BioVie(BIVI) - 2020 Q4 - Annual Report

FORM 10-K Cover Page Information Registrant Information and Filing Status BioVie Inc. filed its annual report on Form 10-K for the fiscal year ended June 30, 2020, classifying as a non-accelerated filer and smaller reporting company - BioVie Inc. is a non-accelerated filer and a smaller reporting company[1] Market Value and Shares Outstanding | Metric | Value | | :----- | :---- | | Market Value of Non-Affiliate Equity (as of last business day of Q2) | $18,143,043 | | Shares of Class A Common Stock Outstanding (as of August 3, 2020) | 5,204,392 | FORWARD-LOOKING STATEMENTS Disclaimer on Forward-Looking Statements This report contains forward-looking statements regarding future events and financial performance, which involve risks and uncertainties that could cause actual results to differ materially - Forward-looking statements are identified by specific terminology (e.g., 'intends,' 'estimates,' 'predicts,' 'potential,' 'continues,' 'anticipates,' 'plans,' 'expects,' 'believes,' 'should,' 'could,' 'may,' 'will')[5] - Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially[5] - The company does not undertake or intend to update or revise forward-looking statements, except as required by applicable law[6] PART I ITEM 1. DESCRIPTION OF BUSINESS BioVie Inc. is a clinical-stage biopharmaceutical company focused on developing BIV201 for ascites due to chronic liver cirrhosis, a condition with significant unmet medical need - BioVie is a clinical-stage company developing BIV201 (continuous infusion terlipressin) for ascites due to chronic liver cirrhosis[9] - Phase 2a clinical trial results for BIV201 showed maintained hemodynamic stability, predicted pharmacokinetics, and increased days between paracenteses (71% to 414%) in some patients[10] - The FDA granted BIV201 Fast-Track status and Orphan Drug designation for ascites and hepatorenal syndrome (HRS), indicating a significant unmet medical need[13][24] - BioVie invented a proprietary novel liquid formulation of terlipressin for outpatient administration, offering potential differentiation through room temperature stability compared to existing refrigerated products[12] Ascites Market Opportunity | Metric | Value | | :----- | :---- | | Estimated U.S. hospital discharges annually for cirrhosis and ascites | 116,000 | | Average hospital stay for paracentesis patients | 8 days | | Average medical costs per paracentesis patient | >$86,000 | | Estimated total addressable ascites market size for BIV201 | >$650 million | | Mean one-year survival rate for refractory ascites patients | 50% | Introduction to BioVie and BIV201 Clinical Development of BIV201 Proprietary Liquid Formulation of Terlipressin Market Opportunity and Unmet Medical Need Acquisition and Intellectual Property Rights About Ascites and Liver Cirrhosis The Need for an Ascites Therapy The Ascites Development Pathway The BIV201 Mechanism of Action Future Possible BIV201 Indications Efflux Pump Antibiotics Program Intellectual Property Government Regulation United States Drug Development Process U.S. Review and Approval Processes Orphan Drug Designation Expedited Development and Review Programs Post-Approval Requirements Employees ITEM 1A. RISK FACTORS BioVie faces substantial risks due to its development-stage nature, including no approved products or revenues, significant capital needs, and uncertainties in clinical trials and regulatory approvals - The company has no products approved for commercial sale, has never generated revenues, and may never achieve profitability, raising substantial doubt about its ability to continue as a going concern[53][54][58] - Successful development and commercialization of BIV201 are highly uncertain, dependent on clinical trial safety/efficacy, regulatory approvals, market acceptance, and the ability to raise substantial additional capital[54][60][76][84] - A U.S. patent ('945 Patent) for 'Treatment of Ascites' was invalidated by the PTAB in November 2019, though Orphan Drug designations and pending liquid formulation patents remain unaffected[111][168][381][382] - The company relies on third-party manufacturers and faces risks related to cGMP compliance, potential shortages, and the need to develop its own manufacturing capabilities if current arrangements fail[90][91][92][93] - The COVID-19 pandemic poses risks of business disruption, affecting clinical trial recruitment and the ability to raise financing[87][195] Risks Relating to Our Business and Industry Risks Relating to