UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 1, 2011
CERUS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware | 0-21937 | 68-0262011 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
2550 Stanwell Drive
Concord, California 94520
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code: (925) 288-6000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition |
On November 1, 2011, Cerus Corporation (the Company) announced its financial results for its third quarter ended September 30, 2011. A copy of the Companys press release, entitled Cerus Corporation Reports Third Quarter 2011 Results, is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
The information in this report, including the exhibit hereto, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits |
(d) | Exhibits. | |
The following exhibit is furnished with this report: |
99.1 | Press release, dated November 1, 2011, entitled Cerus Corporation Reports Third Quarter 2011 Results. |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CERUS CORPORATION | ||||
Dated: November 1, 2011 | By: | /s/ Kevin D. Green | ||
Kevin D. Green Vice President, Finance and Chief Accounting Officer |
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EXHIBIT INDEX
Exhibit Number |
Description | |
99.1 | Press release, dated November 1, 2011, entitled Cerus Corporation Reports Third Quarter 2011 Results. |
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Exhibit 99.1
Contact:
Kevin D. Green
Vice President, Finance & CAO
Cerus Corporation
(925) 288-6138
CERUS CORPORATION REPORTS THIRD QUARTER 2011 RESULTS
CONCORD, CA, November 1, 2011 - Cerus Corporation (NASDAQ: CERS) today announced financial results for the third quarter ended September 30, 2011.
As a result of our strong revenues for the first three quarters of 2011, coupled with new INTERCEPT sites coming online, we expect to surpass our revenue growth guidance of 20% for 2011, said William Obi Greenman, president and chief executive officer of Cerus Corporation. Further, we have been able to achieve this growth while tightly managing our operating expenses and cash burn.
Total revenue for the first nine months of 2011 was $22.6 million, up from $16.6 million recognized during the first nine months of 2010. The increase in revenue in 2011 from 2010 was primarily due to growth from product sales of the INTERCEPT Blood System. Revenue for the third quarter of 2011 was $9.2 million, up from $5.0 million recognized during the third quarter of 2010. Product revenue was $7.8 million during the third quarter of 2011, representing an increase of $3.2 million, from $4.5 million recognized during the third quarter of 2010. As a result of the Companys accounting policies, third quarter 2010 product revenue did not include approximately $1.6 million of late September 2010 customer orders. Product revenue for the first nine months of 2011 was $20.7 million, up from
$15.7 million during the first nine months of 2010. Government grant revenue in support of the red blood cell system development was $1.5 million during the third quarter of 2011, representing an increase of $1.0 million from the $0.5 million of grant revenue recorded during the third quarter of 2010. Government grant revenue for the first nine months of 2011 was $1.9 million, up from $0.9 million in government grant revenue recognized during the first nine months of 2010.
Gross margins for the third quarter of 2011 were 50% compared to gross margins of 53% for the third quarter of 2010. Gross margins for the first nine months of 2011 were 47% compared to 49% for the same period in 2010. The decline in 2011 gross margins is attributable to the mix of products sold over the two periods, and approximately $500,000 of non-routine period costs recorded directly to cost of product revenue during the third quarter of 2011 as a result of contractual obligations.
Total operating expenses for the third quarter of 2011 were $7.2 million, compared to $6.2 million for the same period in 2010. Operating expenses for the first nine months of 2011 were $22.9 million, compared to $19.6 million during the same period in 2010. The increase in operating expenses was primarily due to increased research and development costs associated with the INTERCEPT Blood System for red blood cells incurred throughout 2011 compared to 2010.
Net income for the third quarter of 2011 was $2.3 million, or $0.05 per share, compared to a net loss of $3.6 million, or $0.09 per share, for the third quarter of 2010. The period over period change in net income was attributable to narrowing operating losses and a third quarter 2011 non-cash gain of $5.4 million resulting from mark-to-market adjustments to the fair value of Cerus outstanding warrants. Net loss for the first nine months of 2011 was $9.0 million, or $0.19 per share, compared to a net loss of $14.5 million, or $0.37 per share, for the same period in 2010.
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At September 30, 2011, the Company had cash, cash equivalents and short-term investments of $15.2 million, down from $30.0 million at December 31, 2010 and $17.8 million at June 30, 2011. At September 30, 2011, the Company entered into a growth capital and revolving line of credit facility with Comerica Bank and retired its previous debt facility. At September 30, 2011, Cerus drew the first $5 million available under the new facility but had not drawn against the revolving line of credit.
RECENT HIGHLIGHTS:
| Strong revenue growth with more than 30% year-over-year growth in kit demand for the 9-month period; |
| Expecting to exceed 20% total revenue growth guidance for 2011; |
| Ten new INTERCEPT illuminators deployed in France; |
| Agreement from U.S. Food and Drug Administration to review INTERCEPT red blood cell study design under a Special Protocol Assessment. |
QUARTERLY CONFERENCE CALL
The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview. To access the live webcast, please visit the Investor Relations page of the Cerus web site at http://investor.cerus.com. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the Cerus website, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 45247978. The replay will be available approximately three hours after the call through November 14, 2011.
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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 2011 revenue growth rate 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 risk that Cerus may not reach agreement with the FDA on a clinical trial design for the INTERCEPT Blood System for red blood cells, 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 filed with the SEC on August 8, 2011. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Financial Tables Attached
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CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands except per share information)
Three Months
Ended September 30, |
Nine Months
Ended September 30, |
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2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue |
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Product revenue |
$ | 7,770 | $ | 4,521 | $ | 20,706 | $ | 15,712 | ||||||||
Government grants and cooperative agreements |
1,479 | 470 | 1,915 | 936 | ||||||||||||
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Total revenue |
9,249 | 4,991 | 22,621 | 16,648 | ||||||||||||
Cost of product revenue |
4,650 | 2,324 | 12,073 | 8,416 | ||||||||||||
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Gross profit |
4,599 | 2,667 | 10,548 | 8,232 | ||||||||||||
Operating expenses: |
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Research and development |
1,814 | 1,282 | 5,616 | 3,776 | ||||||||||||
Selling, general and administrative |
5,380 | 5,089 | 17,115 | 15,664 | ||||||||||||
Acquisition-related costs, net |
| (201 | ) | | 182 | |||||||||||
Amortization of intangible assets |
51 | | 152 | | ||||||||||||
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Total operating expenses |
7,245 | 6,170 | 22,883 | 19,622 | ||||||||||||
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Loss from operations |
(2,646 | ) | (3,503 | ) | (12,335 | ) | (11,390 | ) | ||||||||
Other income (expense), net |
4,984 | (128 | ) | 3,350 | (3,073 | ) | ||||||||||
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Net income (loss) |
$ | 2,338 | $ | (3,631 | ) | $ | (8,985 | ) | $ | (14,463 | ) | |||||
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Net income (loss) per common share: |
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Basic |
$ | 0.05 | $ | (0.09 | ) | $ | (0.19 | ) | $ | (0.37 | ) | |||||
Diluted |
$ | 0.05 | $ | (0.09 | ) | $ | (0.19 | ) | $ | (0.37 | ) | |||||
Weighted average common shares outstanding used for computing net income (loss) per common share: |
||||||||||||||||
Basic |
47,710 | 39,310 | 47,600 | 39,020 | ||||||||||||
Diluted |
48,820 | 39,310 | 47,600 | 39,020 |
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CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
September 30, 2011 |
December 31, 2010 |
|||||||
Cash, cash equivalents, and short-term investments |
$ | 15,218 | $ | 30,009 | ||||
Accounts receivable and other current assets |
5,865 | 5,789 | ||||||
Inventories |
9,591 | 5,957 | ||||||
Property and equipment, net |
2,045 | 2,390 | ||||||
Intangible assets and goodwill |
3,114 | 3,266 | ||||||
Other assets |
719 | 756 | ||||||
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Total assets |
$ | 36,552 | $ | 48,167 | ||||
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Accounts payable and accrued liabilities |
$ | 9,467 | $ | 9,243 | ||||
Deferred revenue |
74 | 248 | ||||||
Long-term debt, current |
| 1,747 | ||||||
Warrant liability |
4,643 | 8,465 | ||||||
Long-term debt, non-current |
4,910 | 3,131 | ||||||
Other long-term liabilities |
1,290 | 1,601 | ||||||
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Total liabilities |
20,384 | 24,435 | ||||||
Stockholders equity |
16,168 | 23,732 | ||||||
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Total liabilities and stockholders equity |
$ | 36,552 | $ | 48,167 | ||||
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