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8-K - 8-K - SPECTRANETICS CORPa20118kq2earningsrelease.htm


Exhibit 99.1
 
COMPANY CONTACT
INVESTOR CONTACTS:
Spectranetics Corporation
Lippert/Heilshorn & Associates, Inc.
Guy Childs, Chief Financial Officer
Don Markley or Bruce Voss
(719) 633-8333
(310) 691-7100
 
dmarkley@lhai.com

FOR IMMEDIATE RELEASE
 
SPECTRANETICS ACHIEVES RECORD REVENUE OF $32.2 MILLION IN SECOND QUARTER, 7% GROWTH OVER PRIOR YEAR


COLORADO SPRINGS, Colo. (July 28, 2011) - Spectranetics Corporation (NASDAQ: SPNC) today reported financial results for the quarter and six months ended June 30, 2011. Highlights of the quarter and more recently include:

Record revenue of $32.2 million, representing 7% growth over prior year second quarter
Lead Management revenue increased 15% compared with prior year second quarter
Vascular Intervention revenue continued turnaround with second consecutive quarter of sequential revenue growth, up 8% over first quarter 2011 levels
International revenue grew 42% over prior year second quarter
Net income of $584,000, or $0.02 per diluted share, a significant improvement compared with prior year second quarter net income of $91,000, or $0.00 per diluted share
Enrollment of first patient in EXCITE trial for treatment of in-stent restenosis
Scott Drake named as President and Chief Executive Officer, effective August 10, 2011
 
"The second quarter results reflect continued progress on our key growth initiatives. The second consecutive quarter of sequential growth in our Vascular Intervention business, and the 15% growth in our Lead Management business demonstrate the growing demand for our portfolio of products," said Jason D. Hein, Senior Vice President of Sales, Marketing and Business Development. "Laser placements of 29 laser systems remain strong, and our recently introduced advanced simulator for peripheral atherectomy continues to be very well received."

Shar Matin, Senior Vice President, Operations, Product Development, and International, added, “Our International business continued its strong growth with a 42% increase over last year, driven by broad-based growth in both Vascular Intervention and Lead Management product sales in Europe and Lead Management product sales in Japan. In the United States, we are pleased to have initiated enrollment in the EXCITE trial for in-stent restenosis and are focused on having nearly all of the 30 clinical sites initiated by the end of this year.”

Revenue for the second quarter of 2011 was $32.2 million, an increase of 7% compared with revenue of $30.0 million for the second quarter of 2010. Net income for the second quarter of 2011 was $584,000, or $0.02 per diluted share, compared with net income of $91,000, or $0.00 per diluted share, in the second quarter of 2010. The non-GAAP adjusted net income for the second quarter of 2010 was





$31,000, or $0.00 per diluted share. There were no non-GAAP adjustments during the second quarter of 2011. Please refer to “Reconciliation of Non-GAAP Financial Measures” later in this release.

Second Quarter 2011 Revenue Review
 
Lead Management revenue increased 15% to $11.5 million, laser system revenue increased 48% to $2.3 million, and service and other revenue increased 9% to $2.5 million, all compared with the second quarter of 2010. Vascular Intervention sales declined 1% to $15.8 million, including three product lines: atherectomy (peripheral and coronary), which decreased 2%, crossing solutions, which decreased 2%, and thrombectomy, which increased 1%, all compared with the second quarter of 2010. However, Vascular Intervention revenue continued its turnaround from its lows in the fourth quarter of 2010, increasing sequentially by $1.2 million, or 8%, as compared with the first quarter of 2011, primarily due to improving atherectomy revenue.
 
On a geographic basis, revenue in the United States was $26.5 million in the second quarter of 2011, an increase of 2% from the prior year second quarter. International revenue was $5.7 million, an increase of 42% (31% on a constant currency basis) from the second quarter of 2010.
 
Year-to-Date Financial Results

Revenue for the first half of 2011 rose 6% to $62.6 million, from $59.0 million for the first half of 2010.

Year-to-date 2011 Lead Management revenue was up 14% to $22.8 million, laser system revenue increased 47% to $4.3 million, and service and other revenue increased 10% to $5.1 million, all compared with the first six months in 2010. Vascular Intervention revenue in the first half of 2011 declined 3% to $30.5 million, compared with the first six months of 2010, but continued its turnaround, marked by two consecutive quarters of sequential improvement since the fourth quarter of 2010.

On a geographic basis, revenue in the United States was $52.0 million during the six months ended June 30, 2011, an increase of 2% from the comparable period last year. International revenue totaled $10.6 million, an increase of 29% (24% on a constant currency basis) from the first six months of 2010.

