UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

Form 10-Q

(Mark One) 

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: December 31, 2019

☐

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: 001-39015

BIOVIE INC.

(Exact name of registrant as specified in its charter)

Nevada		46-2510769
(State or other jurisdiction of  incorporation or organization)		(I.R.S. Empl. Ident. No.)

 

2120 Colorado Avenue Suite 230

Santa Monica, CA 90404

(Address of principal executive offices, Zip Code)

(310)-444-4300

(Registrant's telephone number, including area code)

(Former Name, Former Address and Former Fiscal Year if Changed Since Last Report)

   

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes ☒                                          No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

 

Yes ☒                                          No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

  

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes ☐                                          No ☒

 

There were 5,194,924 shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of February 5, 2020.

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

Item 1.	Financial Statements	1
	Condensed Balance Sheets at December 31, 2019 (unaudited) and June 30, 2019	1
	Condensed Statements of Operations (unaudited) - for the three months and six months ended December 31, 2019 and 2018	2
	Condensed Statements of Cash Flows (unaudited) - for the six months ended December 31, 2019 and 2018	3
	Condensed Statements of Changes in Stockholders’ (Deficit) Equity (unaudited) - for the periods July 1, 2018 through December 31, 2018 and July 1, 2019 through December 31, 2019	4
	Notes to Unaudited Condensed Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	20
Item 4.	Controls and Procedures	20

 

PART II – OTHER INFORMATION

 

Item 1.	Legal Proceedings	21
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3.	Defaults Upon Senior Securities	21
Item 4.	Mine Safety Disclosures	21
Item 5.	Other Information	21
Item 6.	Exhibits	22
SIGNATURES		23

 

FORWARD-LOOKING STATEMENTS

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

 

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

 

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. When used in this report, the terms “BioVie”, “Company”, “we”, “our”, and “us” refer to BioVie Inc.

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioVie Inc.

Condensed Balance Sheets

 

		December 31,				June 30,
		2019				2019
ASSETS		(Unaudited)
CURRENT ASSETS:
Cash		$	3,108			$	339,923
Other assets			550,810				334,150
Total current assets			553,918				674,073
OTHER  ASSETS:
Intangible assets, net			1,439,915				1,554,603
Goodwill			345,711				345,711
Total other assets			1,785,626				1,900,314
TOTAL ASSETS		$	2,339,544			$	2,574,387
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses		$	1,085,177			$	443,480
Derivative liability - warrants			2,674,000				—
Derivative liability - conversion option on convertible debenture			573,200				—
Loan payable - related party			30,000
Convertible debenture - related party, net of discount $478,405 and $0 at December 31, 2019 and 2018, respectively			21,595				—
Total current liabilities			4,383,972				443,480
Commitments and contingencies (Note 8)
STOCKHOLDERS' (DEFICIT) EQUITY
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding			—				—
Common stock, $0.0001 par value; 800,000,000 shares authorized at December 31, 2019 and June 30, 2019, respectively; 5,183,724 and 4,058,724 shares issued and outstanding at December 31, 2019 and June 30, 2019, respectively			518				406
Additional paid in capital			19,472,373				9,392,573
Accumulated deficit			(21,517,319	)			(7,262,072	)
Total stockholders' (deficit) equity			(2,044,428	)			2,130,907
TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY		$	2,339,544			$	2,574,387

 

See accompanying notes to unaudited condensed financial statements

 

BioVie Inc.

Condensed Statements of Operations

(Unaudited)

 

		Three Months Ended				Three Months Ended				Six Months Ended				Six Months Ended
		December 31 2019				December 31, 2018				December 31 2019				December 31 2018
OPERATING EXPENSES:
Amortization			57,344			$	57,344				114,689			$	114,689
Research and development expenses			346,514				206,019				688,015				400,540
Selling, general and administrative expenses			306,589				237,507				613,961				477,069
TOTAL OPERATING EXPENSES			710,447				500,870				1,416,665				992,298
LOSS FROM OPERATIONS			(710,447	)			(500,870	)			(1,416,665	)			(992,298	)
OTHER (INCOME) EXPENSE :
Change in fair value of derivative liabilities			(7,396,192	)			—				(7,758,778	)			—
Gain on settlement of debt			—				—				—				(51,400	)
Interest expense			20,920				—				3,498,535				271
Interest income			(213	)			(360	)			(233	)			(788	)
TOTAL OTHER (INCOME) EXPENSE, NET			(7,375,485	)			(360	)			(4,260,476	)			(51,917	)
NET INCOME (LOSS)		$	6,665,038			$	(500,510	)		$	2,843,811			$	(940,381	)
Deemed dividends for commitment shares and rachet adjustments			—				—				17,099,058				48,659
NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS		$	6,665,038			$	(500,510	)		$	(14,255,247	)		$	(989,040	)
NET INCOME (LOSS) PER COMMON SHARE
- Basic		$	1.29			$	(0.20	)		$	(3.06	)		$	(0.40	)
- Diluted		$	1.29			$	(0.20	)		$	(3.06	)		$	(0.40	)
WEIGHTED AVERAGE NUMBER OF COMMON  SHARES OUTSTANDING
- Basic			5,183,724				2,520,429				4,661,183				2,497,457
- Diluted			5,183,724				2,520,429				4,661,183				2,497,457

See accompanying notes to unaudited condensed financial statements

BioVie Inc.

