Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: How many customers for GMP manufacturing products do you expect to have by the end of 2024, and are there any customers beyond the two approved and third pending in conversations? What is the expected test volume for TR8 pharmacogenomic testing services in the coming quarters? A: We are launching our GMP facility at the end of fiscal 2024, so we don't expect to have signed contracts at launch. However, we have been through the evaluation process with two large customers, with GMP manufacturing rounds expected in early calendar year 2025. For pharmacogenomics, we are targeting New York State initially and expect to build volume through concierge physician practices, with plans to expand to larger enterprise customers by the end of the first quarter of '25.
Q: What is the overall picture of how quickly the uptake of GMP customers is expected beyond 2024? A: We have verbal commitments for about half of our GMP capacity in early calendar year 2025. We have a robust sales funnel for the rest of that capacity. It's not about the number of customers but the size and therapeutic modality of their mRNA orders.
Q: Are there any other states you are targeting for pharmacogenomic testing, and do they require a similar approval process? A: We are completing registration to sell in 47 additional states. No additional validation is required due to the rigorous New York State validation process we completed, which took over a year.
Q: Can you provide more details on the pharmacogenomic testing service and its market potential? A: We are the first commercial entity in New York State offering a broad-based panel exploring 130 alleles. We are starting with concierge physician practices to implement precision prescribing, with plans to expand to larger enterprise customers, including hospital networks and self-insured companies. Our capacity can support over $25 million in annual revenue, and it is scalable.
Q: What are the key developments in the commercialization of Linea IVT templates and the Linea IVT platform? A: We are on schedule for GMP startup by September 30, 2024, and have completed scale-up of our Linea RNA polymerase enzyme. We have completed validation studies with two customers and are being onboarded as a validated GMP vendor. We expect to support them with IVT templates for mRNA clinical trial materials in early 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.