Net income for the first half of 2011 was $430,000, or $0.01 per diluted share, compared with a net loss of $867,000, or $0.03 per share, in the first half of 2010. The Non-GAAP adjusted net loss for the first half of 2010 was $574,000. There were no non-GAAP adjustments for the first half of 2011. Please refer to “Reconciliation of Non-GAAP Financial Measures” later in this release.

Cash, cash equivalents and investment securities totaled $35.7 million at June 30, 2011, compared with $33.7 million at December 31, 2010 and $33.5 million at March 31, 2011.
 
2011 Outlook

The Company maintained its previously provided outlook, as described below.
 
The Company's primary focus in 2011 is to improve the revenue growth rate while establishing profitability. Revenue is anticipated to be within the range of $122.5 million to $126.5 million, which represents an increase over 2010 revenue of 4% to 7%.
 
Gross margin is expected to be approximately the same as 2010 levels of 71%, but important initiatives designed to improve manufacturing efficiencies in 2012 and beyond will be implemented this year.






Conference Call
 
Management will host an investment-community conference call today beginning at 9:00 a.m. Mountain time, 11:00 a.m. Eastern time, to discuss these results. Individuals interested in listening to the conference call should dial (888) 803-8271 for domestic callers, or (706) 634-2467 for international callers. The live conference call will also be available via the Internet on the investor relations section of www.spectranetics.com.
 
A telephone replay will be available for 48 hours following the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers and entering reservation code 81924005. The web site replay will be available for 14 days following the completion of the call.
 
About Spectranetics

Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in over 40 countries and are used to treat arterial blockages in the heart and legs as well as the removal of pacemaker and defibrillator leads.
 
The Company's Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.
 
The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management 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. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include greater than anticipated indemnification obligations or other adverse results in connection with any ongoing legal proceeding, or any legal proceeding in which we may become involved, adverse impact to our business of the recently enacted healthcare reform bill and related legislation, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital, market acceptance of excimer laser atherectomy technology and our lead removal products, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, 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 the Company's relocation and consolidation of its manufacturing operations, unexpected delays or costs





associated with any planned improvements to the Company's manufacturing processes, and 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 the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
 
Use of Non-GAAP Financial Measures
 
To supplement the Company's consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), Spectranetics uses certain non-GAAP financial measures in this release. Reconciliations of the non-GAAP financial measures used in this release to the most directly comparable U.S. GAAP measures for the respective periods, and an explanation of the Company's 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 the Company's financial results prepared in accordance with GAAP. 


-Financial tables follow-






THE SPECTRANETICS CORPORATION
Condensed Consolidated Statements of Operations
(000's, except per share data and percentages)
(unaudited)
 
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
 
2011
 
2010
 
2011
 
2010
Revenue
 
$
32,214

 
$
30,025

 
$
62,636

 
$
59,035

Cost of products sold
 
9,313

 
8,540

 
18,240

 
16,907

Gross profit
 
22,901

 
21,485

 
44,396

 
42,128

Gross margin %
 
71
%
 
72
%
 
71
%
 
71
%
Operating expenses:
 
 
 
 
 
 
 
 
Selling, general and administrative
 
17,624

 
17,851

 
34,991

 
35,473

Research, development and other technology
 
4,681

 
3,608

 
8,934

 
7,307

Federal investigation legal and other costs
 

 
(60
)
 

 
293

Total operating expenses
 
22,305

 
21,399

 
43,925

 
43,073

Operating income (loss)
 
596

 
86

 
471

 
(945
)
Other income, net
 
67

 
38

 
117

 
145

Income (loss) before taxes
 
663

 
124

 
588

 
(800
)
Income tax expense
 
(79
)
 
(33
)
 
(158
)
 
(67
)
Net income (loss)
 
$
584

 
$
91

 
$
430

 
$
(867
)
 
 
 
 
 
 
 
 
 
Income (loss) per common and common
equivalent share:
 
 
 
 
 
 
 
 
Basic
 
$
0.02

 
$
0.00

 
$
0.01

 
$
(0.03
)
Diluted
 
0.02

 
0.00

 
0.01

 
(0.03
)
Weighted average shares outstanding:
 
 
 
 
 
 
 
 
Basic
 
33,323

 
33,088

 
33,281

 
33,080

Diluted
 
34,327

 
34,257

 
34,186

 
33,080



 






THE SPECTRANETICS CORPORATION
Condensed Consolidated Balance Sheets
(000's)
 
 
June 30, 2011
 
December 31, 2010
 
(unaudited)
 
 
ASSETS
 
 
 
Current assets:
 
 
 
