Lipocine(LPCN) - 2025 Q2 - Quarterly Results

Corporate Update & Product Pipeline Lipocine is advancing its Neuroactive Steroids program with LPCN 1154 and LPCN 2401, while expanding TLANDO™'s global commercial reach through new licensing agreements Neuroactive Steroids Program Lipocine's Neuroactive Steroids program is advancing two key product candidates: LPCN 1154 for postpartum depression (PPD) and LPCN 2401 for obesity management, both of which are in clinical development with potential for third-party partnerships LPCN 1154 (Postpartum Depression) LPCN 1154, an oral brexanolone product candidate for rapid PPD symptom relief, initiated its pivotal Phase 3 safety and efficacy study in Q2 2025, with topline results expected in Q2 2026 and a U.S. NDA submission in mid-2026. The company is also exploring partnering opportunities for commercialization - Pivotal Phase 3 safety and efficacy study for LPCN 1154 initiated in Q2 2025[4] - Topline results for LPCN 1154 expected in Q2 2026, with a 505(b)(2) New Drug Application (NDA) submission in the U.S. expected in mid-2026[4] - LPCN 1154 is a non-invasive, 48-hour oral treatment option targeted for rapid symptom relief of postpartum depression (PPD)[4] - Lipocine may explore partnering LPCN 1154 with a third party for commercialization[4] LPCN 2401 (Obesity Management) LPCN 2401, an oral anabolic androgen receptor agonist, is targeted as an adjunct to GLP-1 receptor agonists for quality weight loss or as monotherapy for weight maintenance, with a proof-of-concept Phase 2 study targeted for initiation in Q3 2025. Partnering opportunities are also being explored - Lipocine plans to initiate a proof-of-concept Phase 2 study for LPCN 2401 in obese and overweight GLP-1 eligible patients, with first patient dosing targeted for Q3 2025[4] - LPCN 2401 is a once-daily oral formulation comprising a proprietary anabolic androgen receptor agonist, expected to improve body composition for quality weight loss as an adjunct to GLP-1 receptor agonists, or as a monotherapy for weight maintenance[4] - Lipocine may explore partnering LPCN 2401 with a third party[4] TLANDO™ Program The TLANDO™ program focuses on commercializing Lipocine's FDA-approved oral testosterone replacement therapy through exclusive licensing and distribution agreements in various global markets, expanding its reach to Canada, South Korea, GCC countries, and Brazil Commercialization & Licensing Updates Lipocine has expanded TLANDO™'s global commercialization through new licensing agreements, including an exclusive license with Aché Laboratórios Farmacêuitcos S.A. for Brazil in April 2025, and Verity Pharma filing a New Drug Submission for TLANDO in Canada in June 2025 - Lipocine has an exclusive License Agreement with Verity Pharma (entered 2024) for TLANDO in the United States and Canada[11] - In June 2025, Verity Pharma filed a New Drug Submission (NDS) for TLANDO in Canada[11] - In April 2025, Lipocine entered a license and supply agreement with Aché Laboratórios Farmacêuitcos S.A., granting an exclusive license to commercialize TLANDO in Brazil, with expected fees upon regulatory milestones and royalties on net sales[11] - TLANDO is expected to be the first oral testosterone product to be registered in Brazil[11] Financial Performance Lipocine's financial performance for Q2 and H1 2025 shows a net loss, primarily driven by changes in license revenue and operating expenses compared to the prior year Second Quarter Ended June 30, 2025 For Q2 2025, Lipocine reported a reduced net loss of $2.2 million compared to $3.1 million in Q2 2024, with an EPS of ($0.41). The company's unrestricted cash, cash equivalents, and marketable investment securities decreased to $17.9 million as of June 30, 2025, from $21.6 million at December 31, 2024 Q2 2025 Financial Highlights | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :---------------------------------------------------------------- | :---------- | :---------- | :----------- | | Net Loss | $(2.2) million | $(3.1) million | $(0.9) million decrease | | Diluted EPS | $(0.41) | $(0.57) | $0.16 increase | | Unrestricted Cash, Cash Equivalents & Marketable Investment Securities (as of period end) | $17.9 million (June 30, 2025) | $21.6 million (Dec 31, 2024) | $(3.7) million decrease | Revenue Analysis (Q2 2025) Total revenues significantly increased in Q2 2025 to $622,849 from $89,565 in Q2 2024, primarily due to $500,000 in license revenue recognized in 2025, which was absent in the prior year, alongside a modest increase in TLANDO royalty revenue Q2 2025 Revenue Breakdown | Revenue Type | Q2 2025 | Q2 2024 | Change (YoY) | | :------------- | :---------- | :---------- | :----------- | | License revenue | $500,000 | $0 | $500,000 increase | | Royalty revenue | $122,849 | $89,565 | $33,284 increase | | Total Revenues | $622,849 | $89,565 | $533,284 increase | Operating Expenses (Q2 2025) Research and development expenses increased to $2.1 million in Q2 2025 due to the initiation of LPCN 2401 clinical studies, while general and administrative expenses decreased to $0.9 million, driven by lower business development, legal, and professional fees, and reduced Delaware franchise tax Q2 2025 Operating Expenses | Expense Type | Q2 2025 | Q2 2024 | Change (YoY) | | :----------------------- | :---------- | :---------- | :----------- | | Research and development | $2,136,769 | $1,874,721 | $262,048 increase | | General and administrative | $890,433 | $1,507,412 | $(616,979) decrease | - Increase in R&D expenses was due to increased costs related to the initiation of LPCN 2401 clinical studies and other R&D costs[8] - Decrease in G&A expenses was primarily due to lower business development fees, consulting expenses, legal fees, Delaware franchise tax (due to reduced authorized common stock), and corporate insurance premiums[9] Six Months Ended June 30, 2025 For the first half of 2025, Lipocine reported a net loss of $4.1 million, or ($0.76) per diluted share, a significant shift from a net income of $0.4 million in the comparable period of 2024, primarily due to a substantial decrease in license revenue H1 2025 Financial Highlights | Metric | H1 2025 | H1 2024 | Change (YoY) | | :---------------- | :---------- | :---------- | :----------- | | Net Loss (Income) | $(4.1) million | $0.4 million | $(4.5) million decrease | | Diluted EPS | $(0.76) | $0.10 | $(0.86) decrease | Revenue Analysis (H1 2025) Total revenues for the six months ended June 30, 2025, decreased significantly to $716,713 from $7.7 million in H1 2024, mainly due to a substantial reduction in license revenue from $7.5 million in 2024 (Verity Licensing Agreement) to $500,000 in 2025, partially offset by a slight increase in TLANDO royalty revenue H1 2025 Revenue Breakdown | Revenue Type | H1 2025 | H1 2024 | Change (YoY) | | :------------- | :---------- | :---------- | :----------- | | License revenue | $500,000 | $7,500,000 | $(7,000,000) decrease | | Royalty revenue | $216,713 | $206,738 | $9,975 increase | | Total Revenues | $716,713 | $7,706,738 | $(6,990,025) decrease | Operating Expenses (H1 2025) Research and development expenses decreased to $3.2 million in H1 2025 from $4.7 million in H1 2024, primarily due to lower costs for LPCN 1154 studies in 2025 compared to 2024, despite increased costs for LPCN 2401 studies. General and administrative expenses also decreased to $2.0 million from $3.1 million, mainly due to one-time business development fees incurred in 2024 H1 2025 Operating Expenses | Expense Type | H1 2025 | H1 2024 | Change (YoY) | | :----------------------- | :---------- | :---------- | :----------- | | Research and development | $3,198,341 | $4,693,646 | $(1,495,305) decrease | | General and administrative | $2,012,910 | $3,083,131 | $(1,070,221) decrease | - Decrease in R&D expenses was a result of lower costs related to the initiation of the LPCN 1154 Phase 3 clinical study in 2025 compared to 2024, and a decrease in other R&D related costs, offset by increased costs for LPCN 2401 clinical studies and personnel[13] - Decrease in G&A expenses was due to one-time business development fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement, as well as decreases in other business development expenses, legal fees, corporate insurance premiums, and professional fees[14] Other Income (H1 2025) Interest and investment income decreased to $0.4 million in H1 2025 from $0.6 million in H1 2024, attributed to lower interest rates and reduced cash and marketable investment securities balances H1 2025 Other Income | Metric | H1 2025 | H1 2024 | Change (YoY) | | :-------------------------- | :---------- | :---------- | :----------- | | Interest and investment income | $424,149 | $640,209 | $(216,060) decrease | - The decrease in interest and investment income was due to lower interest rates and lower cash and marketable investment securities balances in 2025 compared to 2024[15] About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary oral drug delivery technology to develop a diverse pipeline of clinical candidates for unmet medical needs, including its FDA-approved TLANDO Company Overview and Pipeline Lipocine is a biopharmaceutical company utilizing its proprietary