EX-99.01 2 d224747dex9901.htm EX-99.01 EX-99.01

Exhibit 99.01

 

LOGO

 

  

Cepheid

904 Caribbean Drive

Sunnyvale, CA 94089

Telephone: 408.541.4191

Fax: 408.541.4192

  

For Media & Investor Inquiries:

 

Jacquie Ross, CFA

Tel: (408) 400 8329

corporate.communications@cepheid.com

CEPHEID REPORTS SECOND QUARTER 2016 RESULTS

SUNNYVALE, California, July 28, 2016 – Cepheid (Nasdaq: CPHD) today reported revenue for the second quarter of 2016 of $146.0 million, representing growth of 10%, or 12% on a constant currency basis, from $132.5 million for the second quarter of 2015. Net loss was $(10.2) million, or $(0.14) per share, which compares to net loss of $(16.7) million, or $(0.23) per share, in the second quarter of 2015.

Excluding stock-based compensation expense, amortization of debt discount and transaction costs, and amortization of purchased intangible assets, non-GAAP net income for the second quarter of 2016 was $3.5 million, or $0.05 per share. This compares to non-GAAP net loss of $(4.5) million, or $(0.06) per share, in the second quarter of 2015, which excluded stock-based compensation expense, amortization of debt discount and transaction costs, and amortization of purchased intangible assets.

“Solid second quarter performance was driven by building momentum across our commercial organization that sets us up well for strong growth in the second half of 2016,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “We also continued to move our virology and oncology products closer to market in the United States and Internationally, respectively, and made excellent progress on our next-generation platforms, the Honeycomb and Omni Systems. Taken together, we continue to build an attractive portfolio of products that builds on our leadership in innovation and leverages our substantial worldwide installed base.”

Operational Overview

Total revenue was, in millions:

 

     Three Months Ended June 30,  
     2016      2015      Change
(Reported)
    Change
(Constant Currency)
 

Systems and Other

   $ 24.8       $ 24.4         2     4

Reagents and Disposables

     121.2         108.1         12     14
  

 

 

    

 

 

      

Total Revenue

     146.0         132.5         10     12
  

 

 

    

 

 

      

By geography, total revenue was, in millions:

 

     Three Months Ended June 30,  
     2016      2015      Change
(Reported)
    Change
(Constant Currency)
 

North America

   $ 81.2       $ 76.2         7     —     

International

     64.8         56.3         15     21
  

 

 

    

 

 

      

Total Revenue

     146.0         132.5         10     12
  

 

 

    

 

 

      


    GAAP gross margin was 50% and non-GAAP gross margin was 51% for the second quarter of 2016, which compares to 48% and 49%, respectively, in the second quarter of 2015.

 

    Cash, cash equivalents and investments were $378.7 million as of June 30, 2016.

 

    DSO was 39 days.

Business Outlook

For the fiscal year ending December 31, 2016, the Company now expects:

 

    Total revenue to be in the range of $618 to $635 million;

 

    Net loss in the range of $(0.47) to $(0.44) per share; and

 

    Non-GAAP net income in the range of $0.31 to $0.34 per share.

Expected non-GAAP net income excludes approximately $42 million related to stock-based compensation expense, approximately $11 million related to the amortization of debt discount and transaction costs, and approximately $5 million related to the amortization of purchased intangible assets. The fully diluted share count for the year is expected to be approximately 73 million for net loss per share, and approximately 75 million shares for non-GAAP net income per share.

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

 

     Guidance Range for Year
Ending December 31, 2016
 
     Low      High  

Net Loss Per Share

   $ (0.47    $ (0.44

Stock-Based Compensation Expense

     0.56         0.56   

Amortization of Debt Discount and Transaction Costs

     0.07         0.07   

Amortization of Purchased Intangible Assets

     0.15         0.15   
  

 

 

    

 

 

 

Non-GAAP Measure of Net Income Per Share

   $ 0.31       $ 0.34   
  

 

 

    

 

 

 

Accessing Cepheid’s 2016 Second Quarter Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, July 28, 2016 to discuss the results. To access the live webcast, please visit Cepheid’s website at http://ir.cepheid.com. 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, including (1) non-GAAP net income and non-GAAP gross margin that do not include stock-based compensation expense, amortization of debt discount and transaction costs and amortization of purchased intangible assets and (2) revenue metrics presented on a constant currency basis. 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.