Our Common Stock ITEM 1B. UNRESOLVED STAFF COMMENTS There are no unresolved staff comments from the SEC - No unresolved staff comments[165] ITEM 2. PROPERTIES BioVie Inc. leases its office space on a month-to-month basis from Acuitas Group Holdings, LLC, a related party, for $1,000 per month - The company leases its office space from a related party (Acuitas Group Holdings, LLC) on a month-to-month basis[166] Office Lease Details | Metric | Value | | :----- | :---- | | Lessor | Acuitas Group Holdings, LLC (related party) | | Lease Type | Month-to-month | | Monthly Payment | $1,000 | | Cancellation Notice | 30 days written notice | ITEM 3. LEGAL PROCEEDINGS The company is not a party to any material legal proceedings, except for the invalidation of its U.S. Patent No. 9,655,945 for 'Treatment of Ascites' in November 2019 - The company and its officers/directors are not parties to any material legal proceedings or litigation, except for the invalidated '945 Patent[167] - U.S. Patent No. 9,655,945 ('Treatment of Ascites') was determined not patentable by the PTAB on November 13, 2019, rendering it no longer valid or enforceable[168] ITEM 4. MINE SAFETY DISCLOSURES The company has no mine safety disclosures to report - No mine safety disclosures[169] PART II ITEM 5. MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES All unregistered sales of securities during the fiscal year ended June 30, 2020, were previously disclosed, with no issuer repurchases of common stock in the fourth quarter - All unregistered sales of securities for the year ended June 30, 2020, were previously disclosed[171] - No issuer repurchases of common stock occurred during the fourth quarter of the year ended June 30, 2020[171] ITEM 6. SELECTED FINANCIAL DATA Selected financial data is not required for this report - Selected financial data is not required[172] ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS BioVie Inc. is a clinical-stage biotechnology company focused on BIV201 for liver cirrhosis complications, facing substantial liquidity challenges with a significant net loss in FY2020 - BioVie is a clinical-stage biotechnology company developing BIV201 for life-threatening complications of liver cirrhosis, specifically ascites[174] - Key milestones in 2019 included announcing Phase 2a top-line results, meeting with the FDA for clinical study planning, inventing a novel liquid terlipressin formulation, and submitting a proposed Phase 2b/3 trial protocol[175][176][177] - Key milestones in 2020 included receiving FDA feedback on trial design, submitting a revised Phase 2 design, filing patent applications for liquid terlipressin formulations, confirming 6-month room temperature stability for prefilled syringes, and planning a randomized 24-patient Phase 2 study followed by a pivotal Phase 3 trial[179][180][181][182][183] Financial Performance Summary (FY2020 vs. FY2019) | Metric | FY2020 (approx.) | FY2019 (approx.) | Change (approx.) | Primary Driver of Change | | :----- | :--------------- | :--------------- | :--------------- | :----------------------- | | Net Loss | $16.7 million | $2.4 million | +$14.3 million | Change in fair value of derivative liabilities ($9.2M) and interest expense ($4.8M) | | Total Operating Expenses | $2.7 million | $2.5 million | +$0.2 million | Comparable | | R&D Expenses | $1.2 million | $1.0 million | +$0.14 million | Readying for Phase 2/3 trials, manufacturing prefilled syringe, offset by lower trial expenses | | SG&A Expenses | $1.3 million | $1.3 million | Comparable | Decrease in legal/professional fees offset by increased insurance, payroll, and capital raise related expenses | - As of June 30, 2020, the company had approximately $37,000 in cash and an accumulated deficit of $41.0 million, raising substantial doubt about its ability to continue as a going concern without additional financing[189][190][327] Overview Results of Operations Capital Resources and Liquidity Off-Balance Sheet Arrangements Critical Accounting Policies and Estimates Recent Accounting Pronouncements ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK This item is not applicable to the company - This section is not applicable[204] ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The financial statements and supplementary data are incorporated by reference from Item 15 of this report - Financial information is indexed under Item 15 and incorporated by reference[205] ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE This item is not required for the company - This section is not required[205] ITEM 9A. CONTROLS AND PROCEDURES Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of June 30, 2020, with no material changes reported - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2020[207] - Management concluded that internal control over financial reporting was effective as of June 30, 2020, based on the COSO 2013 Framework[208] - No material changes in internal controls over financial reporting occurred during the fourth quarter of the fiscal year ended June 30, 2020[209] ITEM 9B. OTHER INFORMATION There is no other information to report under this item - No other information to report[209] PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE BioVie's Board of Directors and executive officers include key management and independent directors, supported by established committees and a code of conduct and ethics Board of Directors and Executive Officers (as of 10-K filing date) | Name | Age | Position | | :--- | :-- | :------- | | Terren Peizer | 61 | Chairman of the Board & Chief Executive Officer | | Jonathan Adams | 57 | President & Chief Operating Officer | | Joanne Wendy Kim | 65 | Chief Financial Officer and Corporate Secretary | | Penelope Markham, PhD | 54 | Chief Scientific Officer | | Jim Lang | 55 | Independent Director | | Cuong Do | 54 | Independent Director | | Michael Sherman | 61 | Independent Director | | Richard J. Berman | 76 | Independent Director | | Steve Gorlin | 83 | Independent Director | | Robert Hariri, MD, PhD | 61 | Independent Director | | Sigmund Rogich | 71 | Independent Director | - The company has established three standing committees: an audit committee, a compensation committee, and a nominating and corporate governance committee, all composed solely of independent directors[239] - A code of conduct and ethics has been adopted, designed to deter wrongdoing, promote ethical conduct, ensure accurate disclosures, and comply with applicable laws[250] Board of Directors and Executive Officers Committees of the Board of Directors Code of Ethics ITEM 11. EXECUTIVE COMPENSATION Executive compensation for FY2020 included salaries and stock awards, with directors receiving stock options and common share grants, and the company adopting an Omnibus Equity Incentive Plan Summary Compensation Table (FY2020 vs. FY2019) | Name and Principal Position | Year | Salary | Stock Awards | Option Awards | Total | | :-------------------------- | :--- | :----- | :----------- | :------------ | :---- | | Terren Peizer, CEO & Chairman | 2020 | $— | $5,600 | $— | $5,600 | | | 2019 | $— | $7,000 | $— | $7,000 | | Jonathan Adams, President & COO | 2020 | $250,000 | $5,600 | $1,368 | $256,968 | | | 2019 | $250,000 | $7,000 | $11,789 | $268,789 | - Directors receive stock options and common share grants as remuneration for their service, with 800 stock options and 1,600 common shares granted annually per director[256] - The 2019 Omnibus Equity Incentive Plan was adopted, allowing for grants of stock options, restricted/unrestricted stock, and other stock-based awards, with up to 253,163 shares of common stock available for new awards[258] Summary Compensation Table Employment Agreements Compensation of Directors Long-Term Incentive Plans and Awards 2019 Omnibus Equity Incentive Plan ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS As of August 3, 2020, Terren Peizer, through Acuitas Group Holdings, LLC, is the largest beneficial owner with 85.8% of common stock, indicating significant insider control Beneficial Ownership (as of August 3, 2020) | Name and Address of Beneficial Owner | Number of Common Shares of Beneficial Ownership | Percentage of Beneficial Ownership | | :----------------------------------- | :---------------------------------------------- | :--------------------------------- | | Terren Peizer (via Acuitas Group Holdings, LLC) | 5,712,206 | 85.8% | | Jonathan Adams | 97,037 | 1.9% | | Joanne Wendy Kim | 1,600 | * | | Penelope Markham, PhD | 13,893 | * | | Cuong Do | 170,707 | 3.2% | | James Lang | 47,032 | 1.0% | | Michael Sherman | 36,685 | * | | Richard J. Berman | 2,400 | * | | All directors and executive officers as a group (eight persons) | 11,441,292 | 92.9% | - Terren Peizer, through Acuitas Group Holdings, LLC, is the controlling stockholder[267] - The high concentration of ownership by directors and executive officers could delay, defer, or prevent a change in control[139] ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE The company has engaged in significant related