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8-K - FORM 8-K - CEPHEIDd384857d8k.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 2012 SECOND QUARTER RESULTS

SUNNYVALE, California, July 19, 2012 – Cepheid (Nasdaq: CPHD) today reported revenues for the second quarter of 2012 of $81.0 million, representing growth of 21% from $67.0 million for the second quarter of 2011. Net income was $1.1 million, or $0.02 per share, which compares to net income of $1.8 million, or $0.03 per share, in the second quarter of 2011.

Excluding employee stock-based compensation and amortization of purchased intangible assets, non-GAAP net income for the second quarter was $7.9 million, or $0.11 per share. This compares to non-GAAP net income of $7.2 million, or $0.11 per share, in the second quarter of 2011.

“Growth in our installed base was strong during the second quarter, with a total of 271 GeneXpert system placements. With a cumulative total of 3,350 placements globally, it is clear that benefits of our innovative system and our growing menu of Xpert tests continues to drive broad market adoption of our GeneXpert system,” said John Bishop, Cepheid’s Chief Executive Officer. “We continued to execute well on test menu expansion during the quarter. Our CT/NG test is now under FDA review in the United States, and we have been very encouraged by early customer feedback following the product’s release in Europe.”

“Looking forward, we continue to expect sales of our Xpert MTB/RIF test to grow to volumes in the millions in the next several years. However, we do expect that certain features of the HBDC program could slow our progress on overall profitability goals in the immediate-term,” continued Bishop. “Coupled with a number of macro factors, namely less favorable currency rates and potentially lengthening capital sales cycles as we approach elections here in the United States, we are taking a more cautious view for the remainder of the year.”

Operational Overview

 

  - Total product sales of $78.5 million in the second quarter of 2012 compared to $63.6 million in the second quarter of 2011. By business, product sales were, in millions:

 

     Three Months Ended June 30,  
     2012      2011      Change  

Clinical Systems

   $ 13.9       $ 13.2         5

Clinical Reagents

     55.8         44.1         27
  

 

 

    

 

 

    

Total Clinical

     69.7         57.3         22

Non-Clinical

     8.8         6.3         40
  

 

 

    

 

 

    

Total Product Sales

   $ 78.5       $ 63.6         23
  

 

 

    

 

 

    


  - By geography, product sales were, in millions:

 

     Three Months Ended June 30,  
     2012      2011      Change  

North America

        

Clinical

   $ 47.5       $ 42.1         13

Non-Clinical

     6.9         5.6         23
  

 

 

    

 

 

    

Total North America

     54.4         47.7         14

International

        

Clinical

     22.2         15.2         46

Non-Clinical

     1.9         0.7         171
  

 

 

    

 

 

    

Total International

     24.1         15.9         52
  

 

 

    

 

 

    

Total Product Sales

   $ 78.5       $ 63.6         23
  

 

 

    

 

 

    

 

  - During the quarter, Cepheid installed a total of 133 GeneXpert systems in its commercial Clinical business. Additionally, the Company placed a total of 138 GeneXpert systems as part of its High Burden Developing Country (HBDC) program. Including the HBDC systems, a cumulative total of 3,350 GeneXpert systems have been placed worldwide as of June 30, 2012.

 

  - GAAP gross margin on product sales was 55% and non-GAAP gross margin on product sales was 57%, which compares to 54% and 55%, respectively, in the second quarter of 2011.

 

  - Cash and cash equivalents were $97.3 million as of June 30, 2012.

 

  - DSO was 41 days.

Business Outlook

For the fiscal year ending December 31, 2012, the Company expects:

 

  - Total revenue to be in the range of $333 to $347 million;

 

  - Net income per share in the range of $0.00 to $0.04; and

 

  - Non-GAAP net income per share in the range of $0.38 to $0.42.

Expected non-GAAP net income per share excludes the effect of approximately $26 million related to stock-based compensation expense, approximately $2.8 million related to the amortization of acquired intangibles, and a $1.8 million tax benefit related to an intercompany intellectual property transaction. The fully diluted share count for the year is expected to be between 70 and 71 million.

