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8-K - 8-K - CEPHEIDd25278d8k.htm

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 2015 THIRD QUARTER RESULTS

Commercial Clinical Growth of 22% for First Nine Months of 2015

SUNNYVALE, California, October 20, 2015 – Cepheid (Nasdaq: CPHD) today reported revenue for the third quarter of 2015 of $126.5 million, representing growth of 10% from $115.2 million for the third quarter of 2014. Net loss was $(22.9) million, or $(0.32) per share, which compares to net loss of $(7.2) million, or $(0.10) per share, in the third quarter of 2014.

Excluding stock-based compensation expense, amortization of debt discount and transaction costs, and amortization of purchased intangible assets, non-GAAP net loss for the third quarter of 2015 was $(9.1) million, or $(0.13) per share. This compares to non-GAAP net income of $4.7 million, or $0.06 per share, in the third quarter of 2014.

“Our Commercial Clinical business has grown 22% year-to-date and we currently expect to deliver approximately 20% growth for the full year,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “Worldwide, we now have more than 9,200 GeneXpert Systems installed, and a menu of up to 23 tests spanning healthcare associated infections, critical infectious disease, sexual health and virology. Our objective is to improve lab efficiency and reduce costs through system consolidation and workflow efficiencies while at the same time allowing an ever increasing number of patients to benefit from our accurate, fast, and easy-to-use tests.”

Operational Overview

 

    Total revenue was, in millions:

 

     Three Months Ended September 30,
     2015      2014      Change

Clinical Systems

   $ 17.9       $ 17.0       5%

Clinical Reagents

     102.3         90.1       14%
  

 

 

    

 

 

    

Total Clinical

     120.2         107.1       12%

Non-Clinical & Other

     6.3         8.1       -22%
  

 

 

    

 

 

    

Total Revenue

   $ 126.5       $ 115.2       10%
  

 

 

    

 

 

    


    By geography, total revenue was, in millions:

 

     Three Months Ended September 30,
     2015      2014      Change

North America

        

Clinical

   $ 67.4       $ 61.0       11%

Non-Clinical & Other

     6.2         6.9       -10%
  

 

 

    

 

 

    

Total North America

     73.6         67.9       8%

International

        

Clinical

     52.8         46.1       14%

Non-Clinical & Other

     0.1         1.2       -93%
  

 

 

    

 

 

    

Total International

     52.9         47.3       12%
  

 

 

    

 

 

    

Total Revenue

   $ 126.5       $ 115.2       10%
  

 

 

    

 

 

    

 

    Commercial Clinical sales were $97.8 million and sales to High Burden Developing Countries (HBDC) were $22.4 million.

 

    During the quarter, Cepheid installed a total of 204 GeneXpert systems in its Commercial Clinical business. Additionally, the Company placed a total of 172 GeneXpert systems as part of its HBDC program. Including HBDC sales, a cumulative total of 9,279 GeneXpert systems have been placed worldwide as of September 30, 2015.

 

    GAAP gross margin on sales was 46% and non-GAAP gross margin on sales was 48%, which compares to 51% and 52%, respectively, in the third quarter of 2014.

 

    Cash, cash equivalents and investments were $386.4 million as of September 30, 2015.

 

    DSO was 43 days.

Business Outlook

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

 

    Total revenue to be in the range of $537 to $541 million;

 

    Net loss in the range of $(0.73) to $(0.71) per share; and

 

    Non-GAAP earnings in the range of a loss of $(0.01) to income of $0.01 per share.

Expected non-GAAP net income excludes approximately $37 million related to stock-based compensation expense, approximately $10 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 72 million in the case of a net loss, and approximately 75 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:

 

     Guidance Range for Year
Ending December 31, 2015
 
     Low      High  

Net Loss Per Share

   $ (0.73    $ (0.71

Stock-Based Compensation Expense

     0.51         0.51   

Amortization of Debt Discount and Transaction Costs

     0.14         0.14   

Amortization of Purchased Intangible Assets

     0.07         0.07   
  

 

 

    

 

 

 

Non-GAAP Measure of Net Income Per Share

   $ (0.01    $ 0.01   
  

 

 

    

 

 

 

Accessing Cepheid’s 2015 Third Quarter Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Tuesday, October 20, 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 debt discount and transaction costs, and amortization of purchased intangible assets. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with U.S. GAAP. The Company’s management uses the non-GAAP information internally to evaluate its ongoing business, continuing operational performance and cash requirements, and believes these non-GAAP measures are useful to investors as they provide a basis for evaluating the Company’s cash requirements and additional insight into the underlying operating results and the Company’s ongoing performance in the ordinary course of its operations.