party transactions, primarily with Acuitas Group Holdings, LLC, involving equity purchases, convertible debentures, and multiple agreement amendments - In July 2018, Acuitas Group Holdings, LLC (controlled by CEO Terren Peizer) and other purchasers acquired 2,133,332 shares of Series A Convertible Preferred Stock and warrants for 1,706,666 common shares for $3.2 million[275][365] - In September 2019, Acuitas agreed to purchase a $2.0 million 10% OID Convertible Delayed Draw Debenture and received 1,125,000 commitment shares and warrants[281][369] - The issuance of commitment shares and warrants for the bridge financing was accounted for as a deemed dividend of $17.1 million due to its related party nature, recorded in accumulated deficit[282][372] - Multiple amendments to the purchase agreements and debenture terms have occurred, including cashless exercises of warrants, waivers of price adjustments, and modifications to share issuances to Acuitas, often tied to potential public offerings or capital raises[278][280][285][286][287][368][370][374][376][377] Debenture Draws and Interest (FY2020) | Metric | Amount (approx.) | | :----- | :--------------- | | Total draws under Debenture (FY2020) | $1.3 million | | Total interest expense related to Debenture draws (FY2020) | $99,000 | | Accrued interest paid via common stock issuance (Jan 2020) | $13,487 (4,422 shares) | | Total draws outstanding (as of Aug 3, 2020) | $1,433,000 | Equity Transactions with Acuitas Convertible Debenture Transaction with Acuitas ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES The company incurred $130,000 in audit fees for the fiscal year ended June 30, 2020, an increase from the prior year, with no other reported fees Auditor Fees (FY2020 vs. FY2019) | Fee Type | FY2020 | FY2019 | | :------- | :----- | :----- | | Audit Fees | $130,000 | $63,000 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | Total | $130,000 | $63,000 | - Audit fees increased from $63,000 in FY2019 to $130,000 in FY2020[290] PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES This section lists the financial statements and a comprehensive catalog of exhibits filed as part of the 10-K report, including key corporate and securities documents - Financial statements are listed on page F-1 and filed as part of this report[292] - Exhibits include key corporate documents such as the Agreement and Plan of Merger, Articles of Incorporation, Bylaws, Securities Purchase Agreements, Employment Agreements, and the 2019 Omnibus Equity Incentive Plan[293][294] Signatures Report Signatures The report was duly signed on behalf of BioVie Inc. by its Chief Executive Officer, Chief Financial Officer, President and Chief Operating Officer, and all Directors on August 6, 2020 - The report was signed by the Chief Executive Officer, Chief Financial Officer, President and Chief Operating Officer, and all Directors on August 6, 2020[296][297] Index to Financial Statements Financial Statement Listing This section provides an index to the financial statements, including the Report of Independent Registered Public Accounting Firm, Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity (Deficit), Statements of Cash Flows, and Notes to Financial Statements - The index lists the Report of Independent Registered Public Accounting Firm, Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity (Deficit), Statements of Cash Flows, and Notes to Financial Statements[299][300] Report of Independent Registered Public Accounting Firm Auditor's Opinion and Going Concern EisnerAmper LLP issued an unqualified opinion on BioVie Inc.'s financial statements but highlighted a 'going concern' uncertainty due to recurring losses and negative operating cash flows - EisnerAmper LLP issued an unqualified opinion on the financial statements for June 30, 2020 and 2019[302] - The auditors noted a 'going concern' uncertainty due to recurring losses from operations and negative cash flows, raising substantial doubt about the company's ability to continue[303] - The audit did not include an opinion on the effectiveness of the company's internal control over financial reporting[305] Financial Statements Balance Sheets The balance sheets show a decrease in total assets from $2.57 million in FY2019 to $2.08 million in FY2020, driven by a surge in derivative liabilities and a substantial accumulated deficit Balance Sheet Summary (as of June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Cash | $37,195 | $339,923 | | Total Current Assets | $412,980 | $674,073 | | Intangible Assets, net | $1,325,226 | $1,554,603 | | Goodwill | $345,711 | $345,711 | | Total Assets | $2,083,917 | $2,574,387 | | Accounts Payable and Accrued Expenses | $1,259,206 | $443,480 | | Derivative Liability - Warrants | $16,411,504 | — | | Derivative Liability - Conversion Option on Convertible Debenture | $5,000,800 | — | | Convertible Debenture - Related Party, net | $848,543 | — | | Total Current Liabilities | $23,520,053 | $443,480 | | Total Liabilities | $23,582,553 | $443,480 | | Additional Paid in Capital | $19,538,742 | $9,392,573 | | Accumulated Deficit | $(41,037,898) | $(7,262,072) | | Total Stockholders' (Deficit) Equity | $(21,498,636) | $2,130,907 | - Cash decreased significantly from $339,923 in 2019 to $37,195 in 2020[309] - The company reported substantial derivative liabilities in 2020, totaling over $21 million, which were not present in 2019[309] Statements of Operations BioVie Inc. reported a net loss of $16.68 million for FY2020, a substantial increase from $2.44 million in the prior year, primarily due to derivative liabilities and interest expense Statements of Operations Summary (Year Ended June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Amortization | $229,377 | $229,377 | | Research and Development Expenses | $1,150,581 | $1,008,100 | | Selling, General and Administrative Expenses | $1,312,930 | $1,259,096 | | Total Operating Expenses | $2,692,888 | $2,496,573 | | Loss From Operations | $(2,692,888) | $(2,496,573) | | Change in Fair Value of Derivative Liabilities | $9,211,686 | — | | Gain on Settlement of Debt | — | $(51,400) | | Interest Expense | $4,772,429 | $273 | | Total Other Expense (Income), Net | $13,983,881 | $(52,286) | | Net Loss | $(16,676,768) | $(2,444,287) | | Deemed Dividends for Commitment Shares and Ratchet Adjustments | $17,099,058 | $48,659 | | Net Loss Attributable to Common Stockholders | $(33,775,826) | $(2,492,946) | | Net Loss Per Common Share - Basic | $(6.85) | $(0.98) | | Weighted Average Number of Common Shares Outstanding - Basic | 4,929,497 | 2,539,611 | - Net loss increased significantly from $2.44 million in 2019 to $16.68 million in 2020, primarily due to derivative liabilities and interest expense[314] - Research and development expenses increased by approximately $142,000, while selling, general, and administrative expenses remained comparable year-over-year[187][188][314] Statements of Changes in Stockholders' Equity (Deficit) The statements of changes in stockholders' equity show a shift from positive equity in FY2019 to a significant deficit in FY2020, driven by net loss and deemed dividends Stockholders' Equity (Deficit) Summary (Year Ended June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Common Stock Shares | 5,204,392 | 4,058,724 | | Common Stock Amount | $520 | $406 | | Additional Paid in Capital | $19,538,742 | $9,392,573 | | Accumulated Deficit | $(41,037,898) | $(7,262,072) | | Total Stockholders' Equity/(Deficit) | $(21,498,636) | $2,130,907 | | Net Loss | $(16,676,768) | $(2,444,287) | | Deemed Dividends for Commitment Shares | $17,099,058 | — | | Issuance of Commitment Shares | 1,125,000 shares | — | | Issuance of Shares in Exchange for Debt Settlement | — | 7,804 shares | | Cashless Exercise of Warrants | — | 1,544,746 shares | - The accumulated deficit increased from $7.26 million in 2019 to $41.04 million in 2020[318] - A significant deemed dividend of $17.10 million related to commitment shares contributed to the increase in accumulated deficit in 2020[318] Statements of Cash Flows For FY2020, BioVie Inc. experienced a net decrease in cash of $302,728, with operating activities using $1.63 million and financing activities providing $1.33 million Statements of Cash Flows Summary (Year Ended June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Net Loss | $(16,676,768) | $(2,444,287) | | Net Cash Used in Operating Activities | $(1,628,228) | $(2,501,577) | | Net Cash Provided by Financing Activities | $1,325,500 | $2,795,700 | | Net (Decrease) Increase in Cash | $(302,728) | $294,123 | | Cash, End of Period | $37,195 | $339,923 | | Proceeds from Convertible Debenture - Related Party | $1,263,000 | — | | Proceeds from Loan Payable | $62,500 | — | | Proceeds from Issuance of Preferred Shares | — | $3,040,000 | | Cash Paid for Interest | $3,093 | — | - Net cash used in operating activities decreased from $2.50 million in 2019 to $1.63 million in 2020[319] - Financing activities in 2020 were primarily supported by $1.26 million from a convertible