Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you explain the regulatory requirements for selling research-grade recombinant proteins? A: Joe Hazelton, COO: The main requirement is that manufacturing must be done at an ISO-certified facility. There is no regulatory review by an agency needed to launch these products, but product specifications for QA and QC must meet ISO standards.
Q: How many certificates of analysis do you currently have for your products? A: Joe Hazelton, COO: We have three certificates of analysis for DNAse One, Bovine Transferrin, and Bovine Alpha-Lactalbumin. These certificates confirm that our products perform comparably to existing commercial research-grade products.
Q: Can you elaborate on the production challenges and market dynamics for high-value research products? A: Joe Hazelton, COO: Production challenges vary by market. For example, serum albumin requires large quantities, while DNAse One is needed in smaller amounts due to its toxicity to most cell lines. Our advantage lies in producing at higher levels with lower costs, providing margin flexibility.
Q: How does the market view recombinant versus animal-derived products, particularly in terms of pricing and demand? A: Joe Hazelton, COO: Preferences depend on the market segment. Recombinant products are often preferred for their regulatory advantages and consistency, especially in therapeutic production. However, some applications still favor animal-derived products due to performance.
Q: What is the addressable market for Dyadic's products, and what are the expected royalty rates? A: Joe Hazelton, COO: The addressable market varies by segment. For example, the cell culture media market is $4.7 billion, with a significant portion being recombinant. Royalty rates also vary by product and market, typically ranging from 3% to 10%, or profit-sharing arrangements.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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