Dyax Corp. (NASDAQ: DYAX) today announced financial results for the third quarter ended September 30, 2013. 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 Hereditary Angioedema (HAE) business, including KALBITOR® (ecallantide) and DX-2930, and the Licensing and Funded Research Program (LFRP).
Recent highlights include:
“Dyax saw a number of important milestones in the third quarter, including growth in the KALBITOR business and successful initiation of the clinical program for DX-2930, a wholly-owned product candidate currently in development for potential prophylactic use in HAE,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “Additionally, there were a number of positive Phase 3 data readouts from LFRP candidates, as well as the completion of marketing applications in the U.S. and Europe for one of these candidates, ramucirumab, for second-line advanced gastric cancer.”
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.
Research and development expenses for the third quarter of 2013 were $8.1 million, as compared to $6.2 million for the comparable quarter in 2012. Increases in 2013 were primarily due to pass-through license fees paid by Dyax licensees under the LFRP. For the nine months ended September 30, 2013, research and development expenses were $23.2 million, as compared to $22.7 million for the same period in 2012.
Selling, general and administrative expenses were $8.5 million for the third quarter of 2013, as compared to $9.1 million for the comparable quarter in 2012. For the nine months ended September 30, 2013, selling, general and administrative costs were $29.8 million, as compared to $29.9 million for the same period in 2012.
For the quarter ended September 30, 2013, Dyax reported a net loss of $6.2 million or $0.06 per share attributable to common stockholders, as compared to a net loss of $5.2 million or $0.05 per share for the comparable quarter in 2012. For the nine months ended September 30, 2013, Dyax reported a net loss of $25.8 million or $0.25 per share attributable to common stockholders, as compared to a net loss of $24.4 million or $0.25 per share for the comparable period in 2012.
As of September 30, 2013, Dyax had cash, cash equivalents, and investments totaling $47.1 million, exclusive of restricted cash. Inclusive of the $64.7 million of net proceeds from the equity offering completed in October 2013, Dyax would have had cash, cash equivalents, and investments totaling $111.8 million, as of September 30, 2013.
Dyax has reiterated its previously disclosed financial guidance for 2013:
All revenue guidance is expected to be at the low end of these ranges.
Webcast and Conference Call
|Tuesday, October 22, 2013|
|5:00 p.m. ET|
Domestic callers, dial 877-674-2415; reference the Dyax conference call
International callers, dial 708-290-1364
|No passcode required.|
Go to the Investor Relations section of the Dyax website (www.dyax.com) and follow instructions for accessing the live webcast. Participants may register in advance.
A replay of the conference call will be available through October 27, 2013 and may be accessed by dialing 855-859-2056. International callers should dial 404-537-3406. The replay passcode for all callers is 74956940. The webcast will be archived on the Dyax website for an indefinite period of time.
Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company's key value drivers are the KALBITOR® (ecallantide) business, DX-2930 and the Licensing and Funded Research Program (LFRP).
Dyax developed KALBITOR on its own and, since February 2010, has been selling it in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older. Outside the United States, the Company has established partnerships to obtain regulatory approval and commercialize KALBITOR in certain markets and is evaluating opportunities in others.
The Company is developing products to expand its angioedema portfolio, including a therapeutic candidate, DX-2930, for the prophylactic treatment of HAE and a biomarker assay to identify plasma- kallikrein-mediated disorders. In August 2013, Dyax began a Phase 1 clinical study evaluating the safety and tolerability of single subcutaneous administration of DX-2930 in healthy subjects.
KALBITOR and DX-2930 were identified using Dyax's patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the LFRP. This program has provided the Company a portfolio of product candidates being developed by its licensees, which currently includes 13 revenue eligible product candidates in various stages of clinical development, including three in Phase 3 trials.
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.
This press release contains forward-looking statements, including statements regarding the prospects for ramucirumab and other candidates in the LFRP portfolio, the prospects for continued clinical development of DX-2930 and projected revenues and KALBITOR net sales for 2013. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax and its licensees compete. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements because of uncertainties involved in any future projections, as well as uncertainties associated with various activities and aspects of Dyax’s business, including risks and uncertainties associated with the following: competition from new and existing treatments for HAE; uncertainty whether KALBITOR will gain broader market acceptance; uncertainty regarding treatment rates for patients on KALBITOR and distributor channel inventory levels; Dyax’s dependence on the expertise, effort, priorities and contractual obligations of third parties in the manufacture of KALBITOR worldwide and in the development and any resulting marketing, sales and distribution of KALBITOR outside of the United States; Dyax’s dependence on licensees and collaborators for development, clinical trials, manufacturing, sales and distribution of LFRP candidates and other licensed products; uncertainties as to whether one or more of Dyax’s licensees’ new product candidates will be commercialized and generate royalties; changing requirements and costs associated with Dyax's planned research and development activities; the uncertainty of patent and intellectual property protection; Dyax’s dependence on key management and key suppliers; the impact of future alliances or transactions involving Dyax or others; and other risk factors described or referred to Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.
|SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|(In thousands, except share and per share data)|
|Product sales, net||$||10,772||$||10,814||$||27,927||$||27,988|
|Development and license fee revenues||$||2,919||$||2,287||$||9,140||$||10,632|
|Total revenues, net||$||13,691||$||13,101||$||37,067||$||38,620|
|Costs and expenses:|
|Cost of product sales||720||493||1,991||1,447|
|Research and development expenses||8,105||6,158||23,226||22,664|
|Selling, general and administrative expenses||8,507||9,117||29,804||29,872|
|Total costs and expenses||17,332||15,768||55,021||55,423|
|Loss from operations||(3,641||)||(2,667||)||(17,954||)||(16,803||)|
|Other income (expense):|
|Interest and other income||199||5||206||22|
|Interest and other expense||(2,746||)||(2,548||)||(8,065||)||(7,650||)|
|Total other expense||(2,547||)||(2,543||)||(7,859||)||(7,628||)|
|Net loss attributable to common stockholders||$||(6,188||)||$||(5,210||)||$||(25,813||)||$||(24,431||)|
|Net loss per share attributable to|
|common stockholders, basic and diluted||$||(0.06||)||$||(0.05||)||$||(0.25||)||$||(0.25||)|
|Shares used in computing basic and diluted net loss|
|per share for common stockholders||109,731,276||99,069,928||104,821,199||98,896,984|
SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
|Cash, cash equivalents and investments||$||47,143||$||29,046|
|Accounts receivable, net||6,215||7,507|
Liabilities and Stockholders' Deficit
|Accounts payable and other current liabilities||$||13,866||$||13,146|
|Note payable and other long-term debt||81,933||78,992|
|Other long-term liabilities||3,172||3,057|
|Common and preferred stock and additional paid-in capital||493,194||454,620|
|Accumulated deficit and other comprehensive income||(531,996||)||(506,180||)|
|Total stockholders' deficit||(38,802||)||(51,560||)|
|Total liabilities and stockholders' deficit||$||70,639||$||55,486|
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