[Abstract]:Viva Biotech will continue to advance the integrated CRO-CDMO strategy, aiming to establish comprehensive and comprehensive FIC drug development services to empower our clients.

Highlights of the Annual Results as of December 31, 2023:
Revenue reached RMB2,155.6 million
Gross profit amounted to RMB738.5 million
Adjusted non-IFRS net loss improved to RMB208.8 million, representing a significant turnaround from a negative position compared to the corresponding period of last year
Successfully attracted strategic investors such as Temasek, Highlight Capital, True Light Capital and Investment Corporation of Dubai with a total financing size of nearly US$225 million
 

China, Hong Kong -- On March 28, 2024, Viva Biotech Holdings Group (“Viva Biotech”, “the Group” or “the Company”, stock code: 1873.HK) announced that the Group’s revenue during the Reporting Period achieved RMB2,155.6 million; and our gross profit amounted to RMB738.5 million. In 2023, the Group’s net loss amounted to RMB99.8 million, a significant improvement from a loss of RMB504.2 million for the corresponding period of last year. Adjusted non-IFRS net loss improved from RMB133.9 million for the corresponding period of last year to an adjusted non-IFRS net profit of RMB208.8 million, representing a significant turnaround from a negative position compared to the corresponding period of last year, which was mainly attributable to the stabilization of valuation of certain incubation portfolio companies of the Group as well as the improvement in profitability as a result of the Group’s initiatives to reduce costs and increase efficiency.

In addition, in 2023, the Group achieved breakthrough progress in overall financing and the introduction of strategic investors. We successfully attracted strategic investors such as Temasek, Highlight Capital, True Light Capital and Investment Corporation of Dubai with a total financing size of nearly US$225 million. The completion of the Group’s financing endeavors and the successful introduction of strategic investors have propelled the Company towards a trajectory of smooth and rapid development. On one hand, the substantial financing obtained has allowed the Company to fully repay its previously issued convertible bonds, leading to a substantial improvement in the Company’s balance sheet and cash flow. On the other hand, the successful inclusion of strategic investors will play a pivotal role in enhancing corporate governance, facilitating business operation, optimizing investment and financing plans, and driving strategic development. This collective effort will greatly support the Company’s long-term growth and the successful implementation and continuous advancement of its integrated strategy.

CRO Business Shows an Attractive Outlook in the Long Run Despite Slight Fluctuation in the Short Term

In 2023, the Company’s revenue from CRO business achieved RMB844.9 million, and gross profit of RMB363.7 million. The revenue for 2023 decreased compared to last year, primarily due to the impact of the global slowdown in biopharmaceutical investment and financing on the R&D of innovative drugs, as well as the strategic contraction of the Company’s EFS business. Nevertheless, the Company effectively implemented measures such as cost reduction and efficiency enhancement to maintain a solid profitability for the CRO business.

As at December 31, 2023, the Company had delivered more than 65,035 protein structures to our clients, approximately 16,110 of which were newly delivered in 2023, and conducted R&D on over 1,886 independent drug targets, 8 of which were newly delivered in 2023. Currently, the Company maintains a leading position in the industry worldwide in the field of protein structure analysis. Furthermore, the Company has two key strategies in place. Firstly, it aims to maximize the value from existing customers by fostering synergistic development in biochemistry. Secondly, it is actively enhancing the integration of online digital marketing and offline BD, while expanding its overseas BD team in order to stimulate the recovery and growth of orders. Additionally, the Company is continuously expanding its emerging technology platforms to create new growth drivers and provide sustained support for its existing CRO business.

The cumulative number of CRO clients served had increased to 1,398, including the global top 10 pharmaceutical companies (by reported total revenue for 2023), and revenue from the top ten customers accounted for 25.7% of our total revenue. Clients of our CRO business are geographically diverse, of whom those from overseas contributed approximately 87.1% of our total revenue, and those from Chinese Mainland contributed approximately 12.9% of our total revenue.

