Endo Pharmaceuticals reports $57.6 million second quarter net income

By Jennifer Lanning Drey

Eugene, Ore., July 20 - Endo Pharmaceuticals Holdings Inc. reported second quarter net income of $57.6 million, or $0.43 per diluted share, on net sales of $228.0 million, according to a company news release.

The results were improved from reported net income of $49.0 million, or $0.37 per diluted share, on net sales of $196.4 million in the comparable period of 2005, according to the release.

The company's cash and cash equivalents were $612.7 million on June 30, compared to $501.0 million on Dec. 31, 2005.

The second quarter increases were driven by strong net sales of the Lidoderm patch, which totaled $140.8 million for the quarter, said Peter A. Lankau, president and chief executive officer of Endo, during a company conference call held Thursday.

The company reported net sales of $100.5 million for the Lidoderm patch in the second quarter of 2005.

Endo now believes it is on track to achieve the high end of its previously stated guidance, which projected net sales of $530 million to $540 million for Lidoderm in 2006, Lankau said.

Prescription growth for Lidoderm was up 20% in the second quarter versus the comparable period in 2005, according to the release.

Lankau also said Thursday that the growth in Lidoderm sales was somewhat offset by an expected decline in net sales of its oxycodone extended-release tablets.

Net sales of oxycodone extended-release were $15.3 million in the second quarter versus $29.2 million during the same period of 2005, according to the release.

Opana approved; Synera launched

During the second quarter, Endo also received Food and Drug Administration approval for Opana and its extended release version, Opana ER. The company is in the final stages of product packaging and quality control, and expects to have the drug commercially available by the end of July, Lankau said.

"The approval of Opana represents a major milestone is our continuing development as a premier specialty pharmaceutical company," he said.

Endo also began the commercial launch of Synera, a topical anesthetic patch, in the second quarter.

"We are excited by the possibilities for this product, which our partner Zars is currently studying in new clinical trials for pediatric immunization - which is a large and attractive market," Lankau said.

Product development

Endo is also expecting to continue to achieve product development milestones and has multiple clinical trials underway, Lankau said.

In June, Endo began enrollment in two phase 3 clinical trials for its topical Ketoprofen patch. The first trial will study the safety and efficacy of the drug when used as treatment for pain associated with tendonitis. The second will study the same factors of the drug when used as treatment for pain associated with ankle sprains.

Endo expects to file a New Drug Application for the Ketoprofen patch in the first half of 2008, Lankau said.

Endo is also enrolling patients in phase 3 clinical trials of Rapinyl, an oral, fast-dissolving tablet of fentanyl intended for the treatment of break-through cancer pain.

The company expects to file an NDA for the drug in the second half of 2007.

Endo also recently filed a supplemental NDA for Frova, a long-acting triptan, for short-term prevention of menstrual migraines. The company expects the application to be under review by the FDA for 10 months.

Endo is a specialty pharmaceutical company based in Chadds Ford, Pa., that develops branded and generic pharmaceuticals with a focus on pain management products.

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