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8-K - FORM 8-K - Cardiovascular Systems Inc | c62771e8vk.htm |
Exhibit 99.1
CARDIOVASCULAR SYSTEMS REPORTS FISCAL 2011
SECOND-QUARTER FINANCIAL RESULTS
SECOND-QUARTER FINANCIAL RESULTS
Conference Call Scheduled for Today, February 2, 2011 at 3:45 PM CT (4:45 PM ET)
| Financial performance improved significantly over prior-year second quarter: |
§ | Revenue increased 24 percent to $18.8 million | ||
§ | Gross margin rose to 79 percent, operating expenses declined 7 percent | ||
§ | Adjusted EBITDA improved to $72,000 from $(4.3) million | ||
§ | Net loss improved 71 percent to $(2.0) million, or $(0.13) per share |
| Special 510(k) filing for next generation Orbital PAD System expected in February 2011 | ||
| Enrollment of 50 patients for Phase I of the ORBIT II coronary trial is nearly completed | ||
| Clinical data continues to build, supporting reproducible safety and efficacy |
St. Paul, Minn., February 2, 2011 Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), a medical
device company developing and commercializing innovative interventional treatment systems for
vascular disease, today reported financial results for its fiscal second quarter ended December 31,
2010.
CSIs revenue in the second quarter rose to $18.8 million, a 24-percent gain over revenue of $15.1
million in the second quarter of last fiscal year. Adjusted EBITDA, calculated as loss from
operations, less depreciation and amortization and stock-based compensation expense, improved by
$4.3 million to earnings of $72,000, as a result of stronger revenue and gross margins, and reduced
operating expenses.
Net loss was $(2.0) million for the quarter, or $(0.13) per common share, a 71 percent improvement
over a $(6.8) million net loss, or $(0.46) per common share a year earlier. Net loss was favorably
affected by $371,000 of interest and other income from conversion and valuation changes of the
companys convertible debt.
David L. Martin, CSI president and chief executive officer, said, We made substantial progress
toward profitability and financial independence this quarter, as we continued to balance revenue
growth and spending. We accomplished these gains while making significant advances in improving
the ease-of-use of our Orbital PAD Systems; expanding the wealth of scientific data on our
products safety, efficacy and economic benefits; and moving toward a coronary application of our
device.
During the quarter, 68 new customers were added higher than recent previous quarters as a result
of new atherectomy reimbursement opportunities for non-hospital physician accounts, and increased
demand driven by CSIs compelling body of data. Consequently, revenue from reorders was 91 percent
of total revenue compared to 95 percent in the fiscal 2011 first quarter. Important product
transitions to the Diamondback Predator 360° and the upcoming Stealth 360° Orbital PAD Systems also
affected revenue growth in some existing accounts, but position CSI for expanded growth in the
future.
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Gross margin rose to 79 percent from 77 percent in the same period last year, due to product cost
reductions and manufacturing efficiencies. Operating efficiencies in sales and marketing
contributed to a 7-percent reduction in operating expenses compared to the year-ago period. The
company also received a $488,000 grant from the Qualifying Therapeutic Discovery Project program;
however, its favorable effect on operating expenses was offset by higher product development
expenses related to timing of the Stealth 360° project.
In the first six months of fiscal 2011, revenue increased to $36.9 million, up 22 percent from the
same period last fiscal year. The gross margin improved to 78 percent from 77 percent, while
operating expenses declined 3 percent. Adjusted EBITDA loss improved by 79 percent to $(1.7)
million, while the net loss improved 52 percent to $(6.3) million, or $(0.40) per common share,
compared to $(13.0) million, or $(0.89) last year.
Operating Highlights
Special 510(k) Filing for the Next-Generation Orbital PAD System Expected in February 2011
CSI expects to file a Special 510(k) with the FDA in February 2011 for the Stealth 360° Orbital PAD
System, CSIs next-generation device. The electric powered Stealth 360° will greatly improve
physicians control and ease-of-use, while reducing the products set-up time and staffing
requirements. Stealth 360° also utilizes the improved crown and shaft design of the recently
introduced Diamondback Predator 360°, which allows removal of a high percentage of plaque in less
time and easy advancement through difficult occlusions. CSI expects to begin a limited market
release of Stealth 360° during its fiscal 2011 third quarter, subject to FDA clearance.
According to Martin, Stealth 360°
electric handle
is an exciting product and reflects our commitment to
innovation. The combination of Stealths ease-of-use, with our superior growing body of clinical
and economic data demonstrating the safety, effectiveness and
economic benefit of our unique orbital technology,
sets the stage for significant physician adoption and revenue growth. Elimination of the
controller, the capital equipment portion of our current system, will reduce future product cost.
