The pharmaceutical industry has certainly gotten off to another wild start in 2015. Despite the year being only half over at this point, we've already seen dozens of high profile mergers, several closely-watched experimental drugs report pivotal top-line data, and a number of major developments on the regulatory front.
Given that many of these events are likely to shape the investing landscape going forward, I think it's worth the time to briefly look back at the seven most significant headline-grabbing developments to date. So without further ado, here is a quick recap of what's happened thus far.
Wheeling and dealing
1. Pfizer (NYSE:PFE) helped to get the M&A ball rolling this year with its $17 billion buyout of Hospira for its portfolio of injected drugs and robust biosimilar pipeline. The deal came at a hefty 35% premium compared to where Hospira's shares were trading the day before the deal was announced, and it won't immediately add much in the way to Pfizer's top or bottom-lines. Even so, this deal should create value for Pfizer's shareholders in the long run as a hedge against the emerging biosimilar market, and perhaps as a means toward carving out a separate generics/legacy products business down the line.
2. AbbVie (NYSE:ABBV) joined the M&A frenzy last March with its buyout of cancer drug specialist Pharmacyclics for a mind-boggling premium. Specifically, AbbVie paid a 40% premium for Pharmacyclics and its lead drug Imbruvica. What really caught people's eyes, however, was that AbbVie coughed up $21 billion for about $3 billion in peak revenue for Imbruvica, according to consensus estimates. In a nutshell, Imbruvica is expected to generate somewhere around $6 billion in peak sales by 2020, with roughly half of these sales going to Johnson & Johnson (NYSE:JNJ). Although most analysts savaged the deal, the Street has now pushed AbbVie's shares up almost 25% since this buyout was announced.
New classes of drugs are making their way to the market
3. Last June, an advisory committee for the FDA voted to recommend approval of an entirely new class of injected cholesterol lowering drugs known as PCSK9 inhibitors from Amgen (NASDAQ:AMGN) and Sanofi/Regeneron, respectively.
The twist, though, was that the agency recommended that both drugs be approved for a far smaller patient population than originally intended -- at least until ongoing cardiovascular outcomes trials lend support to the hypothesis that they do indeed lower the risk of heart attacks and strokes. A decision on the drugs' regulatory fate in the U.S. is expected before the end of summer. That said, the FDA's European counterpart has already approved Amgen's drug, Repatha, although the details regarding the drug's label haven't been disclosed yet.
4. Bristol-Myers Squibb's (NYSE:BMY) Opdivo is proving to be a game-changer in the fight against cancer. Bristol's PD-1 inhibitor Opdivo has been reporting some extremely impressive clinical trial data in various cancers such as advanced melanoma, liver, lung, and most recently, metastatic kidney cancer in the second-line setting. In short, there is a good chance this immuno-therapy could achieve some of the loftier peak sales estimates floating around the Street at present that top the $6 billion mark.
A strong dollar and payer push back are negative headwinds facing the industry
5. A recurring theme throughout Big Pharma this year has been the negative impact of a strong dollar on earnings. Johnson & Johnson, for instance, saw a noteworthy 7.9% decline in revenue in the second-quarter, from a year ago, due to negative currency exchange rates. The hope among J&J's management is that the dollar's heyday has already peaked, easing some of this pressure from FX in subsequent quarters.
6. Top pharmacy benefit managers like Express Scripts have been speaking out about their displeasure regarding the enormous cost of new drugs emanating from Big Pharma of late. Earlier this year, Express Script's Dr. Miller, for instance, took direct aim at the host of costly new cancer medicines coming on the market, proposing a plan that would reimburse companies based on the effectiveness of their drugs.
If his plan is adopted, and there are some rumblings from major players like Novartis that big changes to cancer drug pricing schemes are indeed under consideration, such a drastic change could have a widespread impact on the industry in terms of earnings and revenues. So this is a key issue investors should keep an eye on moving forward.