Non-GAAP Net Income and Non-GAAP Gross Margin

As described above, the Company excludes the following items from one or more of its non-GAAP net income and non-GAAP gross margin 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.


Constant Currency

The Company presents certain revenue information in this release on a constant currency basis that excludes the effect of foreign currency rate fluctuations and hedging transactions. The Company calculates constant currency revenue growth by (i) translating current quarter or year-to-date revenues to constant currency revenues using the applicable prior period exchange rates and (ii) excluding any gain or loss from foreign currency hedge contracts that are reported in revenue. The Company believes constant currency revenue growth provides useful supplemental information to investors about the financial performance of the Company’s business and enables a more accurate comparison of financial results between periods, by excluding the impact of currency rate fluctuations and hedging transactions. Investors should be cautioned that the effect of changing foreign currency exchange rates has an actual effect on operating results.

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 projected future growth, future revenues, future net loss/income and profitability and future number of fully-diluted shares, including on a non-GAAP basis, strategic investments, market penetration and expansion, development and timing of new products, effectiveness of product development and commercialization efforts and the breadth and speed of test menu expansion, geographic expansion, customer segment expansion and market 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: the Company’s success in increasing commercial and HBDC sales and the effectiveness of its sales personnel; the efficacy of the Company’s on-going cost-reduction and gross margin improvement efforts; the relative mix of commercial and HBDC sales, and relative mix of instrument and test sales; manufacturing costs associated with the ramp-up of new products; the speed and extent of test menu expansion and utilization; the performance and market acceptance of new products, including the Honeycomb module and Omni System and new products related to oncology and genetics; the Company’s ability to sell directly to the smaller hospital market and independent reference laboratory market; the on-going expansion of the Company’s United States sales organization; sales organization productivity and the productivity and effectiveness of the Company’s distributors; the Company’s reliance on distributors in some regions to market, sell and support its products; sufficient customer demand, customer confidence in product availability and available customer budgets for the Company’s products; the Company’s 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 potential impact of guidelines or recommendations and studies published by various organizations; 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; the Company’s ability to manage its inventory levels; the Company’s 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 occurrence of unforeseen expenditures, acquisitions or other transactions; costs associated with litigation; the impact of competitive products and pricing; the impact of foreign currency exchange; the Company’s ability to manage geographically-dispersed operations; the Company’s ability to penetrate new geographic markets and manage the operational risks associated with such new markets; 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     Six Months Ended  
   June 30,     June 30,  
     2016     2015     2016     2015  

Revenue

   $ 146,001      $ 132,475      $ 290,781      $ 265,112   

Costs and operating expenses:

        

Cost of sales

     73,235        69,377        145,830        130,578   

Collaboration profit sharing

     1,284        1,326        1,942        2,593   

Research and development

     33,592        28,092        63,506        52,078   

Sales and marketing

     29,874        28,078        58,669        54,014   

General and administrative

     15,418        16,352        30,473        31,994   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     153,403        143,225        300,420        271,257   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (7,402     (10,750     (9,639     (6,145

Other income (expense):

        

Interest income

     799        416        1,459        789   

Interest expense

     (3,812     (3,646     (7,577     (7,250

Foreign currency exchange gain (loss) and other, net

     298        (1,496     (230     (2,440
  

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net

     (2,715     (4,726     (6,348     (8,901
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (10,117     (15,476     (15,987     (15,046

Provision for income taxes

     (115     (1,254     (846     (778
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (10,232   $ (16,730   $ (16,833   $ (15,824
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net loss per share

   $ (0.14   $ (0.23   $ (0.23   $ (0.22
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted net loss per share

   $ (0.14   $ (0.23   $ (0.23   $ (0.22
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing basic net loss per share

     72,921        71,861        72,754        71,563   
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing diluted net loss per share

     72,921        71,861        72,754        71,563   
  

 

 

   

 

 

   

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

     June 30,     December 31,  
     2016     2015  
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 100,331      $ 112,568   

Short-term investments

     223,155        210,147   

Accounts receivable, net

     62,828        66,550   

Inventory, net

     156,815        148,690   

Prepaid expenses and other current assets

     23,384        18,515   
  

 

