COLORADO SPRINGS, Colo., Oct. 22, 2015 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) today reported financial results for the three and nine months ended September 30, 2015. Highlights of the quarter, all compared with the three months ended September 30, 2014 include:

  • Revenue of $61.7 million increased 5% (7% constant currency1)
  • Vascular Intervention revenue of $40.4 million increased 10% (12% constant currency)
  • Lead Management revenue of $18.0 million increased 2% (5% constant currency)

“We are pleased with our third quarter results, marked by solid performance within our Vascular Intervention, Lead Management and International businesses. We believe that our team, portfolio, product pipeline and clinical data position us to capitalize on the compelling growth opportunities ahead,” said Scott Drake, President and Chief Executive Officer.

Net loss for the three months ended September 30, 2015 was $14.5 million, or $0.34 per share, compared with net loss of $13.9 million, or $0.33 per share, for the three months ended September 30, 2014. Non-GAAP net loss1 for the three months ended September 30, 2015 was $7.2 million, or $0.17 per share, compared with non-GAAP net loss of $1.9 million, or $0.05 per share, for the three months ended September 30, 2014.

__________________________

1Constant currency and non-GAAP net loss are non-GAAP financial measures. See “Reconciliation of Non-GAAP Financial Measures” later in this release.

Year-To-Date Financial Results

Revenue for the nine months ended September 30, 2015 rose 27% (30% constant currency) to $180.8 million from $142.0 million for the nine months ended September 30, 2014. Total Vascular Intervention revenue increased 49% (50% constant currency), to $117.5 million. Lead Management revenue increased 7% (10% constant currency) to $51.6 million. Laser system, service and other revenue decreased 21% (18% constant currency) to $11.6 million.

AngioSculpt revenue was $42.6 million for the nine months ended September 30, 2015. Excluding AngioSculpt revenue from the June 30, 2014 acquisition date, total revenue increased 9% (11% constant currency) and Vascular Intervention revenue, excluding AngioSculpt, increased 17% (18% constant currency).

Net loss during the nine months ended September 30, 2015 was $49.0 million, or $1.16 per share, compared with net loss of $24.9 million, or $0.60 per share, for the nine months ended September 30, 2014. Non-GAAP net loss during the nine months ended September 30, 2015 was $28.9 million, or $0.68 per share, compared with non-GAAP net loss of $9.6 million, or $0.23 per share, for the nine months ended September 30, 2014.

2015 Financial Outlook

Spectranetics updates its projected 2015 revenue to be within a range of $242 million to $248 million compared with $240 million to $250 million previously projected.

Net loss is projected to be within a range of $65.0 million to $69.0 million, or $1.53 to $1.62 per share, unchanged from previous projections. Non-GAAP net loss is projected to be within a range of $40.0 million to $44.0 million, or $0.94 to $1.04 per share, compared with previous projections of $41 million to $45 million, or $0.96 to $1.07 per share. See “Reconciliation of non-GAAP Financial Measures” later in this release. Gross margin is projected within a range of 73.5% to 74.0%, unchanged from previous projections. Research, development and other technology expenses are expected to be approximately 26.5% to 27.0%, compared with 26.5% to 27.5% previously projected.

Conference Call

Management 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 48806203, 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 Spectranetics

The Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are sold 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 Statement

