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Xpert Xpress SARS-CoV-2 Test

News Releases

Cepheid Reports Fourth Quarter And Full Year 2014 Results
Fourth Quarter Commercial Clinical Up 26% Driven by 29% Growth in Xpert® Reagents

SUNNYVALE, Calif. , Jan. 29, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the fourth quarter of 2014 of $131.5 million.  Net loss was $23.8 million, or $(0.34) per share, which compares to revenue of $113.3 million and net loss of $10.3 million, or $(0.15) per share, in the fourth quarter of 2013.  2014 fourth quarter net loss included a legal contingency charge of $20 million, or $(0.28) per share.

Excluding stock compensation expenses, a legal contingency charge, amortization of debt discount and transaction costs, and amortization of purchased intangible assets, non-GAAP net income for the fourth quarter of 2014 was $7.8 million, or $0.11 per share.  This compares to non-GAAP net income of $2.3 million, or $0.03 per share, for the fourth quarter of 2013, which excluded stock compensation expenses, a restructuring charge (including impairment of certain assets), and amortization of purchased intangible assets.

Fiscal 2014 Overview

For the year ended December 31, 2014, Cepheid reported revenue of $470.1 million which compares to revenue of $401.3 million in 2013.  Net loss for the year was $50.1 million, or $(0.72) per share, which compares to net loss of $18.0 million, or $(0.27) per share, in 2013.  2014 full year net loss included a legal contingency charge of $20 million, or $(0.29) per share.

Excluding stock compensation expenses, a legal contingency charge, amortization of debt discount and transaction costs, and amortization of purchased intangible assets, non-GAAP net income for the full year 2014 was $14.2 million, or $0.19 per share.  This compares to a non-GAAP net income of $17.9 million, or $0.26 per share, for the full year 2013, which excluded stock compensation expenses, a restructuring charge (including impairment of certain assets), and amortization of purchased intangible assets.

"2014 was a very strong year for Cepheid, marked by record revenue, record GeneXpert® System placements, and a record number of additions to our Xpert test menu, in addition to solid progress in further improving our gross margin," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "While we are targeting Commercial Clinical growth of 20% or higher in 2015, we continue to invest strategically and aggressively in further test menu expansion, geographic expansion, and market segment expansion, which we believe sets the stage for a prolonged period of growth ahead for Cepheid."

Operational Overview

  • Fourth quarter of 2014 total Clinical sales of $122.2 million grew 21% from $101.0 million in the fourth quarter of 2013. For the year ended December 31, 2014, total Clinical sales of $441.1 million grew 23% from $359.9 million in 2013.
  • By industry, sales were, in millions:

 


Three Months Ended December 31,


Full Year Ended December 31,


2014


2013


Change


2014


2013


Change













Clinical Systems

$                 22.1


$                 20.2


9%


$                 84.7


$                 67.0


26%

Clinical Reagents

100.1


80.8


24%


356.4


292.9


22%

    Total Clinical 

122.2


101.0


21%


441.1


359.9


23%

Non-Clinical

9.3


12.3


-24%


29.0


41.4


-30%

Total Sales

$               131.5


$               113.3


16%


$               470.1


$               401.3


17%

 

  • By geography, sales were, in millions:

 


Three Months Ended December 31,


Full Year Ended December 31,


2014


2013


Change


2014


2013


Change

North America












     Clinical

$                 71.2


$                 58.6


21%


$               247.1


$               212.4


16%

     Other

8.5


11.1


-23%


24.9


37.0


-33%

Total North America

79.7


69.7


14%


272.0


249.4


9%













International












     Clinical

51.0


42.4


20%


194.0


147.5


31%

     Other

0.8


1.2


-33%


4.1


4.4


-6%

Total International

51.8


43.6


19%


198.1


151.9


30%













Total Sales

$               131.5


$               113.3


16%


$               470.1


$               401.3


17%

 

