SHP-610

November 1, 2016 By Mark Terry , BioSpace.com Breaking News Staff Third-quarter financial reports show how companies are doing going into the end of the year. And this year, at least, they show a number of biopharma companies killing programs. Biogen announced in its third-quarter report that it was ending development of MT-1303 for various immune disorders like multiple sclerosis (MS), and Crohn’s disease. Pfizer announced today that it was ending its PCSK9 cholesterol program. And Shire reported that it was terminating its SHP610 program for Sanfilippo A after a failed Phase IIb study. In its third-quarter report, Shire stated, “The Phase IIb study of SHP610 in pediatric patients with early stage Sanfilippo A did not meet its primary endpoint of slowing the cognitive decline in patients. Shire intends to terminate all clinical trials of SHP610 and plans to publish the results of the SHP610 program for the benefit of the San Filippo community.” It also indicated that as of October 21, Shire was terminating a deal with CTI BioPharma Corp. and returning all rights related to pacritnib to CTI. It also ended relationships with SFJ Pharmaceuticals and its biosimilar collaboration with Coherus Biosciences . “Additionally,” the company said, “Shire has delivered notice of exercise of its right to terminate its biosimilar collaboration with Momenta Pharmaceuticals, Inc. and such termination will be effective upon expiration of the applicable termination notice period. These collaborations were acquired through the Baxalta acquisition.” Overall, Shire’s third-quarter revenues and earnings didn’t quite hit forecasts. The company didn’t raise guidance, but evidence shows that its June acquisition of Baxalta incurred higher costs than expected. Setting aside Baxalta data, Shire’s product sales grew by 12 percent. All of its legacy franchises grew during the third quarter. Both neuroscience and internal medicine grew by 15 percent. Flemming Ornskov , Shire’s chief executive officer, said in a statement, “During the third quarter, we made rapid progress integrating our new company while delivering record quarterly product sales growth and remaining on track to meet our full year Non GAAP guidance. The launch of Xiidra is off to a very strong start, and we are using this momentum to build a leadership position in pharmaceutical ophthalmics.” Xiida brought in $14 million in the third quarter. The company showed a third-quarter loss of $386.8 million, and on a per-share basis, lost $1.29. When adjusted for non-recurring costs and discontinued operations, it was $3.17 per share. According to Zacks Investment Research, nine analysts estimated an average earnings of $3.18 per share. The company’s problems seem to be more operational, than product-related. In the third quarter, it showed $3.315 billion in product sales, a growth of 110 percent. Even excluding Baxalta products, it showed $1.769 billion, a 12 percent growth for the quarter, with total revenues up 109 percent. However, its U.S. GAAP operating loss from continuing operations was $406 million in the quarter. Since the beginning of the year, Shire stock had dropped 18 percent, and 26 percent in the last 12 months. Shire is currently trading for $166.35.