Expands Stellarex™ Program to Below the
Knee Market
Updates 2015 Outlook
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-
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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) |
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|
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: |
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|
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 |
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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 |
|
|
|
|
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|
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 |
|
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|
|
|
|
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 |
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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 |
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(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. |
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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) |
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|
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|
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% |
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Reconciliation of revenue by
product line to non-GAAP revenue by product line |
on a constant currency
basis |
(in thousands, except
percentages) |
(unaudited) |
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|
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 |
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Reconciliation of gross margin
to non-GAAP gross margin |
excluding amortization of
acquired inventory step-up |
(in thousands, except
percentages) |
(unaudited) |
|
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|
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% |
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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) |
|
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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) |
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Reconciliation of Net Loss Per
Share to Non-GAAP Net Loss Per Share |
(unaudited) |
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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) |
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Projected Range |
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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) |
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Reconciliation of 2015
Projected Net Loss Per Share to Non-GAAP Projected Net Loss Per
Share |
(unaudited) |
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Projected Range |
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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.
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.
CONTACT: COMPANY CONTACT
The Spectranetics Corporation
Guy Childs, Chief Financial Officer
(719) 633-8333
INVESTOR CONTACT
Westwicke Partners
Lynn Pieper
(415) 202-5678
lynn.pieper@westwicke.com
The Spectranetics Corp. (MM) (NASDAQ:SPNC)
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