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8-K - FORM 8-K - NxStage Medical, Inc.d308315d8k.htm

Exhibit 99.1

NXSTAGE REPORTS RECORD FOURTH QUARTER AND FULL-YEAR 2011 FINANCIAL RESULTS; REVENUE GROWTH EXCEEDS COMPANY GUIDANCE

Highlights:

 

   

Full-Year Revenue Increases to $217.3 Million, 21% Annual Growth

 

   

Full-Year Home Revenue Increases to $108.5 Million, 27% Annual Growth

 

   

Full- Year Gross Margin Improves to 36%, up from 32% for 2010

 

   

Q4’11 Revenue Increases to a Record $57.0 Million, up 15% from Q4’10

 

   

Company Applauds Favorable Coverage Decision Supporting More Frequent Home Hemodialysis by UnitedHealthcare

LAWRENCE, Mass., February 29, 2012 — NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today reported record financial results for the three and twelve months ended December 31, 2011, that includes revenue above the top end of its guidance range.

Revenue for the full-year 2011 increased 21 percent to $217.3 million, compared with revenue of $179.2 million for the full-year 2010. Revenue for the fourth quarter of 2011 increased 15 percent to a record $57.0 million compared with revenue of $49.8 million for the fourth quarter of 2010. The increase in both periods was led by the Company’s solid performance in the Home market as a result of growing adoption of more frequent home hemodialysis with the NxStage System One™.

Home delivered 27 percent annual growth, with revenue increasing to $108.5 million for the full-year 2011 compared with revenue of $85.8 million for the full-year 2010. Home revenue increased to $28.2 million in the fourth quarter of 2011 compared with revenue of $23.6 million in the fourth quarter of 2010, representing a 20 percent increase.

“Home revenue continued to show strength both on an annual and sequential basis,” stated Jeffrey H. Burbank, Chief Executive Officer of NxStage Medical, Inc. “The majority of Home’s sequential revenue growth in Q4 was driven by our performance in the U.S. which was in-line with normal seasonality and slightly better than our guidance.”

Critical Care delivered 25 percent annual growth, with revenue increasing to $35.0 million for the full-year 2011 compared with revenue of $28.1 million for the full-year 2010. Revenue in Critical Care increased to $9.8 million in the fourth quarter of 2011, compared with revenue of $8.6 million in the fourth quarter of 2010, representing a 14 percent increase.

The Company’s in-center business, Medisystems, delivered 13 percent annual growth with revenue increasing to $73.8 million for the full-year 2011, compared with revenue of $65.4 million for the full-year 2010. Fourth quarter revenue was $19.0 million, compared with $17.6 million in the fourth quarter of 2010.


“NxStage delivered another year of solid growth in 2011. This performance is clear evidence of the strategic progress we continue to make across our business. We achieved both our financial and business objectives and advanced our mission to improve the lives of patients with ESRD,” stated Burbank.

Burbank continued, “Entering 2012, I believe that we have good underlying market fundamentals, a strong balance sheet, a solid operating model, as well as the deepest product pipeline in our Company’s history. We see significant opportunities to advance our long term growth strategy and remain confident in our ability to deliver continued improvement and meaningful growth.”

In commenting on UnitedHealthcare’s recent policy update in support of reimbursement for more frequent home hemodialysis Burbank stated, “We applaud UnitedHealthcare for their leadership in providing greater access to the life changing benefits possible with our therapy. This is an exciting and important step forward in our efforts to make reimbursement simple, predictable and appropriate across all payers, including Medicare.”

NxStage reported a net loss of $21.4 million or ($0.39) per share for the full-year 2011 compared with a net loss of $31.7 million or ($0.66) per share for the full-year 2010. The Company reported a net loss of $4.6 million or ($0.08) per share for the fourth quarter of 2011 compared with a net loss of $6.3 million or ($0.13) per share for the fourth quarter of 2010.

For the full-year 2011, the Company reported Adjusted EBITDA, adjusted for stock-based compensation, deferred revenue recognized, manufacturing transition costs and other non-cash expenses, of $7.3 million, compared with $0.5 million for the full-year 2010. For the fourth quarter of 2011, Adjusted EBITDA was $2.0 million compared with $1.5 million in the fourth quarter of 2010. (See the exhibits for a reconciliation of this non-GAAP measure.)

Guidance:

For the first quarter of 2012, the Company is forecasting revenue to be between $56.0 million and $57.0 million, a net loss in the range of $5.0 to $6.0 million or ($0.09) to ($0.11) per share, and Adjusted EBITDA in the range of $1.0 to $2.0 million.

For the full fiscal year 2012, the Company is forecasting revenue to be between $240 million and $245 million, a net loss in the range of $14.0 to $18.0 million or ($0.25) to ($0.32) per share, and Adjusted EBITDA in the range of $8.0 million to $12.0 million. The Company expects to achieve consolidated gross margins of between 39 percent to 43 percent in the fourth quarter of 2012.

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 today, Wednesday, February 29, 2012, at 9:00 a.m. Eastern Time to discuss its fourth quarter and year-end 2011 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 March 14, 2012. To access the replay, dial 855- 859-2056 (domestic) or 404- 537-3406 (international) and reference conference ID 45478602. 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 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 Adjusted EBITDA numbers, 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 customers, including DaVita Inc. and Fresenius, 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, 2011.

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.

Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended     Twelve Months Ended  
     December 31,     December 31,  
     2011     2010     2011     2010  

Revenues

   $ 57,021      $ 49,769      $ 217,256      $ 179,218   

Cost of revenues

     35,851        32,177        139,648        121,091   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     21,170        17,592        77,608        58,127   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Selling and marketing

     9,525        9,132        37,550        34,166   

Research and development

     3,743        3,531        14,437        12,900   

Distribution

     4,618        3,920        17,916        14,751   

General and administrative

     6,456        6,170        23,206        22,774   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     24,342        22,753        93,109        84,591   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (3,172     (5,161     (15,501     (26,464
  

 

 

   

 

 

   

 

 

   

 

 

 

Other expense:

        

Interest income

     4        3        4        3   

Interest expense

     (1,201     (1,165     (4,714     (4,597

Other income (expense), net

     50        242        (292     114   
  

 

 

   

 

 

   

 

 

   

 

 

 
     (1,147     (920     (5,002     (4,480
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss before income taxes

     (4,319     (6,081     (20,503     (30,944

Provision for income taxes

     245        212        899        768   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (4,564   $ (6,293   $ (21,402   $ (31,712
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.08   $ (0.13   $ (0.39   $ (0.66
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares outstanding, basic and diluted

     54,997        50,233        54,217        48,188   
  

 

 

   

 

 

   

 

 

   

 

 

 


NxStage Medical, Inc.

Consolidated Balance Sheets

(in thousands, except share data)

(unaudited)

 

     December 31,     December 31,  
     2011     2010  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 102,909      $ 104,339   

Accounts receivable, net

     15,808        14,107   

Inventory

     32,775        34,950   

Prepaid expenses and other current assets

     2,777        2,084   
  

 

 

   

 

 

 

Total current assets

     154,269        155,480   

Property and equipment, net

     17,599        8,290   

Field equipment, net

     12,182        13,660   

Deferred cost of revenues

     41,132        40,081   

Intangible assets, net

     22,615        25,412   

Goodwill

     42,698        42,698   

Other assets

     1,213        473   
  

 

 

   

 

 

 

Total assets

   $ 291,708      $ 286,094   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 15,634      $ 16,811   

Accrued expenses

     15,165        19,537   

Current portion of long-term debt

     —          43   
  

 

 

   

 

 

 

Total current liabilities

     30,799        36,391   

Deferred revenues

     57,014        55,366   

Long-term debt

     43,235        40,454   

Other long-term liabilities

     9,474        1,754   
  

 

 

   

 

 

 

Total liabilities

     140,522        133,965   

Commitments and contingencies

    

Stockholders’ equity:

    

Undesignated preferred stock: par value $0.001, 5,000,000 shares authorized; no shares issued and outstanding as of December 31, 2011 and 2010

     —          —     

Common stock: par value $0.001, 100,000,000 shares authorized; 56,167,090 and 54,043,317 shares issued as of December 31, 2011 and 2010, respectively

     56        53   

Additional paid-in capital

     489,542        465,642   

Accumulated deficit

     (329,828     (308,426

Accumulated other comprehensive income

     (68     85   

Treasury stock, at cost: 480,923 and 325,104 shares as of December 31, 2011 and 2010, respectively

     (8,516     (5,225
  

 

 

   

 

 

 

Total stockholders’ equity

     151,186        152,129   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 291,708      $ 286,094   
  

 

 

   

 

 

 


NxStage Medical, Inc.

Cash Flows from Operating Activities

(in thousands)

(unaudited)

 

     Twelve Months Ended  
     December 31,  
     2011     2010  

Cash flows from operating activities:

    

Net loss

   $ (21,402   $ (31,712

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

    

Depreciation and amortization

     23,087        22,379   

Stock-based compensation

     13,093        15,351   

Other

     3,064        2,319   

Changes in operating assets and liabilities:

    

Accounts receivable

     (1,773     235   

Inventory

     (16,371     (28,744

Prepaid expenses and other assets

     (1,491     (877

Accounts payable

     (1,047     (2,781

Accrued expenses and other liabilities

     (324     10,065   

Deferred revenues

     1,648        16,876   
  

 

 

   

 

 

 

Net cash (used in) provided by operating activities

   $ (1,516   $ 3,111   
  

 

 

   

 

 

 


NxStage Medical, Inc.

Revenues by Segment

(in thousands)

(unaudited)

 

     Three Months Ended      Twelve Months Ended  
     December 31,      December 31,  
     2011      2010      2011      2010  

System One segment

           

Home

   $ 28,213       $ 23,558       $ 108,489       $ 85,762   

Critical Care

     9,792         8,565         34,991         28,093   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total System One segment

     38,005         32,123         143,480         113,855   

In-Center segment

     19,016         17,646         73,776         65,363   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 57,021       $ 49,769       $ 217,256       $ 179,218   
  

 

 

    

 

 

    

 

 

    

 

 

 


NxStage Medical, Inc.

Non-GAAP Financial Measures

(in millions)

(unaudited)

 

     Three Months Ended     Twelve Months Ended  
     December 31,     December 31,  
     2011     2010     2011     2010  

Net loss

   $ (4.6   $ (6.3   $ (21.4   $ (31.7

Less: Depreciation, amortization, interest, and taxes

     7.1        6.7        29.0        27.7   

Less: Adjusting items*

     (0.5     1.1        (0.3     4.5   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 2.0      $ 1.5      $ 7.3      $ 0.5   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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


NxStage Medical, Inc.

Non-GAAP Financial Guidance

(in millions)

(unaudited)

 

     Three Months Ended     Twelve Months Ended  
     March 31, 2012     December 31, 2012  
     High
Estimate
    Low
Estimate
    High
Estimate
    Low
Estimate
 

Net loss

   $ (5.0   $ (6.0   $ (14.0   $ (18.0

Less: Depreciation, amortization, interest, and taxes

     7.4        7.4        30.7        30.7   

Less: Adjusting items*

     (0.4     (0.4     (4.7     (4.7
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 2.0      $ 1.0      $ 12.0      $ 8.0   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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