News Releases

SUNNYVALE, Calif., Dec. 1, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that, as part of its participation at the Piper Jaffray Healthcare Conference in New York City later this morning, the Company is reaffirming its outlook for the fourth quarter of 2015 and initiating revenue guidance for 2016, in addition to discussing longer term business model expectations.

"Cepheid continues to successfully execute on its strategic objectives to expand the Xpert® test menu and extend the applications and addressable markets for our GeneXpert® System, both of which are expected to drive sustainable revenue growth above the industry average," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "We continue to be the fastest growing company of the major market participants in molecular diagnostics, and the investments we are making today are designed to extend that lead.  With US commercial launch of our Xpert HIV and Xpert HCV products targeted for 2017, we expect to deliver a 'critical mass' test menu, allowing nearly all high volume molecular tests to run on a single, scalable system that uniquely addresses customers of all sizes.  At that time, with the development of these key tests behind us, we believe Cepheid will be well-positioned to deliver a substantial improvement in profitability and a strong baseline on which to drive further revenue and profitability expansion."

Based on results to date, the Company reaffirms its 2015 Fourth Quarter and Full Year business outlook.  The Company continues to expect fourth quarter revenue in the range of $146 to $150 million, and fourth quarter loss per share of $(0.19) to $(0.17), as well as full year revenue in the range of $537 to $541 million, and full year net loss per share of $(0.73) to $(0.71) per share. 

The Company is also providing initial revenue guidance for the 2016 Full Year of $618 to $635 million, growth of 15 to 18% compared to the midpoint of expected 2015 full year revenue of $537 to $541 million.  Cepheid will offer additional 2016 guidance on its 2015 Fourth Quarter and Full Year Conference Call scheduled for Tuesday, February 2, 2016.

Finally, the Company updated its 2017 outlook to a non-GAAP gross margin range of 56% to 58% and non-GAAP operating margin in the mid- to high-teens.  This compares to the Company's prior 2017 targets of approximately 60% non-GAAP gross margin and low-20s non-GAAP operating margin.

"While we are adjusting our 2017 outlook, we believe that we remain poised for a 'breakthrough' to profitability and are confident in our ability to transition to solid and sustainable operating margin even as we continue to target above industry growth rates," concluded Bishop.   

Accessing the Live Webcast

As previously announced, Cepheid will present at the Piper Jaffray Healthcare Conference in New York City today at 11.00 a.m. Eastern Time.  To access the live webcast for this event, 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 presentation 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 www.cepheid.com.

Use of Non-GAAP Measures

The Company's 2017 targets are based on non-GAAP measures. The Company's management uses the non-GAAP information 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.

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 projected future growth, future revenues, future net loss/income and profitability, future gross margin and operating margin, and future earnings per share and number of fully-diluted shares, including on a non-GAAP basis, strategic investments,  future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert Omni and Xpert tests, including relative to competing products and technologies.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from Cepheid'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 commercial and HBDC sales and the effectiveness of our sales personnel; the relative mix of commercial and HBDC sales, and relative mix of instrument and test sales; manufacturing costs associated with the ramp-up of new products; the performance and market acceptance of new products; sufficient customer demand, customer confidence in product availability and available customer budgets for our customers; our ability to develop new products, complete clinical trials successfully and obtain regulatory clearances in a timely manner for new products; uncertainties related to the FDA regulatory and international 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; long sales cycles and variability in systems placements and reagent pull-through in the Company's HBDC program; the rate of environmental biothreat testing conducted by the USPS, which will affect the amount of consumable products sold to the USPS; unforeseen supply, development and manufacturing problems; our ability to manage our inventory levels; our ability to successfully complete and bring on additional manufacturing lines; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; 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 impact of foreign currency exchange; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and 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.

For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com

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SOURCE Cepheid