$ONVO
ORGANOVO HOLDINGS, INC.

2020 Q4 Form 10-Q Financial Statement

#000156459021004687 Filed on February 08, 2021

View on sec.gov

Income Statement

Concept 2020 Q4 2020 Q1 2019 Q4
Revenue $0.00 $0.00 $298.0K
YoY Change -100.0% -100.0% -61.75%
Cost Of Revenue $0.00 $0.00 $13.00K
YoY Change -100.0% -100.0% -87.0%
Gross Profit $0.00 $0.00 $285.0K
YoY Change -100.0% -100.0% -58.03%
Gross Profit Margin 95.64%
Selling, General & Admin $2.090M $3.090M $5.374M
YoY Change -61.11% -7.49% 58.67%
% of Gross Profit 1885.61%
Research & Development $402.0K $145.0K
YoY Change 177.24% -96.17%
% of Gross Profit 50.88%
Depreciation & Amortization $10.00K $0.00 $760.0K
YoY Change -98.68% -100.0% 204.0%
% of Gross Profit 266.67%
Operating Expenses $2.492M $2.960M $5.519M
YoY Change -54.85% -61.76% -23.02%
Operating Profit -$2.492M -$2.960M -$5.234M
YoY Change -52.39% -58.66% -19.8%
Interest Expense $0.00 $90.00K $130.0K
YoY Change -100.0% -50.0% -31.58%
% of Operating Profit
Other Income/Expense, Net -$19.00K $80.00K $1.864M
YoY Change -101.02% 1367.72%
Pretax Income -$2.510M -$2.720M -$3.370M
YoY Change -25.52% -61.03% -47.34%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$2.511M -$2.720M -$3.370M
YoY Change -25.49% -61.03% -47.34%
Net Earnings / Revenue -1130.87%
Basic Earnings Per Share
Diluted Earnings Per Share -$365.9K -$416.5K -$516.9K
COMMON SHARES
Basic Shares Outstanding
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q4 2020 Q1 2019 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $18.84M $27.36M $30.47M
YoY Change -38.17% -25.0% -13.49%
Cash & Equivalents $18.84M $27.36M $30.47M
Short-Term Investments
Other Short-Term Assets $1.260M $850.0K $470.0K
YoY Change 168.09% -19.05% -11.32%
Inventory $0.00 $0.00
Prepaid Expenses
Receivables $0.00 $111.0K $170.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $20.10M $28.32M $31.11M
YoY Change -35.39% -26.59% -16.97%
LONG-TERM ASSETS
Property, Plant & Equipment $289.0K $0.00 $0.00
YoY Change -100.0% -100.0%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.190M $123.0K $127.0K
YoY Change 837.01% -10.87% -52.96%
Total Long-Term Assets $1.481M $123.0K $200.0K
YoY Change 640.5% -94.0% -90.99%
TOTAL ASSETS
Total Short-Term Assets $20.10M $28.32M $31.11M
Total Long-Term Assets $1.481M $123.0K $200.0K
Total Assets $21.58M $28.44M $31.31M
YoY Change -31.08% -29.99% -21.11%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $410.0K $720.0K $820.0K
YoY Change -50.0% 14.65% 26.15%
Accrued Expenses $420.0K $1.090M $1.540M
YoY Change -72.73% -57.24% -29.36%
Deferred Revenue $0.00 $0.00 $0.00
YoY Change -100.0% -100.0%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $829.0K $1.810M $2.358M
YoY Change -64.84% -51.57% -30.85%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $0.00
YoY Change -100.0% -100.0%
Total Long-Term Liabilities $0.00 $0.00 $0.00
YoY Change -100.0% -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $829.0K $1.810M $2.358M
Total Long-Term Liabilities $0.00 $0.00 $0.00
Total Liabilities $830.0K $1.810M $2.360M
YoY Change -64.83% -58.15% -41.15%
SHAREHOLDERS EQUITY
Retained Earnings -$279.5M
YoY Change 7.18%
Common Stock $306.1M
YoY Change 3.04%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $20.75M $26.63M $28.95M
YoY Change
Total Liabilities & Shareholders Equity $21.58M $28.44M $31.31M
YoY Change -31.08% -29.99% -21.11%

