Valneva(US:VALN)2023-05-07 02:10Financial Data and Key Metrics Changes - Total revenues for Q1 2023 reached EUR 33.5 million, an increase of 53.4% compared to Q1 2022, while product sales increased by 98.6% to EUR 32.1 million, driven by the recovery of the international travel market [11][12] - Gross margin for commercial products, excluding COVID-19, deteriorated to 48.4% compared to 68% in the first quarter of last year, affected by one-off effects in the prior year [28] - Operating loss for the first quarter was negative EUR 16.6 million, an improvement from negative EUR 18.4 million one year ago, while adjusted EBITDA reached negative EUR 12.3 million compared to negative EUR 13.3 million in the previous year [38] Business Line Data and Key Metrics Changes - Sales of IXIARO and DUKORAL both quadrupled year-over-year, reflecting strong recovery in the travel market [27] - Third-party product sales decreased by almost 20% due to supply constraints under a distribution agreement with Bavarian Nordic [27] - Sales and marketing expenses increased significantly from EUR 2 million in Q1 2022 to EUR 9 million in Q1 2023, driven by prelaunch activities for the chikungunya vaccine [37] Market Data and Key Metrics Changes - The company reported solid year-over-year growth across all markets, with price increases for IXIARO and DUKORAL in most markets [27] - Direct sales accounted for 71.6% of total sales in Q1 2023, down from 91% in 2022, due to high sales to Bavarian Nordic for distribution in Germany [73] Company Strategy and Development Direction - The company aims to submit regulatory applications for its chikungunya vaccine in the U.S. and Europe by 2026, a delay from the previous target of 2025 [8] - Valneva is focusing on expanding its clinical pipeline through acquisitions or partnerships to enhance its early clinical stage assets [15] - The company maintains a strong cash position of over $250 million and expects product sales to reach or exceed pre-pandemic levels in 2023 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching the upper end of the sales guidance for 2023, citing a strong start in Q1 and ongoing recovery in travel [72] - The company acknowledged supply constraints in Q1 but anticipates no further issues going forward [80] - Management remains confident in the strength of its vaccine candidates despite a one-year delay in the Lyme program [43] Other Important Information - The chikungunya vaccine is positioned as the world's first if approved, with a PDUFA date confirmed for the end of August 2023 [20] - The company is preparing for a potential DoD contract for IXIARO and is in discussions regarding stockpiling opportunities for the chikungunya vaccine [62][72] Q&A Session Summary Question: Clarification on Lyme cohorts and strategy - Management could not disclose exact cohort sizes but indicated an end of 9,000 participants, with a strategy to maintain the current protocol despite a one-year delay [42][44] Question: Chikungunya mid-cycle review details - No significant safety concerns were reported during the mid-cycle review, and no further points were discussed that would impact the review process [45] Question: Enrollment focus for Lyme disease - Additional cohorts will be U.S. and Canada focused, with no enrollment in Europe [51] Question: Stockpiling opportunities for chikungunya - Discussions are ongoing, but no additional studies are expected beyond those already planned [52] Question: Revenue recognition from Pfizer collaboration - No revenue was recognized in the current quarter, but potential revenue could be recognized in the future as the Phase 3 trial progresses [84]