NxStage® Reports Fourth Quarter and Full-Year 2010 Financial Results; Revenue Growth Exceeds Company Guidance

Thursday February 17, 2011

LAWRENCE, Mass., Feb. 17, 2011 /PRNewswire via COMTEX/ —

NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today reported financial results for the three and twelve months ended December 31, 2010, that includes revenue above the top end of its guidance range.

Net revenue for the twelve months ended December 31, 2010 increased 21 percent to $179.2 million compared with revenue of $148.7 million for the full-year 2009. Revenue for the fourth quarter of 2010 increased 23 percent to a record $49.8 million compared with revenue of $40.5 million for the fourth quarter of 2009. The increase in both periods was driven by the Company’s solid performance in Home and Critical Care, which experienced annual growth of 35 percent and 26 percent, respectively, over 2009.

Home revenue grew to $85.8 million for the full-year 2010 compared with revenue of $63.5 million for the full-year 2009. Home revenue increased to $23.6 million in the fourth quarter of 2010 compared with revenue of $17.5 million in the fourth quarter of 2009, representing a 34 percent increase.

Critical Care revenue grew to $28.1 million for the full-year 2010 compared with revenue of $22.3 million for the full-year 2009. Revenue in Critical Care increased to $8.6 million in the fourth quarter of 2010, compared with revenue of $7.0 million in the fourth quarter of 2009, representing a 23 percent increase.

Annual revenue from the Company’s Medisystems in-center business was $65.4 million for the full-year 2010, compared with revenue of $62.9 million for the full-year 2009. Fourth quarter revenue was $17.6 million, compared with $16.0 million in the fourth quarter of 2009.

2010 was a year of solid revenue growth for NxStage. Our strong fourth quarter results capped a year in which we successfully executed against our strategic initiatives, made significant progress in the Home, and gained momentum across all three markets, stated Jeffrey H. Burbank, Chief Executive Officer of NxStage Medical, Inc.

Burbank continued, We are on a multi-year growth agenda, and I believe that our strategy is right on course. Entering 2011, we have good underlying market fundamentals, a strong balance sheet, a solid operating model, as well as a culture of innovation. We remain confident in our ability to build on our momentum moving forward.

NxStage reported a net loss of $31.7 million or ($0.66) per share for the full-year 2010 compared with a net loss of $43.5 million or ($0.93) per share for the full-year 2009. The Company reported a net loss of $6.3 million or ($0.13) per share for the fourth quarter of 2010 compared with a net loss of $8.7 million or ($0.19) per share for the fourth quarter of 2009.

For the full-year 2010, the Company reported Adjusted EBITDA, adjusted for stock-based compensation, deferred revenue recognized and other non-cash expenses, of $0.5 million, compared with an Adjusted EBITDA loss of $12.7 million for the full-year 2009. For the fourth quarter of 2010, Adjusted EBITDA was $1.5 million compared with an Adjusted EBITDA loss of $1.2 million in the fourth quarter of 2009. (See the exhibits for a reconciliation of this non-GAAP measure.)

Effective January 1, 2011, NxStage adopted Accounting Standards Update (ASU) 2009-13 and ASU 2009-14. Under the new accounting standards, beginning January 1, 2011 revenue from international equipment sales will be recognized upon delivery to distributors rather than ratably over a period of five years. The new accounting standards have been adopted prospectively and therefore, revenue from equipment shipped prior to January 1, 2011 will continue to be recognized ratably.

Guidance:

For the first quarter of 2011, the Company is forecasting revenue to be between $48.0 million and $49.5 million, a net loss in the range of $5.5 to $6.5 million or ($0.10) to ($0.12) per share, and Adjusted EBITDA in the range of $0.5 to $1.5 million.

For the full fiscal year 2011, the Company is forecasting revenue to be between $205 million and $213 million, a net loss in the range of $19 to $23 million or ($0.36) to ($0.43) per share, and Adjusted EBITDA in the range of $6 million to $10 million. The Company expects to achieve consolidated gross margins of between 38 percent to 42 percent in the fourth quarter of 2011.

This release contains a non-GAAP financial measure; a reconciliation of the Company’s non-GAAP financial measure to its most comparable GAAP financial measure is in the exhibits to this press release.

Conference Call:

NxStage will also host a conference call at 9:00 a.m. Eastern Time on Thursday, February 17, 2011 to discuss its fourth quarter and year-end 2010 financial results. To listen to the conference call, please dial 866-804-6927 (domestic) or 857-350-1673 (international). The passcode is 25783380. 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/ir.cfm.

A replay of the conference call will be available 2 hours after the start of the call through February 24, 2011. To access the replay dial 888-286-8010 (domestic) or 617-801-6888 (international) and enter passcode 70668341. An online archive of the conference call can be accessed via the investor relations section of the Company’s website at www.nxstage.com/ir.cfm.

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 revenue, loss, gross margin and Adjusted EBITDA numbers, expectations with respect to market momentum of further product innovation, 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, growth in home and/or daily hemodialysis, unanticipated difficulties in achieving operational efficiencies and cost reductions, changes in reimbursement for home and daily hemodialysis, changes in the regulatory environment, changes in the historical purchasing patterns and preferences of our major customers, including DaVita Inc., 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 period ended September 30, 2010.

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, and other non-cash expenses) to understand cash generated from or used in operations. 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.

Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2010

2009

2010

2009

Revenues

$49,769

$40,510

$179,218

$148,676

Cost of revenues

32,177

29,063

121,091

111,812

Gross profit

17,592

11,447

58,127

36,864

Operating expenses:

Selling and marketing

9,132

7,956

34,166

30,047

Research and development

3,531

2,434

12,900

9,814

Distribution

3,920

3,442

14,751

13,918

General and administrative

6,170

5,020

22,774

19,532

Total operating expenses

22,753

18,852

84,591

73,311

Loss from operations

(5,161)

(7,405)

(26,464)

(36,447)

Other expense:

Interest income

3

3

3

35

Interest expense

(1,165)

(1,020)

(4,597)

(6,522)

Other income (expense), net

242

(288)

114

(268)

(920)

(1,305)

(4,480)

(6,755)

Net loss before income taxes

(6,081)

(8,710)

(30,944)

(43,202)

Provision for income taxes

212

(33)

768

265

Net loss

$ (6,293)

$ (8,677)

$ (31,712)

$ (43,467)

Net loss per share, basic and diluted

$ (0.13)

$ (0.19)

$ (0.66)

$ (0.93)

Weighted-average shares outstanding, basic and diluted

50,233

46,704

48,188

46,627

NxStage Medical, Inc.

Consolidated Balance Sheets

(amount in thousands, except share data)

(unaudited)

December 31,

December 31,

2010

2009

ASSETS

Current assets:

Cash and cash equivalents

$ 104,339

$ 21,720

Accounts receivable, net

14,107

14,238

Inventory

34,950

28,117

Prepaid expenses and other current assets

2,084

1,227

Total current assets

155,480

65,302

Property and equipment, net

8,290

10,336

Field equipment, net

13,660

21,726

Deferred cost of revenues

40,081

27,799

Intangible assets, net

25,412

28,208

Goodwill

42,698

42,698

Other assets

473

909

Total assets

$ 286,094

$ 196,978

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 16,811

$ 19,827

Accrued expenses

19,537

9,377

Current portion of long-term debt

43

61

Total current liabilities

36,391

29,265

Deferred revenues

55,366

38,490

Long-term debt

40,454

37,854

Other long-term liabilities

1,754

1,923

Total liabilities

133,965

107,532

Commitments and contingencies

Stockholders’ equity:

Undesignated preferred stock: par value $0.001, 5,000,000shares authorized; no shares issued and outstanding as of December 31, 2010 and 2009

Common stock: par value $0.001, 100,000,000shares authorized; 54,043,317 shares issued as of December 31, 2010 and 46,795,859shares issued and outstanding as of December 31, 2009

53

47

Additional paid-in capital

465,642

365,548

Accumulated deficit

(308,426)

(276,714)

Accumulated other comprehensive income

85

565

Treasury stock, at cost: 325,104 shares as of December 31, 2010

(5,225)

Total stockholders’ equity

152,129

89,446

Total liabilities and stockholders’ equity

$ 286,094

$ 196,978

NxStage Medical, Inc.

Cash Flows from Operating Activities

(amounts in thousands)

(unaudited)

Twelve Months Ended

December 31,

2010

2009

Cash flows from operating activities:

Net loss

$ (31,712)

$ (43,467)

Adjustments to reconcile net loss to net

cash provided by (used in) operating activities:

Depreciation and amortization

22,379

20,778

Stock-based compensation

15,351

9,226

Other

2,319

2,690

Changes in operating assets and liabilities:

Accounts receivable

235

(2,208)

Inventory

(28,744)

(9,209)

Prepaid expenses and other assets

(877)

1,513

Accounts payable

(2,781)

2,568

Accrued expenses and other liabilities

10,065

(119)

Deferred revenues

16,876

5,071

Net cash provided by (used in) operating activities

$ 3,111

$ (13,157)

NxStage Medical, Inc.

Revenues by Segment

(amounts in thousands)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2010

2009

2010

2009

System One segment

Home

$ 23,558

$ 17,547

$ 85,762

$ 63,461

Critical Care

8,565

6,959

28,093

22,340

Total System One segment

32,123

24,506

113,855

85,801

In-Center segment

17,646

16,004

65,363

62,875

Total

$ 49,769

$ 40,510

$ 179,218

$ 148,676

NxStage Medical, Inc.

Non-GAAP Financial Measures

(amounts in millions)

(unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2010

2009

2010

2009

Net loss

$ (6.3)

$ (8.7)

$ (31.7)

$ (43.5)

Less: Depreciation, amortization, interest, and taxes

6.7

6.7

27.7

27.9

Less: Adjusting items*

1.1

0.8

4.5

2.9

Adjusted EBITDA gain (loss)

$ 1.5

$ (1.2)

$ 0.5

$ (12.7)

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

NxStage Medical, Inc.

Non-GAAP Financial Guidance

(amounts in millions)

Three Months Ended

Twelve Months Ended

March 31, 2011

December 31, 2011

High
Estimate

Low
Estimate

High
Estimate

Low
Estimate

Net loss

$ (5.5)

$ (6.5)

$ (19.0)

$ (23.0)

Less: Depreciation, amortization, interest, and taxes

7.3

7.3

30.2

30.2

Less: Adjusting items*

(0.3)

(0.3)

(1.2)

(1.2)

Adjusted EBITDA gain

$ 1.5

$ 0.5

$ 10.0

$ 6.0

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

SOURCE NxStage Medical, Inc.