UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 23, 2015
The Spectranetics Corporation
(Exact name of registrant as specified in its charter)
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| Delaware | | 000-19711 | | 84-0997049 | |
| (State or other jurisdiction | | (Commission | | (IRS Employer | |
| of incorporation) | | File Number) | | Identification No.) | |
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9965 Federal Drive |
Colorado Springs, Colorado 80921 |
(Address of principal executive offices) (Zip Code) |
(719) 633-8333
Registrant's telephone number, including area code
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 2.02. Results of Operations and Financial Condition.
On April 23, 2015, we issued a press release that sets forth our results of operations for the three months ended March 31, 2015. A copy of the press release is furnished as Exhibit 99.1. The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated by reference into any filing of The Spectranetics Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
ITEM 7.01. Regulation FD Disclosure.
On April 23, 2015, we issued a press release announcing the acceleration of investment in the Stellarex drug-coated balloon platform for treatment of below the knee peripheral vascular disease. A copy of the press release is furnished as Exhibit 99.2 of this report.
The information under Item 7.01 and in Exhibit 99.2 of this report is being furnished and shall not be deemed “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information under Item 7.01 and in Exhibit 99.2 of this report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press release issued by The Spectranetics Corporation on April 23, 2015.
99.2 Press release issued by The Spectranetics Corporation on April 23, 2015.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | | |
| | THE SPECTRANETICS |
| | CORPORATION |
| | |
| | |
Date: | April 23, 2015 | By: | /s/ Jeffrey A. Sherman |
| | | Jeffrey A. Sherman |
| | | Vice President, Deputy General Counsel and Corporate Secretary |
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EXHIBIT INDEX
Exhibit No.
99.1 Press release issued by The Spectranetics Corporation on April 23, 2015.
99.2 Press release issued by The Spectranetics Corporation on April 23, 2015.
Exhibit 99.1
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COMPANY CONTACT | INVESTOR CONTACT |
The Spectranetics Corporation | Westwicke Partners |
Guy Childs, Chief Financial Officer | Lynn Pieper |
(719) 633-8333 | (415) 202-5678 |
| lynn.pieper@westwicke.com |
FOR IMMEDIATE RELEASE
Spectranetics Achieves First Quarter 2015 Revenue of $57.4 Million
Expands Stellarex™ Program to Below the Knee Market
Updates 2015 Outlook
COLORADO SPRINGS, Colo. (April 23, 2015) - 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:
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• | Revenue of $57.4 million, up 45% (47% constant currency1) |
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• | Vascular Intervention revenue of $36.5 million grew 82% (84% constant currency) |
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• | U.S. peripheral atherectomy revenue grew 16% |
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• | AngioSculpt® revenue of $14.0 million achieved |
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• | Lead Management revenue of $16.4 million increased 14% (16% constant currency) |
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• | U.S. revenue grew 53% to $48.6 million; International revenue grew 12% (24% constant currency) to $8.8 million |
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• | Record placements of 54 laser systems |
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• | 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 |
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• | 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.”
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1Constant currency and non-GAAP net loss are non-GAAP financial measures. See “Reconciliation of Non-GAAP Financial Measures” later in this release.
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:
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• | 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. |
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• | 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. |
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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)
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| | | | | | | | |
| | Three Months Ended March 31, |
| | 2015 | | 2014 |
Revenue | | $ | 57,422 |
| | $ | 39,614 |
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Cost of products sold | | 14,802 |
| | 10,334 |
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Amortization of acquired inventory step-up | | 251 |
| | — |
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Gross profit | | 42,369 |
| | 29,280 |
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Operating expenses: | | | | |
Selling, general and administrative | | 36,942 |
| | 27,740 |
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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 |
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THE SPECTRANETICS CORPORATION
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
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| | | | | | | |
| March 31, 2015 | | December 31, 2014 |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 43,639 |
| | $ | 95,505 |
|
Accounts receivable, net | 38,831 |
| | 41,090 |
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Inventories, net | 27,670 |
| | 25,446 |
|
Deferred income taxes, current portion, net | 2,200 |
| | 2,200 |
|
Other current assets | 9,180 |
| | 8,093 |
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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 |
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Other assets | 1,541 |
| | 1,371 |
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Total assets | $ | 443,789 |
| | $ | 466,950 |
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| | | |
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 |
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THE SPECTRANETICS CORPORATION |
Supplemental Financial Information |
(Unaudited) |
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| | | | | | | | | | | | | | | | | | | |
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 |
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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.
