AstraZeneca's Turnaround Story Hasn't Started Yet

Anyone hoping to begin hearing a nice turnaround story from AstraZeneca (NYSE: AZN  ) in the third quarter will have to wait longer. The British drugmaker reported its financial results on Oct. 31. A Halloween announcement was appropriate -- because the numbers were scary.

Down all around
Where do we start? AstraZeneca's revenue of $6.25 billion was down 4% year over year at constant exchange rates. Core operating profit was down 29%, to $2.03 billion. Earnings also fell 16%, to $0.99 per share. Core earnings dropped 26% to $1.21 per share. Wall Street expected earnings of $1.25 per share.

Although the numbers were scary, they weren't shocking -- they were expected. Around half of AstraZeneca's sales declines stemmed from the loss of patent exclusivity for drugs. Arimidex, Atacand, Crestor, Nexium, Seroquel IR, and Seroquel XR all experienced revenue drops, due partially to generic competition -- although only in parts of the world for some of the drugs.

Even though Crestor still hasn't lost patent exclusivity yet in the U.S., sales fell by 14%. That's actually worse than the overall decline of 11%. The top-selling drug for AstraZeneca still accounts for more than 20% of the company's total revenue.

To make matters worse, AstraZeneca is also now being investigated by the U.S. Department of Justice over a clinical study that played a key role in obtaining regulatory approval for cardiovascular drug Brilinta. No details were provided about the nature of the DOJ investigation. AstraZeneca management expressed "full confidence" in the study results.

Developing a plot
If AstraZeneca is truly to have a turnaround story, the plot will likely need to start with the alliance it formed with Bristol-Myers Squibb (NYSE: BMY  ) . Several diabetes drugs jointly marketed by the two companies are doing pretty well.

The Byetta/Bydureon franchise had the most commercial success last quarter, racking up sales of $100 million for AstraZeneca. Onglyza wasn't far behind, with sales of $93 million. Forxiga, which gained approval in Europe in late 2012, hasn't taken off significantly, so far. The drug generated sales of only $3 million in the third quarter.

Other partnerships could also help with AstraZeneca's comeback. For example, the company teamed up with Amgen (NASDAQ: AMGN  ) in 2012 to develop several compounds, including brodalumab. The psoriasis drug is currently in a late-stage study. Amgen is taking the lead in development and potential commercialization efforts for brodalumab.

Brilinta/Brilique was expected to have a starring role in AstraZeneca's turnaround. However, sales haven't grown nearly as much as many observers expected. The full impact of the just-announced DOJ investigation is also yet to be seen.

AstraZeneca submitted a New Drug Application, or NDA, for Epanova as a treatment for patients with severe hypertriglyceridemia earlier this year. A decision from the FDA is scheduled for May 2014. The company also hopes to file for a Crestor/Epanova combo in treating patients with high (but not as severe) tryglyceride levels.

Amarin's (NASDAQ: AMRN  ) recent setbacks from the FDA probably mean those plans will be farther in the future than AstraZeneca would have liked. An FDA advisory panel voted against recommending approval for Amarin's Vascepa in treating patients with high triglyceride levels, stating that a cardiovascular outcomes study would be needed. Earlier this week, the FDA also rescinded its previously granted special protocol assessment agreement for the supplement regulatory submission. AstraZeneca will almost certainly now need to proceed with its own outcomes study prior to filing for approval.

During the conference call following the release of its third-quarter results, AstraZeneca's management was asked when the "trough year" for revenue and earnings would be reached -- in other words, when will the turnaround be visible. Outgoing CFO Simon Lowth responded basically with the answer, "We won't say." This turnaround story just might require a good deal more time to even begin. 

Getting paid to wait
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