As far as developmental companies go, Organovo Holdings (NASDAQ:ONVO) has had a phenomenal 2013. Shares are up more than 240% with just two weeks remaining in the year, although wild volatility could push that figure significantly up or down before the calendar gives way to next year. That should get you thinking: What can investors expect from the company in 2014? Let's review.
3-D liver tissues
Let's just get this out there: I don't think investors should expect shares to triple again in 2014. I'm not convinced progress made this year backs up share gains, and I don't see much on the table for next year. Nonetheless, the company will continue to make strides with 3-D liver tissues, its first product candidate, in preparation for their potential launch late next year. That alone could continue to feed investor optimism, a metric that's difficult to pin down.
The company has already begun functional testing to collect data on how its liver tissues respond to known liver toxicants, which can be compared to native liver function to build predictive models. That will continue early next year before key opinion leaders -- academic and industry labs -- obtain samples for testing of their own to further validate the product. If all goes well, the company will launch 3-D liver tissues for toxicology assays in December 2014, with kidney and heart tissue assay launches following. Thus, investors will have to exhibit extreme patience to realize the company's potential.
A collaboration with Oregon Health & Science University Knight Cancer Institute to develop cancer tissue models for pharmaceutical research is expected to report research progress by the second half of 2014. The cancer models being developed or waiting to be develop include liver, lung, kidney, bone, blood vessel, and heart tissues. Depending on progress and data, Organovo Holdings could announce formal research partnerships with major pharmaceutical companies toward the end of 2014, although investors should remember that progress in this area is extremely preliminary.
Organovo Holdings has been vague on its plans beyond 3-D liver tissues and cancer models, although given the company's youth, that shouldn't be too surprising. It also makes sense to focus its efforts and limited resources on a single, high-probability product to gain credibility. At any rate, management hopes to form additional pharmaceutical partnerships and develop a proof of concept for its tissue therapy ambitions. The latter is pretty exciting, even if it is the furthest from the market.
Tissue therapy products include lung, heart, and bone tissues; blood vessels; and one day, fully functional organs for transplantation. This part of the company's product pipeline will be required to complete clinical testing, which makes their eventual launch at least a decade away (barring any expedited review process initiated by the Food and Drug Administration). The potential is difficult to ignore, although early developments shouldn't be factored into valuation just yet.
Foolish bottom line
As you can tell, 2014 won't be the year Organovo Holdings sheds the title "developmental company." The company won't have product revenue next year and, barring a research partnership with a major pharmaceutical company, won't have substantial collaboration revenue, either. Even in a best-case scenario where the company captures an upfront payment or two, I find it difficult to justify its $700 million market cap. I would advise investors to stick to the sidelines to save themselves from the volatility.
Fool contributor Maxx Chatsko has no position in any stocks mentioned. Check out his personal portfolio or his CAPS page, or follow him on Twitter, @BlacknGoldFool, to keep up with his writing on biopharmaceuticals, industrial biotech, and the bioeconomy.
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