EyePoint Pharmaceuticals(EYPT) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Net revenue from royalties and collaborations for Q3 2023 totaled $14.4 million, a significant increase from $0.3 million in Q3 2022, primarily due to the recognition of deferred revenue from the sale of YUTIQ [51] - Total net revenue for Q3 2023 was $15.2 million, compared to $10 million for the same quarter in 2022 [71] - The net loss for Q3 2023 was $12.6 million, or $0.33 per share, an improvement from a net loss of $18.4 million, or $0.49 per share, in the prior year [64] Business Line Data and Key Metrics Changes - The decline in net product revenue for Q3 2023 was attributed to the exit from the commercial business, specifically the sale of the YUTIQ franchise and the discontinuation of marketing for the DEXYCU franchise [71] - Operating expenses for Q3 2023 were $29.6 million, up from $28.4 million in the prior year, driven by higher R&D spending on EYP-1901 clinical trials [51] Market Data and Key Metrics Changes - The company is addressing a significant portion of a $10 billion-plus market with its EYP-1901 product, which targets previously treated patients [12] Company Strategy and Development Direction - The company plans to initiate a Phase 2 trial for EYP-1901 in diabetic macular edema (DME) in Q1 2024, named the VERONA trial, to gain experience in this potentially large indication [47] - The first Phase 3 trial for EYP-1901 is expected to start in the second half of 2024, primarily in the U.S. and Canada, with a second trial planned outside the U.S. [45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming catalysts, including top-line data from the Phase 2 DAVIO 2 trial anticipated in early December and the initiation of the Phase 2 trial for DME [53] - The management highlighted the potential of EYP-1901 to change the treatment paradigm for wet AMD patients by providing sustained delivery of vorolanib for approximately nine months [65] Other Important Information - The company expanded its board of directors with the appointment of Stuart Duty, a seasoned biopharmaceutical financial executive, and promoted George Elston to Executive Vice President [49] - Cash and investments at September 30, 2023, totaled $136 million, down from $144.6 million at December 31, 2022, which is expected to fund operations into 2025 [64] Q&A Session All Questions and Answers Question: Can you elaborate on the BCVA outcome scenario ranges for the DAVIO 2 trial? - Management indicated that the BCVA ranges were constructed with input from KOLs, who generally expect a good efficacy and safety profile with a numerical change in the range of three to four letters [75] Question: Upon positive data, how quickly could the Phase 3 program start? - Management believes they can start the first Phase 3 trial in the second half of next year, with preparations ongoing for the last nine months [77] Question: What is the rationale for the EYP-2301 product and how does it fit with EYP-1901 strategy? - EYP-2301 is based on a molecule that activates TIE-2 to stabilize blood vessels and downregulate angiopoietin, with potential for sustained release delivery over six months [116] Question: How does the EYLEA induction relate to the mechanism of TKIs in wet AMD? - Management explained that the decision to use EYLEA as a control in the Phase 3 trials was based on discussions with the FDA, aiming to ensure a robust and de-risked pathway to approval [81] Question: Will EYP-1901 be used as a solo therapy initially? - Management stated that the market share will depend on the effectiveness of EYP-1901, and they expect to get a label for every six months reinjection, which could provide a competitive advantage [140]