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8-K - FORM 8-K - CEPHEIDd914504d8k.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, 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 2015 FIRST QUARTER RESULTS

Commercial Clinical Reagents Grow 35%

SUNNYVALE, California, April 23, 2015 – Cepheid (Nasdaq: CPHD) today reported revenue for the first quarter of 2015 of $132.6 million, representing growth of 24% from $106.9 million for the first quarter of 2014. Net income was $0.9 million, or $0.01 per share, which compares to net loss of $(9.3) million, or $(0.13) per share, in the first quarter of 2014.

Excluding stock-based compensation expense, amortization of debt discount and transaction costs, and amortization of purchased intangible assets, non-GAAP net income for the first quarter of 2015 was $12.4 million, or $0.17 per share. This compares to a non-GAAP net loss of $(0.6) million, or $(0.01) per share, in the first quarter of 2014.

“Momentum continues to build across our business, with strong execution on our test menu, geographic expansion, and market extension programs all contributing to record first quarter revenue,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “In the last 12 months, Cepheid has added eight tests to the international Xpert menu, including the milestone HIV Viral Load, HIV Qualitative and HCV Viral Load tests. Regardless of size, many of our international customers now have the capability to offer a broad molecular menu of HAI, sexual health and virology tests on a single accurate, efficient, scalable, and cost-effective platform.”

Operational Overview

 

    Total revenue was, in millions:

 

     Three Months Ended March 31,  
     2015      2014      Change  

Clinical Systems

   $ 16.3       $ 17.3         -6

Clinical Reagents

     109.0         83.1         31
  

 

 

    

 

 

    

Total Clinical

  125.3      100.4      25

Non-Clinical & Other

  7.3      6.5      13
  

 

 

    

 

 

    

Total Revenue

$ 132.6    $ 106.9      24
  

 

 

    

 

 

    


    By geography, total revenue was, in millions:

 

     Three Months Ended March 31,  
     2015      2014      Change  

North America

        

Clinical

   $ 75.5       $ 57.3         32

Non-Clinical & Other

     6.8         5.5         23
  

 

 

    

 

 

    

Total North America

  82.3      62.8      31

International

Clinical

  49.8      43.2      15

Non-Clinical & Other

  0.5      0.9      -46
  

 

 

    

 

 

    

Total International

  50.3      44.1      14
  

 

 

    

 

 

    

Total Revenue

$ 132.6    $ 106.9      24
  

 

 

    

 

 

    

 

    Commercial Clinical sales were $109.0 million and sales to High Burden Developing Countries (HBDC) were $16.3 million.

 

    During the quarter, Cepheid installed a total of 163 GeneXpert systems in its commercial Clinical business. Additionally, the Company placed a total of 133 GeneXpert systems as part of its HBDC program. Including HBDC sales, a cumulative total of 8,321 GeneXpert systems have been placed worldwide as of March 31, 2015.

 

    GAAP gross margin on sales was 54% and non-GAAP gross margin on sales was 55%, which compares to 50% and 51%, respectively, in the first quarter of 2014.

 

    Cash, cash equivalents and investments were $373.3 million as of March 31, 2015.

 

    DSO was 51 days.

Business Outlook

For the fiscal year ending December 31, 2015, the Company now expects:

 

    Total revenue to be in the range of $542 to $553 million;

 

    Net loss in the range of $(0.47) to $(0.43) per share;

 

    Non-GAAP net income in the range of $0.25 to $0.29 per share.

Expected non-GAAP net income excludes approximately $36 million related to stock-based compensation expense, approximately $10 million related to the amortization of debt discount and transaction costs, and approximately $6 million related to the amortization of purchased intangible assets. The fully diluted share count for the year is expected to be approximately 71 million in the case of a net loss, and approximately 74 million shares in the case of net income.


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

 

     Ending December 31, 2015  
     Low      High  

Net Loss Per Share

   $ (0.47    $ (0.43

Stock-Based Compensation Expense

     0.50         0.50   

Amortization of Debt Discount and Transaction Costs

     0.14         0.14   

Amortization of Purchased Intangible Assets

     0.08         0.08   
  

 

 

    

 

 

 

Non-GAAP Measure of Net Income Per Share

$ 0.25    $ 0.29   
  

 

 

    

 

 

 

Accessing Cepheid’s 2015 First Quarter Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, April 23, 2015, 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.

