Dyax second quarter 2012 total revenues increase to $14.0 million

Jul 20 2012

Dyax Corp. (NASDAQ: DYAX) today announced financial results for the second quarter ended June 30, 2012. Dyax will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and provide updates regarding its key value drivers - the KALBITOR^® (ecallantide) business and angioedema franchise, as well as the Licensing and Funded Research Program (LFRP).    

Highlights of the second quarter 2012 include:

• KALBITOR net sales increased to $9.2 million, a 14% increase over first quarter 2012;
• 518 patients have treated with KALBITOR, up 12% from the previous quarter;
• Operating cash burn in the second quarter was reduced to $7.0 million, down from $8.5 million in the prior quarter; and
• Cash, cash equivalents and investments at June 30, 2012 totaled approximately $38.6 million.

"During the second quarter of 2012, our financial results were driven by the strong performance of our KALBITOR business," stated Gustav Christensen, President and Chief Executive Officer of Dyax. "We have made significant strides in providing the HAE community with a comprehensive set of support and service programs. We are carrying this momentum into developing the angioedema franchise with a goal to ultimately diagnose and treat a broader set of plasma kallikrein (bradykinin) mediated angioedemas. Additionally, the Licensing and Funded Research Program continues to be an important near- and long-term driver of growth for Dyax."

2012 Second Quarter Financial Results

Total revenues for the second quarter ended June 30, 2012 were $14.0 million, as compared to $21.9 million for the comparable quarter in 2011. Included in the 2012 revenues were $9.2 million of KALBITOR net sales, as compared to $5.2 million for 2011. The 2011 quarter revenues included $10.7 million of revenue associated with an expanded partnership with Sigma-Tau. Total revenues for the six months ended June 30, 2012 were $25.5 million compared to $30.1 million for the comparable period in 2011, and included $17.2 million and $9.3 million of KALBITOR net sales in 2012 and 2011, respectively.

Quarterly and annual 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 second quarter of 2012 was $416,000, as compared to $282,000 for the comparable quarter in 2011. For the six months ended June 30, 2012, cost of product sales were $1.0 million, as compared to $521,000 for the comparable period in 2011. Costs associated with manufacturing KALBITOR drug substance, 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.

Research and development expenses for the second quarter of 2012 were $8.7 million, as compared to $10.1 million for the comparable quarter in 2011. For the six months ended June 30, 2012, research and development expenses were $16.5 million, as compared to $17.6 million for the same period in 2011.

The 2012 research and development expenses primarily relate to the following Dyax research and development initiatives: 1) KALBITOR post-marketing requirements; 2) development of a single-injection formulation of KALBITOR; 3) a clinical study of the use of ecallantide for the treatment of ACE inhibitor-induced angioedema, including costs related to the discontinuation and close-out of Dyax's Phase 2 study in this indication; 4) development costs associated with DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein; and 5) pass-through license fees paid by Dyax licensees under the LFRP.

Research and development expenses declined in the 2012 periods due primarily to lower personnel costs following the workforce reduction in the first quarter of 2012, and lower pass-through license fees under the LFRP.

Selling, general and administrative expenses for the second quarter of 2012 increased to $10.4 million, as compared to $9.1 million for the comparable quarter in 2011. For the six months ended June 30, 2012, selling, general and administrative costs were $20.8 million, as compared to $18.3 million for the same period in 2011. The higher selling, general and administrative costs in 2012 were primarily due to expanded infrastructure to support KALBITOR commercial efforts.

For the quarter ended June 30, 2012, Dyax reported a net loss of $7.9 million or $0.08 per share, as compared to a net loss of $76,000 or $0.00 per share for the comparable quarter in 2011. For the six months ended June 30, 2012, Dyax reported a net loss of $19.2 million or $0.19 per share, as compared to a net loss of $11.3 million or $0.11 per share for the comparable period in 2011.

As of June 30, 2012, Dyax had cash, cash equivalents, and investments totaling $38.6 million, exclusive of restricted cash.

Financial Guidance

Dyax has re-affirmed its financial guidance for 2012 and beyond:

• 2012 top-line total revenue to be in the range of $50 - 54 million, including KALBITOR net sales in the range of $36 - 40 million; and
• Reach cash flow break-even during 2013.

This guidance excludes revenue and cash flow from potential new licenses or collaborations and any ex-U.S. KALBITOR sales.