2022 Q2 Form 10-Q Financial Statement

#000141057822001688 Filed on May 16, 2022

View on sec.gov

Income Statement

Concept 2022 Q2 2022 Q1 2021 Q4
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $621.2K $532.8K $659.3K
YoY Change 26.74% -17.18% -17.46%
% of Gross Profit
Research & Development $1.172M $1.255M $1.261M
YoY Change -26.04% -14.28% -15.53%
% of Gross Profit
Depreciation & Amortization $188.0K $179.5K $175.3K
YoY Change 6.69% 3.11% 1.38%
% of Gross Profit
Operating Expenses $1.793M $1.788M $1.921M
YoY Change -13.57% -15.17% -16.2%
Operating Profit -$1.788M -$1.921M
YoY Change -15.17% -16.2%
Interest Expense $12.79K $4.789K $2.631K
YoY Change 820.14% 867.47% -92.95%
% of Operating Profit
Other Income/Expense, Net -$4.789K -$558.00
YoY Change 867.47% -98.54%
Pretax Income -$1.780M -$1.793M -$1.921M
YoY Change -14.13% -14.96% -17.55%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$1.780M -$1.793M -$1.921M
YoY Change -14.13% -14.96% -17.55%
Net Earnings / Revenue
Basic Earnings Per Share -$0.16 -$0.17
Diluted Earnings Per Share -$154.0K -$0.16 -$0.17
COMMON SHARES
Basic Shares Outstanding 11.55M 11.54M 11.53M
Diluted Shares Outstanding 11.54M 11.53M

Balance Sheet

Concept 2022 Q2 2022 Q1 2021 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $14.07M $15.57M $17.34M
YoY Change -31.44% -32.0% -5.75%
Cash & Equivalents $14.10M $15.60M $17.30M
Short-Term Investments
Other Short-Term Assets $350.0K $374.6K $179.3K
YoY Change 13.98% 12.98% 90.15%
Inventory
Prepaid Expenses $350.0K $337.2K $141.9K
Receivables
Other Receivables
Total Short-Term Assets $14.42M $15.95M $17.52M
YoY Change -30.77% -31.36% -5.26%
LONG-TERM ASSETS
Property, Plant & Equipment $8.694M $8.805M $8.945M
YoY Change -4.3% -4.03% -3.17%
Goodwill
YoY Change
Intangibles $341.8K $343.9K $346.0K
YoY Change -2.36%
Long-Term Investments
YoY Change
Other Assets $42.44K $49.22K $3.520K
YoY Change 1105.68% 1298.3% -39.83%
Total Long-Term Assets $9.078M $9.198M $9.294M
YoY Change -3.81% -3.49% -3.16%
TOTAL ASSETS
Total Short-Term Assets $14.42M $15.95M $17.52M
Total Long-Term Assets $9.078M $9.198M $9.294M
Total Assets $23.49M $25.14M $26.81M
YoY Change -22.36% -23.25% -4.54%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $272.4K $196.6K $320.1K
YoY Change 17.62% -71.15% 1.94%
Accrued Expenses $45.69K $25.25K $24.16K
YoY Change 88.15% 4.22% -4.37%
Deferred Revenue
YoY Change
Short-Term Debt $94.79K $164.9K $0.00
YoY Change -0.55% -0.54%
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $412.8K $386.7K $344.3K
YoY Change 17.57% -55.62% 1.47%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $0.00 $0.00 $0.00
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $412.8K $386.7K $344.3K
Total Long-Term Liabilities $0.00 $0.00 $0.00
Total Liabilities $412.8K $386.7K $344.3K
YoY Change 17.57% -55.62% 1.47%
SHAREHOLDERS EQUITY
Retained Earnings -$122.5M -$121.0M -$119.0M
YoY Change 7.09%
Common Stock $11.59K $11.55K $11.53K
YoY Change 0.67%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $23.08M $24.76M $26.47M
YoY Change
Total Liabilities & Shareholders Equity $23.49M $25.14M $26.81M
YoY Change -22.36% -23.25% -4.54%

