The Spectranetics Corporation (NASDAQ:SPNC) today reported financial results for the three months ended March 31, 2016.  Highlights of the quarter, all compared with the three months ended March 31, 2015, include:
  • Revenue of $62.9 million increased 10% (both as reported and constant currency1)
  • Vascular Intervention revenue of $41.9 million increased 15% (both as reported and constant currency)
  • Lead Management revenue of $17.1 million increased 4% (5% constant currency)

“Results reflect solid commercial execution across business segments and global regions,” said Scott Drake, President and CEO. “We also displayed traction in our innovation pipeline. In particular, the interim 12-month Stellarex data supports our top-tier First-in-Human results, and compare favorably to similar studies conducted in the marketplace. Our competitive position continues to strengthen as our pipeline matures.”

Net loss for the three months ended March 31, 2016 was $17.3 million, or $0.40 per share, compared with net loss of $27.3 million, or $0.65 per share, for the three months ended March 31, 2015.

__________________________1Constant currency is a non-GAAP financial measure. See “Reconciliation of Non-GAAP Financial Measures” later in this release.

2016 Financial OutlookSpectranetics’ management reaffirms its previously given full year 2016 outlook, as disclosed on February 25, 2016, and as detailed below:

  • 2016 full year revenue is projected to be within a range of $254 million to $266 million, an increase of 3% to 8% over 2015
  • Net loss for 2016 is projected to be within a range of $59 million to $64 million, or $1.34 to $1.45 per share.  Non-GAAP net loss for 2016 is projected to be within a range of $45 million to $50 million, or $1.03 to $1.14 per share.  See “Reconciliation of non-GAAP Financial Measures” later in this release
  • Gross margin is projected to be within a range of 74.4% to 75.0%
  • Research, development and other technology expenses are expected to be in the range of 25% to 26% of revenue
  • Selling, general and administrative expenses are expected to be in the range of 61% to 63% of revenue

Conference CallManagement will host an investment community conference call today beginning at 2:30 p.m. MT / 4:30 p.m. ET. Individuals interested in listening to the conference call may dial (877) 561-2747 for domestic callers, or (973) 409-9689 for international callers, conference ID 81186531, or access the webcast on the investor relations section of the Company’s website at: www.spectranetics.com. The webcast will be available on the Company’s website for 14 days following the completion of the call.

About SpectraneticsThe Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are available in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.

The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee, the AngioSculpt scoring balloon used in both peripheral and coronary procedures, and the Stellarex drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.

The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.

For more information, visit www.spectranetics.com. 

Safe Harbor StatementThis news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. You can identify these statements because they do not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “look forward,” “strive,” “project,” “intend,” “should,” “plan,” “believe,” “hope,” “enable,” “potential,” and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, clinical trials and regulatory approvals, regulatory or competitive environments, outcome of litigation, our intellectual property and product development. These forward-looking statements include, but are not limited to, statements regarding our competitive position, product development and commercialization schedule, expectation of continued growth and the reasons for that growth, growth rates, strength, integration and product launches, and 2016 outlook and projected results including projected revenue and expenses, net loss and gross margin. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements and to note they speak only as of the date of this news release. These risks and uncertainties may include financial results differing from guidance, increasing competition and consolidation in our industry, the impact of rapid technological change, slower revenue growth and losses, inability to successfully integrate AngioScore and Stellarex into our business and the inaccuracy of our assumptions regarding AngioScore and Stellarex, market acceptance of  our technology  and products,  our inability to manage growth, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of our strategic direction, dependence on new product development and successful commercialization of new products, loss of key personnel, uncertain success of or delays in our clinical trials, costs of and adverse results in any ongoing or future legal proceedings, adverse impact to our business of healthcare reform and related legislation and regulations, including changes in reimbursements,  adverse conditions in the general domestic and global economic markets and  volatility and disruption of the credit markets,  our inability to protect our intellectual property and intellectual property claims of third parties, availability of inventory and components from suppliers, adverse outcome of FDA inspections, the receipt of FDA clearance and other regulatory approvals to market new products or applications and the timeliness of any clearance and approvals,  product defects or recalls and product liability claims, cybersecurity breaches, ability to manufacture sufficient volumes to fulfill customer demand, our dependence on third party vendors, suppliers, consultants and physicians, unexpected delays or costs associated with any planned improvements to our manufacturing processes, risks associated with international operations, lack of cash necessary to satisfy our cash obligations under our outstanding 2.625% Convertible Senior Notes due 2034 and our term loan and revolving loan facilities, our debt adversely affecting our financial health and preventing us from fulfilling our debt service and other obligations, and share price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause our actual results, performance or achievements to materially differ from any anticipated results, performance or achievements, please see our previously filed SEC reports, including those risks set forth in our 2015 Annual Report on Form 10-K. We disclaim any intention or obligation to update or revise any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.

