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8-K - FORM 8-K - NanoString Technologies Incd880827d8k.htm

Exhibit 99.1

 

LOGO

FOR IMMEDIATE RELEASE

NanoString Technologies Releases Fourth Quarter and Full Year 2014

Financial Results and Provides 2015 Outlook

Record Revenue Driven by Significant Installed Base Growth, Continued Robust Consumable Pull-Through and Initial Companion Diagnostic Collaboration

SEATTLE February 24, 2015 – NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the fourth quarter and year ended December 31, 2014.

Fourth Quarter Financial Highlights:

 

    Total revenue of $15.6 million, 54% year-over-year growth

 

    Instrument revenue of $6.3 million, 20% year-over-year growth

 

    Consumables revenue of $7.2 million, 69% year-over-year growth

 

    Collaboration revenue of $1.4 million

Full Year 2014 Financial Highlights:

 

    Total revenue of $47.6 million, 52% year-over-year growth

 

    Instrument revenue of $18.1 million, 39% year-over-year growth

 

    Consumables revenue of $23.8 million, 43% year-over-year growth

 

    Collaboration revenue of $3.1 million and approximately $12.0 million of cash received

“Our fourth quarter and full year 2014 results reflect strong performance, with meaningful progress across all three aspects of our business – Life Sciences, Companion Diagnostics, and Prosigna,” said President and Chief Executive Officer, Brad Gray. “Life Sciences continued to be the primary engine driving our growth, as we substantially expanded our installed base of nCounter® Analysis Systems while maintaining a high level of consumable pull-through. The year also marked our entry into companion diagnostics, and I am proud of the results we achieved during 2014 in our collaboration with Celgene.”

Recent Business Highlights:

 

    Delivered validated assay to Celgene, enabling clinical trial initiation in January 2015

 

    Positive results from first Decision Impact Study on Prosigna usage reported at the annual San Antonio Breast Cancer Symposium in December

 

    Installed base of 264 nCounter Analysis Systems at December 31, 2014, representing an increase of 44% over December 31, 2013


    More than 600 cumulative peer-reviewed publications of studies based on nCounter technology

“Entering 2015, our foundation is strong, and we are looking ahead to an exciting year,” added Gray. “Our plans include further penetrating the research and clinical markets with our nCounter technology and Prosigna Breast Cancer Assay, expanding our addressable markets through multiple product launches, and pursuing new collaboration opportunities with biopharmaceutical partners.”

Fourth Quarter Financial Results

Revenue for the three months ended December 31, 2014 rose 54% to $15.6 million, from $10.1 million for the fourth quarter of 2013. Instrument revenue was $6.3 million, up 20% from the prior year period. Consumables revenue was $7.2 million for the fourth quarter of 2014, 69% higher than in the comparable 2013 quarter. Prosigna revenue was $156,000 for the quarter, and collaboration revenue totaled $1.4 million. Gross margin on product and service revenue was 53% for the fourth quarter of 2014 compared to 52% for the prior year period.

Research and development expense increased to $5.4 million for the fourth quarter of 2014, versus $4.5 million for the fourth quarter of 2013, reflecting increased investment in technology development, including the engineering and testing of the next generation nCounter Analysis System, as well as increased costs related to diagnostic product development, including the lymphoma subtyping test being developed in collaboration with Celgene. Selling, general and administrative expense was $15.0 million for the fourth quarter of 2014 compared to $9.1 million for the prior year period. The increase reflects the build-out of the company’s commercial team to support the Prosigna launch, further expansion of the company’s lab-based sales channel and increased administrative costs.

Net loss attributable to common stockholders for the three months ended December 31, 2014 was $12.4 million, or a loss of $0.68 per diluted share, compared with $8.8 million, or a loss of $0.60 per diluted share, for the fourth quarter of 2013. Non-GAAP net loss for the three months ended December 31, 2014 was $9.7 million, or a loss of $0.53 per diluted share, compared with non-GAAP net loss of $7.5 million, or a loss of $0.51 per diluted share, for the prior year period (see accompanying table for reconciliation of GAAP and non-GAAP financial measures).

Full Year 2014 Financial Results

Revenue for 2014 rose 52% to $47.6 million, from $31.4 million for 2013. Instrument revenue was $18.1 million, up 39% from the prior year. Consumables revenue was $23.8 million for 2014, 43% higher than for the prior year. Prosigna revenue for 2014 was $668,000, and revenue associated with companion diagnostic collaborations was $3.1 million for the year. Gross margin on product and service revenue was 52% for 2014.

Research and development expense was $21.4 million for 2014, versus $15.0 million for 2013. Selling, general and administrative expense was $51.1 million for 2014 compared to $29.9 million for the prior year.

Net loss attributable to common stockholders for 2014 was $50.0 million, or a loss of $2.80 per diluted share, compared with $33.9 million, or a loss of $4.44 per diluted share, for 2013. Non-GAAP


net loss for 2014 was $39.4 million, or a loss of $2.21 per diluted share, compared with non-GAAP net loss of $25.6 million, or a loss of $2.14 per diluted share, for the prior year (see accompanying table for reconciliation of GAAP and non-GAAP financial measures).

The company ended 2014 with $72.2 million of cash, cash equivalents, and short-term investments.

Outlook for 2015:

 

    Total revenue in the range of $58 million to $61 million

 

    Gross margin in the range of 53% to 55%

 

    Operating expenses in the range of $77 million to $81 million

 

    Operating loss in the range of $43 million to $49 million

Conference Call

Management will host an investment community conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Individuals interested in listening to the conference call may do so by dialing (888) 793-9492 for domestic callers, or (734) 385-2643 for international callers, or from the webcast link in the investor relations section of the Company’s website at: www.nanostring.com. A replay of the call will be available beginning February 24, 2015 at 7:30pm ET through midnight on February 25, 2015. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 71481687. The webcast will also be available on the Company’s website for one year following the completion of the call.

