3.15$

Current Price

3.15$

Potential

-0.00%

Expected Cash-Flows