Use of Non-GAAP Financial MeasuresTo 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. Reconciliations of the non-GAAP financial measures used in this release to the most directly comparable GAAP measures for the respective periods, and an explanation of our use of these non-GAAP measures, can be found in “Reconciliation of Non-GAAP Financial Measures” 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.

-Financial tables follow-

THE SPECTRANETICS CORPORATION
Condensed Consolidated Statements of Operations
(in thousands, except per share data and percentages)
(unaudited)
 
    Three Months Ended March 31,
    2016   2015
Revenue   $ 62,884     $ 57,422  
Cost of products sold    16,082     14,802  
Amortization of acquired inventory step-up        251  
Gross profit    46,802     42,369  
Operating expenses:        
Selling, general and administrative   40,789     36,942  
Research, development and other technology    16,337     15,261  
Medical device excise tax        806  
Acquisition transaction, integration and legal costs    292     10,391  
Acquisition-related intangible asset amortization    3,203     3,170  
Contingent consideration expense    100     1,024  
Total operating expense    60,721     67,594  
Operating loss    (13,919 )   (25,225 )
Other expense    (3,167 )   (1,933 )
Loss before income tax expense    (17,086 )   (27,158 )
Income tax expense    205     147  
Net loss    $ (17,291 )   $ (27,305 )
         
Net loss per common share:        
Basic and diluted    $ (0.40 )   $ (0.65 )
Weighted average shares outstanding:        
Basic and diluted    42,697     42,156  
             

THE SPECTRANETICS CORPORATION
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
 
    March 31, 2016   December 31, 2015
ASSETS        
Current assets:        
Cash and cash equivalents   $ 67,494     $ 84,594  
Accounts receivable, net   44,204     43,359  
Inventories, net   26,315     25,155  
Other current assets   5,951     5,171  
Total current assets   143,964     158,279  
Property and equipment, net   44,761     44,719  
Goodwill and intangible assets   259,869     263,072  
Other assets   1,953     1,929  
Total assets   $ 450,547     $ 467,999  
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Borrowings under revolving line of credit   $ 19,234     $ 24,232  
Other current liabilities   38,646     39,447  
Convertible debt, net of debt issuance costs   224,328     224,076  
Term loan, net of debt issuance costs   59,611     59,601  
Other non-current liabilities   3,770     3,674  
Stockholders’ equity   104,958     116,969  
Total liabilities and stockholders’ equity   $ 450,547     $ 467,999  
                 
THE SPECTRANETICS CORPORATION
Supplemental Financial Information
(Unaudited)
 
Financial Summary   2015   2016
(000’s, except laser sales and installed base amounts)   1st Qtr   2nd Qtr   3rd Qtr   4th Qtr   1st Qtr
Disposable products revenue:                    
Vascular Intervention   36,513     40,630     40,370     42,967     41,912  
Lead Management   16,431     17,257     17,961     18,250     17,096  
Total disposable products   52,944     57,887     58,331     61,217     59,008  
Laser, service, and other   4,478     3,790     3,329     3,980     3,876  
Total revenue   57,422     61,677     61,660     65,197     62,884  
                     
Gross margin percentage   74 %   74 %   74 %   75 %   74 %
                     
Net loss .   (27,305 )   (7,216 )   (14,493 )   (10,460 )   (17,291 )
                     
