Innovent Announces Financial Results for Six Months Ended June 30, 2020 and Corporate Progress

SAN FRANCISCO, U.S. and SUZHOU, China, Aug. 27, 2020 /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 and other major diseases, announced its financial results for the six months ended June 30, 2020 and the corporate progress.

First Half 2020 Highlights and After Period Development

• Total revenue was RMB984.2 million for the six months ended 30 June 2020, representing an increase of 184.9% from 345.5 million for the six months ended 30 June 2019.
• Product revenue of TYVYT^® (sintilimab injection) was RMB 920.9 million for the six months ended 30 June 2020, representing an increase of 177.7% from RMB331.6 million for the six months ended 30 June 2019.
• BYVASDA^® (bevacizumab injection) was officially approved by the NMPA of China in June 2020, becoming the second commercial product of the Company.
• The supplemental New Drug Application ("sNDA") of TYVYT^® for first-line non-squamous non-small cell lung cancer ("nsqNSCLC") and sNDA for first-line squamous non-small cell lung cancer ("sqNSCLC") were accepted by NMPA of China.
• Interim Phase 3 result of TYVYT^® in first-line nsqNSCLC was presented at WCLC virtual meeting in an oral presentation. On the same day, the data was published online by the Journal of Thoracic Oncology.
• Entered into registrational trials for four assets, including IBI-310 (CTLA-4 antibody), IBI-306 (PCSK9 antibody), IBI-376 (parsaclisib, PI3Kδ inhibitor), and IBI-375 (pemigatinib, FGFR inhibitor).
• Entered into a strategic collaboration with Roche Group ("Roche") that enables the Company to access certain Roche technologies in the discovery and development of specific 2:1 T-cell bispecific antibodies (TCB) as well as its universal CAR-T platform.
• Entered into an over US$1 billion strategic agreement to license out the exclusive rights of TYVYT^® in ex-China market to Eli Lilly and Company ("Lilly"), which plans to pursue registration of TYVYT^® in the U.S. and other markets.

"Although 2020 saw an unanticipated beginning with the pandemic of COVID-19, our footstep never stops. In the first half of 2020, we have brought TYVYT^® to a lot more patients in medical need and achieved strong revenue growth by leveraging its unique advantage as the only PD-1 inhibitor in NRDL, and we successfully launched our second commercial product BYVASDA^®. We have also made significant progress in registration and clinical advancement, manufacturing capability improvement, and cross-company global collaborations. In particular, we are excited that by out-licensing the ex-China rights of TYVYT^® to Lilly, we took the solid first step toward bringing our innovative portfolio to the global market." said Dr. Michael Yu, Founder, Chairman and CEO of Innovent.

"Our journey continues. We have submitted two and plan to submit two more sNDAs for TYVYT^® for major cancer indications by the end of 2020 or early 2021. We also expect to receive approval for two more biosimilars by the end of 2020 or early 2021, which will extend our portfolio to four products, covering both oncology and non-oncology by then. We will also continue to grow our rich pipeline of innovative and complementary therapies, and advance our more than 50 clinical studies, including those for the prioritized assets with meaningful market potential in China and global market."

"The commercial success of TYVYT^® and the launch of our second commercial product BYVASDA^® have further proven Innovent has successfully transformed ourselves from a pure biotech R&D company into a biopharmaceutical with a solid platform of R&D, CMC, clinical development as well as sustainable commercialization capabilities. We firmly believe with the joint efforts of our talented team across all departments, our company will sustain its rapid growth and deliver tremendous value for our patients and shareholders."

Business Performance Summary and Expected Milestones

The Company have developed a rich pipeline with 23 assets, covering a variety of novel and validated therapeutic targets and drug modalities (including monoclonal antibodies, bispecific antibodies, fusion proteins, CAR-T and small molecules), spanning multiple major therapeutic areas including oncology, metabolic, immunology and ophthalmology diseases.

Commercial Stage Products

TYVYT^® (sintilimab injection), an innovative fully human anti-PD-1 monoclonal antibody co-developed with Lilly; accepted into the National Major New Drugs Innovation and Development Program; approved in China

Commercial Development Milestones

• Achieved RMB920.9 million in revenue in the first half of 2020, representing an increase of 177.7% over the same period of last year.
• Leveraged the unique advantage of TYVYT^® as the only PD-1 inhibitor in NRDL to expedite the process of entering hospital channels, expanding coverage in both major cities and lower tier cities, and building up recognition from doctors and patients.
• Expanded sales and marketing team of TYVYT^® from about 700 employees as of 31 December 2019 to over 1,100 employees as of 30 June 2020.
• Expanded coverage from about 2,000 hospitals and 500 DTP/pharmacies at the end of  2019 to about 3,500 hospitals and 900 DTP/pharmacies across more than 300 cities as of 30 June 2020.