Cash, cash equivalents and investment securities
$
35,655

 
$
33,662

Accounts receivable, net
18,159

 
15,664

Inventories
6,984

 
8,054

Deferred tax asset, current, net
83

 
163

Other current assets
1,957

 
1,568

Total current assets
62,838

 
59,111

Property, plant and equipment, net
28,783

 
28,669

Goodwill
5,569

 
5,569

Other assets
209

 
346

Total assets
$
97,399

 
$
93,695

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities
$
20,091

 
$
18,599

Non-current liabilities
590

 
598

Stockholders’ equity
76,718

 
74,498

Total liabilities and stockholders’ equity
$
97,399

 
$
93,695







THE SPECTRANETICS CORPORATION
Supplemental Financial Information
(Unaudited)
Financial Summary
 
2010
 
2011
(000's, except laser sales and installed base amounts)
 
2nd Qtr
 
3rd Qtr
 
4th Qtr
 
1st Qtr
 
2nd Qtr
 
 
 
 
 
 
 
 
 
 
 
Disposable products revenue:
 
 
 
 
 
 
 

 
 
Vascular Intervention revenue
 
$
16,088

 
$
14,569

 
$
14,063

 
$
14,679

 
$
15,848

Lead Management revenue
 
10,029

 
10,617

 
10,597

 
11,282

 
11,505

     Total disposable products revenue
 
26,117

 
25,186

 
24,660

 
25,961

 
27,353

 
 
 
 
 
 
 
 
 
 
 
Service and other revenue
 
2,339

 
2,325

 
2,452

 
2,520

 
2,544

 
 
 
 
 
 
 
 
 
 
 
Laser revenue:
 
 
 
 
 
 
 
 
 
 
Equipment sales
 
313

 
799

 
825

 
617

 
1,024

Rental fees
 
1,256

 
1,267

 
1,368

 
1,324

 
1,293

Total laser revenue
 
1,569

 
2,066

 
2,193

 
1,941

 
2,317

 
 
 
 
 
 
 
 
 
 
 
Total revenue
 
30,025

 
29,577

 
29,305

 
30,422

 
32,214

 
 
 
 
 
 
 
 
 
 
 
Non-GAAP adjusted net income (loss) excluding special items (1)
 
31

 
1,531

 
1,437

 
N/A

 
N/A

Net income (loss)
 
91

 
(12,709
)
 
513

 
(154
)
 
584

 
 
 
 
 
 
 
 
 
 
 
Cash flow generated by operating activities
 
2,048

 
2,995

 
3,556

 
142

 
3,212

Total cash and current investment securities
 
21,894

 
26,427

 
33,662

 
33,493

 
35,655

 
 
 
 
 
 
 
 
 
 
 
Laser sales summary:
 
 
 
 
 
 
 
 
 
 
Laser sales from inventory
 
1

 
6

 
4

 
3

 
6

Laser sales from evaluation/rental units
 
1

 

 
2

 
3

 
2

Total laser sales
 
2

 
6

 
6

 
6

 
8

 
 
 
 
 
 
 
 
 
 
 
(1) Non-GAAP adjusted net income (loss) excluding special items is a non-GAAP financial measure. Please refer to the non-GAAP reconciliation tables following this table. There were no special items reported in the first or second quarters of 2011.
 
 
 
 
 
 
 
 
 
 
 
Worldwide Installed Base Summary:
 
 
 
 
 
 
 
 
 
 
Laser sales from inventory
 
1

 
6

 
4

 
3

 
6

Rental placements
 
10

 
13

 
10

 
30

 
20

Evaluation placements
 
5

 
5

 
2

 
8

 
3

Laser placements during quarter
 
16

 
24

 
16

 
41

 
29

Buy-backs/returns during quarter
 
(11
)
 
(6
)
 
(8
)
 
(21
)
 
(16
)
Net laser placements during quarter
 
5

 
18

 
8

 
20

 
13

Total lasers placed at end of quarter
 
916

 
934

 
942

 
962

 
975






Reconciliation of Non-GAAP Financial Measures

To supplement the Company’s condensed consolidated financial statements prepared in accordance with GAAP, Spectranetics uses 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 the Company’s management uses these non-GAAP measures to conduct and evaluate its business and the reasons why management believes that these non-GAAP measures provide useful information to investors is provided following the reconciliation tables.


