On March 30, 2020 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported its financial results for the full year ended December 31, 2019 and corporate progress (Press release, Innovent Biologics, MAR 30, 2020, View Source [SID1234556012]).
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Full Year 2019 Highlights and After Period Development
Total revenue for the full year of 2019 increased to RMB1,047.5 million, including RMB1,015.9 million attributable to sales of Tyvyt (sintilimab injection).
Gross profit margin was 88.1% for the full year of 2019.
Tyvyt became the first and the only PD-1 inhibitor to be included in the National Reimbursement Drug List (NRDL).
NDAs for IBI-303 (adalimumab biosimilar), IBI-305 (bevacizumab biosimilar) and IBI-301 (rituximab biosimilar) were granted priority review status by the NMPA.
Phase 3 study of Tyvyt in first-line non-squamous NSCLC in China met the predefined primary endpoint of PFS in an interim analysis.
Expanded collaboration with Eli Lilly for the development and commercialization in China of OXM3, a potentially global best-in-class clinical-stage novel diabetic therapy.
Completed GMP commissioning and process validation of the second phase manufacturing facilities housing six 3,000L stainless steel bioreactors.
"2019 saw us start to fulfill our mission. Over the course of last year, our Tyvyt successfully commenced sales and marketing, and became the first and the only PD-1 inhibitor to be included in China’s NRDL," said Dr. Michael Yu, Founder, Chairman and CEO of Innovent. "We have also made significant progress in developing our pipeline products, advancing regulatory filings and registration processes, expanding our manufacturing capabilities, and achieving other corporate development milestones. These achievements have laid the solid foundation for Innovent to seize market opportunities in 2020 and leapfrog into a leadership position. Among other promising prospects, we expect to leverage the unique advantages from the NRDL inclusion and continue to drive the sales of our Tyvyt. Our preparations for the commercial launches of our three NDA-stage biosimilar products have been well under way. In addition, we expect to submit up to five new NDAs for Tyvyt from this year through early next year covering various major cancer indications including lung, liver and esophageal cancers. We will continue to grow our rich pipeline of innovative and complementary therapies, and we expect to leverage our fully-integrated multi-functional platform and advance more than 50 clinical trials (including 17 pivotal registration trials) throughout the year. We are confident that Innovent is well positioned to sustain its rapid growth and deliver tremendous value for our patients and shareholders."
"Despite the recent challenges caused by the global COVID-19 outbreak, we do not expect the pandemic to have a significant impact on our business for 2020," said Dr. Yu. "We have firmly responded to the outbreak by making a charity donation to the City of Wuhan in January and implementing comprehensive measures to protect our staff, prevent interruptions to our business operations, and minimize delays and disruptions to the treatment of our patients. Overall, our operations have gradually resumed since late February and through the month of March. We will be closely monitoring the evolving situation and continue to execute our commercialization, regulatory and clinical development plans and strategies accordingly."
Business Performance Summary and Expected Milestones
Our Commercial and NDA-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
Tyvyt commenced sales in China in March 2019, within the ten-month period ended 31 December 2019, generated RMB1,015.9 million in revenue, becoming one of the best-selling drugs ever launched in China in terms of first-year sales.
In November 2019, Tyvyt became the only PD-1 inhibitor to be included in the NRDL with price slightly under RMB100,000, allowing more patients to enjoy the benefits of our drug product at a reasonable cost. This has demonstrated our company’s commitment to deliver high-quality innovative medicines that are affordable to ordinary people.
Based on the impressive clinical results, Tyvyt was included in the 2019 Guidelines of the CSCO for Lymphoid Malignancies and published in The Lancet Haematology and featured as a cover story.
Clinical Development Milestones
We are executing a broad clinical development program for Tyvyt to evaluate its efficacy and safety and aiming for drug registration in a wide variety of major cancer indications. Currently we have more than 20 trials ongoing including over 10 pivotal registration clinical trials, in both US and China.
Completed patient enrollment in four pivotal registration trials in China, including first-line non-squamous NSCLC, first-line squamous NSCLC, second-line squamous NSCLC and first-line hepatocellular carcinoma (combo with IBI-305 (bevacizumab biosimilar)).
