Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Arcturus Therapeutics Holdings Inc (ARCT, Financial) successfully launched its COVID-19 vaccine, KOSTAIVE, in Japan, marking the company's first commercial product.
- The company received a $25 million commercial milestone from the first sale of KOSTAIVE in Japan.
- Positive Phase 3 results were announced for ARCT-2303, demonstrating superior immune response compared to other vaccines.
- Arcturus Therapeutics Holdings Inc (ARCT) has a strong financial position with cash, cash equivalents, and restricted cash totaling $294.1 million as of September 30, 2024.
- The company is on track to share interim Phase 2 proof of concept data for its cystic fibrosis and OTC deficiency programs in the first half of 2025.
Negative Points
- Revenues for Q3 2024 decreased slightly to $41.7 million from $45.1 million in the same period in 2023.
- Total operating expenses for Q3 2024 were $52.4 million, indicating a higher cost structure compared to revenues.
- The company reported a net loss of approximately $6.9 million for Q3 2024.
- There is uncertainty regarding the timing of revenue recognition from KOSTAIVE sales in Japan, with expectations pushed to 2025.
- The expansion of the Phase 2 clinical program for OTC deficiency into the United States has delayed interim data readouts to the first half of 2025.
Q & A Highlights
Q: Can you provide more details on the commercial launch of KOSTAIVE in Japan and expectations for the winter season going into 2025?
A: Andrew Sassine, CFO, explained that Meiji, the number one flu vaccine company in Japan, plans to sell approximately 4.5 million vaccines this season. The initial shipment of 4 million doses has been made, and the remaining vaccines will be produced domestically by ARCALIS once approved. The full launch is expected by December, with more updates to come from Meiji and CSL.
Q: What can you share about the Phase 2 cystic fibrosis study, including size, cohorts, and proof of concept requirements?
A: Padmanabh Chivukula, COO and CSO, mentioned that the study will evaluate multiple doses and measure FEV1 throughout. The study is open-label, without bronchoscopy, and aims to recruit participants who do not respond to CFTR modulators. More details will be shared early next year.
Q: Regarding the OTC deficiency study, why was the interim data readout shifted to the first half of next year?
A: Joseph Payne, CEO, stated that the US expansion is similar in size to the European study. The decision to combine data from both regions for a comprehensive interim update in the first half of 2025 was made to provide a more complete analysis.
Q: Can you elaborate on the revenue recognition process for KOSTAIVE sales in Japan?
A: Andrew Sassine, CFO, explained that Meiji will report sales to CSL, which will then allocate profit shares among CSL, Meiji, and Arcturus. Revenue recognition will occur once allocations are made, considering the 40% production cost offset. Initial revenues are expected in the first half of 2025.
Q: What differentiates ARCT-032 from competitors like Vertex/Moderna's VX-522 in the cystic fibrosis space?
A: Joseph Payne, CEO, highlighted that ARCT-032 uses a unique Lunar delivery technology, which is biodegradable and non-accumulating. Preclinical data shows significant responses, and the purification process of mRNA is a key differentiator, ensuring high purity for chronic dosing in compromised lungs.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
