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 March 10, 2015 and should be considered current as of that date.
Our commercial launch has met our expectations. As we previously stated, we have won a number of contracts already in this space, and we gave a win rate of “over 80%”. We also reported the first revenues ever from a 3D bioprinted tissue in the quarter ending Dec 31, 2014. As we noted, we recognized $139k of Product and Service revenue, representing the initiation of commercial activity on the exVive3D Liver.
While we appreciate that waiting for further financial results can be frustrating, the company detailed prior to product launch that results would be slow in coming, explained why, and has continued to explain in detail since that time. We described that there would be no revenues from contracts signed after launch to report until the quarter ending June 30, 2015. We further cautioned that due to the irregular nature of signing contracts, the time taken to reach contract with a new potential customer, and our service revenue only being recognized upon the completion of contractual milestones, it will take a number of quarters before investors are able to judge the initial acceptance of the product. Finally, we described that the company expects the market to develop like a typical product launch in the space and showed the relevant curve. A successful product in this space can see slow but steadily growing initial demand, followed by a later, faster phase of growth as a product matures and there are more peer to peer customer conversations about its benefits.
The exVive3D Liver is not a consumer product, it is instead a technical service sold to a finite number of companies. Each contract provides significant value to Organovo, but the sales of contracts is a high-effort, six to nine month endeavor. Rather than a collection of numerous events as in a basketball score, our efforts yield payoff more comparable to touchdowns in football. Although one could conclude that a basketball team that does not score in the first quarter might be destined to lose, one can’t draw sound conclusions about a football team that doesn’t score a touchdown in the early minutes of a game. This metaphor is to clarify the concept of number of outcome events only; certainly, as laid out above, we have already won contracts.
Investors should further understand that our quarter ending March 31 represents our fiscal year end. As that is the case, our results for the quarter will be filed in a 10-K by 70 days after the quarter, in early June. As we have previously guided, this quarter is expected to contain revenues resulting from pre-launch efforts. The results for the quarter ending June 30, 2015 will be filed as a 10-Q within 40 days after quarter end, in early August. Again, this will be the first quarter representing results solely from post-launch activities.
We do not have a plan to do so. The filing, if approved by SEC, allows Organovo to raise up to that amount over an unspecified period. However, it is typical for life science companies to file such plans for up to 40% of market cap, at levels significantly higher than any short term likely equity raises, for the purposes of future flexibility. Each filing has to be reviewed by the SEC, and therefore filing for smaller amounts each time can cause undue delays and lack of flexibility. A given filing can stand for years, and either be not used at all or used only partially.
In the past, Organovo filed a $100M shelf in 2013 and did not elect to raise that amount, but it was helpful to have flexibility up to a high level rather than file individually for each smaller fundraising activity. Later in 2013, we elected to raise $46.6M, but as of one year after the filing no additional amounts had been raised under that shelf registration. Over time, additional smaller amounts were raised via our ATM (which relied on the same $100M total cap), but we did not approach the $100M level total.
Organovo had over $50M cash as of its 10-Q filing representing the period ending Dec 31, 2014. We believe we have sufficient capital to run on our current plan for two years, implying no current need for capital to execute on this plan. As Organovo CEO Keith Murphy explained in his Shareholder Letter of 2/26, we have opportunities that we may choose to take advantage of that would involve raising capital if market conditions allow. We would only elect to do a financing if we believed market conditions were favorable, that doing so was better than available partner funding options, and we made a formal decision to pursue one or more of these business opportunities. Any financing is at our election and meant to take advantage of opportunity rather than done under a present need for capital to run the business.
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 a large share 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 fully 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 exVive3D™ Human Liver, we see performance that has to our knowledge 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 addition, our tissues were able to detect liver toxicity for a product that was taken into human trials, and failed at a late stage. These results demonstrated clearly that our tissue has been able to detect drug-induced liver injury that previously existing methods in the past failed to predict. The liver toxicity of that drug is commonly described as “unforeseen” because the pharma company that developed it studied it in both traditional cell methods and in animal models, and determined that it was likely not toxic to the liver; however, it proved to be toxic after clinical use in humans.
There are other novel attempts to solve the same problem, though Organovo provides a high-content result targeted at a small number of compounds during lead selection, rather than higher throughput screening. Lower cost options such as 3D cell culture/3D spheroid methods sold by Invitrogen and others since 2007, we believe, provide a less biologically relevant result than we have demonstrated and expect to deliver to a customer, and they do not operate at the same stage of research, focusing instead on providing an upstream low cost high throughput option. In fact these may be used by the same customer prior to engaging with Organovo for a final look on a select number of compounds at a higher price per compound. Either traditional 2D cell culture or another method may be used for that screening purpose before engaging with Organovo on a select number of compounds.