Summary of Management Presentation

In conjunction with today’s press release, the Company is making a summary of the management presentation immediately available at http://ir.cepheid.com.

About Cepheid

Based in Sunnyvale, California, 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 purchased intangible assets, amortization of debt discount and transaction 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:

Stock-based Compensation Expense. This consists primarily of expenses for stock options and restricted stock under ASC 718 (formerly SFAS 123(R)). The Company excludes stock-based compensation expense from its non-GAAP measures primarily because it is a non-cash expense that the Company does not believe is 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 Transaction Costs. The Company incurs amortization of debt discount and transaction costs in connection with the Convertible Senior Notes issued 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 the scale and sustainability of future growth, future revenues and future net loss/income and profitability, including on a non-GAAP basis, strategic investments, platform features, the breadth and speed of test menu expansion, geographic expansion and market segment 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 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, complete clinical trials successfully and obtain regulatory clearances in a timely manner for new products; uncertainties related to the FDA regulatory and international 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; long sales cycles and variability in systems placements and reagent pull-through in the Company’s HBDC program; the rate of environmental biothreat testing conducted by the USPS, which will affect the amount of consumable products sold to the USPS; unforeseen supply, development and manufacturing problems; our ability to manage our inventory levels; our ability to successfully complete and bring on additional manufacturing lines; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; 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 STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
March 31,
 
     2015     2014  

Revenue

    

System and other revenue

   $ 18,714      $ 18,529   

Reagent and disposable revenue

     113,923        88,378   
  

 

 

   

 

 

 

Total revenue

  132,637      106,907   

Costs and operating expenses:

Cost of sales

  61,201      53,083   

Collaboration profit sharing

  1,267      1,291   

Research and development

  23,986      21,740   

Sales and marketing

  25,936      23,458   

General and administrative

  15,642      13,667   
  

 

 

   

 

 

 

Total costs and operating expenses

  128,032      113,239   
  

 

 

   

 

 

 

Income (loss) from operations

  4,605      (6,332

Other expense, net

  (4,175   (2,291
  

 

 

   

 

 

 

Income (loss) before income taxes

  430      (8,623

Benefit from (provision for) income taxes

  476      (680
  

 

 

   

 

 

 

Net income (loss)

$ 906    $ (9,303
  

 

 

   

 

 

 

Basic net income (loss) per share

$ 0.01    $ (0.13
  

 

 

   

 

 

 

Diluted net income (loss) per share

$ 0.01    $ (0.13
  

 

 

   

 

 

 

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

  71,262      69,272   
  

 

 

   

 

 

 

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

  73,189      69,272   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

     March 31,
2015
    December 31,
2014
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 109,626      $ 96,663   

Short-term investments

     200,894        196,729   

Accounts receivable, net

     74,719        68,809   

Inventory

     140,761        132,635   

Prepaid expenses and other current assets

     29,120        24,274   
  

 

 

   

 

 

 

Total current assets

  555,120      519,110   

Property and equipment, net

  119,009      115,765   

Investments

  62,798      79,731   

Other non-current assets

  7,911      7,847   

Intangible assets, net

  29,341      31,440   

Goodwill

  39,681      39,681   
  

 

 

   

 

 

 

Total assets

$ 813,860    $ 793,574   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 55,753    $ 50,435   

Accrued compensation

  24,984      33,760   

Accrued royalties

  4,375      5,443   

Accrued and other liabilities

  33,285      34,761   

Current portion of deferred revenue

  13,633      13,447   
  

 

 

   

 

 

 

Total current liabilities

  132,030      137,846   

Long-term portion of deferred revenue

  4,687      4,532   

Convertible senior notes, net

  280,581      278,213   

Other liabilities

  20,126      18,768   
  

 

 

   

 

 

 

Total liabilities

  437,424      439,359   
  

 

 

   

 

 

 

Shareholders’ equity:

Common stock

  435,798      422,151   

Additional paid-in capital

  233,103      225,529   

Accumulated other comprehensive income, net of taxes

  341      247   

Accumulated deficit

  (292,806   (293,712
  

 

 

   

 

 

 

