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 report.
Overview
We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of 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 product 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.
BioVie accomplished the following key milestones in 2019:
- In April, we announced top-line results for the Phase 2a clinical trial of
BIV201 in six patients.
- In June, we met with representatives of the U.S. Food & Drug Administration
("FDA") for a Type C Guidance Meeting to plan our next clinical study. We
discussed our clinical development program with the FDA and proposed clinical
trial endpoints.
- In August, we invented a proprietary novel liquid formulation of terlipressin
that is intended to improve convenience for outpatient administration and
avoid potential formulation errors when pharmacists reconstitute the powder
version.
- In October, we submitted our proposed Phase 2b/3 randomized, controlled
clinical trial protocol to the FDA.
- In November, we announced that the first batch of pre-filled syringes
containing our novel BIV201 liquid formulation was manufactured and had
cleared quality control testing.
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BioVie accomplished the following key milestones in 2020:
- In February, we submitted a detailed meeting information package to the FDA
supporting our proposed trial design.
- In March, we requested feedback from the FDA's CMC division regarding the
novel BIV201 prefilled terlipressin syringe and subsequently submitted a
detailed information package.
- In early April, we received the FDA's written response to our Type B meeting
questions, requiring changes to the clinical trial design. In mid-April we
submitted a revised Phase 2 trial design and follow-up questions for
clarification.
- In April, we submitted a continuation-in-part amendment to the Angeli et al.
'945 patent application to the US Patent & Trademark Office seeking
restricted claims covering the use of BIV201 to treat ascites.
- In May, we received CMC division feedback regarding the new BIV201 prefilled
terlipressin syringe. We may use it in the upcoming Phase 2 trial subject to
conducting certain additional standard analytical testing expected to take
approximately two weeks.
- In May, we filed a PCT ("Patent Cooperation Treaty") application for our
novel liquid terlipressin formulations as we pursue global patent coverage.
- In June, we announced that room temperature stability of the prefilled
syringe had been confirmed at 6 months, with the potential for 12 months or
up to two years of stability (yet to be confirmed). Room temperature storage
presents a key product differentiation versus terlipressin products in
countries where the drug is approved. To the best of the Company's knowledge,
all other terlipressin products sold globally must be stored under
refrigeration and there is no prefilled syringe format of terlipressin
available for treating patients in these countries.
- In June, we also announced further guidance from the FDA regarding clinical
trial design in response to the follow-up questions submitted in April. The
Company plans to commence a randomized 24-patient Phase 2 study in 2020, to
be followed by a larger pivotal Phase 3 clinical trial targeted to begin in
2021. The FDA communicated that pending positive Phase 2 study results, a
sufficiently large and well-controlled Phase 3 trial, with supportive data
from the Phase 2 (statistical significance not required), could potentially
yield the clinical data needed to apply for BIV201 marketing approval.
Results of Operations
Comparison of the Year Ended
Net loss
The net loss for the year ended
Total operating expenses for the year ended
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Research and Development Expenses
Research and development expenses were approximately
Selling, General and Administrative Expenses
Selling, general and administrative expenses were approximately
Capital Resources and Liquidity
At
As of
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.
On
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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.
The emergence of widespread health emergencies or pandemics such as coronavirus ("COVID-19"), may lead to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability, including the duration and spread of the outbreak and restrictions and the impact of COVID-19 on the financial markets and the overall economy, all of which are highly uncertain and cannot be predicted. If the financial markets and/or the overall economy are impacted for an extended period, the Company's ability to raise funds may be materially adversely affected.
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
Accounting for Stock-based Compensation
The Company follows the provision of ASC 718- Stock Compensation, which requires the measurement of compensation expense for all shared - based payment awards made to employees and non-employee director, including employee stock options. Share-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures.
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Goodwill Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets and would be charged to earnings.
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
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