As has been discussed in publications of Organovo Scientific Founder Gabor Forgacs, and in our Investor slides as well, while cellular self-assembly can allow formation of certain microstructures, it not possible for complex tissues or large architectural features to self-assemble. In Prof. Forgacs’ 2010 publication in Biofabrication, a multilayer vascular tube with smooth muscle and fibroblasts, having each layer in the 250-500 micron thickness range is demonstrated, with a distinct cell type in each layer (Previous corporate slide deck: slide 7, column C). A mixture of those same cell types mixed 50:50 and bioprinted into a tube would not result in two layers, one of each cell type. As another example, our image (Prevvious corporate slide deck above, slide 16) showing the three cell types in the exVive3D™ Human Liver shows the way they are organized – that tissue is bioprinted, not self-assembled. In our experience that architecture is impossible to achieve from self-assembly alone. In addition, our bioprinted breast cancer tumor model (Current corporate slide deck: slide 25) has a 3D size and architecture that has not been obtainable by simple self-assembly, with epithelial cancer cells fully surrounded by multicellular stromal layer. In fact, as published literature shows, the natural “self-assembly” process of those same cells generally leads to the opposite structure, with the epithelial cancer cells coating the outside of the rest of the mass. If those cells were left to “self assembly” alone, the cells at the core would be on the outside and the cells on the outside would be at the core, but because the bioprinter can create an intact outer layer around the inside cells, they are trapped in place and form like a native tumor in a way superior to existing 3D tumor models. We have demonstrated repeatedly that the NOVOGEN BIOPRINTER® can direct complex, defined architectures using bioprinting that are simply not attainable via self-assembly.
As Organovo has discussed in its press releases and SEC filings, the Company has conducted and does conduct in-depth research studies. We won’t publish everything we do in our labs, of course, but we have published a significant number of studies. Our 8-K filings, for instance, have featured brief descriptions of a number of cases where we published data at a scientific conference. See, e.g., November 18, 2014. Multiple press releases posted on Organovo’s website discuss data from studies it has presented in settings such as the Experimental Biology Conference in April 2013 and the 3rd Annual Cell Therapy Bioprocessing Conference in October 2013.
Moreover, there are a significant number of peer-reviewed journal publications on our core technology, including one that was the most read publication of the year in 2010 in Biofabrication. We of course anticipate additional publications in the future. Bear in mind that our Liver R&D program reached its completion in the second half of 2014 leading up to the launch, and while peer reviewed journal articles are being pursued, the timeline to publication of a such an article can be as long as one year or more.
Yes. As the Company has previously stated publicly, as we transition from being a development-stage company to having earnings and recognizing revenue, we plan to begin conducting earnings calls.
Comments have been made by some who define themselves as Organovo competitors, and it is hardly surprising that such comments would be critical. Such comments should be taken with a healthy grain of salt, as they largely reflect competitive positioning. To put this in context, one would not rely too heavily on the opinions of Pepsi executives about the quality of Coca-Cola products.
It is important for investors to understand that many sites, including many of those featured in headline bullet points on Yahoo Finance in recent years, allow anyone to submit contributed content. There is no requirement for professional investment experience to be published, no guarantee of quality, and in our experience this contributed content often includes a disappointing lack of factual accuracy. There are often very poor processes for correction of errors or removal of such articles. In short, the greater distribution power of the internet has amplified the voice of individuals regardless of their qualifications, and the world is still learning to not believe everything they read. These outlets may be neither edited nor fact checked, as most publications were before the dawn of the internet, and must be judged accordingly. 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. Beware of reports that:
• Are written by a person with a short position and/or focused only 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;
• Use phrases like “Trading Warning” or “Urgent” explicitly intended to cause fear and based on no new publicly released information about the Company;
• 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 quotes from the Company, its founders, or its officers and suggest that the language of the quotes somehow invalidate Organovo’s potential, when they are obviously taken out of context;
• Cherry-pick quotes from one or a small number of bioprinting academics as indicative of a lack of overall Organovo scientific quality.
One site providing information including % institutional ownership can be found at this link. It consists of both traditional institutional funds, mutual funds, and index funds. The company targeted a fully institutional round for its August, 2013 financing round that brought in $46.6M in investment, and as of February, 2014 the information at the link reflected holdings by some of the funds that bought shares in that round, as well as many other institutions. 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.
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 80 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.
Audited financial statements for the three-month period ended December 31, 2014 can be found in the Form 10-Q filed with the SEC on February 6, 2015. The Company's most recent annual report was filed with the SEC on June 10, 2014 for the year ended March 31, 2014. 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. In general, we are required to file a 10-Q within 40 days from Dec 31, Jun 30, and Sept 30, and a 10-K annual report within 70 days of Mar 31 each year. Our fiscal year is April through March, so the March 31 date represents the end of our fiscal year. 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.
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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.