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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 FOURTH QUARTER AND FULL YEAR 2012 RESULTS

Clinical Reagents Grow 32% in 2012

SUNNYVALE, California, January 24, 2013 – 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 licenses and 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:

 

     Three Months Ended December 31,     Full Year Ended December 31,  
     2012      2011      Change     2012      2011      Change  

Clinical Systems

   $ 13.4       $ 19.9         -33   $ 52.8       $ 58.6         -10

Clinical Reagents

     68.8         49.0         40     233.5         177.4         32
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Clinical

     82.2         68.9         19     286.3         236.0         21

Non-Clinical

     7.5         8.0         -6     35.2         29.5         19
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Product Sales

   $ 89.7       $  76.9         17   $ 321.5       $ 265.5         21
  

 

 

    

 

 

      

 

 

    

 

 

    

 

   

By geography, product sales were, in millions:

 

     Three Months Ended December 31,     Full Year Ended December 31,  
     2012      2011      Change     2012      2011      Change  

North America

                

Clinical

   $ 54.4       $ 46.4         17   $ 190.0       $ 167.9         13

Other

     6.0         7.2         -17     29.0         25.0         16
  

 

 

    

 

 

      

 

 

    

 

 

    

Total North America

     60.4         53.6         13     219.0         192.9         14

International

                

Clinical

     27.8         22.5         24     96.3         68.1         41

Other

     1.5         0.8         90     6.2         4.5         38
  

 

 

    

 

 

      

 

 

    

 

 

    

Total International

     29.3         23.3         26     102.5         72.6         41
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Product Sales

   $ 89.7       $ 76.9         17   $ 321.5       $ 265.5         21
  

 

 

    

 

 

      

 

 

    

 

 

    

 

   

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:

 

     Guidance Range for Year  
     Ending December 31, 2013  
     Low     High  

Net Income (Loss) Per Share

   $ (0.05   $ 0.01   

Stock Compensation Expense

     0.40        0.39   

Amortization of Purchased Intangible Assets

     0.06        0.06   
  

 

 

   

 

 

 

Non-GAAP Measure of Net Income Per Share

   $ 0.41      $ 0.46   

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 licenses 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 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


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

     Three Months Ended
December 31,
    Years Ended
December  31,
 
     2012      2011     2012     2011  

Revenues:

         

System sales

   $ 14,101       $ 20,371      $ 55,447      $ 61,948   

Reagent and disposable sales

     75,557         56,576        266,101        203,576   
  

 

 

    

 

 

   

 

 

   

 

 

 

Total product sales

     89,658         76,947        321,548        265,524   

Other revenues

     2,775         3,167        9,664        12,051   
  

 

 

    

 

 

   

 

 

   

 

 

 

Total revenues

     92,433         80,114        331,212        277,575   
  

 

 

    

 

 

   

 

 

   

 

 

 

Costs and operating expenses:

         

Cost of product sales

     42,896         38,632        153,365        122,840   

Collaboration profit sharing

     1,416         1,582        7,183        4,863   

Research and development

     17,299         16,650        71,673        59,362   

Sales and marketing

     16,294         14,490        61,907        50,691   

General and administrative

     9,470         10,153        43,298        36,004   

Litigation settlement

     —           —          15,110        —     
  

 

 

    

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     87,375         81,507        352,536        273,760   
  

 

 

    

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     5,058         (1,393     (21,324     3,815   

Other income (expense), net

     241         (506     (4     (1,143
  

 

 

    

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     5,299         (1,899     (21,328     2,672   

Benefit from (provision for) income taxes

     345         250        1,285        (45
  

 

 

    

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 5,644       $ (1,649   $ (20,043   $ 2,627   
  

 

 

    

 

 

   

 

 

   

 

 

 

Basic net income (loss) per share

   $ 0.09       $ (0.03   $ (0.30   $ 0.04   
  

 

 

    

 

 

   

 

 

   

 

 

 

Diluted net income (loss) per share

   $ 0.08       $ (0.03   $ (0.30   $ 0.04   
  

 

 

    

 

 

   

 

 

   

 

 

 

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

     66,370         64,113        65,812        62,735   
  

 

 

    

 

 

   

 

 

   

 

 

 

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

     68,787         64,113        65,812        66,750   
  

 

 

    

 

 

   

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     December 31,
2012
    December 31,
2011
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 95,779      $ 115,008   

Accounts receivable, net

     43,999        35,375   

Inventory

     70,114        62,239   

Prepaid expenses and other current assets

     9,448        5,245   
  

 

 

   

 

 

 

Total current assets

     219,340        217,867   

Property and equipment, net

     54,830        35,833   

Other non-current assets

     913        730   

Intangible assets, net

     18,767        13,795   

Goodwill

     37,694        18,445   
  

 

 

   

 

 

 

Total assets

   $ 331,544      $ 286,670   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 33,701      $ 32,167   

Accrued compensation

     16,540        17,928   

Accrued royalties

     7,992        8,357   

Accrued and other liabilities

     4,235        3,086   

Current portion of deferred revenue

     9,599        8,176   

Current portion of notes payable

     183        —     
  

 

 

   

 

 

 

Total current liabilities

     72,250        69,714   

Long-term portion of deferred revenue

     1,156        2,003   

Notes payable, less current portion

     1,685        —     

Other liabilities

     8,911        3,120   
  

 

 

   

 

 

 

Total liabilities

     84,002        74,837   
  

 

 

   

 

 

 

