$ONVO
ORGANOVO HOLDINGS, INC.

2022 Q4 Form 10-Q Financial Statement

#000156459022037381 Filed on November 10, 2022

View on sec.gov

Income Statement

Concept 2022 Q4 2022 Q3 2021 Q3
Revenue $131.0K $77.00K $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.305M $2.200M $2.823M
YoY Change -10.28% -22.07% -53.8%
% of Gross Profit
Research & Development $1.185M $1.231M $649.0K
YoY Change 27.97% 89.68% 2063.33%
% of Gross Profit
Depreciation & Amortization $130.0K $54.00K $34.00K
YoY Change 251.35% 58.82% 240.0%
% of Gross Profit
Operating Expenses $3.490M $3.431M $3.507M
YoY Change 276.89% -2.17% -60.82%
Operating Profit -$3.359M -$3.354M -$3.507M
YoY Change -4.03% -4.36% -60.82%
Interest Expense $95.00K $33.00K $2.000K
YoY Change 4650.0% 1550.0%
% of Operating Profit
Other Income/Expense, Net $95.00K $33.00K $2.000K
YoY Change 1550.0%
Pretax Income -$3.264M -$3.321M -$3.505M
YoY Change -6.69% -5.25% -60.84%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$3.264M -$3.321M -$3.505M
YoY Change -6.74% -5.25% -60.84%
Net Earnings / Revenue -2491.6% -4312.99%
Basic Earnings Per Share -$0.37 -$0.38 -$0.40
Diluted Earnings Per Share -$0.37 -$0.38 -$402.6K
COMMON SHARES
Basic Shares Outstanding 8.713M 8.712M 8.705M
Diluted Shares Outstanding 8.714M 8.712M 8.705M

Balance Sheet

Concept 2022 Q4 2022 Q3 2021 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $20.75M $23.84M $33.79M
YoY Change -31.45% -29.45% 91.34%
Cash & Equivalents $20.20M $13.30M $33.80M
Short-Term Investments $554.0K $10.57M
Other Short-Term Assets $788.0K $519.0K $512.0K
YoY Change -12.64% 1.37% -71.71%
Inventory
Prepaid Expenses
Receivables $76.00K
Other Receivables $0.00
Total Short-Term Assets $21.61M $24.36M $34.30M
YoY Change -30.66% -28.99% 76.0%
LONG-TERM ASSETS
Property, Plant & Equipment $742.0K $758.0K $552.0K
YoY Change -74.6% 37.32% 2660.0%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $920.0K $837.0K $1.026M
YoY Change -8.28% -18.42% -10.0%
Total Long-Term Assets $3.465M $3.553M $1.578M
YoY Change -11.7% 125.16% 36.74%
TOTAL ASSETS
Total Short-Term Assets $21.61M $24.36M $34.30M
Total Long-Term Assets $3.465M $3.553M $1.578M
Total Assets $25.08M $27.91M $35.88M
YoY Change -28.54% -22.22% 73.81%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $242.0K $441.0K $958.0K
YoY Change -60.0% -53.97% 376.62%
Accrued Expenses $646.0K $462.0K $717.0K
YoY Change -53.89% -35.56% 56.89%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $1.376M $1.389M $1.675M
YoY Change -31.41% -17.07% 154.56%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.414M $1.515M
YoY Change -21.27%
Total Long-Term Liabilities $1.414M $1.515M $0.00
YoY Change -21.27%
TOTAL LIABILITIES
Total Short-Term Liabilities $1.376M $1.389M $1.675M
Total Long-Term Liabilities $1.414M $1.515M $0.00
Total Liabilities $2.790M $2.904M $1.675M
YoY Change -26.62% 73.37% 153.79%
SHAREHOLDERS EQUITY
Retained Earnings -$317.5M -$314.3M -$302.3M
YoY Change 3.83% 3.97%
Common Stock $339.8M $339.3M
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $22.29M $25.01M $34.21M
YoY Change
Total Liabilities & Shareholders Equity $25.08M $27.91M $35.88M
YoY Change -28.54% -22.22% 73.84%

Cashflow Statement

Concept 2022 Q4 2022 Q3 2021 Q3
OPERATING ACTIVITIES
Net Income -$3.264M -$3.321M -$3.505M
YoY Change -6.74% -5.25% -60.84%
Depreciation, Depletion And Amortization $130.0K $54.00K $34.00K
YoY Change 251.35% 58.82% 240.0%
Cash From Operating Activities -$3.044M -$2.217M -$2.143M
YoY Change -9.3% 3.45% -70.03%
INVESTING ACTIVITIES
Capital Expenditures $41.00K -$119.0K -$29.00K
YoY Change -130.83% 310.34%
Acquisitions
YoY Change
Other Investing Activities $10.02M $33.00K $0.00
YoY Change -100.0%
Cash From Investing Activities $9.975M -$86.00K -$29.00K
YoY Change -7600.0% 196.55% -390.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 0.000 0.000 -45.00K
YoY Change -100.0% -100.0% -550.0%
NET CHANGE
Cash From Operating Activities -3.044M -2.217M -2.143M
Cash From Investing Activities 9.975M -86.00K -29.00K
Cash From Financing Activities 0.000 0.000 -45.00K
Net Change In Cash 6.931M -2.303M -2.217M
YoY Change -298.6% 3.88% -68.91%
FREE CASH FLOW
Cash From Operating Activities -$3.044M -$2.217M -$2.143M
Capital Expenditures $41.00K -$119.0K -$29.00K
Free Cash Flow -$3.085M -$2.098M -$2.114M
YoY Change -4.28% -0.76%

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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 responsible for driving the disease and intends to initiate drug discovery programs around these validated targets. The Company is initially focusing on the intestine and has ongoing 3D tissue development efforts in ulcerative colitis (“UC”) and Crohn’s disease (“CD”). Recently, the Company announced that it has successfully advanced its first inflammatory bowel disease (“IBD”) model to the next step of target discovery and validation for CD. The Company intends to add additional tissues/diseases/targets to its portfolio over time. 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:6pt;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 across multiple therapeutic areas.</span></p> <p style="margin-top:6pt;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 therapeutics to those targets to treat disease. </span></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 majority of the Company’s current focus is in IBD, including CD and UC. 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 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 has identified and validated novel therapeutic targets and is actively focused 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></p> <p style="margin-top:6pt;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: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;">Except where specifically noted or the context otherwise requires, references to “Organovo Holdings”, “the Company”, and “Organovo” in these notes to the consolidated financial statements refers to Organovo Holdings, Inc. and its wholly owned subsidiaries, Organovo, Inc., and Opal Merger Sub, Inc.</p> <p style="margin-top:6pt;margin-bottom: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;">Global health concerns relating to the COVID-19 pandemic continue to weigh on the macroeconomic environment, and the pandemic has significantly increased economic volatility and uncertainty. </p> <p style="Background-color:#FFFFFF;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 extent to which the coronavirus 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, the duration of the outbreak, and any <span style="color:#212529;">travel bans and restrictions or other limitations that may be imposed in the future</span>. In particular, the continued coronavirus 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. Company employees and consultants have returned to working at the office and lab when necessary. The Company has developed guidelines and protocols to handle exposures and infections to keep disruptions to operations to a minimum. </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: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 revenue recognition and the valuation of stock-based compensation expense. 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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