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EX-99.1 - EX-99.1 - Cardiovascular Systems Incexhibit991-050520.htm
8-K - 8-K - Cardiovascular Systems Inccsii-20200505.htm
Q3 FY20 Earnings Call May 5, 2020


 
Safe Harbor FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Report Act of 1995, which are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this presentation regarding CSI’s strategy; growth; future financial measurements and investments; product development plans, milestones and introductions; geographic expansion; clinical trials and evidence; professional education efforts; market estimates and opportunities; and developments related to the COVID-19 pandemic are forward-looking statements. These statements involve risks and uncertainties that could cause results differ materially from those projected, including, but not limited to, those described in CSI’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly and annual reports. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this presentation. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this presentation. The forward-looking statements contained in this presentation are made only as of the date of this presentation, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances. FINANCIAL INFORMATION This presentation includes calculations or figures that have been prepared internally and have not been reviewed or audited by CSI’s independent registered accounting firm. Use of different methods for preparing, calculating or presenting information may lead to differences, which may be material.


 
Q3 Revenues of $61.2 Million 3% Decrease Revenues US Coronary revenue ($ in millions) declined 2% Drivers US Peripheral revenue Unit sold decreased 9% as declined 6% COVID-19 negatively impacted procedure Drivers US volumes Units sold decreased 6% as Peripheral, US Coronary, Support product revenue COVID-19 negatively impacted $42.1 $16.0 increased 124% procedure volumes Hospital revenue decreased 8% International grew 26% OBL revenue decreased 4% Drivers Coronary Classic and International, ViperWire Flex Tip in Japan $3.1 OAS launched in 13 US Peripheral US Coronary International countries OUS to-date


 
Q3 FY20 Financial Results ($ in millions) Worldwide Peripheral Revenue Worldwide Coronary Revenue $48.3 $47.6 $20.8 $45.2 $45.5 $20.0 $19.0 $42.6 $18.2 $18.5 6% 2% decline growth WW in WW in Q3 Q3 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20 Q3 FY20 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20 Q3 FY20 Gross Margin Cash and Marketable Securities 80.8% 80.3% 80.4% 79.9% 80.0% $115.7 $122.7 $105.0 $109.4 $107.3 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20 Q3 FY20 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20 Q3 FY20


 
Q3 FY20 Highlights Financial Operational - Peripheral Operational – Coronary Other Revenues Decreased -3.4% vs. LY • Low profile peripheral offerings • Growing adoption of coronary • Sold 20,000 OAS units including Exchangeable and toolkit featuring OAS with • Certified 66 international Gross Margin 80.0% Radial are well-positioned to GlideAssist, 1.0mm Sapphire physicians (201 YTD) capture market share as angioplasty balloons, Teleport • REACH Peripheral Radial SGA Expenses +0.1% to $41.4M physicians seek to reduce Microcatheter and nitinol Study data to be presented at procedure time and bleeding ViperWire with Flex Tip driving NCVH in July 2020 R&D Expenses +8.8% to $10.0M complications associated with increased revenue per OAS • Targeting first in human traditional femoral access sold experience for pVAD device in Net Loss of $(2.9)M • Received regulatory approval in • Received regulatory approvals FY21 Australia. Launch timing TBD in New Zealand, Vietnam and • Review of lower extremity Cash and marketable securities • LIBERTY 360 1-Year data is a Indonesia. Launch timing TBD endovascular code set is not $107.3M top 10 download over the past • ECLIPSE enrollment on the May 2020 CPT five years from JEVT suspended with 1364/2000 Editorial Panel agenda No long-term debt • Targeting launch of WIRION patients enrolled EPD in Q1 FY21 Increased LOC capacity to $50M • Targeting launch of peripheral and extended to March 2022 angioplasty balloons in 2H FY21


 
Near-term Financial Commentary • CSI withdrew fiscal 2020 financial guidance on April 1, 2020 due to the impact of COVID-19 on US procedure volumes • Our April US procedure volumes declined 53% vs. LY • Several factors may increase or decrease our procedure volumes during the last two months of Q4, including developments relating to social restrictions and government restrictions on elective and semi-elective cases, level of patient anxiety, availability of PPE, cath lab and workforce capacity, and sales rep access to hospitals to support cases • Q4 international revenue is expected to be approximately $2.0M • Lower projected manufactured unit volumes are expected to result in Q4 gross profit margin in the mid-70% range • Q4 operating expenses are expected to be in a range of $44M-$46M


 
Investor Contact: Jack Nielsen 651-202-4919 j.nielsen@csi360.com CSI®, Diamondback®, Diamondback 360®, GlideAssist®, ViperWire®, WIRION® and ViperWire Advance® are trademarks of Cardiovascular Systems, Inc. © 2020 Cardiovascular Systems, Inc. CSII OrbusNeich®, Teleport® and Sapphire® are trademarks of OrbusNeich Medical, Inc. Cardiovascular Systems, Inc. For more information: www.csi360.com @csi360