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8-K - FORM 8-K - NanoString Technologies Incd772169d8k.htm

Exhibit 99.1

 

LOGO

FOR IMMEDIATE RELEASE

NanoString Technologies Releases Financial Results for Second Quarter of 2014

- Strong Q2 2014 Revenue Growth of 51% Year over Year -

- Initiation of First Companion Diagnostic Collaboration with Celgene Corporation -

SEATTLE Aug. 5, 2014 – NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the quarter ended June 30, 2014.

Financial Highlights:

 

    Record total revenue of $10.9 million, 51% year-over-year growth

 

    Instrument revenue of $3.8 million, 49% year-over-year growth

 

    Cumulative installed base of approximately 220 nCounter® Analysis Systems and 500 publications

 

    Record consumables revenue of $5.9 million, 36% year-over-year growth

 

    First quarterly revenue from Celgene companion diagnostic collaboration of $0.6 million on $5.8 million of cash received

 

    Cash position of $79.6 million as of June 30, 2014

“We sustained momentum throughout the first half of the year, posting our third straight quarter of greater than 50% year-on-year revenue growth,” said President and Chief Executive Officer, Brad Gray. “We continued to grow our nCounter installed base in both research and clinical labs and made important progress in the ongoing launch of our Prosigna Breast Cancer Prognostic Gene Signature Assay. Additionally, our collaboration with Celgene provided our first foray into companion diagnostics, which we believe is an exciting area of potential growth for us.”

Recent Business Highlights:

 

    Initiated companion diagnostic collaboration with Celgene providing up to $45.0 million of cash payments to NanoString

 

    Launched Prosigna Patient Support Program to facilitate utilization while insurance coverage is coming online

 

    Received market approval from the Australian Therapeutic Goods Administration, clearing the way to market Prosigna in Australia.

 

    Expanded the capabilities of nCounter Elements™ General Purpose Reagents for specific detection and analysis of known fusion genes

 

    Enabled the launch of Roswell Park Cancer Institute’s OmniSeq Target™ assay, the first Laboratory Developed Test based on nCounter Elements to win New York State Approval

Second Quarter Financial Results

Revenue for the three months ended June 30, 2014 rose 51% to $10.9 million, from $7.2 million for the second quarter of 2013. Instrument revenue was $3.8 million, up 49% from the prior year period. Consumables revenue, excluding sales of Prosigna, for the quarter was $5.9 million, up 36% from the second quarter of 2013. Collaboration revenue of $0.6 million related to the companion diagnostic collaboration with Celgene represented a new source of growth.


Product and service gross margin was 53% for the three months ended June 30, 2014 compared to 51% for the prior year period. The increase was largely due to consumables manufacturing efficiencies from increasing scale.

Research and development expense for the second quarter of 2014 increased to $5.3 million compared to $3.6 million in the prior year period. The increase reflects an increased investment in technology, new product development, as well as costs to support the Celgene collaboration.

Selling, general and administrative expense for the quarter was $12.9 million compared to $6.7 million in the prior year period. The increase reflects Prosigna launch costs, including establishment of an oncology sales force; expansion of the laboratory focused commercial organization; and other increased corporate costs.

Net loss attributable to common stockholders for the second quarter of 2014 was $14.1 million, or a loss of $(0.78) per diluted share, compared with $7.8 million, or a loss of $(13.69) per diluted share, for the second quarter of 2013. Non-GAAP net loss for the quarter was $10.5 million, or a loss of $(0.58) per diluted share, compared with non-GAAP net loss of $6.0 million, or a loss of $(0.65) per diluted share, for the prior year period (see accompanying table for reconciliation of GAAP and non-GAAP financial measures).

The company had $79.6 million of cash, cash equivalents and short-term investments as of June 30, 2014.

NanoString’s 2014 Outlook

The company’s financial outlook for 2014 includes:

 

    Total revenue in the range of $45.0 to $50.0 million, representing an approximate increase of 43% to 59% over 2013

 

    Gross margin in the range of 52% to 55%

 

    Operating expenses in the range of $70.0 to $75.0 million

 

    Net operating loss in the range of $40.0 to $50.0 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 August 5, 2014 at 7:30pm ET through midnight on August 6, 2014. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 74230430. The webcast will also be available on the company’s website for one quarter 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 500 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.


