ONVO.xyse - Organovo Holdings, Inc.

Organovo Holdings, Inc., a development-stage company, focuses on developing and commercializing functional human tissues that could be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. The company is developing a suite of standardized and three-dimensional human tissues for the preclinical assessment of drug effects, including applications in predictive toxicology, absorption, distribution, metabolism, excretion, and drug metabolism and pharmacokinetics; customized human tissues as living, dynamic models of human biology or disease, for use in drug discovery and development; and three-dimensional human tissues for clinical applications, such as blood vessels for bypass grafting and nerve grafts for nerve damage repair, as well as functional tissue patches for the repair or replacement of damaged tissues and organs. Organovo Holdings, Inc. has collaboration agreements with United Therapeutics Corporation; Knight Cancer Institute at Oregon Health & Science University; Michael J. Fox Foundation; Hoffman La Roche; Janssen Pharmaceuticals; and L'Oreal. The company was founded in 2007 and is headquartered in San Diego, California.

Analise Tecnica:



A cotação encontra-se numa tendência de subida a corrigir nos últimos dias á média movel, acima de um forte suporte e com uma linha de resistência descendente que poderá travar a subida da cotação.

Análise Fundamental:

Não existem dados suficientes para aplicar o modelo económico futuro.

Apresentou resultados a dia 7 de Novembro.

Form 10-Q for ORGANOVO HOLDINGS, INC.

7-Nov-2014

Quarterly Report


Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following management's discussion and analysis should be read in conjunction with the Company's historical consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2014. The management's discussion and analysis contains forward-looking statements, such as statements of our plans, objectives, expectations and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions such as "will," "may," "could," "should,", or similar expressions, identify certain of these forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to risks and uncertainties, including those described in "Item 1A-Risk Factors" of this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the fiscal year ended March 31, 2014 that could cause our actual results or events to differ materially from those expressed or implied by such forward-looking statements. Except to the limited extent required by applicable law, the Company does not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Quarterly Report.

Basis of Presentation

References in this section to "Organovo Holdings, Inc.," "Organovo Holdings," "we," "us," "our," "the Company" and "our Company" refer to Organovo Holdings, Inc. and its consolidated subsidiary Organovo, Inc.

The condensed consolidated financial statements included in this Form 10-Q have been prepared in accordance with the SEC instructions to Quarterly Reports on Form 10-Q. Accordingly, the condensed consolidated financial statements presented elsewhere in this Form 10-Q and discussed below are unaudited and do not contain all the information required by U.S. generally accepted accounting principles ("GAAP") to be included in a full set of financial statements. The audited financial statements for the year ended March 31, 2014, filed with the SEC on Form 10-K on June 10, 2014 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in this Form 10-Q. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results of operations for the entire year.

Overview

Organovo, Inc. was founded in Delaware in April 2007. Activities since Organovo, Inc.'s inception through September 30, 2014 were devoted primarily to developing functional three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. As of September 30, 2014, Organovo, Inc. has devoted substantially all of its efforts to product development, raising capital and building infrastructure. Organovo, Inc. has not, as of that date, realized significant revenues from its planned principal operations.

On February 8, 2012, Organovo, Inc., a privately held Delaware corporation, merged with and into Organovo Acquisition Corp., a wholly-owned subsidiary of the Company, with Organovo, Inc. surviving the merger as a wholly-owned subsidiary of the Company (the "Merger"). As a result of the Merger, the Company acquired the business of Organovo, Inc., and will continue the existing business operations of Organovo, Inc.

Critical Accounting Policies, Estimates, and Judgments

Our financial statements are prepared in accordance with accounting principles that are generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We continually evaluate our estimates and judgments, the most critical of which are those related to revenue recognition, valuation of long-lived assets and warrant liability, stock-based compensation and the timing of the achievement of collaboration milestones. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known. Besides the estimates identified above that are considered critical, we make many other accounting estimates in preparing our financial statements and related disclosures. All estimates, whether or not deemed critical, affect reported amounts of assets, liabilities, revenues and expenses, as well as disclosures of contingent assets and liabilities. These estimates and judgments are also based on historical experience and other factors that are believed to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known, even for estimates and judgments that are not deemed critical.

