Hikma has said revenues in its generic drug division last year were dragged down by remediation costs at a New Jersey plant that the FDA cited in 2012. Even so, the generics unit will be the star of its financial report next month, driven by sales of doxycycline, a drug that was on the FDA shortage list until recently.
The Jordan-based company was issued a warning letter in 2012 for the West-Ward division plant in Eatontown, NJ, over manufacturing and testing issues that led to the release of lithium and digoxin tablets that failed size specifications. Last summer it said that it was slowly ramping up production at the facility. It also said the $45 million it had to shell out for remediation was more than covered by growth in the generics unit in sales of the antibiotic doxycycline.
In fact, doxycycline sales in the first half of the year had boosted its generic drug revenues up 137%, with its pretax profit doubling to $111.6 million. And things only got better as the year progressed. It said Thursday that doxycycline sales would help push its generics revenues to about $270 million for 2013. That is $10 million more than it projected in November.
That said, it warned investors Thursday it expects sales of its generics business to slow in 2014 as more competitors bring doxycycline production online. The drug, used for treating a host of conditions, including malaria and Lyme disease, was on the FDA shortage list for months. But in October, the FDA finally moved it to "resolved" shortage status.
The drugmaker is building business in other areas, however. Its sterile injectable drug business was up about 14% for the year, and margins on those products top 30%. It is also moving further into emerging markets. Last year it said it would participate in a joint venture with MIDROC Pharmaceuticals, part of Sheikh Mohammed Hussein Al Amoudi's MIDROC Group, to build a manufacturing plant in Ethiopia.
- here's the release