OREANDA-NEWS. July 29, 2016. 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 Outlook
Spectranetics’ 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 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 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 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 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 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 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 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
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 geography
on 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 line
on 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 reportedConstant
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 reportedConstant
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 Ending
December 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.