KALA BIO, Inc.

Good morning and welcome to the Call of Pharmaceuticals conference call to review its fourth quarter and full year 2021 financial results. At this time, all participants are in listen-only mode. Following management's prepared remarks, a Q&A session will be held. As a reminder, this call is being recorded. I would like to turn the call over to Jill Steyer, Executive Director, Investor Relations and Corporate Communications for Call of Pharmaceuticals. Please proceed.

Thank you, Operator, and thank you all for participating in today's call. Joining me from the company are Mark Iwicki, Chairman and Chief Executive Officer, Todd Bazemore, President and Chief Operating Officer, Tim Brazel, Head of R&D and Chief Medical Officer, Mary Remeth, Chief Financial Officer, and Darius Karabi, our Chief Business Officer, will also be joining us for the Q&A portion of today's call. Today's call is being webcast live. The webcast link can be found in the investor section of our website at www.callrx.com. During this call, we will be referring to non-GAAP financial measures which are not prepared in accordance with generally accepted accounting principles. A reconciliation of the non-GAAP financial measures to the most direct comparable GAAP measures is available in our press release issued today. which can also be found on our website. On this call, we will make certain comments about COLA's future expectations, plans, and prospects that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements will include statements regarding our commercialization of ISUBIS and INVELTUS, statements regarding the development programs and market potential for KPI 012 and updates on our preclinical programs and the sufficiency of our cash resources. These and other forward-looking statements are based on the beliefs and expectations of management as of this conference call. Our actual results may differ materially from our expectations. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances that occur after this conference call, except as required by law. Investors should carefully read the risk and uncertainties described in today's press release, as well as the risk factors which identify specific risks and other important factors that may cause actual results or events to differ materially from those described in our four statements, included in the company's annual report on Form 10-K, and other filings we make with the SEC. The Form 10-K will be filed with the SEC later today and will be available on our website. I will now turn the call over to College CEO, Mark Iwiki.

Good morning, everyone, and thank you for joining us today to review our fourth quarter and full year 2021 financial results and recent business highlights. Our mission at Kala is to provide patients and eye care professionals with a portfolio of innovative medicines that can better treat diseases that affect the front and back of the eye. As we move into 2022, we've seen continued progress across our commercial portfolio and the expansion of our clinical pipeline with KPI-012, a phase 2-3 ready asset that we're developing to treat an array of devastating rare conditions. Together, We believe that our commercial and clinical programs have the opportunity to deliver tremendous value to the eye care community. Let me now turn to our recent performance, beginning with ISUVIS, our approved medicine for the short-term treatment of dry eye disease. We've spoken about our efforts to expand payer coverage and establish ISUVIS as a preferred first-line therapy for the treatment of dry eye disease, including dry eye flares. Following a number of commercial and Medicare wins in the fourth quarter and recent months, as well as the launch of our first direct-to-consumer marketing campaign, we are seeing persistent upward trends in ISUVIS scripts. In the fourth quarter of 2021, we reported ISUVIS prescription growth of 21% over the third quarter, and we've seen this trend continue through the early months of 2022. We continue to receive positive feedback from both eye care professionals and patients, and we're confident this momentum will continue to build as we implement a number of targeted strategies aimed at patients with the goal of providing them the information and resources necessary to proactively discuss their dry eye disease and flares with our doctors. In parallel, we continue to advance our development portfolio, including our most advanced product candidate, KPI-012, a novel investigational secretome therapy. As a reminder, KPI-012 is a clinical stage asset initially in development for persistent corneal epithelial defect, or PCED, a rare disease associated with vision-threatening morbidity and sequelae, which we acquired in late 2021. We are looking forward to presenting clinical data from the completed Phase 1B trial of KPI-012 at the upcoming ARVO annual meeting in May and, subject to regulatory clearance, plan to initiate our Phase 2-3 clinical trial in patients with PCED in the fourth quarter of 2022. In addition, as we mentioned at the time of the acquisition, we believe KPI-012 has the potential to become a pipeline and a product which could benefit patients with an array of serious ocular diseases. To that end, we are actively evaluating other rare disease indications for KPI-012 and look forward to providing an update on potential further development plans later this year. From a corporate perspective, we are taking steps to reduce our expenses by a target of approximately $25 million in 2022 to extend our cash runway beyond Q2 2023. I will now turn the call over to Todd to review our commercial progress with ISUVIS and Imbeltis.