2021 Q3 Form 10-Q Financial Statement

#000156459021055246 Filed on November 08, 2021

View on sec.gov

Income Statement

Concept 2021 Q3 2020 Q3
Revenue $0.00 $0.00
YoY Change -100.0%
Cost Of Revenue $0.00
YoY Change -100.0%
Gross Profit $0.00
YoY Change -100.0%
Gross Profit Margin
Selling, General & Admin $2.823M $6.110M
YoY Change -53.8% -3.75%
% of Gross Profit
Research & Development $649.0K $30.00K
YoY Change 2063.33% -97.92%
% of Gross Profit
Depreciation & Amortization $34.00K $10.00K
YoY Change 240.0% -94.12%
% of Gross Profit
Operating Expenses $3.507M $8.950M
YoY Change -60.82% 14.85%
Operating Profit -$3.507M -$8.950M
YoY Change -60.82% 31.1%
Interest Expense $2.000K $0.00
YoY Change -100.0%
% of Operating Profit
Other Income/Expense, Net $2.000K $0.00
YoY Change -100.0%
Pretax Income -$3.505M -$8.950M
YoY Change -60.84% 42.29%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$3.505M -$8.950M
YoY Change -60.84% 42.2%
Net Earnings / Revenue
Basic Earnings Per Share -$0.40
Diluted Earnings Per Share -$402.6K -$1.362M
COMMON SHARES
Basic Shares Outstanding 8.705M
Diluted Shares Outstanding 8.705M

Balance Sheet

Concept 2021 Q3 2020 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $33.79M $17.66M
YoY Change 91.34% -41.81%
Cash & Equivalents $33.80M $17.66M
Short-Term Investments
Other Short-Term Assets $512.0K $1.810M
YoY Change -71.71% 30.22%
Inventory
Prepaid Expenses
Receivables $20.00K
Other Receivables $0.00
Total Short-Term Assets $34.30M $19.49M
YoY Change 76.0% -40.42%
LONG-TERM ASSETS
Property, Plant & Equipment $552.0K $20.00K
YoY Change 2660.0% -97.36%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.026M $1.140M
YoY Change -10.0% 770.23%
Total Long-Term Assets $1.578M $1.154M
YoY Change 36.74% -77.18%
TOTAL ASSETS
Total Short-Term Assets $34.30M $19.49M
Total Long-Term Assets $1.578M $1.154M
Total Assets $35.88M $20.64M
YoY Change 73.81% -45.34%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $958.0K $201.0K
YoY Change 376.62% 32.24%
Accrued Expenses $717.0K $457.0K
YoY Change 56.89% -76.35%
Deferred Revenue $0.00
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $1.675M $658.0K
YoY Change 154.56% -78.92%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00
YoY Change -100.0%
Total Long-Term Liabilities $0.00 $0.00
YoY Change -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $1.675M $658.0K
Total Long-Term Liabilities $0.00 $0.00
Total Liabilities $1.675M $660.0K
YoY Change 153.79% -90.15%
SHAREHOLDERS EQUITY
Retained Earnings -$302.3M
YoY Change
Common Stock
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $34.21M $19.99M
YoY Change
Total Liabilities & Shareholders Equity $35.88M $20.64M
YoY Change 73.84% -45.35%

Cashflow Statement

Concept 2021 Q3 2020 Q3
OPERATING ACTIVITIES
Net Income -$3.505M -$8.950M
YoY Change -60.84% 42.2%
Depreciation, Depletion And Amortization $34.00K $10.00K
YoY Change 240.0% -94.12%
Cash From Operating Activities -$2.143M -$7.150M
YoY Change -70.03% 38.83%
INVESTING ACTIVITIES
Capital Expenditures -$29.00K
YoY Change
Acquisitions
YoY Change
Other Investing Activities $0.00 $10.00K
YoY Change -100.0% -66.67%
Cash From Investing Activities -$29.00K $10.00K
YoY Change -390.0% -66.67%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -45.00K 10.00K
YoY Change -550.0%
NET CHANGE
Cash From Operating Activities -2.143M -7.150M
Cash From Investing Activities -29.00K 10.00K
Cash From Financing Activities -45.00K 10.00K
Net Change In Cash -2.217M -7.130M
YoY Change -68.91% 39.26%
FREE CASH FLOW
Cash From Operating Activities -$2.143M -$7.150M
Capital Expenditures -$29.00K
Free Cash Flow -$2.114M
YoY Change