Table of Contents

For further information, refer to the Company's audited financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended March 31, 2014, filed with the Securities and Exchange Commission (the "SEC") on June 10, 2014.

Results of Operations

Comparison of the three months ended September 30, 2014 and 2013

Revenues

For the three months ended September 30, 2014, total revenues of $50,000 were $27,000 or 117% above the $23,000 in revenues for the same period in 2013. For both periods, the majority of revenues were derived from collaborative research agreements. POSITIVE

Operating Expenses

Overview

Operating expenses increased approximately $3.4 million, or 61%, from approximately $5.6 million for the three months ended September 30, 2013 to $9.0 million for the three months ended September 30, 2014. Of this increase, $1.8 million relates to increased selling, general and administrative expense while the other $1.6 million relates to increased investment in research and development. These increases can be attributed to the Company's continued implementation of its business plan, including hiring additional staff to support research and development initiatives, incremental investments associated with strategic growth and commercialization project initiatives, expenses related to operating as a publicly traded corporation, expansion of its facility, and increased stock compensation expense relative to employees and certain consulting services.

Research and Development Expenses

Research and development expenses increased nearly 100% from approximately $1.6 million for the three months ended September 30, 2013 to $3.2 million for the three months ended September 30, 2014, as the Company increased its research staff to support its obligations under certain collaborative research agreements and to expand its product development efforts in preparation for research-derived revenues. Full-time research and development staffing increased from twenty-four full-time employees as of September 30, 2013 to forty-four full-time employees as of September 30, 2014. In addition to an increase in staffing expense of approximately $0.5 million and an increase in stock-based compensation of $0.2 million resulting from increased headcount and increasing stock prices from September 30, 2013 to September 30, 2014, the Company increased its spending on recruiting, lab equipment and supplies in proportion to its increased research activities. In addition, the Company has continued to invest additional resources to advance its bioprinting technology during the period.

General and Administrative Expenses

For the three months ended September 30, 2014, general and administrative expenses were approximately $5.8 million, an increase of $1.8 million, or 44%, over expenses in the same period of 2013 of approximately $4.0 million. Stock-based compensation increased $0.6 million due to additional grants and increasing stock prices from September 30, 2013 to September 30, 2014. Staffing expense increased $0.4 million due to an increase in administrative headcount from twelve full-time employees to sixteen full-time employees to provide strategic infrastructure in developing collaborative relationships and preparation for commercialization of research-derived product introductions. In addition, the Company incurred additional expenses for investor outreach initiatives and consulting activities in the three months ended September 30, 2014 as compared to the three months ended September 30, 2013.

Other Income (Expense)

Other income was less than $0.1 million for the three months ended September 30, 2014 and consisted primarily of a gain related to the revaluation of warrant derivative liabilities. This gain was caused by a declining stock price during the quarter that decreased the value of the derivative liability. For the three months ended September 30, 2013, other expense consisted primarily of a $4.8 million loss related to the revaluation of the warrant derivative liability due to rising stock prices during the period that caused an increase in the value of the derivative liability. In addition, the majority of the underlying warrants to which the derivative relates were exercised or converted to equity instruments during fiscal 2014, significantly lessening the impact of subsequent changes in our stock price.
NEGATIVE

Table of Contents

Comparison of the six months ended September 30, 2014 and 2013

Revenues

For the six months ended September 30, 2014, total revenues of $0.1 million were consistent with the $0.1 million in revenues for the same period in 2013. For both periods, the majority of revenues were derived from collaborative research agreements.

