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8-K - FORM 8-K - CEPHEIDd8k.htm

Exhibit 99.01

 

     CONTACTS:        
     For Media Inquiries:      For Investor Inquiries:   
LOGO     

Jared Tipton

Cepheid Corporate Communications

Tel: (408) 400 8377

communications@cepheid.com

    

Jacquie Ross

Cepheid Investor Relations

Tel: (408) 400 8329

investor.relations@cepheid.com

  
            

Cepheid

904 Caribbean Drive

Sunnyvale, CA 94089

Telephone: 408.541.4191

Fax: 408.541.4192

            

CEPHEID REPORTS 2011 SECOND QUARTER RESULTS

Record GeneXpert® System Placements Contribute to Record Revenue

SUNNYVALE, California, July 21, 2011 – Cepheid (Nasdaq: CPHD) today reported revenue for the second quarter of 2011 of $67.0 million. Net income was $1.8 million, or $0.03 per share, which compares to revenue of $49.6 million and a net loss of $1.8 million, or $(0.03) per share, in the second quarter of 2010.

Excluding amortization of purchased intangible assets and employee stock-based compensation expense, non-GAAP net income for the second quarter was $7.2 million, or $0.11 per share. This compares to a non-GAAP net income of $2.9 million, or $0.05 per share, in the second quarter of 2010.

“Our Clinical business demonstrated particularly strong momentum in the second quarter, with rapid adoption of our GeneXpert system and Xpert® test menu contributing, once again, to record financial results,” said John Bishop, Cepheid’s Chief Executive Officer. “With eleven highly accurate, rapid and easy-to-use Xpert tests now available in the United States, and twelve available internationally, Cepheid customers are increasingly recognizing the economic benefit and the unique flexibility and workflow efficiencies offered by the GeneXpert system which, we believe, is quickly establishing itself as the molecular platform of choice.”

Operational Overview

 

   

Total product sales of $63.6 million in the second quarter of 2011 compared to $48.6 million in the second quarter of 2010. By business, product sales were, in millions:

 

     Three Months Ended June 30,  
     2011      2010      Change  

Clinical Systems

   $ 13.2       $ 8.6         53

Clinical Reagents

     44.1         31.6         40
                    

Total Clinical

     57.3         40.2         42

Non-Clinical

     6.3         8.4         -25
                    

Total Product Sales

   $ 63.6       $ 48.6         31
                    


   

By geography, product sales were, in millions:

 

     Three Months Ended
June 30,
 
     2011      2010      Change  

North America

        

Clinical

   $ 42.1       $ 31.2         35

Non-Clinical

     5.6         7.0         -19
                    

Total North America

     47.7         38.2         25

International

        

Clinical

     15.2         9.0         69

Non-Clinical

     0.7         1.4         -53
                    

Total International

     15.9         10.4         52
                    

Total Product Sales

   $ 63.6       $ 48.6         31
                    

 

   

During the quarter, Cepheid installed a total of 148 GeneXpert systems in its commercial Clinical business. Additionally, the company placed a total of 38 GeneXpert systems as part of its High Burden Developing Country (HBDC) program. Including the HBDC systems, a cumulative total of 2,224 GeneXpert systems have been placed worldwide as of June 30, 2011.

 

   

GAAP gross margin on product sales was 54% and non-GAAP gross margin on product sales was 55%, which compares to 48% and 50%, respectively, in the second quarter of 2010.

 

   

Cash and cash equivalents were $98.3 million as of June 30, 2011.

 

   

DSO was 42 days.

Business Outlook

For the fiscal year ending December 31, 2011, the company expects:

 

   

Total revenue to be in the range of $265 to $270 million;

 

   

Net income in the range of $0.08 to $0.11 per share;

 

   

Non-GAAP net income in the range of $0.41 to $0.44 per share.

Expected non-GAAP net income excludes approximately $20 million related to stock compensation expense and approximately $2 million related to the amortization of acquired intangibles. The fully diluted GAAP share count for the year is expected to be approximately 66 million and the fully diluted non-GAAP share count for the year is expected to be approximately 67 million.