THE SPECTRANETICS CORPORATION
Reconciliation of Net Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and
Net Income (Loss) per Share to Non-GAAP Adjusted Net Income (Loss) per Share
(000’s, except per share data)
(unaudited)
 
 
 
 
 
 
 
 
 
 
 
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2011
 
2010
 
2011
 
2010
 
Net income
Per diluted share (1)
 
Net income
Per diluted share (1)
 
Net income
Per diluted share (1)
 
Net loss
Per diluted share (1)
Net income (loss), as reported
$
584

$
0.02

 
$
91

$
0.00

 
$
430

$
0.01

 
$
(867
)
$
(0.03
)
Federal investigation legal and other costs (2)
 
 
 
(60
)
(0.00
)
 
 
 
 
293

0.01

Non-GAAP adjusted net income (loss)
 
 
 
$
31

$
0.00

 
 
 
 
$
(574
)
$
(0.02
)
 
 
 
 
 
 
 
 
 
 
 
 
__________________
1)
Per diluted share is calculated for the special items based on the fully diluted weighted average shares outstanding for all periods. The fully diluted weighted average shares were 34,326,654 and 34,257,381 for the three months ended June 30, 2011 and 2010, respectively, and 34,185,981 and 33,079,592 for the six months ended June 30, 2011 and 2010, respectively.

2)
In the six months ended June 30, 2010, the Company recorded $0.3 million of legal costs related to a federal investigation that has since been resolved. In the second quarter of 2010, the Company recorded a credit of $60,000 of legal costs related to this matter, due to an insurance payment of approximately $0.2 million which reimbursed certain costs related to the federal investigation previously expensed, due to uncertainties regarding the insurance coverage at the time of payment. The Company did not incur any federal income tax expense or benefit; accordingly, there is no tax effect associated with these costs.







THE SPECTRANETICS CORPORATION
Reconciliation of revenue by geography to non-GAAP revenue by geography
on a constant currency basis
(000’s, except percentages)
(unaudited)
 
 
Three Months Ended
 
 
 
 
June 30, 2011
 
June 30, 2010
 
Change
 
Revenue, as reported
Foreign exchange impact as compared to prior period
Revenue on a constant currency basis
 
Revenue, as reported
 
As reported currency basis
Constant currency basis
United States
$
26,486

 
$

 
$
26,486

 
 
$
25,987

 
 
2

%
2

%
International
5,728
 
 
(429
)
 
5,299
 
 
 
4,038
 
 
 
42

 
31

 
Total revenue
$
32,214

 
$
(429
)
 
$
31,785

 
 
 
30,025

 
 
7

%
6

%
 
 
 
 
 
 
 
 
 
 
Six Months Ended
 
 
 
 
June 30, 2011
 
June 30, 2010
 
Change
 
Revenue, as reported
Foreign exchange impact as compared to prior period
Revenue on a constant currency basis
 
Revenue, as reported
 
As reported currency basis
Constant currency basis
United States
$
52,047

 
$

 
$
52,047

 
 
$
50,838

 
 
2

%
2

%
International
10,589
 
 
(412
)
 
10,177
 
 
 
8,197
 
 
 
29

 
24

 
Total revenue
$
62,636

 
$
(412
)
 
$
62,224

 
 
$
59,035

 
 
6

%
5

%


Spectranetics uses the non-GAAP financial measures described in this release as supplemental measures of performance and believes these measures facilitate operating performance comparisons from period to period and company to company by factoring out potential differences caused by unusual or infrequent charges not related to the Company’s regular, ongoing business.

The impact of foreign exchange rates is highly variable and difficult to predict. The foreign exchange impact is the impact from foreign exchange rates on current period sales compared to prior period sales using the prior period’s foreign exchange rates. In order to properly understand the underlying business trends and performance of its ongoing operations, management believes that investors may find it useful to consider the impact of excluding changes in foreign exchange rates from the Company’s revenue.

The Company’s management uses the non-GAAP financial measures to analyze the underlying trends in the Company’s business, assess the performance of the Company’s core operations, establish operational goals and forecasts that are used in allocating resources and evaluate the Company’s performance period over period and in relation to its competitors’ operating results.






Spectranetics believes that presenting the non-GAAP financial measures used in this release provides investors greater transparency to the information used by management for its financial and operational decision-making and allows investors to see the Company’s results “through the eyes” of management. Spectranetics also believes that providing this information better enables the Company’s investors to understand the Company’s 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 the Company’s financial results prepared in accordance with GAAP. Some of the limitations associated with the Company’s use of these non-GAAP financial measures are:

Items such as the federal investigation legal and other costs that are excluded from net income (loss) and net income (loss) per share can have a material impact on cash flows, GAAP net income (loss) and net income (loss) per share and reflect economic costs to the Company which are not reflected in non-GAAP adjusted net income (loss) and non-GAAP adjusted net income (loss) per share.

Revenue growth rates stated on a constant currency basis, by their nature, exclude the impact of foreign exchange, 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 Spectranetics, limiting the usefulness of those measures for comparative purposes.

The Company’s management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP financial measures Spectranetics uses.

Spectranetics provides detailed reconciliations of each non-GAAP measure to its most directly comparable GAAP measure. Spectranetics encourages investors to review these reconciliations.

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