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

 

     Guidance Range for Year
Ending December 31, 2012
 
     Low     High  

Net Income Per Share

   $ —        $ 0.04   

Stock Compensation Expense

     0.37        0.37   

Tax Benefit Related to Intercompany IP Transaction

     (0.03     (0.03

Amortization of Purchased Intangible Assets

     0.04        0.04   
  

 

 

   

 

 

 

Non-GAAP Measure of Net Income Per Share

   $ 0.38      $ 0.42   


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 19, 2012 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.

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 stock-based compensation expense, amortization of acquired intangible assets and a tax benefit related to an intercompany intellectual property transaction. 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:

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.

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.

Tax benefit related to an 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 first quarter ended March 31, 2012 and for the six months ended June 30, 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 future volumes of product sales and future revenues, future net income per share and future non-GAAP net income per share. 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 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; 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


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

     Three Months Ended
June 30,
    Six months Ended
June 30,
 
     2012     2011     2012     2011  

Revenues:

        

System sales

   $ 14,539      $ 14,138      $ 27,770      $ 26,829   

Reagent and disposable sales

     63,915        49,454        125,977        94,400   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total product sales

     78,454        63,592        153,747        121,229   

Other revenues

     2,561        3,437        4,560        6,019   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     81,015        67,029        158,307        127,248   
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and operating expenses:

        

Cost of product sales

     35,072        29,254        70,680        54,564   

Collaboration profit sharing

     1,645        1,093        3,329        2,185   

Research and development

     16,118        13,915        38,220        27,489   

Sales and marketing

     15,108        11,879        29,620        23,326   

General and administrative

     11,011        8,905        22,062        16,535   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     78,954        65,046        163,911        124,099   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     2,061        1,983        (5,604     3,149   

Other expense, net

     (572     (400     (334     (599
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     1,489        1,583        (5,938     2,550   

Benefit from (provision for) income taxes

     (354     244        1,547        (196
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 1,135      $ 1,827      $ (4,391   $ 2,354   
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net income (loss) per share

   $ 0.02      $ 0.03      $ (0.07   $ 0.04   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted net income (loss) per share

   $ 0.02      $ 0.03      $ (0.07   $ 0.04   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     65,695        62,120        65,361        61,638   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     68,869        66,390        65,361        65,727   
  

 

 

   

 

 

   

 

 

   

 

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     June 30,
2012
    December 31,
2011
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 97,267      $ 115,008   

Accounts receivable, net

     36,826        35,375   

Inventory

     70,997        62,239   

Prepaid expenses and other current assets

     12,721        5,245   
  

 

 

   

 

 

 

Total current assets

     217,811        217,867   

Property and equipment, net

     45,795        35,833   

Other non-current assets

     834        730   

Intangible assets, net

     19,089        13,795   

Goodwill

     26,911        18,445   
  

 

 

   

 

 

 

Total assets

   $ 310,440      $ 286,670   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 26,680      $ 32,167   

Accrued compensation

     16,616        17,928   

Accrued royalties

     7,878        8,357   

Accrued and other liabilities

     2,335        3,086   

Current portion of deferred revenue

     8,418        8,176   

Current portion of notes payable

     161        —     
  

 

 

   

 

 

 

Total current liabilities

     62,088        69,714   

Long-term portion of deferred revenue

     2,200        2,003   

Notes payable, less current portion

     1,623        —     

Other liabilities

     4,268        3,120   
  

 

 

   

 

 

 

Total liabilities

     70,179        74,837   
  

 

 

   

 

 

 

Shareholders’ equity:

    

Common stock

     345,302        324,211   

Additional paid-in capital

     104,732        93,144   

Accumulated other comprehensive income

     173        33   

Accumulated deficit

     (209,946     (205,555
  

 

 

   

 

 

 

Total shareholders’ equity

     240,261        211,833   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 310,440      $ 286,670   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(in thousands)

 

     Six Months Ended
June 30,
 
     2012     2011  

Cash flows from operating activities:

