UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorp ...

Financial Performance - As of September 30, 2021, the company had an accumulated deficit of $185.3 million, with a net loss of $13.3 million for the nine months ended September 30, 2021, compared to $16.5 million for the same period in 2020[89]. - The company has not generated any revenues from product sales and does not expect to do so until regulatory approval is obtained for TLANDO or other products[88]. - The company recorded a litigation settlement expense of $4.0 million during the nine months ended September 30, 2021, related to the Global Agreement with Clarus[162]. - The company has generated $28.1 million in revenue from license fees, royalties, and government grants since inception through September 30, 2021[138]. - Cash used in operating activities for the nine months ended September 30, 2021, was $13.4 million, compared to $11.6 million for the same period in 2020[178]. - Cash used in investing activities increased significantly to $34.1 million in 2021 from $1.5 million in 2020[177]. - Financing activities provided $27.8 million in cash during the nine months ended September 30, 2021, compared to $16.3 million in 2020[177]. - The company anticipates needing to raise additional capital to support operations, including ongoing clinical studies and regulatory compliance[174]. Product Development and Regulatory Approvals - The company received tentative approval from the FDA for TLANDO on December 8, 2020, but final approval is contingent upon the expiration of Clarus Therapeutics' exclusivity period for JATENZO®, which ends on March 27, 2022[84][94]. - TLANDO's resubmission to the FDA will be a Class 1 resubmission, which includes a two-month review goal period[84][94]. - The FDA granted Fast Track Designation to LPCN 1144 for non-cirrhotic NASH, aimed at expediting its development and review[119]. - The FDA granted tentative approval for TLANDO as a testosterone replacement therapy (TRT) in adult males, but final approval is pending until March 27, 2022[140]. - The company plans to initiate a Phase 2 proof-of-concept study for LPCN 1148 in male cirrhotic subjects, targeting approximately 48 to 60 patients[126]. - LPCN 1107 aims to become the first oral product indicated for the reduction of preterm birth risk, addressing a significant unmet need as 11.7% of U.S. pregnancies result in preterm birth[129]. - The FDA has granted orphan drug designation to LPCN 1107, qualifying the company for various development incentives[134]. Clinical Trials and Research - LPCN 1144, currently in Phase 2 testing, showed robust liver fat reduction and improvement in liver injury markers in the LiFT clinical study, with positive results released in January and August 2021[87]. - The LiFT Phase 2 clinical study enrolled 56 male subjects with confirmed non-cirrhotic NASH, showing significant liver fat reduction at Week 12: Treatment A had a -7.7% change and Treatment B had a -9.2% change compared to placebo's -1.7%[106][110]. - In subjects with liver fat ≥ 5% at baseline, Treatment A and B showed a mean relative liver fat reduction of -40.0% and -46.9%, respectively, both statistically significant[111]. - 66.7% of subjects in Treatment A and 63.2% in Treatment B achieved over 30% relative reduction in liver fat at Week 12, compared to 15.8% in the placebo group[112]. - Both treatment arms of LPCN 1144 met the pre-specified regulatory endpoint of NASH resolution with no worsening of fibrosis, with 54% and 69% responders in Treatments A and B, respectively[114]. - A previous 16-week POC study showed that 48% of treated NAFLD subjects achieved resolution, with a mean liver fat reduction of 55% in this group[120]. - TLANDO XR, a next-generation oral testosterone product, completed a Phase 2b study, identifying the Phase 3 dose with good dose-response relationships observed[121]. - TLANDO XR was well tolerated in clinical studies, with no severe or serious drug-related adverse events reported[121]. Licensing and Agreements - The Antares License Agreement includes an initial payment of $11.0 million and potential milestone payments of up to $160.0 million, along with tiered royalty payments ranging from mid-teens to 20% of net sales of TLANDO in the U.S.[96]. - The company entered into the Antares License Agreement, granting Antares exclusive rights to develop and commercialize TLANDO, with an initial payment of $11.0 million and potential milestone payments of up to $160.0 million[165]. - The company is exploring licensing LPCN 1107 to a third party, although no agreements have been finalized[133]. Financial Position and Expenses - Research and development expenses totaled approximately $126.3 million since inception through September 30, 2021[139]. - Research and development expenses for the three months ended September 30, 2021, were $2,366,521, a decrease of $121,340 compared to $2,487,861 in 2020[149]. - Total research and development expenses for the nine months ended September 30, 2021, were $5,411,748, down from $7,268,599 in 2020, reflecting a decrease of $1,856,851[156]. - General and administrative expenses for