Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) stock lost over 3.4% on 4th Feb, 2019 (as of 10:48 am GMT-5; Source: Google fiannce).
ALXN has reported a fourth-quarter loss as the company took a $379.3 million charge related to its acquisition of Syntimmune, an autoimmune therapy. The company has reported a net loss of $45 million, compared with a profit of $30 million, a year earlier.
Soliris sales increased 23% in the quarter to $976.7 million. During the quarter the FDA approved Ultomiris for adults with PNH. Applications for approval in the European Union (EU) and Japan are currently under review for the same indication..
ALXN in the fourth quarter of FY 18 has reported the adjusted earnings per share of $2.14, beating the analysts’ estimates for the adjusted earnings per share of $1.83. The company had reported the adjusted revenue growth of 24 percent to $1.13 billion in the fourth quarter of FY 18, beating the analysts’ estimates for revenue of $1.06 billion. SOLIRIS net product sales were $976.7 million, compared to $791.9 million in the fourth quarter of 2017, which represents a 23 percent increase. SOLIRIS volume increased 28 percent year-over-year. STRENSIQ net product sales were $126.1 million, compared to $95.6 million in the fourth quarter of 2017, which represents a 32 percent increase. STRENSIQ volume increased 43 percent year-over-year. KANUMA net product sales were $25.7 million, compared to $21.9 million in the fourth quarter of 2017, which represents a 17 percent increase. KANUMA volume increased 51 percent year-over-year.
For FY 19, the company expects earnings per share to be in the range $9.10 to $9.30. It projects revenues to be in the range of $4.63 to $4.70 billion. The Zacks Consensus Estimate for earnings for 2019 was $8.78 per share while for sales it was $4.76 billion. Revenues for Soliris and Ultomiris are expected in the $3.97-$4.02 billion range.
Additionally, in late 2018, Alexion had initiated a single, PK-based Phase 3 study of ULTOMIRIS delivered subcutaneously once per week to support registration in PNH and aHUS. Data are expected in early 2020. Further, In January 2019, Alexion announced positive topline results from a Phase 3 study of ULTOMIRIS in complement inhibitor naïve patients with aHUS. The study met its primary objective with 53.6 percent of patients demonstrating complete thrombotic microangiopathy (TMA) response. The safety profile of ULTOMIRIS was generally consistent with that seen in Phase 3 studies in PNH. ALXN now plans to file for regulatory approval in the U.S. in the first half of 2019 followed by the EU and Japan. In addition, a Phase 3 study of ULTOMIRIS in adolescents and children with aHUS is currently underway.