Eylea, a newly approved drug for wet age-related macular degeneration, racked up $276 million in sales in 4Q 2012 for Regeneron Pharmaceuticals Inc., and $838 million for the year overall, driving total revenues of $415 million in the 4Q and $1.4 billion for the year.
Quarterly revenues beat consensus estimates of $392.64 million and $1.35 billion, respectively. With the success of Eylea, Regeneron is becoming a highly profitable company with a healthy balance sheet showing $588 million in cash and marketable securities.
In a conference call Thursday morning, Regeneron senior vice president, commercial, Robert Terifay, said, "We're very pleased with the rapid acceptance of Eylea. It's the third most successful launch in the history of the U.S. biopharmaceutical industry."
Regeneron's non-GAAP net income was $171 million, or $1.47 per diluted share in the 4Q and $520 million, or $4.66 per diluted share, for the full year.
GAAP net income was $470 million, or $408 per diluted share, in the 4Q and $750 million, or $6.75 per diluted share, for the full year.
While Eylea was approved in 2012, Regeneron just received a Medicare J-code for it in January 2013, giving the product yet more potential to grow in sales with proper billing channels in place.
Regeneron's partner Bayer AG has begun launch of Eylea in Japan, Europe, Australia and some other regions, and the companies expect substantial sales growth in 2013 as a result.
Bayer recorded $19 million in net sales outside the U.S. in the 4Q.
Sales of Zaltrap (ziv-aflibercept), for metastatic colorectal cancer, began in August 2012 and the product received marketing authorization from the European Commission for the European Union in February 2013. Regeneron collaborates with Paris-based Sanofi SA on global development and commercialization. Sanofi recorded $23 million in Zaltrap sales in the 4Q, and $32 million for the full year of 2012.
Regeneron cautioned investors that it does not anticipate "meaningful contribution" to its bottom line from Zaltrap for some time because of its obligation to repay Sanofi for 50 percent of the development expenses for the drug.
Pipeline compound REGN727 is advancing with initial data from one of the 12 Phase III studies in the Odyssey program in patients with hypercholesterolemia due in the second half of 2013.
Regeneron also expects to begin Phase IIb trials for REGN668, and outline additional Phase III trials for sarilumab, which is in development for rheumatoid arthritis and ankylosing spondylitis.
RBC Capital Market analyst Adnan Butt saw Regeneron's stock (NASDAQ:REGN) of $169.24 as a good entry point because Eylea's market opportunity and Regeneron's pipeline are discounted.
"Fundamentally, we see REGN transformed into a profitable biotech with operating leverage, top- and bottom-line growth, and multiple chances for long-term success," Butt wrote. He added that competitor events and upcoming earnings dates may contribute to volatility for the company's shares through the second half of the year, but that the risk-reward is still favorable.
Jonathan Aschoff, of Brean Capital LLC, noted that his company had previously downgraded Regeneron shares to Hold due to a concern that the mid-2013 clinical data would be a "significant potential negative catalyst."
Although Regeneron has appreciated due to robust Eylea sales, Ashoff said that Brean would remain on the sidelines until that data release.
On Thursday, Regeneron's stock lost $1.09, closing at $169.24.
Soliris Soars
Alexon Pharmaceuticals Inc. also increased its earnings in 4Q 2012 and for the full year 2012 compared to the same periods in 2011, mainly through increases in sales of Soliris resulting from additions of new patients with paroxysmal nocturnal hemoglobinuria and increases in patients with atypical hemolytic uremic syndrome.
Net product sales of Soliris were $320.5 million, compared to $227.6 million for the same period in 2011, a 41 percent year-on-year increase. The consensus estimate was $319 million, which Alexion modestly beat.
The Cheshire, Conn.-based company had non-GAAP net income of $122.3 million, or $0.60 per share in the 4Q. Full year non-GAAP net income was $425 million, or $2.13 per share.
Its GAAP income for 4Q 2012 was $81 million, or $0.40 per share. Full year GAAP income was $254.8 million, or $1.28 per share.
"We sense there was more caution going into this quarter, and while consistent 'beat and raise' of quarters past may be behind us, we believe the solid commercial execution and potential for a slightly better-than-expected 2013 top line could help improve enthusiasm for the long-term revenue stream despite fewer near-term pipeline catalysts and lingering EU reimbursement uncertainties," wrote Wells Fargo analyst Brian Abrahams.
Alexion stock (NASDAQ:ALXN) fell $4.38, to close at $87.63 Thursday.
In other earnings news:
• Dyax Corp., of Burlington, Mass., reported 4Q 2012 net sales of Kalbitor (ecallantide) of $11.8 million, an increase of 9.3 percent over 3Q 2012. Full year sales of Kalbitor were $39.8 million, and total revenues were $54.7 million. Dyax reported an overall net loss of $4.8 million, or $0.05 per share for 4Q, compared to a net loss of $13.5 million, or $0.14 per share, for the same quarter in 2011. The company's full year net loss was $29.3 million, or $0.30 per share, compared to $34.6 million, or $0.35 cents. It had cash, cash equivalents, and investments worth $29 million as of Dec. 31, 2012.
• Incyte Corp., of Wilmington, Del., reported net product revenues of $43.3 million for Jakafi (ruxolitinib) for 4Q 2012, and $136 million for the full year 2012. Jakafi, a product marketed for myelofibrosis, was launched Nov. 22, 2011, and its revenues for 4Q 2011 were $2 million. The company's total revenues for the quarter were $113.8 million, compared to $28.9 million for the same period in 2011. Full year revenues were $297.1 million, compared to $84.5 million. Incyte had net income of $18.8 million for 4Q 2012, or $0.14 per share, and its net loss for all of 2012 was $44.3 million, or $0.34 per share. Incyte stock (NASDAQ:INCY) gained $1.91, or 10.2 percent, to close at $20.56.
• Ligand Pharmaceuticals Inc., of San Diego, had total revenues of $13.6 million for 4Q 2012, compared to $12.9 million for 4Q 2011. The increase in revenue was due to higher royalties from increased sales of Promacta (eltrombopag), for thrombocytopenia. Net income for the quarter was $1.1 million, or $0.05 per share. Full year revenues were $31.4 million, compared to $30 million in 2011. The company reported a net loss of $0.5 million, or $0.03 per share, for 2012, compared to net income of $9.7 million, or $0.49, for 2011.