NxStage Reports Third Quarter 2013 Financial Results

NXTM

-- Revenue Increases to $66.9 million, up 9% from Q3'12 -- Home Revenue Increases to $33.7 million -- Company Announces Regulatory Approval for Nx2me Connected Health Solution -- Company Updates Full-Year Guidance for 2013

LAWRENCE, Mass., Nov. 7, 2013 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today reported third quarter financial results with total revenue within its guidance range.

(Logo: http://photos.prnewswire.com/prnh/20110503/MM94799LOGO)

Revenue for the third quarter of 2013 increased 9% to a record $66.9 million, compared with revenue of $61.2 million for the third quarter of 2012.  The higher revenues were driven by increased adoption of the NxStage® System One™.

Home revenue increased 5.5% to $33.7 million for the third quarter of 2013 compared with revenue of $31.9 million for the third quarter of 2012.  The Company's domestic home revenue for the third quarter of 2013 increased 8.1% over the prior year period, driving all of Home's annual and sequential growth, and offsetting lower international revenue compared with the prior year. 

Critical Care revenue increased to $10.7 million for the third quarter of 2013 compared with revenue of $9.1 million for the third quarter of 2012. In-center revenue increased to $21.3 million for the third quarter of 2013 compared with revenue of $19.6 million for the third quarter of 2012. 

NxStage reported a net loss of $5.0 million, or $(0.08) per share for the third quarter of 2013 compared with a net loss of $2.6 million, or $(0.04) per share for the third quarter of 2012. 

"We continue to make solid progress in strategic areas that are focused on accelerating growth over the longer term," stated Jeffrey H. Burbank, Founder and Chief Executive Officer of NxStage. "We're seeing good momentum in the domestic market and believe our growth opportunity here remains very robust. In addition to our direct to patient marketing initiatives, we have a significant opportunity to improve our patients' experiences and increase adoption of our therapies with both our innovative product pipeline and our centers of excellence. These initiatives remain solidly on track and we believe they are positioning the Company toward our goal of 15% annual home revenue growth in 2014 and beyond."

Separately, the Company announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Nx2me Connected Health solution. Nx2me Connected Health provides new features and capabilities that are important to home dialysis patients and nurses, including tools that automate a significant part of flow sheet administrative paperwork. With this clearance, the Company expects to begin offering Nx2me in the US later this year.

Guidance:

For the fourth quarter of 2013, the Company is forecasting revenues to be between $67.0 million and $68.5 million, and a net loss in the range of $6.0 to $5.0 million, or ($0.10) to ($0.08) per share.

This translates to full-year 2013 revenue to be within a range of $261.0 to $262.5 million and a net loss in the range of $19.5 to $18.5 million, or ($0.32) to ($0.31) per share, compared with the Company's  previous guidance for full-year 2013 revenue to be a range of $265 to $270 million and a net loss in the range of $17 to $13 million, or ($0.28) to ($0.22) per share. The Company's revised net loss for the full-year 2013 includes continued investment in the Company's strategic growth initiatives, including centers of excellence.

The components of the Company's revised full-year 2013 revenue guidance include Home at 6.5% to 7.5%, Critical Care at approximately 10%, and In-Center at 6% to 7% annual growth. The Company's guidance for $4 million in sales to Asahi remains unchanged for the full-year 2013.

"The net change to our year end revenue guidance reflects a longer ramp of international revenue growth and lower growth in critical care disposable sales compared with our earlier projections," stated Matthew W. Towse, Chief Financial Officer. "We remain committed to the investments that we believe will drive growth in 2014 and beyond."

Conference Call:

NxStage will also host a conference call today, Thursday, November 7, 2013 at 9:00 a.m. Eastern Time to discuss its third quarter financial results.  To listen to the conference call, please dial 877-392-9886 (domestic) or 707-287-9329 (international).  The call will also be webcast LIVE and can be accessed via the investor relations section of the Company's website at www.nxstage.com.

