Heron Therapeutics, Inc.

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q4 2021 Earnings Conference. As a reminder, this conference is being recorded. Now, I would like to turn the call over to David Sikaris, Executive Vice President, Chief Operating Officer. Please proceed.

Thank you, Buena. Good afternoon, everyone, and thank you for joining us. With me today from Heron are Barry Court, Chief Executive Officer and Chairman, John Poynan, President and Chief Commercial Officer, Kimberly Manhard, Executive Vice President of Drug Development and Board Director, and Chris Torgard, our Chief Medical Officer. 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 Heron's future expectations, plans, prospects, corporate strategy, and performance, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation 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 of the SEC, In addition, any forward-looking statements represent our views only as of the date of this webcast and 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. 2021 was one of the most important and productive years in our company's history. we obtained initial approval and successfully launched XenRelief for postoperative pain in the United States. And only five months after launch, we obtained approval for a substantially expanded indication statement, which greatly improves our ability to commercialize the product. With our CINV franchise, we stabilize revenue in a predominantly generic market and see a path towards modest growth in the future. We also filed an NDA for our fourth commercial product, HDX019, for postoperative nausea and vomiting, or PONV, which has the potential to be many times larger than our CINV business. Lastly, we have also focused our energies on both cutting costs, such as eliminating more than half of our leased office space, and partnering ex-U.S. territories for Zin Relief to extend our cash runway. As we reported in December, in a little over two months from submission, the FDA approved our first of two planned supplemental NDAs to expand the indication statement for Zin Relief to cover approximately 7 million procedures compared to only about 2 million in the original label. The first supplemental NDA approved by the FDA mid-December broadened 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 status of the FDA-agreed studies for this second supplemental NDA are listed on slide five. The endpoint in these studies is pharmacokinetics and safety. Demonstration of efficacy is not required for approval. we expect to submit SNDA number two late in the second half of this year. Approval of SNDA number two should expand the label to cover essentially all 14 million target procedures. In addition to SNDA one, the FDA also approved our manufacturing supplements for a secondary supplier of our proprietary polymer and significant increases in batch size for both SynRelief and Synvaki. These approvals are critical to allow us to manufacture sufficient quantities of these important products at a significantly lower cost of goods. Overall, fourth quarter and 2021 as a whole were outstanding for Heron. I will now turn the call over to John to review our achievement of important commercial and corporate milestones in 2021. Thank you, Barry.