Cardiovascular Systems, Inc.

Good day and thank you for standing by. Welcome to the Cardiovascular Systems Inc. Fiscal Year 2021 Fourth Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Mr. Jack Nielsen. Please go ahead.

Thank you, Zena. Good afternoon and welcome to our fiscal 21 fourth quarter conference call. With me today are Scott Ward, CSI Chairman, President, Chief Executive Officer, Rhonda Robb, Chief Operating Officer, and Jeff Points, Chief Financial Officer. Approximately 30 minutes ago, we issued a press release announcing fourth quarter results. You may find a copy of this release on the investor relations section of our corporate website. Here you may also find an earnings supplement that includes additional details on our performance and outlook. In a few moments, CSI management will discuss results for the fourth quarter and fiscal year ended June 30, 2021. After our prepared remarks, we will entertain your questions. During today's call, we will make forward-looking statements. These forward-looking statements are covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding CSI's future financial and operating results or other statements that are not historical facts. Actual results could differ materially from those stated or implied by our forward-looking statements due to certain risks and uncertainties. including those described in our most recent Form 10-K and subsequent quarterly reports on Form 10-Q. In particular, the COVID-19 pandemic has created risks and uncertainties for our business, results of operations, financial condition, and prospects, which we will discuss on this call. CSI disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments, or otherwise. We will also refer to non-GAAP measures because we believe they provide useful information for our investors. Today's press release contains a reconciliation table to GAAP results. I will now turn the call over to Scott Ward.

Scott Ward Thank you, Jack, and good afternoon, everyone. Thank you for joining us today. This afternoon, we reported results of a very strong quarter. With revenues of $71 million, we grew 12% sequentially versus Q3 and 67% versus prior year. Three key factors contributed to our growth in Q4, including COVID recovery, new users and new accounts in our pipeline, and strong sales execution in our high-volume coronary and peripheral accounts. As a result, we achieved double-digit sequential revenue growth in both our U.S. peripheral and coronary franchises compared to our third quarter. In peripheral, we achieved 13% sequential revenue growth with a solid rebound in our hospital business and continued momentum in office-based labs. In coronary, we achieved a 12% sequential increase in Diamondback unit sales and increased revenue generated from the sale of our procedure support devices. International revenue at $3.7 million increased 76% compared to last year. New account growth in Japan and our successful launch of Coronary in the EU both contributed to better-than-expected results. For the full year, fiscal 21 revenues increased 9.5% to a record $259 million. U.S. peripheral revenue increased about 7%, while Coronary revenue increased over 17%. Our full year fiscal 21 revenues also reflect an 11 million or 4.4% increase over our pre COVID fiscal 19 results. In peripheral, our strategy to target high volume office-based labs combined with the migration of patients to this site of service during the pandemic resulted in a 22% year over year increase in OBL revenue in fiscal 21. Our peripheral hospital business was about flat for the year due to COVID-related weakness in the referral pipeline and the deferral of procedures for patients with lower acuity claudication. For the full year, U.S. coronary revenues increased over 17% versus last year, driven by COVID recovery, robust increases in new users, and deeper adoption of orbital arthrectomy at high-volume cath labs that focus on the treatment of complex coronary artery disease. Despite the pandemic, demand for physician education programs has remained strong. In FY21, we certified 384 new customers, including a 53% increase in coronary fellow certifications. And this drove strong unit volume and increased demand for our products throughout the year, even as a new competitor entered the space. Outside the U.S., we are encouraged by the resiliency of our international franchise. Revenue grew 8% in fiscal 21 to 11.3 million. Our peer-to-peer education model in Japan has resulted in strong revenue and market share growth in the three years since launch. We deployed the same education model for the EU coronary launch, and we have built a strong foundation of new accounts that will accelerate OAS adoption and market expansion. Finally, we continue to make progress on our R&D milestones. And with the launch of WIRON and our jade peripheral balloons, we are poised to drive strong revenue growth in fiscal 22. Rhonda will provide additional details on our commercial progress in a few moments. But first, Jeff will provide details regarding our financial results and our fiscal year 22 guidance.