Cardiovascular Systems Inc. (CSI) posted first-quarter sales of $15.2 million for the three months ended Sept. 30, up 30.5 percent compared with $11.6 million during the same period last year. The St. Paul, Minn.-based cardiovascular device maker narrowed its net losses from $13.7 million during the first quarter of fiscal 2009 to $6.2 million during Q1 2010:
Cardiovascular Systems Reports Fiscal First-Quarter 2010 Financial Results
First-Quarter Net Loss Improves 55 Percent Over Prior Year on 30-Percent Revenue Increase, Gross Margin Improvements and Expense Control
CSI’s revenue in the first quarter of fiscal 2010 rose to
The number of hospitals using the Diamondback 360® PAD System rose to 611 by the end of the fiscal 2010 first quarter, a nearly 90-percent increase over a year ago and 55 more than the end of the fourth quarter of fiscal 2009. Sales of disposable device units totaled 4,541 units in the first quarter of fiscal 2010 versus 3,636 units in the first quarter of last fiscal year, a 25-percent increase. Revenue generated from customer reorders continued to grow, increasing to 92 percent of total revenue for the fiscal 2010 first quarter from 72 percent in last year’s first quarter.
The fiscal first-quarter 2010 gross margin increased to 77 percent from 67 percent in the same period last year, driven by higher disposable volumes, manufacturing efficiencies, product cost reductions and shipment of fewer controller units. Operating expenses decreased 18 percent, due to effective expense management, the year-earlier write-off of
Providing Comprehensive Clinical Data and Tools to Treat PAD
CSI is committed to providing physicians with clinical data and endovascular tools to treat PAD. Toward that end, this quarter the company continued to expand its product portfolio through an exclusive distribution agreement with
CSI also continued to make progress providing clinical data. At the Transcatheter Cardiovascular Therapeutics (TCT) conference in September, Dr.
Also at TCT, Dr.
CSI is advancing several clinical studies. COMPLIANCE 360° and CALCIUM 360˚ are prospective, randomized, multi-center studies that will evaluate the clinical benefit of modifying plaque and lesion compliance in leg arteries with the Diamondback 360° (supplemented by low-pressure balloon inflation, if desired, in CALCIUM 360˚) to high-pressure balloon inflation. Both studies call for enrolling 50 patients at five U.S. medical centers. CSI also continues working with the
For the second fiscal quarter of 2010 ending
Martin continued, “Now that proper clinical protocols and related sales tools and training are in place, we will expand investments for re-educating our customer base, driving deeper adoption within accounts, advancing our clinical trials, and introducing product enhancements. These initiatives position us well for significant, profitable growth over the long term and will be balanced with progress toward profitability. We expect revenue growth in the fiscal 2010 second half to be stronger than the first half, as our initiatives take hold. Due to the timing of the effect of our adoption and re-education efforts, we now expect revenue growth will be approximately 15 percent to 20 percent for the fiscal year. We will continue to drive our business toward our first profitable quarter during fiscal 2011, while living within our cash resources and debt capacity.”
About the Diamondback 360® PAD System
CSI’s primary product is the Diamondback 360° PAD System, a minimally invasive catheter system for treating PAD in leg arteries. The Diamondback 360° is highly effective in removing plaque in vessels both below the knee and above the knee in just a few minutes of treatment time. Between 8 million and 12 million Americans suffer from 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. More than 18,000 procedures have been performed to-date using the Diamondback 360° in leading institutions across
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) the timing of our customer re-education process; (ii) our new facility in
Use of Non-GAAP Financial Measures
To supplement CSI’s 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 CSI’s financial results prepared in accordance with GAAP.
The Diamondback 360® PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The system is 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.