Changing the shape of medical research and practice
This FAQ is for general information about Organovo.
Please also see our FAQ for SEC filing interpretation.
This information was last updated on May 15, 2014 and should be considered current as of that date.
Organovo has communicated proactively about planned insider transactions. Starting on October 10, 2013, through an 8-K filing with the SEC, Organovo proactively communicated about the trading plans for a number of its executives, disclosing sales plans that would be no more than 10% of holdings in almost all cases. We can confirm that, as previously guided, the plans that were put into place by Organovo insiders were fully completed by March 31, 2014. Insider selling of 10% or less is commonly referred to as not being a signal of anything other than a proper desire by a company executive to diversify assets. One source of good information on this is the following link: http://wiki.fool.com/Insider_selling
After the announcement regarding planned insider transactions in October 2013, the stock began a significant rise. Given such facts, we do not believe that Organovo shareholders have interpreted responsible insider diversification plans as a negative. The majority of shareholders recognize that under a 10b5-1 trading plan, the executive only specifies a number of shares to be bought or sold and the future timing when sales could commence, and that the magnitude of proceeds, beyond a triggering limit price, is something that is beyond the executive's control once the plan is set in motion. Please find a summary of recent Organovo insider transactions with a description of the activity involved in PDF form using this link.
On April 21, 2014, Organovo filed a libel complaint with the Delaware Court of Chancery against Simeon Research LLC, the author and publisher of two recent reports on Organovo that we believe contain unsubstantiated and intentionally misleading claims. We do not take this step lightly. Organovo continues to encourage an open dialogue about our business with our shareholders and the financial community. However, such dialogue must be truthful and ethically conducted. If lines are crossed, where necessary and appropriate, we will take strong action to protect the interests of our Company and our shareholders.
Organovo has confidence in its case and its ability to demonstrate that statements in the reports are false. The Company also has confidence in how the defendant will be viewed by the Court. Simeon Research LLC was formed as a legal entity, and its website was first created, shortly before the issuance of its first report on Organovo. Although it created the appearance of a “long/short analytical equity research” firm, its reports are not attributed by name to any person, in contrast to standard industry practice. Its website and incorporation documents contain no names of any individuals involved with the entity.
Despite the rapid flow of information on the internet today, only one website eventually saw fit to provide links to Simeon’s reports, despite an attempt to distribute them more broadly. Organovo believes this fact speaks loudly about how the websites judged these reports, and wishes to thank those sites that demonstrated their integrity.
KOL testing was identified as an important milestone for the company because it required delivery of tissues to an outside group of subject matter experts, and because KOL testing can influence our future customers once KOLs begin to publish results and present results at scientific forums. The milestone represents an important one to hit before launch, because independent KOL testing takes time to publish and customer uptake after launch can be improved by enabling earlier KOL testing. Investors should note that there is no expectation of a milestone around the company providing readouts from KOL use of the tissues, but rather the results of KOL testing will be incorporated into customer-facing product marketing on a future basis. KOL testing is not under company direction or control, but is fully independent and data from any KOL research is put into the public sphere directly by the KOLs themselves.
