Spectranetics Achieves First Quarter 2015 Revenue of $57.4 Million

Colorado Springs, Colorado, UNITED STATES


Expands Stellarex™ Program to Below the Knee Market

Updates 2015 Outlook

COLORADO SPRINGS, Colo., April 23, 2015 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today reported financial results for the three months ended March 31, 2015. Highlights of the quarter, all compared with the three months ended March 31, 2014 include:

  • Revenue of $57.4 million, up 45% (47% constant currency1)
  • Vascular Intervention revenue of $36.5 million grew 82% (84% constant currency)
    • U.S. peripheral atherectomy revenue grew 16%
    • AngioSculpt® revenue of $14.0 million achieved
  • Lead Management revenue of $16.4 million increased 14% (16% constant currency)
  • U.S. revenue grew 53% to $48.6 million; International revenue grew 12% (24% constant currency) to $8.8 million
  • Record placements of 54 laser systems
  • Stellarex program expands to below the knee (BTK) market; Investigational Device Exemption (IDE) discussions underway with FDA; Stellarex BTK European launch planned in late 2016
  • CE submission on Drug-Coated Coronary AngioSculpt®; targeting mid-2016 European launch

"Solid execution across commercial, clinical and new product development is evident," said Scott Drake, President and Chief Executive Officer. "Our Lead Management and International businesses continue with solid double-digit growth. Our Vascular Intervention portfolio is profoundly strengthening, especially in our drug-coated balloon (DCB) platform, and record laser placements bode well for future growth. Vascular performance is generally on track, yet scoring balloons in the United States are feeling the effect of recent competitive DCB launches. Given recent launches, it is difficult to predict long-term impact, therefore we are guiding investors to the low end of our previously provided outlook."

Net loss for the three months ended March 31, 2015 was $27.3 million, or $0.65 per share, compared with net loss of $5.7 million, or $0.14 per share, for the three months ended March 31, 2014. Non-GAAP net loss1, which primarily excludes acquisition-related items, for the three months ended March 31, 2015 was $12.5 million, or $0.30 per share, compared with non-GAAP net loss of $5.2 million, or $0.13 per share, for the three months ended March 31, 2014.

2015 Financial Outlook

Spectranetics management continues to project revenue in the range of $258 million to $265 million, an increase of 26% to 29% over 2014, but is guiding to the low end of the range. The revision reflects the potential impact of DCB products recently launched by competitors on the U.S. AngioSculpt business. As a result, Vascular Intervention revenue is anticipated to be at the low end of the previously provided 41% to 46% range. More specifically, AngioSculpt revenue is projected in the range of $59 million to $66 million, compared with previous outlook of $62 million to $66 million. The remainder of our revenue outlook is unchanged, including ISR revenue of $15 million to $20 million, and Lead Management revenue of 8% - 10% growth compared with last year.

Net loss for 2015 is projected to be within a range of $78.0 million to $82.0 million, or $1.84 to $1.93 per share, compared with $58.0 million to $62.0 million, or $1.36 to $1.46 previously provided. The increased net loss consists of approximately $14 million of incremental spending associated with the Stellarex program and $6 million of increased costs related to litigation with TriReme Medical, Inc.

The projected net loss from the Stellarex program has been increased from approximately $30 million, or $0.71 per share, to approximately $44 million or $1.04 per share. The increased costs are primarily due to accelerating the BTK program, and non-recurring integration costs. Management estimates launch of the Stellarex BTK product in Europe in late 2016 and has submitted a pre-IDE application to the Food and Drug Administration to support a randomized clinical trial in the U.S.

Non-GAAP net loss for 2015 is projected to be within a range of $41.3 million to $45.3 million, or $0.97 to $1.07 per share, compared with $31.9 million to $35.9 million, or $0.75 to $0.84 per share previously provided. See "Reconciliation of non-GAAP Financial Measures" later in this release. Additional details supporting the 2015 outlook are provided below:

  • Gross margin is unchanged and expected to be within a range of 74.5% to 75.0%. This includes improvement of approximately 50 basis points within the current business, which is offset by the dilutive impact of approximately 50 to 100 basis points associated with establishing manufacturing operations for the Stellarex product line.
     
