Lipocine Inc
lipocine.comWhat Do They Do?
Develops oral drug candidates for brain, liver and hormone conditions and licenses TLANDO, a testosterone replacement therapy, to pharmaceutical partners.
10-K for FY2025, filed Mar 10, 2026We are a biopharmaceutical company focused on leveraging our proprietary technology platform to develop innovative products with effective…View ↗
On January 12, 2024, we entered into a license agreement (the “Verity License Agreement”) with Gordon Silver Limited (“GSL”) and Verity…View ↗
Additional clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”); LPCN 2201 for major depressive…View ↗
How Do They Make Money?
Lipocine receives fees when it transfers licensed technology rights, may receive added payments when partners meet regulatory or sales milestones, and earns royalties on partner sales; royalties are generally due within 45 days after each quarter.
10-K for FY2025, filed Mar 10, 2026
-
10-K for FY2025, filed Mar 10, 2026
FY2025 revenue by product or service ↗
$2M
-
10-K for FY2025, filed Mar 10, 2026
$2M ↗
| Segment | Share | Revenue | How money arrives |
|---|---|---|---|
|
License
Licensed
10-K for FY2025, filed Mar 10, 2026 |
76%
FY2022: 100%
|
License, FY2025
$1.5M Sources
|
Licensed |
|
Royalty
Licensed
10-K for FY2025, filed Mar 10, 2026 |
24% |
Royalty, FY2025
$476.7K Sources
|
Licensed |
Who Are Their Customers?
Pharmaceutical partners take TLANDO commercialization rights directly from Lipocine; in some territories, Lipocine also supplies the product to those partners for resale.
10-K for FY2025, filed Mar 10, 2026On January 12, 2024, we entered into a license agreement (the “Verity License Agreement”) with Gordon Silver Limited (“GSL”) and Verity…View ↗
In September 2024, we entered into a distribution and license agreement (the “SPC License Agreement”) for the development and…View ↗
SPC paid us a non-refundable, non-creditable upfront fee in October 2024. We also received an additional payment for a non-refundable…View ↗
Upon execution of the Pharmalink Distribution Agreement, Pharmalink paid a non-refundable, non-creditable upfront fee. Under the Pharmalink…View ↗
Upon execution of the Aché License Agreement, Aché paid us a non-refundable, non-creditable upfront fee in May 2025. Under the Aché License…View ↗
10-K for FY2025, filed Mar 10, 2026
Do Revenues Turn Into Profits?
No. It lost $9.6M in FY2025.
10-K for FY2025, filed Mar 10, 2026
How Are They Changing?
- Net income
-
Sources
10-Q for Q2 FY2026, filed Aug 4, 2026
−$2.6MView ↗
- ▲ +19% (Loss)
- vs −$2.2M in Q2 FY2025
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Aug 4, 2026
LPCN 1154 missed its Phase 3 primary endpoint; Lipocine began another trial
The primary endpoint was not met; Lipocine cited a post hoc site-data concern, requested FDA guidance and began another placebo-controlled trial.
Sources
8-K, filed Aug 4, 2026
On April 2, 2026, Lipocine reported topline results from its Phase 3 placebo-controlled trial (N=90) evaluating oral LPCN 1154 (oral…View ↗
Shrinking. Revenue fell 88% in 4 years, from $16.1M in FY2021 to $2M in FY2025, about 41% a year.
Wider TLANDO licensing
The older report described rights for TLANDO licensed to Antares in the United States; the latest report describes Verity covering the United States and Canada, plus partners in South Korea, Gulf Cooperation Council countries and Brazil.
10-K for FY2022, filed Mar 10, 2023 10-K for FY2025, filed Mar 10, 2026We entered into a license agreement for the development and commercialization of our product candidate, TLANDO®, an oral testosterone…View ↗
Who Do They Compete With?
Competes with Seaport Therapeutics, Praxis Precision Medicines, SAGE Therapeutics, Supernus Pharmaceuticals, Bausch Health, Galecto, AbbVie, Lilly and, Endo, Allergan, Antares Pharma, Acerus Pharmaceuticals, Tolmar Pharmaceuticals, Marius Pharmaceuticals, Perrigo, Teva, Upsher-Smith Laboratories, and Acrux
10-K for FY2025, filed Mar 10, 2026The unique potential mechanism of action (“MOA”) of NAS presents an opportunity to treat a variety of CNS disorders. Accordingly, multiple…View ↗
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