the three months ended September 30, 2021, were $1,222,146, a decrease of $665,049 from $1,887,195 in 2020[149]. - The company expects research and development expenses to increase in the future as ongoing clinical studies are completed, including studies for LPCN 1144, LPCN 1148, LPCN 1154, and LPCN 1107[144]. - The company anticipates a decrease in general and administrative expenses due to reduced legal fees from the settlement with Clarus, although this may be offset by increases in other areas[147]. Cash Flow and Capital Management - As of September 30, 2021, the company had $38.7 million in unrestricted cash, cash equivalents, and marketable investment securities, compared to $19.7 million at December 31, 2020[164]. - The gross proceeds from the January 2021 public offering were approximately $28.7 million, after deducting underwriter fees and expenses of $1.9 million[166]. - The company had no capital expenditures for the nine months ended September 30, 2021, and 2020[180]. - The net proceeds from the sale of 16,428,571 shares of common stock in January 2021 generated $26.8 million[182]. - The company received a PPP loan of $234,000 at a 1.0% interest rate, which was fully forgiven by the Small Business Administration[167]. - The company received a PPP Loan of approximately $234,000, which was forgiven as per the terms of the CARES Act[185]. Risk Factors - The company is subject to various risks regarding the realization of milestone and royalty payments from the Antares License Agreement[165]. - The fair value of the investment portfolio is subject to interest rate risk, but a hypothetical ten percent increase in interest rates would have an insignificant impact on the consolidated financial statements[191]. - The company does not hedge interest rate exposures and invests in highly liquid, investment-grade securities[191]. - A one percent increase in the prime rate would result in a $10,000 increase in interest expense, while a one percent decrease would lead to an $11,000 decrease[192].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended June 30, 2021 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended March 31, 2021 ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorp ...

For Quarterly Period ended September 30, 2020 ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporatio ...

WASHINGTON, D.C. 20549 FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For Quarterly Period ended June 30, 2020 ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or ...

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Lipocine Inc. reported a Q1 2020 net loss of $5.8 million, with total assets at $21.0 million and liabilities at $14.4 million [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $21.0 million as of March 31, 2020, driven by cash, while total liabilities rose to $14.4 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2020 (USD) | December 31, 2019 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $15,134,789 | $9,728,523 | | Total current assets | $20,965,448 | $19,630,973 | | Total assets | $20,991,956 | $19,658,280 | | Total current liabilities | $4,059,855 | $4,964,877 | | Warrant liability | $5,691,229 | $4,591,200 | | Total liabilities | $14,439,220 | $13,370,484 | | Total stockholders' equity | $6,552,736 | $6,287,796 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $5.8 million for Q1 2020, up from $3.2 million in Q1 2019, driven by higher operating expenses and a $1.1 million unrealized warrant loss Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2020 (USD) | Three Months Ended March 31, 2019 (USD) | | :--- | :--- | :--- | | Research and development | $2,511,754 | $1,949,821 | | General and administrative | $2,085,261 | $1,175,927 | | Total operating expenses | $4,597,015 | $3,125,748 | | Operating loss | ($4,597,015) | ($3,125,748) | | Unrealized loss on warrant liability | ($1,100,029) | - | | Net loss | ($5,770,651) | ($3,224,472) | | Basic and Diluted loss per share | ($0.14) | ($0.14) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2020 saw $3.4 million cash used in operations, $3.9 million provided by investing, and $4.9 million from financing, resulting in a $5.4 million net cash increase Summary of Cash Flows (Unaudited) | Activity | Three Months Ended March 31, 2020 (USD) | Three Months Ended March 31, 2019 (USD) | | :--- | :--- | :--- | | Cash used in operating activities | ($3,376,262) | ($3,002,879) | | Cash provided by (used in) investing activities | $3,902,221 | ($2,082,438) | | Cash provided by financing activities | $4,880,307 | $5,229,881 | | Net increase in cash and cash equivalents | $5,406,266 | $144,564 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail capital sufficiency through February 2021, a **$10.0 million** SVB loan, a **$6.0 million** stock offering, and ongoing legal proceedings - The company believes its existing capital resources will be sufficient to meet operating requirements through at least February 15, 2021, but will need to raise additional capital. Failure to do so would create a risk to its ability to continue as a going concern[22](index=22&type=chunk) - The