Cashflow Statement

Concept 2022 Q2 2022 Q1 2021 Q4
OPERATING ACTIVITIES
Net Income -$1.780M -$1.793M -$1.921M
YoY Change -14.13% -14.96% -17.55%
Depreciation, Depletion And Amortization $188.0K $179.5K $175.3K
YoY Change 6.69% 3.11% 1.38%
Cash From Operating Activities -$1.398M -$1.655M -$2.114M
YoY Change -37.26% 15.36% -8.69%
INVESTING ACTIVITIES
Capital Expenditures -$75.36K -$39.33K -$185.4K
YoY Change -10.96% -64.42% 2060.26%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$75.36K -$39.33K -$185.4K
YoY Change -10.96% -64.42% 2060.26%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -32.71K -69.30K -61.37K
YoY Change -53.6% -101.15% -94.29%
NET CHANGE
Cash From Operating Activities -1.398M -1.655M -2.114M
Cash From Investing Activities -75.36K -39.33K -185.4K
Cash From Financing Activities -32.71K -69.30K -61.37K
Net Change In Cash -1.506M -1.764M -2.361M
YoY Change -36.81% -139.14% -30.54%
FREE CASH FLOW
Cash From Operating Activities -$1.398M -$1.655M -$2.114M
Capital Expenditures -$75.36K -$39.33K -$185.4K
Free Cash Flow -$1.322M -$1.616M -$1.929M
YoY Change -38.3% 22.02% -16.39%