technology platform for effective oral drug delivery, developing a pipeline of candidates for significant unmet medical needs such as PPD, refractory epilepsy, essential tremor, obesity, and liver cirrhosis, while also exploring partnering opportunities for several assets. TLANDO, an FDA-approved oral testosterone replacement therapy, is also part of its portfolio - Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, targeting large addressable markets with significant unmet medical needs[16] - Clinical development candidates include LPCN 1154 (PPD), LPCN 2101 (refractory epilepsy), LPCN 2203 (essential tremor), LPCN 2401 (obesity management), and LPCN 1148 (liver cirrhosis)[17] - Lipocine is exploring partnering opportunities for LPCN 1107 (preterm birth), LPCN 1154 (PPD), LPCN 2401 (obesity management), LPCN 1148 (decompensated cirrhosis), and LPCN 1144 (MASH)[17] - TLANDO, a novel oral prodrug of testosterone, is approved by the FDA for conditions associated with hypogonadism in adult males[17] Financial Statements This section presents Lipocine's condensed consolidated balance sheets and statements of operations, detailing assets, liabilities, equity, revenues, and expenses for the reported periods Condensed Consolidated Balance Sheets As of June 30, 2025, Lipocine's total assets were $18.6 million, a decrease from $22.5 million at December 31, 2024, primarily driven by a reduction in marketable investment securities and cash. Total stockholders' equity also decreased to $17.1 million from $21.0 million over the same period Condensed Consolidated Balance Sheets Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------------------ | :------------ | :---------------- | :------- | | Cash and cash equivalents | $6,043,980 | $6,205,926 | $(161,946) | | Marketable investment securities | $11,891,702 | $15,427,385 | $(3,535,683) | | Total current assets | $18,420,043 | $22,321,673 | $(3,901,630) | | Total assets | $18,577,193 | $22,510,501 | $(3,933,308) | | Total current liabilities | $1,448,773 | $1,512,936 | $(64,163) | | Total stockholders' equity | $17,128,420 | $20,997,565 | $(3,869,145) | Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) The statements detail the company's revenues, operating expenses, and net income/loss for the three and six months ended June 30, 2025, and 2024, showing a net loss for both periods in 2025 compared to a net income for the six months in 2024, primarily driven by changes in license revenue Condensed Consolidated Statements of Operations Highlights | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :------------------------------------------------ | :---------- | :---------- | :---------- | :---------- | | Total revenues | $622,849 | $89,565 | $716,713 | $7,706,738 | | Total operating expenses | $3,027,202 | $3,382,133 | $5,211,251 | $7,776,777 | | Operating loss | $(2,404,353) | $(3,292,568) | $(4,494,538) | $(70,039) | | Net income (loss) attributable to common shareholders | $(2,205,716) | $(3,068,634) | $(4,070,589) | $444,987 | | Basic earnings (loss) per share | $(0.41) | $(0.57) | $(0.76) | $0.08 | | Diluted earnings (loss) per share | $(0.41) | $(0.56) | $(0.76) | $0.10 | Forward-Looking Statements This section provides a cautionary disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties in product development and commercialization Disclaimer and Risk Factors This section serves as a cautionary note regarding forward-looking statements in the release, highlighting inherent risks and uncertainties associated with product development, clinical trials, regulatory approvals, commercialization, and financial resources, and advises investors to refer to SEC filings for detailed risk factors - The release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[18] - Investors are cautioned that all such statements involve risks and uncertainties, including potential lack of success in developing product candidates, insufficient capital, inability to secure partnerships, unsuccessful safety and efficacy studies, and failure to obtain FDA approval[18] - Lipocine assumes no obligation to update or revise publicly any forward-looking statements, except as required by law[18] Contact Information This section provides essential contact details for media inquiries and investor relations for Lipocine Inc Media and Investor Relations This section provides contact details for media inquiries and investor relations for Lipocine Inc - Media Contact: Krista Fogarty, Phone: (801) 994-7383, Email: kf@lipocine.com[20] - Investors Contact: PJ Kelleher, Phone: (617) 430-7579, Email: pkelleher@lifesciadvisors.com[20]