On March 30, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported its financial results for the year ended December 31, 2020 and the corporate progress. In 2020, the Company achieved total revenue of RMB 3843.8 million (Press release, Innovent Biologics, MAR 30, 2021, View Source [SID1234577391]). In addition to the first commercial product TYVYT (sintilimab injection), the Company successfully added three more antibody drugs to the commercial portfolio with the NMPA approval of BYVASDA (bevacizumab biosimilar), SULINNO (adalimumab biosimilar) and HALPRAZA (rituximab biosimilar), becoming the only biopharmaceutical company that successfully launched four antibody drugs in China in only nine years since inception.
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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "2020 is a landmark year for Innovent. In the past year, despite the challenges of COVID-19, we minimized the impact on our business and achieved remarkable milestones. We ensured product supply with the non-stop operation of our production line even during the peak of pandemic in the beginning of 2020. Production capability expanded significantly from 5,000L to 24,000L. With the NRDL coverage, we more than doubled the sales of Tyvyt with even higher volume growth. We kept advancing our valuable assets rapidly in China and globally, with six NDAs submitted, four NDAs approved, five assets in Phase 3 or pivotal Phase 2 stage, and 14 assets in the early clinical stage. We also accelerated our global footprint with six assets under global development and a series of international collaborations achieved. More importantly, we’ve upgraded our R&D platform to strive toward global innovation for the next stage."
"With the conclusion of the ninth year since incepted, we are now starting the final year of our first decade. Up to now we have built Innovent from a biotech start up to a biopharmaceutical company with a fully integrated functional platform. However, this is just a start. Our journey to excellence is still in the infancy stage. Heading into the next decade, we are committed to moving Innovent to become a global innovative biopharmaceutical company, capturing the substantial potential of the rising innovative drug market both in China and globally, as well as and delivering tremendous value for our patients, employees, and shareholders."
Business Highlights during 2020 to Year-to-Date 2021
Four commercial product portfolio with three new drugs approved; RMB 2,367.5 million product revenue in 2020
After the first product TYVYT (sintilimab injection) was approved in 2018, BYVASDA (bevacizumab biosimilar), SULINNO (adalimumab biosimilar) and HALPRAZA (rituximab biosimilar) were approved by the NMPA during 2020, making Innovent the only biopharmaceutical company that successfully launched four antibody drugs in China in only nine years since inception.
Total product revenue reached RMB 2,367.5 million for the year ended 31 December 2020, an increase of 133.0% compared to RMB 1,015.9 million in the prior year.
The leading product TYVYT (sintilimab injection) generated RMB2,289.8 million in revenue for the year ended 31 December 2020. This represents an increase of 125.4% from RMB1015.9 million in the prior year.
In addition, TYVYT (sintilimab injection) was approved as the first line treatment for non-squamous non-small cell lung cancer (NSCLC) in February 2021. Three more supplemental new drug applications (sNDA) for TYVYT (sintilimab injection) were under NMPA review with expected approval by 2021 or early 2022, including: 1) the first line treatment for squamous NSCLC; 2) the first line treatment for hepatocellular carcinomas in combination with BYVASDA (bevacizumab biosimilar), and 3) the second line treatment of squamous NSCLC.
Robust pipeline of 23 diverse-staged assets
The company has built up a highly differentiated and competitive pipeline consisting of 23 clinical stage valuable assets that are being developed globally, including four assets approved, five assets under Phase 3 or pivotal studies and 14 assets in other clinical stage. The 23 assets cover major areas including monoclonal antibodies, bispecific antibodies, CAR-T and small molecules etc.
Five assets in Phase 3 or pivotal clinical trial
In addition to the four commercial products, the Company owns a total of five assets in Phase 3 or pivotal clinical studies that are expected to be launched within the next several years, including:
IBI-310 (CTLA-4 monoclonal antibody)
IBI-375 (FGFR inhibitor)
IBI-376 (PI3Kδ inhibitor)
IBI-306 (PCSK9 monoclonal antibody)
IBI-326 (BCMA CAR-T)
Comprehensive and differentiated pipeline in oncology and immunology
Supported by the Company’s deep understanding in immunology (IO) and the unique strength in monoclonal antibody and bispecific antibody, the Company’s IO assets have high degree of differentiation and lead the development progress even in the global market. The comprehensive pipeline cover most of the promising IO targets including PD-1, CD47, LAG-3, TIGIT etc.
In CD47 area: the Company owns three differentiated assets in the area. The potential best-in-class CD47 monoclonal antibody IBI-188 have completed Phase 1a dose escalation and started Phase 1b in 2020. The Company plans to enter phase III or pivotal clinical trial this year for 1L MDS for IBI-188. IBI-322 is a first-in-class PD-L1/CD47 bispecific antibody under Phase 1 study in China and the US. The Company plans to obtain proof-of-concept (PoC) data for IBI-322 in 2021. The Company also has the potential best-in-class SIRPα monoclonal antibody under pre-clinical research stage.