This 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, 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 2015 outlook 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 release. These risks and uncertainties may include financial results differing from guidance, inability to successfully integrate AngioScore and Stellarex into our business, market acceptance of excimer laser atherectomy technology and our vascular intervention and lead removal products, lack of cash necessary to satisfy our cash obligations under our outstanding 2.625% Convertible Senior Notes due 2034, our debt adversely affecting our financial health and preventing us from fulfilling our debt service and other obligations, increasing price and product competition, 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, loss of key personnel, uncertain success of or delays in our clinical trials, adverse results in any ongoing legal proceeding, or any legal proceeding in which we may become involved, adverse impact to our business of the health care reform and related legislation or regulations, including changes in reimbursements, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of inspections by the U.S. Food and Drug Administration (FDA), the receipt of FDA approval to market new products or applications and the timeliness of any approvals, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with any planned improvements to our manufacturing processes, 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 reports with the Securities and Exchange Commission, including those risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the three months ended June 30, 2015. 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 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. 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 Nine Months Ended
  September 30, September 30,
  2015 2014 2015 2014
Revenue  $ 61,660  $ 58,786  $ 180,759  $ 141,955
Cost of products sold 15,809 14,686 46,525 35,526
Amortization of acquired inventory step-up 1,014 251 1,014
Gross profit 45,851 43,086 133,983 105,415
Operating expenses:        
Selling, general and administrative 34,116 35,490 106,620 91,682
Research, development and other technology 15,926 7,573 47,847 19,364
Medical device excise tax 916 864 2,543 1,977
Acquisition transaction, integration and other costs 5,403 3,826 26,900 8,055
Acquisition-related intangible asset amortization 3,290 3,055 10,072 3,328
Contingent consideration expense 387 1,037 2,471 1,115
Change in fair value of contingent consideration liability (4,256) (1,064) (22,056) (1,064)
Intangible asset impairment 2,496 4,138 2,496 4,138
Total operating expenses 58,278 54,919 176,893 128,595
Operating loss (12,427) (11,833) (42,910) (23,180)
Other expense (1,890) (1,923) (5,661) (2,409)
Loss before taxes (14,317) (13,756) (48,571) (25,589)
Income tax expense (benefit) 176 188 443 (685)
Net loss $ (14,493) $ (13,944) $ (49,014) $ (24,904)
         
Net loss per common share:        
Basic and diluted $ (0.34) $ (0.33) $ (1.16) $ (0.60)
Weighted average shares outstanding:        
Basic and diluted 42,556 41,822 42,369 41,595
         
         
THE SPECTRANETICS CORPORATION
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
     
  September 30, December 31,
  2015 2014
ASSETS    
Current assets:    
Cash and cash equivalents  $ 41,721  $ 95,505
Accounts receivable, net 40,072 41,090
Inventories, net 27,540 25,446
Other current assets 7,861 10,293
Total current assets 117,194 172,334
Property and equipment, net 45,136 33,819
Debt issuance costs, net 6,174 6,912
Goodwill and intangible assets 266,274 252,514
Other assets 1,947 1,371
Total assets  $ 436,725  $ 466,950
     
LIABILITIES AND STOCKHOLDERS’ EQUITY    
Borrowings under revolving line of credit  $ 23,110 $ —
Other current liabilities 48,094 41,343
Convertible senior notes 230,000 230,000
Other non-current liabilities 9,310 33,450
Stockholders’ equity 126,211 162,157
Total liabilities and stockholders’ equity  $ 436,725  $ 466,950
     
     
THE SPECTRANETICS CORPORATION
Supplemental Financial Information
(Unaudited)
           
Financial Summary 2014 2015
(000’s, except laser sales and installed base amounts) 3rd Qtr 4th Qtr 1st Qtr 2nd Qtr 3rd Qtr
           
Disposable products revenue:          
Vascular Intervention 36,576 39,055 36,513 40,630 40,370
Lead Management 17,569 18,509 16,431 17,257 17,961
Total disposable products 54,145 57,564 52,944 57,887 58,331
           
Laser, service, and other 4,641 5,395 4,478 3,790 3,329
           
Total revenue 58,786 62,959 57,422 61,677 61,660
Non-GAAP gross margin percentage (excluding amortization of acquired inventory step-up) (1) 75% 75% 74% 74% 74%
           
Net loss (13,944) (14,731) (27,305) (7,216) (14,493)
           
Cash flow used in operating activities (3,403) (7,576) (22,461) (10,082) (10,225)
Total cash and cash equivalents at end of quarter 103,538 95,505 43,639 49,255 41,721
           
Laser sales summary:          
Laser sales from inventory 7 11 6 2 1
Laser sales from evaluation/rental units 5 2 2 1
Total laser sales 12 13 8 2 2
           
(1) Non-GAAP gross margin percentage (excluding amortization of acquired inventory step-up) is a non-GAAP financial measure and was recorded during the third quarter of 2014 through the first quarter of 2015. Please refer to the non-GAAP reconciliation tables following this table for the reconciliation to the most comparable GAAP measure.
           
Worldwide Installed Base Summary:          
Laser sales from inventory 7 11 6 2 1
Rental placements 34 26 37 42 35
Evaluation placements 11 8 11 5 5
Laser placements during quarter 52 45 54 49 41
Buy-backs/returns during quarter (11) (10) (16) (11) (16)
Net laser placements during quarter 41 35 38 38 25
Total lasers placed at end of quarter 1,236 1,271 1,309 1,347 1,372
           

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.

