Lilly expands Trulicity marketing push, lowers 2015 guidance

Eli Lilly
Eli Lilly

Patent losses put a dent in Eli Lilly's fourth-quarter and year-end sales, and the company has lowered its expectations for 2015, based in part on foreign exchange pressures.

CEO John Lechleiter indicated Friday that the declines are history and the company is “moving to a period of growth led by diabetes, oncology and health.”

The diabetes claim got some support Monday, with the FDA's approval of the SGLT2/DPPIV diabetes combination drug Glyxambi (empagliflozin/lingaliptin), which was developed and will be co-promoted with Boehringer Ingelheim.

Lilly also said it was making progress with new-to-market diabetes mediation Truclitiy (dulaglutide). The FDA approved the GLP-1 shot in September and the drug hit the market two months later.

Diabetes SVP Enrique Conterno said during Friday's earnings call that professional outreach has focused on specialists until now and that the firm had just kicked off its primary care marketing push. This additional audience should move market awareness beyond the specialist category which Conterno estimated represented about 30% of the market's potential.

Lilly is also in the PD-1 oncology mix and noted its recent agreement to explore pairing its TGF-beta kinase inhibitor galunisertib with Bristol-Myer Squibb's PD-1 Opdivo (nivolumab). It has also inked a two-part deal with Merck that looks at how Merck's PD-1 Keytruda (pembrolizumab) works with its non-small cell lung cancer injection Alimta (pemetrexed) as well as its lung cancer drug Cyramza (ramucirumab).

Lilly's immediate sales tally, however, shows that fourth-quarter sales fell 12%, to $5.12 billion, compared to $5.8 billion for the same period in 2013. Annual sales fell 15%, to $19.6 billion, compared to $23.1 billion in 2013.

Generic competition for depression drug Cymbalta (duloxetine) helped drive down quarterly and annual sales, which slipped 58% (to $367 million from $883 million) and 68% (to $1.6 billion from $5 billion) respectively. Generics of bone drug Evista (raloxifene) also put a dent in performance, with sales falling 74% in the quarter, to $72.1 million, compared to $276 million in 2013. The drug's annual sales fell 60%, to $419.8 million compared to 2013, when sales were $1 billion.

Sales of oral blood drug Effient (prasugrel) rose 6% during the quarter, to $138 million, compared to the fourth quarter in 2013, due to higher prices. This same force drove Effient sales to $522 million for the year, a 3% increase over 2013.

Rising prices also drove sales of bone drug Forteo (teriparatide) to $380 million for the quarter, a 6% bump compared to the same period in 2013. Year-end sales also rose 6% over the year-ago period, hitting $1.3 billion.

Lilly also stands to benefit from what looks like new wave of CETP interest. The company continues to plug along with its cholesterylester transfer protein, evacetrapib. Dave Ricks, who heads up Lilly's Bio-Medicines division, told investors that there was not much to share at this point and that he wanted to “play down expectations of any great news” emerging from a futility trial.

The class looked like it was set to disappear, but research surfaced last month that showed Roche's abandoned CETP candidate may, in fact, work. Leerink analyst Seamus Fernandez wrote in a Friday research note that although “debate over the efficacy of the mechanism remains intense,Lilly's Phase-III candidate could have success.CETPs work by raising HDL, or "good" cholesterol levels.