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Luye Pharma Announces 2022 Financial Results

2023 / 03 / 30 Publisher:Luye Life Sciences Group

- Company embarks on high-quality growth across the globe driven

by growing revenue and profit with the approval of several new drugs -

Yantai, China, March 29, 2023 - Luye Pharma Group (2186.HK) today announced its 2022 financial results and latest developments.

During the reporting period, the group's revenue grew 15.0% year-on-year to RMB 5.982 billion approximately, its normalized EBITDA grew 44.8% year-on-year to RMB 1.963 billion approximately, and its normalized net profit attributable to shareholders grew 101.8% year-on-year to RMB 886 million approximately.

Driven by the dual-strategy of "innovation + internationalization", the group’s fundamentals were significantly improving, with a clear path for growth. While several new drugs were approved for launch in China, Rykindo® (risperidone extended-release microspheres for injection) was also approved for launch in the U.S. That was exciting news, which marked a new chapter for the group in seeking global development. Driven by both new products and existing products, the group saw a growth of both revenue and profit. Besides, the group’s subsidiary Boan Biotech was successfully listed on the Hong Kong Stock Exchange (HKEX), representing a major step forward under the group’s global biopharmaceutical strategy.

I. Multiple innovative products approved in China and abroad

The group’s hard work on innovation over the years has paid off, and it’s time for the group to reap the benefits of its global pipeline. Focusing on three major R&D platforms -- Novel Drug Delivery Systems (NDDS), New Molecular Entity (NME), and Antibodies, the group has achieved breakthroughs on key technologies. Since 2021, multiple new drugs developed on these platforms have been approved in China and abroad:

On the NDDS platform: Rykindo was approved in the U.S., to become the first new Central Nervous System (CNS) drug developed by a Chinese company to get approved in the U.S. The product was also approved in China under the trade name 瑞欣妥®. Rivastigmine Multi-Day Transdermal Patch was approved in multiple European countries.

On the NME platform: Ruoxinlin® (toludesvenlafaxine hydrochloride extended-release tablets) was approved in China, to become China’s first locally developed Class 1 innovative chemical drug for the treatment of Major Depression Disorder.

On the Antibodies platform: Boyoubei® (denosumab injection, a biosimilar to Prolia®) was approved in China, to become the world's first marketed denosumab biosimilar; and Boyounuo® (bevacizumab injection, a biosimilar to Avastin®) was also approved in China.

II. Steady growth for existing products

The group's portfolio includes several exclusive products that are recognized by physicians and patients in clinical practice, enjoying a differentiated competitive edge. The impact of policy factors in China such as volume-based procurement (VBP) and the health insurance policy on the group’s existing products has been gradually eliminated. Supported by growing medical evidence, they were providing a stable cash flow for the group, to help cement its financial foundation.

Lipusu® (paclitaxel liposome for injection), an exclusive anticancer drug of the group, achieved double-digit growth, and renewed its coverage by the 2022 National Reimbursement Drug List (NRDL) at the former reimbursement standard of the health insurance system. Seroquel® (quetiapine fumarate tablets and quetiapine fumarate extended-release tablets), an originator CNS drug of the group, delivered stable sales performance with good momentum for growth, and cemented its position in Chinese and overseas markets.

Xuezhikang, another exclusive drug and a natural lipid-regulating product of the group, maintained high-speed growth last year. Oukai® (sodium aescinate tablets) for treating soft tissue swelling and venous edema saw continuous high-speed sales growth, with strong potential for further growth in the future.

III. Momentum building for new products

The launch of several new products diversified the group's revenue sources, and reduced its dependence on individual products for revenue as it had been the case in the past. The strategic synergy between existing products and new products in key therapeutic areas such as oncology and CNS ensures high-quality growth for the group from shorter to longer terms.

In the CNS therapeutic area, drug development is difficult and there are a smaller number of players in this space. Over the years, the group has obtained international development, registration, supply chain, and commercial capabilities for CNS products in addition to a robust portfolio, to ensure long-term growth. More innovative products like Rykindo/瑞欣妥, Ruoxinlin, and Rivastigmine Multi-Day Transdermal Patch sold in major pharmaceutical markets such as China, the U.S. and Europe will build synergy with Seroquel, to contribute to the group’s strategic goal of "becoming the global leader in the CNS therapeutic area".

In oncology where there are many urgent unmet needs, the sales of Boyounuo quickly increased after it was launched, and two new indications were also approved in 2022. Several new drugs are expected to be approved this year. Together, they will help the group maintain a strong growth momentum in this therapeutic area.

IV. High-quality global growth expected for multiple new drugs in the next 3 years

For nearly 30 years, the group has had a steadfast focus on the “innovation + internationalization” strategy, which is key to achieving the accomplishments above and a driver for future growth. The approval of Rykindo® in the U.S. marked the start of the group’s endeavor to launch in-house developed new drugs overseas and would add further momentum to the growth of its global business. In the next 3 years, the group expects to launch multiple new drugs globally by leveraging its complete "global development + global manufacturing + global marketing” system and strong commercial capabilities in international markets.

In this year, the group is expected to have two products approved: LY01005 (goserelin acetate extended-release microspheres for injection), the world’s first goserelin in microspheres, is to be approved in China; and LY01017 (lurbinectedin for injection), the only new chemical entity approved by the U.S. FDA for the treatment of recurrent small cell lung cancer (SCLC) in the past 26 years, is to be approved in Hong Kong, China. The group is also preparing to submit a New Drug Application(NDA) for LY01017 in the Chinese mainland.

In addition to the above two products, the group also has 6 other projects in the Marketing Authorization Application(MAA) stage and 8 more in the Phase 3 trial/pivotal trial/MAA preparation stages, covering markets such as China, the U.S., Japan, and Europe.

Specifically, LY03010 (paliperidone palmitate injection) is under review for marketing authorization in China, has met endpoints in a pivotal clinical study in the U.S., and has been approved for clinical trials in Europe; LY03003 (rotigotine extended-release microspheres for injection) is in the preparation stage for marketing authorization application in China and undergoing clinical trials in the U.S. and Japan; LY021702 (oxycodone and naloxone extended-release tablets) is currently under review for its marketing authorization in China; BA1102 (denosumab injection, a biosimilar to Xgeva®) is under review for its Biological License Application (BLA) in China and being developed in the U.S. and Europe; and BA5101 (dulaglutide injection, a biosimilar to Trulicity®), the world's first dulaglutide biosimilar to enter Phase 3 clinical trials, is under Phase 3 clinical trials in China. A number of innovative antibodies protected for their international intellectual properties in the group’s biologic pipeline were already under clinical trials last year.

In 2023, the group will continue to be driven by innovation and pursue internationalization. While ensuring the efficient and high-quality launch of key products from its pipeline in global markets, the group will continue to beef up its global commercial system and operational capabilities. This will enable the group to take its business to a new level globally, to achieve strong growth, and to maximize the value for patients, shareholders, and communities.

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