Completed first patient dosing in three pivotal registration trials in China, including first-line esophageal squamous cell carcinoma, first-line gastric or gastroesophageal junction adenocarcinoma, EGFR+ TKI failure non-squamous NCSLC (combo with IBI-305 (bevacizumab biosimilar)).
Entered into research collaborations with strategic partners, including Chi-Med, Chipscreen Biosciences, Shenogen Pharma, Sirnaomics, to explore the potential of Tyvyt in combination therapies.
Presented key results from 6 clinical studies of Tyvyt either orally or by posters/abstracts at ASCO (Free ASCO Whitepaper) in 2019.
Post-Reporting Period (Expected) Milestones
Announced that the Phase 3 study in China of Tyvyt combined with ALIMTA (pemetrexed) and platinum in first-line non-squamous NSCLC met the predefined primary endpoint of PFS in an interim analysis in January 2020.
Received a global Phase 3 study initiation approval in the U.S. from the FDA for Tyvyt in first-line esophageal carcinoma in February 2020. We expect to enroll the first patient in the first half of 2020.
Expected to submit up to 5 NDAs to the NMPA for Tyvyt in 2020 or early 2021, including first-line non-squamous NSCLC, first-line squamous NSCLC, second-line squamous NSCLC, first-line hepatocellular carcinoma and second-line esophageal squamous cell carcinoma.
Expected to present key results of five trials for Tyvyt at medical conferences in 2020 or 2021.
IBI-303 (adalimumab biosimilar), an anti-TNF-α monoclonal antibody; accepted into the National Major New Drugs Innovation and Development Program; NDA submitted in China
Received priority review status grant to the NDA of IBI-303 from the NMPA in March 2019.
The key clinical results from a Phase 3 trial of IBI-303 in ankylosing spondylitis were published in the inaugural issue of The Lancet Rheumatology in August 2019, marking the first time that a China-based Phase 3 biosimilar trial has been reported in a first-tier international medical journal.
Expected Milestone
Receive the NDA approval for IBI-303 in 2020.
IBI-305 (bevacizumab biosimilar), an anti-VEGF monoclonal antibody; accepted into the National Major New Drugs Innovation and Development Program; NDA submitted in China
Received priority review status grant to the NDA from the NMPA in April 2019.
Presented the clinical efficacy and safety results of IBI-305 as compared with bevacizumab in advanced, first-line, non-squamous NSCLC patients at ASCO (Free ASCO Whitepaper) in 2019.
Post-Reporting Period (Expected) Milestones
Entered into an out-license agreement with Coherus in January 2020 to commercialize IBI-305 in US and Canada.
Expected to receive the NDA approval in 2020.
IBI-301 (rituximab biosimilar), an anti-CD20 monoclonal antibody co-developed with Lilly; accepted into the National Major New Drugs Innovation and Development Program; NDA submitted in China
Received priority review status grant to the NDA from the NMPA in August 2019.
Presented data from two clinical studies of IBI-301 at CSCO in 2019.
Expected Milestones
Receive the NDA approval by late 2020 or early 2021.
Our Clinical-Stage Drug Candidates
IBI-306, a novel anti-PCSK9 monoclonal antibody; accepted into the National Major New Drugs Innovation and Development Program
Completed a Phase 2 clinical trial in China for non-familial hypercholesterolemia.
Achieved first patient dosing in a Phase 3 clinical trial in China for heterozygous familial hypercholesterolemia (HeFH) and a pivotal Phase 2b/3 clinical trial in China for homozygous familial hypercholesterolemia (HoFH).
Expected Milestones
Initiate a Phase 3 clinical trial in China for non-familial hypercholesterolemia and enroll the first patient in 2020.
Complete patient enrollment for the Phase 3 trial in HeFH and the pivotal Phase 2b/3 trial in HoFH in 2021.
Present key results data in major medical conferences.
IBI-310, an anti-CTLA-4 monoclonal antibody
Completed a Phase I dose escalation study in China in combination with Tyvyt in patients with melanoma.
