Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII)
- Financial performance rose significantly over prior-year fourth quarter:
- Revenues increased 20 percent to $21.7 million
- Gross profit margin rose to 81 percent
- Operating expenses increased 1 percent
- Adjusted EBITDA improved $2.0 million to earnings of $539,000
- Net loss, including $(1.3) million of expense related to conversion and valuation changes of convertible debt, decreased 44 percent to $(2.5) million
- New Stealth 360° System drove 25-percent increase in device usage in converted accounts
- FDA approved completion of patient enrollment in ORBIT II coronary pivotal trial
Revenue from customer reorders increased to 96 percent of total revenue from 93 percent in last year’s fourth quarter. Gross profit margin increased to 81 percent from 77 percent in the same period last year, primarily due to continued product cost reductions, manufacturing efficiencies and shipment of fewer controller units. Fiscal 2011 ResultsFinancial results for fiscal 2011 also improved significantly over the prior year. Revenues increased 22 percent to $78.8 million. Gross margin rose to 79 percent from 77 percent, while operating expenses declined 2 percent. Adjusted EBITDA improved by 88 percent to a loss of $(1.6) million. Net loss decreased 53 percent to $(11.1) million, or $(0.70) per common share, including $(0.9) million, or $(0.05) per common share, of expense related to conversion and valuation changes of convertible debt. OPERATING HIGHLIGHTS Limited Market Release of Stealth 360° AdvancesCSI is introducing its innovative Stealth 360° PAD System through a limited market release to generate valuable feedback from physicians and establish best practices for device operation. At fiscal 2011 year-end, over 100 customers had purchased the third-generation system. The Stealth 360° offers a simple design with power and speed controls on the handle to give physicians hands-on control of device operation and shorter procedure times. Stealth 360° is as easy to set up as a balloon or stent, and utilizes CSI’s proven orbital mechanism of action that protects healthy tissue while removing even the most difficult-to-treat plaque throughout the entire leg.Martin noted, “At hospitals where the Stealth 360° has been installed, device usage rates increased 25 percent, and the number of sites using 30 or more devices per quarter rose 59 percent in the fourth quarter. Moreover, additional physicians are using the system as they become acquainted with its improved operating performance, and most importantly, its ability to safely treat the entire leg. We are definitely changing the standard of PAD treatment.”CSI plans to begin a broader commercial launch of the Stealth 360° in the second quarter of fiscal 2012. Prospective, Randomized Studies Show Advantages of Orbital PAD Therapy Over Balloon AngioplastyData from CSI’s COMPLIANCE 360° and CALCIUM 360° studies of above-the-knee and below-the-knee lesions, respectively, were presented at two major medical conferences in the fourth quarter.Martin commented, “We are building a foundation of clinical PAD data unlike any other company in our space. Scientifically sound clinical evidence is the best way to demonstrate the ability of our orbital mechanism to help physicians successfully treat patients with PAD. As patient follow-up continues, longer-term data are confirming the durability of our therapy.”Acute data from the prospective, randomized COMPLIANCE 360° clinical trial was presented at the American College of Cardiology meeting. The study directly compared the Diamondback 360 ® PAD System to balloon angioplasty in treating above-the-knee PAD. Results showed that the Diamondback 360° can achieve far superior acute results in treating calcium-containing plaque by improving lesion compliance through differential sanding, without the need for stent placement. Study results with a p value of less than 0.0001 showed the success rate in the Diamondback 360° arm was 360 percent greater than in the balloon arm and required 91 percent less bailout stenting. The COMPLIANCE 360° study enrolled 50 patients at nine U.S. sites. Patients will have clinical follow up at one, six and 12 months. Longer-term results will be reported as they become available.The