Boan Biotech (6955.HK) today announced its 2023 financial results and latest developments.

 

High-quality development delivering remarkable performance

During the reporting period, the company's revenue was RMB 620 million, up 20% year-over-year. In 2023, the company’s management efficiency significantly improved, with sales, R&D and administrative expenses combined going down by 23% year-over-year or by 48% year-over-year as a percentage of revenue.

The company recorded a loss of RMB 120 million during the reporting period, representing a substantial reduction of 64% year-over-year. Operating cash inflow and outflow were basically balanced. It broke even for the first time in the second half of 2023.

 

Strong cash flow from faster commercialization

Boan Biotech is one of a few Chinese biopharmaceutical companies that are able to develop, manufacture and sell pharmaceutical products. Its portfolio is known for being innovative with a balanced risk profile. The portfolio is built to keep a balance between short-term commercial visibility and high-speed growth in the long run. In 2023, two products that had already been launched delivered a remarkable sales performance, and six R&D projects were close to commercialization stage. While contributing to revenue growth, they will also allow the company to spend more on the development of innovative drugs in the future.

The two commercialized products, Boyounuo^® (bevacizumab injection) and Boyoubei^® (denosumab injection for the treatment of osteoporosis, BA6101), were put on China’s latest National Reimbursement Drug List (NRDL), making them more affordable to patients, and more indications or more target patient groups were added as well. By leveraging its robust internal marketing team and strong network of partners, Boan Biotech rapidly expanded its sales channels. It now works with over 200 distributors in China, covering over 2,700 hospitals and other outlets across China, a significant increase from the end of 2022.

 

Among the six R&D projects close to the commercialization stage:

●BA1102 (denosumab injection for the treatment of oncology indications) was being reviewed for its Biologics License Application (BLA) in China.

●BA5101 (dulaglutide injection), the first dulaglutide biosimilar to have completed a Phase 3 clinical trial in the world, was undergoing BLA preparation in China.

●BA9101 (aflibercept injection) completed patient enrollment for a Phase 3 clinical trial in China.

●BA1104 (nivolumab injection) was undergoing a Phase 3 clinical trial in China, the first nivolumab biosimilar to undergo a Phase 3 clinical trial in China.

●Overseas, patient enrollment was completed for the international multicenter Phase 3 clinical trial of BA1102 (denosumab injection for the treatment of oncology indications) and BA6101 (denosumab injection for the treatment of osteoporosis) conducted in Europe, the U.S., and Japan. 

 

Recognized for exceptional innovation capability

Boan Biotech has been very efficient in driving the clinical trials and BLAs for over ten R&D projects. Apart from those to be commercialized soon as mentioned above, in 2023 the company also achieved some milestones in developing innovative antibodies on its three development platforms -- Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, and Antibody-drug Conjugate (ADC) Technology Platform:

●BA2101, a long-acting anti-IL-4Rα monoclonal antibody, undergoing a Phase 2 clinical trial.

●BA1202, an anti-CEA/anti-CD3 bispecific antibody, undergoing a Phase 1 clinical trial, the first innovative bispecific antibody targeting CEA and CD3 to undergo a clinical trial in China.

●BA1106, a non-IL-2 blocking anti-CD25 antibody, undergoing a Phase 1 clinical trial, the first innovative anti-CD25 antibody for the treatment of solid tumors to undergo a clinical trial in China.

●BA1301, an ADC targeting Claudin18.2, and BA1105, an anti-Claudin18.2 monoclonal antibody, undergoing a Phase 1 clinical trial. Both BA1301 and BA1105, were granted the Orphan Drug Designation (ODD) for the treatment of gastric cancer and pancreatic cancer in the U.S.

 

The value of Boan Biotech’s pipeline for innovation and the quality of innovation on its development platforms were also recognized in the industry, and the company also entered into multiple partnerships. For example, it entered into an agreement with Joincare, granting the latter the exclusive rights to develop and commercialize BA2101 in the Chinese mainland for the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). In addition, the company also authorized Zencore Biologics to use its proprietary BA-HIEXcell^® platform for the development of stable cell lines.

Apart from antibodies, Boan Biotech is also working on cell therapies and focuses on a new generation of enhanced and regulated CAR-T technology.

 

Adopting international standards to scale up for better quality and higher efficiency

The ability to do mass production ensures better product quality and higher cost-effectiveness. Boan Biotech is building multiple pilot and commercial production lines to expand capacity on demand and achieve better economies of scale. In addition, Boan Biotech currently is also driving other projects such as adopting a new manufacturing process, building a smart production line (Phase 2) for antibody drugs, and building a digital plant. 

Boan Biotech has put into place a quality management system conforming to Chinese, American and European standards. It has been certified by three major international quality management systems (ISO9001/ISO14001/ISO45001) and has also received the Brazilian ANVISA GMP certification. 

 

Multiple new products likely to be approved in the next three years

Boan Biotech is poised to enter a period of high-speed growth as its robust pipeline is translating into a wave of new product launches. The company is expected to launch multiple new products within the next three years both in China and abroad. In 2024, the company is expected to have BA1102 approved for marketing in China and submit a BLA for BA5101 (dulaglutide injection) and BA9101 (aflibercept injection) respectively in China as well. In addition, the company will continue to drive the clinical trials and registration of BA6101(denosumab injection for the treatment of osteoporosis), BA1102 (denosumab injection for the treatment of oncology indications) and BA5101 (dulaglutide injection) overseas, and to make them available for global patients as soon as possible.

 

Jiang Hua, Chairlady and CEO of Boan Biotech, said:“The biopharmaceutical industry is an important ‘new quality productive force’, and is constantly unleashing its growth potential. As part of this industry, we are set to embrace a new period of growth too. 

For now, we will continue to enhance marketing in preparation for the launch and commercialization of our investigational drugs. Meanwhile, we will also take various measures to speed up the clinical trials and registration of them overseas, to enrich our portfolio of innovative antibodies, and to improve our in-house manufacturing capacity. We will strive to achieve high-speed growth driven both by our own operations and by partnerships with prestigious domestic and international companies. 

We look to break even as soon as possible and deliver exceptional results to reward our shareholders for their support. In the long run, we will strive to become a leading biopharmaceutical company in the world, to serve patients with more innovative products.”