Condensed Statements of Cash Flows

(Unaudited)

		Six Months Ended				Six Months Ended
		December 31, 2019				December 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)		$	2,843,811			$	(940,381	)
Adjustments to reconcile net loss to net cash to cash used in operating activities:
Amortization of intangible assets			114,689				114,689
Stock based compensation expense			11,162				19,697
Gain on settlement of debt			—				51,400
Interest expense from convertible debenture			3,497,264				—
Change in fair value of derivative liabilities			(7,758,778	)			—
Changes in operating assets and liabilities
Other assets			(216,660	)			—
Accounts payable and accrued expenses			641,697				(456,422	)
Net cash used in operating activities			(866,815	)			(1,211,017	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of debt			—				(244,300	)
Proceeds from issuance of preferred shares			—				3,040,000
Proceeds from loan payable - related party			30,000
Proceeds from convertible debenture - related party			500,000				—
Net cash provided by financing activities			530,000				2,795,700
Net (decrease) increase in cash			(336,815	)			1,584,683
Cash, beginning of period			339,923				45,800
Cash, end of period		$	3,108			$	1,630,483
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest		$	1,272			$	—
Cash paid for taxes		$	—			$	—
SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
Conversion of preferred shares to common stock		$	—			$	3,200,000
Settlement of debt by issuance of common stock and forgiveness of debt		$	—			$	1,150,135
Cashless exercise of warrants		$	—			$	224
Deemed dividends for ratchet adjustments to warrants		$	—			$	48,659
Deemed dividends for commitment shares		$	17,099,058				—
Stock warrants classified as derivative liability		$	7,530,308				—

See accompanying notes to unaudited condensed financial statements

BioVie Inc.

Condensed Statements of Changes in Stockholders’ (Deficit) Equity

For the periods July 1, 2018 through December 31, 2018 and July 1, 2019 through December 31, 2019

(Unaudited)

																										Total
																		Additional								Stockholders’
		Preferred Stock								Common Stock								Paid in				Accumulated				Equity
		Shares				Amount				Shares				Amount				Capital				Deficit				(Deficit)
Balance, June 30, 2018			—			$	—				788,026			$	79			$	4,880,246			$	(4,769,126	)		$	111,199
Issuance of preferred stock in a private placement			2,133,332				3,200,000				—				—				3,200,000				—				3,200,000
Conversion of preferred stock to common stock			(2,133,332	)			(3,200,000	)			1,706,666				171				(171	)			—				—
Issuance of shares in exchange for debt settlement			—				—				7,804				1				1,150,134				—				1,150,135
Stock option compensation			—				—				—				—				3,412				—				3,412
Cashless exercise of warrants			—				—				17,935				2				(2	)			—				—
Deemed dividends for ratchet adjustment to warrants			—				—				—				—				48,659				(48,659	)			—
Net loss for the three months ended September 30, 2018			—				—				—				—				—				(439,871	)			(439,871	)
Balance, September 30, 2018			—				—				2,520,431				253				9,282,278				(5,257,656	)			4,024,875
Stock option compensation			—				—				—				—				16,285				—				16,285
Net loss for the three months ended December 31, 2018			—				—				—				—				—				(500,510	)			(500,510	)
Balance, December 31, 2018			—			$	—				2,520,431			$	253			$	9,298,563			$	(5,758,166	)		$	3,540,650
Balance June 30, 2019			—			$	—				4,058,724				406				9,392,573			$	(7,262,072	)		$	2,130,907
Issuance of commitment shares			—				—				1,125,000				112				10,068,638				—				10,068,750
Deemed dividend for commitment shares			—				—				—				—				—				(17,099,058	)			(17,099,058	)
Net loss for the three months ended September 30, 2019			—				—				—				—				—				(3,821,227	)			(3,821,227	)
Balance, September 30, 2019			—				—				5,183,724				518				19,461,211				(28,182,357	)			(8,720,628	)
Stock option compensation			—				—				—				—				11,162				—			$	11,162
Net income for the three months ended December 31, 2019			—				—				—				—				—				6,665,038				6,665,038
Balance, December 31, 2019			—			$	—				5,183,724			$	518			$	19,472,373			$	(21,517,319	)		$	(2,044,428	)

See accompanying notes to unaudited condensed financial statements

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

1.	Background Information

 

BioVie Inc. (the “Company”) is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. We are currently focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites due to chronic liver cirrhosis. Our therapy BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the United States. BIV201’s active agent is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world. The goal is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

BioVie began administering BIV201 to patients in a Phase 2a clinical trial in patients with refractory ascites due to advanced liver cirrhosis at the McGuire Research Institute Inc. in Richmond, VA in September 2017. In April 2019, we announced top-line results and in June met with representatives of the FDA for a Type C Guidance Meeting to discuss the study results and plan our next clinical study. In July 2019, the FDA provided meeting minutes that documented general agreement with the Company’s proposed randomized and controlled study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints, quality of life measures and other key aspects of the clinical trial design. In October 2019, BioVie announced the submission of a Phase 2b/3 clinical trial protocol to the FDA. We are developing a patent-pending novel liquid formulation of terlipressin for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation errors that may occur when pharmacists reconstitute the powder version.

BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. It has FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). The FDA has never approved any drug specifically for treating ascites. In addition, the Company has a pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues according to the patent laws of the issuing country.

The BIV201 development program began at LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently owns all development and marketing rights to its drug candidate. The Company and PharmaIN, Corp. (“PharmaIN”), LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp.’s rights to our program remain unchanged.

The Company’s activities are subject to significant risks and uncertainties including failure to secure additional funding to properly execute the Company’s business plan.

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

2.	Liquidity and Going Concern

 

The Company’s operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company’s financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of December 31, 2019, the Company had an accumulated deficit of approximately $21.5 million and as a development stage enterprise, the Company expects substantial losses in future periods. The accompanying interim financial statements were prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional financing.

On September 24, 2019, the Company entered into a Securities Purchase Agreement with its controlling stockholder regarding bridge financing (the “Bridge Financing”) in the form of up to $2.0 million in convertible debt and warrants, of which $500,000 has been drawn as of December 31, 2019. In December 2019, Acuitas provided the Company, a short-term interest free advance of $30,000. Amounts borrowed under the Bridge Financing must be repaid with the proceeds of our potential public offering of equity securities referred to below. The availability of additional draws under the Bridge Financing is under further discussion with the controlling stockholder in light of delays in the timing of the potential public offering. As further discussed below, the Company is pursuing various options to raise further financing to continue the testing and development of its product. If the Company is not successful in raising additional funds it may reduce its monthly spend and potentially delay the implementation of the larger scale Phase 2b/3 clinical trial until sufficient funding is secured.

Additionally, in April 2019, to facilitate our planned up listing to the NASDAQ Stock Market and related potential future issuances and sales of our equity securities for ordinary corporate finance and general corporate purposes and as recommended by our Board of Directors (“Board”), our stockholders approved an amendment to our Articles of Incorporation to effect a reverse split of our outstanding Class A common stock in the range of 50:1 to 200:1, as determined by our Board. On November 22, 2019, the Company effected the reverse stock split of 125 common stock for every 1 common stock. All share amounts have been updated to reflect the reverse stock split.

The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

3.	Significant Accounting Policies

 

Basis of Presentation – Interim Financial Information

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The condensed balance sheet at June 30, 2019 was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. The accompanying financial statements and information included under the heading: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the year ended June 30, 2019 filed with the SEC on September 27, 2019.

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2019 filed with the SEC on September 27, 2019.

Net income (loss) per Common Share

Basic net income (loss) per common share is computed by dividing the net income (loss) before deemed dividend by the weighted average number of shares of common stock outstanding during the period.

Diluted net income (loss) per common share is computed by dividing by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock and convertible debentures. Due to the net loss for the six months ended December 31, 2019 and 2018 as such amounts were excluded from the diluted loss since their effect was considered anti-dilutive. For the three months ended December 31, 2019, all potential securities were anti-dilutive as a result of the effect of the change in fair value of the derivative liabilities and assumed conversion of debenture in determining the amount of net income (loss) attributable to common stockholders. Due to the net loss for the three months ended December 31, 2018, amounts were excluded from the diluted loss since their effect was considered anti-dilutive.

The table below shows the number of outstanding stock options and warrants as of December 31, 2019 and 2018:

		December 31, 2019				December 31, 2018
		Number of Shares				Number of Shares
Stock Options			60,400				44,400
Warrants			1,374,667				1,731,525
Total			1,435,067				1,775,925

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

  

3.	Significant Accounting Policies (continued)

 

Recent accounting pronouncements

The Company considers the applicability and impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Accounting”. This guidance aligns the accounting for share-based payment transactions with non-employees to accounting for share-based payment transactions with employees. Companies are required to record a cumulative-effect adjustment (net of tax) to retained earnings as of the beginning of the fiscal year of the adoption. Upon transition, non-employee awards are required to be measured at fair value as of the adoption date. This standard will be effective for fiscal years beginning December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company has adopted this ASU as of July 1, 2019. There has been no impact on the financial statements.

In August 2018, the FASB issued ASU 2018-13, “Fair value measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”. The new guidance modifies the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company does not expect ASU 2018-13 to have a significant impact to its condensed consolidated financial statements and related disclosures.