Organovo reserves all of its rights regarding legal action for false or defamatory information. The company has detailed at length the problems with such articles and independent reports in its communications. We ask investors to consider the source and watch for telltale signs in certain reports that:
• Appear only on investor sites that allow “walk-on” report submission, or are linked to by pages on such sites; starting a website that circulates content around Yahoo Finance and other stock quoting websites and filling that content with reports from all comers is a business model, not a path to providing investors with quality investment guidance;
• Use phrases like “Trading Warning” or “Urgent” explicitly intended to cause fear and based on no new publicly released information about the Company;
• Are written by a person with a short position and focused on negative details – with little balanced discussion of positives and negatives about the Company;
• Are written by an individual with no known track record in investing or equity analysis, no known scientific qualifications, or in fact no affiliation with any entity known to the investor which could provide any confidence in his or her qualifications;
• Pretend to a greater understanding of Organovo’s SEC filings, especially in regards to potential future financings or share registrations, and proceed to interpret them selectively in unbalanced ways;
• Are excessively focused on Organovo’s path to becoming public through reverse merger, ignoring the fact that the company’s subsequent fully underwritten secondary offering at >$40M, with full investment bank diligence, removes consideration of Organovo under the typical reverse merger listing standards by both NYSE and NASDAQ;
• Overemphasize Organovo’s lack of current revenue as somehow indicative of the promise of its future products rather than its status as a development stage biotechnology company;
• Highlight and demonize the potential for future financing instead of recognizing it as beneficial for shareholders under the right conditions;
• Focus on Organovo’s institutional investor holdings without noting that these holdings have grown significantly since early 2013, or without noting that the company conducted a financing round in August 2013 that consisted nearly entirely of seasoned institutional biotech investment funds;
• Cherry pick negative details for past companies where Organovo executives played roles, without discussion of the multiple successful roles the same executives have played in companies acquired for nine-figure sums, or their participation in product development for products and product lines currently generating revenue in the billions of dollars;
• Cherry pick quotes from the company, its founders, or its officers and suggest that the language of the quotes invalidate Organovo’s potential, when they are obviously out of context;
• Denigrate Organovo’s partnerships or doubt their existence – when review of all of the company’s relationships with these groups, including reviewing full contract detail and conducting direct discussions with the partner companies, is performed by investment bankers as part of diligence for underwritten deals such as Organovo’s sale of securities on August 1, 2013.
Organovo provides updates regularly on partnerships and collaborations, to the extent that it can, through our SEC Filings and Press Releases. Organovo must follow SEC regulations including Regulation FD and inform all investors of such updates at the same time, and thus cannot provide individual updates.
In a broad sense, we have previously guided that research collaborations with companies generally involve the partner providing research funding to cover the scope of work. These revenues are reflected in our financial statements, but we do not guide that investors should consider an increase in such revenues as a driver of profitability, as these are solely meant to offset costs of the collaborative research. The collaboration results and eventual product opportunities, including royalties and milestones, if any, are what can provide the potential for profitability in the future from such agreements. We have also guided that our academic and research institute collaborations typically involve both us and the academic partner contributing resources directly to projects. Organovo may contribute a bioprinter and technical support or a bioprinter plus significant research headcount, depending on the project scope. Organovo also generates some revenue from such collaborations, through such things as payment for bioprinter consumables, but this revenue is minimal and solely intended to offset costs. The development of new technologies or product opportunities, as well as the generation of fundamental new research and development expertise, provide the real drivers for such collaborations.
As an example of updates we provide, in regard to our work with Pfizer, Organovo noted on its last 10-K that “In December 2010, we entered into a Collaborative Research Agreement with Pfizer, Inc. (“Pfizer”) to develop tissue based drug discovery assays in two therapeutic areas utilizing our NovoGen MMX Bioprinter™ technology. We disclosed in 2012 that we had delivered constructs to Pfizer for internal evaluation as partial completion of the collaboration agreement; we additionally have delivered a study report to complete the scope of work in the original collaboration agreement. Constructs delivered by Organovo are currently being evaluated in the collaborator’s laboratory, and we anticipate that an additional agreement or agreements will be arrived at to utilize Organovo tissues in its future research efforts, although we can give no assurance that future agreements will be secured.” In our next 10-Q, we confirmed that we had recognized all revenue payable by Pfizer under the collaboration agreement, and we can provide no additional information at this time. We engage regularly with a broad set of pharmaceutical companies as part of our ongoing business development efforts, including Pfizer, but we can only provide updates to all investors at once through appropriate communication channels and upon reaching a signed agreement. It should be noted that, as described, our work with Pfizer was to develop tissue for drug discovery assays, and thus was explicitly not for liver toxicity. Organovo’s work on 3D Liver for toxicity began separately from our Pfizer agreement.
Through investor inquiries, Organovo became aware of a potential problem with Kanagawa Associates' representations of selling Organovo stock at a discount in October 2013. When we received inquiries we explained that we had no relationship with Kanagawa and that our stock was instead publicly traded through licensed broker/dealers. We believe that as a result of our expressed concerns and those of investors, several regulatory agencies including those in Japan and Scandinavia successfully posted warnings about Kanagawa in the territories they were operating, which to our knowledge did not include the United States.
