Ocular Therapeutix, Inc.

Good afternoon ladies and gentlemen. Thank you for standing by and welcome to the Ocular Therapeutics second quarter 2022 earnings conference call. At this time all participants are in a listen only mode. Later we will conduct a question and answer session and instructions will follow at that time. It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutics. Please go ahead sir.

Thank you, operator. Good afternoon, everyone, and thank you for joining us on our second quarter 2022 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 quarter ended June 30, 2022. 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 the commercial progress of Dextenda and a summary of our corporate developments. Also speaking on the line today will be Dr. Rabia Ozden, our Chief Medical Officer, who will give an update on our clinical developments and pipeline. Following Rabia's remarks, 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. For Q&A, we will be joined by Chris White, our Chief Business Officer, and Scott Corning, our Senior Vice President, Commercial. As a reminder, on today's call, certain statements we will be making may be considered forward-looking for the purposes of the Private Securities Litigation Reform Act of 1995. In particular, any statements regarding our regulatory and product development plans, as well as our research activities and our financial projections, 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 most recent quarterly report filed this afternoon with the SEC and our annual report on Form 10-K filed on February 28th with the SEC. I will now turn the call over to Anthony.

Thanks, Tom. The second quarter of 2022 was another quarter of great progress for Dr. Therapeutics. Most notably, the development of our pipeline. For those of you following the October story, you'll know that by far the most anticipated development for the company and for the hope of a more durable treatment for patients with wet AMD is our U.S.-based Phase I clinical trial for OTX TKI, our accitinib-containing hydrogel implant for treatment of wet AMD and other retinal diseases. We are developing OTX TKI to reset the standard of care for durability of a single injection in the treatment of wet AMD from two to three months to six months and beyond. To assess this, we have embarked upon a very important study in the U.S. comparing a single injection of OTX TKI against that Librecept dose every eight weeks. I am delighted to announce that all 21 patients in this study have now been on study for 24 weeks or more, and we plan to perform an analysis after 28 weeks. The trial plan dovetails nicely with the American Academy of Ophthalmology meeting in Chicago, where we have already been granted a late-breaker slot on Friday, September 30th. While OTX TKI is our lead program in retinal disease, we also have R&D efforts seeking to develop more durable treatments for geographic atrophy and gene therapy delivery platforms that minimize inflammatory risk and maximize transaction potential. To help us pull all of our retina assets together, we are delighted to announce the addition of Dr. Peter Kaiser to the Ocular team as our Chief Medical Advisor Retina. With Peter added to the considerable retina expertise already at Ocular, we believe we are in a position to plan the optimal path forward for OTX TKI, as well as other in-house programs or any potential collaborations in the retina space. On the glaucoma front, OTXT-IC, our trial approach containing intracameral implants being developed for the treatment of open-angle glaucoma or ocular hypertension to improve patient compliance, continues to enroll its first Phase II trial. We have designed this trial to assess the safety, tolerability, and efficacy of OTXT-IC. In our completed phase one clinical trial, we observed that OTX-TIC did not harm endothelial cells, so we were developing OTX-TIC for chronic or repeat dosing. While this program seldom gets the attention of its sibling, OTX-TKI, we are equally enthusiastic about its prospects. In the treatment of dry eye disease, we have two programs, OTF-CSI, our cyclosporine-containing intracanalicular insert for the chronic treatment of dry eye disease, and OTF-DED, our dexamethasone-containing intracanalicular insert for the short-term treatment of signs and symptoms of dry eye disease. While we'd like to advance both programs, We are acutely aware of the need to preserve cash in the current challenging financial environment and the need to find ways to improve our chances for success in the very difficult regulatory environment of dry eye disease. As a way to continue momentum on these programs while satisfying both objectives, we plan to embark upon a small trial with OTX-DED that will pioneer a trial design that tests OTX-DED against a more appropriate placebo comparator. Simultaneously, we are developing new formulations for OTX-CSI designed to be retained longer in the channel itself. Finally, helping to pay for the development of our exciting pipeline is our commercial business with Dextensa. For the second quarter, Dextensa recorded net product revenue of $12.1 million, a 9% improvement over the same quarter of prior year and down slightly compared to the prior quarter. We were seeing both in the market and also with our own field force. is that staffing levels continue to be a drag on potential growth. Despite the sluggishness of the current market, we are optimistic about the final two quarters of the year and continue our guidance of between 55 million and 60 million of net product revenue for the full year. Beyond this, we are also very happy that the recent Outpatient Prospective Payment System, or OPPS, proposed rule stated that the expenses should remain separately payable in the ASC through 2023. As a result, we are optimistic that we can continue to grow our surgical business as we add to the future potential of the office environment. In summary, we're making great progress at Ocular and are gearing up for a significant moment in our history with presentation of the results of our U.S.-based OTX TKI Phase I trial in late September. To go into more detail on the pipeline, I'll hand over to our newly promoted Chief Medical Officer, Dr. Rabia Osman, our very own Dr. Oz.