 

4.	Intangible Assets

 

The Company’s intangible assets consist of intellectual property acquired from LAT Pharma, Inc. and are amortized over their estimated useful lives. The following is a summary of the intangible assets as of December 31, 2019 and June 30, 2019:

 

		December 31, 2019				June 30, 2019
Intellectual Property		$	2,293,770			$	2,293,770
Less Accumulated Amortization			(853,855	)			(739,167	)
Intellectual Property, Net		$	1,439,915			$	1,554,603

 

Amortization expense for the three-month period ended December 31, 2019 and 2018 was $57,344 and $57,344 respectively Amortization expense for the six-month period ended December 31, 2019 and 2018 was $114,689 and $114,689 respectively.

 

Estimated future amortization expense is as follows:

 

Year ending June 30, 2020 (Remaining six months)	$                         114,689
2021	229,377
2022	229,377
2023	229,377
2024	229,377
2025	229,377
Thereafter	178,341
	$                      1,439,915

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

5.	Related Party Transactions

 

Equity Transactions with Acuitas

 

On July 3, 2018, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holding, LLC (“Acuitas”) and certain other purchasers identified in the Purchase Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred Stock”) at a price per share of $1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to issue warrants (the “Warrants”) to purchase 1,706,666 shares of common stock, each subject to the terms and conditions set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million. We received $160,000 of the $3.2 million in April and May 2018 as prepaid equity. Acuitas also received an additional 6,667 Warrants in connection with the payoff of a note issued by us in favor of Acuitas. The Initial Sale and issuance of the Warrants occurred on July 3, 2018. In addition, Acuitas had the option to purchase up to an additional 1,600,000 shares of common stock at a price per share of $1.88, and warrants on the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the “Subsequent Sale”) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year anniversary of the closing of the Initial Sale, less any federal or FDA grant funding received by the Company. Acuitas is controlled by our Chairman and Chief Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuong Do and Michael Sherman, who are members of our Board.

The Purchase Agreement contained customary representations and warranties. In connection with the disclosure schedule associated with the representations and warranties, we also disclosed customary information, including the following: (i) the existence of the Mallinckrodt petition before the U.S. Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge, Inc. pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy), and (v) certain recent issuances of common stock by us.

Each share of Preferred Stock automatically converted into 100 shares of common stock (prior to reverse split) upon the filing with the Secretary of State of the State of Nevada of a Certificate of Amendment to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized shares of common stock to 800,000,000. The Amendment was approved by the written consent of the holders of more than a majority of our issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20 calendar days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on July 13, 2018.

Pursuant to a letter agreement dated June 24, 2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:

-

Acuitas agreed to immediately exchange its existing 1,606,667 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless exercise thereof at an assumed current market price of $45.00 per share and, as a result received an aggregate of 95% of the shares covered thereby, or 1,526,094 shares of common stock;

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

5.	Related Party Transactions (continued)

 

-

Acuitas agreed to (i) waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of our common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 1,339,958 shares of common stock (the “Subsequent Sale Shares”) to Acuitas, which is expected to occur concurrently with the closing of our potential public offering and listing on Nasdaq;

-

Acuitas shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned above.

Convertible Debenture Transaction with Acuitas

 

On September 24, 2019, the Company entered into a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed to purchase a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 for an aggregate commitment amount of up to $2.0 million, and (ii) the Company issued 1,125,000 shares (the “Commitment Shares”) of the Company’s common stock and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each subject to the terms and conditions set forth in the 2019 Purchase Agreement. The Debenture accrues additional principal at the rate of 6% per annum and interest at the rate of 10% per annum, is convertible into shares of common stock at $4.00 per share prior to the completion of the company’s planned public offering of units (the “Public Offering”) or, subsequent to the closing of the Public Offering, the lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. The Commitment Warrants are five-year warrants, exercisable upon the earlier of the effectiveness of the Company’s current reverse stock split or December 1, 2019, at an amount equal to the lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering. Upon entering into the 2019 Purchase Agreement, the Company drew an initial $500,000 under the Debenture and in accordance with the 2019 Purchase Agreement, Acuitas received an additional 125,000 warrants (the “Bridge Warrants”) having the same terms as the Commitment Warrants. Any future draws under the Debenture, which may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000 each, will entitle Acuitas to receive additional Bridge Warrants in equal amount upon such funding. In addition, the 2019 Purchase Agreement provides that, should the underwriters in the Public Offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas' beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas shall be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60%.

 

The issuance of 1,125,000 shares of the Company’s commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the excess of the fair value of the consideration given for the financing, net of debt discount; was recorded in accumulated deficit for the six months ended December 31, 2019, accordingly. (See accompanied Condensed Statements of Changes in Stockholders’ (Deficit) Equity). A debt discount of $500,000 against the debenture was recorded which will be amortized over the term of the debenture using the effective interest method. The Company recognized amortization of this discount in the amount of $21,595 for the six-month period ended December 31, 2019.

 

The Company received partial draws of draw number two of the Debenture of $25,000 and $5,000 on December 5, 2019 and December 13, 2019 respectively.  Acuitas and the Company continue to discuss the need and timing for some or all of the remaining draws under the Agreement.  (See subsequent events).

