2021 Form 10-K Financial Statement

#000143774922007101 Filed on March 24, 2022

View on sec.gov

Income Statement

Concept 2021 2020 Q4 2020
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $4.587M $900.0K $3.250M
YoY Change 41.14% 91.49% 64.97%
% of Gross Profit
Research & Development $5.423M $700.0K $2.505M
YoY Change 116.49% -9.09% 6.64%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $5.423M $1.600M $2.505M
YoY Change 116.49% 29.03% 6.64%
Operating Profit -$10.01M -$5.754M
YoY Change 73.97% 33.13%
Interest Expense $11.00K -$10.00K $17.00K
YoY Change -35.29% 0.0% -99.23%
% of Operating Profit
Other Income/Expense, Net -$613.0K $550.0K $691.0K
YoY Change -188.71% 189.47% -130.14%
Pretax Income -$10.62M -$950.0K -$5.063M
YoY Change 109.82% -10.38% -23.46%
Income Tax -$488.0K -$70.00K -$295.0K
% Of Pretax Income
Net Earnings -$10.10M -$880.0K -$4.768M
YoY Change 111.83% -9.28% -23.1%
Net Earnings / Revenue
Basic Earnings Per Share -$34.64
Diluted Earnings Per Share -$865.6K -$90.91K -$617.1K
COMMON SHARES
Basic Shares Outstanding 292.6K 9.649M
Diluted Shares Outstanding

Balance Sheet

Concept 2021 2020 Q4 2020
SHORT-TERM ASSETS
Cash & Short-Term Investments $11.87M $9.020M $9.020M
YoY Change 31.56% 268.16% 268.16%
Cash & Equivalents $11.87M $9.022M
Short-Term Investments
Other Short-Term Assets $91.00K $410.0K $410.0K
YoY Change -77.8% 46.43% 46.43%
Inventory
Prepaid Expenses $412.0K
Receivables
Other Receivables
Total Short-Term Assets $12.28M $9.757M $9.760M
YoY Change 25.81% 215.45% 215.86%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $593.0K $56.00K $60.00K
YoY Change 888.33% 9.8% 20.0%
Total Long-Term Assets $593.0K $56.00K $50.00K
YoY Change 1086.0% 9.8% 0.0%
TOTAL ASSETS
Total Short-Term Assets $12.28M $9.757M $9.760M
Total Long-Term Assets $593.0K $56.00K $50.00K
Total Assets $12.87M $9.813M $9.810M
YoY Change 31.21% 212.12% 212.42%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $640.0K $554.0K $550.0K
YoY Change 16.36% -7.2% -8.33%
Accrued Expenses $2.020M $811.0K $810.0K
YoY Change 149.38% 166.78% 170.0%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00 $0.00
YoY Change -100.0% -100.0%
Total Short-Term Liabilities $2.660M $1.365M $1.370M
YoY Change 94.16% -22.4% -22.16%
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 $2.660M $1.365M $1.370M
Total Long-Term Liabilities $0.00 $0.00 $0.00
Total Liabilities $2.660M $1.365M $1.370M
YoY Change 94.16% -22.4% -22.16%
SHAREHOLDERS EQUITY
Retained Earnings -$46.03M
YoY Change 11.56%
Common Stock $10.00K
YoY Change 42.86%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $10.21M $8.448M $8.450M
YoY Change
Total Liabilities & Shareholders Equity $12.87M $9.813M $9.810M
YoY Change 31.21% 212.12% 212.42%

Cashflow Statement

Concept 2021 2020 Q4 2020
OPERATING ACTIVITIES
Net Income -$10.10M -$880.0K -$4.768M
YoY Change 111.83% -9.28% -23.1%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$6.700M -$1.140M -$3.854M
YoY Change 73.85% 31.03% 40.71%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities -$540.0K
YoY Change
Cash From Investing Activities -$540.0K $0.00
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net $0.00 $117.0K
YoY Change -100.0% -27.33%
Cash From Financing Activities $10.10M -720.0K $10.44M
YoY Change -3.34% 928.57% 176.0%
NET CHANGE
Cash From Operating Activities -$6.700M -1.140M -$3.854M
Cash From Investing Activities -$540.0K $0.00
Cash From Financing Activities $10.10M -720.0K $10.44M
Net Change In Cash $2.845M -1.860M $6.573M
YoY Change -56.72% 97.87% 529.6%
FREE CASH FLOW
Cash From Operating Activities -$6.700M -$1.140M -$3.854M
Capital Expenditures
Free Cash Flow
YoY Change