company has a **$10.0 million** Loan and Security Agreement with Silicon Valley Bank (SVB), with principal repayments deferred by six months under an April 1, 2020 agreement. The loan is secured by substantially all assets and requires **$5.0 million** of restricted cash collateral until TLANDO is approved by the FDA[36](index=36&type=chunk)[37](index=37&type=chunk) - In February 2020, the company completed a registered direct offering, raising gross proceeds of approximately **$6.0 million** by selling 10,084,034 Class A Units at **$0.595** per unit[49](index=49&type=chunk) - The company is engaged in ongoing litigation, including a patent infringement lawsuit against Clarus regarding its JATENZO® product, a shareholder derivative complaint, and a shareholder class action lawsuit. The company has not recorded a liability for these matters as the outcomes are not considered probable or estimable[74](index=74&type=chunk)[75](index=75&type=chunk)[77](index=77&type=chunk) - Subsequent to the quarter end, on April 21, 2020, the company was granted a Paycheck Protection Program (PPP) loan of **$233,537**[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Lipocine, a clinical-stage biopharmaceutical company, discusses its lead candidate TLANDO™ (PDUFA August 2020), LPCN 1144 for NASH in Phase 2, Q1 2020 net loss of $5.8 million, and liquidity [Overview of Our Business and Product Candidates](index=21&type=section&id=Overview%20of%20Our%20Business%20and%20Product%20Candidates) The company focuses on TLANDO™, an oral testosterone replacement therapy with an August 2020 PDUFA date, and LPCN 1144 for NASH in Phase 2 - The company's most advanced product candidate, TLANDO™, received a Complete Response Letter (CRL) from the FDA in November 2019 due to not meeting three secondary endpoints for maximal testosterone concentrations (Cmax)[91](index=91&type=chunk) - Following a Post Action meeting, the company resubmitted the TLANDO™ NDA on February 28, 2020, and has been assigned a PDUFA date of **August 28, 2020**[91](index=91&type=chunk) - LPCN 1144 is being tested in the LiFT Phase 2 clinical study for pre-cirrhotic NASH. Top-line liver fat reduction data is expected in **Q4 2020**, with 36-week biopsy data expected by **Q2 2021**, subject to potential COVID-19 delays[134](index=134&type=chunk) - The company plans to focus its 2020 efforts on TLANDO and LPCN 1144 and does not anticipate initiating Phase 3 studies for TLANDO XR or LPCN 1107 unless additional capital is secured or the candidates are out-licensed[137](index=137&type=chunk)[144](index=144&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Q1 2020 R&D expenses rose by **$0.6 million** to **$2.5 million**, G&A by **$0.9 million** to **$2.1 million** (due to legal costs), and an **$1.1 million** unrealized warrant loss was recorded Comparison of Operating Results (Q1 2020 vs Q1 2019) | Expense Category | Q1 2020 (USD) | Q1 2019 (USD) | Variance (USD) | | :--- | :--- | :--- | :--- | | Research and development | $2,511,754 | $1,949,821 | $561,933 | | General and administrative | $2,085,261 | $1,175,927 | $909,334 | | Unrealized loss on warrant liability | $1,100,029 | - | $1,100,029 | - The increase in R&D expenses was primarily driven by **$1.7 million** in costs for the LPCN 1144 LiFT Phase 2 clinical study, offset by a **$1.2 million** decrease in costs for TLANDO following the completion of its ABPM study[158](index=158&type=chunk) - The increase in G&A expenses was mainly due to a **$1.0 million** rise in legal costs associated with the patent infringement lawsuit filed against Clarus[159](index=159&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2020, the company held **$15.6 million** in unrestricted cash and **$5.0 million** restricted, sufficient until February 2021, but additional capital is needed - The company believes its existing capital resources will be sufficient to meet projected operating requirements through at least **February 15, 2021**[172](index=172&type=chunk) - The company will need to raise additional capital to support operations, the ongoing LPCN 1144 clinical study, and litigation. If unsuccessful, its ability to continue as a going concern will be limited[172](index=172&type=chunk) - In February 2020, the company raised gross proceeds of approximately **$6.0 million** through a registered direct offering[165](index=165&type=chunk) - In April 2020, the company received a Paycheck Protection Program (PPP) loan of **$233,537**[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risks](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company faces interest rate risk from its investment portfolio and variable-rate SVB loan, with a 1% prime rate change impacting annual interest expense by **$73,000** to **$89,000** - The company's main market risk is interest rate risk affecting its investment portfolio and its variable-rate debt[190](index=190&type=chunk) - A one percent increase in the prime rate would increase annual interest expense on the SVB loan by **$73,000**, while a one percent decrease would reduce it by **$89,000**[192](index=192&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2020, with