KALA BIO, Inc.

Good morning and welcome to the Cali Pharmaceuticals conference call to review its first quarter 2022 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 now like to turn the call over to Jill Steyer, Executive Director, Investor Relations and Corporate Communications for Cali Pharmaceuticals. Please proceed.

Thank you, Operator, and thank you all for participating in today's call. Joining me from the company are Mark Iwiki, Chief Executive Officer, Todd Basemore, President and Chief Operating Officer, Kim Brazel, Head of R&D and Chief Medical Officer, Mary Remus, Chief Financial Officer, and Darius Karabi, our Chief Business Officer, will also be joining us for the Q&A portion of today's call. During this call, we will make certain comments about CALA'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 observations associated with our commercialization of ISUVIS and INVELTUS, statements regarding the development, program, and market potential of KPI 012, 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 risks and uncertainties described in today's press release. as well as the risk factors which identify specific factors, they may cause actual results or events to differ materially from those described in our forward-looking statements included in the company's quarterly report on Form 10-Q and other filings we made with the SEC. I will now turn the call over to CalA's CEO, Mark Iwicki.

Thanks, Jill, and thank you, everyone, for joining us this morning. We started COLA a number of years ago with the mission to advance the treatment of front and back of the eye diseases by providing patients and physicians with a portfolio of new medicines that are safe, well-tolerated, and highly effective. Over the past several years, consistent with this goal, we've successfully advanced ISUVIS and INVELTUS through clinical development and into the hands of many patients in need. In the case of ISUVIS, we developed the first and only prescription therapy for the short-term treatment of the signs and symptoms of dry eye disease, with a product profile that addresses the unmet needs articulated by patients and eye care professionals alike. Since the product was approved in 2020, we've made great strides toward changing the treatment paradigm for this disease, educating ophthalmologists and optometrists on the frequent, episodic nature of flares, on Isovus as the first FDA-approved therapy to bridge the gap between over-the-counter artificial tears and chronic prescription therapies. In recent weeks, we have also significantly expanded our payer coverage, and with the addition of CVS Caremark, we now have coverage for 92% of commercial lives and 30% of Medicare lives, ensuring that many more patients will be able to easily access ISUVIS. This is a really important milestone in our launch for both patients and for Kala. We expect the additional coverage to translate into a meaningful increase in prescriptions being filled for patients. Moreover, we expect it will significantly reduce reliance on patient assistance programs and therefore support growth in net revenue. As a reminder, we have used patient assistance programs throughout the launch to ensure prescriptions are being filled in situations where a patient's insurance did not fully cover ISUVIS. In recent months, consistent with trends in prior quarters, we have seen increased use of the patient assistance program, representing more demand for ISUVIS, but also negatively impacting our net revenues. With the expansion in payer coverage, we expect our patient assistance programs to be reduced, translating to an improvement in average selling price, and as a result, an increase in future net revenue. As we continue to progress the commercial launch of ISUVIS, we are also focusing on our clinical and research stage programs, which we believe have the potential to meaningfully impact the care and treatment of people living with underserved eye diseases. We are advancing KPI 012 for the treatment of persistent corneal epithelial defect, or PCED, and other rare and severe ocular diseases. In May, we presented the full Phase 1b data for KPI-012 at the ARVO annual meeting. These data, which served as the foundation for our acquisition of Combangio late last year, highlight the significant potential of our novel secretome therapy to deliver a new approach to treat PCED and potentially other front and back of the eye diseases. We look forward to advancing this program into our planned Phase 2-3 clinical trial in the fourth quarter of 2022 and to sharing additional details around our indication expansion strategy later this year. With that, I'll turn the call over to Todd to review our commercial performance.