Dyax Corp. (NASDAQ: DYAX) today announced financial results for the fourth quarter and year ended December 31, 2012. Dyax will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and updates regarding its key value drivers - the KALBITOR® (ecallantide) business and angioedema portfolio, as well as the Licensing and Funded Research Program (LFRP).
Highlights of 2012 include:
KALBITOR® fourth quarter 2012 net sales increased to $11.8 million, a 9.3% increase over the third quarter;
KALBITOR net sales increased 74% to $39.8 million for the year, contributing to total revenues of $54.7 million for 2012;
LFRP portfolio now includes 13 royalty and/or milestone eligible clinical candidates, of which three are in Phase 3 and four are in Phase 2 clinical development; and
Cash, cash equivalents and investments at December 31, 2012 totaled $29 million.
"2012 was another strong year for the KALBITOR business with sales reaching $39.8 million," stated Gustav Christensen, President and Chief Executive Officer of Dyax. "It was also an important year for our Licensing and Funded Research Program (LFRP), which demonstrated its potential for value creation following the release of positive Phase 3 data from one of our collaborator's drug candidates. In the year ahead, the robust LFRP pipeline will continue to mature, with multiple data read-outs expected throughout 2013."
Mr. Christensen added: "Dyax is translating its years of know-how and expertise, both in the angioedema field and antibody discovery, to advance its strategy for creating meaningful value for our shareholders. We look forward to a productive 2013."
2012 Fourth Quarter and Full Year Financial Results
Total revenues for the fourth quarter ended December 31, 2012 were $16.0 million, as compared to $8.5 million for the comparable quarter in 2011. Fourth quarter 2012 revenues included $11.8 million of KALBITOR net sales, as compared to $7.0 million for 2011.
Revenues for the year ended December 31, 2012 were $54.7 million, as compared to $48.7 million in 2011. Included in the 2012 revenues were $39.8 million of KALBITOR net sales, as compared to $22.9 million for 2011. The 2011 revenues also included $10.5 million of development and license fee revenue associated with the expansion of our ex-U.S collaborations for ecallantide.
Quarterly and annual development and license fee revenues are expected to continue to fluctuate due to the timing and amount of 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 fourth quarter of 2012 were $705,000, as compared to $442,000 for the comparable quarter in 2011. For the year ended December 31, 2012, cost of product sales were $2.2 million as compared to $1.2 million for the comparable period in 2011. Costs associated with manufacturing KALBITOR drug substance for these sales, which were incurred prior to KALBITOR's approval in the United States, were expensed as research and development costs and, accordingly, are not included in the cost of product sales during the 2012 and 2011 periods reported.
Research and development expenses for the fourth quarter of 2012 were $7.4 million, as compared to $8.4 million for the comparable quarter in 2011. For the year ended December 31, 2012, research and development expenses decreased to $30.0 million, as compared to $34.7 million for the comparable period in 2011.
The 2012 fourth quarter and year reflect reduced expenses due to lower clinical trial and personnel costs, as well as a reduction in pass-through license fees paid by Dyax licensees under the LFRP.
Research and development expenses primarily relate to the following Dyax research and development initiatives: 1) KALBITOR medical support and post-marketing requirements; 2) development of a single-injection formulation of KALBITOR; 3) development costs associated with DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein; and 4) pass-through license fees paid by Dyax licensees under the LFRP.
Selling, general and administrative expenses for the fourth quarter of 2012 decreased to $10.0 million, as compared to $10.6 million for the comparable quarter in 2011. For the year ended December 31, 2012, selling, general and administrative costs increased to $39.9 million, as compared to $37.7 million for the comparable period in 2011. The higher selling, general and administrative costs for the year 2012 were primarily due to expanded infrastructure to support KALBITOR commercial efforts.
For the quarter ended December 31, 2012, Dyax reported a net loss of $4.8 million or $0.05 per share, as compared to a net loss of $13.5 million or $0.14 per share for the comparable quarter in 2011. For the year ended December 31, 2012, the net loss was $29.3 million or $0.30 per share, as compared to $34.6 million or $0.35 per share for the comparable period in 2011.
As of December 31, 2012, Dyax had cash, cash equivalents, and investments totaling $29.0 million, exclusive of restricted cash.
Dyax's financial guidance for 2013:
2013 top-line total revenue to be in the range of $65-70 million, and
Includes KALBITOR net sales in the range of $52-56 million.
Cash flow breakeven during the latter part of 2013.
When Dyax reaches cash flow breakeven, it will continue disciplined management of operations around the breakeven point. The Company does not expect this to result in positive earnings in 2014. Dyax will invest in plasma kallikrein focused development, either alone or, where appropriate, through partnerships.