Lilly in Full Financial Bloom

It's always tough to complain anytime a large-cap drugmaker boosts its revenue by 14% in a quarter. So I'll be hard-pressed to find much grief to give Eli Lilly (NYSE: LLY) for its first-quarter 2008 financial performance. Its drug-pipeline progress, on the other hand, fell far short of spectacular.

Besides the aforementioned double-digit year-over-year sales gains, Eli Lilly's non-GAAP earnings per share rose 11% from last year, totaling $0.92 per share for the quarter. The impressive top-line revenue and bottom-line earnings gains occurred despite meager 1% worldwide growth in sales of top drug Zyprexa year over year. With multiple other top Lilly compounds growing like crazy -- sales of depression treatment Cymbalta were up 37% in the first quarter -- it truly looks like Lilly has begun to compensate for the impending loss of Zyprexa to U.S. generic competition in 2011.  

Even though Lilly's financials sparkled this quarter, its drug pipeline seemed a bit clogged. The FDA stung Lilly with a not-approvable letter for its long-acting injection formulation of its antipsychotic compound Zyprexa. On its conference call, Lilly said that it was still in talks with the FDA about correcting that latter for the drug, a potential competitor to Johnson & Johnson's (NYSE: JNJ) Risperdal Consta. The FDA concerns centered on the proportion of patients who experienced "profound sedation" (among other side effects) after receiving the compound.

Besides the Zyprexa depot regulatory issues, Lilly also halted its inhaled insulin phase 3 program. However, that decision was definitely expected, and no big loss, considering the weak market demand for that type of drug.

Yesterday, Lilly also adjusted its financial guidance for 2008 slightly upward, on account of an unexpected tax benefit and a few other one-time charges. Its non-GAAP guidance still calls for earnings of $3.85 to $4 per share, 9% to 13% greater than its 2007 non-GAAP EPS. Even with Lilly's success this year financially, and its defeats on the pipeline front, its 2008 share-price performance will likely remain in the FDA's hands. The agency has scheduled its PDUFA decision on Lilly's potential blockbuster acute coronary syndrome treatment Prasugrel for June 26.