During the Reporting Period, our utilization of synchrotron radiation source reached 2,059 hours. The Company established long-term cooperation with 13 synchrotron radiation source centers around the world, which are distributed in ten countries/regions, i.e., Shanghai, China, the United States, Canada, Japan, Australia, the United Kingdom, France, Germany, Switzerland and Taiwan, China, thus guaranteeing uninterrupted data collection all year round.
 

Expanding CDMO Capacity and Increasing CMC Projects

During the Reporting Period, the Group laid great emphasis on strategic cooperation and synergy with Langhua Pharmaceutical. In particular, we strengthened the capacity expansion and adjusted the business structure of CDMO. In addition, efforts were made to optimize and channel resources towards the CMC business.

In 2023, Langhua Pharmaceutical’s revenue amounted to RMB1,310.7 million, and its adjusted gross profit amounted to RMB388.8 million, which was primarily attributable to the impact of delay of orders of certain CDMO clients.

As at December 31, 2023, Langhua Pharmaceutical had served a total of 880 clients, with the top ten clients accounting for 51.2% of its total revenue and a 100% retention rate of top ten clients. In addition, Langhua Pharmaceuticals provided CMC and CDMO services to more than a dozen incubation portfolio companies of the Group or companies redirected from CRO business. During the Reporting Period, in respect of capacity building, our total available capacity reached 860 cubic meters. Furthermore, Langhua Pharmaceuticals plans to establish a new production capacity of 400 cubic meters in 2024 and 2025 to cater to the commercial production of new molecules. The civil engineering project is currently in its final stages, with the workshop’s main structure almost completed. The next phase will involve the procurement and installation of equipment, expected to commence in 2024. This endeavor will provide ample assurance for the Company’s revenue growth with the launch of new products and release of reserved capacity.

The number of CMC projects continues to grow, and the new business is still in the initial phase of profitability. Since its establishment, CMC has completed and is currently progressing with a total of 183 new drug projects. As at the end of the Reporting Period, CMC generated revenue of nearly RMB56.7 million. During the Reporting Period, the projects driven by the Group progressed smoothly, and one pipeline has rapidly advanced to Phase III clinical trials, showcasing the success of the Group’s integrated strategy. In the future, the Group plans to enhance its efforts in BD and customer acquisition for high-quality CMC projects. By fully utilizing internal project resources and implementing cost reduction measures, the Group aims to achieve a balanced financial outcome for its CMC business. Additionally, in terms of customer orders, external BD accounted for nearly 63.0%, while traffic from VIVA represented approximately 37.0%. In terms of order amount, external BD contributed 31.0%, while traffic from VIVA contributed 69.0%.

Successful Exits of Certain Incubation Portfolio Companies and Future Plans for Incubation Business through Establishment of Investment Funds

During the Reporting Period, the Company achieved complete or partial investment exits from six incubation portfolio companies, realizing corresponding investment returns. In addition, one startup company was newly invested and incubated, obtained through a stock-for-stock exchange. In addition, the Company made a new investment and provided incubation support to one startup company through stock-for-stock arrangement. As at December 31, 2023, the Group had invested in a total of 92 portfolio companies. The portfolio companies are mainly from the United States, Canada, Europe and China. 67.0% of the portfolio companies are from North America and 26.0% are from China.

In 2023, 12 of our portfolio companies completed or was close to completing a new round of financing, raising approximately US$236.0 million in total. The R&D efforts of the portfolio companies were advancing smoothly, with the total number of pipeline projects reaching close to 222, of which 185 pipelines are in the preclinical stage and 37 pipelines in the clinical stage. So far, the Group has successfully realized 13 investment exits or partial exits, and may have an additional 7 potential exits for our portfolio companies in the next one to three years.

