Alexion Pharmaceuticals Inc. has expanded its drug pipeline to 20 development programs as of the second quarter of 2020 from four programs at the end of 2017, according to CEO Ludwig Hantson.
Hantson said on a July 30 earnings call that the Boston-based biotech is on track to launch 10 drugs for the treatment of rare diseases, including conditions affecting the kidney, heart and brain, by 2023.
Executive Vice President and Chief Commercial and Global Operations Officer Brian Goff said Ultomiris, or ravulizumab-cwvz, will be launched in the EU after receiving approval in June for the treatment of atypical hemolytic uremic syndrome, or aHUS, a rare, genetic disease that can damage vital organs, such as the kidneys. The drug is also expected to receive approval in Japan in the third quarter.
Alexion also plans to launch Ultomiris for the treatment of generalized myasthenia gravis — a condition affecting multiple muscle groups in the body — in late 2022 or early 2023, said Goff, adding that the company expects this move will expand its target market to about 20,000 patients with the disease in the U.S. The company aims to quadruple the number of kidney disease patients treated with the drug by 2025.
Ultomiris is approved in the U.S. to treat a rare blood disease called paroxysmal nocturnal hemoglobinuria, or PNH. The drug was second to Alexion's blockbuster rare disease drug Soliris, or eculizumab, in terms of net product sales in the second quarter, generating revenues of approximately $251 million and $976 million, respectively.
In the third quarter of 2021, the company plans to submit an application for a formulation of Ultomiris that is administered under the skin to treat aHUS and PHN in the U.S. and EU, according to John Orloff, executive vice president and head of research and development.
Other pipeline programs that will be potentially launched in 2023 include ALXN2040 for PNH and ALXN1210 and ALXN2050 for kidney diseases.
Revenues and share buyback
Alexion's total revenues for the second quarter increased by 20% year over year to $1.44 billion. Non-GAAP EPS was $3.11, representing an 18% rise year over year. CFO Aradhana Sarin noted that the increase was driven primarily by strong top line growth.
The S&P Global Market Intelligence consensus normalized EPS estimate was $2.58 per share.
Alexion raised revenue guidance for the full year 2020 to range between $5.55 billion and $5.6 billion. It previously expected revenue in the range of $5.23 billion to $5.33 billion.
Sarin said on the call that the company's sales guidance for the second half is a little more conservative due to various factors, including patient compliance rates, the conversion of patients to Ultomiris and the uncertainty around COVID-19.
The CFO noted that Alexion is moving its capital allocation strategy to "a more balanced approach" due to the pipeline progress and is committing to a minimum share repurchase of between $500 million and $550 million in 2020. Sarin said the company will increase repurchases to at least one-third of free cash flows on an average annually from 2021 to 2023.