2022 Q1 Form 10-Q Financial Statement

#000143774922012129 Filed on May 12, 2022

View on sec.gov

Income Statement

Concept 2022 Q1 2021 Q1
Revenue $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.796M $1.150M
YoY Change 56.17% 150.0%
% of Gross Profit
Research & Development $2.208M $1.099M
YoY Change 100.91% 83.78%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $2.208M $1.099M
YoY Change 100.91% 83.78%
Operating Profit -$4.004M -$2.248M
YoY Change 78.11% 110.88%
Interest Expense $3.000K $3.000K
YoY Change 0.0% -25.0%
% of Operating Profit
Other Income/Expense, Net $309.0K -$125.0K
YoY Change -347.2% -84.83%
Pretax Income -$3.695M -$2.373M
YoY Change 55.71% 25.56%
Income Tax -$29.00K -$116.0K
% Of Pretax Income
Net Earnings -$3.666M -$2.257M
YoY Change 62.43% 25.53%
Net Earnings / Revenue
Basic Earnings Per Share -$0.27 -$0.23
Diluted Earnings Per Share -$272.7K -$228.5K
COMMON SHARES
Basic Shares Outstanding 13.45M 9.888M
Diluted Shares Outstanding

Balance Sheet

Concept 2022 Q1 2021 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $7.386M $8.100M
YoY Change -8.81% 523.08%
Cash & Equivalents $7.400M $8.098M
Short-Term Investments
Other Short-Term Assets $182.0K $310.0K
YoY Change -41.29% -20.51%
Inventory
Prepaid Expenses $182.0K $310.0K
Receivables
Other Receivables
Total Short-Term Assets $7.933M $8.839M
YoY Change -10.25% 322.72%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.155M $55.00K
YoY Change 5636.36% 22.22%
Total Long-Term Assets $3.155M $55.00K
YoY Change 5636.36% 22.22%
TOTAL ASSETS
Total Short-Term Assets $7.933M $8.839M
Total Long-Term Assets $3.155M $55.00K
Total Assets $11.09M $8.894M
YoY Change 24.67% 316.39%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.986M $782.0K
YoY Change 409.72% 188.56%
Accrued Expenses $521.0K $528.0K
YoY Change -1.33% 71.43%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $4.507M $1.310M
YoY Change 244.05% -7.22%
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 $4.507M $1.310M
Total Long-Term Liabilities $0.00 $0.00
Total Liabilities $4.507M $1.310M
YoY Change 244.05% -7.09%
SHAREHOLDERS EQUITY
Retained Earnings -$59.80M -$48.28M
YoY Change 23.85% 12.14%
Common Stock $13.00K $10.00K
YoY Change 30.0% 42.86%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $6.581M $7.584M
YoY Change
Total Liabilities & Shareholders Equity $11.09M $8.894M
YoY Change 24.67% 316.39%

Cashflow Statement

Concept 2022 Q1 2021 Q1
OPERATING ACTIVITIES
Net Income -$3.666M -$2.257M
YoY Change 62.43% 25.53%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$4.500M -$1.965M
YoY Change 129.01% 75.45%
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
YoY Change
Cash From Financing Activities $0.00 $1.042M
YoY Change -100.0% -4107.69%
NET CHANGE
Cash From Operating Activities -$4.500M -$1.965M
Cash From Investing Activities
Cash From Financing Activities $0.00 $1.042M
Net Change In Cash -$4.481M -$924.0K
YoY Change 384.96% -19.86%
FREE CASH FLOW
Cash From Operating Activities -$4.500M -$1.965M
Capital Expenditures
Free Cash Flow
YoY Change

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<table border="0" cellpadding="0" cellspacing="0" style="width: 100%; text-indent: 0px;"><tbody><tr style="vertical-align: top;"><td style="width: 36pt;"> <p style="margin: 0pt; text-align: left; font-family: &quot;Times New Roman&quot;; font-size: 10pt;"><b><em style="font: inherit;">2.</em></b></p> </td><td style="width: auto;"> <p style="margin: 0pt; text-align: left; font-family: &quot;Times New Roman&quot;; font-size: 10pt;"><b>Risks and Uncertainties</b></p> </td></tr> </tbody></table> <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;text-align:justify;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 in Australia, the European Medicines Agency 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;text-align:justify;margin:0pt;">We have incurred losses of $59.8 million since our inception in <em style="font: inherit;">2011.</em> For the <em style="font: inherit;">three</em> months ended <em style="font: inherit;"> March 31, 2022, </em>we incurred a net loss of $3.7 million. We also incurred negative cash flows from operating activities of approximately $4.5 million for this period. As we continue to pursue development activities and seek commercialization of, we expect to incur substantial losses, which are likely to generate negative net cash flows from operating activities. As of <em style="font: inherit;"> March 31, 2022, </em>we had cash of $7.4 million, working capital of $3.4 million, (current assets less current liabilities) and stockholders’ equity of $6.6 million. The Company’s principal sources of cash have historically included the issuance of convertible debt and equity securities.</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;text-align:justify;margin:0pt;">The accompanying condensed 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. The condensed<b> </b>consolidated financial statements 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 current independent registered public accounting firm included a paragraph emphasizing this going concern uncertainty in their audit report regarding our <em style="font: inherit;">2021</em> financial statements dated <em style="font: inherit;"> March 24, 2022. </em>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 SBP-<em style="font: inherit;">101</em> product candidate in the United States, Australia, the European Union or other markets and ultimately our ability to market and sell our SBP-<em style="font: inherit;">101</em> product candidate. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note <em style="font: inherit;">4</em> titled “Liquidity and Business Plan.”</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; text-align: justify;"><em style="font: inherit;"> March 2022 </em>marked <em style="font: inherit;">two</em> years 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 United States 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. In the fall of <em style="font: inherit;">2021,</em> infection rates increased in the United States and other parts of the world as the result of the delta variant, and in winter of <em style="font: inherit;">2021,</em> infections again increased due to the omicron variant. In the <em style="font: inherit;">first</em> quarter of <em style="font: inherit;">2022,</em> infection rates decreased. 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 operations 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, Europe and the rest of the world. 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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CY2022Q1 us-gaap Use Of Estimates
UseOfEstimates
<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;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;text-align:justify;margin:0pt;">The preparation of condensed 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 condensed consolidated financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties with the ongoing pandemic and control responses.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p>
CY2022Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
7559032
CY2021Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
8100661
CY2022Q1 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
9578808
CY2022Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
334000 USD
CY2021Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
252000 USD
CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
2463636
CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
5.76
CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
8821 USD
CY2022Q1 pbla Sharebased Compensation Arrangement By Sharebased Payment Award Number Of Shares Available For Grant Grants In Period
SharebasedCompensationArrangementBySharebasedPaymentAwardNumberOfSharesAvailableForGrantGrantsInPeriod
-0
CY2022Q1 us-gaap Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
-0
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod
-0
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
19500
CY2022Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
14.07
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
2444136
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
5.76
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
13300 USD
CY2022Q1 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Outstanding Options
ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions
2444136
CY2022Q1 us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Remaining Contractual Term2
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2
P7Y29D
CY2022Q1 us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Exercise Price Beginning Balance1
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1
5.760
CY2022Q1 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Exercisable Options
ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions
1852268
CY2022Q1 us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Exercisable Options Weighted Average Remaining Contractual Term2
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2
P6Y3M3D

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