Clinical Development Milestones and Achievements

Conducting over 20 clinical studies for TYVYT^®, including 12 registrational or pivotal clinical trials completed or ongoing both in China and the U.S.  

• sNDA accepted by China NMPA for TYVYT^® in combination with ALIMTA^® (pemetrexed) and platinum chemotherapy as the first-line therapy in nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement.
• Met primary endpoint in the Phase 3 study for first-line sqNSCLC and the Phase 2 study for second-line esophageal squamous cell carcinoma ("ESCC").
• Presented results from four clinical studies of TYVYT^® by online posters/abstracts at ASCO in 2020.
• Entered into research collaborations with strategic partners, including University of Texas MD Anderson Cancer Center and Sirnaomics Inc. to explore the potential of TYVYT^® in the U.S..

Post-Reporting Period (Expected) Milestones

• sNDA was accepted by China NMPA for TYVYT^® in combination with Gemzar^® (gemcitabine) and platinum chemotherapy as first-line therapy in sqNSCLC.
• Presented the results of the Phase 3 trial for first line nsqNSCLC in an oral presentation at the International Association for the Study of Lung Cancer 2020 World Conference.
• Expected to submit two sNDAs to the NMPA in the end of 2020 or early 2021, including second-line NSCLC and first-line Hepatocellular Carcinomas ("HCC").
• Expected to complete patient enrollment in Phase 3 for first line gastric cancer ("GC"), and the China arm of the global Phase 3 trial for first line ESCC.
• Expected to present the key results of first-line nsqNSCLC (biomarker data), first-line sqNSCLC, first-line HCC and second-line sqNSCLC.

BYVASDA^® (bevacizumab injection), a fully-human anti--vascular endothelium growth factor ("VEGF") monoclonal antibody; accepted into the National Major New Drugs Innovation and Development Program; approved in China

• Entered into an out-license agreement with Coherus to commercialise IBI305 (bevacizumab biosimilar) in the U.S. and Canada in January 2020.
• NDA was officially approved by the NMPA of China in June 2020.

NDA Stage Products

IBI-303 (adalimumab biosimilar), a fully-human anti-TNF-α monoclonal antibody; accepted into the National Major New Drugs Innovation and Development Program; NDA submitted in China

Post-Reporting Period (Expected) Milestones

• Receive NDA approval in China for IBI-303 in the second half of 2020.

IBI-301 (rituximab biosimilar), a recombinant chimeric murine/human anti-CD20 monoclonal antibody co-developed with Lilly; accepted into the National Major New Drugs Innovation and Development Program; NDA submitted in China

Post-Reporting Period (Expected) Milestones

• Receive NDA approval in China in the end of 2020 or early 2021.

Registrational Stage Drug Candidates 

IBI-306, a novel anti-PCSK9 monoclonal antibody; accepted into the National Major New Drugs Innovation and Development Program;

• Initiated a Phase 3 study in China for non-familial hypercholesterolemia and enrolled the first patient.
• Continued patient enrollment for the Phase 3 study for heterozygous familial hypercholesterolemia and the pivotal Phase 2b/3 study for homozygous familial hypercholesterolemia in China.

Post-Reporting Period (Expected) Milestones

• By the end of 2020 or the first half of 2021, to complete patient enrollment for the Phase 3 trial in China for the treatment of non-familial hypercholesterolemia and the Phase 3 trial in China for heterozygous familial hypercholesterolemia.
• To present the results of the Phase 1 and Phase 2 study in the annual meeting of European Society of Cardiology in August 2020.

IBI-310, an anti-CTLA-4 monoclonal antibody

• Enrolled the first patient in the Phase 3 study for the adjuvant treatment of melanoma in combination with TYVYT^® in April 2020.
• Announced the preliminary results of a Phase 1 clinical study of IBI310 and its combination with TYVYT^® at ASCO.

Post-Reporting Period (Expected) Milestones

• Enrolled the first patient for a Phase 1 study in previously treated HCC in July 2020, and expect to complete the patient enrolment for Phase 1b study in 2020.

