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8-K - FORM 8-K - NxStage Medical, Inc.d393263d8k.htm

Exhibit 99.1

NXSTAGE REPORTS RECORD REVENUE FOR THE SECOND QUARTER OF FISCAL 2012

Highlights:

 

   

Revenue Increases to $59.0 million, up 10% from Q2’11

 

   

Home Revenue Increases to $30.7 million, up 14% from Q2’11

 

   

Gross Margin Increases to 38%, up from 35% in Q2’11

 

   

Company Announces European Market Approval for Enhancements to System One

LAWRENCE, Mass., August 8, 2012, — NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today reported record financial results for the second quarter ended June 30, 2012, with total revenue above the top end of its guidance range.

Revenue for the second quarter of 2012 increased 10% to $59.0 million, compared with revenue of $53.8 million for the second quarter of 2011. The higher revenues were driven by increased adoption of the NxStage System One™.

Home revenue for the second quarter of 2012 increased 14% to a record $30.7 million compared with revenues of $27.0 million for the second quarter of 2011.

“Home and more frequent hemodialysis with the System One is great therapy that has been consistently reported to give patients access to a much richer and longer life. We continue to show that our therapy can benefit patients, providers and payors,” stated Jeffrey H. Burbank, Chief Executive Officer of NxStage. “As a result, we continue to break down the barriers to adoption and deliver strong revenue growth consistent with our expectations.”

Critical Care revenue increased 9% to $9.4 million for the second quarter of 2012 compared with revenues of $8.6 million for the second quarter of 2011. Revenue in the In-Center market was $18.2 million for the second quarter of 2012.

“Our results in the second quarter reflect solid and consistent progress. We achieved record revenues, a 300 bps improvement in gross margin, and advanced our robust product pipeline,” continued Burbank. “In sum, our growth strategy remains on track and we remain confident in our outlook for 2012.”

NxStage reported a net loss of $5.1 million or $(0.09) per share for the second quarter of 2012 compared with a net loss of $5.6 million or $(0.10) per share for the second quarter of 2011. The net loss for the second quarter of 2012 includes the impact of $1.0 million for the write-off of unamortized debt discount related to the Asahi debt conversion that occurred in May 2012.

For the second quarter of 2012, the Company reported Adjusted EBITDA, adjusted for stock-based compensation, deferred revenue recognized, manufacturing transition costs and other non-cash expenses, of $1.7 million compared with $1.8 million for the second quarter of 2011. (See the exhibits for a reconciliation of this non-GAAP measure.)

Separately, the Company announced that the European regulatory authority has approved a new feature to automate the administration of bolus for use in the EU. Burbank concluded, “This approval enables us to further advance the simplicity and safety of the System One in Europe. This is an amazing accomplishment to be able to take tap water, purify it, add concentrate, filter it, and infuse it; effectively our system produces fluid similar to that produced in a pharmaceutical plant right in a patient’s home from tap water.”

Guidance:

For the third quarter of 2012, the Company is forecasting revenues to be between $60.0 million and $61.0 million, a net loss in the range of $3.5 million to $4.5 million, or $(0.06) to $(0.08) per share, and Adjusted EBITDA in the range of $1.5 million to $2.5 million. The Company is reaffirming its full year 2012 guidance, which includes Asahi dialyzer sales.


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, August 8, 2012 at 9:00 a.m. Eastern Time to discuss its second 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 August 22, 2012. To access the replay dial 855- 859-2056 (domestic) or 404-537-3406 (international) and reference conference ID 97740600. 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 Medical Care, 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, 2012.

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)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2012     2011     2012     2011  

Revenues

   $ 59,009      $ 53,768      $ 115,960      $ 104,332   

Cost of revenues

     36,620        34,903        72,259        67,434   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     22,389        18,865        43,701        36,898   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Selling and marketing

     9,918        9,369        19,838        18,579   

Research and development

     4,250        3,589        8,147        7,306   

Distribution

     4,582        4,431        9,114        8,589   

General and administrative

     6,930        5,460        13,552        11,042   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     25,680        22,849        50,651        45,516   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (3,291     (3,984     (6,950     (8,618
  

 

 

   

 

 

   

 

 

   

 

 

 

Other expense:

        

Interest expense

     (1,456     (1,170     (2,649     (2,327

Other expense, net

     (79     (170     (131     (196
  

 

 

   

 

 

   

 

 

   

 

 

 
     (1,535     (1,340     (2,780     (2,523

Net loss before income taxes

     (4,826     (5,324     (9,730     (11,141

Provision for income taxes

     237        226        477        419   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (5,063   $ (5,550   $ (10,207   $ (11,560
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.09   $ (0.10   $ (0.18   $ (0.22
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares outstanding, basic and diluted