The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions. OmniSeq Target™ is a trademark of Roswell Park Cancer Institute.

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 our ability to generate future growth from companion diagnostics collaborations, our expectations regarding the Prosigna Patient Support Program to increase utilization of Prosigna, and our estimated 2014 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 regulatory approvals or clearances for products or applications; delays or denials of reimbursement for diagnostic products; the impact of competition; the impact of expanded sales, marketing, product development and clinical activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or clinical studies; 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.

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

Investor Contact:

Leigh Salvo of Westwicke Partners

For NanoString Technologies

leigh.salvo@westwicke.com

415-513-1281

Media Contact:

Nicole Litchfield of Bioscribe Inc.

For NanoString Technologies

nicole@bioscribe.com

415-793-6468

– Financial Tables Follow –


NANOSTRING TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  

Revenue:

        

Instruments

   $ 3,765     $ 2,523     $ 7,213     $ 4,162  

Consumables

     5,857       4,305       10,643       8,004  

In vitro diagnostic kits

     181       —          242       —     

Services

     460       390       916       728  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total products and services revenue

     10,263       7,218       19,014       12,894  

Collaboration

     618       —          618       —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     10,881       7,218       19,632       12,894  

Costs and expenses:

        

Cost of product and service revenue

     4,860       3,522       9,185       6,404  

Research and development

     5,274       3,626       10,006       6,685  

Selling, general and administrative

     12,880       6,708       23,554       12,834  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

     23,014       13,856       42,745       25,923  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (12,133     (6,638     (23,113     (13,029

Other income (expense):

        

Interest income

     75       3       139       6  

Interest expense

     (2,015     (489     (2,551     (874

Revaluation of preferred stock warrant liability

     —          1,638       —          1,156  

Other income (expense)

     (15     (9     15       (13
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

     (1,955     1,143       (2,397     275   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (14,088     (5,495     (25,510     (12,754

Accretion of mandatorily redeemable convertible preferred stock

     —          (2,311     —          (4,653
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (14,088   $ (7,806   $ (25,510   $ (17,407
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.78   $ (13.69   $ (1.46   $ (31.48
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in calculating basic and diluted net loss per share

     18,069       570       17,496       553  
  

 

 

   

 

 

   

 

 

   

 

 

 


NANOSTRING TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     June 30,
2014
     December 31,
2013
 

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 21,186      $ 9,941  

Short-term investments

     58,403        32,715  

Accounts receivable, net

     9,074        8,331  

Inventory

     6,407        6,750  

Prepaid expenses and other

     4,070        2,999  
  

 

 

    

 

 

 

Total current assets

     99,140        60,736  

Property and equipment, net

     5,050        3,065  

Other assets

     867        571  
  

 

 

    

 

 

 

Total assets

   $ 105,057      $ 64,372  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 2,715      $ 3,354  

Accrued liabilities

     7,038        7,088  

Long-term debt, current portion

     160        6,136  

Other

     4,317        2,052  
  

 

 

    

 

 

 

Total current liabilities

     14,230        18,630  

Long-term debt, net of current portion

     20,208        12,157  

Other non-current liabilities

     4,765        2,116  
  

 

 

    

 

 

 

Total liabilities

     39,203        32,903  

Total stockholders’ equity

     65,854        31,469  
  

 

 

    

 

 

 

Total liabilities and stockholder’s equity

   $ 105,057      $ 64,372  
  

 

 

    

 

 

 


NANOSTRING TECHNOLOGIES, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

(in thousands, except per share amounts)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  

Net loss attributable to common stockholders (GAAP)

   $ (14,088   $ (7,806   $ (25,510   $ (17,407

Accretion of mandatorily redeemable convertible preferred stock

     —          2,311       —          4,653  

Change in the fair value of preferred stock warrant liability

     —          (1,638     —          (1,156

Stock-based compensation expense

     1,259       257       2,298       488  

Depreciation and amortization

     349       437       745       901  

Interest expense

     2,015       489       2,551       874  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss (non-GAAP)

   $ (10,465   $ (5,950   $ (19,916   $ (11,647
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     18,069       570       17,496       553  

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

     —          8,631       —          8,631  
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     18,069       9,201       17,496       9,184  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted (GAAP)

   $ (0.78   $ (13.69   $ (1.46   $ (31.48
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ (0.58   $ (0.65   $ (1.14   $ (1.27