Author：Luye Life Sciences
Luye Pharma released its annual results on March 28. The financial report show that in 2018, the company realized revenue of 5.173 billion RMB, up 35.6% year-on-year; EBITDA reached 1.961 billion RMB, up 38.5% year-on-year, while profit attributable to shareholders reached 1.303 billion RMB, up 32.8% year-on-year.
Combining a unique strategic vision and carefully planned approach, the company has enacted a multi-faceted development plan for sales, R&D, M&A and external collaborations, not only bringing excellent business results but also laying a solid foundation for the global launch and commercialization of its new drugs in the future.
In terms of marketing and sales, the company has stepped up its efforts to optimize its organizational structure and marketing in China, and to enhance its capabilities in retail and commercial operations. Core products such as Lipusu (Paclitaxel Liposome for Injection), Maitongna (Sodium Aescinate for Injection), Beixi (Acarbose Capsules), and Xuezhikang (Traditional Chinese Medicine for lipid-regulating) continued to enjoy double-digit growth; products that were included into China’s National Reimbursement Drug List not long ago such as XMNa (Sodium Glycididazole for Injection) and Ou Kai (Sodium Aescinate Tablets) achieved incredible sales results with huge market potential. In addition, Luye Pharma has entered into a strategic partnership with AstraZeneca to jointly explore opportunities in the lipid-regulating drug market. As part of this collaboration, AstraZeneca obtained exclusive rights to promote Xuezhikang Capsules in mainland China.
The performance of overseas business also exceeds the company’s expectations. A number of products have entered the markets of another 17 countries and regions, including Europe, Japan, the Middle East and Southeast Asia. Buprenorphine Transdermal Patch and Rivastigmine Transdermal Patch products are also being introduced to China at an increased speed. In addition, the company has established a globalized commercial network and pharmacovigilance system. The company’s business presence has expanded to more than 80 countries and regions around the world, with strong regional partners.
In terms of R&D, the company has continued to increase investment. Compared to the same period in 2017, R&D expenses in 2018 ramped up by 70.1%, accounting for 9.8% of the company’s total sales expenses. In addition, the R&D pipeline has entered its ‘harvest period’. Aside from Rykindo® ’s NDA submission, two other drug candidates have entered Phase III (including pivotal trials) in the United States, with another five having entered Phase III in China. The company is filing for import registration for one drug to China, and has just received five more global clinical trials approvals. It is worth noting that products currently in the late clinical trials stage are mainly CNS drug candidates. They will help bolster Luye Pharma’s existing CNS portfolio and achieve greater synergetic effect with Rykindo®.
Centered around the company’s globalization strategy, Luye Pharma has conducted a series of mergers and acquisitions and collaboration projects in 2018 to supplement resources for the improvement of product lines and commercialization capabilities. Key projects include the acquisition AstraZeneca's Seroquel and Seroquel XR in 51 countries and regions around the world to rapidly build commercialization capabilities in the CNS area and increase product coverage in emerging markets, the acquisition of Bayer’s Apleek global rights to further enrich the company’s transdermal patch portfolio, granting AstraZeneca the exclusive promotion rights for Xuezhikang capsules in mainland China, and the most recent MOU signed with AstraZeneca on deepening the two parties cooperative strategy for Xuezhikang’s global promotion, especially in the U.S and emerging markets.
In addition, Luye Pharma has conducted a series of cutting-edge research and development cooperation projects with internationally renowned scientific research institutions and innovation companies to actively explore opportunities for innovation in new biological antibodies, novel formations, immuno-oncology, cell and gene therapy, etc. In 2018, the company entered into partnerships with 6 biotech companies from Europe and the U.S., such as Excel and Elpis, to jointly develop innovative medicines.
The management of Luye Pharma Group commented, “Guided by innovation and globalization, we will strive to become one of the world’s top 50 international pharmaceutical companies by 2025, which is our medium-term strategic goal. 2019 will be a ‘harvest year’ and also a crucial year for us. We will work relentlessly to accelerate the launch of Rykindo® in the U.S. and China, and speed up the registration process for new drugs that are in the NDA preparation phase, phase III and critical clinical stages. We look forward to bringing more high-quality and innovative drugs to global patients in need!"