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8-K - FORM 8-K - CEPHEIDd712844d8k.htm

Exhibit 99.01

 

   CONTACTS:  
   For Media Inquiries:   For Investor Inquiries:

 

LOGO

 

Cepheid

904 Caribbean Drive

Sunnyvale, CA 94089

Telephone: 408.541.4191

Fax: 408.541.4192

  

 

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 REPORTS 2014 FIRST QUARTER RESULTS

Strong Commercial and HBDC Drive Clinical Growth of 26%

SUNNYVALE, California, April 17, 2014 – Cepheid (Nasdaq: CPHD) today reported revenues for the first quarter of 2014 of $106.9 million, representing growth of 16% from $91.9 million for the first quarter of 2013. Net loss in the first quarter of 2014 was $(9.3) million, or $(0.13) per share, which compares to net income of $0.3 million, or $0.00 per share, in the first quarter of 2013.

Excluding employee stock-based compensation, amortization of debt discount and debt issuance costs, and amortization of purchased intangible assets, non-GAAP net loss for the first quarter of 2014 was $(0.6) million, or $(0.01) per share. This compares to non-GAAP net income of $7.8 million, or $0.11 per share, in the first quarter of 2013.

“We placed an additional 503 GeneXpert systems globally in the first quarter of 2014, contributing to 26% growth in our clinical business, and bringing our cumulative installed base to more than 6,000,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “Growing adoption of our broad menu of 14 Xpert tests drove Commercial Clinical Xpert reagent growth of 20% in the first quarter. With the recent additions of Xpert HPV and Xpert Norovirus to our test menu outside the US, we are entering a prolific, global product cycle that will further extend the portfolio of accurate, fast and easy-to-use molecular diagnostics available to our customers.”

Operational Overview

 

  - Total sales were, in millions:

 

     Three Months Ended March 31,  
     2014      2013      Change  

Clinical Systems

   $ 17.3       $ 12.5         38

Clinical Reagents

     83.1         67.1         24
  

 

 

    

 

 

    

Total Clinical

     100.4         79.6         26

Non-Clinical & Other

     6.5         12.3         -47
  

 

 

    

 

 

    

Total Sales

   $ 106.9       $ 91.9         16
  

 

 

    

 

 

    


  - By geography, total sales were, in millions:

 

     Three Months Ended March 31,  
     2014      2013      Change  

North America

        

Clinical

   $ 57.3       $ 52.2         10

Non-Clinical & Other

     5.5         11.4         -52
  

 

 

    

 

 

    

Total North America

     62.8         63.6         -1

International

        

Clinical

     43.2         27.4         58

Non-Clinical & Other

     0.9         0.9         0
  

 

 

    

 

 

    

Total International

     44.1         28.3         56
  

 

 

    

 

 

    

Total Sales

   $ 106.9       $ 91.9         16
  

 

 

    

 

 

    

 

  - During the quarter, Cepheid installed a total of 181 GeneXpert systems in its commercial Clinical business. Additionally, the Company placed a total of 322 GeneXpert systems as part of its High Burden Developing Country (HBDC) program. Including the HBDC systems, a cumulative total of 6,012 GeneXpert systems have been placed worldwide as of March 31, 2014.

 

  - GAAP gross margin on sales was 50% and non-GAAP gross margin on sales was 51%, which compares to 53% and 55%, respectively, in the first quarter of 2013.

 

  - Cash, cash equivalents and investments were $391.3 million as of March 31, 2014.

 

  - DSO was 48 days.

Business Outlook

Reflecting the issuance of the Convertible Senior Notes in February 2014, the Company has updated it’s guidance for the fiscal year ending December 31, 2014. The Company expects:

 

  - Total revenue in the range of $446 to $461 million;

 

  - Net loss in a range from $(0.43) to $(0.38) per share; and

 

  - Non-GAAP net income in the range of $0.19 to $0.24 per share.

Expected non-GAAP net income excludes approximately $33 million related to stock compensation expense, approximately $9 million related to the amortization of debt discount and debt issuance costs, and approximately $3 million related to the amortization of acquired intangibles. The fully diluted share count for the year is expected to be approximately 70 million, except in the event we have non-GAAP net income, in which case the share count would be approximately 73 million shares.