A replay of the conference call will be available 2 hours after the completion of the call through November 15, 2013.  To access the replay, dial 855-859-2056 (domestic) or 404-537-3406 (international) and reference conference ID 76263079.  An online archive of the conference call can be accessed via the investor relations section of the Company's website at www.nxstage.com.

About the NxStage System One

The NxStage System One is the first and only truly portable hemodialysis system cleared for home use by the FDA. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage Pureflow™ SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, at home or on vacation, and at a medically appropriate treatment frequency. http://www.nxstage.com/.

About NxStage

NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.

Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Examples of these forward-looking statements include statements as to the anticipated demand for the Company's products, anticipated operating results, including revenues, loss, gross margin, and other expectations as to future operating results. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond NxStage's control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance or achievements, including market acceptance and demand for NxStage's products domestically and internationally, growth in home and/or more frequent hemodialysis, unanticipated difficulties in achieving operational efficiencies and cost reductions, changes in reimbursement for home and more frequent hemodialysis, changes in the regulatory environment, changes in the historical purchasing patterns and preferences of our customers, including DaVita Healthcare Partners Inc. and Fresenius Medical Care, including in response to NxStage's new centers of excellence initiative, and certain other factors that may affect future operating results and which are detailed in NxStage's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013.

In addition, the statements in this press release represent NxStage's expectations and beliefs as of the date of this press release. NxStage anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while NxStage may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events, or otherwise. These forward-looking statements should not be relied upon as representing NxStage's expectations or beliefs as of any date subsequent to the date of this press release.

Contact:
Kristen K. Sheppard, Esq.
VP, Investor Relations
ksheppard@nxstage.com 

Non-GAAP Financial Measure

The Company discloses a certain non-GAAP financial measure to supplement the Company's consolidated financial statements presented on a GAAP basis. This non-GAAP measure is not in accordance with, or an alternative for, generally accepted accounting principles in the United States and may be different from similar non-GAAP financial measures used by other companies. The non-GAAP financial measure disclosed by the Company is not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. Management uses Adjusted EBITDA (EBITDA adjusted for stock based-compensation, deferred revenue recognized, manufacturing transition costs and other non-cash expenses) to understand operational cash usage.  The Company believes the non-GAAP financial measure provides useful and supplementary information allowing investors greater transparency to one measure used by management.  The non-GAAP financial measure is meant to supplement, and to be viewed in conjunction with, GAAP financial measures.  The non-GAAP financial measure is reconciled to the most comparable GAAP financial measure below.

NxStage Medical, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands, except per share data)

(unaudited)



Three Months Ended

September 30,


Nine Months Ended

September 30,


2013


2012


2013


2012









Revenues

$

66,873



$

61,152



$

193,979



$

177,112


Cost of revenues

41,345



37,404



119,364



109,663


Gross profit

25,528



23,748



74,615



67,449


Operating expenses:








Selling and marketing

12,374



10,168



34,786



30,006


Research and development

4,450



4,274



13,924



12,421


Distribution

5,326



4,731



15,271



13,845


General and administrative

7,791



6,921



23,854



20,473


Total operating expenses

29,941



26,094



87,835



76,745


Loss from operations

(4,413)



(2,346)



(13,220)



(9,296)


Other expense:








Interest expense

(162)



(26)



(462)



(2,675)


Other (expense) income, net

(142)



13



(328)



(118)



(304)



(13)



(790)



(2,793)


Net loss before income taxes

(4,717)



(2,359)



(14,010)



(12,089)


Provision for (benefit from) income taxes

269



223



(625)



700


Net loss

$

(4,986)



$

(2,582)



$

(13,385)



$

(12,789)


Net loss per share, basic and diluted

$

(0.08)



$

(0.04)



$

(0.22)



$

(0.22)


Weighted-average shares outstanding, basic and diluted

60,675



58,945



60,029



57,482










Other comprehensive income (loss)