Cash flow used in operating activities   (22,461 )   (10,082 )   (10,225 )   (16,691 )   (12,444 )
Total cash and cash equivalents at end of quarter   43,639     49,255     41,721     84,594     67,494  
                     
Worldwide Installed Base Summary:                    
Laser placements during quarter   54     49     41     46     44  
Buy-backs/returns during quarter   (16 )   (11 )   (16 )   (26 )   (18 )
Net laser placements during quarter   38     38     25     20     26  
Total lasers placed at end of quarter   1,309     1,347     1,372     1,392     1,418  
                               

Reconciliation of Non-GAAP Financial Measures

To supplement our condensed consolidated financial statements prepared in accordance with GAAP, we use certain non-GAAP financial measures in this release. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures for the respective periods can be found in the tables below.  An explanation of the manner in which our management uses these non-GAAP measures to conduct and evaluate our business and the reasons management believes these non-GAAP measures provide useful information to investors are provided following the reconciliation tables.

Reconciliation of revenue by geography to non-GAAP revenue by geographyon a constant currency basis(in thousands, except percentages)(unaudited)
 
  Three Months Ended        
  March 31, 2016   March 31, 2015   % Change
  Revenue, as reported   Foreign exchange impact as compared to prior period   Revenue on a constant currency basis   Revenue, as reported   As reported   Constant currency basis
United States  $ 52,982     $     $ 52,982     $ 48,600     9 %   9 %
International  9,902     331     10,233     8,822     12 %   16 %
Total revenue  $ 62,884     $ 331     $ 63,215     $ 57,422     10 %   10 %
                                           
Reconciliation of revenue by product line to non-GAAP revenue by product lineon a constant currency basis(in thousands, except percentages)(unaudited)
 
  Three Months Ended      
  March 31, 2016   March 31, 2015   % Change
  Revenue, as reported   Foreign exchange impact as compared to prior period   Revenue on a constant currency basis   Revenue, as reported   As reported Constant currency basis
Vascular Intervention $ 41,912     $ 139     $ 42,051     $ 36,513     15 % 15 %
Lead Management 17,096     158     17,254     16,431     4 % 5 %
Laser, service, and other 3,876     34     3,910     4,478     (13 )% (13 )%
Total revenue $ 62,884     $ 331     $ 63,215     $ 57,422     10 % 10 %
Reconciliation of Net Loss to Non-GAAP Net Loss(in thousands) (unaudited)
         
    Three Months Ended
    March 31, 2016   March 31, 2015
Net loss, as reported    $ (17,291 )   $ (27,305 )
Amortization of acquired inventory step-up (1)        251  
Acquisition transaction, integration and legal costs (2)    292     10,391  
Acquisition-related intangible asset amortization (3)    3,203     3,170  
Contingent consideration expense (4)    100     1,024  
Non-GAAP net loss    $ (13,696 )   $ (12,469 )
                 
Reconciliation of Net Loss Per Share to Non-GAAP Net Loss Per Share(unaudited)
         
    Three Months Ended
    March 31, 2016   March 31, 2015
Net loss per share, as reported    $ (0.40 )   $ (0.65 )
Amortization of acquired inventory step-up (1)       0.01  
Acquisition transaction, integration and legal costs (2)   0.01     0.25  
Acquisition-related intangible asset amortization (3)   0.07     0.08  
Contingent consideration expense (4)       0.02  
Non-GAAP net loss per share (5)   $ (0.32 )   $ (0.30 )
                 
Reconciliation of 2016 Projected Net Loss to Non-GAAP Projected Net Loss(in millions) (unaudited)
    Projected Range
    Twelve Months EndingDecember 31, 2016
    Low   High
Net loss, GAAP    $ (64.0 )   $ (59.0 )
Acquisition transaction, integration and legal costs (6)    0.9     0.9  
Acquisition-related amortization and contingent consideration expense (7)    12.8     12.8  
Non-GAAP net loss    $ (50.3 )   $ (45.3 )
                 
Reconciliation of 2016 Projected Net Loss Per Share to Non-GAAP Projected Net Loss Per Share(unaudited)
    Projected Range
    Twelve Months Ending December 31, 2016
    Low   High
Net loss per share, GAAP   $ (1.45 )   $ (1.34 )
Acquisition transaction, integration and legal costs (6)   0.02     0.02  
Acquisition-related amortization and contingent consideration expense (7)   0.29     0.29  
Non-GAAP net loss per share (5)   $ (1.14 )   $ (1.03 )
                 

______________

1) Amortization of acquired inventory step-up relates to the inventory acquired in the AngioScore acquisition.

