Innovent Announced 2022 Interim Results and Business Updates

ROCKVILLE, Md. and SUZHOU, China, Aug. 25, 2022 /PRNewswire/ -- 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, ophthalmology and other major diseases announced 2022 interim results and major company updates.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "This year was a watershed year of Innovent for next decade of development. For the past decade, Innovent has developed itself with an established platform foundation, sustained strong execution and favorable financial position. In 2022 to date, we continue to make remarkable progress in commercialization, product development, business collaboration and CMC under adherence to our long-term strategy of global innovation. Meanwhile, as one of China's leading innovative biopharmaceutical start-ups, Innovent made a pioneering deployment to explore and develop a more sustainable business model via optimizing organizational structure and enhancing refined management capabilities, with aim to support our company's long-term strategies more efficiently. We will continue to enhance drug R&D capability, expand global R&D team and promote global innovation and development, meanwhile expanding our commercial portfolio and improving business benefits and performance to create sustainable value for patients, employees, shareholders and the society."

Business Highlight Overview

• For the first half of 2022: RMB2,240million total revenue, including RMB2,041million product revenue at 10.0% growth compared with the same period of prior year
  - Commercial portfolio increased to seven products; new approvals of additional indications and in new territories attained for marketed products.
  - TYVYT® is successfully included in the updated National Reimbursement Drug List (NRDL) for three additional first-line indication for major types of cancer in beginning of 2022; and is approved for first-line treatment of two additional indications, i.e. esophageal cancer (ESCC) and gastric cancer (GC) in June 2022.
• Upgrading commercial model and platform to 2.0 stage, actively seek to establish a more agile and lean organization with more refined, systematic and scientific management, aiming to further increase output and improve efficiency.
• Unleashing the platform value and unique competitive advantages, solicit more in-depth strategic collaborations with global pharmaceutical companies such as Lilly and Sanofi to accelerate the pace of innovation.
• Insisting on global innovation strategy with acceleration of clinical development and data readout
  - 7 molecules at NDA or late clinical stage
  - Oncology pipeline achieved preliminary positive Proof of Concept (PoC) data readouts for multiple global innovative molecules
  - The non-oncology field entered into the harvest period with encouraging Phase 2 studies data readouts and registraitional clinical trials in plan for two potentially Best-in-Class molecules

Commercial – Product Sales Volume Fast Ramp-up and Commercial Platform Upgraded

• Expansion of commercial portfolio into seven approved products, including: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, NAILIKE and CYRAMZA®.
• Product revenue RMB2,041 million in H1 2022: an increase of 10.0% compared with the same period of the prior year with fast ramp-up of product volume and synergic value unleashing.
• Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 people.
• Upgraded commercial model and platform to 2.0 stage:
  - Upgraded the commercialized business structure, operated in a more professional and precise BU model, and gradually established a more efficient marketing system.
  - Created a good operational capability and model, which will effectively increase the sales scale while improving efficiency and revenue, thereby better supporting the company's long-term sustainable business development.

Pipeline – 34 Valuable Assets, Data Readout for High-Potential Molecules

Valuable pipeline consisted of 7 products approved for marketing in China, 3 assets under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 20 molecules in clinical studies

Oncology: Robust pipeline with 25 assets covering broad cancer types

• TYVYT® as leading brand in PD-(L)1 market:
  - 3 additional indications successfully included in the NRDL, including non-squamous non-small cell lung cancer (NSCLC), squamous NSCLC, and hepatocellular carcinoma (HCC).
  - 2 additional indications approved for 1L ESCC and 1L GC.
• Two NDA stage and multiple pivotal stage assets:
  - Retsevmo® (selpercatinib), NDA accepted
  - IBI-326 (BCMA CAR-T), NDA accepted
  - IBI-310 (CTLA-4)
  - IBI-344 (ROS1/NTRK)
  - IBI-376 (PI3Kδ)
  - IBI-126 (CEACAM5 ADC)
• Multiple global innovative molecules rolled out preliminary positive data:
  - IBI-110 (LAG3): 1L sqNSCLC, 1L GC
  - IBI-188 (CD47): 1L MDS
  - IBI-351 (KRASG12C): NSCLC, CRC
  - IBI-344 (ROS1/NTRK): NSCLC

Non-Oncology: Differentiated 9 molecules represents long-term growth potential

• One NDA accepted and expected to be the second non-oncology product:
  - IBI-306 (PCSK9), NDA accepted
• Robust Phase 2 studies data readout and registrational trials in plan for two potential Best-in-Class molecules:
  - IBI-362 (GLP-1/GCGR): Phase 2 studies data readout in obesity and type 2 diabetes, showing robust efficacy in weight loss, blood glucose lowering and multiple metabolic benefits. Plan to initiate Phase 3 studies for both indications in late 2022 to early 2023.
  - IBI-112 (IL-23p19): observed significant efficacy signal in the Phase 2 study for psoriasis with long-acting potential and long dosing interval convenience. Plan to initiate Phase 3 study in the second half of 2022.

R&D: Global Innovation Continues as Long-term Strategy

• Innovent US and global product development team enhancement:
  - Full operation of Innovent US: 300 Scientists of Innovent Academy based in China and the US work closely in the preclinical research project with focus on global innovation and cutting edge technologies, sustainably providing novel molecules into clinical development stage.
  - Full-function overseas development and registration team established: as important part of the company's global product development platform, the team join and undertake the long-term strategy of global pipeline development.
• Continue to progress global clinical development projects: 
  - First-in-human clinical studies to initiate in Australia for IBI-363 (PD-1/IL2) and IBI-343 (CLDN18.2 ADC) in H2 2022
  - IND approved by the US FDA for the Phase 1 platform study for the treatment of melanoma
• Breakthrough achievement for oversea market access:
  - BYVASDA® (Indonesian trademark: Bevagen®) was approved by the Indonesian Food and Drug Administration (BPOM) and is expected to be the first Chinese anti-body drug to be commercialized and locally manufactured in Southeast Asia markets.

BD: Unique Competitive Advantages to Solicit More In-Depth Strategic Cooperation

• Entered into strategic collaboration with Sanofi to benefit more patients in China and initial equity investment of EUR300 million made by Sanofi in Innovent. Both companies are committed to accelerating the development and commercialization of clinical Phase 3 stage SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody drug conjugates) and clinical Phase 2 stage SAR444245 (non-alpha IL-2) in China.
• Expanded oncology strategic partnership with Lilly: Innovent obtained the sole commercialization right of Cyramza® (ramucirumab) and Retsevmo® (selpercatinib) in Mainland China, and the right of the priority negotiation for future commercialization of Pirtobrutinib (BTK inhibitor) in Mainland China.

CMC: High-Quality and Scalable Manufacturing Capabilities

• 60,000L production capacity which is currently the largest stainless steel production capacity in China with more capacity construction in plan
• Quality compliance to GMP and cost advantage further strengthen market competitiveness

Financial Highlights for H1 2022

• Total revenue was RMB 2,240 million, an increase of 15.3% compared to the same period of the prior year.
• R&D expenses were RMB1,078 million, an increase of 22.5% compared to the same period of the prior year.
• Loss for the year was RMB1,085 million, mainly due to continuous investment in R&D.
• Cash on hand and short-term financial assets was approximately USD1.5 billion, which enables strategical focus on the long-term development.^[1]

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines in the fields of oncology, metabolic, autoimmune, ophthalmology and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 34 valuable assets in the fields of cancer, metabolic, autoimmune, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), NAILIKE(olverembatinib) and Cyramza® (ramucirumab), 3 assets under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 20 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.