THE SPECTRANETICS CORPORATION
Reconciliation of revenue by geography to non-GAAP revenue by geography
on a constant currency basis
(in thousands, except percentages)
(unaudited)
             
  Three Months Ended    
    September 30,  
  September 30, 2015 2014 % Change
    Foreign        
    exchange Revenue on      
    impact as a constant     Constant
  Revenue, compared to currency Revenue, as   currency
  as reported prior period basis reported As reported basis
United States  $ 51,936 $ —   $ 51,936  $ 48,463 7% 7%
International 9,724 1,066 10,790 10,323 (6)% 5%
Total revenue  $ 61,660  $ 1,066  $ 62,726  $ 58,786 5% 7%
             
  Nine Months Ended    
    September 30,  
  September 30, 2015 2014 % Change
    Foreign        
    exchange Revenue on      
    impact as a constant     Constant
  Revenue, compared to currency Revenue, as   currency
  as reported prior period basis reported As reported basis
United States  $ 152,129 $ —   $ 152,129  $ 115,089 32% 32%
International 28,630 3,342 31,972 26,866 7% 19%
Total revenue  $ 180,759  $ 3,342  $ 184,101  $ 141,955 27% 30%
             
             
THE SPECTRANETICS CORPORATION
Reconciliation of revenue by product line to non-GAAP revenue by product line
on a constant currency basis
(in thousands, except percentages)
(unaudited)
             
  Three Months Ended    
        September 30,    
  September 30, 2015 2014 % Change
    Foreign        
    exchange        
    impact as Revenue on      
    compared a constant     Constant
  Revenue, to prior currency Revenue, as   currency
  as reported period basis reported As reported basis
Vascular Intervention  $ 40,370  $ 433  $ 40,803  $ 36,576 10% 12%
Lead Management 17,961 518 18,479 17,569 2% 5%
Laser System, Service & Other 3,329 115 3,444 4,641 (28)% (26)%
Total revenue  $ 61,660  $ 1,066  $ 62,726  $ 58,786 5% 7%
             
  Nine Months Ended    
        September 30,    
  September 30, 2015 2014 % Change
    Foreign        
    exchange        
    impact as Revenue on      
    compared a constant     Constant
  Revenue, to prior currency Revenue, as   currency
  as reported period basis reported As reported basis
Vascular Intervention, ex-AngioSculpt  $ 74,899  $ 938  $ 75,837  $ 64,151 17% 18%
AngioSculpt 42,614 480 43,094 14,942 185% 188%
Total Vascular Intervention  $ 117,513  $ 1,418  $ 118,931  $ 79,093 49% 50%
Lead Management 51,649 1,524 53,173 48,153 7% 10%
Laser System, Service & Other 11,597 400 11,997 14,709 (21)% (18)%
Total revenue  $ 180,759  $ 3,342  $ 184,101  $ 141,955 27% 30%
Total revenue ex-AngioSculpt  $ 138,145  $ 2,862  $ 141,007  $ 127,013 9% 11%
             
             
THE SPECTRANETICS CORPORATION
           
Reconciliation of gross margin to non-GAAP gross margin
excluding amortization of acquired inventory step-up
(in thousands, except percentages)
(unaudited)
           
  Three Months Ended
  Sept. 30, Dec. 31, March 31, June 30, Sept. 30,
  2014 2014 2015 2015 2015
Gross profit, as reported  $ 43,086  $ 46,040  $ 42,369  $ 45,763  $ 45,851
Amortization of acquired inventory step-up (1) 1,014 1,060 251
Adjusted gross profit, excluding amortization of acquired inventory step-up  $ 44,100  $ 47,100  $ 42,620  $ 45,763  $ 45,851
           
Gross margin, as reported 73% 73% 74% 74% 74%
Non-GAAP gross margin, excluding amortization of acquired inventory step-up 75% 75% 74% 74% 74%
           
  Footnote explanations can be found following the last non-GAAP tables.
           
