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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, CFA

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 2013 THIRD QUARTER RESULTS

First $100 Million Revenue Quarter Driven by Record Commercial Clinical and HBDC Sales

SUNNYVALE, California, October 17, 2013 – Cepheid (Nasdaq: CPHD) today reported revenues for the third quarter of 2013 of $100.1 million, representing growth of 24% from $80.5 million for the third quarter of 2012. Net loss in the third quarter of 2013 was $1.4 million, or $(0.02) per share. This compares to net loss of $21.3 million, or $(0.32) per share, in the third quarter of 2012, which included a charge of $15.1 million, or $0.23 per share, associated with a litigation settlement.

Excluding employee stock-based compensation and amortization of purchased intangible assets, non-GAAP net income for the third quarter of 2013 was $6.6 million, or $0.09 per share. This compares to non-GAAP net income of $0.9 million, or $0.01 per share, in the third quarter of 2012.

“Cepheid delivered a record 574 GeneXpert Systems in the third quarter of 2013, bringing our cumulative, global total to more than 5,000. This includes 1,400 systems in the US where there are now more GeneXpert systems in use than any other clinical molecular diagnostic system,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “With our fast-growing menu of Xpert tests, including most recently Xpert CT/NG and Xpert MTB/RIF here in the US, Cepheid is fast emerging as a broad, global leader in the molecular market.”

Operational Overview

 

    By business, total sales were, in millions:

 

     Three Months Ended September 30,  
     2013      2012      Change  

Clinical Systems

   $  17.5       $  13.1         34

Clinical Reagents

     74.4        54.5        36
  

 

 

    

 

 

    

Total Clinical

     91.9        67.6        36

Non-Clinical & Other

     8.2        12.9        -36
  

 

 

    

 

 

    

Total Sales

   $ 100.1       $ 80.5         24
  

 

 

    

 

 

    


    By geography, total sales were, in millions:

 

     Three Months Ended September 30,  
     2013      2012      Change  

North America

        

Clinical

   $ 51.7       $ 42.7         21

Non-Clinical & Other

     7.1        11.5        -38
  

 

 

    

 

 

    

Total North America

     58.8        54.2        8

International

        

Clinical

     40.2        24.9        62

Non-Clinical & Other

     1.1        1.4        -18
  

 

 

    

 

 

    

Total International

     41.3        26.3        57
  

 

 

    

 

 

    

Total Sales

   $ 100.1       $ 80.5         24
  

 

 

    

 

 

    

 

    Commercial sales, including Clinical and Non-Clinical & Other, were $79.8 million in the third quarter of 2013. Sales to High Burden Developing Countries (HBDC) in the third quarter of 2013 were $20.3 million.

 

    During the quarter, Cepheid installed a total of 133 GeneXpert systems in its commercial Clinical business. Additionally, the Company placed a total of 441 GeneXpert systems as part of its HBDC program. Including the HBDC systems, a cumulative total of 5,126 GeneXpert systems have been placed worldwide as of September 30, 2013.

 

    GAAP gross margin on sales was 48% and non-GAAP gross margin on sales was 49%, which compares to 51% and 52%, respectively, in the third quarter of 2012. Lower gross margins were primarily attributed to a larger contribution from our lower margin HBDC business.

 

    Cash, cash equivalents and investments were $84.5 million as of September 30, 2013.

 

    DSO was 38 days.

Business Outlook

For the fiscal year ending December 31, 2013, the Company has increased its full year revenue guidance to reflect much stronger than expected HBDC sales offset in part by a 1% decrease in guidance for Commercial Clinical sales. The change in expected Commercial Clinical sales is driven by a modestly slower than expected recovery in North America sales productivity. The Company now expects:

 

    Total revenue in the range of $389 to $391 million;

 

    Net loss in a range from $(0.26) to $(0.24) per share; and

 

    Non-GAAP net income in the range of $0.22 to $0.24 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 67 million, except in the event we have non-GAAP net income, in which case the share count would be approximately 72 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, 2013
 
     Low     High  

Net Loss Per Share

   $ (0.26   $ (0.24

Stock Compensation Expense

     0.42        0.42   

Amortization of Purchased Intangible Assets

     0.06        0.06   
  

 

 

   

 

 

 

Non-GAAP Measure of Net Income Per Share

   $ 0.22      $ 0.24   
  

 

 

   

 

 

 

Accessing Cepheid’s 2013 Third Quarter Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, October 17, 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 employee stock-based compensation expense, amortization of purchased intangible assets, a tax benefit related to an intercompany intellectual property transaction in the quarter ended March 31, 2012, and litigation settlement expenses in the quarter ended September 30, 2012. 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 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. The Company excluded this item as it believes it was non-recurring in nature, and does not have a direct impact on the operation of the Company’s core business.

