$ONVO
ORGANOVO HOLDINGS, INC.

2023 Q4 Form 10-Q Financial Statement

#000095017023062228 Filed on November 09, 2023

View on sec.gov

Income Statement

Concept 2023 Q4 2023 Q3
Revenue $5.000K $0.00
YoY Change -96.18% -100.0%
Cost Of Revenue $0.00
YoY Change
Gross Profit $0.00
YoY Change
Gross Profit Margin
Selling, General & Admin $2.251M $2.780M
YoY Change -2.34% 26.36%
% of Gross Profit
Research & Development $1.434M $1.335M
YoY Change 21.01% 8.45%
% of Gross Profit
Depreciation & Amortization $69.00K $70.00K
YoY Change -46.92% 29.63%
% of Gross Profit
Operating Expenses $3.685M $4.115M
YoY Change 5.59% 19.94%
Operating Profit -$3.680M -$4.115M
YoY Change 9.56% 22.69%
Interest Expense $76.00K $120.0K
YoY Change -20.0% 263.64%
% of Operating Profit
Other Income/Expense, Net $76.00K $121.0K
YoY Change -20.0% 266.67%
Pretax Income -$3.604M -$3.990M
YoY Change 10.42% 20.14%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$3.604M -$3.994M
YoY Change 10.42% 20.26%
Net Earnings / Revenue -72080.0%
Basic Earnings Per Share -$0.40 -$0.46
Diluted Earnings Per Share -$0.40 -$0.46
COMMON SHARES
Basic Shares Outstanding 8.837M 8.718M
Diluted Shares Outstanding 9.115M 8.719M

Balance Sheet

Concept 2023 Q4 2023 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $5.295M $7.620M
YoY Change -74.48% -68.03%
Cash & Equivalents $5.300M $7.600M
Short-Term Investments $0.00 $0.00
Other Short-Term Assets $913.0K $620.0K
YoY Change 15.86% 19.46%
Inventory
Prepaid Expenses
Receivables $33.00K $55.00K
Other Receivables $0.00 $0.00
Total Short-Term Assets $6.241M $8.296M
YoY Change -71.13% -65.94%
LONG-TERM ASSETS
Property, Plant & Equipment $739.0K $808.0K
YoY Change -0.4% 6.6%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $498.0K $550.0K
YoY Change -45.87% -34.29%
Total Long-Term Assets $2.640M $2.865M
YoY Change -23.81% -19.36%
TOTAL ASSETS
Total Short-Term Assets $6.241M $8.296M
Total Long-Term Assets $2.640M $2.865M
Total Assets $8.881M $11.16M
YoY Change -64.59% -60.01%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $471.0K $435.0K
YoY Change 94.63% -1.36%
Accrued Expenses $727.0K $666.0K
YoY Change 12.54% 44.16%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $1.700M $1.600M
YoY Change 23.55% 15.19%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $999.0K $1.110M
YoY Change -29.35% -26.73%
Total Long-Term Liabilities $999.0K $1.110M
YoY Change -29.35% -26.73%
TOTAL LIABILITIES
Total Short-Term Liabilities $1.700M $1.600M
Total Long-Term Liabilities $999.0K $1.110M
Total Liabilities $2.699M $2.705M
YoY Change -3.26% -6.85%
SHAREHOLDERS EQUITY
Retained Earnings -$336.6M -$333.0M
YoY Change 6.02% 5.95%
Common Stock $342.8M $341.5M
YoY Change 0.88% 0.65%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $6.182M $8.456M
YoY Change
Total Liabilities & Shareholders Equity $8.881M $11.16M
YoY Change -64.59% -60.01%

Cashflow Statement

Concept 2023 Q4 2023 Q3
OPERATING ACTIVITIES
Net Income -$3.604M -$3.994M
YoY Change 10.42% 20.26%
Depreciation, Depletion And Amortization $69.00K $70.00K
YoY Change -46.92% 29.63%
Cash From Operating Activities -$3.522M -$3.150M
YoY Change 15.7% 42.08%
INVESTING ACTIVITIES
Capital Expenditures $2.000K $20.00K
YoY Change -95.12% -116.81%
Acquisitions
YoY Change
Other Investing Activities $25.00K $40.00K
YoY Change -99.75% 21.21%
Cash From Investing Activities $23.00K $20.00K
YoY Change -99.77% -123.26%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 1.173M 0.000
YoY Change
NET CHANGE
Cash From Operating Activities -3.522M -3.150M
Cash From Investing Activities 23.00K 20.00K
Cash From Financing Activities 1.173M 0.000
Net Change In Cash -2.326M -3.130M
YoY Change -133.56% 35.91%
FREE CASH FLOW
Cash From Operating Activities -$3.522M -$3.150M
Capital Expenditures $2.000K $20.00K
Free Cash Flow -$3.524M -$3.170M
YoY Change 14.23% 51.1%