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

5.	Related Party Transactions (continued)

 

Pursuant to the 2019 Purchase Agreement, Acuitas has agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’ previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July 2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 2,679,916 shares of common stock and 2,679,916 warrants having the same terms as the Commitment Warrants to Acuitas, upon the closing of the Public Offering.

Pursuant to an amendment to the 2019 Purchase Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:

-

The Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the common stock;

 

-

Acuitas' existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement); and

 

-

The provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas’ beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas’ fully diluted beneficial ownership after the exercise of such option being the same as prior thereto.

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

6.	Fair Value Measurements

 

At December 31, 2019, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

		Fair Value Measurements at
		December 31, 2019
		Level 1				Level 2				Level 3				Total
Derivative liability - Warrants		$	—			$	—			$	2,674,000			$	2,674,000
Derivative liability -Conversion option on convertible debenture			—				—				573,200				573,200
Total derivatives		$	—			$	—			$	3,247,200			$	3,247,200

 

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the six months ended December 31, 2019:

		Derivative liabilities - Warrants				Derivative liability - Conversion Option on Convertible Debenture
Beginning balance at July 1, 2019		$	—			$	—
Additions to level 3 liabilities			8,367,012				2,638,966
Change in in fair value of level 3 liability			(257,288	)			(105,298	)
Transfer in and/or out of Level 3			—				—
Balance at September 30, 2019			8,109,724				2,533,668
Additions to level 3 liabilities			—				—
Change in in fair value of level 3 liability			(5,435,724	)			(1,960,468	)
Transfer in and/or out of Level 3			—				—
Balance at December 31, 2019		$	2,674,000			$	573,200

 

Derivative liability – Warrants

The Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet anti-dilution provisions or the adjustments to the strike price due to an occurrence of a future event; are accounted for as derivative financial instruments. The stock warrants issued September 24, 2019 were not considered indexed to the Company’s own stock because of the adjustment to strike price, an occurrence of a future event such as the Company’s pending capital raise.

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited) 

 

6.	Fair Value Measurements (continued)

 

The warrants associated with the level 3 liability were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model with the following assumptions: stock price of $8.95, exercise price of $4.00, term of 5 years expiring September 2024, volatility of 71.44%, dividend yield of 0%, and risk-free interest rate of 1.52%. The valuation at December 31, 2019 used the following assumptions: stock price of $3.50, exercise price of $4.00, term of 5 year expiring September 2024, volatility of 80.79%, dividend yield of 0%, and risk-free interest rate of 1.69%. (See note 5 “Related Party Transactions – Convertible debenture transactions”)

Derivative liability – Conversion option in convertible debenture

The Company valued the conversion option of the $2 million 10% OID Convertible Delayed Draw Debenture which may be convertible into shares of common stock at $4.00 per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower of $4.00 or 80% of the offering price per unit to the public in such offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. (See note 5 “Related Party Transactions – Convertible debenture transactions with Acuitas” as of September 24, 2019). The conversion option was valued on September 24, 2019 using the Black Scholes-Mertons model with the following assumptions: stock price of $8.95, conversion price of $4.00, term of 1 year expiring September 2020, volatility of 75.48%, dividend yield of 0%, and risk-free interest rate of 1.78%. The valuation at December 31, 2019 used the following assumptions: stock price of $3.50, conversion price of $4.00, term of 1 year expiring September 2020, volatility of 109.83%, dividend yield of 0%, and risk-free interest rate of 1.59%.

7.	Equity Transactions

 

Stock Options

The following table summarizes the activity relating to the Company’s stock options for the six months ended December 31, 2019:

 

		Options				Weighted-Average Exercise Price				Weighted Remaining Average Contractual Term				Aggregate Intrinsic Value
Outstanding at June 30, 2019			58,000			$	12.50				5.2			$	87,480
Granted			2,400				7.42				4.1				—
Options Exercised or Forfeited			—				—				—				—
Outstanding at December 31, 2019			60,400			$	12.29				4.5			$	2,100
Exercisable at December 31, 2019			60,400			$	12.29				4.5			$	2,100

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

7.	Equity Transactions (continued)

 

The fair value of each option grant on the date of grant is estimated using the Black-Scholes option. The pricing model reflected the following weighted-average assumptions for the six months ended December 31, 2019:

		December 31 2019				December 31 2018
Expected life of options (In years)			5				5
Expected volatility			71.55	%			67.91	%
Risk free interest rate			1.61	%			2.98	%
Dividend Yield			0	%			0	%

 

Expected volatility is based on the historical volatilities of three comparable companies of the daily closing price of their respective common stock and the expected life of options is based on historical data with respect to employee exercise periods. The Company accounts for forfeitures as they are incurred.

The Company recorded stock-based compensation expense of $0 and $11,162 for the three- and six- month periods ended December 31, 2019, respectively, and $16,285 and $19,697 for the three- and six- month periods ended December 31, 2018, respectively.

