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.
The following information was last updated on June 24, 2015 and should be considered current as of that date.
Yes. On June 18, 2015, we issued a press release announcing the sale of 9,425,000 shares of our common stock in an underwritten public offering at a price to the public of $4.25 per share. Jefferies LLC and Piper Jaffray & Co. acted as joint book-running managers for the offering, and Cantor Fitzgerald & Co. acted as a co-manager for the offering. At the same time, we also announced that the we had granted the underwriters a 30-day option to purchase up to an additional 1,413,750 shares of common stock on the same terms and conditions and that we planned to close the offering on June 23, 2015. On June 19, 2015, the underwriters formally notified us that they had exercised their option to purchase the additional 1,413,750 shares of common stock. As a result, on June 23, 2015, we closed the public offering by selling an aggregate of 10,838,750 shares of common stock to the underwrites and raised gross proceeds of $46,064,688.
We undertook the financing to help us achieve several goals:
• Grow the number of tissue types we commercialize and expand the uses of current tissues;
• Bring more institutional investors in directly through the round, which should provide greater stability in stock trading; and
• Build our reputation with investment banks to encourage additional analyst coverage, which is necessary to attract long-term institutional holders to acquire our stock.
We have a number of promising uses for the funds from this round, both in growing the liver and kidney tissues business and in new areas that require additional capital:
• Capacity expansion for liver and kidney tissues. We have been adding capacity under our current operating plan which is expected to come on line in the second half of 2015. However, we are projecting demand that will require us to grow beyond this capacity expansion, and our belief that we need to add another manufacturing facility has been reinforced by the strong launch success of exVive3D Liver. We will need to invest to grow the capacity to meet that demand, or face not being able to take full advantage of the commercial opportunity.
• Investment in new tissue buildouts for commercial uses. For example, while our collaboration with L’Oréal funds the development of one or more 3D skin models, this development is through the point of model validation focused on cosmetic uses. The opportunity to use it more broadly requires a further investment, to commercialize the model for wider use, make it relevant for dermatology pharma use, etc. We can accelerate its readiness as a service and product offering, and in parallel develop disease models. Similarly, our cancer models are advancing and will do so more rapidly with resources we can provide given this capital raise.
• Drug discovery models. We have invested heavily in liver and kidney and have built "healthy tissues". That investment can be further leveraged by investing in disease models – for instance, working to adapt the healthy liver tissue to a liver fibrosis model, or to adapt the kidney tissue to build a polycystic kidney disease model. These investments directly in disease models can transform us from doing deals at the current level with pharma to doing larger deals, because the data sets are at the ready and don't need time to be developed. These models can even be used directly by Organovo to screen for drug candidates, a step that may enable us to garner even more value from pharma.
We strongly believe we have passed a point of validation on our tissues where investment beyond the plans that we had at the beginning of 2015 is warranted and provides us with the opportunity to build tremendous value. We've now hit critical validating proof in liver tissue, kidney tissue, skin tissue, cancer models, and others. One year ago, we were at that point of high confidence only with liver tissue. Now that in recent months we've hit such tremendous milestones from a scientific R&D perspective, it’s time to jump on the opportunity to do even more and create even larger value for shareholders. We all share the vision that bioprinting can be a dominant technology to solve biomedical problems in the future - but that doesn't happen by Organovo being content with simply moving the ball forward commercially with liver and kidney for toxicology. We believe our shareholders are investing in a leader in the space, and we want to extend that position into new areas where we think it can yield long term value for shareholders.
Organovo regularly emphasizes to our investors that our 3D bioprinting capability is a platform technology. We have been consistent in communicating to our shareholders that we will take advantage of financing opportunities when we believe they can offer long term shareholder benefit. We have often repeated this after discussing that we had two years of capital in hand under our previous operating plan, that we would seek to be opportunistic if we could do more.
Our financing in August 2013 and subsequent ATM capital raises created the opportunity to build the tissue models we have highlighted throughout 2014 and 2015. Without those funds we wouldn't have had the ability to continue to operate, build out and launch liver tissue, or have developed kidney and cancer tissues to the points they have now reached. For $46M raised in August 2013, we have been building what we believe can grow to be two $100M+ annual revenue first to market tissue franchises. One way to think of the recent financing is to consider point number two in terms of potential uses of funds: we can now choose to develop four tissues that have the potential to deliver $400M+ per year in top line revenue instead of two tissues at $200M+. That is a considerable generalization of our potential opportunities, and there are other opportunities that we can get out of this financing as described above, but we strongly believe these additional opportunities to be a win for all shareholders.
The discount level in our deal reflects a market rate within the normal discount range in biotech financings. It is customary to see discounts offered in follow-on raises to institutional investors, and they happen as a normal part of the secondary market. Institutional investors in biotech are accustomed to seeing deals like the recent Organovo offering take place. Over the three months prior to our deal, the average discount in the life sciences for confidential secondary offerings, for companies with a market cap in our range, was 14.3%.
We communicated in the shareholder letter in February about the benefits of additional capital and some of the opportunities we saw, about which we can now be more specific. We had no specific plans in place until shortly before commencing the financing. Our communication during and after the offering last week was limited by rules that bound the company until the closing of the deal, which took place more recently this week.
The information below was last updated on April 2, 2015 and should be considered current as of that date.
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 (Previous 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.
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.