Cashflow Statement

Concept 2020 Q4 2020 Q1 2019 Q4
OPERATING ACTIVITIES
Net Income -$2.511M -$2.720M -$3.370M
YoY Change -25.49% -61.03% -47.34%
Depreciation, Depletion And Amortization $10.00K $0.00 $760.0K
YoY Change -98.68% -100.0% 204.0%
Cash From Operating Activities -$1.490M -$3.210M -$580.0K
YoY Change 156.9% -36.81% -85.32%
INVESTING ACTIVITIES
Capital Expenditures -$290.0K $0.00 $0.00
YoY Change -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $20.00K $700.0K
YoY Change -100.0%
Cash From Investing Activities -$290.0K $20.00K $700.0K
YoY Change -141.43% -140.0% -3600.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 3.070M 0.000 0.000
YoY Change -100.0% -100.0%
NET CHANGE
Cash From Operating Activities -1.490M -3.210M -580.0K
Cash From Investing Activities -290.0K 20.00K 700.0K
Cash From Financing Activities 3.070M 0.000 0.000
Net Change In Cash 1.290M -3.190M 120.0K
YoY Change 975.0% -368.07% -105.66%
FREE CASH FLOW
Cash From Operating Activities -$1.490M -$3.210M -$580.0K
Capital Expenditures -$290.0K $0.00 $0.00
Free Cash Flow -$1.200M -$3.210M -$580.0K
YoY Change 106.9% -36.31% -85.2%