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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 | % |
|
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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.
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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 | ) |
|
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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 | ) |
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1) | Amortization of acquired inventory step-up relates to the inventory acquired in the AngioScore acquisition. |
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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. |
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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. |
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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. |
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5) | Per share amounts may not add due to rounding. |
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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. |
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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:
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• | Management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP financial measures used. |
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• | 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. |
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• | 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. |
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• | 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. |
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• | 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. |
# # #
Exhibit 99.2
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COMPANY CONTACT | INVESTOR CONTACT |
The Spectranetics Corporation | Westwicke Partners |
Guy Childs, Chief Financial Officer | Lynn Pieper |
(719) 633-8333 | (415) 202-5678 |
| lynn.pieper@westwicke.com |
FOR IMMEDIATE RELEASE
Spectranetics Accelerates Investment in StellarexTM Drug-Coated Balloon Platform for Treatment of Below the Knee (BTK) Peripheral Vascular Disease
BTK Market Segment Expected to Grow to $150 Million by 2020
COLORADO SPRINGS, Colo. (Apr. 23, 2015) - The Spectranetics Corporation (SPNC) today announced it is accelerating investments in the Stellarex drug-coated balloon angioplasty (DCB) platform for treatment of Below the Knee (BTK) peripheral artery disease. The Company estimates this will represent a $150 million market opportunity by 2020.
“Our team and global thought leaders believe the Stellarex DCB platform is ideally suited to treat BTK disease,” said Scott Drake, President and CEO. “Accelerating this investment amplifies and elongates the impact of our powerful DCB program. Stellarex, in combination with our crossing solutions and laser atherectomy, establishes a comprehensive portfolio to treat peripheral artery disease (PAD) generally and critical limb ischemia (CLI) patients specifically.”
Spectranetics estimates that treatment of BTK disease will become a meaningful segment of the global market for drug-coated balloons, representing a potential market opportunity of $150 million. The Company anticipates the global market for DCBs to reach between $700 million and $1 billion over the next seven years. Spectranetics is targeting CE mark approval for the Stellarex DCB BTK platform in the second half of 2016.
“Wound healing is always a concern in the treatment of BTK disease. Robust patency and coating stability with minimal flaking is critical in those situations,” said William Gray, MD, Columbia University Medical Center, New York. “The Stellarex DCB was designed to optimize drug delivery to the treatment site while minimizing downstream drug loss through the unique coating formula and manufacturing process. The unique coating coupled with the strong clinical data on the Stellarex DCB platform set the stage for an ideal application in treatment of BTK disease.”
The acceleration of the investment in the BTK program is expected to represent an incremental $5 to $6 million of product development, regulatory and clinical expense in 2015. The Company expects to commence enrollment in an Investigational Device Exemption (IDE) clinical trial in the US in mid-2016. The commencement of the IDE trial is conditioned upon receipt of regulatory approval from the FDA.
About the Stellarex™ DCB Platform
The Stellarex DCB platform is designed to treat peripheral arterial disease. Stellarex uses EnduraCoat™ technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. It is not approved for use in the United States.
About Spectranetics
SPNC 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 as well as the AngioSculpt(R) scoring balloon used in both peripheral and coronary procedures. 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 expectation of continued growth and strength and the reasons for that growth, growth rates, strength, and outlook including projected revenue and net loss. 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 inability to compete with larger companies in our highly competitive industry, inability to successfully penetrate our target markets and develop new products for those markets, financial results differing from guidance, inability to successfully integrate AngioScore and the Stellarex platform into our business, market acceptance of excimer laser atherectomy technology and our vascular intervention and lead removal products, market acceptance of drug-coated balloon technology, inability to meet projected development or commercialization goals, inability to return to profitability, significant costs related to the acquisitions of AngioScore and the Stellarex platform, 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.
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