Accessing Cepheid’s Second Quarter Results’ Conference Call

The company will host a management presentation at 2:00 p.m. Pacific Time on Thursday, July 21, 2011 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) 804-6926 or (857) 350-1672, and entering participant code 75697734. A replay will be available for seven days beginning at 4:00 p.m. Pacific Time. Access numbers for this replay are (888) 286-8010 or (617) 801-6888, with passcode 67835349.

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 employee share-based compensation expense and 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 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 potential growth, future revenues and future net income/loss, including on a non-GAAP basis. 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, acquisitions or other transactions; 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

# # # #


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2011     2010     2011     2010  

Revenues:

        

System sales

   $ 14,138      $ 9,808      $ 26,829      $ 20,725   

Reagent and disposable sales

     49,454        38,840        94,400        75,105   
                                

Total product sales

     63,592        48,648        121,229        95,830   

Other revenues

     3,437        994        6,019        1,857   
                                

Total revenues

     67,029        49,642        127,248        97,687   
                                

Costs and operating expenses:

        

Cost of product sales

     29,254        25,215        54,564        51,286   

Collaboration profit sharing

     1,093        1,654        2,185        3,309   

Research and development

     13,915        10,150        27,489        19,851   

Sales and marketing

     11,879        9,260        23,326        18,245   

General and administrative

     8,905        5,848        16,535        11,563   
                                

Total costs and operating expenses

     65,046        52,127        124,099        104,254   
                                

Income (loss) from operations

     1,983        (2,485     3,149        (6,567

Other expense, net

     (400     (261     (599     (537
                                

Income (loss) before income taxes

     1,583        (2,746     2,550        (7,104

Benefit from (provision for) income taxes

     244        945        (196     964   
                                

Net income (loss)

   $ 1,827      $ (1,801   $ 2,354      $ (6,140
                                

Basic net income (loss) per share

   $ 0.03      $ (0.03   $ 0.04      $ (0.10
                                

Diluted net income (loss) per share

   $ 0.03      $ (0.03   $ 0.04      $ (0.10
                                

Shares used in computing basic net income (loss) per share

     62,120        59,493        61,638        59,216   
                                

Shares used in computing diluted net income (loss) per share

     66,390        59,493        65,727        59,216   
                                


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     June 30, 2011     December 31,
2010
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 98,252      $ 79,538   

Accounts receivable, net

     31,072        28,010   

Inventory

     45,144        37,598   

Prepaid expenses and other current assets

     5,837        4,138   
                

Total current assets

     180,305        149,284   

Property and equipment, net

     30,010        27,438   

Other non-current assets

     682        607   

Intangible assets, net

     22,037        24,688   

Goodwill

     17,753        18,594   
                

Total assets

   $ 250,787      $ 220,611   
                
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 24,291      $ 21,957   

Accrued compensation

     13,664        12,594   

Accrued royalties

     7,530        7,994   

Accrued and other liabilities

     1,790        1,288   

Current portion of deferred revenue

     8,616        8,207   

Current portion of notes payable

     1,696        1,679   
                

Total current liabilities

     57,587        53,719   

Long-term portion of deferred revenue

     3,661        4,057   

Notes payable, less current portion

     4,216        4,991   

Other liabilities

     3,288        4,182   
                

Total liabilities

     68,752        66,949   
                

Shareholders’ equity:

    

Common stock

     305,316        288,387   

Additional paid-in capital

     81,956        72,731   

Accumulated other comprehensive income

     591        726   

Accumulated deficit

     (205,828     (208,182
                

Total shareholders’ equity

     182,035        153,662   
                

Total liabilities and shareholders’ equity

   $ 250,787      $ 220,611   
                


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(in thousands)

 

(13,270) (13,270)
     Six Months Ended
June 30,
 
     2011     2010  

Cash flows from operating activities:

    

Net income (loss)

   $ 2,354      $ (6,140

Adjustments to reconcile net income (loss) to net cash used in operating activities:

    

Depreciation and amortization of property and equipment

     5,031        4,604   

Amortization of intangible assets

     3,452        3,472   

Stock-based compensation related to employees and consulting services rendered

     9,343        7,919   

Unrealized gain on auction rate securities

     —          (1,714

Unrealized loss on put option

     —          1,844   

Deferred rent

     32        31   

Changes in operating assets and liabilities:

