BioVie(BIVI) - 2023 Q4 - Annual Report

PART I Business Overview BioVie Inc. is a clinical-stage biopharmaceutical company developing innovative drug therapies for neurological and neurodegenerative disorders and advanced liver disease, with lead candidates NE3107 and BIV201 in clinical development stages - BioVie Inc. is a clinical-stage company developing drug therapies for neurological/neurodegenerative disorders and liver disease[15][52][513] - NE3107, acquired from NeurMedix, is a novel orally administered small molecule believed to inhibit inflammation-driven insulin resistance and inflammatory cascades, implicated in Alzheimer's Disease (AD) and Parkinson's Disease (PD)[16][56][522] - BIV201 (continuous infusion terlipressin) is an Orphan Drug candidate with FDA Fast Track status, being evaluated for refractory ascites due to liver cirrhosis[59][104][524] Neurodegenerative Disease Program BioVie's neurodegenerative program focuses on NE3107 for Alzheimer's and Parkinson's diseases, with a Phase 3 AD study targeting Q4 2023 completion and a successful Phase 2 PD study showing motor control improvements - NE3107 inhibits inflammatory activation of ERK and NFkB, which are drivers of Alzheimer's disease (AD) and Parkinson's disease (PD)[53][81] - The Phase 3 study for NE3107 in mild to moderate AD (NCT04669028) is fully enrolled and targeting primary completion in Q4 2023[54][62][533] - The Phase 2 study of NE3107 in Parkinson's disease (NCT05083260) met its primary (safety and drug-drug interaction) and secondary (promotoric activity) objectives, showing greater motor control improvements in patients, especially those under 70[55][92][93][98][534] - Exploratory Phase 2 AD data showed NE3107 enhanced cognition, reduced inflammation (TNF-α), decreased CSF phospho-tau levels, and improved neuronal health, with no drug-related adverse events[37][63][64][65] Liver Disease Program BioVie's liver disease program centers on BIV201 for refractory ascites, a condition with no FDA-approved treatments, showing significant fluid reduction in a Phase 2b study and holding Orphan Drug and Fast Track designations - BIV201 (continuous infusion terlipressin) has FDA Fast Track status and Orphan Drug designation for refractory ascites due to liver cirrhosis, a condition with high mortality and no FDA-approved drugs[59][60][97][104][111][524] - Interim data from the Phase 2b study showed BIV201 plus SOC resulted in a 34% reduction in ascites fluid during treatment, significantly different from SOC only, with patients completing BIV201 treatment experiencing a 53% reduction[38][107] - The company is developing a proprietary room-temperature stable liquid formulation of terlipressin in a pre-filled syringe, offering improved convenience and potential for up to two years of stability, differentiating it from existing refrigerated products[110] - The BIV201 program aims to alleviate portal hypertension and correct splanchnic vasodilation to reduce salt and water retention, thereby halting ascites fluid generation[70] Intellectual Property BioVie protects its drug candidates BIV201 and NE3107 through patents, trade secrets, and non-disclosure agreements, with BIV201 holding Orphan Drug Designations and NE3107 protected by 15 issued U.S. patents - BioVie relies on patents, trade secrets, and non-disclosure agreements to protect its products[73][214] - BIV201 has U.S. Orphan Drug Designations for hepatorenal syndrome (Nov 2018) and ascites (Sept 2016)[74][164] - The company has filed a PCT application for BIV201's novel liquid formulations and is seeking patent protection in the U.S., Europe, China, Japan, and other jurisdictions[74][110][217] - As of August 15, 2023, NE3107 and related compounds are protected by 15 issued U.S. patents, 6 pending U.S. patent applications, 1 pending U.S. PCT application, and 6 issued foreign patents[76][217] Government Regulation BioVie's drug candidates are subject to extensive FDA regulation covering R&D, clinical trials, and approval, with BIV201 benefiting from expedited programs like Orphan Drug Designation and Fast Track status - Drug development is extensively regulated by the FDA in the U.S. and comparable foreign authorities, covering R&D, manufacturing, labeling, approval, and marketing[203][263][264] - The U.S. drug development process includes preclinical tests, IND application, three phases of human clinical trials (Phase 1, 2, 3), NDA/BLA submission, FDA