Release Date: August 22, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Bavarian Nordic A/S (BVNKF, Financial) reported exceptionally strong performance in Q2 and the first half of the year, driven by both travel health and public preparedness segments.
- The Travel Health business saw a 15% year-on-year growth, particularly strong in the rabies segment.
- The company is on track to complete the tech transfer of both rabies and TBE vaccines, enhancing future production capabilities.
- The chikungunya vaccine program is advancing ahead of schedule, with submissions made to both EU and FDA regulatory authorities.
- Bavarian Nordic A/S (BVNKF) has largely secured all anticipated contracts for the year, allowing them to confirm the upper range of their guidance for 2024.
Negative Points
- The company faced a temporary stock out in Europe for the rabies vaccine, impacting market share.
- Gross profit margin decreased to 44% in the first half of the year, down from previous levels, partly due to a water damage incident in their factory.
- The current mpox outbreak in Africa presents challenges, including the need for emergency use authorization and regulatory approvals in multiple countries.
- The company’s ability to ramp up production for mpox vaccines may require compromises in other production areas.
- There is uncertainty regarding the timing and securing of additional orders related to the current mpox outbreak, impacting future guidance.
Q & A Highlights
Highlights of Bavarian Nordic A/S (BVNKF) Earnings Call Transcript
Q: Can you clarify the capacity for additional doses this year and next year?
A: We can supply 2 million additional doses this year and 8 million next year, totaling 10 million by the end of next year. This capacity includes compromises in other production areas. Using BARDA's inventory would be an upside to this capacity. - Paul Chaplin, CEO
Q: What is the status of the tech transfer for Encepur and Rabipur?
A: The tech transfer for Encepur is on track, with regulatory approval expected in the first half of next year. For Rabipur, we should start seeing inventory reductions sooner, with full impact by 2026. - Paul Chaplin, CEO & Henrik Juuel, CFO
Q: How does the current mpox outbreak compare to the '22-'23 outbreak?
A: We are better prepared with inventory to supply 2 million doses this year. The major outbreak is in Africa, and we need regulatory approvals to expand usage. We are working with WHO and other stakeholders to address this. - Paul Chaplin, CEO
Q: What is known about the new mpox variant and vaccine efficacy?
A: There is no specific data on the new variant, but protection against one pox virus generally means protection against others. We have good effectiveness data from the '22-'23 outbreak and will generate data against the latest clade through collaborations. - Paul Chaplin, CEO
Q: Why hasn't the guidance been increased despite the potential for additional orders?
A: Historically, we have not included non-contracted sales in our guidance due to timing uncertainties. The current guidance reflects largely secured contracts, and additional capacity would come at the expense of other production areas. - Paul Chaplin, CEO
Q: How will the potential tech transfer to African manufacturers be monetized and what volumes can be expected?
A: Discussions are in early stages, focusing on technical capabilities and capacities. Previous expansions took 4-6 months, but mpox is endemic in Africa, suggesting long-term vaccination campaigns and the need for expanded manufacturing footprint. - Paul Chaplin, CEO
Q: What is the impact of the current mpox outbreak on the full-year guidance?
A: The current guidance is largely secured by contracts, with minimal impact from the current outbreak. The 2 million additional doses capacity remains available for new orders. - Henrik Juuel, CFO
Q: Does the chikungunya vaccine qualify for a priority review voucher?
A: Chikungunya is on the tropical disease list, and if the vaccine addresses new populations or improved safety, it may qualify for a priority review voucher, depending on the approval and label. - Paul Chaplin, CEO
Q: How are the discussions progressing for new mpox contracts?
A: We are in discussions with WHO, Gavi, Africa CDC, and CEPI. The major bottleneck is regulatory approval in African countries, which we are working to expand. - Paul Chaplin, CEO
Q: What are the scenarios for the development of the current mpox outbreak?
A: The outbreak originated in Africa, and international cooperation is crucial to address it. We are better prepared with inventory and effectiveness data, and we need to address the outbreak in Africa to prevent global spread. - Paul Chaplin, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