Operating Expenses

Overview

Operating expenses increased approximately $6.0 million, or 64%, from approximately $9.5 million for the six months ended September 30, 2013 to $15.5 million for the six months ended September 30, 2014. Of this increase, $3.1 million is related to increased selling, general and administrative expense while the other $2.9 million relates to increased investment in research and development. These increases are attributed to the Company's continued implementation of its business plan, including hiring additional staff to support research and development initiatives, incremental investments associated with strategic growth and commercialization project initiatives, expenses related to operating as a publicly traded corporation, expansion of its facility, and increased stock compensation expense relative to employees and certain consulting services.

Research and Development Expenses

Research and development expenses increased by approximately $2.9 million, or 95%, from approximately $3.1 million for the six months ended September 30, 2013 to approximately $6.0 million for the six months ended September 30, 2014, as the Company increased its research staff to support its obligations under certain collaborative research agreements and to expand its product development efforts in preparation for research-derived revenues. Full-time research and development staffing increased from twenty-four full-time employees as of September 30, 2013 to forty-four full-time employees as of September 30, 2014. In addition to increases in staffing expense of approximately $0.9 million and an increase in stock-based compensation of $0.4 million resulting from increased headcount and increasing stock prices from September 30, 2013 to September 30, 2014, the Company increased its spending on recruiting, lab equipment, supplies and contracted services in proportion to its increased research activities. In addition, the Company has continued to invest additional resources to advance its bioprinting technology during the period.

General and Administrative Expenses

For the six months ended September 30, 2014, general and administrative expenses were approximately $9.5 million, an increase of $3.1 million, or 49%, over expenses in the same period of 2013 of approximately $6.4 million. Stock-based compensation increased $1.1 million due to additional grants and increasing stock prices from September 30, 2013 to September 30, 2014. Staffing expense increased $0.7 million due to an increase in administrative headcount from twelve full-time employees to sixteen full-time employees to provide strategic infrastructure in developing collaborative relationships and preparation for commercialization of research-derived product introductions. In addition, the Company incurred additional expenses for investor outreach initiatives, consulting and legal activities in the six months ended September 30, 2014 as compared to the six months ended September 30, 2013.

Other Income (Expense)

Other income was less than $0.1 million for the six months ended September 30, 2014 and consisted primarily of a gain related to the revaluation of warrant derivative liabilities. This gain was caused by a declining stock price during the period that decreased the value of the derivative liability. For the six months ended September 30, 2013, other expense consisted primarily of a $4.8 million loss related to the revaluation of the warrant derivative liability due to rising stock prices during the period that caused an increase in the value of the derivative liability. In addition, the majority of the underlying warrants to which the derivative relates were exercised or converted to equity instruments during fiscal 2014, significantly lessening the impact of subsequent changes in our stock price.

Financial Condition, Liquidity and Capital Resources

Since its inception, the Company has primarily devoted its efforts to research and development, business planning, raising capital, recruiting management and technical staff, and acquiring operating assets. The Company has not commenced principal operations or realized significant revenue therefrom.

Since inception, the Company incurred negative cash flows from operations. As of September 30, 2014, the Company had cash and cash equivalents of approximately $54.4 million and an accumulated deficit of $107.5 million. The Company also had negative cash flow from operations of $9.7 million during the six months ended September 30, 2014. At March 31, 2014, the Company had cash and cash equivalents of approximately $48.2 million and an accumulated deficit of $92.2 million.

Table of Contents

At September 30, 2014, the Company had total current assets of approximately $55.1 million and current liabilities of approximately $3.1 million, resulting in working capital of $52.0 million. At March 31, 2014, we had total current assets of approximately $49.2 million and current liabilities of approximately $1.9 million, resulting in working capital of $47.3 million.

Net cash used by operating activities for the six months ended September 30, 2014 was approximately $9.7 million as compared to $6.3 million used in operating activities for the six months ended September 30, 2013. This $3.4 million increase in cash usage can be attributed to a $6.0 million increase in operating expenses, partially offset by an overall increase of $2.0 million of non-cash expenses included in operations, including stock-based compensation, depreciation and amortization, as well as changes in working capital.

Net cash used in investing activities was approximately $0.6 million and $0.1 million for the six months ended September 30, 2014 and 2013, respectively. This increase can be attributed to increased capital spending as the company expands its research capabilities.