Facts In Submission

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onvo Sales Of Equity Securities
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
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CashAndCashEquivalentsAtCarryingValue
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us-gaap Nature Of Operations
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<p style="text-indent:0;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Note</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1. Description of Business</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0;font-size:10pt;margin-top:6pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Nature of Operations</span></p><p style="text-indent:0;font-size:10pt;margin-top:6pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Organovo Holdings, Inc. (“Organovo Holdings,” “Organovo,” and the “Company”) is a pharmaceutical and biotechnology company that focuses on clinical drug development of the farnesoid X receptor (“FXR”) agonist FXR314. FXR is a mediator of gastrointestinal </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">and liver diseases. FXR agonism has been tested in a variety of preclinical models of inflammatory bowel disease ("IBD"). FXR314 is the lead compound in the Company's established FXR program containing </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">two</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> clinically tested compounds (including FXR314) and over </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">2,000</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> discovery or preclinical compounds. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis ("UC").</span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company’s current clinical focus is in advancing FXR314 in IBD, including UC and Crohn’s disease (“CD”). The Company plans to start a Phase 2a clinical trial in UC in the calendar year 2024.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">A second focus of the Company is building high fidelity, 3D tissues that recapitulate key aspects of human disease. 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. Management believes these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs across multiple therapeutic areas.</span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">As with the clinical development program, the Company is initially focusing on the intestine and has ongoing 3D tissue development efforts in human tissue models of UC and CD. The Company uses these models to identify new molecular targets responsible for driving these diseases and to explore the mechanism of action of known drugs including FXR314 and related molecules. The Company intends to initiate drug discovery programs around these new validated targets to identify drug candidates for partnering and/or internal clinical development.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#212121;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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. </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is creating high fidelity disease models, leveraging its prior work including the work found in its peer-reviewed publication on bioprinted intestinal tissues (</span><span style="color:#212121;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.) </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Organovo’s advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures.</span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#212121;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Using these disease models, the Company intends to identify and validate novel therapeutic targets. After finding therapeutic drug targets, the Company intends to focus on developing 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 potential future clinical trials.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#212121;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span></p>
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<p style="text-indent:0;font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Use of Estimates</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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. On an ongoing basis, management reviews these estimates and assumptions.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
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us-gaap Operating Lease Expense
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CY2022Q3 us-gaap Operating Lease Expense
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us-gaap Operating Lease Expense
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us-gaap Operating Lease Payments
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CY2022Q3 us-gaap Operating Lease Payments
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us-gaap Operating Lease Payments
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245000
CY2023Q3 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
256000
CY2023Q3 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
523000
CY2023Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
538000
CY2023Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
460000
CY2023Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
1777000
CY2023Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
173000
CY2023Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
1604000
CY2023Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
499000
CY2023Q3 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
1105000
CY2023Q3 us-gaap Restructuring And Related Activities Initiation Date
RestructuringAndRelatedActivitiesInitiationDate
2023-08-25
CY2023Q3 us-gaap Restructuring And Related Cost Number Of Positions Eliminated
RestructuringAndRelatedCostNumberOfPositionsEliminated
6
CY2023Q3 us-gaap Restructuring And Related Cost Number Of Positions Eliminated Period Percent
RestructuringAndRelatedCostNumberOfPositionsEliminatedPeriodPercent
0.24
CY2023Q3 us-gaap Severance Costs1
SeveranceCosts1
400000
CY2023Q3 onvo Restructuring Annual Cost Savings
RestructuringAnnualCostSavings
1500000
CY2023Q3 us-gaap Restructuring Charges
RestructuringCharges
400000
CY2023Q3 us-gaap Severance Costs1
SeveranceCosts1
380000
CY2023Q3 us-gaap Restructuring Charges
RestructuringCharges
380000

Files In Submission

Name View Source Status
onvo-20230930_cal.xml Edgar Link unprocessable
onvo-20230930_def.xml Edgar Link unprocessable
0000950170-23-062228-index-headers.html Edgar Link pending
0000950170-23-062228-index.html Edgar Link pending
0000950170-23-062228.txt Edgar Link pending
0000950170-23-062228-xbrl.zip Edgar Link pending
FilingSummary.xml Edgar Link unprocessable
Financial_Report.xlsx Edgar Link pending
MetaLinks.json Edgar Link pending
onvo-20230930.htm Edgar Link pending
onvo-20230930.xsd Edgar Link pending
onvo-ex31_1.htm Edgar Link pending
onvo-ex31_2.htm Edgar Link pending
onvo-ex32_1.htm Edgar Link pending
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onvo-20230930_lab.xml Edgar Link unprocessable
onvo-20230930_pre.xml Edgar Link unprocessable
onvo-20230930_htm.xml Edgar Link completed
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