inspection of manufacturing facilities, and review/approval[77][114][122][123][124][266] - BIV201 has received Orphan Drug Designation, which grants 7 years of market exclusivity upon first FDA approval for the designated rare disease, under specific conditions[136][137] - The FDA's Fast Track program, also granted to BIV201, expedites review for drugs treating serious conditions with unmet medical needs, potentially allowing rolling submissions[138] - Post-approval, products are subject to ongoing FDA regulation, including adverse event reporting, updated safety information, and compliance with cGMP for manufacturing[143][144] Employees BioVie Inc. has 18 full-time employees, including its executive officers, and supplements its product development activities with a team of experienced scientific, medical, and regulatory consultants - The Company has 18 full-time employees, including its CEO, CFO, and Chief Medical Officer[142] - BioVie relies on a team of highly experienced scientific, medical, and regulatory consultants for product development[142] Risk Factors BioVie faces significant risks as a development-stage biopharmaceutical company, including lack of approved products, continuous losses, dependence on successful clinical trials and regulatory approvals, need for additional capital, competition, reliance on third parties, and stock volatility - The company has no products approved for commercial sale, has not generated revenue, and may never achieve profitability, raising substantial doubt about its ability to continue as a going concern[150][151][155][168] - Significant additional capital will be required to fund operations, and there is no assurance that sufficient financing will be obtained on acceptable terms, which could force delays, reductions, or termination of R&D programs[167][170][172] - Drug development is a time-consuming and uncertain process; product candidates may fail clinical trials, not receive regulatory approval, or be less effective/more expensive than competitors, leading to potential cessation of operations[174][176][182][183][235][236] - Reliance on third parties (CROs, CMOs) for clinical trials and manufacturing poses risks, including failure to meet deadlines, non-compliance with regulations (cGCPs, cGMP), and potential supply shortages[185][186][189][193][194][196] - Future equity offerings or issuance of shares upon exercise of options/warrants could result in substantial dilution for existing stockholders[243][244][245][246][249] Unresolved Staff Comments The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[6] Properties BioVie Inc. maintains its headquarters in Carson City, Nevada, with an annual rent of $2,200, and a San Diego office under a 38-month lease with a monthly base rate of $4,175, subject to annual 3% increases - The company's headquarters in Carson City, NV, has an annual rent of $2,200 for a one-year term starting October 1, 2022[7][85][628] - The San Diego office relocated on February 26, 2022, with a 38-month lease commencing March 1, 2022, and a monthly base rate of $4,175 that began June 1, 2022, with annual 3% increases[7][85][315] Legal Proceedings To the company's knowledge, neither BioVie Inc. nor its officers or directors are party to any material legal proceedings or litigation, nor are there any judgments against them - Neither the Company nor its officers or directors are party to any material legal proceeding or litigation[8] - There are no judgments against the company or its officers/directors, and none have been convicted of securities-related felonies or misdemeanors[8] Mine Safety Disclosures BioVie Inc. has no mine safety disclosures to report - No mine safety disclosures are applicable to the company[9] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities All sales of unregistered securities during FY2023 were previously disclosed in Form 10-Q or 8-K reports, and the company made no repurchases of Common Stock during this period - All sales of unregistered securities during the year ended June 30, 2023, were previously disclosed in Quarterly Reports on Form 10-Q or Current Reports on Form 8-K[12] - There were no issuer repurchases of Common Stock during the year ended June 30, 2023[13] Reserved This item is reserved and contains no information - Item 6 is reserved[14] Management's Discussion and Analysis of Financial Condition and Results of Operations BioVie Inc. is a clinical-stage company with no