 

   

 

 

 

Total current assets

     566,513        556,470   

Property and equipment, net

     151,999        127,639   

Investments

     55,184        62,175   

Other non-current assets

     5,665        4,205   

Intangible assets, net

     22,383        25,241   

Goodwill

     39,681        39,681   
  

 

 

   

 

 

 

Total assets

   $ 841,425      $ 815,411   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 64,296      $ 57,771   

Accrued compensation

     35,944        39,015   

Accrued royalties

     4,730        5,469   

Accrued and other liabilities

     29,483        27,451   

Current portion of deferred revenue

     15,116        12,778   
  

 

 

   

 

 

 

Total current liabilities

     149,569        142,484   

Long-term portion of deferred revenue

     7,489        5,538   

Convertible senior notes, net

     287,005        281,627   

Other liabilities

     19,665        15,779   
  

 

 

   

 

 

 

Total liabilities

     463,728        445,428   
  

 

 

   

 

 

 

Shareholders’ equity:

    

Common stock

     454,488        449,704   

Additional paid-in capital

     282,337        263,429   

Accumulated other comprehensive loss, net

     (53     (908

Accumulated deficit

     (359,075     (342,242
  

 

 

   

 

 

 

Total shareholders’ equity

     377,697        369,983   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 841,425      $ 815,411   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Six Months Ended
June 30,
 
     2016     2015  

Cash flows from operating activities:

    

Net loss

   $ (16,833   $ (15,824

Adjustments to reconcile net loss to net cash provided by operating activities:

    

Depreciation and amortization of property and equipment

     15,331        13,435   

Amortization of intangible assets

     2,858        3,334   

Unrealized foreign exchange differences

     57        1,338   

Amortization of debt discount and transaction costs

     5,377        5,044   

Impairment of acquired intangible assets, licenses, property and equipment

     —          224   

Stock-based compensation expense

     18,839        15,799   

Excess tax benefits from stock-based compensation expense

     —          (53

Other non-cash items

     547        28   

Changes in operating assets and liabilities:

    

Accounts receivable

     3,722        (8,949

Inventory, net

     (8,058     (9,267

Prepaid expenses and other current assets

     (4,252     (5,151

Other non-current assets

     (91     (207

Accounts payable and other current and non-current liabilities

     6,024        9,695   

Accrued compensation

     (3,071     (2,514

Deferred revenue

     4,288        991   
  

 

 

   

 

 

 

Net cash provided by operating activities

     24,738        7,923   

Cash flows from investing activities:

    

Capital expenditures

     (34,167     (19,308

Cost of acquisitions, net

     —          (3,000

Proceeds from sale of equipment and an intangible asset

     44        834   

Proceeds from sales of marketable securities and investments

     40,730        44,873   

Proceeds from maturities of marketable securities and investments

     112,313        118,497   

Purchases of marketable securities and investments

     (158,527     (156,401

Transfer from (to) restricted cash

     (2,049     1,328   
  

 

 

   

 

 

 

Net cash used in investing activities

     (41,656     (13,177

Cash flows from financing activities:

    

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

     4,836        20,592   

Excess tax benefits from stock-based compensation expense

     —          53   

Principal payment of notes payable

     (85     (80
  

 

 

   

 

 

 

Net cash provided by financing activities

     4,751        20,565   

Effect of foreign exchange rate change on cash and cash equivalents

     (70     (1,405
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     (12,237     13,906   

Cash and cash equivalents at beginning of period

     112,568        96,663   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 100,331      $ 110,569   
  

 

 

   

 

 

 


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2016     2015     2016     2015  

Revenue, as reported

   $ 146,001      $ 132,475      $ 290,781      $ 265,112   

Foreign currency exchange impact on Q2’16 revenue using Q2’15 rates

     (88     —          2,481        —     

Loss/(benefit) from cash flow hedges

     248        (2,391     222        (4,585
  

 

 

   

 

 

   

 

 

   

 

 

 

Revenue, at constant currency

   $ 146,161      $ 130,084      $ 293,484      $ 260,527   

Revenue growth, as reported

     10       10  

Revenue growth, at constant currency

     12       13  

International Revenue, as reported

   $ 64,799      $ 56,288      $ 127,189      $ 106,620   

Foreign currency exchange impact on Q2’16 revenue using Q2’15 rates

     (88     —          2,481        —     

Loss/(benefit) from cash flow hedges

     248        (2,391     222        (4,585
  

 

