Alexion Pharmaceuticals Inc. bested consensus estimates for the third quarter and disclosed promising advancements in its pipeline, notably the launch of registrational trials for ALXN1210, its next-generation anti-C5 antibody, expected to bolster the firm's blockbuster complement franchise.
Shares of the New Haven, Conn.-based firm (NASDAQ:ALXN) gained $9.78, or 8 percent, to close Thursday at $131.37.
RBC Capital Markets analyst Simos Simeonidis called it a "great quarter" for Alexion, beating top and bottom lines. The company posted total revenues of $799 million for the three months ending Sept. 30, a 20 percent jump over the same period in 2015. Consensus estimates had predicted revenues of $786.9 million.
Strong product sales led the way. Soliris (eculizumab), Alexion's flagship orphan product, recorded net sales of $729 million. The drug, already approved for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), is set to go before regulators in the first quarter of 2017, with Alexion seeking an expanded label to include myasthenia gravis. The company is expected to present late-stage data for the drug's use in delayed graft function and neuromyelitis optica spectrum disorder in the fourth quarter and 2017, respectively.
Sales of Strensiq (asfotase alfa), which gained approval a year ago for perinatal-, infantile- and juvenile-onset bone disorder hypophosphatasia, totaled $61 million, soundly beating consensus estimates of $51.7 million. And the launch of Kanuma (sebelipase alfa), the drug acquired in last year's buyout of Synageva Biopharma Corp. and approved in December for lysosomal acid lipase deficiency, continued its good start, with third-quarter sales of $9 million, marking a 43 percent increase quarter over quarter. (See BioWorld Today, Oct. 27, 2015, and Dec. 9, 2015.)
The company reported non-GAAP earnings per share of $1.23, above consensus estimates of $1.17. It also raised its revenue guidance slightly for the year, now expecting to be on the "upper end of our previously guided range of $3.05 [billion] to $3.10 billion."
As of Sept. 30, the firm had cash and equivalents of about $762 million.
Meanwhile, Alexion's pipeline is "moving full speed ahead," noted Cowen and Co. analyst Eric Schmidt, starting with ALXN1210 in a pair of phase III studies.
Like Soliris, ALXN1210 is an anti-C5 antibody designed to inhibit the terminal complement, but it is designed to be longer-acting. The first trial will test the drug in PNH, with an open-label, active-controlled design comparing it to Soliris in complement inhibitor-naive patients, while the second phase III will enroll adult and adolescent aHUS patients. A phase III trial in pediatric aHUS patients is set to start next year.
Alexion also started dosing in a phase I study testing a new formulation of ALXN1210, administered subcutaneously, in healthy volunteers.
Elsewhere in the pipeline, it has ALXN1007, a complement inhibitor targeting C5a, which is in a phase II study in graft-vs.-host disease involving the lower gastrointestinal tract. Beyond its complement portfolio, the firm is advancing a number of other programs, including SBC-103, a recombinant form of the NAGLU enzyme, in a phase I/II study in patients with mucopolysaccharidosis IIIB; ALXN1101, a cPMP replacement therapy, in a pivotal trial in neonates with molybdenum cofactor deficiency type A; and samalizumab (ALXN6000), an immunomodulatory humanized monoclonal antibody targeting immune checkpoint protein CD200, for acute myeloid leukemia, which is part of a multi-arm clinical trial (BEAT AML) by the Leukemia and Lymphoma Society.
In other earnings news:
Celgene Corp., of Summit, N.J., beat consensus, posting third-quarter earnings per share of $1.58, 10 cents higher than estimates. Third-quarter revenue reached $2.98 billion, up 28 percent over the same period in 2015. Sales of Revlimid (lenalidomide) totaled $1.89 billion, a 30 percent increase year over year, driven by new patient market share gains and increased duration, the company said. U.S. sales totaled $1.15 billion, with the remaining $738 million coming from international sales. Pomalyst (pomalidomide) sales were $341 million for the quarter, marking a 33 percent year-over-year increase. Otezla (apremilast) sales reached $275 million, jumping 98 percent year over year, and Abraxane (nab-paclitaxel) recorded sales of $233 for the third quarter. Celgene ended the quarter with about $6.9 billion in cash, equivalents and marketable securities. Shares of Celgene (NASDAQ:CELG) closed Thursday at $104.72, up $6.31.
United Therapeutics Corp., of Silver Spring, Md., reported total revenues of $408.2 million for the third quarter. Net income was $161.8 million, or $4.36 per share, beating analyst estimates of $3.34 per share. Net product sales totaled $152.4 million for Remodulin (treprostinil injectable), $101.8 million for Tyvaso (treprostinil inhaled), $96 million for Adcirca (tadalafil), $40.7 million for Orenitram (treprostinil extended-release tablets) and $17.3 million for Unituxin (dinutuximab). The company had roughly $1 billion in cash, equivalents and marketable securities as of Sept. 30. Shares of United (NASDAQ:UTHR) closed Thursday at $116.34, up $3.26.