Cepheid Reports 2014 First Quarter Results Strong Commercial and HBDC Drive Clinical Growth of 26%

SUNNYVALE, Calif., April 17, 2014 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today reported revenues for the first quarter of 2014 of $106.9 million, representing growth of 16% from $91.9 million for the first quarter of 2013.  Net loss in the first quarter of 2014 was $(9.3) million, or $(0.13) per share, which compares to net income of $0.3 million, or $0.00 per share, in the first quarter of 2013. 

Excluding employee stock-based compensation, amortization of debt discount and debt issuance costs, and amortization of purchased intangible assets, non-GAAP net loss for the first quarter of 2014 was $(0.6) million, or $(0.01) per share.  This compares to non-GAAP net income of $7.8 million, or $0.11 per share, in the first quarter of 2013.

"We placed an additional 503 GeneXpert systems globally in the first quarter of 2014, contributing to 26% growth in our clinical business, and bringing our cumulative installed base to more than 6,000," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "Growing adoption of our broad menu of 14 Xpert tests drove Commercial Clinical Xpert reagent growth of 20% in the first quarter.  With the recent additions of Xpert HPV and Xpert Norovirus to our test menu outside the US, we are entering a prolific, global product cycle that will further extend the portfolio of accurate, fast and easy-to-use molecular diagnostics available to our customers." 

Operational Overview

  • Total sales were, in millions:

Three Months Ended March 31,


2014


2013


Change







Clinical Systems

$    17.3


$  12.5


38%

Clinical Reagents

83.1


67.1


24%

    Total Clinical 

100.4


79.6


26%







Non-Clinical & Other

6.5


12.3


-47%

Total Sales

$  106.9


$  91.9


16%

  • By geography, total sales were, in millions:

Three Months Ended March 31,


2014


2013


Change

North America






     Clinical

$    57.3


$  52.2


10%

     Non-Clinical & Other

5.5


11.4


-52%

Total North America

62.8


63.6


-1%







International






     Clinical

43.2


27.4


58%

     Non-Clinical & Other

0.9


0.9


0%

Total International

44.1


28.3


56%







Total Sales

$  106.9


$  91.9


16%

  • During the quarter, Cepheid installed a total of 181 GeneXpert systems in its commercial Clinical business. Additionally, the Company placed a total of 322 GeneXpert systems as part of its High Burden Developing Country (HBDC) program. Including the HBDC systems, a cumulative total of 6,012 GeneXpert systems have been placed worldwide as of March 31, 2014.
  • GAAP gross margin on sales was 50% and non-GAAP gross margin on sales was 51%, which compares to 53% and 55%, respectively, in the first quarter of 2013.
  • Cash, cash equivalents and investments were $391.3 million as of March 31, 2014.
  • DSO was 48 days.

Business Outlook

Reflecting the issuance of the Convertible Senior Notes in February 2014, the Company has updated it's guidance for the fiscal year ending December 31, 2014.  The Company expects:

  • Total revenue in the range of $446 to $461 million;
  • Net loss in a range from $(0.43) to $(0.38) per share; and
  • Non-GAAP net income in the range of $0.19 to $0.24 per share.

Expected non-GAAP net income excludes approximately $33 million related to stock compensation expense, approximately $9 million related to the amortization of debt discount and debt issuance costs, and approximately $3 million related to the amortization of acquired intangibles.  The fully diluted share count for the year is expected to be approximately 70 million, except in the event we have non-GAAP net income, in which case the share count would be approximately 73 million shares.

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



Guidance Range for Year



Ending December 31, 2014



Low 


High

Net Loss Per Share


$ (0.43)


$ (0.38)

   Stock Compensation Expense


0.46


0.46

   Amortization of Debt Discount and Debt Issuance Costs


0.12


0.12

   Amortization of Purchased Intangible Assets


0.04


0.04

Non-GAAP Measure of Net Income Per Share


$   0.19


$   0.24

 

Accessing Cepheid's 2014 First Quarter Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, April 17, 2014, to discuss the results.  To access the live webcast, please visit Cepheid's website at http://ir.cepheid.com at least 15 minutes before the scheduled start time to download any necessary audio or plug-in software.  A replay of the webcast will be available shortly following the call and will remain available for at least 90 days.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.  By automating highly complex and time-consuming manual procedures, the Company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases.  Through its strong molecular biology capabilities, the Company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