The following is a summary of stock options outstanding and exercisable by exercise price as of December 31, 2019:

Exercise Price				Outstanding				Weighted Average Contract Life				Exercisable
$	3.75				5,600				4.1				5,600
$	6.25				11,200				4.2				11,200
$	7.50				25,600				6.2				25,600
$	8.75				1,600				4.3				1,600
$	12.50				4,000				3.1				4,000
$	25.00				1,600				2.8				1,600
$	26.25				4,400				2.3				4,400
$	27.50				800				2.2				800
$	28.75				1,600				2.6				1,600
$	31.25				4,000				1.9				4,000

Stock Warrants

The following table summarizes the warrants activity during the six months ended December 31, 2019:

 

		Number of Shares				Weighted Average Exercise Price				Weighted Average Remaining Life (Years)				Aggregate Intrinsic Value
Outstanding and exercisable at June 30, 2019			124,667			$	45.00				5.6			$	716,653
Granted			1,250,000			$	4.00				4.7			$	—
Expired			—			$	—				—			$	—
Outstanding and exercisable at December 31, 2019			1,374,667			$	7.72				4.7			$	139,498

 

Of the above warrants, 9,391 expire in fiscal year ending June 30, 2022, 4,455 expire in fiscal year ending June 30, 2023, and 1,360,821 expire in fiscal year ending June 30, 2025.

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

7.	Equity Transactions (continued)

 

Offerings of Common Stock and Warrants

 

Issuance of Stock Options

 

On October 1, 2019, the Company issued stock options to purchase 800 shares of common stock to the Chief Financial Officer as part of her compensation. The stock options were issued and are exercisable at an exercise price of $8.75 at any time from date of issuance and expire in 5 years from the date of issuance.

On October 13, 2019, the Company issued stock options to purchase 800 shares of common stock as part of their annual board of director compensation. The stock options were issued and are exercisable at $7.50 at any time from date of issuance and expire in 5 years from the date of issuance.

On November 10, 2019, the Company issued stock options to purchase 800 shares of common stock as part of their annual board of director compensation. The stock options were issued and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date of issuance. 

8.	Commitments and Contingencies

 

Office Lease 

On July 1, 2019, the Company’s office moved with Acuitas’ new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404. There is no lease agreement for the new premises and the Company continues to accrue monthly lease payments of $1,000 for the new office under the terms of the previous month-to-month lease for the previous premises which may be cancelled upon 30 days’ written notice.

Challenge to US Patent

On April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S. Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents and printed publications.

 

On November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds. The result of the Board’s decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the company in July 2018.

This ruling is unrelated to the Company’s Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition, the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing country.

 

 BIOVIE INC.

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2019 and 2018

(unaudited)

 

8.	Commitments and Contingencies (continued)

 

Royalty Agreements

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016 between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

The Company and PharmaIN Corporation, LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp. rights to our program remain unchanged. Additionally the Company obligation to pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, and The Barrett Edge, Inc. pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC. The Company has an obligation to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy).

Pursuant to the Technology Transfer Agreement entered into on July 25, 2016 between BioVie and the University of Padova (Italy), BioVie is obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances capped at a maximum of $200,000 per year.  

9.	Subsequent Events

 

On January 2, 2020, the Company issued 11,200 shares of common stock as part of the annual board of director compensation. The share price on date of issuance was $3.50.

 

On January 3, 2020, the Company received a third partial draw of $20,000 and on January 14, 2020 a fourth partial draw of $250,000 of draw number two of the Debenture.   The total of the partial draw received under draw number two of the Debenture was $300,000 at February 12, 2020. Acuitas and the Company continue to discuss the need and timing for some or all the remaining draws under the Debenture Agreement.

 

On February 11, 2020, the Company entered into a letter agreement dated February 10, 2020 with Acuitas regarding Acuitas’ previous agreement to modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase price applicable to its initial investment in the Company and the exercise price of the warrants received in such transaction and the price per share should it exercise certain rights to purchase additional securities in the event of certain reductions in the useful life of the Company’s intellectual property rights and commitment to purchase such securities upon the closing of the Company’s planned public offering (the “Public Offering”) of shares of Class A common stock (the “Common Stock”) as described in its Registration Statement on Form S-1 (File No. 333-231136) and commitment to purchase such additional securities would remain effective until April 30, 2020, and accordingly Acuitas shall be entitled to receive an aggregate of 5,359,832 shares of Common Stock at such closing. In addition, the parties agreed that certain draws under the Company’s current bridge financing with Acuitas were to be made based with respect to the Company’s ongoing capital requirements and current market conditions, notwithstanding certain scheduled availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued in connection therewith.

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our; research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. 

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. 

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. When used in this report, the terms “BioVie”, “Company”, “we”, “our”, and “us” refer to BioVie Inc. 

The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this document. 

