Medical device manufacturer Bioteque Corporation announced that audits and validations of its new Yike Branch plant by both new and existing clients are gradually being completed, with a focus on TPU (thermoplastic polyurethane) catheters as the top priority. Two U.S. clients have already finished factory inspections, and there is potential for significant order expansion from these clients. Additionally, a new client has begun mass production. The facility has commenced small-scale production, with a goal to secure product registration and free sales certificates in the fourth quarter of this year, which will support shipment growth. Bioteque expects to obtain Taiwan's National Health Insurance (NHI) code in the first quarter of next year, which will help increase operational capacity utilization and improve overall gross margins.
At the company's investor briefing on the 24th, Bioteque's management noted that two existing CDMO clients from the U.S. recently completed factory audits this month. Once production is transferred to the Yike Branch, there is a possibility of increasing production volume, though the audit results are still pending feedback from the U.S. headquarters of these two clients. Meanwhile, a new client has started small-scale mass production, with further updates expected in the fourth quarter following an assessment of market sales performance after the initial shipment. The decision on whether to place a second order will depend on this feedback.
Currently, TPU catheters remain the primary focus for Yike's audit and validation processes. Internal catheters and angiography catheters are expected to receive product registration and free sales certificates from Taiwan’s FDA in the fourth quarter of this year, which will support the expansion into international markets. By the first quarter of 2025, Bioteque expects to secure Taiwan's NHI code, allowing distributors to bid on hospital contracts and apply for NHI reimbursements. The verification process for peripheral products, such as internal catheters, is ongoing and expected to be completed by the first quarter of 2025.
The operational capacity utilization rate is currently around 85% at Bioteque's Yilan plant and 70-75% at its Philippine plant. However, the Yike Branch is still in small-scale production, making it difficult to compare capacity utilization and gross margins between these plants. Once the Yike Branch secures Taiwan's NHI code and begins full production of internal catheters, production will initially remain small-scale, followed by semi-finished goods. By the end of the first quarter of 2025, Bioteque anticipates a significant improvement in Yike's gross margin, which will also contribute to the overall improvement of the company's gross margins.
Resource (mandarin): 邦特新廠客戶陸續完成查廠驗證，爭取CDMO訂單放大
