The wait is over. After almost three years of being listed as a public company, Organovo (NASDAQ:ONVO) -- the 3D bioprinting company that has captured the imagination of dreamers and ire of short-sellers alike -- is finally releasing its first product: exVive3D Human Liver Tissues.
The important details
At the beginning of 2014, Organovo promised that it would have its first marketable product -- the 3-D liver tissues -- available for purchase by the end of the year. Shortly thereafter, it accelerated that timetable by a month -- saying that the liver tissues would be released before the end of November. With Tuesday's announcement, the company has fulfilled those promises -- which should help explain the stock's 10% jump Tuesday morning.
There were many details in the announcement that had already been made public -- like the fact the liver assays have been able to respond as native tissues would to closely related toxic and non-toxic compounds. But a couple of new details were released that were of interest.
Previously, the company has said that only the liver tissues could live for over 40 days. Tuesday's release stated that, "The tissues are functional and stable for at least 42 days, which enables assessment of drug effects over study durations that well beyond those offered by industry-standard 2D liver cell culture systems." That differentiation -- between the duration of 2D and Organovo's 3D cells -- will be a critical factor in winning over customers.
Another curious detail, which has been hinted at in the past, is that Organovo won't actually ship the liver tissues to drug companies. Instead, if a drug company wants to test their compound for liver toxicity, they'll have to do it through Organovo's Contract Research Services program. In other words, the work is going to be done in-house. Though no specific details were given, the release insinuated that liver tissues would eventually be able for delivery.
How this could change things
For those unfamiliar with the idea behind Organovo's first product, the premise is simple: Pharmaceutical companies spend billions on bringing drugs to the market that eventually fail during late stage trials due to previously undetected liver toxicity issues. Because Organovo's tissues can detect these toxicities much earlier in the process, they can save Big Pharma companies billions by killing drugs quicker and sending them back to the drawing board.
So far, the results have been impressive. According to the company, "Organovo and Roche (OTC:RHHBY) did a retrospective analysis of a FDA-approved drug that was pulled from the market due to liver toxicity. Organovo's exVive is the only test that identified this drug as toxic."
Does that make the company a good buy?
To be certain, Tuesday's news is great for shareholders. But Organovo is far from a sure-bet investment. While the technology has proven to be effective, it remains to be seen what kind of reception it will get from the drug industry, and what customers will be willing to pay to have research done at Organovo's labs.
While the company has plans to branch out and create several other types of tissues, the liver assays are still the only product on the market right now.
When Organovo announced earnings a few weeks ago, it revealed that Selling, General, and Administrative costs had jumped almost 50% while research and development spending was up a whopping 95%. With the company not having brought in any substantial revenue in its entire history, some may be worried about such increases. On the other hand, the significant uptick could be viewed as a positive sign that management is working to make sure there are enough hands on deck to meet demand.
As of Sept. 30, the company had about $54 million in cash on hand. That's a decent safety net that should be more than enough if demand is strong for the liver tissues. If not, however, Organovo could find itself in a very tough spot.