Dyax Corp. (NASDAQ: DYAX) today announced financial results for the fourth quarter and year ended December 31, 2013. Dyax will host a webcast and conference call at 8:30 a.m. (ET) today to review financial results and provide updates regarding its key value drivers - the hereditary angioedema (HAE) business, including KALBITOR® (ecallantide) and DX-2930, and the Licensing and Funded Research Portfolio (LFRP).
Positive results from the Phase 1a clinical study of DX-2930, Dyax's investigational product being developed for the prevention of HAE attacks;
DX-2930 program on track to commence a Phase 1b clinical study in mid-2014;
KALBITOR net sales for the fourth quarter 2013 increased to $12.6 million;
KALBITOR patient demand units (units sold by distributors to hospitals or patients) increased in the fourth quarter by an estimated 11% over the third quarter of 2013;
Cash, cash equivalents and investments at December 31, 2013 totaled approximately $111.4 million.
"Dyax achieved a number of milestones during 2013, including the advancement of DX-2930 into human clinical trials, profitability of the KALBITOR business, and a significant strengthening of our balance sheet," said Gustav Christensen, President and Chief Executive Officer of Dyax. "Several LFRP product candidates saw positive data readouts in 2013, and last week Eli Lilly reported positive results from the REVEL study, their global Phase 3 trial evaluating the most advanced LFRP product candidate, ramucirumab, in lung cancer."
Mr. Christensen added: "Looking forward to 2014, Dyax will continue to serve the HAE community and is on track to begin by mid-year the Phase 1b clinical study of DX-2930 in HAE patients. We are also expecting a number of key events from the LFRP, including regulatory action on Lilly's ramucirumab submission for the treatment of advanced gastric cancer."
2013 Fourth Quarter and Full Year Financial Results
Total revenues for the fourth quarter ended December 31, 2013 were $16.9 million, as compared to $16.0 million for the comparable quarter in 2012. These include KALBITOR net sales of $12.6 million and $11.8 million for the fourth quarter of 2013 and 2012, respectively.
Total revenues for the twelve months ended December 31, 2013 were $53.9 million, compared to $54.7 million for the comparable period in 2012, and included $40.5 million and $39.8 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, clinical activities of collaborators and licensees, and timing and completion of contractual commitments.
Cost of product sales for KALBITOR was approximately $700,000 for both the fourth quarters of 2013 and 2012. For the twelve months ended December 31, 2013, cost of product sales were $2.7 million, as compared to $2.2 million for the comparable period in 2012. For the fourth 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, together with other research programs; 2) KALBITOR medical support and post-marketing requirements; and 3) pass-through license fees paid by Dyax licensees under the LFRP.
Research and development expenses for the fourth quarter of 2013 were $6.5 million, as compared to $7.4 million for the comparable quarter in 2012. For the twelve months ended December 31, 2013, research and development expenses were $29.7 million, as compared to $30.0 million for the same period in 2012. These expenses decreased in the fourth quarter of 2013, primarily due to a lower level of expenditure associated with DX-2930. For the 2013 year, DX-2930 costs increased over 2012 and the net decrease in research and development costs were primarily due to lower KALBITOR medical support and post-marketing expenditures.
Selling, general and administrative expenses were $8.9 million for the fourth quarter of 2013, as compared to $10.0 million for the comparable quarter in 2012. For the twelve months ended December 31, 2013, selling, general and administrative costs were $38.7 million, as compared to $39.9 million for the same period in 2012.
For the quarter ended December 31, 2013, Dyax reported a net loss of $2.0 million, or $0.02 per share attributable to common stockholders, as compared to a net loss of $4.8 million, or $0.05 per share, for the comparable quarter in 2012. For the twelve months ended December 31, 2013, Dyax reported a net loss of $27.8 million, or $0.26 per share attributable to common stockholders, as compared to a net loss of $29.3 million, or $0.30 per share, for the comparable period in 2012.
As of December 31, 2013, Dyax had cash, cash equivalents, and investments totaling $111.4 million, exclusive of restricted cash.
Dyax financial guidance for 2014:
Top-line total revenue to be in the range of $53-59 million, including KALBITOR net sales of $44-49 million.
Due to the significant variability in the rate at which HAE patients treat their acute attacks, the Company relies on an annualized treatment rate for net sales guidance.
Total top-line revenue excludes potential royalties which would be earned from sales of LFRP product candidates that may receive marketing approval in 2014.
Operating costs and expenses (cost of product sales, research and development expenses, and selling, general and administrative costs) to be in the range of $72-75 million.