     57,733        54,014        55,319        53,716   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive loss:

        

Foreign currency (loss) gain

   $ (249   $ 80      $ (100   $ 304   

Other (loss) gain

     (48     1        (24     6   
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (5,360   $ (5,469   $ (10,331   $ (11,250
  

 

 

   

 

 

   

 

 

   

 

 

 


NxStage Medical, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share data)

(unaudited)

 

     June 30,
2012
    December 31,
2011
 

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 102,859      $ 102,909   

Accounts receivable, net

     17,643        15,808   

Inventory

     34,670        32,775   

Prepaid expenses and other current assets

     2,084        2,777   
  

 

 

   

 

 

 

Total current assets

     157,256        154,269   

Property and equipment, net

     29,049        17,599   

Field equipment, net

     9,971        12,182   

Deferred cost of revenues

     39,792        41,132   

Intangible assets, net

     21,217        22,615   

Goodwill

     42,698        42,698   

Other assets

     2,066        1,213   
  

 

 

   

 

 

 

Total assets

   $ 302,049      $ 291,708   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 14,559      $ 15,634   

Accrued expenses

     17,932        15,165   
  

 

 

   

 

 

 

Total current liabilities

     32,491        30,799   

Deferred revenues

     55,668        57,014   

Long-term debt

     —          43,235   

Other long-term liabilities

     18,612        9,474   
  

 

 

   

 

 

 

Total liabilities

     106,771        140,522   

Commitments and contingencies

    

Stockholders’ equity:

    

Undesignated preferred stock: par value $0.001, 5,000,000 shares authorized; no shares issued and outstanding as of June 30, 2012 and December 31, 2011

     —          —     

Common stock: par value $0.001, 100,000,000 shares authorized; 59,391,169 and 56,167,090 shares issued as of June 30, 2012 and December 31, 2011, respectively

     59        56   

Additional paid-in capital

     544,997        489,542   

Accumulated deficit

     (340,035     (329,828

Accumulated other comprehensive loss

     (192     (68

Treasury stock, at cost: 541,584 and 480,923 shares as of June 30, 2012 and December 31, 2011, respectively

     (9,551     (8,516
  

 

 

   

 

 

 

Total stockholders’ equity

     195,278        151,186   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 302,049      $ 291,708   
  

 

 

   

 

 

 


NxStage Medical, Inc.

Cash Flows from Operating Activities

(in thousands)

(unaudited)

 

     Six Months Ended June 30,  
     2012     2011  

Cash flows from operating activities:

    

Net loss

   $ (10,207   $ (11,560

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

    

Depreciation and amortization

     11,580        11,459   

Stock-based compensation

     6,252        6,701   

Other

     2,345        1,737   

Changes in operating assets and liabilities:

    

Accounts receivable

     (1,851     (1,753

Inventory

     (7,809     (13,363

Prepaid expenses and other assets

     (170     (546

Accounts payable

     (946     5,471   

Accrued expenses and other liabilities

     3,038        (2,446

Deferred revenues

     (1,346     629   
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

   $ 886      $ (3,671
  

 

 

   

 

 

 

NxStage Medical, Inc.

Revenues by Segment

(in thousands)

(unaudited)

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2012      2011      2012      2011  

System One segment

           

Home

   $ 30,693       $ 27,013       $ 60,246       $ 53,058   

Critical Care

     9,371         8,591         19,158         16,029   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total System One segment

     40,064         35,604         79,404         69,087   

In-Center segment

     18,229         18,164         35,840         35,245   

Other

     716         —           716         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 59,009       $ 53,768       $ 115,960       $ 104,332   
  

 

 

    

 

 

    

 

 

    

 

 

 


NxStage Medical, Inc.

Non-GAAP Financial Measures

(in millions)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2012     2011     2012     2011  

Net loss

   $ (5.1   $ (5.6   $ (10.2   $ (11.6

Less: Depreciation, amortization, interest, and taxes

     7.6        7.3        14.7        14.4   

Less: Adjusting items*

     (0.8     0.1        (1.0     0.1   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 1.7      $ 1.8      $ 3.5      $ 2.9   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

* 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
September 31, 2012
 
     High
Estimate
    Low
Estimate
 

Net loss

   $ (3.5   $ (4.5

Less: Depreciation, amortization, interest, and taxes

     6.6        6.6   

Less: Adjusting items*

     (0.6     (0.6
  

 

 

   

 

 

 

Adjusted EBITDA

   $ 2.5      $ 1.5   
  

 

 

   

 

 

 

 

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