Baxter On A Roll -- Wins Approval For OBIZUR

In early June, I wrote a bullish article on Baxter (NYSE:BAX), with a thesis that the company's outlook should improve with aging populations, which will increase the demand for elective and non-elective medical procedures, and, in turn, dictate the need for specialized medical devices. I also stated that the expansion of Baxter's ADVATE program into emerging markets, namely China and Brazil, was another compelling reason to accumulate. However, there are underlying risks to a Baxter investment, considering the company reeled from suboptimal growth in many areas over the past year, warranting concern amid the company's plans to spin off its lucrative Biosciences division, Baxalta, in mid 2015. Nevertheless, Baxter's latest quarterly report was better than expected, and it has received back-to-back approvals of three important treatments, OBIZUR, Hyqvia and Rixubis for Hemophilia A, primary immunodeficiency (PI) and Hemophilia B, respectively. As a result, I reiterate my bull thesis.

Some key highlights from Baxter's latest announcement are as follows:

  • OBIZUR is FDA approved for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA).
  • Approval was based on the findings of a Phase 2/3 study, which yielded positive efficacy and safety data in all 57 patients administered OBIZUR.
  • Designated as an Orphan Drug by the FDA, OBIZUR will be marketed under seven years of exclusivity in the US.
  • OBIZUR is expected to hit the US market in the following months as Baxter seeks approval in Europe and Canada.

Baxter's future earnings performance should improve with the approval for OBIZUR. Similar to Hyqvia, the value proposition of OBIZUR is compelling. Specifically, OBIZUR has been shown to reduce bleeding episodes in adults with AHA with an 86 percent success rate. Indeed, some patients enrolled in the clinical study expressed inhibitor development, a common side effect of hemophilia treatments. Nevertheless, considering the treatment is now approved in the US for this rare population, I see no reason that Canada and the EU would deny approval for OBIZUR. These market approvals would benefit Baxter, as the market share for OBIZUR would substantially increase. This comes as Baxter recently won FDA approval for both Rixbuis and Hyqvia, accompanied by the announcement of positive data from the late-stage study of BAX 855 for Hemophilia A. All of these developments should complement Baxter's growth prior to the spin-off. As we approach this event, therefore, I'm left with no reason to amend my bull thesis, and would encourage investors to consider options strategies as a way to play the spin-off.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate a position over the next 72 hours. The information presented is for entertainment purposes ...

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