no material changes to internal control over financial reporting - Based on an evaluation as of the end of the reporting period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[194](index=194&type=chunk) - There were no material changes in internal control over financial reporting during the most recent fiscal quarter[196](index=196&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in three significant legal proceedings: a shareholder derivative complaint, a patent infringement lawsuit against Clarus, and a shareholder class action lawsuit - A shareholder derivative complaint was filed against certain current and former officers and directors regarding allegedly false and misleading statements about the TLANDO NDA filing. A motion to dismiss is pending[196](index=196&type=chunk) - The company filed a lawsuit against Clarus alleging its JATENZO® product infringes on six Lipocine patents. A five-day jury trial is scheduled to begin on **February 8, 2021**[197](index=197&type=chunk) - A shareholder class action lawsuit was filed against the company and certain officers, alleging misleading statements about deficiencies in the TLANDO NDA. The company has insurance for such claims with a **$1.25 million** retention[198](index=198&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Key risk factors include COVID-19 impacts, substantial litigation costs, reliance on a sole manufacturer for TLANDO, warrant liability volatility, and restrictive loan covenants - The ongoing COVID-19 pandemic could disrupt clinical trials, reduce access to capital, and harm business operations and financial results[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) - The company may have to dedicate substantial resources to defend against ongoing shareholder lawsuits, which could divert managerial attention and financial resources from business operations[202](index=202&type=chunk) - The company relies on a sole contract manufacturer, M.W. Encap Ltd., for the supply of TLANDO capsules, and any disruption could significantly harm the business[212](index=212&type=chunk) - The fair value of the warrant liability from the November 2019 offering is subject to material fluctuations based on the company's stock price, which could impact reported financial results[215](index=215&type=chunk)[216](index=216&type=chunk) - The loan agreement with SVB contains restrictive covenants that could adversely impact the business, and failure to comply could result in the debt becoming immediately payable[220](index=220&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period [Item 3. Defaults Upon Senior Securities](index=42&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period [Item 4. Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including warrant forms, securities agreements, CEO/CFO certifications, and XBRL data - Exhibits filed include certifications from the Principal Executive Officer and Principal Financial Officer, as well as documents related to a securities purchase agreement and XBRL data[236](index=236&type=chunk)

PART I [Business](index=4&type=section&id=Item%201.%20Business) Lipocine Inc. is a clinical-stage biopharmaceutical company developing oral drug delivery solutions for metabolic and endocrine disorders - The company focuses on developing pharmaceutical products for metabolic and endocrine disorders using its proprietary oral drug delivery technology[15](index=15&type=chunk) - The lead product candidate, TLANDO™ (oral TRT), had its NDA resubmitted on **February 28, 2020**, with a PDUFA date of **August 28, 2020**, following a CRL from the FDA[16](index=16&type=chunk) - The product pipeline includes LPCN 1144 (NASH), TLANDO XR (next-gen TRT), LPCN 1148 (NASH cirrhosis), and LPCN 1107 (preterm birth)[18](index=18&type=chunk) Research and Development Expenses | Year | Amount (in millions) | | :--- | :--- | | 2019 | $7.5 | | 2018 | $6.5 | [Product Candidates](index=6&type=section&id=Product%20Candidates) The company's portfolio, based on Lip'ral technology, features TLANDO™ as its lead candidate and other drugs for NASH and preterm birth in development - TLANDO™ (oral TU) is the most advanced product candidate, with NDA resubmitted on **February 28, 2020**, and a PDUFA date of **August 28, 2020**, following a CRL on **November 8, 2019**, citing secondary Cmax endpoint deficiency[29](index=29&type=chunk)[32](index=32&type=chunk) - LPCN 1144 for pre-cirrhotic NASH is in the LiFT Phase 2 clinical study, with prior Proof-Of-Concept showing substantial liver fat reductions[54](index=54&type=chunk)[61](index=61&type=chunk) - TLANDO XR (LPCN 1111), a potential once-daily oral TRT, completed Phase 2b testing, with further development contingent on additional capital or out-licensing[62](index=62&type=chunk)[66](index=66&type=chunk) - LPCN 1148 for NASH in cirrhotic patients plans an IND filing in **March 2020**, but a Phase 2 study depends on additional funding or licensing[67](index=67&type=chunk)[69](index=69&type=chunk) - LPCN 1107, an oral HPC for preventing preterm birth, received orphan drug designation, with a Phase 3 study planned but not