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Product Sales: EUR68.3 million, 7% growth over prior year on a comparable basis.
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IXIARO Sales: EUR41.9 million, 38% increase year-over-year.
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DUKORAL Sales: EUR14.9 million, 13% decline year-over-year.
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IXCHIQ Sales: EUR1 million in the United States by June 30.
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Total Revenues: EUR70.8 million, 4% decrease from the first half of 2023.
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Gross Margin (IXIARO): 57.5% compared to 40.2% in the first half of 2023.
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Total Gross Margin (excluding IXCHIQ): 47.7%, up from 40% in the first half of 2023.
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R&D Expenses: EUR29.7 million, up from EUR26 million in the first half of 2023.
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Marketing and Distribution Expenses: EUR23.2 million, approximately 15% increase.
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Operating Profit: EUR46.7 million, compared to an operating loss of EUR35 million in the prior year.
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Adjusted EBITDA: Improved from minus EUR28 million to positive EUR56 million.
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2024 Guidance: Product sales of EUR160 million to EUR180 million; other income of EUR100 million to EUR110 million; R&D expenses of EUR60 million to EUR75 million.
Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Valneva SE (INRLF) reported product sales of EUR68.3 million for the first half of 2024, including first recognized sales for IXCHIQ, aligning with anticipated supply and sales phasing.
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The company achieved significant R&D milestones, including the development of a new Shigella vaccine and strategic partnerships to accelerate its progress.
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Valneva SE (INRLF) received additional IXCHIQ approvals in Canada and Europe, slightly ahead of schedule, allowing for market launches in the last quarter of the year.
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The company maintained a solid cash position due to the successful sale of a priority review voucher and deferral of loan reimbursement.
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Valneva SE (INRLF) reported positive Phase 3 IXCHIQ data in adolescents and published two-year antibody persistence data, supporting further label extensions.
Negative Points
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DUKORAL sales declined by 13% year-over-year due to reduced marketing investments and regulatory evaluations.
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Total revenues decreased by 4% compared to the first half of 2023, driven by lower revenues from R&D collaborations and prior year COVID-19 vaccine sales.
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The total gross margin was adversely affected by IXCHIQ-related overhead costs and idle costs related to new manufacturing sites.
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Research and development expenses increased from EUR26 million to EUR29.7 million, mainly due to tech transfer costs and higher R&D spend for IXCHIQ.
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The company faces challenges in building awareness and adoption for the new chikungunya vaccine, IXCHIQ, as it is a brand-new disease and vaccine.
Q & A Highlights
Q: Can you walk us through which markets IXCHIQ is available today and which territories you expect to be the most important contributors to sales in the future? A: Currently, IXCHIQ is only available in the United States. We have received approvals in Canada and Europe slightly ahead of expectations and plan to launch in selected European countries and Canada in the fourth quarter. Sales in these regions are expected to be moderate initially. We are confident about the overall market size and growth projection for IXCHIQ, but it is too early to predict the exact trajectory.
Q: Can you clarify what data sets are expected from the Phase 2 two-year antibody persistence study for Lyme disease? A: The study will measure immunological responses pre- and post-second booster at month 30 and month 31, respectively. Our current hypothesis is that the Lyme vaccine will require an annual booster shot, and this data will provide insights into the necessity of such boosters.
Q: Could you provide an update on the launch metrics for IXCHIQ in the US, including access and reimbursement progress? A: We are seeing growing awareness and engagement with healthcare providers, with over 50% coverage achieved. Customers are reordering IXCHIQ, indicating uptake. However, the ACIP recommendations for chikungunya have not yet been published in the MMWR, which is important for driving further reimbursement and prescribing.
Q: Regarding IXCHIQ, can we expect major contracts similar to IXIARO in the future? A: While the US Military process may not work the same way as with IXIARO, we expect the military to become a major customer for IXCHIQ in the United States, especially after the Defense Health Agency adopted CDC recommendations.
Q: Are the regulatory approvals for DUKORAL resolved, and do you expect it to grow in 2024? A: Yes, all regulatory approvals for DUKORAL have been obtained, resolving previous phasing issues. We expect DUKORAL to continue growing year-over-year, despite a 13% decline in sales year-to-date.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.