Cepheid Reports 2010 Second Quarter Results

SUNNYVALE, Calif., July 22 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the second quarter of 2010 of $49.6 million. Net loss was $1.8 million, or $(0.03) per share, which compares to revenue of $41.0 million and a net loss of $6.8 million, or $(0.12) per share, in the second quarter of 2009.

Excluding amortization of purchased intangible assets and stock compensation expense, non-GAAP net income for the second quarter was $2.9 million, or $0.05 per share. This compares to a non-GAAP net loss of $2.2 million, or $(0.04) per share, in the second quarter of 2009.

“Second quarter highlights included record revenue and gross margin performance driven by the continued rapid adoption of our industry-leading GeneXpert® System in the clinical market,” said John Bishop, Cepheid’s Chief Executive Officer. “With our heavy royalty burden starting to ease in the third quarter, combined with our continued market growth, we have our eye firmly set on achieving sustainable profitability without compromising the research and development investment we are making to protect and grow our leadership position in molecular diagnostics.”

Operational Overview

  • Total product sales of $48.6 million in the second quarter of 2010, compared to $39.6 million in the second quarter of 2009. By industry, product sales were, in millions:

Three Months Ended June 30,


2010


2009


Change







Clinical Systems

$ 6.1


$ 5.7


7%

Clinical Reagents

31.6


21.0


51%

Total Clinical

37.7


26.7


41%

Industrial

4.7


4.3


8%

Biothreat

5.0


7.8


-35%

Partner

1.2


0.8


47%

Total Product Sales

$ 48.6


$ 39.6


23%







  • By geography, product sales were, in millions:

Three Months Ended June 30,


2010


2009


Change

North America






Clinical

$ 29.1


$ 20.2


44%

Other

9.1


11.2


-18%

Total North America

38.2


31.4


22%







International






Clinical

8.6


6.5


32%

Other

1.8


1.7


8%

Total International

10.4


8.2


27%







Total Product Sales

$ 48.6


$ 39.6


23%

  • During the quarter, Cepheid installed a total of 106 GeneXpert systems and 478 modules. As of June 30, 2010, a cumulative total of 1,605 GeneXpert systems and 8,618 modules have been placed worldwide.
  • GAAP gross margin on product sales was 48% and non-GAAP gross margin on product sales was 50%, which compares to 41% and 44%, respectively, in the second quarter of 2009.
  • Cash, cash equivalents and investments, net of associated debt, were $47 million as of June 30, 2010.
  • DSO was 51 days.

Business Outlook

For the fiscal year ending December 31, 2010, the company expects:

  • Total revenue to be in the range of $200 to $205 million;
  • Net loss in the range of $(0.25) to $(0.21) per share;
  • Non-GAAP net income in the range of $0.05 to $0.09 per share.

Expected non-GAAP net income excludes approximately $16.5 million related to stock compensation expense and approximately $2 million related to the amortization of acquired intangibles.

Accessing Cepheid’s Q210 Results Conference Call

The company will host a management presentation at 2:00 p.m. Pacific Time on Thursday, July 22, 2010 to discuss the results. To access the live webcast, please visit Cepheid’s website at www.cepheid.com/investors 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.

Interested participants may also listen to the live teleconference call by dialing (866) 761-0748 (domestic) or (617) 614-2706 (international), and entering participant code 64453418. A replay will be available for seven days beginning at 4 p.m. Pacific Time. Access numbers for this replay are (888) 286-8010 (domestic) and (617) 801-6888 (international), with participant code 17778236.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See www.cepheid.com for more information.

Use of Non-GAAP Measures

The company has supplemented its reported GAAP financial information with non-GAAP measures that do not include employee share-based compensation expense and amortization of purchased intangible assets and, for the first quarter of 2009, restructuring charges. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with 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 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:

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. 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.

Amortization of purchased intangible assets. The company incurs amortization of purchased intangible assets in connection with acquisitions. 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.

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 product pipeline and timeline, product performance, future revenues and future net income or loss. 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 success in increasing direct sales and the effectiveness of new sales personnel; the performance and market acceptance of new products; sufficient customer demand; our ability to develop 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; changes in the protocols or levels of testing 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; unforeseen 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, including expenditures related to litigation, acquisitions or other transactions; the impact of acquisitions and stock-based compensation expense; the impact of competitive products and pricing; the company’s ability to manage geographically-dispersed operations; and underlying market conditions worldwide, including the uncertain impact of the significant global economic downturn on our business, and that of our customers, potential customers and business partners. 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

CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share data)


Three Months Ended
June 30,


Six Months Ended
June 30,


2010


2009


2010


2009









Revenues:








System sales

$ 9,808


$ 8,911


$ 20,725


$ 16,820

Reagent and disposable sales

38,840


30,649


75,105


59,328

Total product sales

48,648


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