On March 29, 2021 GenScript Biotech Corporation (HKEX: 1548.HK), a leading global biotechnology group, reported its 2020 Annual Results Conference (Press release, GenScript, MAR 29, 2021, View Source [SID1234577299]). Its management team announced the business updates and financial performance of the Group’s four business segments, sharing the achievements that bolster its confidence in future prospects.
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According to the full-year 2020 financial report, the Group earned a USD 390 million revenue, representing a 42.9% YoY growth, and a USD 260 million gross profit, for an increase of 41.9% YoY. The Group’s total R&D expenses reached USD 260 million, a 41.6% YoY increase, while R&D expenses of non-cell therapy business segments remained at about 10% of revenue.
Benefitting from strong global momentum in the life science services & products segment and biologics CDMO segment, revenue of the Group’s non-cell therapy businesses increased by 45.9% to USD 315 million, reporting its fastest growth within the past five years, and a gross profit of USD 180 million, growing 46.6% year-on-year. The non-cell therapy business segments’ net profit was USD 22.1 million, a 42.6% YoY increase, and adjusted net profit approximately USD 44.4 million, a 105.6% YoY growth. This was also largely built on the success of answering global demands for COVID-19 related services, including the launch of cPass sVNT Kit – the world’s first reagent kit able to detect functional neutralizing antibodies quickly and effectively. Key highlights include:
The life science services and products business generated USD 250 million in revenue, a 44.4% YoY increase, maintaining its leading position as the world’s No. 1 gene synthesis supplier.
Revenue from GenScript Probio, the biologics CDMO business, reached USD 40.4 million, a 78% YoY growth. Among its business lines, revenue from CDMO services for gene and cell therapy increased by 148% YoY and from CDMO services for antibody drugs by 78.2%. And as a result of the Group’s long-standing commitment to high-quality standards and global business development, revenue increased by over 50% from Chinese customers, and over 150% from overseas customers.
Bestzyme, its industrial synthetic biology products business, boosted its revenue by 24%, maintaining a growth rate that exceeded the industry average and major competitors, and earning recognition as one of the top three industrial enzyme suppliers in China.
Legend Biotech, a Group subsidiary, continued to drive progress in its cell therapy business. It achieved a series of key milestones, including a successful Nasdaq IPO and the submission of Biologics License Application (BLA) to the US FDA for cilta-cel, an Anti-BCMA CAR T-Cell Therapy for treating Relapsed or Refractory Multiple Myeloma. Legend Biotech reached a USD 75.7 million gross profit, primarily attributable to its Janssen collaboration’s revenue recognition of upfront payment and milestone payment for developing and commercializing cilta-cel. Legend Biotech also spent USD 230 million in R&D, including USD 160 million on cilta-cel clinical trials in the United States and China and USD 68.2 million for other pipelines.
The Group’s capital expenditure amounted to USD 130 million to strengthen its competitiveness and profitability. The investments covered the construction of GMP facilities for the cell therapy business to support current clinical trials and future commercial needs; GMP facilities in Nanjing and Zhenjiang that will support the long-term development of the CDMO business; and its life science segment’s product upgrade and facility automation.
"Last year’s outbreak of a global pandemic presented both challenges and opportunities to the life science community. At GenScript Biotech, our people remained dedicated and strong, supporting the group to maintain the growth it has earned since listing, with all four business segments reporting outstanding performance," said Patrick Liu, Rotating CEO of GenScript Biotech. "To prove our unwavering commitment to the field, we will continue to invest in talents, innovation, R&D, infrastructure and other core competencies. As we hone our competitive edge for the future, we will also create more value for both our customers and shareholders. Guided by our mission to make people and nature healthier through biotechnology, we strive to advance the biotech community so that we can better serve society."
2020 Business Highlights
The Group’s high throughput gene synthesis production line achieved automation, adding 60% to production capacity, lowering costs and boosting efficiency while ensuring quality. Its protein, oligo and peptide services also established automated production lines, gaining a leading position in the market.
The company not only launched the only easily affordable EasyEdit sgRNA platform in China, but also formulated the first basic GMP quality management system for sgRNA service, contributing to promoting IND application and clinical trials for the gene and cell therapy community.
In May, GenScript partnered with Duke-NUS to launch the cPass sVNT Kit, the world’s first test that allows rapid and effective detection of neutralizing antibodies (Nabs), and obtained an exclusive agreement for its global commercialization. cPass is also the only serology test that received an Emergency Use Authorization by the US FDA. It has also acquired the CE (Conformite Europeenne) mark in Europe, HSA authorization in Singapore, ANVISA authorization in Brazil, ANMAT authorization in Argentina, and MOHAP authorization in the UAE as a medical device.
The bio-pharmaceutical CDMO business launched the GenScript ProBio brand. Its antibody GMP production center in Nanjing, China, went into production in November, increasing GMP production capacity to 2600L, able to meet the GMP production needs of Phase I/II clinical trials.
The GenScript Life Science Building, the integrated platform for innovative biologics R&D and production services, broke ground in Zhenjiang, Jiangsu Province, in June. Upon commission, it will cover over 30,000 m2 and serve as GenScript’s production and R&D platform for customized peptide services, and an oligo production platform with R&D and GMP production capability, helping GenScript maintain its competitive edge in the field.
Legend Biotech, cell therapy subsidiary, was successfully listed on Nasdaq in June and received USD 650 million in gross proceeds during Pre-IPO and IPO process, earning recognition from the international industry and capital market. Its product cilta-cel obtained the first "Breakthrough Therapy Designation" in China in August, and initiated rolling submission of BLA to the US FDA in December.
Legend Biotech further expanded its innovative product pipelines, and received IND approval from FDA for an investigational CAR-T therapy for the treatment of adults with relapsed or refractory T-cell lymphoma (RR TCL) in December, marking the company’s second successful IND application in the US.
Bestzyme launched the most heat-resistant glucose oxidase in China, becoming the main enzyme solution for antibiotic replacement and reduction, helping customers replace and reduce the use of the antibiotics in animal breeding. Furthermore, it obtained certifications for its products from the US FDA and Southeast Asian countries, and is actively exploring the overseas food enzyme market.
2021 Prospects
The cPass sVNT Kit is currently seeking regulatory approval in China, and has already signed a cooperation agreement to promote its commercial application in the market. With expanding commercial channels and approvals in more countries, the product is expected to achieve considerable sales.
GenScript ProBio’s second GMP plasmid plant is under construction in Zhenjiang, China, which is expected to go into production in the second half of 2021 and double its current plasmid and virus production capacity. Its third GMP facility for clinical study and commercialization of GCT projects is also in the planning stages.
Legend Biotech is expected to submit a Marketing Authorization Application (MAA) for cilta-cel to the EMA in the first half of 2021, and submit a BLA to the National Medical Products Administration (NMPA) of China and receive BLA approval from the US FDA in the second half of 2021.
Legend Biotech is also promoting several investigator-initiated clinical studies, including studies on allogenic therapies for diffuse large B cell lymphoma (DLBCL), acute myelogenous leukemia (AML), gastric cancer, pancreatic cancer, and non-Hodgkin’s lymphoma (NHL).