Cardiovascular Systems, Inc. (Cardiovascular Systems) has reported revenues of $56.5 million for the fiscal 2009, compared with the revenues of $22.2 million in the previous year-end. It has also reported a net loss of $31.9 million, or $1.13 loss per share, for the fiscal 2009, compared with the net loss of $39.2 million, or $13.25 loss per share, in the previous year-end.

CSI’s revenue in the fourth quarter of fiscal 2009 rose to $15.7 million, a 59-percent increase over revenue of $9.9 million in the fourth quarter of last fiscal year. The net loss improved 50 percent to $(5.6) million, or $(0.40) per basic and diluted share, in the fourth quarter, from $(11.3) million, or $(2.34) per basic and diluted share, in the year-ago period. Adjusted EBITDA, calculated as loss from operations, less depreciation and amortization and stock-based compensation expense, also improved by 64 percent to a loss of $(3.6) million versus $(10.0) million in the year-ago period. The number of weighted average common shares outstanding increased to 14.0 million from 8.3 million in the third quarter of fiscal 2009 and 4.9 million in the last quarter of fiscal 2008, primarily due to the February 2009 completion of the reverse merger with Replidyne, Inc. Cash and cash equivalents remained strong at $33.4 million, declining only $4.4 million from the end of the third quarter of fiscal 2009.

David L. Martin, CSI president and chief executive officer, said: “We’ve made significant progress toward our goal to achieve profitability. We have limited operating expense growth, which has improved the bottom line dramatically, and continued to grow our revenue sequentially each quarter. Investments have focused on new procedure and product training for our commercial team, clinical studies to provide useful data to physicians, and product development to expand our peripheral and coronary product portfolios.”

CSI’s primary product is the Diamondback 360o® Peripheral Arterial Disease System, a minimally invasive catheter system for treating peripheral arterial disease (PAD) in leg arteries. The Diamondback 360º removes calcified and fibrotic plaque in just a few minutes of treatment time. Significant blood flow improvements are achieved using the Diamondback 360º alone or with adjunctive use of low-pressure balloon inflation (i.e. three atmospheres of pressure) after vessel compliance has been changed with the Diamondback 360º. An unprecedented safety profile has driven procedures to date to over 15,000 in leading institutions across the United States.

The number of hospitals using the Diamondback 360º rose to 556 by the end of the fiscal 2009 fourth quarter, up sequentially from 487 at the end of the third quarter 2009 and up from 183 at the end of the fiscal 2008 fourth quarter. Sales of disposable device units also grew, with nearly 4,700 units sold in the fourth quarter, up sequentially from 4,600 units sold in the third quarter this fiscal year, and 3,000 units in the fourth quarter of last fiscal year. Both the 90-day reorder rate and the percentage of revenue generated from reorders were strong at nearly 90 percent for the quarter.

The fiscal fourth-quarter gross margin increased to 73 percent from 63 percent in the same period last year, driven by higher disposable volumes, product cost reductions and manufacturing efficiencies. Sales, general and administrative expenses grew 18 percent – a rate less than one-third of the revenue growth rate – to $14.2 million. The increase was due to expansion of the direct sales organization to just over 100 professionals from 55 in the fourth quarter last year. The commercial team did not grow significantly from third quarter fiscal 2009 and is not expected to grow further in the first quarter of fiscal 2010. CSI invests significantly in innovation and product development; however, research and development expenses declined nearly 50 percent from the fourth quarter last year to $2.8 million, due to the completion and timing of projects.

The gross margin in fiscal 2009 was 71 percent, up from 60 percent in fiscal 2008, due to higher product volumes, manufacturing efficiencies and product cost reductions.

The lower net loss reflects higher revenue and gross profit, partially offset by investments in sales and marketing, infrastructure to support growth and product development. Adjusted EBITDA for fiscal 2009 narrowed to $(27.0) million from $(30.5) million in the previous fiscal year. Net loss available to common shareholders decreased to $(9.1) million, or $(1.13) per basic and diluted common share, from $(58.6) million, or $(13.25) per share in fiscal 2008. The decrease was driven by a $22.8 million decline in value of preferred stock in fiscal 2009, versus a $19.4 million increase in value in fiscal 2008, and by the lower net loss between periods. All preferred stock and preferred stock warrants were converted to common stock and common stock warrants upon completion of the reverse merger in February 2009.

Growing Clinical Data

In June, the first patient was enrolled in the COMPLIANCE 360° clinical trial, the first of two PAD studies scheduled to begin in calendar 2009. This prospective, randomized, multi-center study will evaluate the clinical benefit of modifying plaque to change large vessel compliance above the knee with the Diamondback 360o. The study compares the performance of the Diamondback 360º, plus low-pressure balloon inflation, if desired, with that of high-pressure balloon inflation alone. The study calls for enrolling 50 patients at five U.S. medical centers.

Hospital internal review board (IRB) submissions are in progress for the CALCIUM 360o study, a prospective, randomized, multi-center study, which will compare the effectiveness of the Diamondback 360o to balloon dilation in treating heavily calcified lesions below the knee. Calcified plaque exists in about 75 percent of lesions below the knee. This study will also enroll 50 patients at five U.S. medical centers.

A retrospective study evaluating the long-term results of 64 patients from the pivotal OASIS trial has been completed. Outcomes were analyzed out to a mean of 29 months and include limb salvage rate, target lesion revascularization rate (TLR) and ankle-brachial index (ABI). Results are expected to be reported by Dr. Barry Weinstock, an interventional cardiologist at Orlando Regional Medical Center, in an abstract at the Transcatheter Cardiovascular Therapeutics (TCT) conference in September 2009.

Martin continued, “Most PAD patients do not receive the care they need. The physical, emotional and financial costs are enormous for patients and their families. CSI is committed to generating scientifically sound and clinically useful data that will guide the best use of limited healthcare resources.”

In addition, based on the excellent clinical outcomes in treating lower-extremity PAD with the Diamondback 360º, CSI intends to leverage the device’s capabilities to expand into the interventional coronary market. A coronary application would address a large market opportunity, further leveraging the company’s core technology and expanding its market potential. In 2008, the company completed the ORBIT I trial, a 50-patient study in India which investigated the safety of the Diamondback 360º device in treating calcified coronary artery lesions. Results successfully met both safety and efficacy endpoints. An IDE application was recently submitted to the FDA for ORBIT II, a pivotal trial in the United States to evaluate the safety and effectiveness of the Diamondback 360º in treating severely calcified coronary lesions.