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. In order to comply with the terms of the safe harbor, the Company notes that in addition to the description of historical facts contained herein, this report contains certain forward-looking statements that involve risks and uncertainties as detailed herein and from time to time in the Company’s other filings with the Securities and Exchange Commission and elsewhere. Such statements are based on management’s current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those, described in the forward-looking statements. These factors include, among others: (a) the Company’s fluctuations in sales, expenses and operating results; (b) risks associated with international operations; (c) regulatory, competitive and contractual risks; (d) product development risks; (e) the ability to achieve strategic initiatives, including but not limited to the ability to achieve sales growth across the business segments through a combination of enhanced sales force, new products, and customer service; and (f) pending litigation. 

Management’s Discussion

 

BioVie is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies targeting life-threatening complications of liver cirrhosis. Our initial disease target is ascites, a serious medical condition affecting about 100,000 Americans and many times more worldwide. Our therapeutic drug candidate BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the US. The active agent in BIV201, terlipressin, is a potent vasoconstrictor which is in use for various medical conditions around the world. The goal is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

Comparison of the three months ended December 31, 2019 to the three months ended December 31, 2018

 

Net income (loss)

The net income for the three months ended December 31, 2019 was $6.7 million as compared to a net loss of $501,000 for the three months ended December 31, 2018. The increase in net income (loss) of $7.2 million was due to a decrease in fair value of derivative liabilities of approximately $7.4 million offset by an increase in operating expenses of approximately $210,000. The change in the fair value of derivative liabilities was due to a decrease in the Company’s stock price.

 

Total operating expenses for the three months ended December 31, 2019 were approximately $710,000 compared to $501,000 for the three months ended December 31, 2018.  The net increase of approximately $209,000 was primarily due to activities related to the Phase 2a clinical trials wrap up and preparation of the protocols for the Phase 2b/3 trials during the three months ended December 31, 2019 and an increase in selling, general and administrative expenses.

Research and Development Expenses

Research and development expenses were approximately $347,000 for the three months ended December 31, 2019, an increase of $141,000, from $206,000 for the three months ended December 31, 2018. The increase was primarily attributed to the wrapping up of the phase 2a clinical trials and readying for the next phase of trials including the preparing the protocols and manufacturing of the prefilled syringe which may be used in the next phase of trials subject to FDA clearance.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $307,000 for the three months ended December 31, 2019, a net increase of approximately $69,000, from $238,000 for the three months ended December 31, 2018. The net increase was primarily attributed to an increase in the insurance premiums of approximately $73,000 for increased coverage.

Comparison of the six months ended December 31, 2019 to the six months ended December 31, 2018

 

Net income (loss)

The net income for the six months ended December 31, 2019 was $2.8 million as compared to a net loss of $940,000 for the six months ended December 31, 2018. The increase in net income of $3.8 million was due to a decrease in fair value of derivative liabilities of $7.8 million offset by an increase in operating expenses of $424,000 and increase in interest expense of $3.5 million related to the embedded derivative liability warrants. The change in the fair value of derivative liabilities was due to a decrease in the Company’s stock price.

 

Total operating expenses for the six months ended December 31, 2019 were approximately $1.4 million compared to $992,000 for the six months ended December 31, 2018.  The net increase of approximately $424,000 was primarily due to activities related to the Phase 2a clinical trials wrap up and preparation of the protocols for the Phase 2b/3 trials during the six months ended December 31, 2019 and an increase in selling, general and administrative expenses.

Research and Development Expenses

Research and development expenses were approximately $688,000 for the six months ended December 31, 2019, an increase of $287,000, from $401,000 for the six months ended December 31, 2018. The increase was primarily attributed to the wrapping up of the phase 2a clinical trials and readying for the next phase of trials including the preparing the protocols and manufacturing of the prefilled syringe which may be used in the next phase of trials subject to FDA clearance.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $614,000 for the six months ended December 31, 2019, a net increase of approximately $137,000, from $477,000 for the six months ended December 31, 2018. The net increase was primarily attributed to an increase in the insurance premiums of approximately $88,000 for increased coverage, increased payroll of approximately $30,000 due the hiring of a half time chief financial officer that joined in October 2018 and other expenses of approximately $19,000 related to activities of the Company’s capital raise and up listing to the Nasdaq.

Capital Resources and Liquidity

 

At December 31, 2019 the Company had approximately $3,000 in cash and had completed its Phase 2a clinical trial of the BIV201 therapy. On September 24, 2019, the Company entered into a Securities Purchase Agreement with its controlling stockholder regarding bridge financing (the “Bridge Financing”) in the form of up to $2.0 million in convertible debt and warrants, of which $750,000 has been drawn to date. Amounts borrowed under the Bridge Financing must be repaid with the proceeds of our potential public offering of equity securities referred to below. The availability of additional draws under the Bridge Financing is under discussion with Acuitas in light of delays in the timing of the potential public offering. As further discussed below, the Company is pursuing various options to raise further financing to continue the testing and development of its product. If the Company is not successful in raising additional funds it may reduce its monthly spend and potentially delay the implementation of the larger scale Phase 2b Clinical trial until sufficient funding is secured. On January 3, 2020, Acuitas provided the Company a short-term interest free advance of $20,000. The short-term advance along with the $30,000 advances in December 2019 were rolled into the partial draw number 2 of $250,000 received on January 14, 2020.

