2019 Q4 Form 10-K Financial Statement

#000143774921007154 Filed on March 25, 2021

View on sec.gov

Income Statement

Concept 2019 Q4 2019 2018 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 $470.0K $1.970M $330.0K
YoY Change 42.42% -6.64% -71.79%
% of Gross Profit
Research & Development $770.0K $2.349M $310.0K
YoY Change 148.39% 31.74% -51.56%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $1.240M $2.349M $640.0K
YoY Change 93.75% 31.74% -64.64%
Operating Profit -$4.322M
YoY Change 11.08%
Interest Expense -$10.00K $2.194M -$50.00K
YoY Change -80.0% 20.95% -89.36%
% of Operating Profit
Other Income/Expense, Net $190.0K -$2.293M -$140.0K
YoY Change -235.71% 1.1% -450.0%
Pretax Income -$1.060M -$6.615M -$830.0K
YoY Change 27.71% 7.4% -62.95%
Income Tax -$80.00K -$415.0K -$90.00K
% Of Pretax Income
Net Earnings -$970.0K -$6.200M -$740.0K
YoY Change 31.08% 5.0% -65.74%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$146.1K -$1.088M -$145.7K
COMMON SHARES
Basic Shares Outstanding
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q4 2019 2018 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $2.450M $2.450M $1.410M
YoY Change 73.76% 73.76% 840.0%
Cash & Equivalents $2.449M $1.405M
Short-Term Investments
Other Short-Term Assets $280.0K $280.0K $110.0K
YoY Change 154.55% 154.55% -45.0%
Inventory
Prepaid Expenses $283.0K $110.0K
Receivables
Other Receivables
Total Short-Term Assets $3.093M $3.090M $1.847M
YoY Change 67.46% 67.03% 140.81%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $51.00K $50.00K $51.00K
YoY Change 0.0% 0.0%
Total Long-Term Assets $51.00K $50.00K $51.00K
YoY Change 0.0% 0.0%
TOTAL ASSETS
Total Short-Term Assets $3.093M $3.090M $1.847M
Total Long-Term Assets $51.00K $50.00K $51.00K
Total Assets $3.144M $3.140M $1.898M
YoY Change 65.65% 65.26% 147.46%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $597.0K $600.0K $1.064M
YoY Change -43.89% -43.4% -11.04%
Accrued Expenses $304.0K $300.0K $216.0K
YoY Change 40.74% 36.36% -82.78%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $860.0K $860.0K $286.0K
YoY Change 200.7% 145.71% 1942.86%
Total Short-Term Liabilities $1.759M $1.760M $1.630M
YoY Change 7.91% 7.98% -60.91%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $0.00 $0.00
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $1.759M $1.760M $1.630M
Total Long-Term Liabilities $0.00 $0.00
Total Liabilities $1.759M $1.760M $1.630M
YoY Change 7.91% 7.98% -63.42%
SHAREHOLDERS EQUITY
Retained Earnings -$41.26M -$35.06M
YoY Change 17.68% 20.26%
Common Stock $7.000K $5.000K
YoY Change 40.0% 25.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $1.384M $1.390M $268.0K
YoY Change
Total Liabilities & Shareholders Equity $3.144M $3.140M $1.898M
YoY Change 65.65% 65.26% 147.46%

Cashflow Statement

Concept 2019 Q4 2019 2018 Q4
OPERATING ACTIVITIES
Net Income -$970.0K -$6.200M -$740.0K
YoY Change 31.08% 5.0% -65.74%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$870.0K -$2.739M -$160.0K
YoY Change 443.75% 14.75% -79.75%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net $161.0K
YoY Change 1050.0%
Cash From Financing Activities -70.00K 3.784M 1.330M
YoY Change -105.26% 3.87%
NET CHANGE
Cash From Operating Activities -870.0K -2.739M -160.0K
Cash From Investing Activities
Cash From Financing Activities -70.00K 3.784M 1.330M
Net Change In Cash -940.0K 1.044M 1.170M
YoY Change -180.34% -16.88% -248.1%
FREE CASH FLOW
Cash From Operating Activities -$870.0K -$2.739M -$160.0K
Capital Expenditures
Free Cash Flow
YoY Change