Phase I Enrollment Nearly Completed in ORBIT II, the Coronary Pivotal Trial
CSI has nearly completed enrollment of the first 50 patients in Phase I of the ORBIT II trial,
which is evaluating the safety and effectiveness of the Diamondback 360° in treating calcified
coronary lesions. ORBIT II is expected to enroll a total of 429 patients, subject to FDA review of
data from the first 50 cases. CSI anticipates submitting the results of Phase I to the FDA during
the third quarter of fiscal 2011.
Martin continued, Our unique orbital technology is especially effective in treating small vessels
with calcified lesions and may be well suited for a coronary application, potentially sparing many
patients from highly invasive surgery and improving long-term outcomes. Our ORBIT I coronary
feasibility trial provided strong safety and efficacy data, and we have received positive feedback
from physicians using our technology in ORBIT II.
Expanding Body of Scientific Data Reinforces Safety, Efficacy and Economic Feasibility
The CONFIRM II prospective registry has completed enrollment, bringing the total number of patients
studied to date in 11 CSI studies to nearly 2,500. Preliminary results of CONFIRM II reinforce the
safety of the Predator 360° with its extremely low rates of procedural events in the most
challenging patients.
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Key study findings demonstrate the consistency of CSIs Orbital PAD systems performance and
reliability of data:
| Excellent Safety In preliminary results of 500 patients and 766 lesions, CONFIRM II showed extremely low rates of perforations (0.5 percent), bailout stenting (2.5 percent) and mortality (0 percent). This confirms data compiled from 10 other CSI studies to date: perforations (0.6 percent), bailout stenting (2.4 percent) and mortality (<0.1 percent). |
| Reproducible Results in the Most Challenging Lesions In more than 3,500 lesions studied, the Diamondback has shown to be effective in small, calcified vessels (86 percent of lesions were calcified and 40 percent of vessels had diameters of less than 4 mm). These lesions were treated by over 300 physicians in more than 240 hospitals, demonstrating reproducible procedural outcomes in the hands of a variety of operators. |
| 360° Clinical Series Provides Growing Body of Data Acute results of the COMPLIANCE 360° study will be presented in a poster session at the upcoming American College of Cardiology (ACC) meeting in New Orleans, April 3-5, by Dr. Raymond Dattilo, the studys principal investigator and director of peripheral vascular intervention at the Kansas Heart and Vascular Center, Cardiology Consultants of Topeka, P.A. In addition, CSI will be featured for both its peripheral and coronary innovations at ACCs new Cardiovascular Innovations Forum. |
| Economic Feasibility Use of the Diamondback compared to balloon angioplasty showed no differences in procedural costs or procedure times in data now available from the CALCIUM 360° study. To demonstrate the economic viability of a Diamondback procedure to hospitals, CSI is collecting economic data through 24 months as part of its CALCIUM 360° and COMPLIANCE 360° studies. |
Martin commented, We continue to lead the industry in the scope of our clinical trial programs and
patient outcomes achieved to date. Our scientific studies show that two minutes of treatment safely
and routinely removes decades of arterial plaque buildup. Our studies enroll patients typically
excluded from other studies, including those scheduled for amputation, patients with widespread
PAD, and patients with hard calcified plaque. Our products also routinely treat small vessels,
which are critical to providing blood flow to the foot.
Fiscal 2011 Third-Quarter Outlook
For the fiscal 2011 third quarter ending March 31, 2011, CSI anticipates:
| Revenue in the range of $19.0 million to $20.0 million, or growth of 15 percent to 21 percent over the third quarter of fiscal 2010, as new product transitions are expected to affect revenue growth; |
| Gross profit as a percentage of revenue at approximately the same level as the fiscal 2011 second quarter; |
| Operating expenses of about 5 percent higher than second quarter of 2011, due to increasing ORBIT II enrollment and additional sales and marketing expenses; |
| Interest and other expense of about $(400,000), excluding the potential effect of conversions or valuation changes of convertible debt; |
| Net loss in the range of $(2.3) million to $(2.9) million, or loss per common share ranging from $(0.14) to $(0.18), assuming 16.2 million average shares outstanding; and |
| Adjusted EBITDA between earnings of $0.2 million and loss of $(0.4) million. |
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Conference Call Today at 3:45 PM CT (4:45 PM ET)
Cardiovascular Systems, Inc. will host a live conference call and webcast of its fiscal
second-quarter results today, February 2, 2011, at 3:45 p.m. CT (4:45 p.m. ET). To access the call,
dial (888) 713-4211 and enter access number 43108086. Please dial in at least 10 minutes prior to
the call and wait for operator assistance, or dial 0 for operator assistance. To listen to the
live webcast, go to the investor information section of the companys website,
www.csi360.com, and click on the webcast icon. A webcast replay will be available beginning
at 7 p.m. CT the same day.