current revenues, reporting a net loss of $50.3 million in FY2023 due to increased clinical activities, and faces substantial doubt about its going concern ability due to an accumulated deficit of $301 million and reliance on future financing - BioVie Inc. is a clinical-stage company developing drug therapies for neurological/neurodegenerative disorders and liver disease, with no revenues generated to date and none expected in the foreseeable future[15][45][513][538] Net Loss and Operating Expenses (Year Ended June 30) | Metric | 2023 (approx.) | 2022 (approx.) | Change (YoY) | | :----- | :------------- | :------------- | :----------- | | Net Loss | $(50.3) million | $(26.1) million | $(24.2) million increase | | Total Operating Expenses | $45.1 million | $27.3 million | $17.8 million increase | - The increase in net loss was primarily due to increased clinical activities ($16.0 million), administrative expenses ($1.8 million), and a $6.3 million increase in other expenses, mainly from a change in fair value of derivative liabilities ($4.7 million)[20][21][42] Capital Resources and Liquidity (as of June 30, 2023) | Metric | Amount (approx.) | | :----- | :--------------- | | Working Capital | $19.5 million | | Cash, Cash Equivalents & U.S. Treasury Bills | $33.9 million | | Stockholders' Equity | $15.3 million | | Accumulated Deficit | $(301) million | - The company sold approximately 7.5 million shares of Common Stock under its Controlled Equity Offering Sales Agreement for total net proceeds of approximately $49.5 million during FY2023[44][599] - Management expects future funding sources to include equity sales, loans, or strategic transactions, but there is no assurance of obtaining sufficient financing, raising substantial doubt about the company's ability to continue as a going concern[45][46][539][541] Results of Operations BioVie's FY2023 financial results show a net loss increase to $50.3 million from $26.1 million in FY2022, driven by a $17.8 million rise in operating expenses, primarily from R&D activities and a $6.4 million increase in other expenses Net Loss and Operating Expenses (Year Ended June 30) | Metric | 2023 (approx.) | 2022 (approx.) | Change (YoY) | | :----- | :------------- | :------------- | :----------- | | Net Loss | $(50.3) million | $(26.1) million | $(24.2) million increase | | Total Operating Expenses | $45.1 million | $27.3 million | $17.8 million increase | Expense Breakdown (Year Ended June 30) | Expense Category | 2023 (approx.) | 2022 (approx.) | Change (YoY) | | :--------------- | :------------- | :------------- | :----------- | | Research and Development | $33.3 million | $17.3 million | $16.0 million increase | | Selling, General and Administrative | $11.6 million | $9.8 million | $1.8 million increase | | Other Expense (Income), Net | $5.2 million | $(1.2) million | $6.4 million increase | - The $16.0 million increase in R&D expenses was mainly due to increased clinical activities for Neuroscience NE3107 studies, including the completion of the Parkinson's Phase 2 study and full enrollment of the Alzheimer's Phase 3 study[22][40] - The $1.8 million increase in SG&A expenses was primarily attributed to increased stock compensation expense for the board of directors, legal, investor relations, and other professional fees[41] - The $6.4 million increase in net other expenses was driven by a $2.1 million increase in interest expense and a $4.7 million change in the fair value of derivative liabilities, partially offset by increased interest income[42] Capital Resources and Liquidity As of June 30, 2023, BioVie reported $19.5 million in working capital and $33.9 million in cash, cash equivalents, and U.S. Treasury bills, but an accumulated deficit of $301 million, with future operations contingent on securing additional financing, raising substantial doubt about its going concern ability Capital Resources (as of June 30, 2023) | Metric | Amount (approx.) | | :----- | :--------------- | | Working Capital | $19.5 million | | Cash, Cash Equivalents & U.S. Treasury Bills | $33.9 million | | Stockholders' Equity | $15.3 million | | Accumulated Deficit | $(301) million | - The company has not generated any revenue and does not expect to in the foreseeable future, making future operations dependent on successful development and commercialization efforts, and securing additional financing[45][538] - During FY2023, BioVie sold approximately 7.5 million