Facts In Submission

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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Note<span style="font-weight:normal;"> </span>1. Description of Business </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-style:italic;color:#000000;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">Nature of Operations</p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Organovo Holdings, Inc. (“Organovo Holdings,” “Organovo,” and the “Company”) is an early-stage biotechnology company that focuses on building high fidelity, 3D tissues that recapitulate key aspects of human disease. The Company uses these models to identify gene targets capable of modulating the disease phenotype across multiple patients and intends to initiate drug discovery programs around these validated targets. The Company is initially targeting the intestine and has ongoing 3D tissue development efforts in Ulcerative colitis (“UC”) and Crohn’s disease (“CD”). The Company intends to add additional tissues/diseases/targets to its portfolio in the coming year. In line with these plans, the Company is building upon both its external and in house scientific expertise, which will be essential to its drug development effort. </p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The Company uses its proprietary technology to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. Organovo’s advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. Management believes these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs for a variety of therapeutic areas.</span></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s NovoGen Bioprinters<span style="font-weight:bold;"><sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup></span> are automated devices that enable the fabrication of 3D living tissues comprised of mammalian cells. <span style="color:#000000;">The Company believes that the use of its bioprinting platform as well as complementary 3D technologies will allow it to develop an understanding of disease biology that leads to validated novel drug targets, and that it can develop therapeutics to those targets to treat disease. </span></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The majority of the Company’s current focus is in inflammatory bowel disease (“IBD”), including CD and UC.  The Company expects to create disease models, leveraging its prior work including the work found in its peer-reviewed publication on bioprinted intestinal tissues (<span style="Background-color:#FFFFFF;color:#212121;">Madden et al. Bioprinted 3D Primary Human Intestinal Tissues Model Aspects of Native Physiology and ADME/Tox Functions. iScience. 2018 Apr 27;2:156-167. doi: 10.1016/j.isci.2018.03.015.)  The Company’s current understanding of intestinal tissue models and IBD disease models leads it to believe that it can create models that provide greater insight into the biology of these diseases than are generally currently available.  Using these disease models, the Company intends to identify and validate therapeutic targets.  After finding novel therapeutic drug targets, the Company intends to develop novel small molecule, antibody, or other therapeutic drug candidates to treat the disease, and advance these novel drug candidates towards an Investigational New Drug (“IND”) filing and clinical trials.  </span></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;color:#212121;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The Company expects to broaden its work into additional therapeutic areas over time and is currently exploring specific tissues for development.  In the Company’s work to identify the areas of interest, it evaluates areas that might be better served with 3D disease models than currently available models as well as the potential commercial opportunity.</span></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Except where specifically noted or the context otherwise requires, references to “Organovo Holdings”, “the Company”, and “Organovo” in these notes to the unaudited condensed consolidated financial statements refers to Organovo Holdings, Inc. and its wholly owned subsidiaries, Organovo, Inc. and Opal Merger Sub, Inc.</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;"> </p> <p style="margin-bottom:0pt;margin-top:8pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">COVID-19</p> <p style="Background-color:#FFFFFF;margin-top:6pt;margin-bottom:0pt;text-indent:0%;color:#212529;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In December 2019, a respiratory illness caused by a novel strain of coronavirus, SARS-CoV-2, causing the Coronavirus Disease 2019, also known as COVID-19 emerged. While initially the outbreak was largely concentrated in China, it has since spread globally and has been declared a pandemic by the World Health Organization. Global health concerns relating to the COVID-19 pandemic have been weighing on the macroeconomic environment, and the pandemic has significantly increased economic volatility and uncertainty. The pandemic has resulted in government authorities implementing numerous measures to try to contain the virus, such as travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns. In 2020, the Company adapted quickly to COVID-19, instituting universal masking and distancing in the lab and in the offices. The Company encouraged and enabled remote work whenever possible. The Company instituted safety check software to monitor symptoms and successfully maintained a robust level of progress while ensuring the safety of its employees. As the viral load and variants allow, the Company intends to carefully return to more typical lab and office work flow. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The extent to which COVID-19 impacts the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the rise of vaccine-resistant variants, duration of the outbreak, <span style="color:#212529;">travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns</span>. In particular, the continued COVID-19 </p> <p style="margin-bottom:0pt;margin-top:12pt;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">pandemic could adversely impact various aspects of the Company’s operations, including among others, the ability to raise additional capital, the timing and ability to pursue the Company’s strategy, given the impact the pandemic may have on the manufacturing and supply chain, sales and marketing and clinical trial operations of potential strategic partners, and the ability to advance its research and development activities and pursue development of its pipeline products, each of which could have an adverse impact on the Company’s business and financial results.</span></p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;"> </p>
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<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">Use of Estimates </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Significant estimates used in preparing the unaudited condensed consolidated financial statements include those assumed in the valuation of stock-based compensation expense and the valuation allowance on deferred tax assets. On an ongoing basis, management reviews these estimates and assumptions. Though the impact of the COVID-19 pandemic to its business and operating results presents additional uncertainty, the Company continues to use the best information available to inform its significant accounting estimates.</p>
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SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1
P6Y
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
6.52
CY2021Q3 onvo Number Of Participants Enrolled In Employee Stock Purchase Plan
NumberOfParticipantsEnrolledInEmployeeStockPurchasePlan
0
CY2021Q1 onvo Combination Of Securities Authorized For Offer And Sale
CombinationOfSecuritiesAuthorizedForOfferAndSale
150000000.0
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
1004655
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
20.03
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
0
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
856400
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
12000
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
7.66
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod
354530
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice
40.95
us-gaap Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
0
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
0
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
662125
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
8.61
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
0
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
108492
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
7.61
CY2021Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
0
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableWeightedAverageRemainingContractualTerm1
P8Y11M15D
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
P8Y11M15D
CY2021Q3 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
1794206
CY2021Q3 onvo Number Of Additional Ipr Proceedings Filed
NumberOfAdditionalIPRProceedingsFiled
2
onvo Monthly Rent Payments
MonthlyRentPayments
4000
CY2020Q4 onvo Number Of Lease Agreement
NumberOfLeaseAgreement
2
CY2021Q3 us-gaap Lease And Rental Expense
LeaseAndRentalExpense
5000
us-gaap Lease And Rental Expense
LeaseAndRentalExpense
18000
us-gaap Lease And Rental Expense
LeaseAndRentalExpense
25000
CY2021Q3 us-gaap Variable Lease Cost
VariableLeaseCost
9000
us-gaap Variable Lease Cost
VariableLeaseCost
18000
CY2020Q3 us-gaap Variable Lease Cost
VariableLeaseCost
0
us-gaap Variable Lease Cost
VariableLeaseCost
0
CY2021Q3 us-gaap Short Term Lease Cost
ShortTermLeaseCost
39000
us-gaap Short Term Lease Cost
ShortTermLeaseCost
78000
CY2020Q3 us-gaap Short Term Lease Cost
ShortTermLeaseCost
0
us-gaap Short Term Lease Cost
ShortTermLeaseCost
0

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