IBI-375 (pemigatinib), a novel FGFR inhibitor in-licensed from Incyte Biosciences International Sarl ("Incyte", a subsidiary of Incyte Corporation (Nasdaq ticker symbol: INCY))

• U.S. FDA approved pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test in April, 2020.
• The Company dosed the first patient in the Phase 2 potentially registrational trial of pemigatinib (IBI-375) as treatment for patients with second-line mCCA with FGFR2 fusion or rearrangement in China.
• The Company submitted an NDA application in Taiwan for the treatment of patients with second-line mCCA with FGFR2 fusion or rearrangement. The NDA application was accepted by Taiwan FDA.

Post-Reporting Period (Expected) Milestones

• Complete enrollment of the Phase 2 potentially registrational trial of IBI-375 (pemigatinib) as treatment for patients with second-line mCCA with FGFR2 fusion or rearrangement in China.
• The Company joined the Incyte-sponsored global Phase 3 clinical trial (FIGHT-302) evaluating the efficacy and safety of IBI-375 (pemigatinib) versus gemcitabine plus cisplatin chemotherapy in first-line treatment of mCCA with FGFR2 fusion or rearrangement, with expect first patient dose in Q4 2020 in China.

IBI-376 (parsaclisib), a novel PI3Kδ inhibitor in-licensed from Incyte

• Dosed the first patient in a Phase 2 potentially registrational trial in China for r/r FL or MZL in China in April 2020.

Prioritized Clinical Stage Drug Candidates 

IBI-188, a novel fully human anti-CD47 monoclonal antibody; with best-in-class potential

• Completed the Phase 1a dosage escalation study in the U.S..
• Finalizing the Phase 1a study in China.

Post-Reporting Period (Expected) Milestones

• In China, initiate a pivotal Phase 1b/2 trial in recurrent or refractory acute myeloid leukemia ("r/r AML") with first patient of the Phase 1b study enrolled.
• In China, initiate the China arm of a global pivotal Phase 1b/3 trial in MDS ("myelodysplastic syndrome") with first patient of the Phase 1b study enrolled.
• In the U.S., initiate the Phase 1b trial in MDS with plan for a registration development thereafter.
• Present the safety results of the phase 1a study to evaluate IBI-188 in advanced malignant tumors and lymphomas in the U.S. at the annual meeting of SITC.

IBI-318, a first-in-class anti-PD-1/PD-L1 bispecific antibody co-developed with Lilly

• Completed the Phase 1a dosage escalation in advanced malignancies in China.
• Presented the preliminary results of the Phase 1a study at ASCO in June 2020.

IBI-939, a novel anti-TIGIT monoclonal antibody

• Received IND approval from the NMPA, and dosed the first patient in a Phase 1 study in advanced malignancies in China.

Post-Reporting Period (Expected) Milestones

• Submit IND application for a Phase 1 study in the U.S. by the end of 2020.

IBI-322, a novel first-in-class anti-CD47/PD-L1 bispecific antibody

• Received IND approvals from the NMPA and the U.S. FDA, respectively, in January 2020.

Post-Reporting Period (Expected) Milestones

• Dosed the first patient in a Phase 1a/1b study in advanced malignancies in China in August 2020.
• To initiate Phase 1 study and dose the first patient in the U.S. in 2020.

Other Clinical Stage Drug Candidates 

The Company has continued to advance the other pipeline assets in addition to what is mentioned above. In oncology area, the other pipeline assets include IBI-326(anti-BCMA CAR-T, co-developed with Nanjing IASO), IBI-315(PD-1/HER2 bispecific antibody, co-developed with Hanmi), IBI-101(OX-40 antibody), IBI-110(LAG-3 antibody), IBI-323(LAG3/PD-L1 bispecific anitody), IBI-319(a bispecific antibody binding PD-1 and undisclosed target), and IBI-102 (GITR antibody). For non-oncology area, the other pipeline assets include IBI-302(anti-VEGF/complement bispecific fusion protein), IBI-362(OXM3, in-licensed from Lilly), and IBI-112(IL-23 antibody).

Manufacturing Facilities

• Currently operating 5x1,000L bioreactors to support the production needs for TYVYT^®, BYVASDA^® and other product candidates in pipeline.
• Completed GMP commissioning and process validation of second phase manufacturing facilities housing six 3,000L stainless steel bioreactors, expanding total production capacity to 23,000L.
• Plan to further expand manufacturing facilities to provide sufficient capacity to commensurate with growing and maturing drug pipeline and to support the continued business expansions.