 

   

 

 

   

 

 

   

 

 

 

Revenue, at constant currency

   $ 64,959      $ 53,897      $ 129,892      $ 102,035   

International Revenue growth, as reported

     15       19  

International Revenue growth, at constant currency

     21       27  

Systems and Other Revenue, as reported

   $ 24,838      $ 24,360      $ 49,122      $ 43,074   

Foreign currency exchange impact on Q2’16 revenue using Q2’15 rates

     (2     —          319        —     

Loss/(benefit) from cash flow hedges

     (19     (515     (18 )     (681
  

 

 

   

 

 

   

 

 

   

 

 

 

Systems and Other Revenue, at constant currency

   $ 24,817      $ 23,845      $ 49,423      $ 42,393   

Systems and Other Revenue growth, as reported

     2       14  

Systems and Other Revenue growth, at constant currency

     4       17  

Reagents and Disposables Revenue, as reported

   $ 121,163      $ 108,115      $ 241,659      $ 222,038   

Foreign currency exchange impact on Q2’16 revenue using Q2’15 rates

     (86     —          2,162        —     

Loss/(benefit) from cash flow hedges

     267        (1,876     240        (3,904
  

 

 

   

 

 

   

 

 

   

 

 

 

Reagents and Disposables Revenue, at constant currency

   $ 121,344      $ 106,239      $ 244,061      $ 218,134   

Reagents and Disposables Revenue growth, as reported

     12       9  

Reagents and Disposables Revenue growth, at constant currency

     14       12  

Cost of sales

   $ 73,235      $ 69,377      $ 145,830      $ 130,578   

Stock-based compensation expense

     (1,583     (1,008     (3,098     (2,048

Amortization of purchased intangible assets

     (829     (1,024     (1,658     (2,048
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of cost of sales

   $ 70,823      $ 67,345      $ 141,074      $ 126,482   

Gross margin on revenue per GAAP

     50     48     50     51

Gross margin on revenue per Non-GAAP

     51     49     51     52

Operating expenses

   $ 78,884      $ 72,522      $ 152,648      $  138,086   

Stock-based compensation expense

     (8,272     (7,262     (15,795     (13,779

Amortization of purchased intangible assets

     (341     (382     (681     (766
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of operating expenses

   $ 70,271      $ 64,878      $ 136,172      $ 123,541   


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (continued)

(in thousands, except per share data)

(unaudited)

 

 

Loss from operations

   $ (7,402   $ (10,750   $ (9,639   $ (6,145

Stock-based compensation expense

     9,855        8,270        18,893        15,827   

Amortization of purchased intangible assets

     1,170        1,406        2,339        2,814   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of income (loss) from operations

   $ 3,623      $ (1,074   $ 11,593      $ 12,496   

Net loss

   $ (10,232   $ (16,730   $ (16,833   $ (15,824

Stock-based compensation expense

     9,855        8,270        18,893        15,827   

Amortization of debt discount and transaction cost

     2,710        2,542        5,377        5,044   

Amortization of purchased intangible assets

     1,170        1,406        2,339        2,814   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net income (loss)

   $ 3,503      $ (4,512   $ 9,776      $ 7,861   

Basic net loss per share

   $ (0.14   $ (0.23   $ (0.23   $ (0.22

Stock-based compensation expense

     0.14        0.12        0.26        0.23   

Amortization of debt discount and transaction cost

     0.04        0.03        0.07        0.06   

Amortization of purchased intangible assets

     0.01        0.02        0.03        0.04   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ 0.05      $ (0.06   $ 0.13      $ 0.11   

Diluted net loss per share

   $ (0.14   $ (0.23   $ (0.23   $ (0.22

Stock-based compensation expense

     0.14        0.12        0.26        0.23   

Amortization of debt discount and transaction cost

     0.04        0.03        0.07        0.06   

Amortization of purchased intangible assets

     0.01        0.02        0.03        0.04   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ 0.05      $ (0.06   $ 0.13      $ 0.11   

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

     72,921        71,861        72,754        71,563   

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

     74,267        71,861        74,143        74,330