Total shareholders’ equity

  376,436      354,215   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

$ 813,860    $ 793,574   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Three Months Ended
March 31,
 
     2015     2014  

Cash flows from operating activities:

    

Net income (loss)

   $ 906      $ (9,303

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

    

Depreciation and amortization of property and equipment

     6,045        4,977   

Amortization of intangible assets

     1,673        919   

Unrealized foreign exchange differences

     1,455        (52

Amortization of debt discount and transaction costs

     2,502        1,257   

Stock-based compensation expense

     7,557        6,782   

Excess tax benefits from stock-based compensation expense

     (53     —     

Loss on the disposal of property, equipment and intangible assets

     142        —     

Changes in operating assets and liabilities:

    

Accounts receivable

     (5,910     (4,400

Inventory

     (8,160     (15,270

Prepaid expenses and other current assets

     (2,299     (5,842

Other non-current assets

     (197     122   

Accounts payable and other current and non-current liabilities

     5,512        3,470   

Accrued compensation

     (8,776     (1,595

Deferred revenue

     341        2,079   
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

  738      (16,856

Cash flows from investing activities:

Capital expenditures

  (9,989   (8,762

Cost of acquisitions, net

  (3,000   —     

Proceeds from sale of an intangible asset

  339      —     

Proceeds from sales of marketable securities and investments

  13,303      18,788   

Proceeds from maturities of marketable securities and investments

  61,774      4,650   

Purchases of marketable securities and investments

  (62,494   (259,553

Transfer from restricted cash

  31      —     
  

 

 

   

 

 

 

Net cash used in investing activities

  (36   (244,877

Cash flows from financing activities:

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

  13,804      21,631   

Excess tax benefits from stock-based compensation expense

  53      —     

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

  —        335,789   

Purchase of convertible note capped call hedge

  —        (25,082

Principal payment of notes payable

  (39   (48
  

 

 

   

 

 

 

Net cash provided by financing activities

  13,818      332,290   

Effect of foreign exchange rate change on cash and cash equivalents

  (1,557   89   
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

  12,963      70,646   

Cash and cash equivalents at beginning of period

  96,663      66,072   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

$ 109,626    $ 136,718   
  

 

 

   

 

 

 


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
March 31,
 
     2015     2014  

Cost of sales

   $ 61,201      $ 53,083   

Stock-based compensation expense

     (1,040     (381

Amortization of purchased intangible assets

     (1,024     (223
  

 

 

   

 

 

 

Non-GAAP measure of cost of sales

$ 59,137    $ 52,479   

Gross margin on revenue per GAAP

  54   50

Gross margin on revenue per Non-GAAP

  55   51

Operating expenses

$ 65,564    $ 58,865   

Stock-based compensation expense

  (6,517   (6,401

Amortization of purchased intangible assets

  (384   (429
  

 

 

   

 

 

 

Non-GAAP measure of operating expenses

$ 58,663    $ 52,035   

Income (loss) from operations

$ 4,605    $ (6,332

Stock-based compensation expense

  7,557      6,782   

Amortization of purchased intangible assets

  1,408      652   
  

 

 

   

 

 

 

Non-GAAP measure of income from operations

$ 13,570    $ 1,102   

Net income (loss)

$ 906    $ (9,303

Stock-based compensation expense

  7,557      6,782   

Amortization of debt discount and transaction cost

  2,502      1,257   

Amortization of purchased intangible assets

  1,408      652   
  

 

 

   

 

 

 

Non-GAAP measure of net income (loss)

$ 12,373    $ (612

Basic net income (loss) per share

$ 0.01    $ (0.13

Stock-based compensation expense

  0.11      0.09   

Amortization of debt discount and transaction cost

  0.03      0.02   

Amortization of purchased intangible assets

  0.02      0.01   
  

 

 

   

 

 

 

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

$ 0.17    $ (0.01

Diluted net income (loss) per share

$ 0.01    $ (0.13

Stock-based compensation expense

  0.11      0.09   

Amortization of debt discount and transaction cost

  0.03      0.02   

Amortization of purchased intangible assets

  0.02      0.01   
  

 

 

   

 

 

 

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

$ 0.17    $ (0.01

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

  71,262      69,272   

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

  73,189      69,272   

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

  74,097      69,272