Corporate Development

• Entered into a collaboration agreement with Coherus Biosciences, Inc. to out-license commercial rights for IBI 305 (bevacizumab biosimilar) in the United States ("U.S.") and Canada.
• Entered into a collaboration with Sirnaomics Inc. to use TYVYT^® and Sirnaomics' RNAi drug candidate STP705 (cotsiranib) to conduct clinical studies in advanced cancers in the U.S..
• Entered into an in-licensing agreement with Alector Inc. to develop and commercialize AL008, a first-in-class anti-signal regulatory protein ("SIRP") alpha antibody, for the treatment of oncology indications in China.
• Entered into a strategic collaboration with the University of Texas MD Anderson Cancer Center to co-develop TYVYT^® in rare cancers in the U.S..
• Entered into a strategic collaboration with Roche that enables the Company to access certain Roche technologies in the discovery and development of specific 2:1 T-cell bispecific antibodies (TCB) as well as its universal CAR-T platform.
• Entered into a strategic milestone agreement to license out the exclusive rights of TYVYT^® for geographies outside of China to Lilly, which plans to pursue registration of TYVYT^® in the U.S. and other markets. Innovent will receive an upfront payment of US$200 million and will be eligible for up to US$825 million in potential development and commercial milestones, as well as tiered double-digit royalties on net sales.
• In February 2020 and July 2020, successfully raised funds of approximately HK$2.3 billion and HK$2.8 billion, respectively, through placing of new shares.
• The "B" marker was removed from the Company's stock name and stock short name in June 2020.
• The Company's shares were included into the Hang Seng Composite Index, with the change taking effect from 7 September 2020. The Company's shares may be considered for inclusion in the Stock Connect in the future.

Financial Performance Summary

• Total revenue was RMB984.2 million for the six months ended 30 June 2020, representing an increase of 184.9% from 345.5 million for the six months ended 30 June 2019. Product revenue of TYVYT^® was RMB 920.9 million for the six months ended 30 June 2020, representing an increase of 177.7% from RMB331.6 million for the six months ended 30 June 2019.
• Gross profit margin, was 81.2% for the six months ended 30 June 2020, decreased slightly as compared with 88.1% for the six months ended 30 June 2019, primarily due to the lowered effective price of TYVYT^® after being included in NRDL.
• Research and development expenses were RMB808.0 million for the six months ended 30 June 2020, increased by RMB137.3 million from the six months ended 30 June 2019. The spending was mainly incurred for multiple pivotal or registration trials of TYVYT^®, as well as increased trial need of other promising late-stage assets and prioritized assets.
• Selling and marketing expenses were RMB446.6 million, or 45.4% of total revenue for the six months ended 30 June 2020, as compared with RMB266.7 million, or 77.2% of total revenue for the six months ended 30 June 2019. The expense increase was primarily attributable to the continuous commercialization efforts as well as the expansion of sales and marketing team from 408 employees as at 30 June 2019 to 1,176 employees as at 30 June 2020. The selling and marketing expense ratio was lowered due to improved efficiency along with the rapid sales growth of TYVYT^®, as well as reduced promotion activities particularly in the first quarter of 2020 due to the impact of COVID-19.
• Loss and total comprehensive expenses were RMB608.2 million for the six months ended 30 June 2020, representing a decrease of 14.9% or RMB106.2 million from RMB714.4 million for the six months ended 30 June 2019, primarily attributable to the sales growth of TYVYT^®.
• Net cash from financing activities was RMB2,186.2 million for the six months ended 30 June 2020, mainly attributable to net cash generated from the successful placement in February 2020. As of 30 June 2020, the company had approximately US$875.0 million cash on hand.

For more detail review of Innovent's operation for the six months ended 30 June 2020, please refer to the Company's announcement posted on HKEX website as well as the Company's website.

Conference Call Information

Innovent will host a live conference call at 9:00 a.m. August 28, 2020 Beijing time to review its financial results and provide a general corporate progress.

Please pre-register using the link http://apac.directeventreg.com/registration/event/7149458.

Once registered, an email will be sent with important details for this call such as the dial in numbers from different regions and a unique registrant ID (password). This ID is going to be used for the call. Please keep it confidential and not share with other participants.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop 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 for the treatment of cancer, metabolic, autoimmune 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 23 valuable assets in the fields of oncology, metabolic, autoimmune diseases and other major therapeutic areas, with 19 in clinical development, 5 in Phase 3 or pivotal clinical trials, 2 under NDA reviews by the NMPA with priority review status, while 2 products, TYVYT^® (sintilimab injection) and BYVASDA^® (bevacizumabinjection), officially approved for marketing in China. TYVYT^® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Alector, Hanmi and other international pharmaceutical companies. For more information, please visit：www.innoventbio.com .

SOURCE Innovent Biologics, Inc.