- 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.
2013 Fourth Quarter and Full Year Financial ResultsTotal 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. Financial Guidance 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.
|Date:||Friday, February 28, 2014|
|Time:||8:30 a.m. ET|
|Telephone Access:||Domestic callers, dial 877-674-2415; reference the Dyax conference call|
|International callers, dial 708-290-1364|
|No passcode required.|
|Online Access:||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.|
For additional information about Dyax, please visit www.dyax.com.For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com. Disclaimer This press release contains forward-looking statements, including statements regarding the prospects for ramucirumab and other product candidates in the LFRP, the prospects for continued clinical development of DX-2930 and projected revenues, and forecasts for KALBITOR net sales and operating costs and expenses for 2014. 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 regarding KALBITOR’s market share;uncertainty regarding treatment rates for patients on KALBITOR and distributor channel inventory levels; Dyax’s dependence on licensees and collaborators for development, clinical trials, manufacturing, sales and distribution of product candidates in the LFRP; uncertainties as to whether one or more of new product candidates in the LFRP will be commercialized and generate royalties; 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; 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.
|DYAX CORP. SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|(In thousands, except share and per share data)|
|Product sales, net||$||12,599||$||11,795||$||40,526||$||39,783|
|Development and license fees||$||4,260||$||4,235||$||13,400||$||14,867|
|Total revenues, net||$||16,859||$||16,030||$||53,926||$||54,650|
|Costs and expenses:|
|Cost of product sales||697||705||2,688||2,152|
|Research and development||6,469||7,364||29,695||30,028|
|Selling, general and administrative||8,938||10,043||38,742||39,915|
|Total costs and expenses||16,104||18,112||71,125||73,535|
|Income (loss) from operations||755||(2,082||)||(17,199||)||(18,885||)|
|Other income (expense):|
|Interest and other income||8||92||214||111|
|Interest and other expense||(2,727||)||(2,844||)||(10,792||)||(10,491||)|
|Total other expense||(2,719||)||(2,752||)||(10,578||)||(10,380||)|
|Net loss attributable to common stockholders||$||(1,964||)||$||(4,834||)||$||(27,777||)||$||(29,265||)|
|Net loss per share attributable to common stockholders, basic and diluted|
|Shares used in computing basic and diluted net loss per share for common stockholders|
|SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION (Unaudited)|
|December 31,||December 31,|
|Cash, cash equivalents and investments||$ 111,381||$ 29,046|
|Accounts receivable, net||6,506||7,507|
|Total assets||$ 134,207||$ 55,486|
|Liabilities and Stockholders' Equity (Deficit)|
|Accounts payable and other current liabilities||$ 14,822||$ 13,146|
|Note payable and other long-term debt||81,979||78,992|
|Other long-term liabilities||3,063||3,057|
|Common and preferred stock and additional paid-in capital||560,282||454,620|
|Accumulated deficit and other comprehensive income||(533,960)||(506,180)|
|Total stockholders' equity (deficit)||26,322||(51,560)|
|Total stockholders' equity (deficit)||$ 134,207||$ 55,486|