As at the end of the Reporting Period, Viva has strategically invested in a series of high-quality assets, including portfolio companies such as Dogma, Arthrosi, Basking, Triumvira, Deka, Mediar, Cybrexa, and VivaVision. In the future, as these portfolio companies continue to develop successfully, secure ongoing financing, and realize exits, the initial investments will gradually enter the harvesting phase, providing sustained cash returns for the Group.

In addition, the fund raising in and setting up of the incubation fund of the Company in the early stage are progressing smoothly. It also intends to conduct incubation business through the establishment of investment funds in future, so as to mitigate pressure on Group-level liquidity and the appropriation of funds.
 

Technological Highlights and R&D Breakthroughs

For our CRO business, we have built several core technological platforms, including: the PROTAC/molecular glue technology platform, protein production& structural biology, Cryo-EM technology platform, membrane protein technology, hit discovery technology, Bioassay platform, computer-aided drug design (CADD) and artificial intelligence in drug discovery (AIDD) platform, antibody/biologics R&D service platform, medicinal chemistry, etc. During the Reporting Period, the Company has introduced several new platforms, including XDC platform, V-DEL technology platform, covalent compound library and molecular glue technology platform, and enhanced the peptide drug development platform. Furthermore, the Company has expanded the services offered by the antibody and large molecule drug R&D platform.

The CDMO business has further enhanced the construction of its R&D technology platform. In terms of API (Active Pharmaceutical Ingredient) R&D, Langhua Pharmaceutical has established a green chemistry technology platform, including enzyme reaction, continuous flow processes, catalyst and ligand screening platforms, enabling the efficient and cost-effective development of optimized synthetic routes. Additionally, in the field of formulation CMC (Chemistry, Manufacturing, and Controls), Langhua Pharmaceutical has established distinctive innovative platforms such as the insoluble drug solubilization technology platform, compound drug characterization, salt form and polymorph screening, etc.

During the Reporting Period, the development of the newly expanded emerging technology platforms within the Company showed promising progress. The V-DEL technology platform has introduced novel library construction strategies and innovative DNA-compatible reactions. Leveraging Viva’s extensive experience in non-commercial building block molecules, it has launched various 100-billion grade DEL libraries for cyclic peptides, PROTAC, covalent inhibitors and fragments. Furthermore, based on Viva’s competitive strength in protein production and structural biology, the platform engages in specialized screening activities driven by artificial intelligence and machine learning to facilitate next-generation data analysis and prediction, and efficiently integrates subsequent validation and synthesis processes to ensure seamless workflow.
 

Furthermore, regarding the latest progress in the peptide technology platform, it has achieved the capability to synthesize a wide range of peptides. Particularly, it focuses on the synthesis of challenging and technologically advanced peptide chains. Extensive research and technical expertise have been accumulated in peptide coupling, PDC, RDC, monocyclic peptides, stapled peptides, complex multi-cyclic peptides (involving peptide folding and selective folding), biotin-labeled peptides and fluorescent-labeled peptides. Viva’s peptide technology platform envisions a collaborative approach with Viva’s phage display platform and V-DEL platform, aiming to provide customers with one-stop comprehensive services encompassing the entire process from the discovery and validation of hit peptide chains to the identification and optimization of lead compounds, and ultimately the determination of candidate compounds.

In addition, the Company has made initial strides in establishing the XDC platform, an all-in-one conjugate development platform that integrates Viva’s extensive R&D expertise in antibody drugs, peptide drugs, and small molecule chemical drugs. This platform is dedicated to delivering efficient and top-quality services for conjugate development to clients.

