EyePoint Pharmaceuticals(EYPT) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the first quarter ended March 31, 2023, total net revenue was $7.7 million compared to $9.3 million for the same period in 2022, indicating a decline [51] - Net product revenue for the first quarter was $7.4 million, down from $9 million in the first quarter of 2022, primarily due to a significant reduction in DEXYCU revenues following the discontinuation of pass-through reimbursement [52] - Operating expenses for the first quarter totaled $29.2 million, an increase from $27.6 million in the prior year, driven by continued investment in R&D for EYP-1901 development [53] Business Line Data and Key Metrics Changes - The YUTIQ franchise reported $7.4 million in net product revenue, a 60% increase over the first quarter of 2022, with customer demand rising to approximately 930 units compared to 650 units in the previous year [30][49] - Enrollment in the Phase II DAVIO clinical trial for wet AMD exceeded the original target, with 160 patients enrolled instead of the planned 144, reflecting high interest from physicians and patients [24][40] Market Data and Key Metrics Changes - The market for non-proliferative diabetic retinopathy (NPDR) is projected to impact over 14 million Americans by 2050, with only about 3% of NPDR patients currently being treated with available therapies [71][72] - The company aims to change the treatment paradigm for NPDR, which is currently characterized by a watchful waiting approach until vision loss occurs [70] Company Strategy and Development Direction - The company is focused on becoming a leader in sustained ocular drug delivery, with EYP-1901 positioned as a potentially game-changing treatment for serious eye diseases [10][11] - Plans include initiating a Phase II trial for EYP-1901 in diabetic macular edema in the first quarter of 2024 and expanding the product pipeline beyond EYP-1901 [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in clinical trials and the commercial performance of YUTIQ, anticipating top-line results from the Phase II DAVIO 2 trial in the fourth quarter of 2023 [61] - The company remains optimistic about potential partnerships for EYP-1901, with ongoing discussions with strategic players in the ophthalmology space [79] Other Important Information - The company has a collaboration with Rallybio to evaluate a C5 complement inhibitor using its Durasert E technology for sustained delivery treatment options [29] - The erodable Durasert technology has been safely used in thousands of eyes across four FDA-approved products, ensuring a strong safety profile [23] Q&A Session Summary Question: How does the Phase II trial design align with the FDA's recent draft guidance? - The company planned the DAVIO 2 study to mirror the FDA's guidance received during a Type C meeting, indicating confidence in meeting Phase III requirements [59] Question: What is the expected reduction in treatment burden for the DAVIO 2 trial? - A reduction in treatment burden of around 50% would be considered an excellent result, with previous trials showing significant reductions [59] Question: What is driving physician enthusiasm for the EYP-1901 trials? - The aging population and increasing diabetic patient numbers are contributing to higher demand for treatments that reduce the frequency of office visits [66] Question: Can you elaborate on the NPDR patient population size and treatment rates? - Approximately 8 million people in the U.S. have diabetic retinopathy, with only about 3% currently treated, indicating a significant market opportunity for EYP-1901 [71][72] Question: What are the next steps for the Rallybio C5 inhibitor program? - The development pathway includes formulation, pre-IND studies, and a Phase I trial for safety and dosing, with further studies planned based on initial results [73] Question: What evidence supported the decision to reduce the NPDR trial size? - Strong preclinical and Phase I data on vorolanib's efficacy and safety provided confidence to reduce the trial size while maintaining statistical validity [74][75]