  • Commercial Clinical sales were $104.8 million in the fourth quarter of 2014 and $356.0 million for the full year 2014. Sales to High Burden Developing Countries (HBDC) in the fourth quarter of 2014 were $17.4 million and $85.1 million for the full year 2014.
  • During the fourth quarter of 2014, Cepheid placed a total of 261 GeneXpert systems in its commercial Clinical business. Additionally, Cepheid placed a total of 211 GeneXpert systems as part of its High Burden Developing Country (HBDC) program. For the year ended December 31, 2014, Cepheid placed a total of 773 GeneXpert systems in its commercial Clinical business and an additional 1,743 GeneXpert systems as part of its HBDC program. As of December 31, 2014, a cumulative total of 8,025 GeneXpert systems have been placed worldwide.
  • GAAP gross margin on sales was 54% and non-GAAP gross margin on sales was 56% in the fourth quarter of 2014, which compares to 47% and 50%, respectively, in the fourth quarter of 2013. GAAP gross margin on sales was 51% and non-GAAP gross margin on sales was 52% for the full year 2014, which compares to 48% and 50%, respectively, for the full year 2013.
  • Cash, cash equivalents and investments were $373.1 million as of December 31, 2014.
  • DSO was 48 days.

Business Outlook

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

  • Total revenue to be in the range of $538 to $553 million;
  • Net loss in the range of $(0.55) to $(0.51) per share;
  • Non-GAAP net income in the range of $0.19 to $0.23 per share.

Expected non-GAAP net income excludes approximately $37 million related to stock 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:

 



Guidance Range for Year



Ending December 31, 2015



Low 


High

Net Income (Loss) Per Share


$       (0.55)


$       (0.51)

   Stock-Based Compensation Expense


0.52


0.52

   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


$         0.19


$         0.23

 

Accessing Cepheid's Fourth Quarter and Full Year 2014 Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, January 29, 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.

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 stock-based compensation expense, a legal contingency charge, amortization of purchased intangible assets, amortization of debt discount and transaction costs, and a restructuring charge in the quarter ended December 31, 2013.   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.

Legal Contingency. In the fourth quarter of 2014, the Company recorded a charge for an estimated loss related to ongoing legal proceedings.  The Company excluded this item as it believes it is not reflective of ongoing operating results in the period incurred.

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.

Restructuring .  The Company excluded a restructuring charge and impairment of certain assets totaling $4.4 million in the fourth quarter of 2013.   In connection with the Company's preparation of its annual operating plan, whereby the Company routinely assesses its investments to align its operations with its highest potential opportunities, the Company terminated a small international research team, eliminated a non-GeneXpert clinical product line acquired in a 2007 acquisition, including the impairment of an intangible asset of approximately $1.1 million and the write-down of approximately $0.3 million of inventory, and wrote-off certain manufacturing capital assets totaling approximately $1.3 million that management concluded will not be utilized and therefore have no future realizable value.  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 the scale and sustainability of future growth, future revenues and future net loss/income and profitability, including on a non-GAAP basis, strategic investments, 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: 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 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; 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
December 31,


Years Ended
December 31,


2014


2013


2014


2013









Revenues:








System and other sales

$       24,177


$       22,263


$     90,849


$     76,763

Reagent and disposable sales

107,345


90,998


379,292


324,529

Total sales

131,522


113,261


470,141


401,292

Costs and operating expenses:








Cost of sales

59,885


60,483


229,327


207,933

Collaboration profit sharing 

1,923


2,567


5,154


7,512

Research and development

27,572


25,340


96,851


80,197

Sales and marketing

26,975


21,922


97,848


79,941

General and administrative

13,971


12,854


55,047


41,719

Legal contingencies and settlements

20,000


-


20,000


-

Total costs and operating expenses 

150,326


123,166


504,227


417,302

Loss from operations

(18,804)


(9,905)


(34,086)


(16,010)

Other expense, net

(4,272)


(264)


(13,506)


(807)

Loss before income taxes

(23,076)


(10,169)


(47,592)


(16,817)

Provision for income taxes

(692)


(148)


(2,557)


(1,148)

Net loss

$     (23,768)


$     (10,317)


$    (50,149)


