Many, but not all, analysts had a dim view of Onyx Pharmaceuticals (ONXX) at the beginning of 2012. Onyx had only one approved therapy, Nexavar for liver and kidney cancer. Between sharing Nexavar revenues with marketing partner Bayer and heavy R&D spending on new drugs and indications, Onyx ended in the red in most quarters.
What a difference a year makes. Onyx now has four approved indications and data that should earn approval for two more. A deeper pipeline exists as well. Its newly approved drug Kyprolis for MM (multiple myeloma) had revenues of $62 million, most of which would have been in the fourth quarter. This does not necessarily mean that Onyx will show a profit for Q4, but it does look like 2013 will be remarkably good, with 2014 even better.
The third approved therapy, and fourth approved indication, is Stivarga (formerly Regorafenib), which was also developed in conjunction with Bayer. Bayer will do the selling and Onyx will receive a 20% royalty, which will be cash that goes straight to the bottom line. Stivarga was approved in September 2012 for colorectal cancer patients who have been previously treated with currently available therapies. Royalties should ramp in 2013.
The fifth indication for Nexavar is iodine-refractory differentiated thyroid cancer. Again, Bayer will do the sales and share revenue with Onyx. The Phase III trial results are still to be submitted to the FDA, but approval is likely and revenue could commence in late 2013 or early 2014. Sixth, we have Stivarga for GIST, gastrointestinal stromal tumors.
So in 2013, we have a mid-sized biotechnology company with high expectations of multiple revenue ramps that should continue into 2014 and beyond. Early in 2012, you could have bought ONXX at its 52-week low of $35.73. As I write this, the price is $81.41, or 128% above that. It already hit a 52-week high of $93.18.
I see Onyx as a company that will demonstrate its ability to generate revenue and profits during 2013 and 2014, but it is important to keep in mind how lengthy global cancer ramps can be. There is the whole rest of the world and even today Nexavar is still expanding into new nations for liver and kidney cancer, several years after introduction. Cancer approvals often start in second-line or later settings. Revenues can ramp significantly if the drugs can get approvals for administering to new, first-line patients.
Also, there has to be a lot of unrealized value in the management team. There are a lot of therapies out there to buy the rights to develop. Most drugs fails somewhere between Phase I trials and FDA approval. Onyx management, led by Anthony Coles, M.D., has done a remarkable job picking therapies and targets for development. It might be just luck, but it likely means they will do well with their earlier-stage pipeline and any future rights they acquire.
Onyx still has a very high P/E ratio, but that should drift down as profits ramp in 2013. It looks to me like Onyx Pharmaceuticals is a stock to buy and hold for at least the remainder of this decade -- if you can think that long term.
Disclaimer: I am long ONXX and will not trade the stock for three days after the publication of this article.