Cardiovascular Systems, Inc. Reports Fiscal 2022 Fourth Quarter and Full Year Financial Results
Cardiovascular Systems, Inc. (CSII) reported fourth-quarter revenues of $62.5 million, a 12% decrease year-over-year but an 11% increase sequentially. The company anticipates fiscal 2023 revenues between $255 million and $265 million, projecting 8% to 12% growth compared to fiscal 2022. A net loss of $9.7 million was reported for Q4, an increase from $5.3 million in the prior year, with an Adjusted EBITDA loss of $4.3 million. Key operational milestones were achieved, with growth in both peripheral and coronary business segments.
- Sequential revenue growth of 11% in Q4.
- Fiscal 2023 revenue guidance of $255 million to $265 million, indicating growth potential.
- 9% and 16% sequential growth in U.S. peripheral and coronary atherectomy franchises, respectively.
- International revenues increased 14% sequentially.
- Achievement of key product development milestones.
- Q4 revenue decreased 12% compared to Q4 of the previous year.
- Net loss increased to $9.7 million from $5.3 million year-over-year.
- Adjusted EBITDA loss worsened from near breakeven to $4.3 million.
Webcast Scheduled for Tomorrow,
-
Revenues of
increased$62.5 million 11% sequentially compared to third quarter this year and decreased12% compared to fourth quarter last year -
Management provides fiscal 23 revenue guidance of
to$255 million , representing$265 million 8% to12% growth compared to fiscal 22 -
Capital Markets Day on
August 3 to highlight product development in large, high-growth markets
Executive Commentary –
“During Q4, we achieved strong sequential growth across all business segments with our
“In addition, key operating statistics, like new accounts, new customers trained and new contracts, continue to demonstrate strong demand for our products and position us for continued momentum in fiscal 23.
“We also achieved our key product development milestones in the quarter. Following the first in human experiences with our Propel™ percutaneous ventricular assist device in March, we recently submitted the investigational device exemption for the early feasibility study, which we expect to start in Q3. We also remain on track to achieve the milestones for our thrombectomy devices, intravascular lithotripsy and Everolimus drug-coated balloons.
“With strong execution in R&D and a compelling rebound in sales, we have renewed momentum in our business and we are excited about the prospects for a strong year in fiscal 23.”
Fourth Quarter Financial Highlights
CSI’s fiscal 2022 fourth quarter revenues were
Selling, general and administrative expenses were
Fourth-quarter net loss of
Fiscal Year 2022 Financial Highlights
CSI’s fiscal year 2022 revenues were
Selling, general and administrative expenses were
Net loss of
As of
Fiscal Year 2023 Guidance
Ward added, “Our guidance anticipates attractive revenue growth in fiscal 23 with a gradual improvement in the state of the
For the fiscal year ending
-
Revenue of
to$255 million ;$265 million -
Gross profit as a percentage of approximately
72% to74% of revenues; -
Research and development expenses will be approximately
16% to17% of revenues; -
Net loss in a range of
9% to11% of revenues; and - Adjusted EBITDA near break-even.
Webcast Scheduled for Tomorrow at
In lieu of hosting a quarterly earnings call, CSI management will discuss fourth-quarter results at the beginning of its Capital Markets Day on
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the
About Peripheral Artery Disease (PAD)
Eighteen to 20 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
About
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) CSI’s strategy, goals and prospects; (ii) the ongoing COVID-19 pandemic, its potential impact on our business, including trends in procedure volumes, the effects on the healthcare system, staffing shortages, patients returning for interventions, and case backlogs; (iii) expansion of our product portfolio and milestones relating thereto, including the specific products, clinical trials and experiences, and timing thereof, and the benefits to CSI; (iv) our expectations regarding attractive revenue growth, improvement in the state of the
Product Disclosures:
Peripheral Products
Indications: The Stealth 360® PAD System and Diamondback 360® PAD System are percutaneous orbital atherectomy systems (OAS) indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.
Contraindications: The
Warnings/Precautions: 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.
See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (
The Stealth 360® PAD System and Diamondback 360® PAD System received FDA 510(k) clearance. The Stealth 360® PAD System is CE Marked.