initiated in **2020** without additional capital or a licensing agreement[70](index=70&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) [Competition](index=13&type=section&id=Competition) The company faces significant competition across its target markets, including established TRT therapies and emerging treatments for NASH and preterm birth - The TRT market is highly competitive, with dominant products including gels like AbbVie's AndroGel® and injectables; Clarus Therapeutics' oral TRT, JATENZO®, was approved in **March 2019** and launched in **February 2020**[76](index=76&type=chunk)[53](index=53&type=chunk) - The NASH market has no FDA-approved medications, but several companies, including Genfit, Gilead, and Allergan, have product candidates in Phase 3 or earlier development[84](index=84&type=chunk)[85](index=85&type=chunk) - The primary competitor for LPCN 1107 in preventing preterm birth is AMAG Pharmaceuticals' Makena®, an injectable HPC, whose approval future is uncertain following a negative advisory committee vote[87](index=87&type=chunk) [Manufacturing and Intellectual Property](index=15&type=section&id=Manufacturing%20and%20Intellectual%20Property) The company utilizes a third-party manufacturer for TLANDO and protects its product candidates with an extensive intellectual property portfolio - The company has a Commercial Manufacturing Services and Supply Agreement with M.W. Encap Ltd. (a subsidiary of Lonza) for TLANDO manufacture[89](index=89&type=chunk) - The patent portfolio for Oral TU (TLANDO) includes **11 issued U.S. patents** expiring between **2029-2030** and numerous pending applications[94](index=94&type=chunk) - The portfolio for TLANDO XR includes **2 issued U.S. patents** expiring in **2035**, and LPCN 1107 includes **6 U.S. patents** expiring in **2031**[94](index=94&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) The company's drug development and commercialization are subject to extensive FDA regulations, encompassing preclinical studies, clinical trials, and post-market requirements - The FDA drug approval process requires extensive preclinical and clinical trials (Phase 1, 2, and 3) to demonstrate safety and efficacy before NDA submission and approval[101](index=101&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - FDA Orphan Drug Designation for rare diseases (fewer than **200,000 individuals** in the U.S.) provides incentives like **seven years of market exclusivity**; LPCN 1107 has this designation[113](index=113&type=chunk)[114](index=114&type=chunk)[74](index=74&type=chunk) - Sales of approved products depend on coverage and reimbursement from third-party payers, including government programs and private insurers, who increasingly focus on cost-effectiveness[120](index=120&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, primarily concerning TLANDO's regulatory approval, market competition, capital requirements, and ongoing intellectual property litigation - Company success is highly dependent on TLANDO, which has received **three Complete Response Letters (CRLs)** from the FDA, creating significant uncertainty for approval and commercialization[134](index=134&type=chunk)[135](index=135&type=chunk) - The TRT market faces risks from potential FDA label restrictions and perceived health risks (e.g., cardiovascular events), which could shrink the market and harm TLANDO sales if approved[139](index=139&type=chunk)[142](index=142&type=chunk) - The company faces substantial competition, including from JATENZO®, an approved oral TRT, and generic T-gels, leading to downward pricing pressure[166](index=166&type=chunk)[173](index=173&type=chunk) - Substantial additional capital is required to continue operations and fund clinical trials; failure to secure funding could lead to program delays, reductions, or cessation[274](index=274&type=chunk) - Intellectual property litigation, including a lawsuit against Clarus Therapeutics for patent infringement related to JATENZO®, consumes capital and management resources[234](index=234&type=chunk)[293](index=293&type=chunk) - On **December 27, 2019**, the company received a NASDAQ notice for failing to maintain the minimum **$1.00 bid price**, risking delisting[262](index=262&type=chunk) [Unresolved Staff Comments](index=55&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company has no unresolved staff comments from the Securities and Exchange Commission - None[308](index=308&type=chunk) [Properties](index=55&type=section&id=Item%202.%20Properties) The company leases its corporate headquarters in Salt Lake City, Utah, with the current facility deemed adequate for its operational needs - The company leases its corporate headquarters in Salt Lake City, Utah, with the lease expiring on **February 28, 2021**[309](index=309&type=chunk) [Legal Proceedings](index=55&type=section&id=Item%203.