Financial Data and Key Metrics Changes - In Q4 2023, consolidated global net revenue grew 88% to $26.3 million compared to Q4 2022 [9] - For the full year 2023, net revenue increased 49% to $80.8 million compared to $54.1 million in 2022 [21] - Adjusted EBITDA in Q4 2023 was $5 million, a significant improvement from an adjusted EBITDA loss of $1.2 million in Q4 2022 [10] - For the full year 2023, adjusted EBITDA was $8.7 million compared to a loss of $7.9 million in 2022 [23] Business Line Data and Key Metrics Changes - US net revenue in Q4 2023 increased 104% to $19.2 million compared to $9.4 million in Q4 2022 [10] - For the full year 2023, US net revenue increased 66% to $56.7 million compared to $34.2 million in 2022 [21] - International net revenue in Q4 2023 grew 54% to $7.1 million compared to approximately $4.6 million in Q4 2022 [20] - For the full year 2023, international net revenue increased 21% to approximately $24 million compared to $19.9 million in 2022 [21] Market Data and Key Metrics Changes - US end-user demand for products was up 4.4% in Q4 2023 versus the prior year and 11% on a pro forma basis for the full year [10] - International segment end-user demand grew 16.7% in Q4 and 11.8% for the full year, driven by markets such as the UK, Portugal, Ireland, Spain, and France [12] Company Strategy and Development Direction - The company aims to leverage the acquisition of YUTIQ to increase utilization of both ILUVIEN and YUTIQ in the US market [7] - The strategy includes expanding the sales force and promoting both products to enhance physician engagement and treatment options [28] - The company anticipates achieving over $105 million in revenue with an adjusted EBITDA margin of 20% for 2024 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming supply issues and expects to meet end-user demand in Europe moving forward [12] - The company is optimistic about the potential impact of NICE's guidance on expanding the patient base for ILUVIEN in the UK and potentially in other markets [15] - Management highlighted the importance of upcoming clinical study results, particularly the NEW DAY and SYNCHRONICITY studies, in shaping future treatment paradigms [17][18] Other Important Information - The company completed enrollment in two Phase IV clinical studies, which are expected to provide impactful data [16] - Cash and cash equivalents as of December 31, 2023, were approximately $12.1 million, up from $5.3 million at the end of 2022 [24] - The company increased the size of its loan facility by an additional $5 million to enhance operational flexibility [25] Q&A Session Summary Question: What is the expected utilization crossover for ILUVIEN and YUTIQ? - Management aspires to increase the crossover utilization to over 50% in the next 12 months, acknowledging that not all specialists will use both products [32] Question: What is the competitive environment for DME and Uveitis? - Management noted increased competition from new entrants but believes there remains a significant patient population that requires corticosteroid treatment [35] Question: When can top-line data for the NEW DAY study be expected? - Top-line data is anticipated in early 2025, following the last patient visit in Q4 2024 [37] Question: What is the expected interest expense for 2024? - The typical run rate for interest expense is expected to be around $3.5 million quarterly, with additional contingent interest payments anticipated [41]
Alimera Sciences(ALIM) - 2023 Q4 - Earnings Call Transcript