$   (17,965)









Basic net loss per share 

$         (0.34)


$         (0.15)


$        (0.72)


$       (0.27)









Diluted net loss per share 

$         (0.34)


$         (0.15)


$        (0.72)


$       (0.27)









Shares used in computing basic net loss per share 

70,689


68,230


70,069


67,485









Shares used in computing diluted net loss per share 

70,689


68,230


70,069


67,485

 

CEPHEID


CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 (unaudited)




December 31,
2014


December 31,
2013





ASSETS




Current assets:




Cash and cash equivalents

$             96,663


$            66,072

Short-term investments

196,729


8,837

Accounts receivable, net

68,809


52,202

Inventory

132,635


103,866

Prepaid expenses and other current assets 

24,274


13,037

Total current assets

519,110


244,014

Property and equipment, net

115,765


84,886

Investments

79,731


9,820

Other non-current assets

7,847


958

Intangible assets, net

31,440


15,245

Goodwill

39,681


39,681

Total assets

$           793,574


$          394,604





LIABILITIES AND SHAREHOLDERS' EQUITY




Current liabilities:




Accounts payable 

$             50,435


$            52,609

Accrued compensation 

33,760


22,009

Accrued royalties 

5,443


5,245

Accrued and other liabilities 

34,761


7,440

Current portion of deferred revenue

13,447


8,183

Total current liabilities 

137,846


95,486

Long-term portion of deferred revenue

4,532


3,424

Convertible senior notes, net

278,213


-

Other liabilities

18,768


10,454

Total liabilities

439,359


109,364

Shareholders' equity:




Common stock

422,151


383,379

Additional paid-in capital 

225,529


145,900

Accumulated other comprehensive income (loss)

247


(476)

Accumulated deficit 

(293,712)


(243,563)

Total shareholders' equity 

354,215


285,240

Total liabilities and shareholders' equity 

$           793,574


$          394,604

 

CEPHEID


CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 (unaudited)


Years Ended December 31,


2014


2013

Cash flows from operating activities:




Net loss

$      (50,149)


$      (17,965)

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




Depreciation and amortization of property and equipment

21,604


17,769

Amortization of intangible assets 

4,739


5,418

Unrealized foreign exchange differences

1,836


419

Amortization of debt discount and transaction costs

8,600


-

Impairment of acquired intangible assets,  licenses, property and equipment

-


2,855

Stock-based compensation expense

32,207


27,635

Excess tax benefits from stock-based compensation

(66)



Changes in operating assets and liabilities:




Accounts receivable 

(16,606)


(6,960)

Inventory 

(29,346)


(32,638)

Prepaid expenses and other current assets 

(5,184)


(5,263)

Other non-current assets

(2)


150

Accounts payable and other current and non-current liabilities

3,438


17,334

Accrued expense for estimated legal contingency

20,000


-

Accrued compensation 

11,751


5,421

Deferred revenue 

6,372


837

Net cash provided by operating activities 

9,194


15,012





Cash flows from investing activities:




Capital expenditures 

(46,979)


(47,526)

Payments for technology licenses 

-


(1,125)

Cost of acquisitions, net

(18,000)


(3,669)

Proceeds from sales of marketable securities and investments

115,881


2,503

Proceeds from maturities of marketable securities and investments

102,733


1,347

Purchases of marketable securities and investments

(477,485)


(22,511)

Transfer to restricted cash

(1,875)


-

Net cash used in investing activities 

(325,725)


(70,981)





Cash flows from financing activities:




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

38,615


27,512

Excess tax benefits from stock-based compensation

66


-

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

335,789


-

Purchase of convertible note capped call hedge

(25,082)


-

Principal payments of notes payable

(180)


(874)

Net cash provided by financing activities 

349,208


26,638





Effect of foreign exchange rate change on cash and cash equivalents

(2,086)


(376)

Net increase (decrease) in cash and cash equivalents 

30,591


(29,707)

Cash and cash equivalents at beginning of period 

66,072


95,779

Cash and cash equivalents at end of period

$        96,663


$        66,072

 