%20Legal%20Proceedings) The company is engaged in patent litigation with Clarus Therapeutics and is defending against shareholder lawsuits concerning TLANDO NDA disclosures - The company is appealing a PTAB judgment that canceled all claims on Clarus's '428 Patent, with oral arguments at the CAFC scheduled for **April 6, 2020**[310](index=310&type=chunk) - On **April 2, 2019**, Lipocine filed a lawsuit against Clarus alleging its JATENZO® product infringes six of Lipocine's patents, with a jury trial scheduled for **February 8, 2021**[312](index=312&type=chunk) - The company is defending a shareholder derivative complaint (**February 15, 2019**) and a shareholder class action lawsuit (**November 14, 2019**) alleging misleading statements about the TLANDO NDA[311](index=311&type=chunk)[313](index=313&type=chunk) [Mine Safety Disclosures](index=55&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not Applicable[314](index=314&type=chunk) PART II [Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=56&type=section&id=Item%205.%20Market%20for%20the%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Lipocine's common stock trades on The NASDAQ Capital Market, with the company prioritizing retained earnings for future growth over cash dividends - The company's common stock is listed on The NASDAQ Capital Market under the ticker **LPCN**[317](index=317&type=chunk) - As of **March 12, 2020**, there were approximately **103 holders of record** of common stock[319](index=319&type=chunk) - The company plans no cash dividends, intending to retain future earnings for business development[326](index=326&type=chunk) [Selected Financial Data](index=57&type=section&id=Item%206.%20Selected%20Financial%20Data) The company's selected financial data for the past five years reflects consistent operating losses and a growing accumulated deficit Selected Financial Data | | 2019 (in millions) | 2018 (in millions) | 2017 (in millions) | 2016 (in millions) | 2015 (in millions) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Operating loss** | $(12.900) | $(11.326) | $(21.218) | $(19.187) | $(18.382) | | **Net loss** | $(13.007) | $(11.660) | $(20.983) | $(18.972) | $(18.208) | | **Net loss per share** | $(0.50) | $(0.55) | $(1.05) | $(1.04) | $(1.11) | | **Total assets** | $19.658 | $20.852 | $25.325 | $27.343 | $45.377 | | **Total liabilities** | $13.370 | $11.418 | $6.345 | $1.326 | $3.392 | | **Shareholders' equity** | $6.288 | $9.434 | $18.980 | $26.017 | $41.985 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=58&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, noting increased net loss in 2019 due to R&D and legal costs, and the need for additional capital beyond March 2021 - The company's primary focus in **2020** is on TLANDO regulatory approval and LPCN 1144 clinical development[386](index=386&type=chunk) Comparison of Results for Years Ended Dec 31 | Metric | 2019 (in millions) | 2018 (in millions) | | :--- | :--- | :--- | | **Net Loss** | $13.0 | $11.7 | | **R&D Expenses** | $7.5 | $6.5 | | **G&A Expenses** | $5.6 | $5.3 | - The increase in R&D expense in **2019** was mainly due to costs for the LPCN 1144 LiFT Phase 2 clinical study, offset by decreased TLANDO-related costs after NDA filing[405](index=405&type=chunk) - Existing capital resources are sufficient to fund operations through at least **March 31, 2021**, but additional capital will be required thereafter[420](index=420&type=chunk) - The company raised gross proceeds of approximately **$6.0 million** in a **November 2019** public offering and another **$6.0 million** in a **February 2020** registered direct offering[412](index=412&type=chunk)[413](index=413&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=76&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate risk from its investment portfolio and variable-rate debt, with a 1% prime rate increase impacting annual interest expense by $63,000 - The company's primary market risk is interest rate risk associated with its investment portfolio and variable-rate debt[446](index=446&type=chunk) - The investment portfolio is managed to preserve principal and maintain liquidity, and the impact of a **10% change** in interest rates is considered insignificant[447](index=447&type=chunk) - A **1% increase** in the prime rate would increase annual interest expense on the SVB loan by approximately **$63,000**[448](index=448&type=chunk) [Financial Statements and Supplementary Data](index=76&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2019 and 2018, including balance sheets, statements of operations, equity, and cash flows Key Balance Sheet Data (as of Dec 31, 2019) | Account | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents | $9.7 | | Restricted cash | $5.0 | | Marketable investment securities | $4.3 | | Total Assets | $19.7 | | Total Liabilities | $13.4 | | Total Stockholders' Equity | $6.3 | Key Operations Data (for year ended Dec 31, 2019) | Account | Amount (in millions) | | :--- | :--- | | Total Revenues | $0.165 | | R&D Expense | $7.5 | | G&A Expense | $5.6 | | Net Loss | $(13.0) | | Net Loss Per Share | $(0.50) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=104&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting and financial disclosure - None[582](index=582&type=chunk) [Controls and Procedures](index=104&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2019 - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2019**[584](index=584&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2019**, based on the COSO framework[586](index=586&type=chunk) [Other Information](index=104&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[588](index=588&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=105&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the 2019 Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement[591](index=591&type=chunk) [Executive Compensation](index=105&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation information is incorporated by reference from the company's 2019 definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement[592](index=592&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=105&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership and related stockholder matters are incorporated by reference from the company's 2019 definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement[593](index=593&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=105&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2019 Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement[594](index=594&type=chunk) [Principal Accountant Fees and Services](index=105&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Principal accountant fees and services information is incorporated by reference from the company's 2019 definitive Proxy Statement - Information is incorporated by reference from the definitive Proxy Statement[595](index=595&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=105&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section details the financial statements and exhibits filed as part of the Annual Report on Form 10-K - This section lists all financial statements and exhibits filed with the Form 10-K[597](index=597&type=chunk)[598](index=598&type=chunk) [10-K Summary](index=109&type=section&id=Item%2016.%2010-K%20Summary) The company reports no summary for this item - None[605](index=605&type=chunk)

[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss and decreased assets for the period, with a significant regulatory setback for its lead drug candidate TLANDO Condensed Consolidated Balance Sheet (Unaudited) | | September 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Total current assets** | $17,310,742 | $20,809,203 | | **Total assets** | $17,341,910 | $20,851,953 | | **Total current liabilities** | $5,234,733 | $4,491,748 | | **Total liabilities** | $9,836,570 | $11,418,280 | | **Total stockholders' equity** | $7,505,340 | $9,433,673 | Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | **Total revenues** | $164,990 | $0 | $164,990 | $428,031 | | **Operating loss** | $(2,975,688) | $(2,353,056) | $(9,451,538) | $(8,154,451) | | **Net loss** | $(3,060,200) | $(2,459,072) | $(9,715,269) | $(8,434,543) | | **Basic and Diluted loss per share** | $(0.12) | $(0.12) | $(0.40) | $(0.40) | Condensed Consolidated Statements of Cash Flows (Unaudited, Nine Months Ended) | | September 30, 2019 | September 30, 2018 | | :--- | :--- | :--- | | **Cash used in operating activities** | $(8,358,175) | $(9,845,998) | | **Cash provided by investing activities** | $2,440,822 | $6,347,294 | | **Cash provided by financing activities** | $4,504,322 | $10,090,761 | | **Net (decrease) increase in cash** | $(1,413,031) | $6,592,057 | - The company received a **Complete Response Letter (CRL)** from the FDA regarding its New Drug Application (NDA) for TLANDO on November 8, 2019[75](index=75&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company discusses the FDA's rejection of its lead candidate TLANDO, pipeline progress, and significant going concern risks due to limited capital [Overview of Our Business](index=23&type=section&id=Overview%20of%20Our%20Business) The company's lead candidate TLANDO received a CRL from the FDA due to efficacy endpoint failures, while its NASH candidate LPCN 1144 advances - On November 8, 2019, the company received a **Complete Response Letter (CRL)** from the FDA for its TLANDO New Drug Application (NDA)[79](index=79&type=chunk) - The CRL identified one deficiency: the efficacy trial **did not meet the three secondary endpoints** for maximal testosterone concentrations (Cmax)[80](index=80&type=chunk) - The company's pipeline includes LPCN 1144 for pre-cirrhotic NASH, TLANDO XR (next-gen TRT), LPCN 1148 for NASH cirrhosis, and LPCN 1107 for prevention of preterm birth[81](index=81&type=chunk) [Our Product Candidates](index=26&type=section&id=Our%20Product%20Candidates) The pipeline is led by TLANDO, which received a CRL, while LPCN 1144 for NASH shows progress and other candidates face funding-dependent delays - **TLANDO**: Received a CRL on November 8, 2019, because the efficacy trial did not meet three Cmax secondary endpoints[90](index=90&type=chunk) - **LPCN 1144 (NASH)**: Currently in the LiFT Phase 2 clinical study, with top-line liver fat reduction data expected in mid-2020 and 36-week biopsy data by late 2020 or early 2021[120](index=120&type=chunk) - **LPCN 1107 (Preterm Birth)**: The company does not anticipate initiating a Phase 3 study in 2019 unless additional capital is