shares of Common Stock, generating $49.5 million in net proceeds[44][599] - Management's plans for future funding include equity sales, loans, or strategic transactions, but the uncertainty of obtaining sufficient financing raises substantial doubt about the company's ability to continue as a going concern[45][46][539][541] Recently Issued Accounting Pronouncement The company does not expect a material impact from the adoption of ASU No. 2016-13, which replaces the incurred loss impairment methodology with expected credit losses, with its effective date for smaller reporting companies deferred to fiscal years beginning after December 15, 2022 - ASU No. 2016-13, which replaces the incurred loss impairment methodology with expected credit losses, is not expected to have a material impact on the company's financial statements[47][552] - The effective date for smaller reporting companies for ASU 2016-13 was deferred for fiscal years beginning after December 15, 2022[47][552] Off-Balance Sheet Arrangements BioVie Inc. has no off-balance sheet arrangements that are material or reasonably likely to have a current or future significant effect on its financial condition, revenues, expenses, results of operations, liquidity, capital expenditures, or capital resources - The company has no off-balance sheet arrangements that are material or likely to significantly affect its financial condition or results[48] Critical Accounting Policies and Estimates BioVie's critical accounting policies involve significant management estimates for clinical accruals, share-based compensation, derivatives, leases, and intangible asset valuation, while monitoring credit risk in cash and accounting for U.S. Treasury Bills as available-for-sale investments at fair value - The preparation of financial statements requires management to make estimates and assumptions affecting reported amounts, including for clinical accruals, share-based compensation, derivatives, leases, and impairment of intangible assets and goodwill[526][550] - Cash and cash equivalents include cash deposits and money market funds, with investments in U.S. Treasury Bills (maturities of three months or less) also classified here[50][527] - Investments in U.S. Treasury Bills with maturities greater than three months are accounted for as available-for-sale and recorded at fair value, with unrealized gains included in other comprehensive income[39][528][646] - The company monitors the financial stability of institutions holding cash in excess of federally insured levels, acknowledging heightened uncertainties in financial markets could impact access to cash or financing[277][645] - Operating leases are recognized as right-of-use assets and lease liabilities based on the present value of future minimum lease payments, using an incremental borrowing rate[530][638] - Fair values of financial instruments are determined using a hierarchy (Level 1, 2, 3) that prioritizes observable inputs[278][570][571][572][639][649][650] Quantitative and Qualitative Disclosures About Market Risk BioVie Inc. has no material market risk disclosures to report - No quantitative and qualitative disclosures about market risk are applicable[658] 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[659] Changes in and Disagreements with Accountants on Accounting and Financial Disclosure BioVie Inc. has no changes in or disagreements with accountants on accounting and financial disclosure to report - No changes in or disagreements with accountants on accounting and financial disclosures are applicable[659] Controls and Procedures BioVie's management, including the CEO and CFO, concluded that both disclosure controls and internal control over financial reporting were effective as of June 30, 2023, based on the COSO 2013 Framework, with no material changes during the quarter - Management concluded that disclosure controls and procedures were effective as of June 30, 2023[651] - Management concluded that internal control over financial reporting was effective as of June 30, 2023, based on the COSO 2013 Framework[660] - There were no material changes in internal controls over financial reporting during the quarter ended June 30, 2023[661] Other Information BioVie Inc. has no other information to report under this item - No other information is applicable[662] Disclosure Regarding Foreign Jurisdictions that Prevent Inspections BioVie Inc. has no disclosures regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections are applicable[368] PART III Directors, Executive Officers and Corporate Governance BioVie Inc.'s Board of Directors comprises seven members, with six independent, and has established Audit, Compensation, and Nominating and Corporate Governance committees, all composed of independent directors, while also adopting a Code of Conduct and Ethics and an anti-hedging policy Board of Directors and Executive Officers (as of August 9, 2023) | Name | Age | Director Since | Position | | :--- | :-- | :------------- | :------- | | Cuong Do | 57 | 2016 | CEO & President and Director | | Joanne Wendy Kim | 68 | — | CFO | | Joseph M. Palumbo, MD | 63 | — | Chief Medical Officer | | Jim Lang | 58 | 2016 | Chairman of the Board | | Michael Sherman | 64 | 2017 | Director | | Richard J. Berman | 81 | 2019 | Director | | Steve Gorlin | 86 | 2020 | Director | | Robert Hariri, MD, PhD | 64 | 2020 | Director | | Sigmund Rogich | 79 | 2020 | Director | - Six of the seven Board members qualify as 'independent' under Nasdaq listing standards[396] - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, all composed solely of independent directors[388] - The company has adopted a Code of Conduct and Ethics and an insider trading policy that includes anti-hedging provisions[410][411][415] Executive Compensation Executive compensation for BioVie's named executive officers includes salary, bonus, and equity awards, with CEO Cuong Do's total compensation at $2.34 million in FY2023, and director compensation primarily consisting of equity awards under the 2019 Omnibus Equity Incentive Plan Summary Compensation Table (Year Ended June 30) | Name and Principal Position | Year | Salary | Bonus | Stock Awards | Option Awards | Total | | :-------------------------- | :--- | :----- | :---- | :----------- | :------------ | :---- | | Cuong Do, CEO & President | 2023 | $618,000 | $463,500 | $734,668 | $521,500 | $2,337,668 | | | 2022 | $300,000 | $400,000 | $210,439 | $3,632,382 | $4,542,821 | | Joanne Wendy Kim, CFO | 2023 | $246,750 | $150,625 | $242,499 | $582,343 | $723,874 | | | 2022 | $235,000 | $127,656 | — | $84,000 | $944,999 | | Joseph Palumbo, CMO | 2023 | $525,000 | $197,000 | $242,499 | $126,000 | $1,090,499 | | | 2022 | $333,333 | $239,167 | — | $244,465 | $816,965 | Compensation Actually Paid (CAP) vs. Summary Compensation Table (SCT) Total (Year Ended June 30) | Metric | 2023 | 2022 | | :----- | :--- | :--- | | SCT Total for PEO | $2,337,668 | $4,542,821 | | Compensation Actually Paid to PEO | $3,434,517 | $916,050 | | Average SCT Total for Non-PEO NEOs | $1,185,289 | $605,653 | | Average Compensation Actually Paid to Non-PEO NEOs | $1,185,289 | $605,653 | - As of June 30, 2023, named executive officers held stock options to purchase 1,371,729 shares (aggregate grant date fair value of ~$5.4 million) and 351,386 RSUs (market value of ~$1.5 million)[427] - Non-employee directors received compensation primarily in the form of equity awards, with FY2023 annual compensation including 155,636 RSUs (grant date market value $952,492) or stock options for 195,000 shares (grant date fair value $791,700)[431] Equity Compensation Plan Information (as of June 30, 2023) | Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance | | :------------ | :---------------------------------------------------------------------------------------- | :---------------------------------------------------------- | :----------------------------------------------------------- | | Approved by security holders | 4,530,121 | $6.71 | 2,269,952 | | Not approved by security holders | — | — | — | | Total | 4,530,121 | $6.71 | 2,269,952 | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters As of August 9, 2023, Acuitas Group Holdings, LLC, owned 69.1% of BioVie's common stock, making it the majority stockholder, with directors and executive officers as a group owning 4.8%, a concentration that could significantly influence company affairs Beneficial Ownership (as of August 9, 2023) | Name and Address of Beneficial Owner | Beneficial Ownership | Percentage of Beneficial Ownership | | :----------------------------------- | :------------------- | :------------------------------- | | Acuitas Group Holdings | 30,503,938 | 69.1% | | All directors and executive officers as a group | 1,784,243 | 4.8% | - Acuitas Group Holdings, LLC, 100% owned by Terren Peizer, is the majority stockholder, holding 69.1% of