$ONVO
ORGANOVO HOLDINGS, INC.

2024 Q3 Form 10-Q Financial Statement

#000095017024090726 Filed on August 05, 2024

View on sec.gov

Income Statement

Concept 2024 Q3 2024 Q2 2023 Q2
Revenue $30.00K $39.00K $75.00K
YoY Change -48.0%
Cost Of Revenue $1.000K $2.000K $0.00
YoY Change
Gross Profit $29.00K $37.00K $75.00K
YoY Change -50.67%
Gross Profit Margin 96.67% 94.87% 100.0%
Selling, General & Admin $1.653M $2.021M $2.604M
YoY Change -40.54% -22.39% 17.35%
% of Gross Profit 5700.0% 5462.16% 3472.0%
Research & Development $984.0K $1.402M $1.666M
YoY Change -26.29% -15.85% 63.33%
% of Gross Profit 3393.1% 3789.19% 2221.33%
Depreciation & Amortization $68.00K $70.00K $67.00K
YoY Change -2.86% 4.48% 34.0%
% of Gross Profit 234.48% 189.19% 89.33%
Operating Expenses $2.637M $3.423M $4.270M
YoY Change -35.92% -19.84% 31.83%
Operating Profit -$2.608M -$3.386M -$4.195M
YoY Change -36.62% -19.28% 29.52%
Interest Expense $59.00K $44.00K $169.0K
YoY Change -50.83% -73.96% 550.0%
% of Operating Profit
Other Income/Expense, Net $59.00K $44.00K $169.0K
YoY Change -51.24% -73.96% 550.0%
Pretax Income -$2.549M -$3.342M -$4.026M
YoY Change -36.12% -16.99% 25.3%
Income Tax $0.00 $2.000K $2.000K
% Of Pretax Income
Net Earnings -$2.549M -$3.344M -$4.028M
YoY Change -36.18% -16.98% 25.29%
Net Earnings / Revenue -8496.67% -8574.36% -5370.67%
Basic Earnings Per Share -$0.14 -$0.23 -$0.46
Diluted Earnings Per Share -$0.14 -$0.23 -$0.46
COMMON SHARES
Basic Shares Outstanding 15.36M 14.37M 8.717M
Diluted Shares Outstanding 17.99M 14.66M 8.717M

Balance Sheet

Concept 2024 Q3 2024 Q2 2023 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $3.174M $6.187M $10.75M
YoY Change -58.35% -42.47% -58.94%
Cash & Equivalents $3.200M $6.200M $10.80M
Short-Term Investments $0.00
Other Short-Term Assets $940.0K $640.0K $792.0K
YoY Change 51.61% -19.19% 10.46%
Inventory $640.0K $408.0K
Prepaid Expenses
Receivables $29.00K $48.00K $149.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $4.783M $7.283M $11.70M
YoY Change -42.35% -37.73% -56.54%
LONG-TERM ASSETS
Property, Plant & Equipment $545.0K $601.0K $850.0K
YoY Change -32.55% -29.29% 23.19%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $340.0K $392.0K $605.0K
YoY Change -38.18% -35.21% -32.1%
Total Long-Term Assets $1.971M $2.187M $3.061M
YoY Change -31.2% -28.55% -15.84%
TOTAL ASSETS
Total Short-Term Assets $4.783M $7.283M $11.70M
Total Long-Term Assets $1.971M $2.187M $3.061M
Total Assets $6.754M $9.470M $14.76M
YoY Change -39.49% -35.82% -51.69%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $419.0K $1.119M $488.0K
YoY Change -3.68% 129.3% 275.38%
Accrued Expenses $879.0K $404.0K $787.0K
YoY Change 31.98% -48.67% 17.46%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $385.0K
YoY Change
Total Short-Term Liabilities $2.414M $2.033M $1.770M
YoY Change 50.88% 14.86% 38.07%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $660.0K $775.0K $1.210M
YoY Change -40.54% -35.95% -24.84%
Total Long-Term Liabilities $660.0K $775.0K $1.210M
YoY Change -40.54% -35.95% -24.84%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.414M $2.033M $1.770M
Total Long-Term Liabilities $660.0K $775.0K $1.210M
Total Liabilities $3.074M $2.808M $2.980M
YoY Change 13.64% -5.77% 3.04%
SHAREHOLDERS EQUITY
Retained Earnings -$345.6M -$343.0M -$329.0M
YoY Change 3.78% 4.26% 5.79%
Common Stock $349.2M $349.7M $340.8M
YoY Change 2.27% 2.6% 0.65%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $3.680M $6.662M $11.78M
YoY Change
Total Liabilities & Shareholders Equity $6.754M $9.470M $14.76M
YoY Change -39.49% -35.82% -51.69%

Cashflow Statement

Concept 2024 Q3 2024 Q2 2023 Q2
OPERATING ACTIVITIES
Net Income -$2.549M -$3.344M -$4.028M
YoY Change -36.18% -16.98% 25.29%
Depreciation, Depletion And Amortization $68.00K $70.00K $67.00K
YoY Change -2.86% 4.48% 34.0%
Cash From Operating Activities -$2.642M -$3.000M -$5.300M
YoY Change -16.13% -43.4% 120.83%
INVESTING ACTIVITIES
Capital Expenditures $13.00K $0.00 $15.00K
YoY Change -35.0% -100.0% -79.73%
Acquisitions
YoY Change
Other Investing Activities $13.00K $20.00K $779.0K
YoY Change -67.5% -97.43% -107.34%
Cash From Investing Activities $0.00 $20.00K $764.0K
YoY Change -100.0% -97.38% -107.14%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -371.0K 6.249M 0.000
YoY Change
NET CHANGE
Cash From Operating Activities -2.642M -3.000M -5.300M
Cash From Investing Activities 0.000 20.00K 764.0K
Cash From Financing Activities -371.0K 6.249M 0.000
Net Change In Cash -3.013M 3.286M -4.547M
YoY Change -3.74% -172.27% -65.31%
FREE CASH FLOW
Cash From Operating Activities -$2.642M -$3.000M -$5.300M
Capital Expenditures $13.00K $0.00 $15.00K
Free Cash Flow -$2.655M -$3.000M -$5.315M
YoY Change -16.25% -43.56% 114.83%

Facts In Submission

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<p style="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-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="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="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-size:10pt;font-family:Times New Roman;min-width:fit-content;">Organovo Holdings, Inc. (“Organovo Holdings,” “Organovo,” and the “Company”) is a clinical stage biotechnology company that is focused on developing FXR314 in inflammatory bowel disease ("IBD"), including ulcerative colitis ("UC"), based on demonstration of clinical promise in three-dimensional ("3D") human tissues as well as strong preclinical data. FXR is a mediator of gastrointestinal </span><span style="color:#000000;white-space:pre-wrap;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 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;min-width:fit-content;">two</span><span style="color:#000000;white-space:pre-wrap;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;min-width:fit-content;">2,000</span><span style="color:#000000;white-space:pre-wrap;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 UC.</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="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-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 2025. The Company released Phase 2 data for FXR314 for the treatment of metabolic function-associated steatohepatitis (“MASH”) in April 2024 that is supportive of ongoing development, and the Company believes FXR314 has a commercial opportunity in MASH, most likely in combination therapy. The Company is exploring the potential for combination therapies using FXR314 and currently approved mechanisms in preclinical animal studies and the Company's IBD disease models.</span></p><p style="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-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="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-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company's second focus 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. The Company 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="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-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-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="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-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-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-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-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="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-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-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="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-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-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="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="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-size:10pt;font-family:Times New Roman;min-width:fit-content;">In February 2024, the Company formed its Mosaic Cell Sciences division (“Mosaic”) to serve as a key source of certain primary human cells that the Company utilizes in its research and development efforts. The Company believes Mosaic can help optimize its supply chain, reduce operating expenses related to cell sourcing and procurement and ensure that the cellular raw materials the Company uses are of the highest quality and are derived from tissues that are ethically sourced in full compliance with state and federal guidelines. Mosaic provides the Company with qualified human cells for use in its clinical research and development programs. In addition to supplying the Company with primary human cells, Mosaic offers human cells for sale to life science customers, both directly and through distribution partners, which the Company expects to offset costs and over time become a profit center that offsets overall research and development ("R&amp;D") spending by the Company.</span></p><p style="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-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 subsidiary, Organovo, Inc.</span></p>
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