AMAG Pharmaceuticals, Inc. (AMAG) reported a fourth-quarter 2014 loss of 2 cents per share, narrower than the year-ago loss of 17 cents per share. The Zacks Consensus Estimate was earnings of 30 cents per share.
Fourth quarter revenues jumped 145% to $53.3 million, in line with the Zacks Consensus Estimate. Revenues were boosted by strong Feraheme and Makena sales.
Full year loss narrowed 149% to 24 cents per share. Revenues increased 54% to $124.4 million.
Quarter in Detail
During the reported quarter, U.S. sales of Feraheme amounted to $24.1 million, up 26.8% year over year. The increase was attributable to both price and volume growth.
Fourth-quarter Makena sales came in at $22.5 million. Revenues from Makena were recorded from the closing date of the acquisition of Lumara Health (Nov 12, 2014) through the end of 2014.
We note that Makena was added to AMAG’s portfolio following the acquisition of Lumara Health. Makena is the only U.S. approved drug to reduce recurrent preterm birth in certain at-risk women. Meanwhile, AMAG is seeking approval from the FDA for a single-dose 1 ml vial of Makena. A response from the FDA is expected in the second quarter of 2015. The drug is presently approved for the 5 ml dose.
Research and development (R&D) expenses increased 18% to $7.8 million. Selling, general and administrative (SG&A) expenses shot up 74.2% from the year-ago quarter to $27.5 million.
Feraheme Label Expansion Update
AMAG is looking to strengthen the portion of Feraheme’s U.S. label dealing with warnings and precautions to further ensure the safety of patients. The FDA came up with certain changes in the label and AMAG is working with the FDA to finalize an updated label.
Feraheme is currently approved for the treatment of iron deficiency anemia (IDA) in adults suffering from chronic kidney disease.
The company also intends to expand Feraheme’s label to include the intravenous use of the drug for the treatment of IDA in all adults with a history of unsuccessful oral iron therapy. AMAG plans to continue working with the FDA to expand Feraheme’s label with an update on the path forward expected shortly.
During the fourth quarter, AMAG and Takeda Pharmaceuticals (TKPYY) mutually terminated their licensing deal for Feraheme in ex-U.S. territories including Europe. Per the terms of the termination agreement, AMAG will regain worldwide development and commercialization rights to Feraheme. AMAG had an agreement with Takeda for Feraheme in the EU and Canada.
AMAG informed that Takeda has withdrawn EU label expansion application as chances of gaining EU approval were unlikely. Presently, AMAG is evaluating the commercial value and viability of the current label in the EU. Meanwhile, a response from Health Canada on Feraheme’s label update is expected in the second quarter of 2015.
We remind investors that in both these regions, Takeda had filed applications seeking label expansion for the drug to include all patients with IDA regardless of the underlying cause.
Reaffirms 2015 Guidance
For 2015, total revenues are still expected in the range of $380 million to $420 million including net product sales between $335 million and $375 million. The Zacks Consensus Estimate for total revenues currently stands at $394 million.
The company’s net product sales guidance for 2015 includes Makena net sales between $245 million and $270 million, Feraheme and MuGard net sales between $90 million and $105 million and collaboration revenue of around $45 million.
Moreover, AMAG is expecting cash earnings of around $150 million to $170 million for 2015.
AMAG currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Ophthotech Corporation (OPHT) and Prothena Corporation plc (PRTA). Both stocks carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment