Press Releases

SUNNYVALE, Calif., Jan. 24, 2013 /PRNewswire/ --Cepheid (Nasdaq: CPHD) today reported revenue for the fourth quarter of 2012 of $92.4 million. Net income was $5.6 million, or $0.08 per share, which compares to revenue of $80.1 million and net loss of $1.6 million, or $(0.03) per share, in the fourth quarter of 2011. 2011 fourth quarter results reflected a one-time, non-cash charge to cost of sales of $5.4 million, or $0.08 per share, associated with the termination of a patent license.

Excluding stock compensation expenses, impairment of intangible assets and licensesand amortization of acquired intangibles, non-GAAP net income for the fourth quarter of 2012 was $14.2 million, or $0.20 per share. This compares to a non-GAAP net income of $9.4 million, or $0.14 per share, in the fourth quarter of 2011.

Fiscal 2012 Overview

For the year ended December 31, 2012, Cepheid reported revenue of $331.2 million which compares to revenue of $277.6 million in 2011. Net loss for the year was $20.0 million, or $(0.30) per share, which compares to net income of $2.6 million, or $0.04 per share, in 2011. 2012 full year net loss reflected a charge of $15.1 million, or $0.23 per share, associated with a litigation settlement.

Excluding stock compensation expenses, a litigation settlement charge, impairment of intangible assets and licenses,amortization of acquired intangibles and a tax benefit related to an intercompany intellectual property transaction, non-GAAP net income for the year was $21.8 million, or $0.31 per share. This compares to a non-GAAP net income of $29.6 million, or $0.44 per share, for the full year 2011.

"2012 was a challenging year for Cepheid as we worked through growing pains associated with the scale-up of our manufacturing operations and adapted to the incremental variability associated with our HBDC program," said John Bishop, Cepheid's Chief Executive Officer. "Despite these distractions, we were able to grow our clinical test revenue by 32%, including 25% growth in our commercial business."

Continued Bishop, "We are proud of our commitment to innovation, and our investment in R&D continues to be among the most aggressive in the industry. As we move into 2013 and beyond, Cepheid is entering a pivotal period of Xpert test menu expansion with a number of high volume, high value tests that substantially extend our opportunities in new and existing markets. We fully expect this product cycle to drive both market expansion and menu consolidation within accounts thereby benefiting continued, industry-leading revenue growth and improving profitability."

Operational Overview

• Fourth quarter of 2012 Clinical sales of $82.2 million grew 19% from $68.9 million in the fourth quarter of 2011, and total fourth quarter of 2012 product sales of $89.7 million grew 17% from the same quarter a year ago. For the year ended December 31, 2012, total Clinical sales of $286.3 million grew 21% from $236.0 million reported for 2011.
• By industry, product sales were, in millions:

• By geography, product sales were, in millions:

• During the fourth quarter of 2012, Cepheid placed a total of 153 GeneXpert systems in its commercial Clinical business. Additionally, the Company placed a total of 68 GeneXpert systems as part of its High Burden Developing Country (HBDC) program. For the year ended December 31, 2012, Cepheid placed a total of 523 GeneXpert systems in its commercial Clinical business and an additional 506 GeneXpert systems as part of its HBDC program. As of December 31, 2012, a cumulative total of 3,835 GeneXpert systems have been placed worldwide.
• Cash and cash equivalents were $95.8 million as of December 31, 2012.
• DSO was 43 days.

Business Outlook

For the fiscal year ending December 31, 2013, the Company expects:

• Total revenue to be in the range of $375 to $385 million;
• Net income to range from a net loss of $(0.05) to net income of $0.01 per share;
• Non-GAAP net income in the range of $0.41 to $0.46 per share.

Expected non-GAAP net income excludes approximately $29 million related to stock compensation expense and approximately $4 million related to the amortization of acquired intangibles. The fully diluted share count for the year is expected to be approximately 72 million, except in the event of a GAAP loss where the share count would be approximately 67 million shares.

The following table reconciles net income (loss) per share to the non-GAAP net income per share range:

Accessing Cepheid's Fourth Quarter and Full Year 2012 Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, January 24, 2013, to discuss the results. To access the live webcast, please visit Cepheid's website at http://ir.cepheid.com at least 15 minutes before the scheduled start time to download any necessary audio or plug-in software. A replay of the webcast will be available shortly following the call and will remain available for at least 90 days.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the Company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the Company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

Use of Non-GAAP Measures

The Company has supplemented its reported GAAP financial information with non-GAAP measures that do not include litigation settlement expenses, employee stock-based compensation expense, a non-cash charge associated with the termination of a patent license, impairment of intangible assets and licensesand amortization of purchased intangible assets. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with U.S. GAAP.The Company's management uses the non-GAAP information internally to evaluate its ongoing business, continuing operational performance and cash requirements, and believes these non-GAAP measures are useful to investors as they provide a basis for evaluating the Company's cash requirements and additional insight into the underlying operating results and the Company's ongoing performance in the ordinary course of its operations.

These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. The Company believes that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with its results of operations as determined in accordance with U.S. GAAP and that these measures should only be used to evaluate the Company's results of operations in conjunction with the corresponding GAAP measures.

As described above, the Company excludes the following items from one or more of its non-GAAP measures when applicable:

Litigation Settlement Expenses. These expenses consist primarily of expenses related to the settlement of our previously outstanding litigation with Abaxis. This allocation was determined in accordance with ASC 450, Accounting for Contingencies (formerly SFAS No. 5), and ASC 605-25 (formerly EITF 00-21) using the concepts of fair value based on the past and estimated future revenue streams related to the products covered by the patents previously under dispute. Specifically, the amount recorded in the income statement as Litigation settlement in the year ended December 31, 2012 represents the fair value of the royalty paid on past revenue streams and the residual amount after allocating value to the future revenue streams. The Company excluded this item as it believes it is non-recurring in nature, and does not have a direct impact on the operation of the Company's core business.

Employee Stock-based Compensation Expense. These expenses consist primarily of expenses for employee stock options and employee restricted stock under ASC 718 (formerly SFAS 123(R)). The Company excludes employee stock-based compensation expenses from its non-GAAP measures primarily because they are non-cash expenses that the Company does not believe are reflective of ongoing operating results in the period incurred. Further, as the Company applies ASC 718, it believes that it is useful to investors to understand the impact of the application of ASC 718 on its results of operations.

Impairment of Intangible Assets and Licenses and Amortization of Purchased Intangible Assets. The Company incurs amortization of purchased intangible assets in connection with acquisitions and incurs impairment of intangible assets and licenses. The Company excludes these items because these expenses are not reflective of ongoing operating results in the period incurred. These amounts arise from the Company's prior acquisitions and have no direct correlation to the operation of the Company's business.

Tax Benefit Related to Intercompany Intellectual Property (IP) Transaction. The Company excluded a tax benefit related to an intercompany IP transaction from its results for non-GAAP net loss for the year ended December 31, 2012. The Company excluded this item as it believes it is non-recurring in nature, and does not have a direct impact on the operation of the Company's core business.

Forward-Looking Statements

This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to potential growth, future revenues and future net income/loss and profitability, including on a non-GAAP basis, and test menu expansion. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: our ability to successfully complete and bring on line additional manufacturing lines; our success in increasing direct sales and the effectiveness of our sales personnel; the performance and market acceptance of new products; sufficient customer demand; our ability to develop new products and complete clinical trials successfully in a timely manner for new products; uncertainties related to the FDA regulatory and European regulatory processes; the level of testing at clinical customer sites, including for Healthcare Associated Infections (HAIs); the Company's ability to successfully introduce and sell products in clinical markets other than HAIs; the rate of environmental biothreat testing conducted by the USPS, which will affect the amount of consumable products sold to the USPS; variability in systems placements and reagent pull-through in the Company's HBDC program and the level of sales through that program; other unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; lengthy sales cycles in certain markets; the Company's reliance on distributors in some regions to market, sell and support its products; the occurrence of unforeseen expenditures, acquisitions or other transactions; costs associated with litigation; the impact of competitive products and pricing; the Company's ability to manage geographically-dispersed operations; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.

FINANCIAL TABLES FOLLOW

SOURCE Cepheid