For an audio replay of the conference call, dial (888) 286-8010 and enter access number 51161917.
The audio replay will be available beginning at 8 p.m. CT on Wednesday, February 2, 2011, through 6
p.m. CT on Friday, February 4, 2011.
Use of Non-GAAP Financial Measures
To supplement CSIs consolidated condensed financial statements prepared in accordance with U.S.
generally accepted accounting principles (GAAP), CSI uses certain non-GAAP financial measures in
this release. Reconciliations of the non-GAAP financial measures used in this release to the most
comparable U.S. GAAP measures for the respective periods can be found in tables later in this
release immediately following the consolidated statements of operations. Non-GAAP financial
measures have limitations as analytical tools and should not be considered in isolation or as a
substitute for CSIs financial results prepared in accordance with GAAP.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on
developing and commercializing interventional treatment systems for vascular disease. The companys
Diamondback 360® and Diamondback Predator 360® PAD Systems treat calcified
and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and
address many of the limitations associated with existing surgical, catheter and pharmacological
treatment alternatives. As many as 12 million Americans suffer from peripheral arterial disease
(PAD), which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or
leg) reducing blood flow. Symptoms include leg pain when walking or at rest, and can lead to tissue
loss and eventually limb amputation. In August 2007, the U.S. FDA granted 510(k) clearance for the
use of the Diamondback 360° as a therapy for PAD, and CSI commenced a U.S. product launch in
September 2007. Since then, more than 37,000 procedures have been performed using the Diamondback
360° in leading institutions across the United States. For more information visit the companys Web
site at www.csi360.com.
Safe Harbor
Certain statements in this news release are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe
harbor for forward-looking statements provided by that Act. For example, statements in this press
release regarding (i) CSIs future profitability; (ii) the use of the Diamondback 360° to treat
coronary lesions; (iii) the expected Special 510(k) filing, release and benefits of the Stealth
360°; (iv) anticipated future product adoption, revenue growth and reduced product cost; (v) CSIs
clinical trials; and (vi) anticipated revenue, gross profit, operating expenses, interest and other
expense, net loss and adjusted EBITDA in future periods, are forward-looking statements. These
statements involve risks and uncertainties which could cause results to differ materially from
those projected, including but not limited to the potential for unanticipated delays in enrolling
medical centers and patients for clinical trials; dependence on market growth; the reluctance of
physicians to accept new products; the impact of competitive products and pricing; the difficulty
to successfully manage operating costs; fluctuations in quarterly results; FDA clearances and
approvals; approval of products for reimbursement and the level of reimbursement;
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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general economic conditions and other factors detailed from time to time in
CSIs SEC reports,
including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.
CSI encourages you to consider all of these risks, uncertainties and other factors carefully in
evaluating the forward-looking statements contained in this release. As a result of these matters,
changes in facts, assumptions not being realized or other circumstances, CSIs actual results may
differ materially from the expected results discussed in the forward-looking statements contained
in this release. The forward-looking statements made in this release are made only as of the date
of this release, and CSI undertakes no obligation to update them to reflect subsequent events or
circumstances.
Product Disclosure
The Diamondback 360® PAD System and Diamondback Predator 360® PAD System are
percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive
atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous
dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts,
stents or where thrombus or dissections are present. Although the incidence of adverse events is
rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death,
dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute
vessel closure, or arterial spasm.
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Cardiovascular Systems, Inc.