prospective CALCIUM 360° study randomized 50 patients with Critical Limb Ischemia (CLI) below the knee to either orbital treatment or balloon angioplasty. Six-month results presented at the New Cardiovascular Horizons meeting showed orbital treatment outperformed balloon angioplasty. A key finding was that by modifying calcified lesions first, the Diamondback 360° allows use of a lower-pressure adjunctive balloon therapy, reducing the need for bailout stenting with improved longer-term patient outcomes. Orbital treatment outperformed balloon angioplasty on the primary endpoint of device success (less than or equal to 30 percent restenosis with no dissection C-F) with 92.6 percent in the Diamondback 360° arm versus 78.7 percent in the balloon arm. Approval Received to Complete Patient Enrollment in ORBIT II Coronary Clinical TrialIn May, CSI received FDA approval to complete enrollment of 429 patients in its ORBIT II Investigational Device Exemption (IDE) clinical trial for a coronary application of its orbital technology. The approval came following FDA review of data from the first 50 cases, as called for in the trial protocol. As many as 50 U.S. medical centers are expected to participate in ORBIT II."FDA approval to proceed with patient enrollment is a significant milestone in the ORBIT II trial," said Martin. "Many patients with small calcified coronary arteries are excluded from other clinical studies because there are limited treatment options. A coronary application would give patients a new minimally invasive treatment option, as well as provide a sizeable expansion opportunity for CSI. We have demonstrated that our orbital mechanism of action is effective in treating small, calcified vessels in PAD cases, and our ORBIT I coronary feasibility trial of 50 patients met both its safety and efficacy endpoints.” Fiscal 2012 First-Quarter and Full-Year OutlookMartin said, “With the introduction of Stealth 360° and FDA approval to proceed with our ORBIT II coronary trial, CSI is now at an appropriate stage to invest further in sales and marketing and clinical trials to capitalize on our growth opportunities. Therefore, we plan to increase operating expenses in fiscal year 2012 to enhance future growth. This is expected to temporarily increase our net losses in the first half of fiscal 2012 compared to the last half of fiscal 2011. However, we expect to resume progress toward profitability in the second half of fiscal 2012.”For the fiscal 2012 first quarter ending September 30, 2011, CSI anticipates:
- Revenues in the range of $21.0 million to $22.0 million, or growth of 16 percent to 21 percent over the first quarter of fiscal 2011. The revenue range reflects seasonally lower procedure volume during the summer months. Additionally, the transition to the Stealth 360° product line will limit the rate of revenue growth until a broader commercial launch begins, targeted for the fiscal 2012 second quarter.
- Gross profit as a percentage of revenue about 2 percentage points lower than the fiscal 2011 fourth quarter. Stealth 360° will become a higher percentage of revenue, but will still be at limited volumes, which raises its unit cost compared to the Diamondback 360° device. Also, ramp up of the Texas manufacturing facility for higher future production volumes will temporarily increase costs, but enhance efficiencies over time.
- An increase in operating expenses of about 7 percent to 8 percent from the fiscal 2011 fourth quarter, due to expansion of the ORBIT II trial, and additional investments in sales and marketing programs and infrastructure.
- Interest and other expense of about $(350,000), excluding the potential effect of conversions or valuation changes of convertible debt.
- Net loss in the range of $(2.9) million to $(3.5) million, or loss per common share ranging from $(0.17) to $(0.20), assuming 17.4 million average shares outstanding, excluding the potential effect of conversions or valuation changes of convertible debt.
- Adjusted EBITDA loss between $(0.8) million and $(1.4) million.
- Revenue growth of 20 percent to 25 percent over fiscal 2011.
- Net loss for the full year, but positive net income in the fourth quarter, excluding the potential effect of conversions or valuation changes of convertible debt.
