What: Shares of Regeneron Pharmaceuticals (NASDAQ:REGN), a globally diversified biotechnology company, shed another 12% of its value in June, based on data from S&P Global Market Intelligence. The reason for the drop appears to be concerns tied to PCSK9 inhibitor Praluent.
So what: Regeneron's woes can actually be traced back more than three months to mid-March when a Delaware jury decided that Regeneron and collaborative partner Sanofi (NYSE:SNY) had infringed on two of Amgen's (NASDAQ:AMGN) patents for Repatha, its PCSK9 inhibitor. Regeneron and Sanofi announced plans to appeal the decision, but it leaves Praluent, a possible blockbuster drug that's designed to lower LDL-cholesterol levels -- the bad kind -- in limbo.
One solution for Regeneron and Sanofi could include admitting patent-infringement guilt, and forging a royalty agreement with Amgen. Some analysts, according to FiercePharma, believe a royalty arrangement could cost the duo between 5% and 20% of total sales.
The other option, assuming their appeal is denied, is worse. Praluent could wind up being completely barred from sale in the United States, leaving Amgen's Repatha as the lone approved PCSK9 inhibitor. As long as Praluent's future remains uncertain, Regeneron's share price could be quite volatile.
Now what: Regeneron is now forced to fight a number of "battles." In addition to its court battle with Amgen over Repatha, Regeneron is dealing with skeptical investors, who've focused on slowing year-over-year growth for eye drug Eylea. The company recently upped its full-year sales growth for Eylea to a range of 20% to 25% in 2016, but this is down substantially from the 47% year-over-year growth Eylea delivered in 2015, from 2014.
Despite these near-term concerns, I believe the recent downside in Regeneron could be overstated. Eylea's growth isn't slowing so much as it's reaching a steadier percentage of available patients. It'll remain a growth driver for both Regeneron and Sanofi for the foreseeable future.
Additionally, Regeneron has a promising pipeline that could rapidly expand its top line. In early June, Regeneron and Sanofi announced the results of their LIBERTY AD CHRONOS phase 3 study of dupilumab in combination with topical corticosteroids as a treatment for moderate-to-severe atopic dermatitis. Dupilumab wound up meeting both the primary and key secondary endpoints in the study. A regulatory submission for dupilumab is expected this quarter.
Worries over Praluent have pushed Regeneron below a PEG of two, a figure that it's regularly been above for years, implying that it could be attractively priced relative to its other high-growth biotech peers. It's true that Praluent's future is still up in the air, but Regeneron is far more than just Praluent. My suggestion would be to take this recent dip in its share price as an opportunity to further dig into Regeneron's pipeline and underlying fundamentals.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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