To the Company’s knowledge, Kanagawa never actually sold shares to any investors, but is alleged instead to have simply accepted wired funds and not returned them. The practice of “cold-calling” is explicitly defined on the Japanese Financial Services Agency website warning as this practice – not actually selling shares, but promising to do so and then simply keeping the funds. The Japanese site also lists a “cold-calling” firm named “Tesla Acquisition Corporation”, so we assume that Organovo is not the only stock that cold-callers have used as bait. However, Organovo is unaware of how any such activity taking place outside the equity markets and not involving a broker/dealer who could actually sell shares can be hypothesized to have a material impact on the trading price of a NYSE MKT stock that has an average trading volume of over $60M a day.
Organovo had very little institutional ownership in the early days of the stock prior to our uplisting to the NYSE MKT, but institutional holdings have grown since then. One site providing information including % institutional ownership can be found at this link. The company targeted a fully institutional round for its August, 2013 financing round that brought in $46.6M in investment. With the help of the highly regarded investment bankers at Lazard and Oppenheimer, we achieved this, attracting investment from top healthcare investors who have some of the best research teams in the market. Our institutional holdings are strong and we intend to continue outreach to institutional investors by conducting activities such as those at last year’s Piper Jaffray and Oppenheimer Conferences, and by holding ongoing meetings through multiple investment banks who make introductions to institutional investment funds.
No, those numbers were taken from the Company’s three-month transition report for the period from January 1, 2013 and ending March 31, 2013. As such, they represent quarterly cash compensation for our named executives.
Organovo, Inc. was incorporated in 2007 to advance bioprinting technology and began its operations in San Diego, California in January 2009. Read more about our company's history.
The common stock of Organovo Holdings, Inc. became publicly traded on February 14, 2012.
Organovo’s common stock is publicly traded on NYSE MKT, under the symbol ONVO.
There are no currently marketed in vitro cell assays that use 3D Bioprinting in any way. There are cell models and 3D culture models that we believe do not achieve adequate representation of human biology, as evidenced by the fact that 40% of total pharma R&D spending is on drugs that fail in human trials. Current animal trials and human cellular models simply do not reproduce human biology sufficiently to be predictive. Many current products have limited markets specifically because of their lack of strong performance to customer needs.
Based on the data achieved to date with 3D Bioprinted tissues such as our 3D Liver, we see performance that has never been achieved previously. For example, in comparison to 2D cell cultures of human liver, which is by far the common standard used in the industry today, with over 90% market share, our 3D Liver tissues last for 40 days instead of 2 days, and demonstrate exceptional liver functional activity for that entire time. In short, in the same way that 3D printing enables new materials, structure complexity and manufactured item performance over the old tools of casting and molding, our technology is opening up brand new horizons in life science.
Other 3D Bioprinting efforts exist, but to date we have developed the only technology that can create tissues that consist entirely of human cells. We respect and partner with a number of the key academic centers also working on 3D Bioprinting. As it is very uncommon to see industries in which a full monopoly is maintained by any one company, we do expect competition to arise, but we expect to have excellent opportunities regardless. Rather than expecting Organovo to be the only 3D Bioprinting player in the future, investors might best consider Organovo to have the potential for a future market share befitting an early leader with strong intellectual property. Organovo notes that both the original biotechnology wave (Amgen, Genentech, Biogen, Genzyme) and the newer 3D Printing space have had multiple leaders, none of whom had complete IP control of the space, and each company achieved highly and retained tremendous potential as the market expanded. Organovo must execute strongly to achieve such potential, but does not have to achieve monopoly to do so.
Our CUSIP is 68620A 10 4.
