Financial Data and Key Metrics Changes - Consolidated revenue for Q1 2022 was $11.9 million, up 6% compared to Q1 2021 [7][20] - U.S. net revenue increased by 23% to $6.9 million from $5.6 million in the same period last year [20] - Adjusted EBITDA loss was $3.1 million in Q1 2022, compared to a loss of $1.3 million in Q1 2021 [24] - Net loss for Q1 2022 was $6 million, compared to a net loss of $3.6 million in Q1 2021 [24] - Basic and diluted net loss per share for Q1 2022 was $0.85, compared to $0.63 in Q1 2021 [25] Business Line Data and Key Metrics Changes - U.S. end user demand grew 25% to 918 units in Q1 2022 compared to 737 units in Q1 2021 [7][20] - International segment sales decreased by 11% year-over-year to $5 million due to COVID-19 impacts [22] - End user demand in international distributor markets was up 9% in Q1 2022 versus Q1 2021 [15][22] Market Data and Key Metrics Changes - End user demand in the U.S. was up 30% year-to-date through April 2022 compared to the same period in 2021 [9] - Demand in Portugal was up 35% in Q1 2022 over the prior year [17] - The U.K. returned to growth at the end of April 2022 in a year-over-year comparison [17] Company Strategy and Development Direction - The company is focusing on increasing engagement with retina specialists and has restarted a direct-to-patient campaign to support growth [11][13] - Anticipated launches for non-infectious posterior uveitis in Portugal and France are expected to contribute to growth [27] - The company is controlling spending in European markets to align with current revenue levels [18][26] Management's Comments on Operating Environment and Future Outlook - Management noted ongoing recovery from the pandemic across most markets and expects strong performance to continue throughout the year [7][27] - The company aims to achieve adjusted EBITDA break-even or better in future quarters to mitigate cash burn [26] - Management expressed confidence in returning to pre-COVID run rates by mid to late Q3 2022 [40] Other Important Information - The company is enrolling patients in the NEW DAY study, which is over 50% enrolled [19] - The company has received orders for approximately 2,300 units valued at over $6 million for 2022 from international distributors [15][22] Q&A Session Summary Question: How is the PALADIN data influencing physician habits post-pandemic? - Management indicated a shift in treatment approaches for diabetic macular edema is occurring, with increased recognition of the need for anti-inflammatory treatments alongside anti-VEGF therapies [31][32] Question: What is the impact of the FDA's new requirements on commercialization? - Management does not anticipate significant impacts on ILUVIEN's commercialization but is monitoring the situation closely [42] Question: What were the non-performing items in spending? - Management mentioned postponing certain investments in advisory boards and additional personnel until patient flow justifies those expenses [46][47] Question: Is the company still on track for 15% year-over-year growth? - Management confirmed they feel good about achieving that growth, despite some supply chain issues [48][49] Question: How is the sales team performing? - Management expressed satisfaction with the U.S. sales team performance, noting they are close to hitting targets consistently [51]
Alimera Sciences(ALIM) - 2022 Q1 - Earnings Call Transcript