2010: A Big Year for Big Pharma

by: Morningstar

By Damien Conover

As we highlighted in the December issue of Morningstar Healthcare Observer, the uncertainty surrounding potential health-care reform outcomes have suppressed the market valuations of the biggest pharmaceutical firms throughout 2009. As we move into 2010, the reform overhang that has been weighing on large pharma firms should gradually dissipate. We expect investor focus in the upcoming year will return to the industry-specific nonregulatory issues that continue to drive pharmaceutical profitability, including patent losses, pipeline productivity, and continuing cost-saving efforts.

Reform or No Reform, Pharmaceutical Industry Poised to Win
U.S. health-care reform represents one of the most important issues facing pharmaceutical stocks in 2010. However, the passage of health-care reform is far from certain, especially since the loss of the Democratic seat in Massachusetts means the Democrats no longer hold a filibuster-proof majority in the Senate. Also, the loss of Democratic power in the Senate will likely mean any potential health-care reform will be scaled back from the current proposals in the House and the Senate.

Further, if both houses of Congress hold up the bill beyond the second quarter of 2010, we believe the prospects for far-reaching reform will diminish greatly, as politicians won't likely want the contentious issue of health-care reform hanging over midterm elections.

Regardless of whether reform passes, we believe the pharmaceutical industry will come out on top, as the direst scenarios for the sector--a single-payer system or its "cousin," a public plan with a Medicare-linked fee schedule--have been all but ruled out as outcomes. (Click to enlarge)

Beyond Reform, Many Drivers of 2010 Pharma Performance
While the conclusion of reform efforts in 2010 should be a positive for the pharma industry regardless of whether a bill successfully passes (full analysis of the reform's impact on the pharmaceutical sector is available here), performance of the biggest pharma firms in 2010 will also be driven by several factors at the individual firm level. We've teased apart the winners and losers regarding upcoming clinical data for pharma firms in 2010. We've also reviewed the upcoming patent losses and drug launches to determine which pharmaceutical firms are best-positioned in the upcoming year.

Clinical Data
Game-changing clinical data are expected throughout 2010. We believe strong data could shift negative investor sentiment surrounding pharma industry pipelines, leading to better valuations for the entire group.

Pfizer (NYSE:PFE) (JAK inhibitor). In the arthritis market, we will likely see data from Pfizer's JAK inhibitor, currently in a Phase III program known as ORAL. Based on very strong Phase II data, we think the drug could significantly dent TNF-alpha dominance in the rheumatoid arthritis market. Since the drug has already established strong efficacy, safety will be key in the Phase III data.

Bristol-Myers Squibb (NYSE:BMY) AstraZeneca (NYSE:AZN) (dapagliflozin). In diabetes, Bristol-Myers Squibb and partner AstraZeneca should report on the majority of its five remaining trials for dapagliflozin. Based on the drug's strong data demonstrating efficacy and weight loss in the first three studies, we expect positive results in additional studies will position the companies to file for approval in late 2010.

Johnson & Johnson (NYSE:JNJ) (telaprevir, Xarelto). In the hepatitis C market, J&J and Vertex (NASDAQ:VRTX) (should report strong pivotal Phase III data on protease inhibitor telaprevir. We also expect J&J's cardiovascular drug Xarelto will post solid data in the ROCKET study, demonstrating its ability to prevent strokes in patients with atrial fibrillation.

Merck (NYSE:MRK) (boceprevir, Vytorin, TRA). While we believe telaprevir may have a leg up on Merck's hepatitis C drug candidate boceprevir based on a shorter duration of treatment, we expect both drugs will become blockbusters. We also expect data from the SHARP study will show favorable results for cholesterol-lowering drug Vytorin, which has been marred by data putting the efficacy of this combination therapy into question. While flying under the radar, Merck's cardiovascular thrombin receptor antagonist (TRA, known as SCH 530348) is positioned to potentially match Plavix sales of over $8 billion, in our opinion. We expect data from the TIMI 50 Phase III trial in September 2010 will confirm the drug candidate's positive Phase II data.

Bristol/Pfizer (apixaban). We expect poor clinical data from Bristol and Pfizer's apixaban. The drug failed to show noninferiority versus Lovenox in a 3,195 patient trial called ADVANCE-1. Regardless, the companies are forging ahead with Phase III trials in stroke prevention and other cardiovascular diseases, with approximately 35,000 patients across all ongoing trials. Out of several leading replacements for warfarin, we are most skeptical of apixaban given the uninspiring efficacy shown in ADVANCE.

Merck (anacetrapib). We hold low expectations for Merck's anacetrapib, which appears very similar to Pfizer's failed torcetrapib. We expect Merck will discontinue the drug following Phase III data in 2010.

Wild Cards
Alzheimer's drugs bapineuzumab and dimebon represent the real wild cards for 2010. Strong Phase III data in Alzheimer's disease would likely translate into mega-blockbuster sales at a rapid rate, as current treatment options fail to halt progression of the disease.

Pfizer and J&J (bapineuzumab). Pfizer shares rights to bapineuzumab with J&J and Elan (NYSE:ELN). We project a 50% chance of success for bapineuzumab. While Phase II data showed strong performance for bapineuzumab relative to placebo, the lower-than-normal performance of the placebo group may have accounted for the portion of bapineuzumab's success. Also, Phase II data analysis was done retrospectively, making positive statistical results less conclusive. We expect we could see the first Phase III data for this drug candidate in late 2010.

Pfizer (dimebon). Studies in Russia showed positive results from treating Alzheimer's patients with dimebon. Given Pfizer's $225 million payment to Medivation and commitments of close to $1 billion related to the success of the drug, the company clearly believes in dimebon's early-stage data. However, we remain skeptical and project only a 30% chance of approval for the drug, based on incomplete early-stage data and Pfizer's poor track record of partnerships.