In LAG-3 area: the Company’s LAG-3 monoclonal antibody IBI-110 is the first LAG-3 approved for IND in China. The Company has completed phase 1b enrollment for IBI-110 and will obtain PoC data in 2021. The potential first-in-class PD- L1/LAG-3 bispecific antibody has also received IND approval recently, and the Company will start Phase 1 study in 2021.
In TIGIT area: the TIGIT monoclonal antibody IBI-939 has entered Phase 1b study, with plan to obtain PoC data in 2021. The Company also submitted the IND application for its PD-1/TIGIT bispecific antibody IBI-321 recently, and plans to start clinical study in 2021.
Besides, in 2020, the PD-1/PD-L1 bispecific antibody IBI-318 has finished Phase 1a study and entered multiple Phase 1b studies to explore the potential of IBI-318 in different cancer indications.
Featured non-oncology pipeline with significant progress
The Company’s featured pipeline in non-oncology cover high potential areas with unmet medical needs, including autoimmunity, metabolism, cardiovascular and ophthalmology. In particular, two unique assets with Best-in-Class or First-in-Class potentials made significant progress in 2020, including:
IBI-302 (VEGF/complement fusion protein): The Company has completed the Phase 1a study with optimistic preliminary data for the treatment of wet age-related macular degeneration ("wet AMD"). The Company plans to start Phase 2 clinical study in 2021.
IBI-362 (OXM3): The Company is conducting Phase 1b studies in both obesity objects and diabetic patients. IBI-362 has shown very promising effect on glucose control and weight reduction. The Company plans to start Phase 2 clinical studies in 2021.
Entered strategic collaborations with world-class partners
The company has made a series of collaborations with international and regional partners during the year of 2020. In particular:
The strategic expanded licensing out agreement with Lilly on the exclusive rights of TYVYT (sintilimab injection) outside of China marked the first major step in bringing our innovative portfolio to the global market.
The collaboration with Roche on the discovery and development of bispecific antibodies and multiple cell therapies shows the recognition of our drug discovery and R&D capabilities by a global top-tier pharmaceutical company, and could also further enrich our potential First-in-Class pipeline down the road.
Significant expansion in manufacturing capacity
In 2020, the Company expanded the manufacturing capacity from 5,000L to a total of 24,000L production capacity to support the production needs for both commercial product and clinical stage candidates in the pipeline.
In 2020, the Company has also started the construction of a new manufacturing facility that is designed to house additional twelve 3,000L production capacities, which once completed, will expand the production capacity to a total of 60,000L.
Continuous enlargement of talent pool; upgrade of R&D toward global innovation
In the year of 2020, the talent team increase from about 2,000 employees as at 31 December 2019 to more than 3,200 employees as at 31 December 2020.
In particular, the Company appointed Dr. Yongjun Liu, a renowned world class scientist and successful leader in biopharmaceutical industry as the president of the Company, responsible for our global R&D, portfolio strategy, business development as well as international operation.
In order to achieve the strategic goal of global innovation, the Company is upgrading the R&D to a fully functional structure with global scope, global talents and global vision.
Fruitful capital market achievements
In 2020, the "B" marker was also successfully removed from the Company’s stock name.
The stock was also included in the Hang Seng Composite Index and the Stock Connect in 2020.
During 2020 to year to the date of 2021, the Company has successfully raised a total of approximately US$1.3 billion fund from three rounds of new share placements, backed by strong subscription of well-known international and regional investors.
As the end of February 2021, the Company has approximately US$1.8 billion cash on hand, providing a strong support to our drug R&D, potential business collaboration, production facility expansion and increased international operation needs.
Financial highlights for the year ended December 31, 2020
Total revenue was RMB3,843.8 million for the year ended 31 December 2020, representing an increase of 266.9% from RMB1047.5 million in the prior year. The growth was mainly driven by the strong product growth as well as increase in license fee and service income in 2020.
Product revenue increased by 133.0% to RMB2,367.5 million in 2020 from RMB1,015.9 million in 2019. This was mainly driven by the strong growth of our leading product Tyvyt coupled with revenue contribution of three newly approved antibody drugs in the second half of 2020.
R&D expenses increased by 43.0% to RMB1,851.5 million for 2020. The R&D expenses were spent on progressing clinical trials of late-stage and prioritized assets towards our robust pipeline globally, and expanding collaboration and licensing programs to further enhance our all-rounded R&D capabilities.
Loss and total comprehensive expenses decreased by 42.0% to RMB998.4 million. This reduction in loss was primarily driven by higher product sales as well as license fee income from the upfront payment for the out-license of Tyvyt to Lilly in ex China region.