    

Net income (loss)

   $ (4,391   $ 2,354   

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

    

Depreciation and amortization of property and equipment

     6,308        5,031   

Amortization of intangible assets

     2,633        3,452   

Stock-based compensation related to employees and consulting services rendered

     11,567        9,343   

Changes in operating assets and liabilities:

    

Accounts receivable

     761        (3,527

Inventory

     (5,950     (7,650

Prepaid expenses and other current assets

     (7,475     (1,440

Other non-current assets

     (105     (74

Accounts payable and other current liabilities

     (12,233     2,145   

Accrued compensation

     (1,312     1,069   

Deferred revenue

     438        13   
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     (9,759     10,716   

Cash flows from investing activities:

    

Capital expenditures

     (11,168     (6,974

Payments for technology license

     —          (1,000

Cost of acquisitions, net

     (17,462     (296
  

 

 

   

 

 

 

Net cash used in investing activities

     (28,630     (8,270

Cash flows from financing activities:

    

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

     21,091        16,962   

Principal payment of notes payable

     —          (757
  

 

 

   

 

 

 

Net cash provided by financing activities

     21,091        16,205   

Effect of exchange rate change on cash

     (443     63   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     (17,741     18,714   

Cash and cash equivalents at beginning of period

     115,008        79,538   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 97,267      $ 98,252   
  

 

 

   

 

 

 


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,
 
     2012     2011     2012     2011  

Cost of product sales

   $ 35,072      $ 29,254      $ 70,680      $ 54,564   

Stock compensation expense

     (700     (435     (1,335     (934

Amortization of purchased intangible assets

     (333     (345     (666     (689
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of cost of product sales

   $ 34,039      $ 28,474      $ 68,679      $ 52,941   

Gross margin on product sales per GAAP

     55     54     54     55

Gross margin on product sales per Non-GAAP

     57     55     55     56

Operating expenses

   $ 42,237      $ 34,699      $ 89,902      $ 67,350   

Stock compensation expense

     (5,346     (4,508     (10,209     (8,409

Amortization of purchased intangible assets

     (381     (107     (697     (215
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of operating expenses

   $ 36,510      $ 30,084      $ 78,996      $ 58,726   

Income (loss) from operations

   $ 2,061      $ 1,983      $ (5,604   $ 3,149   

Stock compensation expense

     6,046        4,943        11,544        9,343   

Amortization of purchased intangible assets

     714        452        1,363        904   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of income from operations

   $ 8,821      $ 7,378      $ 7,303      $ 13,396   

Net income (loss)

   $ 1,135      $ 1,827      $ (4,391   $ 2,354   

Stock compensation expense

     6,046        4,943        11,544        9,343   

Tax benefit related to intercompany IP transaction

     —          —          (1,815     —     

Amortization of purchased intangible assets

     714        452        1,363        904   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income

   $ 7,895      $ 7,222      $ 6,701      $ 12,601   

Basic net income (loss) per share

   $ 0.02      $ 0.03      $ (0.07   $ 0.04   

Stock compensation expense

     0.09        0.08        0.18        0.15   

Tax benefit related to intercompany IP transaction

     —          —          (0.03     —     

Amortization of purchased intangible assets

     0.01        0.01        0.02        0.01   

Non-GAAP measure of net income per share

   $ 0.12      $ 0.12      $ 0.10      $ 0.20   

Diluted net income (loss) per share

   $ 0.02      $ 0.03      $ (0.07   $ 0.04   

Stock compensation expense

     0.08        0.07        0.18        0.14   

Tax benefit related to intercompany IP transaction

     —          —          (0.03     —     

Amortization of purchased intangible assets

     0.01        0.01        0.02        0.01   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income per share

   $ 0.11      $ 0.11      $ 0.10      $ 0.19   

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

     65,695        62,120        65,361        61,638   

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

     68,869        66,390        65,361        65,727   

Impact of dilutive securities in periods of GAAP net loss and Non- GAAP net income

     —          —          3,174        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     68,869        66,390        68,535        65,727