Bora Pharmaceuticals reported second-quarter revenue of NT$5.18 billion, slightly below market expectations, mainly due to the appreciation of the New Taiwan dollar and production delays at its sterile injectable plant in Maryland, USA. With the shutdown impact from the first quarter now resolved, the company’s Q2 gross margin is expected to surpass that of Q1. Looking ahead to the second half of the year, the market expansion of the pediatric epilepsy oral solution VIGAFYDE and increasing CDMO orders—totaling US$138 million in new orders during the first half—are anticipated to steadily boost performance. Analysts are optimistic that these dual engines will drive a significant rebound in gross and operating margins in the latter half of the year.
In April, monthly revenue surpassed NT$2 billion, but declined to NT$1.5–1.6 billion in May and June. This fluctuation was mainly attributed to production adjustments, the shutdown of older facilities, the shift of U.S. generic drug production back to Taiwan, bottlenecks at the injectable plant delaying shipments, and the appreciation of the New Taiwan dollar.
However, CDMO prospects remain positive for the second half. New orders accumulated in the first half rose 60% quarter-over-quarter to US$138 million, with the highest contributions from the Canadian site and the Maryland sterile injectable facility. The Maryland plant resumed production in late June, and the resulting deferred revenue is expected to gradually recover. Additionally, the Maple Grove site in Minnesota has seen order shifts from European clients, including early-stage development orders from major pharmaceutical firms and rare disease drug orders from smaller clients. Some of these projects could enter mass production by next year.
Currently, capacity utilization rates vary across sites. The Zhunan facility is operating at full capacity, largely due to the return of USL projects. The Canadian site is also fully utilized, and the injectable plant is close to full based on order volumes. The Zhongli facility is operating at 60–70% capacity, while the Jingde and Maple Grove sites are low, at just 10–20%. Analysts note that the Maple Grove plant is affected by U.S. drug tariff uncertainties, and clients are still assessing whether to shift production back to the U.S., so no contracts are expected in the short term. Nonetheless, CDMO revenue is still projected to grow 30–40% this year.
On the pharmaceutical sales front, the key growth driver is VIGAFYDE, an oral solution for pediatric epilepsy. Currently, there are three to four generic competitors alongside the original brand. Vigadrone, a next-generation product, is gaining traction due to the withdrawal of older formulations and original brand competition, with revenue expected to increase month by month. Meanwhile, DLS, a drug for gastroesophageal reflux disease, is nearing the end of its product life cycle. With Mylan gradually exiting the market, its market share will be redistributed, although price competition among manufacturers cannot be ruled out.
At present, Bora has seven generic drugs in specialized dosage forms, accounting for 25–30% of global sales. The majority of revenue is derived from the three formulations of Vigabatrin, with a target of increasing this share to 50% by 2027. In the second half of the year, Bora’s global sales pipeline will shift toward 505(b)(2) non-generic drugs, focusing on specialized indications such as DEE (Developmental and Epileptic Encephalopathy). Five projects are set to be filed sequentially, and orphan drug designation will be pursued for these as well.
Looking ahead, analysts note that the negative impact of plant closures in Q1 has been resolved. While the appreciation of the New Taiwan dollar and lower utilization rates may weigh on margins, Q2 gross margin is still expected to exceed that of Q1. The continued expansion of VIGAFYDE’s market presence will drive monthly revenue growth, and the strong CDMO order book, combined with the resolution of production delays at the Maryland facility and the launch of new production lines, are expected to reduce expense ratios. As a result, gross and operating margins are projected to recover significantly by the end of Q3.
Resource: 保瑞Q2毛利率估勝前一季，雙引擎拉動下半年營運轉強