 

As of December 31, 2019, the Company had an accumulated deficit of approximately $21.5 million and as a development stage enterprise, the Company expects substantial losses in future periods. The accompanying interim financial statements were prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional financing.

We cannot assure you that our drug candidate will be developed, work, or receive regulatory approval; that we will ever earn revenues sufficient to support our operations or that we will ever be profitable. Furthermore, since we have no committed source of sufficient financing, we cannot assure you that we will be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.

Additionally, in April 2019, to facilitate our planned up listing to the NASDAQ Stock Market and related potential future issuances and sales of our equity securities for ordinary corporate finance and general corporate purposes and as recommended by our Board of Directors (“Board”), our stockholders approved an amendment to our Articles of Incorporation to effect a reverse split of our outstanding Class A common stock in the range of 50:1 to 200:1, as determined by our Board. On November 22, 2019, the Company effected a reverse stock split of 125 common stock for every 1 common stock. All share amounts have been updated to reflect the reverse stock split.

Management intends to attempt to secure additional required funding primarily through additional equity or debt financings.  We may also seek to secure required funding through sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions.  However, there can be no assurance that we will be able to obtain required funding.  If we are unsuccessful in securing funding from any of these sources, we will defer, reduce or eliminate certain planned expenditures in our research protocols.  If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us.

These circumstances raise substantial doubt on our ability to continue as a going concern. These financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might result from this uncertainty. 

Off-Balance Sheet Arrangements

 

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect or change on the Company’s financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. The term “off-balance sheet arrangement” generally means any transaction, agreement or other contractual arrangement to which an entity unconsolidated with the Company is a party, under which the Company has (i) any obligation arising under a guarantee contract, derivative instrument or variable interest; or (ii) a retained or contingent interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market risk support for such assets. 

Critical Accounting Policies and Estimates

 

For the six-month period ended December 31, 2019, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2019.

New Accounting Pronouncements

 

The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable

 

Item 4.  Controls and Procedures

 

We maintain “disclosure controls and procedures.” Such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Office and Chief Financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of and disclosure controls and procedures also are based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15f and 15d-15(f) under the Exchange Act), that occurred during the quarter ended December 31, 2019 that have materially affected or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

To our knowledge, neither the Company nor any of our officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.

Item 2. Unregistered sales of equity securities

 

All sales of unregistered securities during the six months ended December 31, 2019 were previously disclosed in a Current report on Form 8-K.

 

Item 3. Defaults Upon Senior Securities

 

None

 

Item 4.  Mine Safety Disclosures

 

None

 

Item 5.  Other Information

 

On February 11, 2020, the Company entered into a letter agreement dated February 10, 2020 with Acuitas regarding Acuitas’ previous agreement to modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase price applicable to its initial investment in the Company and the exercise price of the warrants received in such transaction and the price per share should it exercise certain rights to purchase additional securities in the event of certain reductions in the useful life of the Company’s intellectual property rights and commitment to purchase such securities upon the closing of the Company’s planned public offering (the “Public Offering”) of shares of Class A common stock (the “Common Stock”) as described in its Registration Statement on Form S-1 (File No. 333-231136) and commitment to purchase such additional securities would remain effective until April 30, 2020, and accordingly Acuitas shall be entitled to receive an aggregate of 5,359,832 shares of Common Stock at such closing. In addition, the parties agreed that certain draws under the Company’s current bridge financing with Acuitas were to be made based with respect to the Company’s ongoing capital requirements and current market conditions, notwithstanding certain scheduled availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued in connection therewith.

 

Director Hari Kumar resigned from the Company’s Board of Directors effective February 12, 2020. Dr. Kumar had served as a director since May 2017. The Company appreciates the dedicated service of Dr. Kumar.

 

Item 6. Exhibits

 

(a) Exhibit index

 

Exhibit
10.1*		BioVie, Inc. Letter Agreement with Acuitas Group Holdings, LLC dated as of February 10, 2020
31.1*		Certification of Chief Executive Officer (Principal Executive Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
31.2*		Certification of Chief Financial Officer (Principal Financial Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
32.1**		Certifications of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**		Certification of Chief Financial Officer (Principal Financial Officer) pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

101.INS		XBRL Instance Document
101.SCH		XBRL Taxonomy Extension Schema Document
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB		XBRL Taxonomy Extension Label Linkbase Document
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

 

 

*	Filed herewith.
**	Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filings of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

BioVie Inc.,

Signature		Titles		Date
/s/ Terren Peizer ________________ Terren Peizer		Chairman and Chief Executive Officer (Principal Executive Officer)		February 13, 2020
/s/ Joanne Wendy Kim _________________ Joanne Wendy Kim		Chief Financial Officer (Principal Financial and Accounting Officer)		February 13, 2020