257



711



(302)



587


Total comprehensive loss

$

(4,729)



$

(1,871)



$

(13,687)



$

(12,202)


 

 

NxStage Medical, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share data)

(unaudited)



September 30,


December 31,


2013


2012





ASSETS




Current assets:




Cash and cash equivalents

$

83,159



$

106,439


Accounts receivable, net

22,523



18,990


Inventory

37,097



33,504


Prepaid expenses and other current assets

5,024



2,534


Total current assets

147,803



161,467


Property and equipment, net

47,106



36,320


Field equipment, net

13,670



10,101


Deferred cost of revenues

33,692



38,028


Intangible assets, net

17,894



19,819


Goodwill

42,329



42,421


Other assets

2,108



3,793


Total assets

$

304,602



$

311,949


LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable

$

16,798



$

16,645


Accrued expenses

18,160



20,400


Other current liabilities

2,516



2,187


Total current liabilities

37,474



39,232


Deferred revenues

52,361



59,262


Other long-term liabilities

19,676



15,864


Total liabilities

109,511



114,358


Commitments and contingencies




Stockholders' equity:




Undesignated preferred stock: par value $0.001, 5,000,000 shares authorized;  no

shares issued and outstanding as of September 30, 2013 and December 31, 2012




Common stock: par value $0.001, 100,000,000 shares authorized; 61,333,363 and

59,850,117 shares issued as of September 30, 2013 and December 31, 2012,

respectively

61



59


Additional paid-in capital

563,191



551,594


Accumulated deficit

(358,366)



(344,981)


Accumulated other comprehensive income

168



470


Treasury stock, at cost: 575,895 and 541,584 shares as of September 30, 2013

and December 31, 2012, respectively

(9,963)



(9,551)


Total stockholders' equity

195,091



197,591


Total liabilities and stockholders' equity

$

304,602



$

311,949


 

 

NxStage Medical, Inc.

Cash Flows from Operating Activities

(in thousands)

(unaudited)



Nine Months Ended September 30,


2013


2012





Cash flows from operating activities:




Net loss

$

(13,385)



$

(12,789)


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




Depreciation and amortization

18,430



17,495


Stock-based compensation

7,830



9,213


Other

2,251



3,047


Changes in operating assets and liabilities:




Accounts receivable

(3,473)



(3,753)


Inventory

(14,498)



(11,638)


Prepaid expenses and other assets

(2,549)



(384)


Accounts payable

49



(863)


Accrued expenses and other liabilities

(3,847)



3,691


Deferred revenues

(5,707)



(3,449)


Net cash (used in) provided by operating activities

$

(14,899)



$

570


 

 

NxStage Medical, Inc.

Revenues by Segment

(in thousands)

(unaudited)



Three Months Ended

September 30,


Nine Months Ended

September 30,


2013


2012


2013


2012

System One segment








Home

$

33,666



$

31,925



$

97,796



$

92,171


Critical Care

10,671



9,099



32,207



28,257


Total System One segment

44,337



41,024



130,003



120,428


In-Center segment

21,269



19,637



61,207



55,477


Other

1,267



491



2,769



1,207


Total

$

66,873



$

61,152



$

193,979



$

177,112


 

 

NxStage Medical, Inc.

Non-GAAP Financial Measures

(in millions)

(unaudited)



Three Months Ended

September 30,


Nine Months Ended

September 30,


2013


2012


2013


2012









Net loss

$

(5.0)



$

(2.6)



$

(13.4)



$

(12.8)


Less: Depreciation, amortization, interest, and taxes

6.7



6.2



18.6



21.0


Less: Adjusting items*

(1.8)



(1.2)



(4.4)



(2.3)










Adjusted EBITDA

$

(0.1)



$

2.4



$

0.8



$

5.9










* Adjusting items include stock-based compensation, deferred revenue recognized, manufacturing transition costs and other non-cash expenses

 

SOURCE NxStage Medical, Inc.


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