About NanoString Technologies, Inc.

NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company’s nCounter Analysis System has been employed in life sciences research since it was first introduced in 2008 and has been cited in over 600 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company’s technology has now been applied to diagnostic use. The Prosigna Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer.

For more information, please visit www.nanostring.com.

The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding further penetration of the research and clinical markets, expansion of market potential through planned product introductions, anticipated companion diagnostic collaborations and our estimated 2015 operating results. Such statements are based on current assumptions that involve


risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include market acceptance of our products; delays or denials of reimbursement for diagnostic products; delays or other unforeseen problems with respect to manufacturing, product development or clinical studies; the impact of competition; the impact of expanded sales, marketing, product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.

Use of Non-GAAP Financial Measures

To supplement our condensed consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures in this release. Management of the company believes that these non-GAAP financial measures, considered together with GAAP financial information, provide useful information for investors by excluding certain non-cash and other income and expense that are not indicative of the company’s core operating performance. Reconciliations of the non-GAAP financial measures used in this release to the most directly comparable GAAP measures for the respective periods can be found in “Reconciliation of GAAP to Non-GAAP Financial Information” immediately following the financial tables. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP.

Contact:

Leigh Salvo of Westwicke Partners

leigh.salvo@westwicke.com

415-513-1281


NANOSTRING TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended December 31,     Year Ended December 31,  
     2014     2013     2014     2013  

Revenue:

        

Instruments

   $ 6,337     $ 5,281     $ 18,078     $ 12,995  

Consumables

     7,198       4,262       23,819       16,642  

In vitro diagnostic kits

     156       140       668       181  

Services

     528       437       1,932       1,585  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total products and services revenue

  14,219     10,120     44,497     31,403  

Collaboration

  1,399     —        3,096     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

  15,618     10,120     47,593     31,403  

Costs and expenses:

Cost of product revenue

  6,693     4,821     21,149     15,009  

Research and development

  5,437     4,510     21,404     14,979  

Selling, general and administrative

  14,994     9,090     51,063     29,912  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

  27,124     18,421     93,616     59,900  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

  (11,506   (8,301   (46,023   (28,497

Other income (expense):

Interest income

  68     40     272     68  

Interest expense

  (892   (530   (4,140   (1,942

Revaluation of preferred stock warrant liability

  —        —        —        1,156  

Other income (expense)

  (50   (36   (147   (66
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

  (874   (526   (4,015   (784
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  (12,380   (8,827   (50,038   (29,281

Accretion of mandatorily redeemable convertible preferred stock

  —        —        —        (4,653
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

$ (12,380 $ (8,827 $ (50,038 $ (33,934
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

$ (0.68 $ (0.60 $ (2.80 $ (4.44
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in calculating basic and diluted net loss per share

  18,219     14,617     17,839     7,643  
  

 

 

   

 

 

   

 

 

   

 

 

 


NANOSTRING TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

     December 31,
2014
     December 31,
2013
 

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 17,223      $ 9,941  

Short-term investments

     55,002        32,715  

Accounts receivable, net

     12,436        8,331  

Inventory

     5,444        6,750  

Prepaid expenses and other

     5,242        2,999  
  

 

 

    

 

 

 

Total current assets

  95,347     60,736  

Property and equipment, net

  6,366     3,065  

Other assets

  1,035     571  
  

 

 

    

 

 

 

Total assets

$ 102,748   $ 64,372  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 3,380   $ 3,354  

Accrued liabilities

  10,403     7,088  

Long-term debt, current portion

  251     6,136  

Deferred revenue, current portion

  4,627     1,462  

Other

  147     590  
  

 

 

    

 

 

 

Total current liabilities

  18,808     18,630  

Long-term debt, net of current portion

  30,675     12,157  

Deferred revenue, net of current portion

  7,135     803  

Other non-current liabilities

  1,317     1,313  
  

 

 

    

 

 

 

Total liabilities

  57,935     32,903  

Total stockholders’ equity

  44,813     31,469  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

$ 102,748   $ 64,372  
  

 

 

    

 

 

 


NANOSTRING TECHNOLOGIES, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended December 31,     Year Ended December 31,  
     2014     2013     2014     2013  

Net loss attributable to common stockholders (GAAP)

   $ (12,380   $ (8,827   $ (50,038   $ (33,934

Accretion of mandatorily redeemable convertible preferred stock

     —          —          —          4,653  

Change in the fair value of preferred stock warrant liability

     —          —          —          (1,156

Stock-based compensation expense

     1,322       379       4,926       1,145  

Depreciation and amortization

     424       419       1,539       1,779  

Interest expense

     892       530       4,140       1,942  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss (non-GAAP)

$ (9,742 $ (7,499 $ (39,433 $ (25,571
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in calculating basic and diluted net loss per share (GAAP)

  18,219     14,617     17,839     7,643  

Shares of common stock issuable upon conversion of mandatorily redeemable convertible preferred stock

  —        —        —        4,280  
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in calculating basic and diluted net loss per share (non-GAAP)

  18,219     14,617     17,839     11,923  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted (GAAP)

$ (0.68 $ (0.60 $ (2.80 $ (4.44
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted (non-GAAP)

$ (0.53 $ (0.51 $ (2.21 $ (2.14