Regulatory and clinical catalysts are the lifeblood of developmental-stage biotechs in many ways. And as we've seen multiple times this year, these types of catalysts can catapult biotech stocks higher or cause them to crash with lightning speed. Nektar Therapeutics (NKTR 2.43%) is an interesting biotech in this regard because it has not one but three major catalysts coming down the pike within the next nine months. So, let's take a closer look at them and consider how they could affect Nektar's share price over the long term.
Naloxegol is up for regulatory approval
Perhaps the most talked about catalyst with Nektar is its treatment for opioid-induced constipation called naloxegol. Naloxegol was developed by Nektar using its PEGylation technology and subsequently licensed out to AstraZeneca (AZN +0.00%). Presently, the drug is up for regulatory approvals in the U.S., EU, and Canada later this year. However, investors are currently keying in on naloxegol's pending Advisory Committee date with the Food and Drug Administration, currently scheduled for June 11 to 12, followed by a PDUFA date of September 16.
The concern is that the FDA will ask for either a cardiovascular outcomes trial prior to approval or as a condition of approval. So, it's important to pay attention to the comments made at this upcoming meeting. What's particularly important to understand is that if the FDA asks for a full-blown safety study prior to approval, AstraZeneca can terminate its licensing agreement with Nektar. And adding insult to injury, Nektar would have to repay a $70 million milestone payment it received earlier with interest. On the other hand, if the FDA requests a post-approval safety study, Nektar will lose 2 percentage points on its royalty rate until $35 million in reduced payments is reached from global sales.
On the bright side, Nektar could bank up to $175 million in additional milestone payments if no safety studies are required. For a company presently slated to haul in only $190 to $195 million in licensing and royalty revenues this year, that's a nice chunk of change. So, you might want to circle naloxegol's upcoming advisory committee meeting on your calendar.
Baxter's licensed drug for hemophilia A will post top-line data this year
In another licensing deal, Nektar could benefit from the top-line data release for Baxter's (BAX +0.47%) treatment for hemophilia A called BAX 855. We should see this release sometime in the third quarter of this year, according to both companies. Moreover, Baxter plans on immediately filing a Biologics License Application following the data release, assuming the data warrants such a filing. What's key to understand is that Nektar is entitled up to $28 million in milestone payments for BAX 855, as well as royalties on worldwide sales. Some of these milestone payments have already been paid out over the course of the drug's development, but it's yet another potential revenue stream for Nektar going forward.
Nektar's breast cancer drug will report top-line results in early 2015
Nektar's metastatic breast cancer drug NKTR-102 is presently in a pivotal late-stage study that is expected to yield top-line results in early 2015. Because NKTR-102 has obtained fast-track status from the FDA, management plans on filing for a priority review and submitting a rolling New Drug Application if the data warrants a regulatory filing. In short, we could see NKTR-102 gain approval fairly quickly in 2015, if the study reports positive data. In my view, this is Nektar's biggest forthcoming catalyst and potentially its least noticed by investors. Breast cancer drugs tend to post absolutely staggering sales numbers in general, so it wouldn't take much in terms of market share for NKTR-102 to be a major value driver for Nektar.
Foolish wrap-up
I am closely watching Nektar as it heads into these three pivotal catalysts and am considering adding this stock to my personal portfolio. My take is that the market is presently discounting the value of these three catalysts, with the stock's current valuation primarily linked to Nektar's licensing revenues. Although it's premature to quantify the value of each of these catalysts in terms of a forward-looking share price, my view is that Nektar shares could do very well if one or more of these catalysts go the company's way. On the flip side, a large safety study for naloxegol that causes AstraZeneca to tear up the agreement would certainly rain on Nektar's parade. That said, I believe this is the only major downside risk facing Nektar, besides getting the red light from the FDA, as the market doesn't appear to have cooked in much value regarding either BAX 855 or NKTR-102.
