IVERIC bio, Inc.

Good morning and welcome to the IVARIC-Bio fourth quarter 2022 earnings conference call. All participants will be in listen-only mode. If you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, Please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Kathy Galante, Investor Relations. Please go ahead.

Good morning and welcome to the Iverik Bio conference call. Representing Iverik Bio today are Glenn Splendorio, Chief Executive Officer, Dr. Praveen Dougal, President, Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Devil Desai, Chief Development Officer, Chris Simms, Chief Commercial Officer, and Tony Gibney, Chief Business and Strategy Officer. I would like to remind you that today we will be making statements relating to Ivericbio's future expectations regarding operational, financial, and research and development matters. These statements constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and materials that are subject to various risks that could cause actual results to differ materially from those expressed or implied by any forward-looking statement. I refer you to our SEC filings, and in particular to the risk factors included in our quarterly report on Form 10Q, filed on November 4, 2022, for a detailed description of the risk factor affecting our business that could cause actual results or events to differ materially from the forward-looking statements that we make. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we disclaim any obligation to do so except as required by law. I would now like to turn the call over to Glenn.

Well, thanks, Kathy, and good morning, everybody. In 2022, we continue to deliver on our goal to deliver, to provide potential treatments to patients suffering from retinal diseases with Avacyncaptiv-Pegel, or ACP, achieving a statistically significant reduction in the rate of geographic atrophy progression at the 12-month pre-specified primary endpoint across two Phase III clinical trials. We begin 2023 with the FDA's acceptance of the filing of our new drug application for ACP for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration. With the achievement of this important milestone, we move closer to our goal of providing patients with a treatment for GA, a devastating disease that leads to irreversible blindness. Additionally, our NDA has been granted priority review by the FDA and given a prescription drug user fee act or PDUFA date of August 19th, 2023. We were also informed that at the time of the FDA acceptance letter, the FDA had not identified any potential review issues and the FDA was not currently planning to hold an advisory committee meeting for ACP. This morning we announced results of a post hoc analysis on the data from the ACP Gather 1 and Gather 2 clinical trials signaling an up to 59% risk reduction in the rate of vision loss for the ACP 2 milligram groups compared to sham at 12 months of treatment. Praveen will discuss this new data in more details in a few moments. As we move closer to potential approval, our key focus in 2023 is to make ACP commercially available to physicians and their patients suffering with GA as quickly as possible. About a year ago, we started to build a world-class commercial team that includes sales leadership, reimbursement, marketing, and market access. Our commercial leadership team brings extensive experience in launching drugs for retinal diseases in large markets. We continue to accelerate our launch plans and expect to have a full U.S. team, including a field-based sales team hired by early April of this year. Our commercial team, which is led by Chris Sims, expects to have a field force of approximately 50 to 70 sales representatives and an organization of about 120 in total. Since this is our year-end call, I wanted to reflect back on some of the significant accomplishments of 2022. We received top-line data from Gather 2 in early September and finished our rolling submission of the NDA for ACP in late December. This was done in just over three months. In November 2022, we announced the FDA-granted breakthrough therapy designation for ACP for the treatment of GA secondary to AMD. To date, ACP is the first and only investigational drug to receive breakthrough therapy status for this indication, which was granted based on the 12-month results from both GATHER1 and GATHER2. We also intend to pursue further discussions with the FDA about utilizing the GATHER1 and GATHER2 clinical trial data included in the current NDA submission to support treatment of GA associated with earlier stage disease, including patients with intermediate AMD. We do not plan to conduct a new clinical trial of ACP in patients with intermediate AMD. We initiated an open-label extension study for patients who have completed their month 24 visit in the Gather 2 clinical trial with the aim of providing patients long-term access to ACP and collecting additional safety data. And we continue to invest in additional lifecycle initiatives for ACP to expand the patient population and evaluate multiple sustained delivery technologies for ACP. On the financial front, In December of 2022, we raised approximately $324.3 million in net proceeds in an underwritten public offering of our common stock. Also in 2022, we secured a term loan credit facility, providing us with up to $250 million in non-dilutive debt financing, under which we have drawn down $100 million to date. These financings further strengthen our balance sheet and provide financial flexibility as we continue to build by U.S. launch readiness plan and prepare for the potential commercialization of ACP. Dave's going to provide some more details on our cash position in a moment. I also want to acknowledge Praveen's election to the Board of Directors at the beginning of this year. Praveen has been instrumental in helping to shape the company's business strategy and in overseeing the development and regulatory strategy for ACP. Praveen, it's truly a pleasure to work with you, and I look forward to our continued work together. Before I turn the call over to Praveen, on behalf of Iveric Bio, we want to take a moment to congratulate Apellis for their approval of Cyphore, which finally provides patients with the first treatment for GA. We also want to commend the FDA for their ongoing commitment to finding treatments for patients suffering from AMD. I want to thank all of you for your continued support of Iveric Bio, and I will now turn the call over to Praveen.