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<font style="font-weight:normal;">&#160;</font>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&#160;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. (&#8220;Organovo&#8221; or the &#8220;Company&#8221;) is<font style="color:#000000;"> an early-stage biotechnology company that is developing and utilizing</font> highly customized 3D human tissues as dynamic models of healthy and diseased human biology for drug development<font style="color:#000000;">. </font>The Company&#8217;s proprietary technology is being used to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. The Company&#8217;s advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. The Company believes these attributes can enable critical complex, multicellular disease models that the Company will use to develop clinically effective drugs for selected therapeutic areas. Except where specifically noted or the context otherwise requires, references to the &#8220;Company,&#8221; or &#8220;Organovo&#8221; 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-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-style:italic;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">Historical Operations and Strategic Alternatives Process</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;">Prior to August 2019, the Company has focused its efforts on developing its <font style="font-style:italic;">in vivo</font> liver tissues to treat end-stage liver disease and a select group of life-threatening, orphan diseases, for which there are limited treatment options other than organ transplantation. The Company also explored the development of other potential pipeline <font style="font-style:italic;">in vivo</font> tissue constructs in-house and through collaborations with academic and government researchers. In the past, the Company also explored the development of <font style="font-style:italic;">in vitro </font>tissues, including proof of concept models of diseased tissues, for use in drug discovery and development.</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;">In August 2019, after a rigorous assessment of its <font style="font-style:italic;">in vivo </font>liver therapeutic tissue program, the Company concluded that the variability of biological performance and related duration of potential benefits no longer supported an attractive opportunity due to redevelopment challenges and lengthening timelines to compile sufficient data to support an investigational new drug (&#8220;IND&#8221;) filing. As a result, the Company suspended development of its lead program and all other related in-house pipeline development activities.</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&#8217;s Board of Directors (the &#8220;Board&#8221;) also engaged a financial advisory firm to explore the Company&#8217;s available strategic alternatives, including evaluating a range of ways to generate value from its technology platform and intellectual property, its commercial and development capabilities, its listing on the Nasdaq Capital Market, and the Company&#8217;s remaining financial assets. These strategic alternatives included possible mergers and business combinations, sales of part or all of its assets, and licensing and partnering arrangements. The Company implemented various restructuring steps to manage its resources and extend its cash runway, including reducing commercial activities related to its liver tissues, except for sales of primary human cells out of inventory, negotiating an exit from its long-term facility lease, selling various assets, and reducing its workforce. Additionally, in November 2019, the Company sold certain inventory and equipment and related proprietary information held by its wholly-owned subsidiary, Samsara Sciences, Inc. (&#8220;Samsara&#8221;), and as a result of such sale, Samsara ceased its operations.</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;">After conducting a diligent and extensive process of evaluating strategic alternatives and identifying and reviewing potential candidates for a strategic acquisition or other transaction, which included the receipt of more than 27 non-binding indications of interest from interested parties and careful evaluation and consideration of those proposals, and following extensive negotiation with Tarveda Therapeutics, Inc. (&#8220;Tarveda&#8221;), on December 13, 2019, the Company entered into a merger agreement with Tarveda (the &#8220;Merger Agreement&#8221;). Pursuant to the Merger Agreement, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, the Company&#8217;s wholly-owned merger subsidiary would merge with and into Tarveda (the &#8220;Merger&#8221;), with Tarveda <font style="Background-color:#FFFFFF;color:#000000;">becoming a wholly-owned subsidiary of Organovo and the surviving corporation of the Merger&#160;</font>. The Merger Agreement included various conditions to the consummation of the Merger, including approval by the Company&#8217;s stockholders at a Special Meeting of Stockholders to be held on April 7, 2020 (the &#8220;Special Meeting&#8221;).</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;">At the Special Meeting, the Merger was not approved by the Company&#8217;s stockholders. As a result, the Company terminated the Merger Agreement with Tarveda. Pursuant to the terms of the Merger Agreement, the Company was obligated to reimburse certain of Tarveda&#8217;s merger-related expenses not to exceed $300,000, which was offset by Tarveda&#8217;s portion of shared expenses incurred by Organovo in fiscal 2020.</p> <p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-style:italic;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">The Cooperation Agreement and Advisory Nominees Proposal</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;">Following the Special Meeting and the termination of the Merger Agreement, the Board continued to solicit stockholder feedback regarding the Company&#8217;s strategic alternatives and how to maximize stockholder value. In response to feedback from its largest stockholder regarding its desire for the Board to consider opportunities in the 3D bioprinting field and suggestion that the Board should speak with Keith Murphy, the Company&#8217;s founder, stockholder and former Chief Executive Officer and Chairman, for potential business ideas, the Board initiated discussions with Mr. Murphy. Based on these discussions, the Company entered into a Cooperation Agreement with Mr. Murphy on July 14, 2020 (the &#8220;Cooperation Agreement&#8221;). Under the terms of the Cooperation Agreement, the Board appointed Mr. Murphy and Adam K. Stern to the Board as Class III directors, and two of the Company&#8217;s existing directors, Richard Maroun and David Shapiro, resigned from the Board and all Board committees. The Board also agreed to nominate, recommend, support and solicit proxies for the re-election of Messrs. Murphy and Stern at the Company&#8217;s 2020 Annual Meeting of Stockholders (the &#8220;2020 Annual Meeting&#8221;). The Board also agreed to nominate, recommend, support and solicit proxies for an advisory stockholder vote (the &#8220;Advisory Nominees Proposal&#8221;) at the 2020 Annual Meeting to appoint three individuals, Douglas Jay Cohen, David Gobel and Alison Tjosvold Milhous (collectively, the &#8220;Advisory Nominees&#8221;), to the Board. Mr. Murphy identified each of the Advisory Nominees. The Board approved the appointment of the Advisory Nominees, to be automatically effective immediately following the final adjournment of the 2020 Annual Meeting if the final vote tabulation for the Advisory Nominees Proposal received more votes cast &#8220;FOR&#8221; than &#8220;AGAINST&#8221; its approval. In addition, each of the Company&#8217;s then-current directors (other than Messrs. Murphy and Stern) agreed to resign from the Board immediately following the appointment of the Advisory Nominees. At the 2020 Annual Meeting held on September 15, 2020, the Company&#8217;s stockholders approved the re-election of Messrs. Murphy and Stern to the Board as Class III directors with votes &#8220;For&#8221; of 59,229,909 (98.9%) and 59,147,657 (98.8%), respectively, to hold office until the 2023 Annual Meeting of Stockholders. The final vote tabulation for the Advisory Nominees Proposal received more votes cast &#8220;FOR&#8221; than &#8220;AGAINST&#8221; its approval, with votes &#8220;For&#8221; of 54,368,360 (91.4%) and, accordingly, effective upon the final adjournment of the 2020 Annual Meeting, Ms. Milhous was appointed as a Class I director to hold office until the 2021 Annual Meeting of Stockholders and Messrs. Cohen and Gobel were appointed as Class II directors to hold office until the 2022 Annual Meeting (collectively, the &#8220;New Director Slate&#8221;) and Carolyn Beaver, Taylor Crouch, Mark Kessel and Kirk Malloy, Ph.D. each resigned as directors.</p> <p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Current Drug Discovery Business</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;">Following the election of the New Director Slate, the Company has recommenced operations and is now focusing its future efforts on <font style="color:#000000;">developing highly customized 3D human tissues as dynamic models of healthy and diseased human biology for drug development</font>. <font style="color:#000000;">The Company&#8217;s proprietary technology is being used to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. The Company&#8217;s advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. The Company believes these attributes can enable critical complex, multicellular disease models that it will use to develop clinically effective drugs for selected therapeutic areas.</font> Market opportunities may include externally-partnered or internally-directed drug discovery and the clinical development of new molecular entities or repurposed drugs in-licensed from other pharmaceutical companies. The Company's goal is to establish a pipeline of drug candidates in high-value disease areas, aiming to commence human clinical testing for at least one drug candidate within a three to five year timeframe. </p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</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,&nbsp;&nbsp;emerged. While initially the outbreak was largely concentrated in China, it has since spread globally and 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. </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&#8217;s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak and <font style="color:#212529;">travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns</font>. In particular, the continued coronavirus pandemic could adversely impact the Company&#8217;s operations, including among others, raising additional capital, the timing and ability to pursue its strategy, given the impact it 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&#8217;s business and financial results.</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<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 critical accounting estimates.</p>
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