These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. The


Company believes that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with its results of operations as determined in accordance with U.S. GAAP and that these measures should only be used to evaluate the Company’s results of operations in conjunction with the corresponding GAAP measures.

As described above, the Company excludes the following items from one or more of its non-GAAP measures when applicable:

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 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, 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, and relative mix of instrument and test sales; manufacturing costs associated with the ramp-up of new products; 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 impact of foreign currency exchange; 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
September 30,
    Nine Months Ended
September 30,
 
     2015     2014     2015     2014  

Revenue

   $ 126,465      $ 115,209      $ 391,577      $ 338,619   

Costs and operating expenses:

        

Cost of sales

     67,681        56,791        198,259        169,442   

Collaboration profit sharing

     1,286        1,291        3,879        3,231   

Research and development

     32,909        23,541        84,987        69,279   

Sales and marketing

     28,664        23,913        82,678        70,873   

General and administrative

     15,401        13,069        47,395        41,076   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     145,941        118,605        417,198        353,901   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (19,476     (3,396     (25,621     (15,282

Other income (expense):

        

Interest income

     494        325        1,283        784   

Interest expense

     (3,687     (3,640     (10,937     (9,003

Foreign currency exchange loss and other, net

     (408     (258     (2,848     (1,015
  

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net

     (3,601     (3,573     (12,502     (9,234
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (23,077     (6,969     (38,123     (24,516

Benefit from (provision for) income taxes

     176        (266     (602     (1,865
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (22,901   $ (7,235   $ (38,725   $ (26,381
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net loss per share

   $ (0.32   $ (0.10   $ (0.54   $ (0.38
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted net loss per share

   $ (0.32   $ (0.10   $ (0.54   $ (0.38
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing basic net loss per share

     72,199        70,326        71,777        69,859   
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing diluted net loss per share

     72,199        70,326        71,777        69,859   
  

 

 

   

 

 

   

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     September 30,
2015
    December 31,
2014
 
     (unaudited)        
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 136,487      $ 96,663   

Short-term investments

     189,697        196,729   

Accounts receivable, net

     60,383        68,809   

Inventory, net

     144,808        132,635   

Prepaid expenses and other current assets

     30,990        24,274   
  

 

 

   

 

 

 

Total current assets

     562,365        519,110   

Property and equipment, net

     124,366        115,765   

Investments

     60,168        79,731   

Other non-current assets

     8,215        7,847   

Intangible assets, net

     26,700        31,440   

Goodwill

     39,681        39,681   
  

 

 

   

 

 

 

Total assets

   $ 821,495      $ 793,574   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 65,789      $ 50,435   

Accrued compensation

     33,248        33,760   

Accrued royalties

     4,862        5,443   

Accrued and other liabilities

     28,769        34,761   

Current portion of deferred revenue

     12,102        13,447   
  

 

 

   

 

 

 

Total current liabilities

     144,770        137,846   

Long-term portion of deferred revenue

     5,081        4,532   

Convertible senior notes, net

     285,406        278,213   

Other liabilities

     19,421        18,768   
  

 

 

   

 

 

 

Total liabilities

     454,678        439,359   
  

 

 

   

 

 

 

Shareholders’ equity:

    

Common stock

     448,525        422,151   

Additional paid-in capital

     251,772        225,529   

Accumulated other comprehensive income (loss), net of taxes

     (1,043     247   

Accumulated deficit

     (332,437     (293,712
  

 

 

   

 

 

 

Total shareholders’ equity

     366,817        354,215   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 821,495      $ 793,574   
  

 

 

   

 

 

 


CEPHEID

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Nine Months Ended  
     September 30,  
     2015     2014  

Cash flows from operating activities:

    

Net loss

   $ (38,725   $ (26,381

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

    

