Bora Pharmaceuticals, Taiwan’s largest CDMO (Contract Development and Manufacturing Organization), is ramping up its U.S. manufacturing operations in pursuit of becoming a U.S.-based pharmaceutical company. Bora announced that its board of directors has approved a capital expenditure plan to expand aseptic manufacturing capacity at its Maple Grove site in Minnesota. Upon approval, the expansion is expected to lead to contract signings with more than three major potential clients and facilitate the addition of approximately ten new molecular entities to the site’s aseptic drug product platform. Bora shared these updates on U.S. market progress during an institutional investor forum held yesterday (June 4).
Meanwhile, Bora’s Flex Pro aseptic injectable production line in Maryland is set to boost capacity by 30% starting in July—earlier than originally planned. This expansion will accommodate up to 20 new orders.
Reflecting optimism in Bora’s outlook, a U.S.-based brokerage recently initiated coverage with an “overweight” rating, setting a target price of NT$1,060 by June 26. The report also projects a compound annual growth rate (CAGR) of 30% in Bora’s earnings per share (EPS) from 2025 to 2027.
The report notes that Bora’s gross margin is expected to improve starting in the second half of 2025, recommending investors to buy on dips. Analysts believe Bora stands to benefit structurally from increasing demand for local U.S.-based pharmaceutical manufacturing.
Among Bora’s flagship products in the U.S. is Vigabatrin, a pediatric neurological medication, which now holds over 40% market share across its three formulations for the first time in Q1 of this year. In addition, Bora’s gastroesophageal reflux treatment DLS has seen market stabilization since April, with potential for its current 40% market share to grow further.
Bora also stated that with the completion of multiple integration and restructuring initiatives in the U.S. by Q1 2025, it expects to generate approximately NT$200 million in free cash flow per quarter starting in Q2, totaling an estimated NT$600 million in operating cash flow for the year. With capital expenditures projected at NT$1 billion this year, Bora emphasized that the NT$600 million released from integration activities will cover the majority of its CapEx requirements.
Bora’s acquisition of Pyros Pharmaceuticals Inc. in October last year brought Vigabatrin into its portfolio. The drug is a primary treatment for infantile spasms and rare pediatric epilepsies. Bora is currently the only company in the U.S. market offering all three Vigabatrin formulations—oral powder, tablets, and ready-to-use oral solution.
Of the three formulations, two are generics, while the third is a 505(b)(2) improved formulation that has already received orphan drug designation in the U.S. Bora plans to meet with the FDA in Q2 of this year to discuss market exclusivity opportunities. With complete control over all three formulations, the company expects its market share in the Vigabatrin segment to reach 40%.
Additionally, Bora launched its first CDMO project at the Maple Grove site in Minnesota this March.
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