- Total revenue of $10.4 million, a 61% increase from the fourth quarter of 2010;
- Product revenue of $9.9 million, a 66% increase from the fourth quarter of 2010;
- Operating expenses of $7.6 million compared to $7.4 million incurred during the fourth quarter of 2010.
- Total revenue of $33.0 million, a 43% increase from 2010;
- Product revenue of $30.6 million, a 41% increase from 2010;
- Operating expenses of $30.4 million compared to $27.0 million during 2010;
- Cash of $25.8 million at December 31, 2011 compared to $30.0 million at December 31, 2010.
Total revenue for the year ended December 31, 2011 was $33.0 million, up from $23.1 million recognized during the year ended December 31, 2010. The increase in revenue in 2011 from 2010 was primarily due to a 38% increase in demand for INTERCEPT disposable kits. Product revenue for the year ended December 31, 2011 was $30.6 million, up from $21.7 million during the year ended December 31, 2010. Government grant revenue for the year ended December 31, 2011 was $2.4 million, up from $1.4 million in government grant revenue recognized during the year ended December 31, 2010.Gross Margins Gross margins for the fourth quarter of 2011 were 40% compared to 44% for the fourth quarter of 2010. Gross margins for the year ended December 31, 2011 were 44% compared to 48% during the same period in 2010. 2011 gross margins were impacted by certain costs recorded directly to cost of product revenue as a result of contractual obligations and higher scrap rates for certain components. Operating Expenses Total operating expenses for the fourth quarter of 2011 were $7.6 million, compared to $7.4 million for the fourth quarter of 2010. Operating expenses for the year ended December 31, 2011 were $30.4 million, compared to $27.0 million during the same period in 2010. The increase in operating expenses was largely driven by increased research and development costs associated with the INTERCEPT Blood System for red blood cells incurred throughout 2011 compared to 2010. Net Loss Net loss for the fourth quarter of 2011 was $7.7 million, or $0.16 per share, compared to a net loss of $2.4 million, or $0.06 per share, for the fourth quarter of 2010. In addition to the difference in revenues, margins and operating expenses between the two periods, the change in net loss was affected by a fourth quarter 2011 non-cash loss of $3.3 million compared to a fourth quarter 2010 non-cash gain of $2.4 million, based on the mark-to-market adjustments of Cerus’ outstanding warrants. Net loss for the year ended December 31, 2011 was $17.0 million, or $0.35 per share, compared to a net loss of $16.9 million, or $0.42 per share, for the year ended December 31, 2010.
Cash and InvestmentsAt December 31, 2011, the Company had cash, cash equivalents and short-term investments of $25.8 million, down from $30.0 million at December 31, 2010 and up from $15.2 million at September 30, 2011. During the fourth quarter of 2011, the Company sold common stock under its At-the-Market (“ATM”) sales agreement for net proceeds of $9.7 million and drew down $2.3 million on its revolving line of credit facility with Comerica Bank. Since December 31, 2011, the Company has raised an additional $9.1 million of net proceeds under the ATM sales agreement, substantially exhausting the $20 million facility. RECENT HIGHLIGHTS:
- 2011 revenue growth of 43% from 2010;
- INTERCEPT disposable kit demand up 38% from 2010 and 49% Q4 2011 over Q4 2010;
- Entered into a new two-year Supply Agreement for INTERCEPT platelet and plasma kits with French National Blood Service;
- Tender awarded and fulfilled for 19 new INTERCEPT illuminators in Russia;
- Regulatory approval obtained in Israel for the INTERCEPT Blood System for both platelets and plasma.
- 2012 expected product revenue of between $34 and $36 million, representing approximately 11-18% year-over-year growth in U.S. dollars, or 20-25% year-over-year growth in constant currency;
- Expansion of global INTERCEPT market through regulatory approvals and new distribution agreements;
- Initiation of both acute and chronic anemia Phase III clinical trials for the INTERCEPT red blood cell system to support CE Mark approval in EU;
- Submission of clinical protocol for review under the Special Protocol Assessment process with the U.S. Food and Drug Administration for treatment of chronic anemia using the INTERCEPT red blood cell system.
ADDITIONAL INFORMATIONThe company refers to the projected product revenue growth rate in constant currency so that its anticipated results may be viewed without the impact of fluctuations in foreign currency exchange rates, thereby helping to facilitate period-to-period comparisons of its business performance. In order to compute its projected constant currency product revenue growth rate for 2012, the company compares its anticipated product revenue for 2012 denominated in Euro to its product revenue denominated in Euro for 2011, rather than by conversion to U.S. dollars. ABOUT CERUS Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Blood System for red blood cells is in clinical development. See http://www.cerus.com for more information. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Forward-Looking Statements Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and results, including statements concerning Cerus’ expectations regarding its 2012 revenues and growth rate, statements relating to potential regulatory approvals and new distribution agreements, and statements relating to the development of the INTERCEPT Blood System for red blood cells. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, the uncertain and time-consuming clinical development and regulatory process, including the risks that Cerus may not reach agreement with the FDA on a clinical trial design for the INTERCEPT Blood System for red blood cells or may be unable to initiate planned clincial trials for the INTERCEPT Blood System for red blood cells in a timely manner or at all, adverse market and economic conditions, adverse fluctuations in foreign exchange rates, Cerus’ reliance on third parties to market, sell, distribute and maintain its products, Cerus’ ability to maintain an effective manufacturing supply chain, intellectual property protection, the sufficiency of Cerus’ cash resources, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 3, 2011. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
|CERUS CORPORATION CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS (in thousands except per share information)|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Government grants and cooperative agreements||527||496||2,442||1,432|
|Cost of product revenue||6,206||3,630||18,535||12,046|
|Research and development||1,562||1,419||7,178||5,195|
|Selling, general and administrative||5,938||5,913||23,053||21,577|
|Acquisition-related costs, net||--||--||--||182|
|Amortization of intangible assets||50||67||202||67|
|Total operating expenses||7,550||7,399||30,433||27,021|
|Loss from operations||(3,333||)||(4,568||)||(15,924||)||(15,958||)|
|Non-operating income (expense), net||(4,402||)||2,120||(1,058||)||(953||)|
|Net loss per common share:|
|Weighted average common shares outstanding used for computing net loss per common share:|
|CERUS CORPORATION CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS (in thousands)|
|December 31, 2011||December 31, 2010|
|Cash, cash equivalents, and short-term investments||$||25,784||$||30,009|
|Accounts receivable and other current assets||7,511||5,789|
|Property and equipment, net||2,032||2,390|
|Goodwill and intangible assets||3,064||3,266|
|Accounts payable and accrued liabilities||$||10,505||$||9,243|
|Debt - current||2,519||1,747|
|Debt - non-current||4,697||3,131|
|Other long-term liabilities||1,243||1,601|
|Total liabilities and stockholders’ equity||$||45,367||$||48,167|