Use of Non-GAAP Measures

The Company has supplemented its reported GAAP financial information with non-GAAP measures that do not include employee stock-based compensation expense, amortization of purchased intangible assets and amortization of debt discount and debt issuance 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:

Employee Stock-based Compensation Expense. These expenses consist primarily of expenses for employee stock options and employee restricted stock under ASC 718 (formerly SFAS 123(R)).  The Company excludes employee stock-based compensation expenses from its non-GAAP measures primarily because they are non-cash expenses that the Company does not believe are reflective of ongoing operating results in the period incurred.  Further, as the Company applies ASC 718, it believes that it is useful to investors to understand the impact of the application of ASC 718 on its results of operations.

Amortization of Debt Discount and Debt Issuance Costs.  The Company incurs amortization of debt discount and debt issuance costs in connection with the issuance of Convertible Senior Notes 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 potential growth, future revenues and future net loss/income and profitability, including on a non-GAAP basis, test menu expansion and utilization, consistency of product availability and delivery, sales organization productivity, improving gross margins, execution of manufacturing operations, product sales under the High Burden Developing Country (HBDC) program, commercial test and commercial system sales and resolution of manufacturing scale-up issues. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: our ability to successfully complete and bring on line additional manufacturing lines; our ability to manage our inventory levels; long sales cycles and variability in systems placements and reagent pull-through in the Company's HBDC program; our success in increasing commercial and HBDC sales and the effectiveness of our sales personnel; the performance and market acceptance of new products; sufficient customer demand, customer confidence in product availability and available customer budgets for our customers; our ability to develop new products and complete clinical trials successfully in a timely manner for new products; uncertainties related to the FDA regulatory and European regulatory processes; the level of testing at clinical customer sites, including for Healthcare Associated Infections (HAIs); the Company's ability to successfully introduce and sell products in clinical markets other than HAIs; the rate of environmental biothreat testing conducted by the USPS, which will affect the amount of consumable products sold to the USPS; other unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; lengthy sales cycles in certain markets; the Company's reliance on distributors in some regions to market, sell and support its products; the occurrence of unforeseen expenditures, acquisitions or other transactions; costs associated with litigation; the impact of competitive products and pricing; the Company's ability to manage geographically-dispersed operations; and underlying market conditions worldwide.  Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.

CONTACTS:


For Media Inquiries:

For Investor Inquiries:

Jared Tipton

Cepheid Corporate Communications

Tel: (408) 400 8377

communications@cepheid.com

Jacquie Ross

Cepheid Investor Relations

Tel: (408) 400 8329

investor.relations@cepheid.com



 

FINANCIAL TABLES FOLLOW  

 

CEPHEID

 

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share data)




Three Months Ended
March 31, 


2014


2013





Sales:




System and other sales

$  18,529


$  16,010

Reagent and disposable sales

88,378


75,928

Total sales

106,907


91,938

Costs and operating expenses:




Cost of sales 

53,083


42,892

Collaboration profit sharing 

1,291


2,110

Research and development

21,740


17,727

Sales and marketing

23,458


19,126

General and administrative

13,667


9,763

Total costs and operating expenses 

113,239


91,618

Income (loss) from operations 

(6,332)


320

Other income (expense), net

(2,291)


374

Income (loss) before income taxes

(8,623)


694

Provision for income taxes

(680)


(381)

Net income (loss)

$   (9,303)


$       313





Basic net income (loss) per share 

$     (0.13)


$      0.00





Diluted net income (loss) per share 

$     (0.13)


$      0.00





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

69,272


66,824





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

69,272


69,406

 

CEPHEID

 

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)






March 31,
2014


December
31, 2013





ASSETS




Current assets:




Cash and cash equivalents

$               136,718


$          66,072

Short-term investments

131,035


8,837

Accounts receivable, net

56,602


52,202

Inventory

119,564


103,866

Prepaid expenses and other current assets 

19,493


13,037

Total current assets

463,412


244,014

Property and equipment, net

96,949


84,886

Investments

123,552


9,820

Other non-current assets

7,633


958

Intangible assets, net

14,326


15,245

Goodwill

39,681


39,681

Total assets

$              745,553


$        394,604





LIABILITIES AND SHAREHOLDERS' EQUITY




Current liabilities:




Accounts payable 

$                60,924


$          52,609

Accrued compensation 

20,413


22,009

Accrued royalties 

3,884


5,245

Accrued and other liabilities 

7,270


7,440

Current portion of deferred revenue

9,978


8,183

Total current liabilities 

102,469


95,486

Long-term portion of deferred revenue

3,708


3,424

Convertible senior notes, net

271,207


-

Other liabilities

15,067


10,454

Total liabilities

392,451


109,364

Shareholders' equity:




Common stock

405,010


383,379

Additional paid-in capital 

201,042


145,900

Accumulated other comprehensive loss

(84)


(476)

Accumulated deficit 

(252,866)


(243,563)

Total shareholders' equity 

353,102


285,240

Total liabilities and shareholders' equity 

$              745,553


$        394,604

   

CEPHEID

 

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(in thousands)




Three Months Ended
March 31, 


2014


2013

Cash flows from operating activities:




Net income (loss)

$     (9,303)


$         313

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




Depreciation and amortization of property and equipment

4,977


3,768

Amortization of intangible assets 

919


1,560

Unrealized exchange differences

(52)


444

Amortization of debt discount and transaction costs

1,257


-

Stock-based compensation related to employees and consulting services rendered

6,782


6,277

Changes in operating assets and liabilities:




Accounts receivable 

(4,400)


(1,047)

Inventory 

(15,270)


(7,814)

Prepaid expenses and other current assets 

(5,842)


(3,528)

Other non-current assets

122


168

Accounts payable and other current and non-current liabilities 

3,470


8,342

Accrued compensation 

(1,595)


(614)

Deferred revenue 

2,079


2,608

Net cash provided by (used in) operating activities 

(16,856)


10,477





Cash flows from investing activities:




Capital expenditures 

(8,762)


(8,929)

Payments for technology licenses 

-


(1,000)

Proceeds from maturities and sales of marketable securities and investments

23,438


-

Purchases of marketable securities and investments

(259,553)


-

Net cash used in investing activities 

(244,877)


(9,929)





Cash flows from financing activities:




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

21,631


6,145

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

335,789


-

Purchase of convertible note hedge ("capped call")

(25,082)


-

Principal payment of notes payable

(48)


(41)

Net cash provided by financing activities 

332,290


6,104





Effect of exchange rate change on cash

89


(443)

Net increase in cash and cash equivalents 

70,646


6,209

Cash and cash equivalents at beginning of period 

66,072


95,779

Cash and cash equivalents at end of period

$  136,718


$  101,988

 

CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)

(in thousands, except per share data)




Three Months Ended
March 31,


2014


2013

Cost of sales

$    53,083


$  42,892

  Stock compensation expense

(381)


(542)

  Amortization of purchased intangible assets

(223)


(854)

Non-GAAP measure of cost of sales

$    52,479


$  41,496





Gross margin on sales per GAAP

50%


53%

Gross margin on sales per Non-GAAP

51%


55%





Operating expenses

$    58,865


$  46,616

  Stock compensation expense

(6,401)


(5,735)

  Amortization of purchased intangible assets

(429)


(374)

Non-GAAP measure of operating expenses

$    52,035


$  40,507





Income (loss) from operations

$    (6,332)


$       320

  Stock compensation expense

6,782


6,277

  Amortization of purchased intangible assets

652


1,228

Non-GAAP measure of income from operations

$      1,102


$    7,825





Net income (loss)

$    (9,303)


$       313

  Stock compensation expense

6,782


6,277

  Amortization of debt discount and debt issuance costs

1,257


-

  Amortization of purchased intangible assets

652


1,228

Non-GAAP measure of net income (loss)

$       (612)


$    7,818





Basic net income (loss) per share

$      (0.13)


$      0.00

  Stock compensation expense

0.09


0.10

  Amortization of debt discount and debt issuance costs

0.02


-

  Amortization of purchased intangible assets

0.01


0.02

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

$      (0.01)


$      0.12





Diluted net income (loss) per share

$      (0.13)


$      0.00

  Stock compensation expense

0.09


0.09

  Amortization of debt discount and debt issuance costs

0.02


-

  Amortization of purchased intangible assets

0.01


0.02

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

$      (0.01)


$      0.11





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

69,272


66,824





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

69,272


69,406

SOURCE Cepheid



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