Mr. Christensen added: “We also expect a number of key milestones this year from the LFRP, where multiple portfolio candidates are advancing through the clinic and toward pivotal data outcomes and regulatory milestones, including completion of the rolling BLA submission for ramucirumab as a treatment for second line gastric cancer.”
2013 Second Quarter Financial Results
Total revenues for the second quarter ended June 30, 2013 were $11.3 million, as compared to $14.0 million for the comparable quarter in 2012. Included in the 2013 revenues were $8.6 million of KALBITOR net sales, as compared to $9.2 million for the same period in 2012. The 2013 second quarter revenues also included $2.8 million in development and license fee revenue from its development partners.
Total revenues for the six months ended June 30, 2013 were $23.4 million, compared to $25.5 million for the comparable period in 2012, and included $17.2 million of KALBITOR net sales for the comparable periods in both 2013 and 2012.
Dyax expects quarterly and annual revenues to continue to fluctuate due to the timing and amount of distributor demand, future milestone payments, the clinical activities of collaborators and licensees, and the timing and completion of contractual commitments.
Cost of product sales for KALBITOR for the second quarter of 2013 were $563,000, as compared to $416,000 for the comparable quarter in 2012. For the six months ended June 30, 2013, cost of product sales were $1.3 million, as compared to $1.0 million for the comparable period in 2012. Costs associated with manufacturing KALBITOR prior to its approval for sale in the United States were expensed as research and development costs and, accordingly, are not included in cost of product sales during the 2012 periods. For the 2013 periods, KALBITOR sales were comprised of a combination of product manufactured both prior to and following FDA approval. Cost of product sales during the 2013 periods, therefore, do not reflect the full KALBITOR manufacturing cost.