Net cash provided by financing activities decreased from $44.1 million provided during the six months ended September 30, 2013 to $16.5 million provided during the six months ended September 30, 2014. This decrease is primarily due to the inclusion of $43.4 million in net proceeds from the issuance of common stock during the six months ended September 30, 2013, as compared to $16.1 million in net proceeds from the issuance of common stock during the six months ended September 30, 2014.

We believe our cash and cash equivalents on hand as of September 30, 2014, together with amounts to be received from our collaborative research agreements and the commercialization of our products and services, should be sufficient to fund our ongoing operations as currently planned for at least the next twelve months. Through September 30, 2014, we have financed our operations primarily through the sale of convertible notes, the private placement of equity securities, the sale of common stock through public offerings, and from revenue derived from grants or collaborative research agreements.

In addition, in November 2013, the Company entered into an equity distribution agreement with an investment banking firm. Under the terms of the distribution agreement, the Company may offer and sell up to 4,000,000 shares of its common stock, from time to time, through the investment bank in "at the market" offerings, as defined by the SEC, and pursuant to the Company's effective shelf registration statement previously filed with the SEC. During the three and six months ended September 30, 2014, the Company issued 2,197,768 shares of common stock in at the market offerings under the distribution agreement with net proceeds of $16.1 million. We intend to use the net proceeds from these offerings for general corporate purposes, including research and development, the development and commercialization of our products, general administrative expenses, license or technology acquisitions, and working capital and capital expenditures. We may also use the net proceeds to repay any debts and/or invest in or acquire complementary businesses, products or technologies, although we have no current commitments or agreements with respect to any such investments or acquisitions as of the date of this Quarterly Report on Form 10-Q.

The Company will need additional capital to further fund product development and commercialization of its human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. The Company intends to cover its future operating expenses through cash on hand, through additional financing from existing and prospective investors, from revenue derived from grants and collaborative research agreements, and revenue from the commercialization of products and services. However, we may not be successful in obtaining sufficient funding to support our operations from new or existing collaborative research agreements or the commercialization of products and services. In addition, we cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. Further, we cannot assure you that we will receive 100% of the potential funding under existing grants, and we may not be successful in securing additional grants in the future.

Having insufficient funds may require us to delay, scale back, or eliminate some or all of our development programs or relinquish rights to our technology on less favorable terms than we would otherwise choose. Failure to obtain adequate financing could eventually adversely affect our ability to operate as a going concern. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business.

As of September 30, 2014, the Company had 80,404,648 total issued and outstanding shares of Common Stock, and five year warrants for the opportunity to purchase an additional 869,239 shares of Common Stock at exercise prices between $0.85 and $1.00 per share and 263,870 warrants with terms between two and five years and exercise prices between $2.21 and $7.62 per share. If all warrants were exercised on a cash basis, the Company would realize approximately $2.3 million additional gross proceeds.

Table of Contents

The 2008 Equity Incentive Plan provides for the issuance of up to 896,256 shares of our outstanding Common Stock and the 2012 Equity Incentive Plan, as amended, provides for the issuance of up to 11,553,986 shares, or approximately 16% of our outstanding Common Stock, to executive officers, directors, advisory board members, employees and consultants. In aggregate, issued and outstanding common stock, shares underlying outstanding warrants, and shares reserved for the 2008 and 2012 incentive plans total 91,712,297 shares of common stock as of September 30, 2014.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements, including unrecorded derivative instruments that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. We have certain warrants and options outstanding but we do not expect to receive sufficient proceeds from the exercise of these instruments unless and until the underlying securities are registered, and/or all restrictions on trading, if any, are removed, and in either case the trading price of our Common Stock is significantly greater than the applicable exercise prices of the options and warrants.

Effect of Inflation and Changes in Prices

Management does not believe that inflation and changes in price will have a material effect on the Company's operations.

Recomendação:

Pelo gráfico técnico julgo que a tendência é de subida.

Visão geral da empresa: AQUI .

