Biogen Inc. (NASDAQ:BIIB) perceives greater long-term growth opportunities than anticipated in the EU and emerging markets, the company's CEO Michel Vounatsos said on its earnings call Tuesday, while noting that the U.S. market remains its key driver of growth.
The bellwether reported an overall increase in ex-U.S. sales in the first quarter, even as it saw a decline in U.S. sales for some drugs, including spinal muscular atrophy drug Spinraza nusinersen.
The company reported 1Q18 ex-U.S. product revenues of $986 million, a 32% bump from the same period last year. Biogen’s European biosimilar business could climb to at least $500 million annually from $380 million in 2017, Vounatsos said, while ex-U.S. sales of MS drugs are generally on the rise.
“Our MS volumes continue to grow outside of the U.S., and it is still an under-diagnosed disease in many developed countries,” Vounatsos said.
Overall, the company reported 1Q18 non-GAAP EPS of $6.05, up from $5.20 in 1Q17. 1Q18 revenues were $3.13 billion, up 11% from $2.8 billion 1Q17. The Street was expecting 1Q18 EPS of $5.93 on revenues of $3.15 billion.
Spinraza's sales outside the U.S. rose 22% to $176 million compared with 4Q17 but fell 14% to $188 million in the U.S. during the same period. The number of patients grew 56% outside of the U.S. from 4Q17, vs.16% in the U.S. Biogen reported 280 new patient starts in the U.S. in 1Q18, down 33% from 420 patient starts last quarter. Biogen reported the average dose per patient was 1.1, marking the third straight quarter the biotech has reported a decrease in the figure.
The company expects "stable" U.S. revenues for the next couple quarters, with potential increases by year end as it targets older patients, according to CFO and EVP Jeffrey Capello. Worldwide, Spinraza generated sales of $364 million for the quarter, missing consensus estimates of $382.7 million. Biogen launched Spinraza in the U.S. in 4Q16; and the drug was approved in the EU and Japan in the following summer.
Biogen reported 1Q18 biosimilar revenues of $128 million, up 93% from 1Q17. It expects additional growth with the anticipated October launch in the EU of Humira adalimumab biosimilar Imraldi (SB5) from Samsung Bioepis Co. Ltd., Capello noted. Biogen also said it plans to exercise an option to acquire up to 49.9% of the JV; at Dec. 31 it held a 5% stake.
This month, Samsung Bioepis and AbbVie Inc. (NYSE:ABBV) agreed to settle all litigation related to autoimmune drug Humira in a deal that will allow Samsung Bioepis to launch Imraldi in the EU on Oct. 16, 2018 and in the U.S. on June 30, 2023. Samsung Bioepis is a JV between Biogen and Samsung BioLogics Co. Ltd. (KOSDAQ:207940) (see BioCentury Extra, April 5).
Worldwide MS drug sales fell 4% to $2.1 billion for the quarter compared with the prior year’s period, including about $77 million in royalties on sales of Ocrevus ocrelizumab. U.S. sales of Tecfidera dimethyl fumarate fell 3% to $728.9 million, while sales outside the U.S. rose 25% to $258 million. Biogen is eligible to receive a 3% royalty on net sales of Ocrevus in countries outside the U.S. for an 11-year period under agreement with the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). Ocrevus was approved in March 2017.
Capello noted that business development efforts will focus on assets "closer to being market ready," but added that the biotech has the capital to add "both later stage assets and mid-stage assets and also return capital to shareholders."
In March, Biogen acquired its first neuropsychiatry program: BIIB104 (formerly PF-04958242) from Pfizer Inc. (NYSE:PFE). Biogen plans to develop the Phase II AMPA glutamate receptor (GRIA; GLUR) potentiator to treat cognitive impairment associated with schizophrenia (see BioCentury Extra, March 12).
Last week, Biogen expanded an existing partnership with Ionis Pharmaceuticals Inc. (NASDAQ:IONS) to develop antisense therapies for a range of neurological diseases, including dementia, in a 10-year collaboration. Biogen will select targets, and Ionis will identify antisense candidates. Biogen will have options to license therapies. Biogen has rights to Spinraza from Ionis (see BioCentury Extra, April 20).
Consensus figures provided by FactSet.
Biogen added $2.85 to $262.15 Tuesday.