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

 

     Guidance Range for Year  
     Ending December 31, 2014  
     Low     High  

Net Loss Per Share

   $ (0.43   $ (0.38

Stock Compensation Expense

     0.46       0.46  

Amortization of Debt Discount and Debt Issuance Costs

     0.12       0.12  

Amortization of Purchased Intangible Assets

     0.04       0.04  
  

 

 

   

 

 

 

Non-GAAP Measure of Net Income Per Share

   $ 0.19      $ 0.24   
  

 

 

   

 

 

 

Accessing Cepheid’s 2014 First Quarter Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, April 17, 2014, 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 employee stock-based compensation expense, amortization of purchased intangible assets and amortization of debt discount and debt issuance costs. 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 Debt Discount and Debt Issuance Costs. The Company incurs amortization of debt discount and debt issuance costs in connection with the issuance of Convertible Senior Notes in February 2014. The Company excludes these amounts because these expenses are not reflective of ongoing operating results in the period incurred. These amounts arise from the Company’s issuance of debt and have no direct correlation to the operation of the Company’s business.

Amortization of Purchased Intangible Assets. The Company incurs amortization of purchased intangible assets in connection with acquisitions. The Company excludes these amounts 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 loss/income and profitability, including on a non-GAAP basis, test menu expansion and utilization, consistency of product availability and delivery, sales organization productivity, improving gross margins, execution of manufacturing operations, product sales under the High Burden Developing Country (HBDC) program, commercial test and commercial system sales and resolution of manufacturing scale-up issues. 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 ability to manage our inventory levels; long sales cycles and variability in systems placements and reagent pull-through in the Company’s HBDC program; our success in increasing commercial and HBDC sales and the effectiveness of our sales personnel; 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 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; 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
March 31,
 
     2014     2013  

Sales:

    

System and other sales

   $ 18,529      $ 16,010   

Reagent and disposable sales

     88,378        75,928   
  

 

 

   

 

 

 

Total sales

     106,907        91,938   
  

 

 

   

 

 

 

Costs and operating expenses:

    

Cost of sales

     53,083        42,892   

Collaboration profit sharing

     1,291        2,110   

Research and development

     21,740        17,727   

Sales and marketing

     23,458        19,126   

General and administrative

     13,667        9,763   
  

 

 

   

 

 

 

Total costs and operating expenses

     113,239        91,618   
  

 

 

   

 

 

 

Income (loss) from operations

     (6,332     320   

Other income (expense), net

     (2,291     374   
  

 

 

   

 

 

 

Income (loss) before income taxes

     (8,623     694   

Provision for income taxes

     (680     (381
  

 

 

   

 

 

 

Net income (loss)

   $ (9,303   $ 313   
  

 

 

   

 

 

 

Basic net income (loss) per share

   $ (0.13   $ 0.00   
  

 

 

   

 

 

 

Diluted net income (loss) per share

   $ (0.13   $ 0.00   
  

 

 

   

 

 

 

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

     69,272        66,824   
  

 

 

   

 

 

 

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

     69,272        69,406   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     March 31,
2014
    December 31,
2013
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 136,718      $ 66,072   

Short-term investments

     131,035        8,837   

Accounts receivable, net

     56,602        52,202   

Inventory

     119,564        103,866   

Prepaid expenses and other current assets

     19,493        13,037   
  

 

 

   

 

 

 

Total current assets

     463,412        244,014   

Property and equipment, net

     96,949        84,886   

Investments

     123,552        9,820   

Other non-current assets

     7,633        958   

Intangible assets, net

     14,326        15,245   

Goodwill

     39,681        39,681   
  

 

 

   

 

 

 

Total assets

   $ 745,553      $ 394,604   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 60,924      $ 52,609   

Accrued compensation

     20,413        22,009   

Accrued royalties

     3,884        5,245   

Accrued and other liabilities

     7,270        7,440   

Current portion of deferred revenue

     9,978        8,183   
  

 

 

   

 

 

 

Total current liabilities

     102,469        95,486   

Long-term portion of deferred revenue

     3,708        3,424   

Convertible senior notes, net

     271,207        —     

Other liabilities

     15,067        10,454   
  

 

 

   

 

 

 

Total liabilities

     392,451        109,364   
  

 

 

   

 

 

 

Shareholders’ equity:

    