Litigation Settlement Expenses. These expenses consisted primarily of expenses related to the settlement of the Company’s 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 consolidated income statement as Litigation settlement in the three months ended September 30, 2012 represented 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 was 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 loss/income and profitability, including on a non-GAAP basis, and the breadth and speed of 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 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 relative mix of commercial and HBDC sales; 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
September 30,
    Nine months Ended
September 30,
 
     2013     2012     2013     2012  

Sales:

        

System and other sales

   $ 19,694      $ 15,905      $ 54,500      $ 48,235   

Reagent and disposable sales

     80,387        64,567        233,531        190,544   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total sales

     100,081        80,472        288,031        238,779   

Costs and operating expenses:

        

Cost of product sales

     51,669        39,789        147,450        110,469   

Collaboration profit sharing

     1,410        2,438        4,945        5,767   

Research and development

     18,558        16,154        54,857        54,374   

Sales and marketing

     19,788        15,993        58,019        45,613   

General and administrative

     9,490        11,766        28,865        33,828   

Litigation settlement

     —          15,110        —          15,110   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     100,915        101,250        294,136        265,161   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (834     (20,778     (6,105     (26,382

Other income (expense), net

     (200     89        (543     (245
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (1,034     (20,689     (6,648     (26,627

Benefit from (provision for) income taxes

     (347     (607     (1,000     940   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (1,381   $ (21,296   $ (7,648   $ (25,687
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net loss per share

   $ (0.02   $ (0.32   $ (0.11   $ (0.39
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted net loss per share

   $ (0.02   $ (0.32   $ (0.11   $ (0.39
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing basic net loss per share

     67,573        66,145        67,234        65,624   
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing diluted net loss per share

     67,573        66,145        67,234        65,624   
  

 

 

   

 

 

   

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     September 30,
2013
    December 31,
2012
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 68,753      $ 95,779   

Short-term investments

     5,785        —     

Accounts receivable, net

     42,027        43,999   

Inventory

     101,582        70,114   

Prepaid expenses and other current assets

     15,976        9,448   
  

 

 

   

 

 

 

Total current assets

     234,123        219,340   

Property and equipment, net

     73,744        54,830   

Investments

     9,980        —     

Other non-current assets

     846        913   

Intangible assets, net

     17,662        18,767   

Goodwill

     39,681        37,694   
  

 

 

   

 

 

 

Total assets

   $ 376,036      $ 331,544   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 46,451      $ 33,701   

Accrued compensation

     18,863        16,540   

Accrued royalties

     4,567        7,992   

Accrued and other liabilities

     5,197        4,235   

Current portion of deferred revenue

     10,866        9,599   

Current portion of notes payable

     195        183   
  

 

 

   

 

 

 

Total current liabilities

     86,139        72,250   

Long-term portion of deferred revenue

     3,115        1,156   

Notes payable, less current portion

     1,566        1,685   

Other liabilities

     10,006        8,911   
  

 

 

   

 

 

 

Total liabilities

     100,826        84,002   
  

 

 

   

 

 

 

Shareholders’ equity:

    

Common stock

     369,614        355,867   

Additional paid-in capital

     138,593        117,217   

Accumulated other comprehensive income

     249        56   

Accumulated deficit

     (233,246     (225,598
  

 

 

   

 

 

 

Total shareholders’ equity

     275,210        247,542   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 376,036      $ 331,544   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(in thousands)

 

     Nine Months Ended
September 30,
 
     2013     2012  

Cash flows from operating activities:

    

Net loss

   $ (7,648   $ (25,687

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

    

