PharmaEssentia held its first-quarter earnings conference on the 15th, stating that there is a chance for revenue growth this year to surpass last year's figures. The global sales team has been gradually deployed according to plan, accelerating the growth curve as planned. With appropriate control of operational expenses and improved sales capabilities, profitability is expected to continue to improve.
Earlier, PharmaEssentia announced its first-quarter financial report, with quarterly revenue reaching 1.65 billion NTD, an 86% year-on-year increase, making it the leader among listed biotech and medical companies in terms of growth rate. The gross profit margin for the first quarter reached 88%, up three percentage points from the previous quarter. Operating profit was 17.58 million NTD, with a net profit after tax of 330 million NTD, turning from a loss to a profit compared to the same period last year, representing a 1.84-fold increase in quarterly profit. Earnings per share (EPS) after tax were 1 NTD, marking PharmaEssentia's first profit from its core business.
PharmaEssentia stated that its global sales of Ropeginterferon alfa-2b (Ropeg, also known as P1101), a treatment for Polycythemia Vera (PV), continue to grow. Conversely, expenses for the first quarter decreased compared to the same period last year and the previous quarter, mainly due to cost control and sales expenses. With the current trend, there is a chance for revenue growth this year to surpass last year's figures. The global sales team deployment is proceeding according to plan, accelerating the growth curve as planned. Combined with appropriate control of operational expenses and improved sales capabilities, profitability is expected to continue to improve.
PharmaEssentia indicated that its global operations continue to grow steadily, with double-digit growth in revenue in the U.S. market in April, accelerating in growth rate. Since its launch in mid-2023, the Japanese market has shown steady monthly revenue growth, with a significant increase in April this year, reaching a record high shipment.
Furthermore, the company recently launched the PV Patient Support Program (PSP) in Japan, establishing a PV health education and consultation website staffed by qualified nurses to provide disease and medical expense consultation services, assisting PV patients and their families in actively dealing with the disease and treatment. Additionally, PV patients in Japan can self-administer Ropeg starting from June this year, with a maximum of three months' worth available per injection. As Ropeg is covered by health insurance, this reduces the burden of out-of-pocket expenses for patients, greatly facilitating the increase in the number of patients and market expansion. The Japanese team is optimistic about this year's operations.
In terms of expanding its global presence, applications for PV drug licenses have been submitted to Brazil and Colombia recently to supply self-pay patients with urgent medical needs. Shipments to Colombia have been made through project imports.
Moreover, PharmaEssentia plans to collaborate with international pharmaceutical companies to introduce Ropeg to Canada, benefiting more PV patients in North America and further expanding the Ropeg market in North America. The board of directors recently approved the terms of distribution and authorization for Ropeg in Canada, and formal announcements will be made after the contract is signed, completing the layout of the entire American market. It is expected that Ropeg will apply for PV drug licenses in Canada this year and for a second indication, essential thrombocythemia (ET), next year.
PharmaEssentia also stated that Ropeg is expected to obtain PV drug licenses in mainland China, Singapore, and Malaysia this year, entering the markets of mainland China and Southeast Asia. Currently, active marketing preparations are underway, and Ropeg's global sales growth is expected to be further enhanced. Once Ropeg obtains PV drug licenses in mainland China, it will be the only drug approved for PV in mainland China. Ropeg was recently recommended in the latest treatment guidelines by the Chinese Society of Clinical Oncology (CSCO) for both high- and low-risk PV patients, demonstrating high attention from the PV medical community in mainland China.
In terms of the European market, there were a small number of shipments in the first quarter of this year, and more shipments are expected throughout the year. Regarding the progress of expanding Ropeg's new indications, the global Phase III clinical trial for essential thrombocythemia (ET) was completed with the enrollment of 174 ET patients in October 2023, with the collection of primary efficacy data expected to be completed by the end of 2024 or early 2025. Applications for drug licenses will begin in various countries, including the United States, mainland China, and Japan, with certification expected by the end of 2025 at the earliest, and marketing preparations are currently underway.
The ET single-arm clinical trial of Ropeg in the United States has attracted great attention from the medical community, with enthusiastic enrollment completed in March 2024, including 92 ET patients in the United States, far exceeding the originally expected 64. The related clinical data is expected to further strengthen Ropeg's similarity and expand the U.S. market. With the number of ET patients being comparable to that of PV and the limited existing treatment options, Ropeg is expected to double its market share and contribute to revenue growth after obtaining ET drug licenses.
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