Common stock

     405,010        383,379   

Additional paid-in capital

     201,042        145,900   

Accumulated other comprehensive loss

     (84     (476

Accumulated deficit

     (252,866     (243,563
  

 

 

   

 

 

 

Total shareholders’ equity

     353,102        285,240   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 745,553      $ 394,604   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(in thousands)

 

     Three Months Ended
March 31,
 
     2014     2013  

Cash flows from operating activities:

    

Net income (loss)

   $ (9,303   $ 313   

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

    

Depreciation and amortization of property and equipment

     4,977        3,768   

Amortization of intangible assets

     919        1,560   

Unrealized exchange differences

     (52     444   

Amortization of debt discount and transaction costs

     1,257        —     

Stock-based compensation related to employees and consulting services rendered

     6,782        6,277   

Changes in operating assets and liabilities:

    

Accounts receivable

     (4,400     (1,047

Inventory

     (15,270     (7,814

Prepaid expenses and other current assets

     (5,842     (3,528

Other non-current assets

     122        168   

Accounts payable and other current and non-current liabilities

     3,470        8,342   

Accrued compensation

     (1,595     (614

Deferred revenue

     2,079        2,608   
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     (16,856     10,477   

Cash flows from investing activities:

    

Capital expenditures

     (8,762     (8,929

Payments for technology licenses

     —          (1,000

Proceeds from maturities and sales of marketable securities and investments

     23,438        —     

Purchases of marketable securities and investments

     (259,553     —     
  

 

 

   

 

 

 

Net cash used in investing activities

     (244,877     (9,929

Cash flows from financing activities:

    

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

     21,631        6,145   

Proceeds from borrowings of convertible senior notes, net of issuance costs

     335,789        —     

Purchase of convertible note hedge (“capped call”)

     (25,082     —     

Principal payment of notes payable

     (48     (41
  

 

 

   

 

 

 

Net cash provided by financing activities

     332,290        6,104   

Effect of exchange rate change on cash

     89        (443
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     70,646        6,209   

Cash and cash equivalents at beginning of period

     66,072        95,779   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 136,718      $ 101,988   
  

 

 

   

 

 

 


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)

(in thousands, except per share data)

 

     Three Months Ended
March 31,
 
  
     2014     2013  

Cost of sales

   $ 53,083      $ 42,892   

Stock compensation expense

     (381     (542

Amortization of purchased intangible assets

     (223     (854
  

 

 

   

 

 

 

Non-GAAP measure of cost of sales

   $ 52,479      $ 41,496   

Gross margin on sales per GAAP

     50     53

Gross margin on sales per Non-GAAP

     51     55

Operating expenses

   $ 58,865      $ 46,616   

Stock compensation expense

     (6,401     (5,735

Amortization of purchased intangible assets

     (429     (374
  

 

 

   

 

 

 

Non-GAAP measure of operating expenses

   $ 52,035      $ 40,507   

Income (loss) from operations

   $ (6,332   $ 320   

Stock compensation expense

     6,782        6,277   

Amortization of purchased intangible assets

     652        1,228   
  

 

 

   

 

 

 

Non-GAAP measure of income from operations

   $ 1,102      $ 7,825   

Net income (loss)

   $ (9,303   $ 313   

Stock compensation expense

     6,782        6,277   

Amortization of debt discount and debt issuance costs

     1,257        —     

Amortization of purchased intangible assets

     652        1,228   
  

 

 

   

 

 

 

Non-GAAP measure of net income (loss)

   $ (612   $ 7,818   

Basic net income (loss) per share

   $ (0.13   $ 0.00   

Stock compensation expense

     0.09        0.10   

Amortization of debt discount and debt issuance costs

     0.02        —     

Amortization of purchased intangible assets

     0.01        0.02   
  

 

 

   

 

 

 

Non-GAAP measure of net income (loss) per share

   $ (0.01   $ 0.12   

Diluted net income (loss) per share

   $ (0.13   $ 0.00   

Stock compensation expense

     0.09        0.09   

Amortization of debt discount and debt issuance costs

     0.02        —     

Amortization of purchased intangible assets

     0.01        0.02   
  

 

 

   

 

 

 

Non-GAAP measure of net income (loss) per share

   $ (0.01   $ 0.11   

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

     69,272        66,824   

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

     69,272        69,406