![]() We are confident that we have compelling data to secure the PMA approval. While we asked for earlier meeting dates, May the 4th was the earliest date that the agency was able to provide.įollowing this May 4th meeting, we'll have a clearer view of the path and timing to the PMA, including any further preclinical studies as needed. In addition, the FDA has confirmed the date for our requests for the submission issue review meeting on May the 4th to drive towards alignment on our responses. Since we last spoke in February, we have completed and have shared with the agency our responses that address their main questions related to preclinical data, including the impact of different sterilization doses on materials used in the final product. We've made important progress for support SurVeil's pre-market approval. Third, to drive top line revenue growth and optimize cash flow from our IVD and medical device coatings offering. Second, to build a commercial pipeline for our Sublime Radial and Pounce arterial and Venous Thrombectomy platforms. ![]() As a reminder, these are, first to achieve the PMA for SurVeil and support Abbott's commercialization efforts. Tim will provide additional detail on our quarterly results, as well as our updated guidance later in today's call.ĭuring our second quarter, we continue to make progress on our strategic objectives for the fiscal year. We are updating our financial guidance for the full year to reflect the strength the following year-to-date financial performance. We reported GAAP diluted loss per share of $0.29 and non-GAAP diluted loss per share of $0.22. Normalizing for this milestone payment, we grew revenue by $1.5 million or 6% year-over-year, driven by solid performance from both our medical device and IVD businesses. Starting with our second quarter financial performance, which delivered above expectations, we achieved revenue of $26.1 million in the second quarter compared to $35 million in the prior year quarter, which included $10.8 million in revenue recognized on the $15 million Abbott milestone payment associated to the successful completion of the TRANSCEND clinical report. We are pleased with both our financial performance and the progress we've made in executing our strategic priorities during the quarter. Good morning and thank you for joining us on our second quarter earnings call. I will now turn the call over to Gary Maharaj. A press release disclosing our quarterly results was issued this morning and is available on our website at. This conference call is being webcast and is accessible through the Investor Relations section of the Surmodics website, where the audio recording of the webcast will also be archived for future reference. ![]() Today's news release containing reconciliation tables to GAAP results. We'll also refer to non-GAAP measures because we believe they provide useful information for our investors. Surmodics disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments or otherwise. Please be advised that actual results could differ materially from those stated or implied by our forward-looking statements resulting from certain risks and uncertainties, including those described in our SEC filings. These forward-looking statements are covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding Surmodics' future financial and operating results or other statements that are not historical facts. Before we begin, I would like to remind you that during this call, we will make forward-looking statements. Good morning and welcome to Surmodics' fiscal 2022 second quarter earnings call. Tim Arens, Senior Vice President of Finance and Chief Financial Officer. Today's conference is being recorded.Īt this time, I would like to turn the conference over to Mr. Good day, and welcome to the Surmodics Second Quarter Fiscal 2022 Conference Call. ![]() ( NASDAQ: SRDX) Q2 2022 Earnings Conference Call Ap8:30 AM ETīrooks O'Neil - Lake Street Capital Markets
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