2) Acquisition transaction, integration and legal costs relate to the AngioScore and Stellarex acquisitions, which closed on June 30, 2014 and January 27, 2015, respectively, and included investment banking fees, accounting, consulting, and legal fees, severance and retention costs, and non-recurring costs associated with establishing manufacturing operations to support the Stellarex program.  In addition, these costs included $0.2 million and $8.0 million in the three months ended March 31, 2016, and 2015, respectively, for legal fees, including legal fees and costs advanced, associated with a patent and breach of fiduciary duty matter in which AngioScore is the plaintiff.  

3) Acquisition-related intangible asset amortization relates primarily to intangible assets acquired in the AngioScore acquisition in June 2014 and the Stellarex acquisition in January 2015.

4) Contingent consideration expense primarily represents the accretion of the estimated contingent consideration liability related to future amounts payable to former AngioScore stockholders, based on sales of the AngioScore products and achievement of regulatory milestones.  

5) Per share amounts may not add due to rounding.

6) Acquisition transaction, integration and legal costs consist of integration costs for the Stellarex and AngioScore acquisitions, which include legal fees and costs advanced associated with a patent and breach of fiduciary duty matter in which AngioScore is the plaintiff.  

7) Acquisition-related intangible asset amortization relates primarily to intangible assets acquired in the AngioScore acquisition in June 2014 and the Stellarex acquisition in January 2015. Contingent consideration expense primarily represents the accretion of the estimated contingent consideration liability related to future amounts payable to former AngioScore stockholders, based on sales of the AngioScore products and achievement of regulatory milestones.

Management uses the non-GAAP financial measures as supplemental measures to analyze the underlying trends in our business, assess the performance of our core operations, establish operational goals and forecasts that are used in allocating resources and evaluate our performance period over period and in relation to our competitors’ operating results.

The impact of foreign exchange rates is highly variable and difficult to predict. We use a constant currency basis to show the impact from foreign exchange rates on current period revenue compared to prior period revenue using the prior period’s foreign exchange rates. In order to properly understand the underlying business trends and performance of our ongoing operations, we believe that investors may find it useful to consider the impact of excluding changes in foreign exchange rates from our revenue.

We believe presenting the non-GAAP financial measures used in this release provides investors greater transparency to the information used by our management for financial and operational decision-making and allows investors to see our results “through the eyes” of management. We also believe providing this information better enables our investors to understand our operating performance and evaluate the methodology used by management to evaluate and measure such performance.

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. Some limitations associated with using these non-GAAP financial measures are provided below:

  • Management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP financial measures used.
  • Amortization expense, while not requiring cash settlement, is an ongoing and recurring expense and has a material impact on GAAP net income or loss and reflects costs to us not reflected in non-GAAP net loss.
  • Items such as the acquisition transaction and integration costs and contingent consideration expense excluded from non-GAAP net loss can have a material impact on cash flows and GAAP net loss and reflect economic costs to us not reflected in non-GAAP net loss.
  • Revenue growth rates stated on a constant currency basis, by their nature, exclude the impact of changes in foreign currency exchange rates, which may have a material impact on GAAP revenue.
  • Non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles and therefore other companies may calculate similarly titled non-GAAP financial measures differently than we do, limiting the usefulness of those measures for comparative purposes. 
Investor Relations Contacts

Zach Stassen
Investor.relations@spnc.com
(719) 447-2292

Michaella Gallina
Investor.relations@spnc.com
(719) 246-1713
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