Lauren Miller

March 21, 2024 - 11:53 am

Henlius Achieves Its First Full-Year Profits Backed by Strong Product Sales and Global Expansion

SHANGHAI, March 21, 2024 – Henlius (2696.HK), a frontrunner in the biopharmaceutical industry, recently unveiled its stellar 2023 annual results. The company's buoyant financials are cause for celebration; Henlius reported income soaring to about RMB 5.3949 billion, a formidable spike of 67.8% year-over-year, and also disclosed a substantial net profit of RMB 546.0 million. This financial achievement is a landmark event, marking the first full fiscal year of profits for the company, which heralds Henlius' transition to a profitable era following its profitable first half in 2023. The full-year profitability can be attributed to the increasing commercial sales of the enterprise's linchpin products coupled with an augmented sales volume. During 2023, Henlius' products enjoyed robust total sales of close to RMB 4.5535 billion, escalating by 70.2% in comparison to the prior year.

Henlius boasts significant milestones in its journey, with its products penetrating the global market. To date, five products have been launched in China, with two making their way to overseas markets, and a commendable 19 indications receiving approval globally. These developments have positively impacted over 560,000 patients and have enabled the company's reach to extend to more than 40 territories across continents such as Asia, Europe, Latin America, and Oceania. The company's commitment to contributing effectively to the medical field is evident with more than 50 marketing applications for its products currently under review in regulatory zones that span China, the EU, the U.S., Canada, Singapore, and Thailand. Moreover, the company's steadfast dedication to differentiated innovation propels the development of a robust product pipeline. Reflecting this commitment, R&D expenditure for 2023 amounts to approximately RMB 1.4336 billion.

Chairman and Executive Director of Henlius, Wenjie Zhang, expressed his views on the company's accomplishments. "Henlius has demonstrated extraordinary performance and recorded full-year profits for the first time. Our unwavering commitment to innovation and exemplary execution have laid a strong groundwork for the high-quality development. The ongoing improvements to the efficiency of our integrated biopharmaceutical platform are clear indicators of our ability to expedite our business growth. Furthermore, our operational and managerial efficiencies across the board have driven robust and sustainable growth, emboldening our aspirations to cultivate an innovative, globally-grounded biopharmaceutical entity."

The Executive Director, CEO and CFO of Henlius, Jason Zhu, highlighted the company's strategic direction. "Guided by our dual-drive strategy encompassing biosimilars and novel biologics, Henlius continues to press forward with domestic and international market penetration, adhere to lean operations, and foster high-quality, symbiotic product development. This approach has amplified our profitability and advanced our comprehensive capabilities. As we look to the future, our patient-centric philosophy will remain our cornerstone. We will refine our innovative approaches, broaden the scope for the global distribution of high-quality biological medicines, and make substantive contributions to the advancement of human health."

Breakthroughs in Commercial Performance and Overseas Market Penetration

The remarkable year 2023 witnessed Henlius making significant commercialization strides, optimizing its business models, perfecting its market layout and broadening its international horizons. The combined sales of its five signature products approximated a staggering RMB 4.5535 billion. The oncology heavyweights such as HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) generated sales revenues of RMB 2.7370 billion, RMB 1119.8 million and RMB 119.4 million respectively. Additionally, partnerships have garnered the company sales revenues of RMB 540.5 million and RMB 58.6 million for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.

The core oncology product of Henlius, HANQUYOU, maintained robust growth within the reporting period. Domestic sales totaled RMB 2.6444 billion, marking a 56.1% uptick over the prior year. The dual dosage strengths of 150mg/60mg and the preservative-free formulation of HANQUYOU have rendered it a preferred choice in China, thus broadening its market share and positively affecting over 180,000 Chinese patients to date. Additionally, overseas sales scaled sharply by 162.3% year-on-year to about RMB 92.6 million. As a trailblazer in Chinese biopharmaceuticals' global journey, HANQUYOU has secured marketing approvals in over 40 countries including the UK, Germany, Spain, France, Italy, Switzerland, Australia, Singapore, Argentina, Brazil, and is recognized as the Chinese-developed biosimilar with the most extensive international approvals. The product’s accessibility has also improved, witnessing national reimbursement in China, the UK, France, and Germany. In 2023, the introduction of HANQUYOU in Thailand, the Philippines, and Brazil magnified its reach, while its marketing applications in the United States and Canada anticipate approval in 2024.

Henlius has also been making waves with its innovative product HANSIZHUANG, ushering it to the global stage as the first-ever approved anti-PD-1 monoclonal antibody for the initial treatment of small cell lung cancer (SCLC), now available in China and Indonesia. In 2023, HANSIZHUANG's total sales surged to RMB 1119.8 million, an extraordinary YoY increase of 230.2%. It's now validated for four indications and the previous year saw it receiving approval for treating both extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). More than 60,000 Chinese patients have reaped the product’s benefits. Furthermore, with the 5th NDA for treating non-squamous non-small cell lung cancer (nsNSCLC) accepted by the National Medical Products Administration (NMPA), HANSIZHUANG is set to extend its therapeutic reach.