    

Accounts receivable

     (3,527     (4,703

Inventory

     (7,650     437   

Prepaid expenses and other current assets

     (1,440     (502

Other non-current assets

     (74     (632

Accounts payable and other current liabilities

     2,113        (6,333

Accrued compensation

     1,069        (181

Deferred revenue

     13        257   
                

Net cash provided by (used in) operating activities

     10,716        (1,641

Cash flows from investing activities:

    

Capital expenditures

     (6,994     (6,488

Payments for technology licenses

     (1,000     (1,000

Cost of acquisitions, net

     (296     (574

Proceeds from the sales of short-term investments

     —          12,975   

Proceeds from the sale of fixed assets

     20        78   
                

Net cash provided by (used in) investing activities

     (8,270     4,991   

Cash flows from financing activities:

    

Net proceeds from the issuance of common shares and exercise of stock options

     16,962        7,520   

Proceeds from notes payable

     —          2,448   

Principal payment of bank borrowing

     —          (13,270

Principal payment of notes payable

     (757     (111
                

Net cash provided by (used in) financing activities

     16,205        (3,413

Effect of exchange rate change on cash

     63        811   
                

Net increase in cash and cash equivalents

     18,714        748   

Cash and cash equivalents at beginning of period

     79,538        35,786   
                

Cash and cash equivalents at end of period

   $ 98,252      $ 36,534   
                


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)

(in thousands, except per share data)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2011     2010     2011     2010  

Cost of product sales

   $ 29,254      $ 25,215      $ 54,564      $ 51,286   

Stock compensation expense

     (435     (537     (934     (1,007

Amortization of purchased intangible assets

     (345     (361     (689     (689
                                

Non-GAAP measure of cost of product sales

   $ 28,474      $ 24,317      $ 52,941      $ 49,590   

Gross margin on product sales per GAAP

     54     48     55     46

Gross margin on product sales per Non-GAAP

     55     50     56     48

Operating expenses

   $ 34,699      $ 25,258      $ 67,350      $ 49,659   

Stock compensation expense

     (4,508     (3,636     (8,409     (6,912

Amortization of purchased intangible assets

     (107     (128     (215     (209
                                

Non-GAAP measure of operating expenses

   $ 30,084      $ 21,494      $ 58,726      $ 42,538   

Income (loss) from operations

   $ 1,983      $ (2,485   $ 3,149      $ (6,567

Stock compensation expense

     4,943        4,173        9,343        7,919   

Amortization of purchased intangible assets

     452        489        904        898   
                                

Non-GAAP measure of income from operations

   $ 7,378      $ 2,177      $ 13,396      $ 2,250   

Net income (loss)

   $ 1,827      $ (1,801   $ 2,354      $ (6,140

Stock compensation expense

     4,943        4,173        9,343        7,919   

Amortization of purchased intangible assets

     452        489        904        898   
                                

Non-GAAP measure of net income

   $ 7,222      $ 2,861      $ 12,601      $ 2,677   

Basic net income (loss) per share

   $ 0.03      $ (0.03   $ 0.04      $ (0.10

Stock compensation expense

     0.08        0.07        0.15        0.13   

Amortization of purchased intangible assets

     0.01        0.01        0.01        0.02   
                                

Non-GAAP measure of net income per share

   $ 0.12      $ 0.05      $ 0.20      $ 0.05   

Diluted net income (loss) per share

   $ 0.03      $ (0.03   $ 0.04      $ (0.10

Stock compensation expense

     0.07        0.07        0.14        0.13   

Amortization of purchased intangible assets

     0.01        0.01        0.01        0.01   
                                

Non-GAAP measure of net income per share

   $ 0.11      $ 0.05      $ 0.19      $ 0.04   

Shares used in computing basic net income per share

     62,120        59,493        61,638        59,216   

Shares used in computing diluted net income per share

     66,390        59,493        65,727        59,216   

Incremental shares from the assumed conversion of dilutive stock options

     977        3,935        997        3,793   
                                

Shares used in computing Non-GAAP diluted net income per share

     67,367        63,428        66,724        63,009