Heron Therapeutics, Inc.

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q3 2021 Earnings Conference. As a reminder, this conference is being recorded. Now I would like to turn the call over to David Sakaris, Executive Vice President, Chief Operating Officer. Please proceed.

Thank you, Gigi. Good afternoon, everyone, and thank you for joining us. With me today from Heron are Barry Cort, Chief Executive Officer and Chairman of John Poyant, President and Chief Commercial Officer, and Kimberly Manhart, Executive Vice President of Drug Development and a Board Director. For those of you participating via conference call, the slides are made available via webcast and can also be accessed by going to the Investor Relations page of our website following conclusion of today's call. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning inherent future expectations, plans, prospects, corporate strategy, and performance, which constitute forward-looking statements for the purposes of the safe harbor of provision under the Private Securities Litigation and Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this webcast It should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. Now, I'll turn the call over to Barry.

Thank you, David. Welcome, everyone, and thank you for joining us. The last several months have been one of the most important and productive periods in our company's history. We successfully launched ZenRelief for postoperative pain in the United States, which represents our first product in our acute care franchise and our third commercial product overall. And we were focused on creating long-term growth in this franchise with ZinRelief. We've had great success with P&T committee approvals, which is very encouraging for our first quarter of launch. Right now, we're focused on expanding the label and our commercial opportunity with ZinRelief, which I'll talk more about in a minute. We're also focused on stabilizing our sales in our oncology care franchise through this year and seeing modest growth next year. We've had successful interactions with the FDA to support the label expansion of XenRelief and to increase product supply. The FDA agreed to two SNDAs for label expansion for XenRelief. The first supplemental NDA was submitted to the FDA at the end of September and is expected to broaden the label to include foot and ankle, small to medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. The FDA also agreed to contents of the second supplemental NDA to broadly cover orthopedic and soft tissue surgical procedures. The FDA-agreed studies for this second SNDA are already ongoing. The endpoints in these studies is pharmacokinetics and safety. Demonstration of efficacy is not required for approval. We expect to submit this second SNDA in the second half of 2022. If approved, this broad indication would cover over 14 million target procedures. In addition, the FDA also approved our manufacturing supplement to add a secondary supplier of our proprietary polymer. This approval is a critical step in giving us the ability to manufacture millions of doses annually and to significantly lower the cost of goods. This approval was received in under four months, and together, with future label expansions will allow us to supply a highly effective non-opioid postoperative pain drug to millions of patients annually. Overall, the quarter was outstanding for Heron. As a company, we remain in a strong position and we're looking forward to achieving additional key commercial and corporate milestones in the coming year. With that, I'll turn the call over to John to review our commercial portfolio. John?