Dyax Corp. (NASDAQ: DYAX) today announced financial results for the second quarter ended June 30, 2010. Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.
“Even with those new commercial costs, our net operating cash burn has been reduced and we have the necessary capital to support the KALBITOR launch and other strategic projects.”
- Patients currently in KALBITOR AccessSM program expanded to 264
- HAE patients with KALBITOR® (ecallantide) at their treatment center increased to 117, a 266% increase over Q1
- 2010 KALBITOR net sales reached $3.2 million, which represents a 55% increase over Q1
- Second quarter 2010 net operating cash usage reduced to $11.4 million
- First half 2010 operating costs reduced by 25%, despite adding new KALBITOR commercial launch expenses
- Cash, cash equivalents and investments at June 30, 2010 total $94.4 million
Total revenues for the second quarter ended June 30, 2010 increased to $15.1 million, as compared to $4.8 million for the same quarter in 2009. Total revenues for the six months ended June 30, 2010 increased to $35.2 million from $10.8 million in the comparable period in 2009. For the six month 2010 period, the increase in revenues was due to $3.2 million of net product sales of KALBITOR, which became commercially available during the first quarter of 2010 for treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. Additionally, $13.8 million of revenue was recognized following Cubist Pharmaceuticals' termination of its development of DX-88 for blood loss during cardiac surgery. In the second quarter of 2010, the Company recognized approximately $9.8 million of revenue for the sale of its rights to royalties and other payments related to the commercialization of Xyntha® by Pfizer, Inc. Quarterly revenues are expected to fluctuate due to the timing and amount of future milestone payments, the clinical activities of our collaborators and licensees, the timing and completion of contractual commitments, and the timing of KALBITOR sales during the commercial launch of KALBITOR.
"The second quarter of 2010 is the first full quarter of our launch of KALBITOR," commented Gustav A. Christensen, President and Chief Executive Officer of Dyax. "KALBITOR Access, which is designed as a one-stop point of contact for treatment support service for patients with HAE and their healthcare providers, now has 264 patients, including 117 patients with drug in-place at treatment sites. Our KALBITOR case managers, who provide comprehensive product and disease information, treatment site coordination, financial assistance for qualified patients and reimbursement facilitation services, are an important element in the early success of our commercial launch of KALBITOR."
Cost of product sales for KALBITOR for the three and six months ended 2010 were $92,000 and $128,000, respectively. Costs associated with manufacturing KALBITOR drug substance, which were incurred in 2009 prior to FDA approval, were expensed as research and development costs and accordingly are not included in the cost of product sales during the 2010 period reported. This existing supply of KALBITOR is expected to meet anticipated commercial needs well into 2011.
Research and development expenses for the second quarter of 2010 decreased to $8.0 million, as compared to $11.4 million for the same quarter in 2009. For the six months ended June 30, 2010, research and development expenses decreased to $15.8 million, as compared to $30.7 million for the comparable period in 2009. The 2010 decreases in research and development expenses were primarily related to cost savings resulting from a restructuring in March 2009, lower KALBITOR manufacturing costs and other reduced external research and development expenses.
Selling, general and administrative expenses for the second quarter of 2010 increased to $8.4 million, as compared to $5.2 million for the same quarter in 2009. For the six months ended June 30, 2010, selling, general and administrative costs increased to $17.0 million, as compared to $13.0 million for the comparable period in 2009. The higher selling, general and administrative costs in 2010 were primarily due to increased infrastructure to support the commercialization of KALBITOR, including the addition of sales and marketing personnel, as well as other external marketing activities.
For the quarter ended June 30, 2010, Dyax reported a net loss of $5.3 million or $0.05 per share, as compared to a net loss of $14.4 million or $0.23 per share for the comparable quarter in 2009. For the six months ended June 30, 2010, Dyax reported net loss was $4.3 million or $0.05 per share, as compared to $39.3 million or $0.62 per share for the comparable period in 2009.
As of June 30, 2010, Dyax had cash, cash equivalents, and investments totaling $94.4 million, exclusive of restricted cash.
"The ongoing commitment to effectively manage our resources has been demonstrated by the significant reduction of operating expenses during the first half of 2010, a period which includes the additional costs for infrastructure to support the commercialization of KALBITOR," stated George Migausky, Executive Vice President and Chief Financial Officer. "Even with those new commercial costs, our net operating cash burn has been reduced and we have the necessary capital to support the KALBITOR launch and other strategic projects."