Acompanhamento da empresa: AQUI .

Organovo: Competition And Profit Potential
Sep. 29, 2014 4:52 PM ET  
Summary

   Organovo, a human tissue-engineering company, is on its way to launch the first 3-D bioprinted liver assay before the end of 2014.
   The market potential of the liver and kidney assays combined is in the billions.
   There are number of competitors emerging, but Organovo has a strong foothold.
   The stock comes with multiple risks, the major one being its volatility, but the profit potential is high.
   The current low price is a good entry point to go long on the stock.

Organovo Holdings, Inc. (NYSEMKT:ONVO) is a development stage company with the aim to produce functional human tissues to be used in drug discovery and development. These tissues will also be employed in therapeutic areas to treat damaged tissues and organs. The question arising here is how will they achieve the production of functional human tissues? This is where the magic word "3-D Printing" comes in - or "3-D Bioprinting" in Organovo's case. The company uses their proprietary 3-D bioprinting technology to print three-dimensional human tissues that replicate the composition and architecture of a natural human tissue. The printing is done through a first-in-class bioprinter named as NovoGen MMX that uses hydrogel and combinations of cellular building blocks or bio-ink. The printer uses a custom graphic user interface that facilitates 3-D design and execution thus allowing for better precision of the dispensing heads. In addition, the standard biosafety cabinet in which it fits ensures the sterility of the bioprinted tissues.
Collaborations

Organovo has a number of collaborations and agreements with pharmaceutical companies and research organizations. The company has partnerships with Johnson & Johnson (NYSE:JNJ) to use bioprinted tissue in drug discovery; AutoDesk Inc. for developing software for 3-D bioprinting; and also with ZenBio for cellular inputs for the live tissue generation.

Organovo has research agreements with United Therapeutics Corporation; Knight Cancer Institute to develop 3-D cancer models; Michael J. Fox Foundation for Parkinson's Research for developing of tissues for drug discovery; and also with Hoffman La Roche (OTCQX:RHHBY) to explore the use of 3-D liver tissue in toxicology.

The company also has collaborations with Harvard Medical School for vascularization of tissues; National Institute of Health partnerships with National Eye Institute for building eye tissue and with National Center for Advancement of Translational Sciences for drug discovery; with L'Oreal to explore the use of 3-D skins to test skin care products; and with University of Queensland for source cell lines development for 3-D kidney tissue bioprinting activities.
Candidates

The company's candidates are categorized into 3-D Human Novotissues for research, and the 3-D Human Therapeutics Novotissues, for research and therapeutics. The company has fabricated 3-D tissues for research, which include liver, bone, small airway, blood vessels, skeletal muscle, cardiac tissue and peripheral nerve conduits.

The main candidate of interest at the moment is the 3-D Human Liver Tissue Model to test the potential efficacy and toxicity of the drugs. These bioprinted liver tissues contain cells that are distinctive to the native tissue and replicate its architecture and composition. An important feature of the bioprinted tissues is the development of microvascular networks within the tissue. Vasculature - the vessel system of the body - is the major challenge when bioprinting tissues. The tissues can't survive without their supply of oxygen and nutrients, thus the presence of microvasculature networks in Organovo's 3-D tissue is a major achievement.


The tissue has the ability to survive for up to 42 days after printing, and is metabolically active. The opportunity for the use of these liver tissues is vast, and it's hoped and expected that the bioprinted tissues will save the exorbitant expenditure on clinical trials. The bioprinted liver tissue will be used to assess the toxicity of the drug under development and possibly save companies the sunk costs of failed clinical trials.

Roche used the 3-D liver tissue to assess the toxicity of its drugs in discovery. They reported that the response of the bioprinted tissue was like that of the native tissue. Not only this, the toxicity of the drug didn't show when originally tested on the 2-D liver assays until late stage trials, however, the toxicity was accurately predicted in Organovo's liver tissue.