Coronary Product
Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The
Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The
See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (
The Diamondback 360® Coronary
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Consolidated Statements of Operations |
||||||||||||||||
(Dollars in Thousands) |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
|
Three Months Ended |
|
Year Ended |
||||||||||||
|
|
|
|
|
||||||||||||
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Net revenues |
|
$ |
62,496 |
|
|
$ |
70,987 |
|
|
$ |
236,222 |
|
|
$ |
258,973 |
|
Cost of goods sold |
|
|
16,269 |
|
|
|
20,634 |
|
|
|
63,440 |
|
|
|
61,131 |
|
Gross profit |
|
|
46,227 |
|
|
|
50,353 |
|
|
|
172,782 |
|
|
|
197,842 |
|
Expenses: |
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative |
|
|
46,593 |
|
|
|
45,713 |
|
|
|
170,526 |
|
|
|
167,498 |
|
Research and development |
|
|
8,773 |
|
|
|
9,245 |
|
|
|
36,720 |
|
|
|
41,061 |
|
Amortization of intangible assets |
|
|
346 |
|
|
|
304 |
|
|
|
1,342 |
|
|
|
1,216 |
|
Total expenses |
|
|
55,712 |
|
|
|
55,262 |
|
|
|
208,588 |
|
|
|
209,775 |
|
Loss from operations |
|
|
(9,485 |
) |
|
|
(4,909 |
) |
|
|
(35,806 |
) |
|
|
(11,933 |
) |
Other (income) expense, net |
|
|
157 |
|
|
|
313 |
|
|
|
817 |
|
|
|
1,236 |
|
Loss before income taxes |
|
|
(9,642 |
) |
|
|
(5,222 |
) |
|
|
(36,623 |
) |
|
|
(13,169 |
) |
Provision for income taxes |
|
|
48 |
|
|
|
63 |
|
|
|
310 |
|
|
|
252 |
|
Net loss |
|
$ |
(9,690 |
) |
|
$ |
(5,285 |
) |
|
$ |
(36,933 |
) |
|
$ |
(13,421 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Basic and diluted earnings per share |
|
$ |
(0.25 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Basic and diluted weighted average shares outstanding |
|
|
39,346,771 |
|
|
|
38,926,490 |
|
|
|
39,229,734 |
|
|
|
38,832,002 |
|
|
||||||
Consolidated Balance Sheets |
||||||
(Dollars in Thousands) |
||||||
(unaudited) |
||||||
|
|
|
|
|||
|
2022 |
|
2021 |
|||
|
|
|
|
|||
ASSETS |
|
|
|
|||
Current assets |
|
|
|
|||
Cash and cash equivalents |
$ |
66,424 |
|
$ |
71,070 |
|
Marketable securities |
|
93,409 |
|
|
135,968 |
|
Accounts receivable, net |
|
39,678 |
|
|
40,033 |
|
Inventories |
|
34,567 |
|
|
32,313 |
|
Prepaid expenses and other current assets |
|
7,768 |
|
|
5,285 |
|
Total current assets |
|
241,846 |
|
|
284,669 |
|
Property and equipment, net |
|
29,035 |
|
|
28,894 |
|
Intangible assets, net |
|
15,734 |
|
|
15,376 |
|
Strategic investments |
|
33,425 |
|
|
20,657 |
|
Other assets |
|
2,637 |
|
|
2,971 |
|
Total assets |
$ |
322,677 |
|
$ |
352,567 |
|
|
|
|
|
|||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|||
Current liabilities |
|
|
|
|||
Accounts payable |
$ |
14,383 |
|
$ |
14,061 |
|
Accrued expenses |
|
23,464 |
|
|
38,189 |
|
Deferred revenue |
|
2,107 |
|
|
2,400 |
|
Total current liabilities |
|
39,954 |
|
|
54,650 |
|
Long-term liabilities |
|
|
|
|||
Financing obligation |
|
20,298 |
|
|
20,596 |
|
Deferred revenue |
|
— |
|
|
2,194 |
|
Other liabilities |
|
12,945 |
|
|
4,169 |
|
Total liabilities |
|
73,197 |
|
|
81,609 |
|
Commitments and contingencies |
|
— |
|
|
— |
|
Total stockholders’ equity |
|
249,480 |
|
|
270,958 |
|
Total liabilities and stockholders’ equity |
$ |
322,677 |
|
$ |
352,567 |
Non-GAAP Financial Measures
To supplement CSI's 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 these non-GAAP measures to the most comparable
Adjusted EBITDA |
||||||||||||||||
(Dollars in Thousands) |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
Three Months Ended |
|
Year Ended |
|||||||||||||
|
|
|
|
|||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ |
(9,690 |
) |
|
$ |
(5,285 |
) |
|
$ |
(36,933 |
) |
|
$ |
(13,421 |
) |
|
Less: Other (income) and expense, net |
|
157 |
|
|
|
313 |
|
|
|
817 |
|
|
|
1,236 |
|
|
Less: Provision for income taxes |
|
48 |
|
|
|
63 |
|
|
|
310 |
|
|
|
252 |
|
|
Loss from operations |
|
(9,485 |
) |
|
|
(4,909 |
) |
|
|
(35,806 |
) |
|
|
(11,933 |
) |
|
Add: Stock-based compensation |
|
4,037 |
|
|
|
3,742 |
|
|
|
17,841 |
|
|
|
16,230 |
|
|
Add: Depreciation and amortization |
|
1,198 |
|
|
|
1,169 |
|
|
|
5,029 |
|
|
|
4,312 |
|
|
Adjusted EBITDA |
$ |
(4,250 |
) |
|
$ |
2 |
|
|
$ |
(12,936 |
) |
|
$ |
8,609 |
|
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 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.
Beginning with the quarter ended
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 provides 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220802005993/en/
Vice President, Investor Relations & Corporate Communications
(651) 202-4919
j.nielsen@csi360.com
Source:
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