CEPHEID


RECONCILIATION OF GAAP TO NON-GAAP MEASURES

(in thousands, except per share data)

(unaudited)






Three Months Ended
December 31,


Years Ended
December 31,












2014


2013


2014


2013

Cost of sales




$       59,885


$         60,483


$       229,327


$      207,933

  Stock-based compensation expense


(796)


(1,084)


(4,087)


(2,927)

  Restructuring charge including impairment of intangibles


-


(2,651)


-


(2,651)

  Amortization of purchased intangible assets


(1,157)


(345)


(1,826)


(2,349)

Non-GAAP measure of cost of sales


$       57,932


$         56,403


$       223,414


$      200,006













Gross margin on sales per GAAP



54%


47%


51%


48%

Gross margin on sales per Non-GAAP


56%


50%


52%


50%













Operating expenses




$       88,518


$         60,116


$       269,746


$      201,857

  Stock-based compensation expense


(6,756)


(6,534)


(28,120)


(24,708)

   Restructuring charge including impairment of intangibles


-


(1,783)


-


(1,783)

   Legal contingencies and settlements


(20,000)


-


(20,000)


-

  Amortization of purchased intangible assets


(435)


(458)


(1,731)


(1,715)

Non-GAAP measure of operating expenses


$       61,327


$         51,341


$       219,895


$      173,651













Loss from operations




$     (18,804)


$         (9,905)


$       (34,086)


$      (16,010)

  Stock-based compensation expense


7,552


7,618


32,207


27,635

   Restructuring charge including impairment of intangibles


-


4,434


-


4,434

   Legal contingencies and settlements


20,000


-


20,000


-

  Amortization of purchased intangible assets


1,592


803


3,557


4,064

Non-GAAP measure of income from operations


$       10,340


$           2,950


$         21,678


$        20,123













Net loss





$     (23,768)


$       (10,317)


$       (50,149)


$      (17,965)

  Stock-based compensation expense


7,552


7,618


32,207


27,635

   Restructuring charge including impairment of intangibles


-


4,201


-


4,201

   Legal contingencies and settlements


20,000


-


20,000


-

  Amortization of debt discount and transaction cost


2,453


-


8,600


-

  Amortization of purchased intangible assets


1,592


803


3,557


4,064

Non-GAAP measure of net income



$         7,829


$           2,305


$         14,215


$        17,935













Basic net loss per share



$         (0.34)


$           (0.15)


$           (0.72)


$          (0.27)

  Stock-based compensation expense


0.11


0.11


0.46


0.41

   Restructuring charge including impairment of intangibles


-


0.06


-


0.07

   Legal contingencies and settlements


0.28


-


0.29


-

  Amortization of debt discount and transaction cost


0.04


-


0.12


-

  Amortization of purchased intangible assets


0.02


0.01


0.05


0.06

Non-GAAP measure of net income per share


$           0.11


$             0.03


$             0.20


$            0.27













Diluted net loss per share



$         (0.34)


$           (0.15)


$           (0.72)


$          (0.27)

  Stock-based compensation expense


0.11


0.11


0.45


0.41

   Restructuring charge including impairment of intangibles


-


0.06


-


0.06

   Legal contingencies and settlements


0.28


-


0.28


-

  Amortization of debt discount and transaction cost


0.04


-


0.13


-

  Amortization of purchased intangible assets


0.02


0.01


0.05


0.06

Non-GAAP measure of net income per share


$           0.11


$             0.03


$             0.19


$            0.26













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

70,689


68,230


70,069


67,485













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

73,469


70,644


72,901


69,928

 

CONTACTS:


For Media Inquiries:

For Investor Inquiries:



Jared Tipton

Jacquie Ross, CFA

Cepheid Corporate Communications

Cepheid Investor Relations

Tel: (408) 400 8377

Tel: (408) 400 8329

communications@cepheid.com

investor.relations@cepheid.com

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cepheid-reports-fourth-quarter-and-full-year-2014-results-300027917.html

SOURCE Cepheid

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