  • Research, development and other technology expenses are expected to be approximately 27.0% to 28.0% of revenue, revised from 25.5% to 26.0% provided previously. The increase is entirely due to costs associated with the Stellarex program.

_____________________
1Constant currency and non-GAAP net loss are non-GAAP financial measures. 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 19910355, 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

Spectranetics 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.

Spectranetics recently acquired AngioScore Inc., a leading developer, manufacturer and marketer of cardiovascular, specialty scoring balloons, and the Stellarex drug-coated balloon platform from Covidien.

The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee as well as the AngioSculpt® scoring balloon used in both peripheral and coronary procedures and the Stellarex drug-coated balloon platform. 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 and 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, 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 prevent 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 FDA inspections, 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 SEC reports, including those risks set forth in our 2014 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 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 March 31,
  2015 2014
Revenue  $ 57,422  $ 39,614
Cost of products sold 14,802 10,334
Amortization of acquired inventory step-up 251
Gross profit 42,369 29,280
Operating expenses:    
Selling, general and administrative 36,942 27,740
Research, development and other technology 15,261 6,087
Medical device excise tax 806 525
Acquisition transaction and integration costs 10,391 271
Acquisition-related intangible asset amortization 3,170 137
Contingent consideration expense 1,024 38
Total operating expenses 67,594 34,798
Operating loss (25,225) (5,518)
Other (expense) income, net (1,933) 4
Loss before taxes (27,158) (5,514)
Income tax expense 147 147
Net loss  $ (27,305)  $ (5,661)
     
Net loss per common share:    
Basic and diluted  $ (0.65)  $ (0.14)
Weighted average shares outstanding:    
Basic and diluted 42,156 41,354
     
     
THE SPECTRANETICS CORPORATION
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
     
  March 31, 2015 December 31, 2014
ASSETS    
Current assets:    
Cash and cash equivalents  $ 43,639  $ 95,505
Accounts receivable, net 38,831 41,090
Inventories, net 27,670 25,446
Deferred income taxes, current portion, net 2,200 2,200
Other current assets 9,180 8,093
Total current assets 121,520 172,334
Property and equipment, net 38,260 33,819
Debt issuance costs, net 6,668 6,912
Goodwill and intangible assets 275,800 252,514
Other assets 1,541 1,371
Total assets  $ 443,789  $ 466,950
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current liabilities  $ 39,207  $ 41,343
Convertible senior notes 230,000 230,000
Other non-current liabilities 34,774 33,450
Stockholders' equity 139,808 162,157
Total liabilities and stockholders' equity  $ 443,789  $ 466,950
     
           
THE SPECTRANETICS CORPORATION
Supplemental Financial Information
(Unaudited)
           
Financial Summary 2014 2015
(000's, except laser sales and installed base amounts) 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 1st Qtr
           
Disposable products revenue:          
Vascular Intervention revenue (ex-AngioSculpt)  $ 20,021  $ 22,496  $ 21,634  $ 24,371  $ 22,492
Vascular Intervention revenue (AngioSculpt) 14,942 14,684 14,021
Total Vascular Intervention revenue 20,021 22,496 36,576 39,055 36,513
Lead Management revenue 14,470 16,114 17,569 18,509 16,431
Total disposable products revenue 34,491 38,610 54,145 57,564 52,944
           
Laser, service, and other revenue 5,123 4,945 4,641 5,395 4,478
           
Total revenue 39,614 43,555 58,786 62,959 57,422
Non-GAAP gross margin percentage (excluding amortization of acquired inventory step up) (1) 73.9% 75.9% 75.0% 74.8% 74.2%
           
Net loss (5,661) (6,565) (13,944) (14,731) (27,305)
           
Cash flow used in operating activities (8,359) (1,111) (3,403) (7,576) (22,874)
Total cash and cash equivalents at end of quarter 120,866 107,027 103,538 95,505 43,639
           
Laser sales summary:          
Laser sales from inventory 9 8 7 11 6
Laser sales from evaluation/rental units 4 1 5 2 2
Total laser sales 13 9 12 13 8
           