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-align:justify;margin:0pt 0pt 12pt 0pt;">Note 1 – Organization and Nature of Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">NanoViricides, Inc. (the “Company”) is a nano-biopharmaceutical research and development company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides is also unique in the bio-pharma field in that it possesses its own state of the art facilities for the design, synthesis, analysis and characterization of the nanomedicines that the Company develops, as well as for production scale-up, and c-GMP-like production in quantities needed for human clinical trials, where the Company’s design, development, and production work is performed. The biological studies such as the effectiveness, safety, bio-distribution and Pharmacokinetics/Pharmacodynamics on the Company’s drug candidates are performed by external collaborators and contract organizations.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">The Company has several drugs in various stages of early development. COVID-19 has become the Company’s lead drug program due to the necessity of responding to the pandemic. The Company began development of a drug to treat COVID-19 patients just as the cases of the novel disease were being reported from China. The Company’s drug candidates for COVID-19 successfully entered core safety pharmacology studies required prior to any human clinical trials around October/November, 2020. The studies were completed in January and February 2021, and the Company had received, at that time, draft reports from the external Contract Research Organization (CRO). The final quality audited reports on these studies have been signed and released to the Company. These cGLP core safety pharmacology reports are required for an Investigational New Drug (IND) Application. The Company is currently working on a pre-IND application to the US Food and Drug Administration (FDA) to seek guidance for an IND. The Company is also involved with tasks needed for setting up and executing human clinical trials for the Company’s COVID-19 drug candidates, including selection of a Clinical Trial Contract Research Organization. In addition to the FDA, the Company is also seeking to obtain regulatory approvals from other international bodies in order to perform the clinical trials in countries other than the USA. The Company cannot provide a timeline at this point because of external dependencies in the filing of regulatory applications, their approval(s) and beginning of clinical trials. There are 15 COVID-19 drugs that have received Emergency Use Authorization (EUA) and one drug that has received full approval (remdesivir) from the FDA (https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap#dashboard). In addition, there are at least three vaccines licensed in the USA and several more are in use internationally. Apart from remdesivir and antibodies, there are very few drugs with direct antiviral effect that have EUA or are in clinical trials. Internationally, virus variants have continued to emerge with resistance to drugs and vaccines. Scientists believe it is only a matter of time before resistant variants against existing vaccines and therapeutics become commonplace. Thus the need for therapeutics that the virus would not escape by mutations, such as the broad-spectrum, pan-coronavirus nanoviricides drug candidates, remains unmet. Additionally, specific populations such as immune-compromised persons, HIV-positive persons, and others would require therapeutics even if they are fully vaccinated, as the weak immune system in these populations limits the ability of vaccines to protect from COVID-19 infection and disease.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company plans on re-engaging its other lead antiviral program against herpes viruses, i.e. the HerpeCide™ program, as soon as it becomes feasible to conduct the corresponding antiviral human clinical studies. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. Of these, the Company is advancing the shingles drug candidate towards human clinical trials. The IND-enabling Safety/Toxicology studies required for doing so have been completed and the Company was in the process of preparing an IND application for this drug candidate when the SRAS-CoV-2 virus struck, whereupon management pivoted its efforts to respond to the threat of what has now become the COVID-19 pandemic. In addition, the Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced studies and are expected to follow the shingles drug candidate into human clinical trials. Shingles in adults and chicken pox in children is caused by the same virus, namely VZV (Varicella-zoster virus, aka HHV-3 or human herpesvirus-3). There are estimated to be approximately 120,000-150,000 annual chickenpox cases in the USA in the post-vaccination-era, i.e. since childhood vaccination with the live attenuated varicella virus Oka strain has become standard. In addition, the Company has drugs in development against all influenzas in our FluCide™ program, as well as drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), to which the Company has broad, exclusive licenses. The first license agreement the Company executed with TheraCour on September 1, 2005 (“Exclusive License Agreement”), gave the Company an exclusive, worldwide license for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV), Influenza and Asian Bird Flu Virus. On February 15, 2010, the Company executed an Additional License Agreement with TheraCour. Pursuant to the Additional License Agreement, the Company was granted exclusive licenses for technologies, developed by TheraCour, for the development of drug candidates for the treatment of Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes. In addition, on November 1, 2019, the Company entered into a world-wide, exclusive, sub-licensable, license (“VZV License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat VZV infections, using TheraCour’s proprietary as well as patented technology and intellectual property. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour, as defined in the agreement. The Company was not required to make any upfront payments to TheraCour and agreed to the following milestone payments to TheraCour; the issuance of 75,000 shares of the Company’s Series A preferred stock upon the grant of an IND Application; $1,500,000 in cash upon completion of Phase I Clinical Trials; $2,500,000 in cash upon completion of Phase II clinical trials; and $5,000,000 in cash upon completion of Phase III clinical trials. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">On September 9, 2021, the Company entered into a world-wide, exclusive, sub-licensable, license (“Covid-19 License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat Covid-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour, as defined in the agreement. The Company was not required to make any upfront cash payments to TheraCour and agreed to the following milestone payments to TheraCour: (i) the issuance of 100,000 shares of the Company’s Series A preferred stock within 30 days upon execution of this agreement; (ii) the issuance of 50,000 shares of the Company’s Series A preferred stock upon the approval of the Company's IND Application or its equivalent by a competent regulatory authority; (iii) $1,500,000 upon initiation of Phase I clinical trials, or its equivalent, for at least one licensed product within-the field on, or before, three (3) months from the date of the authority’s acceptance of the IND, or its equivalent; (iv) $2,000,000 in cash upon completion of Phase 1 clinical trials; (v)  $2,500,000 in cash upon completion of Phase IIA clinical trials, or, its equivalent; (vi) the issuance of 100,000 shares of the Company’s Series A preferred stock upon the initiation of Phase 3 clinical trials, or, its equivalent, for at least one licensed product within the field; and (vii) $5,000,000 in cash, or 500,000 shares of the Company’s Series A preferred stock upon completion of Phase III clinical trials, or its equivalent. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour, as defined in the agreement.</p>
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