Depreciation and amortization of property and equipment

     20,170        15,877   

Amortization of intangible assets

     4,814        2,775   

Unrealized foreign exchange differences

     2,242        1,107   

Amortization of debt discount and transaction costs

     7,627        6,147   

Impairment of acquired intangible assets, licenses, property and equipment

     224        —     

Stock-based compensation expense

     25,752        24,655   

Excess tax benefits from stock-based compensation expense

     (53     —     

Loss on the disposal of property, equipment and intangible assets

     56        —     

Other non-cash items

     198        —     

Changes in operating assets and liabilities:

    

Accounts receivable

     8,426        (3,568

Inventory, net

     (11,733     (25,223

Prepaid expenses and other current assets

     (9,691     (5,544

Other non-current assets

     (801     (22

Accounts payable and other current and non-current liabilities

     12,297        6,070   

Accrued compensation

     (511     5,940   

Deferred revenue

     (795     3,010   
  

 

 

   

 

 

 

Net cash provided by operating activities

     19,497        4,843   

Cash flows from investing activities:

    

Capital expenditures

     (29,087     (37,323

Cost of acquisitions, net

     (3,000     —     

Proceeds from sale of equipment and an intangible asset

     834        —     

Proceeds from sales of marketable securities and investments

     49,173        77,038   

Proceeds from maturities of marketable securities and investments

     175,272        66,148   

Purchases of marketable securities and investments

     (198,701     (381,632

Transfer from restricted cash

     1,792        —     
  

 

 

   

 

 

 

Net cash used in investing activities

     (3,717     (275,769

Cash flows from financing activities:

    

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

     26,444        30,137   

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

     (121     (139
  

 

 

   

 

 

 

Net cash provided by financing activities

     26,376        340,705   

Effect of foreign exchange rate change on cash and cash equivalents

     (2,332     (1,175
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     39,824        68,604   

Cash and cash equivalents at beginning of period

     96,663        66,072   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 136,487      $ 134,676   
  

 

 

   

 

 

 


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2015     2014     2015     2014  

Cost of sales

   $ 67,681      $ 56,791      $ 198,259      $ 169,442   

Stock-based compensation expense

     (1,129     (1,437     (3,177     (3,291

Amortization of purchased intangible assets

     (829     (223     (2,877     (669
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of cost of sales

   $ 65,723      $ 55,131      $ 192,205      $ 165,482   

Gross margin on revenue per GAAP

     46     51     49     50

Gross margin on revenue per Non-GAAP

     48     52     51     51

Operating expenses

   $ 76,974      $ 60,523      $ 215,060      $ 181,228   

Stock-based compensation expense

     (8,846     (7,288     (22,625     (21,364

Amortization of purchased intangible assets

     (383     (435     (1,149     (1,296
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of operating expenses

   $ 67,745      $ 52,800      $ 191,286      $ 158,568   

Loss from operations

   $ (19,476   $ (3,396   $ (25,621   $ (15,282

Stock-based compensation expense

     9,975        8,725        25,802        24,655   

Amortization of purchased intangible assets

     1,212        658        4,026        1,965   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of loss from operations

   $ (8,289   $ 5,987      $ 4,207      $ 11,338   

Net loss

   $ (22,901   $ (7,235   $ (38,725   $ (26,381

Stock-based compensation expense

     9,975        8,725        25,802        24,655   

Amortization of debt discount and transaction cost

     2,583        2,505        7,627        6,147   

Amortization of purchased intangible assets

     1,212        658        4,026        1,965   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP measure of net loss

   $ (9,131   $ 4,653      $ (1,270   $ 6,386   

Basic net loss per share

   $ (0.32   $ (0.10   $ (0.54   $ (0.38

Stock-based compensation expense

     0.14        0.12        0.36        0.35   

Amortization of debt discount and transaction cost

     0.03        0.04        0.10        0.09   

Amortization of purchased intangible assets

     0.02        0.01        0.06        0.03   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ (0.13   $ 0.07      $ (0.02   $ 0.09   

Diluted net loss per share

   $ (0.32   $ (0.10   $ (0.54   $ (0.38

Stock-based compensation expense

     0.14        0.12        0.36        0.35   

Amortization of debt discount and transaction cost

     0.03        0.03        0.10        0.09   

Amortization of purchased intangible assets

     0.02        0.01        0.06        0.03   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ (0.13   $ 0.06      $ (0.02   $ 0.09   

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

     72,199        70,326        71,777        69,859   

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

     72,199        72,672        71,777        72,689