Depreciation and amortization of property and equipment

     12,904        9,867   

Amortization of intangible assets

     4,278        3,745   

Stock-based compensation related to employees and consulting services rendered

     20,017        17,932   

Unrealized exchange differences

     307        —     

Changes in operating assets and liabilities:

    

Accounts receivable

     3,216        6,447   

Inventory

     (30,044     (4,014

Prepaid expenses and other current assets

     (6,799     (5,259

Other non-current assets

     263        (46

Accounts payable and other current liabilities

     9,767        (2,278

Accrued compensation

     2,276        (2,044

Deferred revenue

     3,211        1,105   
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     11,748        (232

Cash flows from investing activities:

    

Capital expenditures

     (31,005     (17,079

Payments for technology licenses

     (1,125     (2,140

Cost of acquisitions, net

     (3,571     (17,462

Purchase of marketable securities and investments

     (15,770     —     
  

 

 

   

 

 

 

Net cash used in investing activities

     (51,471     (36,681

Cash flows from financing activities:

    

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

     13,746        26,404   

Proceeds from notes payable

     —          156   

Principal payment of notes payable

     (828     (39
  

 

 

   

 

 

 

Net cash provided by financing activities

     12,918        26,521   

Effect of exchange rate change on cash

     (221     (1,096
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (27,026     (11,488

Cash and cash equivalents at beginning of period

     95,779        115,008   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 68,753      $ 103,520   
  

 

 

   

 

 

 


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)

(in thousands, except per share data)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2013     2012     2013     2012  

Cost of sales

   $ 51,669      $ 39,789      $ 147,450      $ 110,469   

Stock compensation expense

     (461     (894     (1,843     (2,229

Amortization of purchased intangible assets

     (345     (332     (2,004     (998
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of cost of sales

   $ 50,863      $ 38,563      $ 143,603      $ 107,242   

Gross margin on sales per GAAP

     48     51     49     54

Gross margin on sales per Non-GAAP

     49     52     50     55

Operating expenses

   $ 47,836      $ 43,913      $ 141,741      $ 133,815   

Stock compensation expense

     (6,750     (5,450     (18,174     (15,659

Amortization of purchased intangible assets

     (442     (379     (1,257     (1,076
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of operating expenses

   $ 40,644      $ 38,084      $ 122,310      $ 117,080   

Loss from operations

   $ (834   $ (20,778   $ (6,105   $ (26,382

Stock compensation expense

     7,211        6,344        20,017        17,888   

Litigation Settlement

     —          15,110        —          15,110   

Amortization of purchased intangible assets

     787        711        3,261        2,074   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of income from operations

   $ 7,164      $ 1,387      $ 17,173      $ 8,690   

Net loss

   $ (1,381   $ (21,296   $ (7,648   $ (25,687

Stock compensation expense

     7,211        6,344        20,017        17,888   

Litigation Settlement

     —          15,110        —          15,110   

Amortization of purchased intangible assets

     787        711        3,261        2,074   

Tax benefit related to intercompany IP transaction

     —          —          —          (1,815
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income

   $ 6,617      $ 869      $ 15,630      $ 7,570   

Basic net loss per share

   $ (0.02   $ (0.32   $ (0.11   $ (0.39

Stock compensation expense

     0.11        0.09        0.29        0.28   

Litigation Settlement

     —          0.23        —          0.23   

Amortization of purchased intangible assets

     0.01        0.01        0.05        0.03   

Tax benefit related to intercompany IP transaction

     —          —          —          (0.03
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income per share

   $ 0.10      $ 0.01      $ 0.23      $ 0.12   

Diluted net loss per share

   $ (0.02   $ (0.32   $ (0.11   $ (0.39

Stock compensation expense

     0.10        0.09        0.29        0.27   

Litigation Settlement

     —          0.23        —          0.03   

Amortization of purchased intangible assets

     0.01        0.01        0.04        0.23   

Tax benefit related to intercompany IP transaction

     —          —          —          (0.03
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income per share

   $ 0.09      $ 0.01      $ 0.22      $ 0.11   

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

     67,573        66,145        67,234        65,624   

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

     69,822        69,963        69,668        69,921