debenture and $62,500 from a loan payable[319] Notes to Financial Statements Note 1. Background Information BioVie Inc. is a clinical-stage company developing BIV201 for ascites due to chronic liver cirrhosis, holding FDA Fast-Track and Orphan Drug designations, and effected a 125-for-1 reverse stock split in November 2019 - BioVie Inc. is a clinical-stage company developing BIV201 (continuous infusion terlipressin) for ascites due to chronic liver cirrhosis[320] - BIV201 has FDA Fast-Track status and Orphan Drug designation for ascites, potentially granting 7 years of market exclusivity[322] - The company is developing a patent-pending novel liquid formulation of terlipressin, which could provide up to 20 years of patent coverage[322] - A 125-for-1 reverse stock split was effected on November 22, 2019, in preparation for a potential NASDAQ listing[325] Note 2. Liquidity and Going Concern The company's recurring losses and accumulated deficit of approximately $41 million as of June 30, 2020, raise substantial doubt about its ability to continue as a going concern without additional financing - As of June 30, 2020, the company had an accumulated deficit of approximately $41 million and has not generated any revenues, raising substantial doubt about its ability to continue as a going concern[327] - Future viability is dependent on raising additional capital through equity sales, loans, or strategic transactions, with no assurance of success[329][330] - The COVID-19 pandemic may materially adversely affect the company's ability to raise funds if financial markets and the overall economy are impacted for an extended period[329] Note 3. Significant Accounting Policies The financial statements are prepared in accordance with GAAP, relying on management estimates for key areas, with R&D expenses expensed as incurred, and a $62,500 PPP loan received in May 2020 - Financial statements are prepared in accordance with GAAP, relying on management estimates for areas such as share-based compensation, derivatives, and income taxes[332][333] - Research and development expenses are expensed as incurred[338] - The company received a $62,500 loan under the Paycheck Protection Program (PPP) in May 2020, accounted for as debt, with forgiveness application pending[337] - Goodwill is tested annually for impairment, and long-lived assets are reviewed for impairment when circumstances indicate carrying amounts may not be recoverable[345][347] Note 4. Intangible Assets The company's intangible assets, primarily intellectual property acquired from LAT Pharma, Inc., are amortized over a 10-year useful life, with a net value of $1,325,226 as of June 30, 2020 Intangible Assets (as of June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Intellectual Property | $2,293,770 | $2,293,770 | | Less Accumulated Amortization | $(968,544) | $(739,167) | | Intellectual Property, Net | $1,325,226 | $1,554,603 | | Amortization Expense (annual) | $229,377 | $229,377 | - Intangible assets are amortized over an estimated useful life of 10 years[353] Note 5. Renegotiated Debt In July 2018, Geis-Hides Consulting LLC settled a $132,000 debt with the company for $65,000 cash and 2,080 common shares, resulting in a $51,400 gain on settlement - A debt of $132,000 owed to Geis-Hides Consulting LLC was settled for $65,000 cash and 2,080 common shares in July 2018[355] - This settlement resulted in a $51,400 gain on settlement of debt, recorded as other income for the year ended June 30, 2019[355] Note 6. Related Party Transactions BioVie has engaged in extensive related party transactions, primarily with Acuitas Group Holdings, LLC, involving debt settlements, equity purchases, and a convertible debenture, leading to significant deemed dividends - Debt settlements with related parties (Barrett Ehrlich, Elliot Ehrlich, Jonathan Adams) in 2018 resulted in significant gains recorded in additional paid-in capital[358][360][362] - In July 2018, Acuitas Group Holdings, LLC and other related parties purchased $3.2 million in Series A Convertible Preferred Stock and warrants[365] - In September 2019, Acuitas provided bridge financing of up to $2.0 million via a convertible debenture, leading to the issuance of 1,125,000 commitment shares and warrants[369] - The issuance of commitment shares and warrants to Acuitas was accounted for as a $17.1 million deemed dividend, recorded in accumulated deficit for FY2020[372] - Multiple amendments to the Acuitas agreements have occurred, modifying warrant terms, share