Rare disease specialist Alexion Pharmaceuticals Inc. is striding ahead with fast-rising sales of its sole approved product, Soliris (eculizumab), and soon a new chief executive, it said in an earnings report Thursday. Departing CEO and founder Leonard Bell will leave the company poised for a likely second product approval before midyear as Chief Operating Officer David Hallal prepares to lead the firm through industrywide foreign exchange challenges that have hit other reporting companies, including Celgene Corp.
The Cheshire, Conn.-based company said it's providing Soliris to an increasing number of patients with paroxysmal nocturnal hemoglobinuria (PNH) and hemolytic uremic syndrome (HUS) in 50 countries, driving net product sales up about 36 percent to $599.5 million during the fourth quarter, up from $441.9 million a year ago.
As part of an ongoing diversification of its prospects, the company also continues to push asfotase alfa, its potential treatment for patients with hypophosphatasia (HPP), closer to market with regulatory applications filed in the U.S., Europe and Japan. The company could launch the drug in the U.S. and Germany during the first half of this year, said Brean Capital LLC analyst Jonathan Aschoff, who added that since "HPP is characterized by low incidence and high mortality rate," the company could likely set high product pricing. "We continue to view Alexion as a core biotech holding," he said. (See BioWorld Today, Oct. 22, 2014.)
The company said it earned $153 million, or 76 cents per share, in the fourth quarter, compared to a net loss of $19 million, or 10 cents per share, a year earlier.
Excluding special items, Alexion earned $1.30 per share. Analysts on average expected $1.29, according to Thomson Reuters I/B/E/S.
Alexion forecast 2015 earnings of $5.60 to $5.80 per share, which includes a negative impact of about 30 cents per share attributable to foreign exchange rates. But Piper Jaffray & Co. analyst Joshua Schimmer suggested that estimate was conservative, noting that "given strength across the Soliris indications and ongoing global expansion plus launch of asfotase alfa likely around midyear, we'd be surprised if the company didn't finish the year much stronger."
Shares of Alexion (NASDAQ:ALXN) rose $10.27 to $188.05 at Thursday's market close.
SOLID EARNINGS FOR CELGENE
Celgene Corp. also turned in strong earnings Thursday, citing expanding sales of Revlimid (lenalidomide), Abraxane (nab-paclitaxel) and Pomalyst/Imnovid (pomalidomide), among other factors for its success.
Fourth quarter profits rose to $613.9 million, or 74 cents per share, as compared with $214.4 million, or 25 cents per share, in the forth quarter of 2013. Adjusted diluted EPS in the quarter increased 33 percent to $1.01 from 76 cents in the year-ago fourth quarter. Analysts on average expected EPS of 99 cents, according to Thomson Reuters I/B/E/S.
Fourth quarter total net sales grew 19 percent compared to the prior year, exceeding $2 billion in quarterly net sales for the first time.
For the full year, total net product sales also grew 19 percent and accelerated compared to a prior year-over-year comparison. Drivers included the global rollout of Pomalyst/Imnovid for myeloma and Abraxane for pancreatic cancer; the U.S. launch of Otezla (apremilast) for psoriatic arthritis and psoriasis; and, most importantly, a solid performance by Revlimid, the company said.
Revlimid's growing market share and duration of use, in particular, contributed to the company's bottom line, with fourth quarter sales of the drug rising by 16 percent to $1.3 billion, as compared to the fourth quarter of 2013.
Celgene's chief financial officer, Peter Kellogg, said that sales growth was primarily driven by volume. Volatility in foreign exchange markets toward the end of the year, though, in which the value of foreign sales has shrunk in dollar terms, drove about $25 million "unfavorable impact" to total net product sales in the fourth quarter, he said, resulting in a negative 1.4 percent impact to growth.
The company guided investors to expect full-year 2015 adjusted earnings per share of $4.60 to $4.75, a little lower than analysts expectations of $4.87, according to Thomson Reuters I/B/E/S. It also projected 2015 total net product sales of $9 billion to $9.5 billion, including a negative impact from foreign exchange approaching $100 million.
Celgene CEO and Chairman Bob Hugin said he sees "extraordinary promise" in 2015, a year in which he said "early first quarter trends are providing a very strong start." The company plans to initiate eight new phase I programs this year on its way to what it has predicted will, in 2020, be a year of net product sales exceeding $20 billion, composed largely of revenue from its hematology franchise.
Celgene shares (NASDAQ:CELG) rose $1.90 to close at $120.87 on Thursday.
VERTEX LOOKING FOR GROWTH IN CF
Vertex Pharmaceuticals Inc. also joined the earnings parade Thursday, reporting a net loss for the fourth quarter of 2014 of $177 million, or 74 cents per share, including net charges of $45 million. Analysts on average expected a net loss of 66 cents per share, according to Thomson Reuters I/B/E/S.
Fourth quarter 2014 sales rang in at $144.5 million, up from $351.2 million in the fourth quarter of 2013 and including revenues of $124 million from Kalydeco (ivacaftor) in cystic fibrosis, the company said.
Jeffrey Leiden, chairman, president and CEO of the Boston-based company, said potential approval and launch of the combination of lumacaftor and ivacaftor and continued label and geographic expansion for Kalydeco are expected to "significantly increase both the number of people treated with our medicines and our revenues to support the long-term growth of our business."
Vertex shares (NASDAQ:VRTX) fell $7.12 to close at $114.14 on Thursday and some analysts even downgraded Vertex shares after the company downplayed the significance of upcoming phase IIb data on VX-661.