This presents a major opportunity for Organovo and is a path forward to saving millions of dollars that go to waste on the failure of a trial. The company estimates an average contract for the liver assays to be around $150,000 and for the kidney assays, expected in 2016, of about $250,000, and a customer opportunity of 6500 for both. Each contract means a healthy stream of revenue from testing the toxicity of drugs over the development period. This presents a market opportunity in billions, thus the company could turn to profitability sooner rather than later.


Competitors

Organovo does not have major competitors listed on Yahoo Finance; however, it must be noted that there are number of companies focused on 3-D printing. The first company is Texas-based Tevido BioDevices that uses 3-D bioprinting to print living human cells to use as grafts or implants in reconstructive surgery and wound care. Their focus at the moment is breast cancer patients who have undergone mastectomies. They use inkjet printers that have been modified to print cells in place of ink. They are taking baby steps and now have printed breast nipples, and expect to launch the products in about three years' time on successful completion of clinical trials. The question here is whether Tevido is a threat to Organovo. And the simple answer to this is "No", because the focus of both the companies is different.

Another company that has surfaced with a 3-D bioprinter is Regenovo Biotechnology Co., a Chinese company printing tissue samples such as liver units and human ear cartilage. They expect to produce fully functional printed organs in the next ten to twenty years. However, they are yet to provide solid information to be able to compare their samples with those of Organovo or other similar concerns. What we do know is that Regenovo's bioprinter has a low cell damage rate, with about 90% cell surviving, and are able to stay alive for up to four months. Again, Regenovo is not a direct threat for Organovo, firstly because there is not sufficient information regarding their methods and effectiveness, and secondly because Organovo is way ahead of them in their advancement.

Another company making the rounds as a direct competitor of Organovo is Insphero AG - a privately held Swiss company - already in the market for organotype biological in vitro 3-D micro-tissues used for drug testing. Insphero uses its patented hanging-drop technology to produce scaffold-free 3-D microtissues that are very similar to native tissues. They claim to be the leader in 3-D cell culture technology and have already commercialized their 3-D Insight Liver Microtissues - which will be the source of competition for Organovo. However, Organovo's bio-printed liver tissues last for 42 days, while Insphero's 3-D liver microtissues last for 35 days. Not only this, Insphero already has deals with a number of pharmaceutical companies, including Pfizer, which use the company's assays for drug testing. Moreover, the company also has some 30+ collaboration partners, and a healthy stream of revenues. Organovo will have to prove the superiority of its product, once launched, to spearhead the competition.

Other competitors for Organovo include Cyfuse Biomedical KK, a Japanese corporation 3-D bioprinting 3-D tissues as well as bio-printed blood vessels; MicroFab Technologies Inc., which is developing a 3-D bioprinter along with Wake Forest Institute of Regenerative Medicine for skin engineering, among other applications; 3Dynamic Systems Ltd., a UK-based company developing 3-D bioprinters; and Aspect Biosystems aiming to provide living human tissues on demand; among others.
Market Performance

In the year 2013, the stock price of Organovo appreciated a whopping 369% and garnered major attention based on its sci-fi equivalent technology prospects. However, the attention did not continue into 2014 and to-date the shares have seen an almost 42% decline in the prices. The stock price as of Friday was $6.44 and is slowly nearing its 52-week low of $5.12. With the product launch a few months away, this low may in fact be a lucrative entry point since the shares of Organovo are volatile and a successful product launch may cause a major rally.
Financials

The company as of June 30, 2014 has cash and equivalents of approximately $44.9 million, down from $48.2 million at the year ended March 31, 2014. The company has a cash burn rate of approximately $1.1 million per month, thus the company should have about $41.6 million cash at the same level of operations. However, the company is expected to launch its liver tissue by the end of November, which will use up cash. If the company is able to strike a collaboration or licensing agreement deal in the upcoming months then cash availability may not be a major concern. On the contrary, without a deal the company at current levels of operations has cash enough for almost three years. However, increased usage of cash for marketing and sales efforts of the liver tissue product and other R&D activities may force the company to turn to raising additional capital, probably by next year.