Organovo, Inc. has been an operating company in San Diego, California since 2009 and currently operates as a fully owned subsidiary of Organovo Holdings, Inc. As a vehicle to provide capital for Organovo, Inc. operations and to provide access to public markets for equity securities, Organovo, Inc. entered into a reverse merger with Organovo Holdings, Inc. in February, 2012 concurrent with a private placement financing. Organovo Holdings, Inc. was a publicly traded shell company before completion of the reverse merger. Upon effectiveness of the reverse merger, former officers and directors of Organovo Holdings, Inc. resigned their positions and officers and directors associated with Organovo, Inc. assumed control of Organovo Holdings, Inc. In aggregate, approximately $15.2 million was raised in the private placement.
Subsequently, in August, 2013, Organovo Holdings, Inc. raised $46.6M in a fully underwritten secondary offering. Because of this, the Company is no longer treated as a reverse merger company in terms of qualification for exchange listing in compliance with SEC regulations.
No. You may purchase Organovo’s common stock through a registered brokerage or stock purchase service provider of your choice.
Approximately 78 million shares of common stock are issued and outstanding. Organovo has not issued any shares of preferred stock. There are approximately 90 million fully diluted shares, including approximately 1 million warrants and 10 million shares reserved under our 2008 and 2012 incentive compensation plans, combined. Of the 10M shares reserved under our incentive compensation plans, about 6M shares have been awarded already, leaving 4M shares for future awards.
Audited financial statements for the three-month transition period ended March 31, 2013 and for fiscal years ended December 31, 2012 and 2011 can be found in the form 10-KT filed with the SEC on May 24, 2013. The Company's most recent quarterly report was filed with the SEC on February 6, 2014 for the three month period ended December 31, 2013. These and all other reports filed with the SEC are accessible under the Investors/SEC Filings tab of our website.
We report earnings (Form 10-Q or Form 10-K) on or before the dates required by the SEC, which for non-accelerated filers is 45 days following the end of a quarter and 75 days following the end of a fiscal year. Our fiscal year ends March 31st. For periods beginning April 1, 2014, we will be classified as an accelerated filer and our filing requirements will accelerate to 40 days and 70 days for the quarter and annual filings, respectively.To stay informed about our SEC filings and press releases, please sign up for investor email alerts.
We do not pay a dividend on stock, and do not foresee doing so in the immediate future.
Our fiscal year-end is March 31.
Our auditors are Mayer Hoffman McCann P.C.
DLA Piper US, LLP serves as Organovo's legal counsel.
Please see this page for our Board of Directors.
Continental Stock Transfer and Trust. They can be reached at 1-800-509-5586.
The transfer agent is responsible for maintaining all records of registered stockholders (including change of address, telephone number and name), canceling or issuing stock certificates and resolving problems related to lost, destroyed or stolen certificates. If your shares are held in street name (i.e. by your broker), you must contact your broker for these services.
If you have lost a stock certificate, you should contact our transfer agent, Continental Stock Transfer and Trust, immediately so that they may place a "stop" on the form of certificate. Once the "stop" is placed, you may need to complete a "lost instrument bond" form. You can contact the transfer agent at 1-800-509-5586. Please note that surety bonds are typically required by transfer agents to replace lost, stolen, or damaged stock certificates.
If your shares are held in your name, you may contact Continental Stock Transfer and Trust, Organovo’s Transfer Agent, at 1-800-509-5586. If your shares are held in street name (by your broker), contact your broker to update your address.
Organovo is headquartered in San Diego, California.
Our introductory video provides representative exterior and interior views of our San Diego facility, and provides a view of our NovoGen Bioprinter™ in operation. The cleanroom environment in which our bioprinters operate renders tours impractical. Moreover, access to our laboratories is limited to individuals with adequate safety and GLP training.
You can sign up for email alerts and follow us on Twitter (@Organovo).
Contact our investor relations team by submitting this form.
Any statements contained in this website that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any such forward-looking statements are based on our current expectations, but are subject to a number of risks and uncertainties. The factors that could cause our actual future results to differ materially from our current expectations include, but are not limited to, the risks and uncertainties relating to our ability to develop, market and sell products based on our technology; the expected benefits and efficacy of our products and technology; the market acceptance for our products and technology, and the risks related to our business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including our reports on Forms 10-K, 10-Q and 8-K, as well as our other filings with the SEC. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.