Latest news with #IXIARO
Yahoo
2 days ago
- Business
- Yahoo
Valneva SE (INRLF) (H1 2025) Earnings Call Highlights: Robust Revenue Growth Amid Operational ...
Total Revenue: EUR97.6 million, a 37.8% increase from EUR70.8 million in the first half of 2024. Product Sales: EUR91 million, up 33.3% from EUR68.3 million in the first half of 2024. IXIARO Sales: EUR54.7 million, a 30.6% increase year-over-year. DUKORAL Sales: EUR17.4 million, a 16.4% increase year-over-year. IXCHIQ Sales: EUR7.5 million, up from EUR1 million in the first half of 2024. Gross Margin (excluding IXCHIQ): 59.2%, up from 47.7% in the prior year. IXIARO Gross Margin: 65.5%, compared to 57.5% in the first half of 2024. DUKORAL Gross Margin: 52.9%, compared to 34.8% last year. Operating Loss: EUR16.8 million, compared to an operating profit of EUR46.7 million last year. Adjusted EBITDA: Minus EUR6 million, compared to a positive EUR56.2 million last year. Cash Position: EUR161.3 million as of June 30, 2025. Cash Used in Operations: EUR10.9 million, down from EUR66.3 million in the first half of 2024. 2025 Financial Guidance: Product sales of EUR170 million to EUR180 million; total revenues of EUR180 million to EUR190 million. Warning! GuruFocus has detected 8 Warning Signs with INRLF. Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Valneva SE (INRLF) achieved significant year-over-year revenue growth, reaching close to EUR100 million in the first half of 2025. The company maintained a strong cash position of over EUR160 million, indicating effective cash management and reduced operating cash burn. Valneva SE (INRLF) secured additional marketing authorizations for its chikungunya vaccine, IXCHIQ, in the UK, Brazil, and Europe, expanding its market reach. The Lyme disease vaccine candidate, VALOR, is progressing as planned, with Pfizer aiming for regulatory submissions in 2026. The company reported positive Phase III pediatric safety and immunogenicity results for IXCHIQ, reinforcing its potential in the market. Negative Points Valneva SE (INRLF) reported an operating loss of EUR16.8 million in the first half of 2025, compared to an operating profit in the previous year. The company experienced adverse foreign currency fluctuations, impacting revenues by EUR500,000. Research and development expenses increased, driven by costs related to the Shigella vaccine candidate. The company faced temporary restrictions on its chikungunya vaccine, IXCHIQ, due to safety concerns, impacting market uptake. Valneva SE (INRLF) anticipates an acceleration of R&D costs in the second half of 2025, which could further impact financial performance. Q & A Highlights Q: Regarding the 40,000 doses sold to the French government, should we expect any additional revenue recognition in Q3? Also, could you share your perspective on demand scenarios for IXCHIQ through year-end, considering the evolving CHIKV outbreak in the Indian Ocean and China? A: The 40,000 doses were all shipped in the first half of the year, and the revenue was fully recognized in that period. Regarding demand scenarios, we are in contact with governments where outbreaks are occurring. We have no supply constraints and sufficient material available, but it's too early to state where and how we will respond. We aim to stay in control over potential vaccination campaigns given past experiences. Q: For the Lyme vaccine, could you provide insight on how the reporting of data readouts will transpire at year-end? Will the disclosure only report top-line data, or can we expect detailed results? A: The reporting of Phase III results is under Pfizer's responsibility. We expect data readout in two steps: a report on top-line data, primarily efficacy numbers, followed by communication on other endpoints. All data should be out by the end of the first quarter, supporting regulatory submissions around mid-next year. Q: Could you elaborate on what might trigger an acceleration in IXCHIQ sales uptake within the traveler market? Are you still in discussions with the U.S. for potential stockpiling? A: The uncertainty from safety investigations has impacted market uptake. However, the vaccine's profile, especially as a live-attenuated single-shot vaccine, has advantages for outbreak preparedness. We expect new momentum now that restrictions are lifted and investigations concluded. Discussions on stockpiling will hopefully resume later this year. Q: On the Lyme and VALOR trial, suggests a primary completion date of December 26. Are you confident that Phase III headline data will come in 2025, or could it spill into 2026? What is the bar for success in this trial? A: The primary completion date includes safety follow-up periods. Case counts will continue until the end of October, followed by Pfizer's case adjudication and database cleaning. The timing of data readout is not in our control, but Pfizer reaffirms submission timelines. There is no specific communicated bar for approval, but we expect non-inferiority or superiority compared to past vaccines. Q: What should we expect in terms of financial impact from the distribution agreement with CSL? A: The commercial terms with CSL are similar to our previous agreement, so we do not expect an immediate difference in prospects around Germany. However, as CSL gears up, there may be potential upside in the mid- to long term. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
4 days ago
- Business
- Yahoo
Valneva SE (INRLF) (H1 2025) Earnings Call Highlights: Robust Revenue Growth Amid Operational ...