issuances, and the debenture's draw schedule, often in anticipation of a public offering[368][374][376][377] Equity Transactions with Acuitas Convertible Debenture Transaction with Acuitas Note 7. Commitments and Contingencies BioVie's commitments include a related-party office lease, while a significant contingency is the invalidation of its '945 Patent, though Orphan Drug designations and pending liquid formulation patents remain unaffected - The company has a month-to-month office lease with Acuitas Group Holdings, LLC (a related party) for $1,000 per month[379] - U.S. Patent No. 9,655,945 ('Treatment of Ascites') was invalidated by the PTAB on November 13, 2019, rendering it no longer valid or enforceable[381] - The patent invalidation does not affect the company's Orphan Drug designations for ascites and hepatorenal syndrome, nor its pending patent application for liquid terlipressin formulations[382] - BioVie is obligated to pay low single-digit royalties on BIV201 net sales to LAT Pharma LLC members, PharmaIN Corporation, and The Barrett Edge, Inc., and up to $200,000 annually to the University of Padova for terlipressin products covered by specified patents[383][384][385] Note 8. Fair Value Measurements As of June 30, 2020, BioVie reported total derivative liabilities of $21.41 million, valued using the Black-Scholes-Merton model with Level 3 unobservable inputs Fair Value Measurements of Derivative Liabilities (as of June 30, 2020) | Derivative Liability | Level 3 Fair Value | | :------------------- | :----------------- | | Warrants | $16,411,504 | | Conversion Option on Convertible Debenture | $5,000,800 | | Total Derivatives | $21,412,304 | - Derivative liabilities are classified as Level 3, meaning they are valued using unobservable inputs[386] - The Black-Scholes-Merton model is used for valuation, incorporating assumptions such as stock price, exercise/conversion price, term, volatility, and risk-free interest rate[390] - Warrants are accounted for as derivative financial instruments due to anti-dilution provisions or strike price adjustments based on future events[388] Note 9. Equity Transactions BioVie's equity transactions include stock option grants, share issuances for cash, services, and debt settlement, and warrants subject to price adjustments due to down-round features Stock Option Activity (Year Ended June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Options Outstanding | 60,400 | 58,000 | | Options Granted | 10,400 | 16,800 | | Options Exercised or Forfeited | (8,000) | — | | Weighted Average Exercise Price | $11.06 | $12.50 | | Aggregate Intrinsic Value | $352,600 | $273,000 | | Stock-based Compensation Expense | $24,846 | $64,860 | - The company issued 1,526,094 common shares in June 2019 from a cashless exercise of warrants[406] - Warrants issued in 2017 and 2018 included down-round features, triggering reductions in exercise price and resulting in deemed dividends of $20,995 and $44,889, respectively[419][420][421][423] Warrant Activity (Year Ended June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Warrants Outstanding and Exercisable | 1,374,667 | 124,667 | | Warrants Granted | 1,250,000 | 1,713,333 | | Warrants Exercised | — | 1,626,859 | | Weighted Average Exercise Price | $7.72 | $45.00 | | Aggregate Intrinsic Value | $13,799,331 | $1,202,678 | Note 10. Income Taxes As of June 30, 2020, BioVie had net deferred tax assets of $1,737,206, primarily from tax loss carryforwards, but a full valuation allowance was recorded due to uncertainty of realization Deferred Tax Assets (as of June 30) | Metric | 2020 | 2019 | | :----- | :--- | :--- | | Tax Loss Carryforward | $2,100,816 | $1,424,714 | | Intangible Assets | $(371,063) | $(450,835) | | Stock Based Compensation | $7,453 | $18,809 | | Valuation Allowance | $(1,737,206) | $(992,688) | | Net Deferred Tax Assets | $— | $— | - A full valuation allowance of $1,737,206 was recorded against net deferred tax assets in 2020, as realization is not more likely than not[426] - The company had approximately $5.1 million in Net Operating Loss (NOL) carryforwards as of June 30, 2020[427] Note 11. Subsequent Events Subsequent to June 30, 2020, the company received additional draws totaling $170,000 under the convertible debenture, bringing the total outstanding draws to $1,433,000 as of August 3, 2020 - Additional draws of $170,000 were received under the debenture after June 30, 2020[429] - Total outstanding draws under the debenture amounted to $1,433,000 as of August 3, 2020[429]