(1) Non-GAAP gross margin percentage (excluding amortization of acquired inventory step up) is a non-GAAP financial measure. 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 9 8 7 11 6
Rental placements 20 32 34 26 37
Evaluation placements 8 6 11 8 11
Laser placements during quarter 37 46 52 45 54
Buy-backs/returns during quarter (17) (15) (11) (10) (16)
Net laser placements during quarter 20 31 41 35 38
Total lasers placed at end of quarter 1,164 1,195 1,236 1,271 1,309
           

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    
  March 31, 2015 March 31, 2014 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  $ 48,600 $ —  $ 48,600  $ 31,772 53% 53%
International 8,822 917 9,739 7,842 12% 24%
Total revenue  $ 57,422  $ 917  $ 58,339  $ 39,614 45% 47%
             
             
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    
  March 31, 2015 March 31, 2014 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  $ 36,513  $ 363  $ 36,876  $ 20,021 82% 84%
Lead Management 16,431 402 16,833 14,470 14% 16%
Laser System, Service & Other 4,478 152 4,630 5,123 (13)% (10)%
Total revenue  $ 57,422  $ 917  $ 58,339  $ 39,614 45% 47%
             
     
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
  March 31, 2015 March 31, 2014
Gross profit, as reported  $ 42,369  $ 29,280
Amortization of acquired inventory step-up (1) 251
Adjusted gross profit, excluding amortization of acquired inventory step-up  $ 42,620  $ 29,280
     
Gross margin percentage, as reported 73.8% 73.9%
Non-GAAP gross margin percentage, excluding amortization of acquired inventory step-up 74.2% 73.9%
     
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
  March 31, 2015 March 31, 2014
Net loss, as reported  $ (27,305)  $ (5,661)
Acquisition transaction and integration costs (2) 10,391 271
Amortization of acquired inventory step-up (1) 251
Acquisition-related intangible asset amortization (3) 3,170 137
Contingent consideration expense (4) 1,024 38
Non-GAAP net loss  $ (12,469)  $ (5,215)
     
     
Reconciliation of Net Loss Per Share to Non-GAAP Net Loss Per Share
(unaudited)
     
  Three Months Ended
  March 31, 2015 March 31, 2014
Net loss per share, as reported  $ (0.65)  $ (0.14)
Acquisition transaction and integration costs (2) 0.25 0.01
Amortization of acquired inventory step-up (1) 0.01
Acquisition-related intangible asset amortization (3) 0.08
Contingent consideration expense (4) 0.02
Non-GAAP net loss per share (5)  $ (0.30)  $ (0.13)
     
     
THE SPECTRANETICS CORPORATION
Reconciliation of 2015 Projected Net Loss to Non-GAAP Projected Net Loss
(in millions)
(unaudited)
     
  Projected Range
  Twelve Months Ending
  December 31, 2015 December 31, 2015
Net loss, GAAP  $ (82.0)  $ (78.0)
Acquisition-related transaction and integration costs (6) 19.0 19.0
Acquisition-related amortization & contingent consideration expense (7) 17.7 17.7
Non-GAAP net loss  $ (45.3)  $ (41.3)
     
     
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 December 31, 2015
Net loss per share, GAAP  $ (1.93)  $ (1.84)
Acquisition-related transaction and integration costs (6) 0.45 0.45
Acquisition-related amortization & contingent consideration expense (7) 0.41 0.41
Non-GAAP net loss per share (5)  $ (1.07)  $ (0.97)
     

__________________

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

2) Acquisition transaction and integration costs primarily 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, $5.6 million, and $8.0 million during the third and fourth quarters of 2014 and the first quarter of 2015, respectively, for legal fees associated with a patent-related 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 product development milestones.

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

6) Acquisition-related transaction and integration costs include AngioScore severance and retention costs of $2.1 million, legal fees associated with a patent-related matter in which AngioScore is the plaintiff of $10.6 million and estimated transaction and integration costs for the Stellarex acquisition of $6.3 million.

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, and the amortization of acquired inventory step-up related to the inventory acquired in the AngioScore acquisition. 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 product development 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.


        

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