Total Revenue: EUR97.6 million, a 37.8% increase from EUR70.8 million in the first half of 2024. Product Sales: EUR91 million, up 33.3% from EUR68.3 million in the first half of 2024. IXIARO Sales: EUR54.7 million, a 30.6% increase year-over-year. DUKORAL Sales: EUR17.4 million, a 16.4% increase year-over-year. IXCHIQ Sales: EUR7.5 million, up from EUR1 million in the first half of 2024. Gross Margin (excluding IXCHIQ): 59.2%, up from 47.7% in the prior year. IXIARO Gross Margin: 65.5%, compared to 57.5% in the first half of 2024. DUKORAL Gross Margin: 52.9%, compared to 34.8% last year. Operating Loss: EUR16.8 million, compared to an operating profit of EUR46.7 million last year. Adjusted EBITDA: Minus EUR6 million, compared to a positive EUR56.2 million last year. Cash Position: EUR161.3 million as of June 30, 2025. Cash Used in Operations: EUR10.9 million, down from EUR66.3 million in the first half of 2024. 2025 Financial Guidance: Product sales of EUR170 million to EUR180 million; total revenues of EUR180 million to EUR190 million. Warning! GuruFocus has detected 8 Warning Signs with INRLF. Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Valneva SE (INRLF) achieved significant year-over-year revenue growth, reaching close to EUR100 million in the first half of 2025. The company maintained a strong cash position of over EUR160 million, indicating effective cash management and reduced operating cash burn. Valneva SE (INRLF) secured additional marketing authorizations for its chikungunya vaccine, IXCHIQ, in the UK, Brazil, and Europe, expanding its market reach. The Lyme disease vaccine candidate, VALOR, is progressing as planned, with Pfizer aiming for regulatory submissions in 2026. The company reported positive Phase III pediatric safety and immunogenicity results for IXCHIQ, reinforcing its potential in the market. Negative Points Valneva SE (INRLF) reported an operating loss of EUR16.8 million in the first half of 2025, compared to an operating profit in the previous year. The company experienced adverse foreign currency fluctuations, impacting revenues by EUR500,000. Research and development expenses increased, driven by costs related to the Shigella vaccine candidate. The company faced temporary restrictions on its chikungunya vaccine, IXCHIQ, due to safety concerns, impacting market uptake. Valneva SE (INRLF) anticipates an acceleration of R&D costs in the second half of 2025, which could further impact financial performance. Q & A Highlights Q: Regarding the 40,000 doses sold to the French government, should we expect any additional revenue recognition in Q3? Also, could you share your perspective on demand scenarios for IXCHIQ through year-end, considering the evolving CHIKV outbreak in the Indian Ocean and China? A: The 40,000 doses were all shipped in the first half of the year, and the revenue was fully recognized in that period. Regarding demand scenarios, we are in contact with governments where outbreaks are occurring. We have no supply constraints and sufficient material available, but it's too early to state where and how we will respond. We aim to stay in control over potential vaccination campaigns given past experiences. Q: For the Lyme vaccine, could you provide insight on how the reporting of data readouts will transpire at year-end? Will the disclosure only report top-line data, or can we expect detailed results? A: The reporting of Phase III results is under Pfizer's responsibility. We expect data readout in two steps: a report on top-line data, primarily efficacy numbers, followed by communication on other endpoints. All data should be out by the end of the first quarter, supporting regulatory submissions around mid-next year. Q: Could you elaborate on what might trigger an acceleration in IXCHIQ sales uptake within the traveler market? Are you still in discussions with the U.S. for potential stockpiling? A: The uncertainty from safety investigations has impacted market uptake. However, the vaccine's profile, especially as a live-attenuated single-shot vaccine, has advantages for outbreak preparedness. We expect new momentum now that restrictions are lifted and investigations concluded. Discussions on stockpiling will hopefully resume later this year. Q: On the Lyme and VALOR trial, suggests a primary completion date of December 26. Are you confident that Phase III headline data will come in 2025, or could it spill into 2026? What is the bar for success in this trial? A: The primary completion date includes safety follow-up periods. Case counts will continue until the end of October, followed by Pfizer's case adjudication and database cleaning. The timing of data readout is not in our control, but Pfizer reaffirms submission timelines. There is no specific communicated bar for approval, but we expect non-inferiority or superiority compared to past vaccines. Q: What should we expect in terms of financial impact from the distribution agreement with CSL? A: The commercial terms with CSL are similar to our previous agreement, so we do not expect an immediate difference in prospects around Germany. However, as CSL gears up, there may be potential upside in the mid- to long term. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
