The Spectranetics Corporation (NASDAQ:SPNC) today reported financial results for the three months ended June 30, 2016.  Highlights of the quarter, all compared with the three months ended June 30, 2015, include:
  • Revenue of $67.7 million increased 10% (both as reported and constant currency1)
  • Vascular Intervention revenue of $46.2 million increased 14% (13% constant currency)
  • Lead Management revenue of $17.8 million increased 3% (both as reported and constant currency)

Net loss for the three months ended June 30, 2016 was $14.9 million, or $0.35 per share, compared with net loss of $7.2 million, or $0.17 per share, for the three months ended June 30, 2015.

“Broad-based execution and strength in our innovation pipeline drove solid second quarter results,” said Scott Drake, President and CEO. “Overall, I am pleased with the growth that our team has delivered in the first half of the year and continue to be encouraged by progress in our clinical and product pipeline.”

2016 Financial OutlookSpectranetics’ management is providing the following updated full year 2016 financial outlook:

  • Revenue is projected to be within a range of $258 million to $268 million, an increase of 5% to 9% over 2015
  • Loss per share for 2016 is projected to be within a range of $1.37 to $1.49. Non-GAAP loss per share for 2016 is projected to be within a range of $1.06 to $1.18.  See “Reconciliation of Non-GAAP Financial Measures” later in this release

The following guidance metrics, as previously disclosed on February 25, 2016, remain unchanged:

  • 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 projected to be in the range of 61% to 63% of revenue
  • Net loss for 2016 is projected to be within a range of $59 million to $64 million. Non-GAAP net loss for 2016 is projected to be within a range of $45 million to $50 million.  See “Reconciliation of Non-GAAP Financial Measures” later in this release

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

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 42100557, 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, including FDA warning letters and any remediation efforts, 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, and our Quarterly Report on Form 10-Q for the three months ended March 31, 2016. 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 June 30,   Six Months Ended June 30,
    2016   2015   2016   2015
Revenue    $ 67,748     $ 61,677     $ 130,632     $ 119,099  
Cost of products sold    16,983     15,914     33,065     30,967  
Amortization of acquired inventory step-up                 
Gross profit   50,765     45,763     97,567     88,132  
Operating expenses:                
Selling, general and administrative    40,643     35,562     81,432     72,504  
Research, development and other technology    17,657     16,660     33,994     31,921  
Medical device excise tax        821         1,627  
Acquisition transaction, integration and legal costs    500     11,106     792     21,497  
Acquisition-related intangible asset amortization    3,202     3,612     6,405     6,782  
Contingent consideration expense    67     1,060     167     2,084  
Change in fair value of contingent consideration liability       (17,800 )       (17,800 )
Total operating expense    62,069     51,021     122,790     118,615  
Operating loss    (11,304 )   (5,258 )   (25,223 )   (30,483 )
Other expense    (3,452 )   (1,838 )   (6,619 )   (3,771 )
Loss before income tax expense    (14,756 )   (7,096 )   (31,842 )   (34,254 )
Income tax expense    150     120     355     267  
Net loss    $ (14,906 )   $ (7,216 )   $ (32,197 )   $ (34,521 )
                 
Net loss per common share:                
Basic and diluted    $ (0.35 )   $ (0.17 )   $ (0.75 )   $ (0.82 )
Weighted average shares outstanding:                
Basic and diluted    42,804     42,389     42,751     42,273  
                         

THE SPECTRANETICS CORPORATION
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
 
    June 30, 2016   December 31, 2015
ASSETS        
Current assets:        
Cash and cash equivalents    $ 64,343     $ 84,594  
Accounts receivable, net    43,248     43,359  
Inventories, net    25,672     25,155  
Other current assets    5,924     5,171  
Total current assets    139,187     158,279  
Property and equipment, net    44,624     44,719  
Goodwill and intangible assets    253,533     263,072  
Other assets    1,917     1,929  
Total assets    $ 439,261     $ 467,999  
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Borrowings under revolving line of credit    $ 19,232     $ 24,232  
Other current liabilities    41,798     39,447  
Convertible debt, net of debt issuance costs    224,581     224,076  
Term loan, net of debt issuance costs    59,628     59,601  
Other non-current liabilities    3,771     3,674  
Stockholders’ equity    90,251     116,969  
Total liabilities and stockholders’ equity    $ 439,261     $ 467,999  
                 
THE SPECTRANETICS CORPORATION
Supplemental Financial Information
(Unaudited)
 
Financial Summary     2015   2016
(000’s, except laser sales and installed base amounts)     2nd Qtr   3rd Qtr   4th Qtr   1st Qtr   2nd Qtr
Disposable products revenue:                      
Vascular Intervention     40,630     40,370     42,967     41,912     46,218  
Lead Management     17,257     17,961     18,250     17,096     17,767  
Total disposable products     57,887     58,331     61,217     59,008     63,985  
Laser, service, and other     3,790     3,329     3,980     3,876     3,763  
Total revenue     61,677     61,660     65,197     62,884     67,748  
                       