For development of Viva’s existing emerging technology platforms, computer-aided drug design (CADD) and artificial intelligence in drug discovery (AIDD) platforms have been widely used in various stages of drug development, utilizing physical chemistry models, artificial intelligence algorithms, and leveraging supercomputing clusters. Various methods have been extensively applied in drug discovery. The computational chemistry division of the Company has developed a series of advanced algorithms tailored to specific projects (such as FEP) to address drug design challenges. Application of these cutting-edge technologies has significantly facilitated the progress of drug development projects compared to traditional computational tools and commercial software packages. In addition to traditional small molecule drug design, methods developed by the computational chemistry platform have also been applied to various drug modalities, achieving breakthroughs through experimental validation. This includes the development of antibodies, peptides, RNA-targeted small molecule drugs, and more. Overall, Viva’s CADD and AIDD platforms have assembled a talented and multidisciplinary team, primarily consisting of individuals with advanced degrees (Masters and Ph.D.). This team possesses the expertise to develop proprietary algorithms and methods, as well as the capability to explore various drug modalities with the hardware support of computing force from the Shanghai Supercomputing Center.
 

Currently, the Company also provides services relevant to PROTAC/molecular glue drug R&D, and revenue generated in this regard accounted for almost 10.42% of total revenue from CRO business. Our services primarily include studies on protein production& structural biology, screening of PROTAC molecules, kinetics studies, drug metabolism, medicinal chemistry, Bioassay, CADD/AIDD, etc. As at December 31, 2023, the Company has studied more than 50 E3 ligases and delivered 131 target protein-PROTAC-E3 ligase ternary complex structures. Additionally, the PROTAC business is expected to contribute to the continuous growth of CRO revenue in the future.

Overall, based on the existing technology platforms, the Company aims to serve the increasing demands of more customers, and consistently invests in expanding and integrating emerging technology platforms, thereby achieving channeling and synergy among different platforms, driving continuous growth in CRO revenue, and building a comprehensive and refined FIC drug R&D platform.
 

Staff and Facilities

As at December 31, 2023, the Group had a total of 2,077 employees, of whom the number of CRO R&D personnel reached 1,155, and the number of Langhua Pharmaceutical was 689. The Company also has been accelerating the construction of office and laboratory facilities in line with its workforce expansion plans and expanding production capacity to meet the fast-growing business needs, including:
 

• The Group’s new headquarters in Zhoupu, Shanghai with a total area of approximately 40,000 square meters had been put into full operation.
• The incubation center located in Faladi Road, Shanghai has an actual usable area of approximately 7,576 square meters, including 5,552 square meters of laboratory area.
• The park in Chengdu has a GFA of approximately 64,564 square meters, of which 12,210 square meters of properties had been put into use as at December 31, 2023, including 10,800 square meters of laboratory area.
• The novel drug incubation center in Qiantang New District, Hangzhou has a GFA of approximately 77,500 square meters. During the Reporting Period, the Company successfully established a collaboration with a local state-owned enterprise. Initially, the Company held full ownership, but it has now transitioned to a 30% equity participation. In the future, the Company plans to engage in cooperation through a leasing arrangement upon completion of construction.
• A park in Suzhou with a total GFA of approximately 7,545 square meters, including nearly 5,305 square meters of laboratory area.
• A park in Jiaxing with a GFA of approximately 6,362 square meters, including nearly 5,335 square meters of laboratory area.
• Shanghai Supercomputing Center has been officially put into operation. At present, it can support computer aided drug design (CADD) calculation, artificial intelligence in drug discovery (AIDD) related calculation, and crystal structure and Cryo-EM (Micro-ED) calculation.
• The factory of Langhua Pharmaceutical in Taizhou, Zhejiang has a GFA of approximately 35,168 square meters, including the Taizhou R&D center with an area of approximately 2,500 square meters. The R&D center of Ningbo Nuobai has an area of approximately 1,300 square meters and the office building of Ningbo Nuobai has an area of approximately 1,500 square meters.

Dr. Chen (Cheney) Mao, Chairman and CEO of Viva Biotech, said: “With unique advantages in structure-based drug R&D (SBDD), the Company will increase the cross-sell between biological and chemical businesses, continue to strengthen the construction of a one-stop drug R&D and manufacturing service platform, deepen the synergy between CRO and CDMO business, improve the capacity building for front-end services and drive business to back-end services to further enhance the business funnel effect. The Company is in an effort to establish an open eco-system for global biopharma innovators.”