The revenue for the first quarter of FY-2015 (ending June 31, 2014) was $0.1 million, attributed mainly to the collaborative agreements. The expenses and cash burn of the company has increased over the months, but it has not been able to increase the revenues through additional collaborations. The company does expect sales revenue if the 3-D liver tissue product turns out to be a major success - as touted.
Insider Trades


The institutional ownership of 20.14% is encouraging; however, the lack of insider buying is concerning. Over the period, there have been extensive insider selling, though they have been labeled as part of their 10b5-1 trading plan, as was seen recently in David Eric's case. However, this does not indicate that the company is going to falter and the science is going to fail - or similar speculations doing the rounds. Nevertheless, insider purchases before the launch of the 3-D liver assay would have a positive impact on the stock price and the investor sentiment.

Upcoming Events

The big catalyst for Organovo is the 3-D Human Liver Tissue launch by the end of November 2014. This event holds major importance for the company and owing to the stock's volatile nature will result in a price hike. The company has undertaken necessary steps for the launch of the product; a major step among them is the appointment of Gregory T. Lucier as the Corporate Advisor. If a successful launch is able to garner interest and a large number of customers, then the stock price will be able to sustain itself over a longer period.

Other upcoming events for Organovo include Stem Cell Meeting on the Mesa from 7-9 October, 2014; 19th North American Regional ISSX Meeting and 29th JSSX Annual Meeting from 19-23 October, 2014; Functional Analysis and Screening Technologies Congress from 17-19 November, 2014; and Society of Tox, 54th Annual Meeting and Tox Expo from 21-26 November, 2014. Any positive news relayed from these events will affect the stock prices. Additionally, if the company is able to attract a partner for developing and commercializing, it would help to reduce the high chances of dilution.

Risks

A major risk facing Organovo is the failure of its 3-D printed liver, expected to launch at the end of this year. The shares of Organovo are highly volatile and a failure or even a delay will result in a major price slash. The price slash will be further fueled by the investors who are negative on Organovo, as this will be major opportunity for them to jump on the 'bash Organovo' bandwagon. On the contrary, the success of the product would result in a major price hike.

Another concerning factor for Organovo is the shares sold by insiders and the lack of share purchases over an extended period. Reading too much into the selling may not be wise, but it does raise a red flag as to the reason for the sale, with the product launch few months away. The Chief Strategy Officer David Eric, who sold 30,000 shares executing the 10b5-1 trading plan, undertook the most recent insider selling.

The cash position of Organovo is expected to dwindle if they fail to attract partners or other agreements for its technology. With the increase in R&D and other expenditure, a dilutive stock offering may be on the horizon - probably early next year. The company also states the need for raising capital to fund its R&D efforts in its latest investor presentation, outlining the benefits it could reap from it.

Bottom Line

Organovo has an impressive technology and if successful in not only the functional tissues but also the future goal of printing organs, the company could turn around the biotechnology and healthcare sector forever. It would not only facilitate drug testing allowing the drugs to reach the market quickly, but would also help the patients awaiting donated organs. Printing the organs may be years away, but the launch of the functional liver tissue is just around the corner, and has already proven to be effective.

The presence of competition for Organovo may concern investors, but it must be kept in mind that when 3-D bioprinting takes off full force, there will be myriad of aspects where it will be applicable. Thus, the presence of others may not impede the progress of Organovo, at least not right away. Moreover, Organovo is the first company to have commercialized 3-D bioprinting and is already operating as a public company with million dollar potential. And with the success of its 3-D liver tissue most of the concerns, if not all, will somewhat disappear.

Organovo may have the attractive science, minimal competition, and growth prospects, but it is one risky investment - attractive mostly to those with risk appetites. The benefits of going long do compensate for the risks, and thus is worth the investment. However, the stock's volatility must be considered, as it is quick in declining and spiking. In my opinion, the current price decline is a good entry point to go long on the stock, and the prospect can be better understood with the upcoming events.

A cotação continua a lateralizar junto ao canal de resistência de tendencia descendente.