           
Reconciliation of Net Loss to Non-GAAP Net Loss
(in thousands)
(unaudited)
         
  Three Months Ended Nine Months Ended
  September 30, September 30, September 30, September 30,
  2015 2014 2015 2014
Net loss, as reported $ (14,493) $ (13,944) $ (49,014) $ (24,904)
Acquisition transaction, integration and other costs (2) 5,403 3,826 26,900 8,055
Amortization of acquired inventory step-up (1) 1,014 251 1,014
Acquisition-related intangible asset amortization (3) 3,290 3,055 10,072 3,328
Contingent consideration expense (4) 387 1,037 2,471 1,115
Change in fair value of contingent consideration liability (5) (4,256) (1,064) (22,056) (1,064)
Intangible asset impairment (5) 2,496 4,138 2,496 4,138
Release of valuation allowance related to AngioScore acquisition (6) (1,266)
Non-GAAP net loss $ (7,173) $ (1,938) $ (28,880) $ (9,584)
         
         
THE SPECTRANETICS CORPORATION
Reconciliation of Net Loss Per Share to Non-GAAP Net Loss Per Share
(unaudited)
         
  Three Months Ended Nine Months Ended
  September 30, September 30, September 30, September
  2015 2014 2015 30, 2014
Net loss per share, as reported $ (0.34) $ (0.33) $ (1.16) $ (0.60)
Acquisition transaction, integration and other costs (2) 0.13 0.09 0.63 0.19
Amortization of acquired inventory step-up (1) 0.02 0.01 0.02
Acquisition-related intangible asset amortization (3) 0.08 0.07 0.24 0.08
Contingent consideration expense (4) 0.01 0.02 0.06 0.03
Change in fair value of contingent consideration liability (5) (0.10) (0.03) (0.52) (0.03)
Intangible asset impairment (5) 0.06 0.10 0.06 0.10
Release of valuation allowance related to AngioScore acquisition (6) (0.03)
Non-GAAP net loss per share (7) $ (0.17) $ (0.05) $ (0.68) $ (0.23)
         
         
Reconciliation of 2015 Projected Net Loss to Non-GAAP Projected Net Loss
(in millions)
(unaudited)
  Projected Range
  Twelve Months Ending
  December 31, 2015
  Low High
Net loss, GAAP $ (69.0) $ (65.0)
Acquisition transaction, integration and other costs (8) 28.4 28.4
Acquisition-related amortization and contingent consideration expense (9) 16.2 16.2
Change in fair value of contingent consideration liability and intangible asset impairment, net (5) (19.6) (19.6)
Non-GAAP net loss $ (44.0) $ (40.0)
     
Reconciliation of 2015 Projected Net Loss Per Share to Non-GAAP Projected Net Loss Per Share
(unaudited)
  Projected Range
  Twelve Months Ending
  December 31, 2015
  Low High
Net loss per share, GAAP $ (1.62) $ (1.53)
Acquisition transaction, integration and other costs (8) 0.67 0.67
Acquisition-related amortization and contingent consideration expense (9) 0.38 0.38
Change in fair value of contingent consideration liability and intangible asset impairment, net (5) (0.46) (0.46)
Non-GAAP net loss per share (7) $ (1.04) $ (0.94)
     

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

2) Acquisition transaction, integration and other 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 $1.2 million in the three months ended September 30, 2014, and $2.5 million and $18.9 million in the three and nine months ended September 30, 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 represents the accretion of the estimated contingent consideration liability related to future amounts payable to former AngioScore stockholders primarily based on sales of the AngioScore products and achievement of regulatory milestones. 

5) During the three months ended September 30, 2015, we remeasured the contingent consideration liability related to the AngioScore regulatory milestones to its fair value and reduced it by approximately $4.3 million. The intangible asset impairment of $2.5 million was to record a partial impairment of the in-process research and development intangible assets acquired as part of the AngioScore acquisition.

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

6) Income tax benefit for the nine months ended September 30, 2014 included a tax benefit of $1.3 million resulting from a reduction in the valuation allowance against our deferred tax assets related to the acquisition of AngioScore.

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

8) Acquisition transaction, integration and other costs consist of integration costs for the Stellarex and AngioScore acquisitions of $8.9 million and legal fees of $19.5 million, which includes legal fees and costs advanced, associated with a patent and breach of fiduciary duty matter in which AngioScore is the plaintiff.

9) 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 represents the accretion of the estimated contingent consideration liability related to future amounts that may be payable to former AngioScore stockholders primarily 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. The intangible asset impairment, while not requiring cash settlement, reflects an economic cost to us not reflected in non-GAAP net loss.
  • Items such as the acquisition transaction and integration costs, contingent consideration expense and the change in fair value of contingent consideration liability 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.
CONTACT: Investor Relations Contacts
         Guy Childs
         [email protected]
         (719) 447-2415
         
         Lynn Pieper
         [email protected]
         (415) 202-5678