Shareholders’ equity:

    

Common stock

     355,867        324,211   

Additional paid-in capital

     117,217        93,144   

Accumulated other comprehensive income

     56        33   

Accumulated deficit

     (225,598     (205,555
  

 

 

   

 

 

 

Total shareholders’ equity

     247,542        211,833   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 331,544      $ 286,670   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(in thousands)

 

     Years Ended December 31,  
     2012     2011  

Cash flows from operating activities:

    

Net income (loss)

   $ (20,043   $ 2,627   

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

    

Depreciation and amortization of property and equipment

     13,446        10,298   

Amortization of intangible assets

     4,965        6,523   

Amortization of terminated patent license and impairment of acquired intangible assets

     1,399        5,372   

Stock-based compensation related to employees and consulting services rendered

     24,496        19,768   

Changes in operating assets and liabilities:

    

Accounts receivable

     (6,443     (7,830

Inventory

     (5,105     (23,982

Prepaid expenses and other current assets

     (2,714     (237

Other non-current assets

     (172     (122

Accounts payable and other current liabilities

     (5,740     11,365   

Accrued compensation

     (1,736     5,334   

Deferred revenue

     575        (2,084
  

 

 

   

 

 

 

Net cash provided by operating activities

     2,928        27,032   

Cash flows from investing activities:

    

Capital expenditures

     (23,150     (18,922

Cash paid for intangible asset

     (2,140     —     

Payments for technology licenses

     —          (1,655

Cost of acquisitions, net

     (24,021     (296
  

 

 

   

 

 

 

Net cash used in investing activities

     (49,311     (20,873

Cash flows from financing activities:

    

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

     27,079        35,857   

Proceeds from notes payable

     156        —     

Principal payment of notes payable

     (72     (6,669
  

 

 

   

 

 

 

Net cash provided by financing activities

     27,163        29,188   

Effect of exchange rate change on cash

     (9     123   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     (19,229     35,470   

Cash and cash equivalents at beginning of period

     115,008        79,538   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 95,779      $ 115,008   
  

 

 

   

 

 

 


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)

(in thousands, except per share data)

 

     Three Months Ended
December 31,
    Years Ended
December 31,
 
     2012     2011     2012     2011  

Cost of product sales

   $ 42,896      $ 38,632      $ 153,365      $ 122,840   

Stock compensation expense

     (808     (443     (3,037     (1,684

Impairment of intangible assets and licenses

     (1,233     (5,372     (1,233     (5,372

Amortization of purchased intangible assets

     (332     (347     (1,330     (1,383
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of cost of product sales

   $ 40,523      $ 32,470      $ 147,765      $ 114,401   

Gross margin on product sales per GAAP

     52     50     52     54

Gross margin on product sales per Non-GAAP

     55     58     54     57

Operating expenses

   $ 43,063      $ 41,293      $ 176,878      $ 146,057   

Stock compensation expense

     (5,756     (4,806     (21,415     (18,084

Impairment of intangible assets and licenses

     (328     —          (328     —     

Amortization of purchased intangible assets

     (376     (107     (1,452     (429
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of operating expenses

   $ 36,603      $ 36,380      $ 153,683      $ 127,544   

Income (loss) from operations

   $ 5,058      $ (1,393   $ (21,324   $ 3,815   

Stock compensation expense

     6,564        5,249        24,452        19,768   

Amortization of purchased intangible assets

     708        454        2,782        1,812   

Impairment of intangible assets and licenses

     1,561        5,372        1,561        5,372   

Litigation settlement

     —          —          15,110        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of income from operations

   $ 13,891      $ 9,682      $ 22,581      $ 30,767   

Net income (loss)

   $ 5,644      $ (1,649   $ (20,043   $ 2,627   

Stock compensation expense

     6,564        5,249        24,452        19,768   

Amortization of purchased intangible assets

     708        454        2,782        1,812   

Impairment of intangible assets and licenses, net of tax

     1,288        5,372        1,288        5,372   

Litigation settlement

     —          —          15,110        —     

Tax benefit related to intercompany IP transaction

     —          —          (1,815     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income

   $ 14,204      $ 9,426      $ 21,774      $ 29,579   

Basic net income (loss) per share

   $ 0.09      $ (0.03   $ (0.30   $ 0.04   

Stock compensation expense

     0.09        0.08        0.37        0.32   

Amortization of purchased intangible assets

     0.01        0.01        0.04        0.03   

Impairment of intangible assets and licenses, net of tax

     0.02        0.09        0.02        0.08   

Litigation settlement

     —          —          0.23        —     

Tax benefit related to intercompany IP transaction

     —          —          (0.03     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income per share

   $ 0.21      $ 0.15      $ 0.33      $ 0.47   

Diluted net income (loss) per share

   $ 0.08      $ (0.03   $ (0.30   $ 0.04   

Stock compensation expense

     0.09        0.08        0.35        0.29   

Amortization of purchased intangible assets

     0.01        0.01        0.04        0.03   

Impairment of intangible assets and licenses, net of tax

     0.02        0.08        0.02        0.08   

Litigation settlement

     —          —          0.23        —     

Tax benefit related to intercompany IP transaction

     —          —          (0.03     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income per share

   $ 0.20      $ 0.14      $ 0.31      $ 0.44   

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

     66,370        64,113        65,812        62,735   

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

     68,787        64,113        65,812        66,750   

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

     589        4,480        3,888        878   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     69,376        68,593        69,700        67,628