Generic drug maker Lotus Pharmaceuticals Co (美時化學製藥) yesterday gave an optimistic outlook for the second half of this year, supported by anticipated growth in domestic and international sales.
The company said that its affiliate, Alvogen Group Inc, won non-infringement decisions from a US court for two of its abbreviated new drug applications seeking commercialization of two high-value generic drugs.
The court’s decision has made the path toward commercialization approval clearer, and prompted the company to transfer the two drug pipeline assets from its South Korean subsidiary back to Taiwan.
In anticipation of regulatory approvals from the US Food and Drug Administration (FDA), the company has also returned portions of its offshore funds to Taiwan to ensure adequate funding for acquisitions and expansions at its plant in Nantou County.
Domestic and export sales in Taiwan accounted for 14 percent of total sales in the first half of the year and continued to post double-digit growth on an annual basis, the company said.
The capacity utilization rate is expected to continue accelerating in the second half, boosted by rising domestic demand for Aclasta, an osteoporosis treatment, and benzonatate, a cough treatment, as well as by increasing orders from China for trazodone, an antidepressant, Lotus said.
The company said it would also file applications for a hormonal drug, a soft tissue sarcoma drug and a renal cell carcinoma drug with the FDA.
In addition, Lotus said it aims to meet proliferating demand for trazodone from a new customer in China and plans to file applications for a hormonal drug and a late-stage, solid oral dossier that treats soft tissue sarcoma and renal cell carcinoma with the FDA.
The company yesterday reported net losses of NT$48.8 million (US$1.58 million) in the April-to-June quarter, down from NT$57.52 million in the same period a year earlier, while sales rose 3.57 percent annually to NT$1.63 billion.
Losses per share were NT$0.23 last quarter, it added.
Over the same period, gross margin inched up to 48 percent from 47 percent, while operating margin dipped to 6 percent from 11 percent a year ago.
In the second quarter, Lotus said its earnings and profitability were negatively affected by an additional cost of NT$17 million, as the firm is in the middle of executing a series of incentive programs to transition employees at its South Korean subsidiary to a newly defined contribution pension plan in accordance with the nation’s labor standard law.
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