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<div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt 0pt 0pt 9pt;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;">Concentration of credit risk</div></div></div> <div style=" font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</div> <div style=" font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash. Cash is deposited in demand accounts at commercial banks. At times, such deposits <div style="display: inline; font-style: italic; font: inherit;"> may </div>be in excess of insured limits. As of <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2020, </div><div style="display: inline; font-style: italic; font: inherit;">$8.7</div> million of the Company's cash is in excess of insured limits. The Company has <div style="display: inline; font-style: italic; font: inherit;">not</div> experienced any losses on its deposits of cash.</div></div></div></div></div>
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<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 36pt;"> <div style=" margin: 0pt; text-align: justify; font-family: &quot;Times New Roman&quot;; font-size: 10pt;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">2.</div></div></div> </td> <td> <div style=" margin: 0pt; text-align: justify; font-family: &quot;Times New Roman&quot;; font-size: 10pt;"><div style="display: inline; font-weight: bold;">Risks and Uncertainties</div></div> </td> </tr> </table> <div style=" font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</div> <div style=" font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">The Company operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (&#x201c;FDA&#x201d;) in the United States, the Therapeutic Goods Administration (&#x201c;TGA&#x201d;) in Australia, the European Medicines Agency (&#x201c;EMA&#x201d;) in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, <div style="display: inline; font-style: italic; font: inherit;"> may </div>take many years, and is normally expected to involve substantial expenditures.</div> <div style=" font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</div> <div style=" font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">We have incurred losses of <div style="display: inline; font-style: italic; font: inherit;">$46.0</div> million since our inception in <div style="display: inline; font-style: italic; font: inherit;">2011.</div> For the year ended <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2020 </div>we incurred a net loss and negative cash flows from operating activities of <div style="display: inline; font-style: italic; font: inherit;">$4.8</div> million and <div style="display: inline; font-style: italic; font: inherit;">$3.9</div> million, respectively. We expect to incur substantial losses for the foreseeable future, which will continue to generate negative net cash flows from operating activities, as we continue to pursue research and development activities and the clinical development of our primary product candidate, SBP-<div style="display: inline; font-style: italic; font: inherit;">101.</div> As of <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2020, </div>we had cash of <div style="display: inline; font-style: italic; font: inherit;">$9.0</div> million, working capital (defined as current assets less current liabilities) of <div style="display: inline; font-style: italic; font: inherit;">$8.4</div> million and stockholders' equity of <div style="display: inline; font-style: italic; font: inherit;">$8.4</div> million. The Company's principal sources of cash have included the issuance of equity securities and convertible debt.</div> <div style=" font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</div> <div style=" font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">The accompanying Consolidated Financial Statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business and do <div style="display: inline; font-style: italic; font: inherit;">not</div> include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our initial product candidate, SBP-<div style="display: inline; font-style: italic; font: inherit;">101,</div> in the United States, Australia, the European Union or other markets and ultimately our ability to market and sell our initial product candidate. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern.</div> <div style=" font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</div> <div style=" font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">In <div style="display: inline; font-style: italic; font: inherit;"> March 2020, </div>the World Health Organization declared the spread of a novel strain of coronavirus (&#x201c;COVID-<div style="display: inline; font-style: italic; font: inherit;">19&#x201d;</div>) a global pandemic. Actions have been taken by federal, state and local governmental authorities to combat the spread of COVID-<div style="display: inline; font-style: italic; font: inherit;">19,</div> including through issuances of &#x201c;stay-at-home&#x201d; directives and similar mandates for many individuals to substantially restrict daily activities and for many businesses to curtail or cease normal operations. These measures, while intended to protect human life, have led to significantly reduced economic activity. At the end of <div style="display: inline; font-style: italic; font: inherit;">2020</div> <div style="display: inline; font-style: italic; font: inherit;">two</div> vaccines became available although they are <div style="display: inline; font-style: italic; font: inherit;">not</div> yet in wide distribution. While many state and local authorities have started to reopen businesses, others have adopted additional measures to mitigate COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> and the rapid development and uncertainty of the situation continues to preclude any prediction as to the ultimate impact COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> will have on the Company's business, financial condition, results of operation and cash flows, which will depend largely on future developments directly or indirectly relating to the duration and scope of the COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> outbreak in the United States and Australia. During <div style="display: inline; font-style: italic; font: inherit;"> April 2020, </div>we initiated a temporary pause in the enrollment of new patients in our clinical trial. After <div style="display: inline; font-style: italic; font: inherit;">six</div> weeks, we reauthorized our clinical sites to resume recruitment and enrollment of patients in the clinical trial. We continued to treat patients already enrolled throughout the temporary pause in enrollment. New enrollments were <div style="display: inline; font-style: italic; font: inherit;">not</div> interrupted again once the temporary pause was lifted in <div style="display: inline; font-style: italic; font: inherit;"> May 2020, </div>and the enrollment in this study was completed in the <div style="display: inline; font-style: italic; font: inherit;">fourth</div> quarter <div style="display: inline; font-style: italic; font: inherit;">2020.</div> The Company also experienced a brief delay in the manufacturing of the active product ingredient. As we have adequate supply of drug product, there was <div style="display: inline; font-style: italic; font: inherit;">no</div> disruption in supply for our clinical or preclinical testing. The Company's administrative operations have been decentralized since inception so the Company experienced <div style="display: inline; font-style: italic; font: inherit;">no</div> administrative disruptions or additional costs due to the pandemic or related restrictions.</div> <div style=" font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</div></div>
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