Consolidated Statements of Operations
(Dollars in Thousands, except per share and share amounts)
(unaudited)
Consolidated Statements of Operations
(Dollars in Thousands, except per share and share amounts)
(unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenues |
$ | 18,756 | $ | 15,097 | $ | 36,921 | $ | 30,295 | ||||||||
Cost of goods sold |
3,972 | 3,515 | 8,113 | 7,003 | ||||||||||||
Gross profit |
14,784 | 11,582 | 28,808 | 23,292 | ||||||||||||
Selling, general and administrative |
14,687 | 15,912 | 30,183 | 30,768 | ||||||||||||
Research and development |
2,114 | 2,181 | 4,536 | 4,962 | ||||||||||||
Total expenses |
16,801 | 18,093 | 34,719 | 35,730 | ||||||||||||
Loss from operations |
(2,017 | ) | (6,511 | ) | (5,911 | ) | (12,438 | ) | ||||||||
Interest and other income (expense) |
27 | (274 | ) | (347 | ) | (547 | ) | |||||||||
Net loss |
$ | (1,990 | ) | $ | (6,785 | ) | $ | (6,258 | ) | $ | (12,985 | ) | ||||
Net loss per common share: |
||||||||||||||||
Basic and diluted |
$ | (0.13 | ) | $ | (0.46 | ) | $ | (0.40 | ) | $ | (0.89 | ) | ||||
Weighted average common shares
used in computation: |
||||||||||||||||
Basic and diluted |
15,827,046 | 14,651,641 | 15,598,101 | 14,584,242 | ||||||||||||
Stock-based compensation supplemental detail (included in amounts above): (Dollars in Thousands) |
||||||||||||||||
Cost of goods sold |
$ | 91 | $ | 148 | $ | 368 | $ | 277 | ||||||||
Selling, general and administrative |
1,479 | 1,674 | 2,876 | 3,485 | ||||||||||||
Research and development |
346 | 295 | 661 | 576 | ||||||||||||
Totals |
$ | 1,916 | $ | 2,117 | $ | 3,905 | $ | 4,338 | ||||||||
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Cardiovascular Systems, Inc.
Consolidated Balance Sheets
(Dollars in Thousands)
(unaudited)
Consolidated Balance Sheets
(Dollars in Thousands)
(unaudited)
December 31, | June 30, | |||||||
2010 | 2010 | |||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 22,540 | $ | 23,717 | ||||
Accounts receivable, net |
10,739 | 9,394 | ||||||
Inventories |
4,321 | 4,319 | ||||||
Prepaid expenses and other current assets |
1,036 | 1,048 | ||||||
Total current assets |
38,636 | 38,478 | ||||||
Property and equipment, net |
2,315 | 1,964 | ||||||
Patents, net |
2,015 | 1,712 | ||||||
Other assets |
106 | 180 | ||||||
Total assets |
$ | 43,072 | $ | 42,334 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Current maturities of long-term debt |
$ | 6,361 | $ | 3,613 | ||||
Accounts payable |
4,114 | 3,353 | ||||||
Deferred grant incentive |
1,252 | 1,181 | ||||||
Accrued expenses |
6,202 | 6,569 | ||||||
Total current liabilities |
17,929 | 14,716 | ||||||
Long-term liabilities |
||||||||
Long-term debt, net of current maturities |
5,675 | 7,286 | ||||||
Deferred grant incentive |
1,911 | 2,208 | ||||||
Other liabilities |
114 | 409 | ||||||
Total long-term liabilities |
7,700 | 9,903 | ||||||
Total liabilities |
25,629 | 24,619 | ||||||
Commitments and contingencies |
||||||||
Total stockholders equity |
17,443 | 17,715 | ||||||
Total liabilities and stockholders equity |
$ | 43,072 | $ | 42,334 | ||||
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Non-GAAP Financial Measures
To supplement CSIs consolidated condensed financial statements prepared in accordance with GAAP,
CSI uses a non-GAAP financial measure referred to as Adjusted EBITDA in this release.
Reconciliations of Adjusted EBITDA to the most comparable U.S. GAAP measure for the respective
periods can be found in the table below. In addition, an explanation of the manner in which CSIs
management uses Adjusted EBITDA to conduct and evaluate its business, the economic substance behind
managements decision to use Adjusted EBITDA, the substantive reasons why management believes that
Adjusted EBITDA provides useful information to investors, the material limitations associated with
the use of Adjusted EBITDA and the manner in which management compensates for those limitations is
included following the reconciliation table below.
Cardiovascular Systems, Inc.
Supplemental Sales Information
(Dollars in Thousands)
(unaudited)
Supplemental Sales Information
(Dollars in Thousands)
(unaudited)
Three months ended | Six months ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Device revenue |
$ | 16,397 | $ | 13,340 | $ | 32,460 | $ | 26,980 | ||||||||
Other product revenue |
2,359 | 1,757 | 4,461 | 3,315 | ||||||||||||
Total revenue |
$ | 18,756 | $ | 15,097 | $ | 36,921 | $ | 30,295 | ||||||||
Device units sold |
5,504 | 4,449 | 10,846 | 8,990 | ||||||||||||
New customers |
68 | 48 | 124 | 103 | ||||||||||||
Reorder revenue % |
91 | % | 92 | % | 93 | % | 92 | % |
Cardiovascular Systems, Inc.
