Ocular Therapeutix, Inc.

Good day. Thank you for standing by. Welcome to the third quarter 2023 Ocular Therapeutics 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 that session, you'll need to press star 1-1 on your telephone. You'll then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Donald Notman, CFO.

Thank you, operator. Good afternoon, everyone, and thank you for joining us on our third quarter 2023 financial results and business update conference call. This afternoon after the close, we issued a press release providing an update on the company's product development programs and details of the company's financial results for the third quarter ended September 30th, 2023. The press release can be accessed on the investors portion of our website at investors.ocutx.com. Leading the call today will be Anthony Modisich, our President and Chief Executive Officer, who will provide an update on our pipeline developments and the commercial progress of Dextenza. Also speaking on the call today will be Dr. Rabia Adson, our Chief Medical Officer, Steve Myers, our Senior Vice President Commercial, and Dr. Peter Kaiser, our Chief Medical Advisor Retina. Unfortunately, Peter will not be available during the Q&A session. Following their comments, I will provide an overview of the financial highlights for the quarter before turning the call back over to Anthony for a summary and questions. As a reminder on today's call, Certain statements we will be making may be considered forward-looking for purposes of the Private Securities Litigation Reform Act of 1995. In particular, any statements regarding our anticipated net product revenues and our regulatory and product development plans, as well as our research activities, are forward-looking statements. These statements are subject to a variety of risks and uncertainties that may cause actual results to differ from those forecasted, including those risks described in our Form 10-Q filed this afternoon with the SEC and our most recent annual report on Form 10-K filed March 6, 2023. I will now turn the call over to Anthony.

Thanks, Donald. Hello and welcome everyone to our third quarter 2023 earnings call. We're pleased to share with you the tremendous progress we've made over the past three months to build on our previous successes and provide clarity on our plans going forward. I'm also pleased to announce a number of exciting developments for OTX TKI, our accident-containing intravitreal implant for the treatment of wet AMD. To begin, I'm pleased to share that we have announced a new trade name for OTX TKI that we will now refer to as AxPaxLit. As the program has advanced into its first pivotal trial, we thought it appropriate to introduce this new name to begin to establish a brand identity for potential commercialization. Clearly, though, the most important development in the AxPaxLit program is the recent agreement on our special protocol assessment with the FDA we received just last week. The special protocol assessment, or SPA, allows the FDA to officially evaluate and provide written guidance to sponsors. This feedback helps companies assess the adequacy and acceptability of critical elements in the protocol design to support future marketing applications on the basis of the efficacy and safety endpoints in the trial. For our SPA, we aim to secure alignment with the FDA on both the protocol design and the statistical analysis plan. Regarding protocol design, we have gained agreement on several crucial aspects. These include the precise competition of the study population to be enrolled in our clinical trial, the identification of a suitable control arm for X-Faxley, the determination of its dosing regimen, the specification of baseline criteria, the selection of primary endpoints and their corresponding timing, as well as the establishment of an appropriate sample size to ensure statistical robustness of our pivotal trial. This alignment with the FDA is instrumental in upholding the scientific rigor and regulatory standards of our study. By coming to an agreement with the FDA on the specific elements of our pivotal trial design and statistical analysis plan, we believe we now have a clear regulatory path forward. This is a program we are very excited about based on the compelling data that we have shared in the past year. This program has demonstrated the potential for best-in-class durability, and we believe truly has the potential to change the standard of care in this multibillion-dollar market. Now, with the initiation of trial sites already underway and the spa in place, we look forward to screening and enrolling patients. We remain on track to begin dosing our first subject before the end of the year. While we believe the path for ex-factually is now clear and our internal focus now turns from careful planning to flawless execution, there's still a tremendous amount of education to be done. We believe the FDA's new draft guidance, coupled with our interpretation of the additional feedback we have received from the FDA, has created significant change for the development of treatments in wet AMD, particularly for treatments like ex-factually that are designed to demonstrate extended durability. We are extremely lucky to have deep connections in the retina community with Dr. Jeff Heyer on our board and the recent addition of Dr. Peter Kaiser as our chief medical advisor of retina. Both Jeff and Peter have been instrumental in guiding the community through the implications of the changes and the reasons behind them. Our goal in bringing X-Faxly forward is to improve the lives of patients living with wet AMD, and we realize that only strong endorsements from the retina community will allow X-Faxly to achieve its full potential. Let me finish with an update on that standard. We are pleased to report another impressive quarter for Dextenza with net product revenues of $15 million for the third quarter of this year, 26% over the same quarter previous year and in line with Q2 net product revenues. Based on the trends, we continue to anticipate Dextenza net product revenue guidance for the full year 2023 will come in at the upper end of our current $55 million to $60 million range provided at the start of the year. Steve Myers, our Senior Vice President Commercial, will walk you through the drivers behind this growth. With this background, I'd like to turn the call over to Dr. Rabia Ozden, our Chief Medical Officer, who will introduce you to the ongoing Expaxly pivotal trial, which we refer to as the SAL trial, and provide some details on the SPA agreement. Rabia?