secured or the product is out-licensed[130](index=130&type=chunk)[131](index=131&type=chunk) - **LPCN 1148 (NASH Cirrhosis)**: The company expects to file an Investigational New Drug (IND) application by December 31, 2019[127](index=127&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses increased year-over-year, driven by higher R&D costs for the LPCN 1144 study and increased G&A legal fees Comparison of Operations (Three Months Ended Sep 30) | | 2019 | 2018 | Variance | | :--- | :--- | :--- | :--- | | **License revenue** | $164,990 | $0 | $164,990 | | **Research and development expenses** | $1,713,417 | $1,422,919 | $290,498 | | **General and administrative expenses** | $1,427,261 | $930,137 | $497,124 | Comparison of Operations (Nine Months Ended Sep 30) | | 2019 | 2018 | Variance | | :--- | :--- | :--- | :--- | | **License revenue** | $164,990 | $428,031 | $(263,041) | | **Research and development expenses** | $5,626,883 | $4,282,823 | $1,344,060 | | **General and administrative expenses** | $3,989,645 | $4,299,659 | $(310,014) | - The increase in Q3 2019 R&D expenses was primarily due to costs related to the **LPCN 1144 LiFT Phase 2 clinical study**[147](index=147&type=chunk) - The increase in Q3 2019 G&A expenses was primarily due to a **$565,000 increase in legal fees**, mainly from the patent infringement lawsuit against Clarus[148](index=148&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) Existing capital is only sufficient through March 2020, creating substantial doubt about its ability to continue as a going concern - The company believes its existing capital resources will be sufficient to meet projected operating requirements **only through at least March 31, 2020**[163](index=163&type=chunk) - The company will need to raise additional capital to support operations, and if unsuccessful, its ability to continue as a **going concern will become a risk**[163](index=163&type=chunk) - As of September 30, 2019, the company had sold 6,261,342 shares under its ATM Sales Agreement, resulting in **net proceeds of approximately $18.2 million** since program inception[162](index=162&type=chunk) - The company has a $10.0 million loan with Silicon Valley Bank, which requires maintaining **$5.0 million of restricted cash** as collateral until TLANDO is approved by the FDA[157](index=157&type=chunk)[158](index=158&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company is exposed to interest rate risk from its investment portfolio and variable-rate debt with Silicon Valley Bank - The company's investment portfolio is subject to interest rate risk, but a hypothetical 10% increase in rates is **not expected to have a significant impact** on the fair value of its marketable securities[181](index=181&type=chunk) - The company's **$10.0 million loan from SVB** bears interest at a variable rate, and a 1% increase in the prime rate would result in a $79,000 increase in future annual interest expense[182](index=182&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective as of September 30, 2019**[185](index=185&type=chunk) - **No material changes** in internal control over financial reporting occurred during the most recent fiscal quarter[186](index=186&type=chunk) [PART II—OTHER INFORMATION](index=47&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in multiple legal proceedings, including patent litigation with Clarus and a shareholder derivative lawsuit - On April 2, 2019, Lipocine filed a lawsuit against Clarus Therapeutics alleging that its JATENZO® product **infringes six of Lipocine's U.S. patents**[190](index=190&type=chunk) - A **shareholder derivative complaint** was filed on February 15, 2019, against certain officers and directors for alleged breaches of fiduciary duty[189](index=189&type=chunk) - Clarus has appealed a December 2018 PTAB ruling that was in favor of Lipocine, which had **canceled all claims in a Clarus patent**[188](index=188&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.Risk%20Factors) Key risks include the uncertain approval of TLANDO, significant going concern risk due to funding needs, ongoing litigation, and stock price volatility - The company's business depends primarily on the success of TLANDO, which recently received its **third Complete Response Letter (CRL)** from the FDA[192](index=192&type=chunk)[193](index=193&type=chunk) - The company will need substantial additional capital as existing resources are only projected to last through **March 31, 2020**, creating a going concern risk[203](index=203&type=chunk) - The company is engaged in **patent litigation with Clarus** and defending a shareholder derivative lawsuit, which will require substantial costs and resources[199](index=199&type=chunk)[202](index=202&type=chunk) - The company's common stock is **thinly traded**, with an average daily volume of approximately 147,000 shares in Q3 2019, which can lead to significant price volatility[207](index=207&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[209](index=209&type=chunk) [Exhibits](index=53&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including officer certifications and XBRL data files