Formosa Laboratories has seen steady growth in its core API business, and its recent investments in CDMO and injectables have become the key drivers of its next wave of operational growth. The injectable for breast cancer, Eribulin Injectable, is expected to receive FDA approval this year. The number of CDMO clients has increased by 30% compared to the same period last year, with stable shipments from European, American, and Japanese originators. Chairman Cheng Cheng-Yu stated that the injectable and CDMO businesses will see significant growth this year, with even higher growth in the following years. In three years, their performance could surpass the API business.
In recent years, Formosa Laboratories has been actively expanding its business scope. Its CDMO client base covers APIs, formulations, and ADCs, and this segment now accounts for approximately 10% of revenue. The contribution from injectables is even smaller, with external attention focused on the timeline for regulatory approval of Eribulin Injectable for breast cancer in overseas markets and its contribution to performance.
Formosa's CDMO offers one-stop services, with a 30% increase in the number of clients this year compared to the same period last year. Stable supply agreements continue with European, American, and Japanese originator clients. After the acquisition of Synchem-Formosa, the company has steadily expanded its North American CDMO business. In addition to two major clients now in commercial production, a European client has entered Phase 1 clinical trials, and a new ADC drug development project has been signed. Another client has requested one-stop services for multi-country, multi-center Phase 1 clinical trials, with patient recruitment now underway in the U.S.
For injectables, the cancer drug production line passed the TFDA plant inspection in Q2 2022. In July 2024, the high-potency injectable plant passed the U.S. FDA GMP inspection, with the European EMA plant inspection expected in Q2 this year. The general production line will undergo TFDA inspection in August 2024, with GMP certification expected in the second quarter of this year. Currently, the utilization rate of the three production lines for injectables is 20-30%, with an estimated growth to 40% next year.
The injectable for breast cancer, Eribulin Injectable, is actively being introduced to medical centers in Taiwan. The first medical center tender is expected to be secured in the first half of this year, and other hospitals will begin purchasing soon thereafter. In Europe, a contract has already been signed, with the production line audit scheduled for Q2 this year. Contracts have also been signed for markets including Hong Kong, Pakistan, and Singapore, with ongoing negotiations in other emerging markets.
Other injectable products under development include treatments for anemia, GLP-1 drugs, and chronic kidney disease. These developments are progressing as planned, with discussions ongoing with potential partners for licensing agreements. Chairman Cheng Cheng-Yu stated that the U.S. approval for Eribulin Injectable is expected this year, likely in the second half, and production preparations are underway, with shipments ready to go the day after approval. Once the hospital orders are secured in Taiwan, shipments will begin, although the contribution to overall revenue will be small.
The generic API business remains positive, with significant growth expected from the CDMO and injectable businesses. The injectable and CDMO segments are expected to surpass the API business in performance, although this will likely take more than three years. This year, the API business will continue to be the main contributor to revenue, with substantial growth expected in the following years.
Resource: 台耀CDMO、針劑新引擎，董座稱三年後業績超越原料藥