Após uma correcção na linha de suporte, a empresa tocou na linha de tendência ascendente com um enorme branco longo.

ANÁLISE DO SEEKING ALPHA


These Headwinds Make Organovo A Short Candidate
Dec. 10, 2014 2:39 PM ET

Summary

Organovo is highly overvalued.
Increasing expense is a big negative.
A secondary offering looks likely as the company is running out of cash.
Organovo is a short going into 2015.

After a rough 2014, shareholders of Organovo (NYSEMKT:ONVO) finally had something to cheer about when the company released its first product called exVive3D Human Liver Tissues last month. However, Organovo's stock price hasn't reflected the launch of its first official product as it has dropped almost 10% since the day of its launch, bringing the YTD total to -47%. Despite the steep drop, I think Organovo has a lot more downside, which is why I think it is the best short idea for 2015.

O ANALISTA AFIRMA QUE SE DEVE SHORTAR A EMPRESA.

Organovo has always been a speculative stock and has captured the interest of short-sellers. Although the launch of its first product may convince some investors to buy the stock, I think it may be a bad idea due to the reasons I've discussed below. But first, let's take a look at the company's business and how it expects to make money.

Organovo's business and the risks

As mentioned above, presently, Organovo only has one product in the market. The primary motive behind Organovo's liver tissue assay is to save big pharmaceutical companies money. Big pharmaceutical companies pour billions of dollars into bringing a new product into the market that ultimately fail due to undetected liver toxicity. Organovo claims that its liver tissues detect these toxicities sooner, saving the pharmaceutical companies a lot of cash.

While the technology did prove to be effective earlier in 2014, it's not possible to predict how the company's product will be received in the market. And given Organovo's present lofty valuation, I don't think investors should consider buying this stock. Although it isn't new for a small biotech company with potential to have lofty valuations, Organovo isn't worth buying.

The company is yet to report a profit or positive cash flow, however it commands a market cap of over $470 million. The company's annual revenue is less than $400,000, which means the company has a ridiculously high P/S ratio of 1,192!! Given these valuations, I think investors will be better off shorting Organovo as I don't see the company's new liver tissues justifying these towering valuations.

Dilution is on the cards

In the company's latest presentation, CEO Keith Murphy highlighted the concern of the company running out of cash. He said, "To be frank...we have to be cautious about the fact that we have a budget."

Also, in its latest earnings report, the company shared the expenditure figures which make the situation worse for long-term Organovo investors. The company's administrative expense has jumped 50% while the R&D expense is also up by 95%. This is a big cause of concern as Organovo only has under $55 million in cash and an accumulated deficit of $107.5 million and with a negative cash flow of almost $10 million, the company may soon run out of money. In the presentation, Keith Murphy didn't hide the fact that Organovo may have to offer secondary offering in order to raise cash to fund future expenses. Thus, I am confident that Organovo's stock will fall further in 2015.

High short interest

As it turns out, I'm not the only one who thinks Organovo is a great short. The short interest in Organovo has been on the up consistently. As of November 28th, there was short interest totaling 17,942,451 shares, an increase of 8.7% from the November 14th total of 16,513,962 shares. This means that almost 25% of the company's shares are being sold short. Such high short interest will limit Organovo's upside and also shows the company's aims are too far-fetched. Hence, I think investors should short Organovo going into 2015.

Conclusion

The effect of Organovo's new liver tissues on the company's revenue will not be known till mid to late-2015. And by that time, there's a high chance that the company may run out of cash due to the increasing expenditure. As a result of which a dilutive offering may occur. Hence, I think investors should short Organovo going into 2015.

Após o rally de final de Dezembro, a ONVO tem vindo a corrigir.
Tecnicamente consideramos uma boa compra se vier novamente ao suporte dos 5,50 dolares. Quebrou a mm20 e 50 dias. Vamos ver como se comporta nos próximos dias.

O sector onde se enquadra a empresa está bastante bullish e daí que a cotação já possa ter corrigido no cp.

A cotação encontra-se num canal descendente.