Gross margin percentage     74 %   74 %   75 %   74 %   75 %
                       
Net loss      (7,216 )   (14,493 )   (10,460 )   (17,291 )   (14,906 )
                       
Cash flow used in operating activities     (10,082 )   (10,225 )   (16,691 )   (12,444 )   (1,873 )
Total cash and cash equivalents at end of quarter     49,255     41,721     84,594     67,494     64,343  
                       
Worldwide Installed Base Summary:                      
Laser placements during quarter     49     41     46     44     45  
Buy-backs/returns during quarter     (11 )   (16 )   (26 )   (18 )   (21 )
Net laser placements during quarter     38     25     20     26     24  
Total lasers placed at end of quarter     1,347     1,372     1,392     1,418     1,442  
                                 

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        
    June 30, 2016   June 30, 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    $ 56,334     $     $ 56,334     $ 51,593     9 %   9 %
International   11,414     (209 )   11,205     10,084     13 %   11 %
Total revenue    $ 67,748     $ (209 )   $ 67,539     $ 61,677     10 %   10 %
                         
    Six Months Ended        
    June 30, 2016   June 30, 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    $ 109,316     $     $ 109,316     $ 100,193     9 %   9 %
International   21,316     123     21,439     18,906     13 %   13 %
Total revenue    $ 130,632     $ 123     $ 130,755     $ 119,099     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      
    June 30, 2016   June 30, 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    $ 46,218     $ (136 )   $ 46,082     $ 40,630     14 % 13 %
Lead Management    17,767     (62 )   17,705     17,257     3 % 3 %
Laser, service, and other    3,763     (11 )   3,752     3,790     (1 )% (1 )%
Total revenue    $ 67,748     $ (209 )   $ 67,539     $ 61,677     10 % 10 %
                       
    Six Months Ended      
    June 30, 2016   June 30, 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    $ 88,130     $ 3     $ 88,133     $ 77,143     14 % 14 %
Lead Management    34,863     96     34,959     33,688     3 % 4 %
Laser, service, and other    7,639     24     7,663     8,268     (8 )% (7 )%
Total revenue    $ 130,632     $ 123     $ 130,755     $ 119,099     10 % 10 %
                                           
Reconciliation of Net Loss to Non-GAAP Net Loss(in thousands) (unaudited)
                 
    Three Months Ended   Six Months Ended
    June 30, 2016   June 30, 2015   June 30, 2016   June 30, 2015
Net loss, as reported   $ (14,906 )   $ (7,216 )   $ (32,197 )   $ (34,521 )
Acquisition transaction, integration and legal costs (1)   500     11,106     792     21,497  
Acquisition-related intangible asset amortization (2)   3,202     3,612     6,405     6,782  
Contingent consideration expense (3)   67     1,060     167     2,084  
Change in fair value of contingent consideration liability (4)       (17,800 )       (17,800 )
Non-GAAP net loss   $ (11,137 )   $ (9,238 )   $ (24,833 )   $ (21,958 )
                                 
Reconciliation of Net Loss Per Share to Non-GAAP Net Loss Per Share(unaudited)
                 
    Three Months Ended   Six Months Ended
    June 30, 2016   June 30, 2015   June 30, 2016   June 30, 2015
Net loss per share, as reported   $ (0.35 )   $ (0.17 )   $ (0.75 )   $ (0.82 )
Acquisition transaction, integration and legal costs (1)    0.01     0.26     0.02     0.51  
Acquisition-related intangible asset amortization (2)    0.07     0.09     0.15     0.16  
Contingent consideration expense (3)        0.03         0.05  
Change in fair value of contingent consideration liability (4)        (0.42 )       (0.42 )
Non-GAAP net loss per share (5)    $ (0.26 )   $ (0.22 )   $ (0.58 )   $ (0.52 )
                                 
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   $ (1.49 )   $ (1.37 )
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)    $ (1.18 )   $ (1.06 )

______________

1) 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 $0.5 million and $8.5 million in the three months ended June 30, 2016 and 2015, respectively, and $0.7 million and $16.5 million in the six months ended June 30, 2016, and 2015, respectively, for legal fees, including legal fees associated with a patent matter and breach of fiduciary duty matter in which AngioScore is the plaintiff, and costs advanced associated with the breach of fiduciary duty matter.

2) 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.

3) 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.

4) During the three months ended June 30, 2015, we remeasured the contingent consideration liability related to the AngioScore acquisition to its fair value and reduced it by approximately $17.8 million. This reduction was the result of a decrease in future revenue estimates for the AngioSculpt products.

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 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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