outstanding common stock[346][455] - The concentration of ownership by directors, executive officers, and affiliates (64.0% as of August 9, 2023) could significantly influence company management and stockholder approval matters[248][251] Certain Relationships and Related Transactions, and Director Independence BioVie Inc. engages in related party transactions, including a Securities Purchase Agreement with majority stockholder Acuitas Group Holdings, LLC, for common stock and warrants, with all such transactions subject to review and approval by the audit committee or Board of Directors - The company entered into a Securities Purchase Agreement with Acuitas Group Holdings, LLC (a related party and majority stockholder) on July 15, 2022[467][582] - Under this agreement, Acuitas purchased 3,636,364 shares of Class A Common Stock at $1.65 per share and warrants to purchase 7,272,728 shares at an exercise price of $1.82, for an aggregate purchase price of $6 million[467][582] - All related party transactions are approved by either the audit committee or the Board of Directors, with policies and procedures in place to ensure proper review[458][474] Principal Accountant Fees and Services For FY2023 and FY2022, BioVie Inc. incurred $317,772 and $223,102 in audit fees, respectively, from its independent registered public accounting firm, with the Audit Committee responsible for appointing and overseeing auditors and pre-approving all services Principal Accountant Fees (Year Ended June 30) | Fee Category | 2023 | 2022 | | :----------- | :--- | :--- | | Audit Fees | $317,772 | $223,102 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | Total | $317,772 | $223,102 | - The Audit Committee is responsible for appointing, setting compensation, and overseeing the work of the independent registered public accounting firm[469] - The Audit Committee has a policy to pre-approve all audit and permissible non-audit services, with delegation authority to one or more members[469][478][479] PART IV Exhibits and Financial Statement Schedules This section lists all exhibits and financial statement schedules, including audited financial statements for FY2023 and FY2022 by EisnerAmper LLP, which present the company's financial position, operations, equity changes, and cash flows in accordance with GAAP, while also highlighting a going concern uncertainty - The financial statements for the years ended June 30, 2023 and 2022 are filed as part of this report[489] - EisnerAmper LLP served as the independent registered public accounting firm and issued an unqualified opinion on the financial statements[486][504][517] - The financial statements were prepared assuming the company will continue as a going concern, but recurring losses and negative cash flows raise substantial doubt about this ability[514][538][541] Financial Statements The financial statements, including Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, reflect a net loss of $50.3 million in FY2023 and an accumulated deficit of $301 million, detailing assets, liabilities, equity, critical accounting policies, and related party transactions - The financial statements include Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Changes in Stockholders' Equity, Statements of Cash Flows, and Notes to Financial Statements[484] Balance Sheet Highlights (as of June 30) | Metric | 2023 | 2022 | | :----- | :--- | :--- | | Total Assets | $35,104,730 | $20,114,594 | | Total Liabilities | $19,764,444 | $16,443,659 | | Total Stockholders' Equity | $15,340,286 | $3,670,935 | Statements of Operations and Comprehensive Loss Highlights (Year Ended June 30) | Metric | 2023 | 2022 | | :----- | :--- | :--- | | Net Loss | $(50,255,815) | $(26,084,468) | | Basic Net Loss Per Common Share | $(1.55) | $(1.06) | | Diluted Net Loss Per Common Share | $(1.55) | $(1.06) | | Weighted Average Common Shares Outstanding (Basic & Diluted) | 32,483,489 | 24,662,557 | Statements of Cash Flows Highlights (Year Ended June 30) | Cash Flow Activity | 2023 | 2022 | | :----------------- | :--- | :--- | | Net cash used in operating activities | $(40,252,881) | $(18,990,850) | | Net cash used in investing activities | $(14,301,135) | — | | Net cash provided by financing activities | $55,373,183 | $33,120,924 | | Net increase in cash and cash equivalents | $819,167 | $14,130,074 | - The company's accumulated deficit increased to approximately $301 million as of June 30, 2023[43][506][538]