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<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b><em style="font: inherit;">2.</em></b>         <b>Risks and Uncertainties</b></p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p 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 (“FDA”) in the United States, the Therapeutic Goods Administration (“TGA”) in Australia, the European Medicines Agency (“EMA”) in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, <em style="font: inherit;"> may </em>take many years, and is normally expected to involve substantial expenditures.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">We have incurred losses of $56.2 million since our inception in <em style="font: inherit;">2011.</em> For the year ended <em style="font: inherit;"> December 31, 2021, </em>we incurred a net loss and negative cash flows from operating activities of $10.1 million and $6.7 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-<em style="font: inherit;">101.</em> As of <em style="font: inherit;"> December 31, 2021, </em>we had cash of $11.9 million, working capital (defined as current assets less current liabilities) of $9.6 million and stockholders’ equity of $10.2 million. The Company’s principal sources of cash have included the issuance of equity securities and convertible debt.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p 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 <em style="font: inherit;">not</em> 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-<em style="font: inherit;">101,</em> 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.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family: &quot;Times New Roman&quot;; font-size: 10pt; font-variant: normal; margin: 0pt;"><em style="font: inherit;"> December 2021 </em>marked <em style="font: inherit;">21</em> months since the World Health Organization declared the spread of a novel strain of coronavirus (“COVID-<em style="font: inherit;">19”</em>) a global pandemic. Early in the pandemic, federal, state and local governmental authorities took actions to combat the spread of COVID-<em style="font: inherit;">19,</em> including through issuances of “stay-at-home” 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, led to significantly reduced economic activity. Vaccines became available at the end of <em style="font: inherit;">2020</em> and distribution in the U.S. accelerated during the <em style="font: inherit;">first</em> quarter of <em style="font: inherit;">2021</em> and then leveled off in the <em style="font: inherit;">second</em> quarter. While most state and local authorities have reopened businesses, infection rates increased in the United States and other parts of the world as the result of the delta variant in fall of <em style="font: inherit;">2021</em> and in winter of <em style="font: inherit;">2021</em> infections again increased due to the omicron variant, infection rates are once again decreasing in the <em style="font: inherit;">first</em> quarter of <em style="font: inherit;">2022.</em> The rapid development and uncertainty of the situation continues to preclude any prediction as to the ultimate impact COVID-<em style="font: inherit;">19</em> 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-<em style="font: inherit;">19</em> outbreak in the United States, Australia and the rest of the world. During the spring of <em style="font: inherit;">2020</em> enrollment in our clinical trial was temporarily paused to allow our clinical sites time to prepare for COVID -<em style="font: inherit;">19.</em> <em style="font: inherit;">No</em> disruption occurred as a result of COVID -<em style="font: inherit;">19</em> to the treatment of subjects enrolled prior to or after this pause in the study and the study enrollment was completed in <em style="font: inherit;"> December </em>of <em style="font: inherit;">2020.</em> During the spring of <em style="font: inherit;">2021,</em> the Company also experienced a delay in the manufacturing of the active product substance, which is manufactured in India. There was also a delay in the final manufacturing steps which are completed in the United States, in part related to COVID-<em style="font: inherit;">19.</em> To date there has been <em style="font: inherit;">no</em> disruption in supply for our clinical or preclinical testing. In <em style="font: inherit;"> January </em>of <em style="font: inherit;">2022,</em> the Company announced the opening of a global randomized Phase II/III clinical trial, which is expected to be conducted in the United States, Europe and Australia. The Company does <em style="font: inherit;">not</em> expect any disruption to the conduct of this new clinical trial associated with COVID-<em style="font: inherit;">19.</em> The Company’s administrative operations have been decentralized since inception so the Company experienced <em style="font: inherit;">no</em> administrative disruptions or additional costs due to the pandemic or related restrictions.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p>
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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"/> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"/> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt 0pt 0pt 9pt;"><b><i>Use of estimates</i></b></p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">The preparation of Consolidated Financial Statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the Consolidated Financial Statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimates.</p>
CY2021 us-gaap Concentration Risk Credit Risk
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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"/> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt 0pt 0pt 9pt;"><b><i>Concentration of credit risk</i></b></p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p 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 <em style="font: inherit;"> may </em>be in excess of insured limits. As of <em style="font: inherit;"> December 31, 2021, </em>$11.6 million of the Company’s cash was in excess of insured limits. The Company has <em style="font: inherit;">not</em> experienced any losses on its deposits of cash.</p>
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CY2021Q4 us-gaap Income Taxes Receivable
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321000 USD
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