Mr. Christensen added: “Dyax is well positioned for growth and value creation with our KALBITOR business remaining profitable and cash flow positive, DX-2930 moving through the clinic, a maturing portfolio of LFRP candidates, and a stronger balance sheet after our recently completed equity financing.”
2013 Third Quarter Financial Results
Total revenues for the third quarter ended September 30, 2013 were $13.7 million, as compared to $13.1 million for the comparable quarter in 2012. These include KALBITOR net sales of $10.8 million for both the third quarter of 2013 and the third quarter of 2012.
Total revenues for the nine months ended September 30, 2013 were $37.1 million, compared to $38.6 million for the comparable period in 2012, and included $27.9 million and $28.0 million of KALBITOR net sales for the comparable periods in 2013 and 2012, respectively.
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 third quarter of 2013 were $720,000, as compared to $493,000 for the comparable quarter in 2012. For the nine months ended September 30, 2013, cost of product sales were $2.0 million, as compared to $1.4 million for the comparable period in 2012. For the third quarter of 2013, KALBITOR net sales were from product manufactured following the FDA’s approval of KALBITOR for sale in the United States and, therefore, cost of product sales reflects the full manufacturing cost. Costs associated with manufacturing KALBITOR prior to FDA approval were expensed as research and development costs and, accordingly, are not included in cost of product sales during the 2012 and earlier 2013 quarters.
Research and development expenses at Dyax are primarily related to the following research and development initiatives: 1) development costs associated with DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein; 2) KALBITOR medical support and post-marketing requirements; and 3) pass-through license fees paid by Dyax licensees under the LFRP.