|Cardiovascular Systems, Inc.Consolidated Statements of Operations(Dollars in Thousands, except per share and share amounts)(unaudited)|
|Three Months EndedJune 30,||Year EndedJune 30,|
|Revenues||$ 21,707||$ 18,015||$ 78,780||$ 64,829|
|Cost of goods sold||4,214||4,153||16,277||15,003|
|Selling, general and administrative||15,775||15,297||62,372||62,447|
|Research and development||2,624||2,857||8,940||10,278|
|Loss from operations||(906)||(4,292)||(8,809)||(22,899)|
|Interest and other income (expense)||(1,577)||(109)||(2,316)||(1,005)|
|Net loss||$ (2,483)||$ (4,401)||$ (11,125)||$ (23,904)|
|Net loss per common share:|
|Basic and diluted||$ (0.15)||$ (0.29)||$ (0.70)||$ (1.62)|
|Weighted average common shares used in computation:|
|Basic and diluted||16,329,850||14,950,869||15,915,800||14,748,293|
|Cardiovascular Systems, Inc.Consolidated Balance Sheets(Dollars in Thousands)(unaudited)|
|June 30,||June 30,|
|Cash and cash equivalents||$ 21,159||$ 23,717|
|Accounts receivable, net||13,254||9,394|
|Prepaid expenses and other current assets||797||1,048|
|Total current assets||41,028||38,478|
|Property and equipment, net||2,383||1,964|
|Total assets||$ 46,758||$ 42,722|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current maturities of long-term debt||$ 3,813||$ 2,302|
|Deferred grant incentive||647||1,181|
|Total current liabilities||15,186||13,405|
|Long-term debt, net of current maturities||8,331||8,985|
|Deferred grant incentive||1,497||2,208|
|Total long-term liabilities||9,937||11,602|
|Commitments and contingencies|
|Total stockholders’ equity||21,635||17,715|
|Total liabilities and stockholders’ equity||$ 46,758||$ 42,722|
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 CSI's management uses Adjusted EBITDA to conduct and evaluate its business, the economic substance behind management's 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)|
|Three months endedJune 30,||Year ended June 30,|
|Other product revenue||2,538||2,130||9,512||7,478|
|Device units sold||6,255||5,318||22,917||19,178|
|Reorder revenue %||96%||93%||94%||93%|
|Cardiovascular Systems, Inc.Adjusted EBITDA(Dollars in Thousands)(unaudited)|
|Three Months EndedJune 30,||Year EndedJune 30,||Three Months EndedSeptember 30, 2011|
|Loss from operations||$ (906)||$ (4,292)||$ (8,809)||$ (22,899)||$ (2,300)||$ (2,900)|
|Add: Stock-based compensation||1,247||2,634||6,468||9,094||1,300||1,300|
|Add: Depreciation and amortization||198||164||716||599||200||200|
|Adjusted EBITDA||$ 539||$ (1,494)||$ (1,625)||$ (13,206)||$ (800)||$ (1,400)|
Use and Economic Substance of Non-GAAP Financial Measures Used by CSI and Usefulness of Such Non-GAAP Financial Measures to InvestorsCSI 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. CSI's management uses Adjusted EBITDA to analyze the underlying trends in CSI's business, assess the performance of CSI's core operations, establish operational goals and forecasts that are used to allocate resources and evaluate CSI's performance period over period and in relation to its competitors' operating results. Additionally, CSI's 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 CSI's management for its financial and operational decision-making and allows investors to see CSI's results "through the eyes" of management. CSI also believes that providing this information better enables CSI's investors to understand CSI's operating performance and evaluate the methodology used by CSI's 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. CSI's management also believes that excluding this item from CSI's non-GAAP results is useful to investors to understand the application of stock-based compensation guidance and its impact on CSI's operational performance, liquidity and its ability to make additional investments in the company, and it allows for greater transparency to certain line items in CSI's 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 CSI's management to assess the core profitability of CSI's business operations. CSI's management also believes that excluding these items from CSI's non-GAAP results is useful to investors to understand CSI's 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 CSI's financial results prepared in accordance with GAAP. Some of the limitations associated with CSI's use of these non-GAAP financial measures are: -- Items such as stock-based compensation do not directly affect CSI's cash flow position; however, such items reflect economic costs to CSI and are not reflected in CSI's "Adjusted EBITDA" and therefore these non-GAAP measures do not reflect the full economic effect of these items. -- 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. -- CSI's 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.