Adjusted EBITDA
(Dollars in Thousands)
(unaudited)
Adjusted EBITDA
(Dollars in Thousands)
(unaudited)
Actual | Projected Range | |||||||||||||||||||||||
Three Months Ended | Six Months Ended | Three Months Ending | ||||||||||||||||||||||
December 31, | December 31, | March 31, 2011 | ||||||||||||||||||||||
2010 | 2009 | 2010 | 2009 | High | Low | |||||||||||||||||||
Loss from operations |
$ | (2,017 | ) | $ | (6,511 | ) | $ | (5,911 | ) | $ | (12,438 | ) | $ | (1,900 | ) | $ | (2,500 | ) | ||||||
Add: Stock-based
compensation |
1,916 | 2,117 | 3,905 | 4,338 | 1,900 | 1,900 | ||||||||||||||||||
Add: Depreciation
and amortization |
173 | 143 | 337 | 279 | 200 | 200 | ||||||||||||||||||
Adjusted EBITDA |
$ | 72 | $ | (4,251 | ) | $ | (1,669 | ) | $ | (7,821 | ) | $ | 200 | $ | (400 | ) | ||||||||
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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Use and Economic Substance of Non-GAAP Financial Measures Used by CSI and Usefulness of Such
Non-GAAP Financial Measures to Investors
CSI uses Adjusted EBITDA as a supplemental measure of performance and believes this measure
facilitates operating performance comparisons from period to period and company to company by
factoring out potential differences caused by depreciation and amortization expense and non-cash
charges such as stock based compensation. CSIs management uses Adjusted EBITDA to analyze the
underlying trends in CSIs business, assess the performance of CSIs core operations, establish
operational goals and forecasts that are used to allocate resources and evaluate CSIs performance
period over period and in relation to its competitors operating results. Additionally, CSIs
management is evaluated on the basis of Adjusted EBITDA when determining achievement of their
incentive compensation performance targets.
CSI believes that presenting Adjusted EBITDA provides investors greater transparency to the
information used by CSIs management for its financial and operational decision-making and allows
investors to see CSIs results through the eyes of management. CSI also believes that providing
this information better enables CSIs investors to understand CSIs operating performance and
evaluate the methodology used by CSIs management to evaluate and measure such performance.
The following is an explanation of each of the items that management excluded from Adjusted EBITDA
and the reasons for excluding each of these individual items:
Stock-based compensation. CSI excludes stock-based compensation expense from its non-GAAP
financial measures primarily because such expense, while constituting an ongoing and recurring
expense, is not an expense that requires cash settlement. CSIs management also believes that
excluding this item from CSIs non-GAAP results is useful to investors to understand the
application of stock-based compensation guidance and its impact on CSIs operational performance,
liquidity and its ability to make additional investments in the company, and it allows for greater
transparency to certain line items in CSIs financial statements.
Depreciation and amortization expense. CSI excludes depreciation and amortization expense from
its non-GAAP financial measures primarily because such expenses, while constituting ongoing and
recurring expenses, are not expenses that require cash settlement and are not used by CSIs
management to assess the core profitability of CSIs business operations. CSIs management also
believes that excluding these items from CSIs non-GAAP results is useful to investors to
understand CSIs operational performance, liquidity and its ability to make additional investments
in the company.
Material Limitations Associated with the Use of Non-GAAP Financial Measures and Manner in which CSI
Compensates for these Limitations
Non-GAAP financial measures have limitations as analytical tools and should not be considered in
isolation or as a substitute for CSIs financial results prepared in accordance with GAAP. Some of
the limitations associated with CSIs use of these non-GAAP financial measures are:
Items such as stock-based compensation do not directly affect CSIs cash flow position; however,
such items reflect economic costs to CSI and are not reflected in CSIs Adjusted EBITDA and
therefore these non-GAAP measures do not reflect the full economic effect of these items.
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Cardiovascular Systems, Inc.
February 2, 2011
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February 2, 2011
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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 CSI, limiting the usefulness of those measures for comparative purposes.
CSIs management exercises judgment in determining which types of charges or other items should
be excluded from the non-GAAP financial measures CSI uses.
CSI compensates for these limitations by relying primarily upon its GAAP results and using non-GAAP
financial measures only supplementally. CSI provides full disclosure of each non-GAAP financial
measure CSI uses and detailed reconciliations of each non-GAAP measure to its most directly
comparable GAAP measure. CSI encourages investors to review these reconciliations. CSI qualifies
its use of non-GAAP financial measures with cautionary statements as set forth above.
Contacts:
Cardiovascular Systems, Inc.
|
Padilla Speer Beardsley Inc. | |
Investor Relations
|
Marian Briggs | |
(651) 259-2800
|
(612) 455-1742 | |
investorrelations@csi360.com
|
mbriggs@psbpr.com | |
Nancy A. Johnson | ||
(612) 455-1745 | ||
njohnson@psbpr.com |
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