Expected Milestones
Enroll the first patient in a Phase 3 study in melanoma and a pivotal Phase 2 study dMRD or MSI-H locally-advanced or metastatic colorectal cancer in China in the first half of 2020, in each case combined with Tyvyt.
IBI-188, a potentially best-in-class anti-CD47 monoclonal antibody;
Announced first patient dosed in a Phase 1 clinical trial in China in advanced malignant tumors in January 2019.
Announced first patient dosed in a Phase 1 clinical trial in US in advanced malignant tumors and lymphomas in March 2019.
Expected Milestones
Clinical phase I dose escalation study is on-going in both US and China. Preliminary data indicates IBI-188 is well tolerated in patients.
Expected to initiate a global pivotal registration study with first patient enrolled in the second half of 2020 in both US and China.
IBI-375 (pemigatinib), a novel FGFR inhibitor in-licensed from Incyte
Received IND approval from the NMPA in November 2019.
The FDA accepted the NDA submitted by Incyte for pemigatinib in second-line metastatic cholangiocarcinoma (mCCA) and granted priority review status. The Prescription Drug User Fee Act target action date is May 30, 2020.
Post-Reporting Period (Expected) Milestones
Announced first patient dosed in the pivotal Phase 2 trial of IBI-375 in second-line mCCA in China in March 2020. We expect to submit NDAs for IBI-375 in second-line mCCA to the NMPA in mainland China, Hong Kong and Taiwan in 2021.
Expected to join an Incyte-sponsored global Phase 3 clinical trial in first-line mCCA.
IBI-376 (parsaclisib), a novel PI3Kδ inhibitor in-licensed from Incyte
Received IND approval from the NMPA in November 2019.
In the U.S., Incyte is evaluating parsaclisib in three Phase 2 studies in patients with relapsed or refractory follicular, marginal zone and mantle cell lymphoma, respectively.
Expected Milestones
Enroll first patient in a pivotal Phase 2 trial in China in third-line follicular lymphoma or marginal zone lymphoma in the first half of 2020.
IBI-377 (itacitinib), a novel JAK1 inhibitor in-licensed from Incyte
Received IND approval from the NMPA in November 2019.
In January 2020, Incyte announced Phase 3 trial of itacitinib in patients with newly diagnosed acute GVHD did not meet the primary endpoint.
Expected Milestones
Keep on developing IBI-377 in other indications, as the clinical data suggested it may have specific effects in other indications.
IBI-326, a novel fully-human anti-BCMA CAR-T therapy, co-developed with IASO BIO
Received IND approval from the NMPA to evaluate IBI-326 in hematology in September 2019.
Presented promising clinical data of IBI-326 at ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ASH (Free ASH Whitepaper) in 2019, with 100% ORR, over 72% CR in patients with relapse/refractory multiple myeloma (r/r MM).
Expected Milestones
Initiate a pivotal Phase 2 trial in r/r MM with first patient enrolled in 2020.
Report the results of extended follow-up on IIT at ASH (Free ASH Whitepaper) in 2020.
IBI-318, a first-in-class anti-PD-1/PD-L1 bispecific antibody co-developed with Lilly
Announced first patient dosed in a Phase 1 clinical trial in patients with advanced malignancies in China in April 2019.
Expected Milestone
Present preliminary clinical data in major medical conferences.
IBI-315, a first-in-class anti-PD-1/HER2 bispecific antibody co-developed with Hanmi
Announced first patient dosed in a Phase 1 clinical trial in patients with advanced malignancies in China in November 2019.
IBI-302, a potential first-in-class anti-VEGF/complement bispecific fusion protein; accepted into the National Major New Drugs Innovation and Development Program
Announced first patient dosed in a Phase 1 clinical trial in China for wet AMD in April 2019.
Expected Milestones
Enroll first patient in a Phase 1b study in China in wet AMD in 2020.
Present the clinical results of the Phase 1 study at a scientific conference.
IBI-101, a novel fully humanized anti-OX40 monoclonal antibody
Completed first patient dosed in a Phase 1a study as monotherapy and a Phase 1b study of in combination with Tyvyt, in each case in advanced solid tumors in China in February 2019.
Obtained IND approval from the FDA in advanced solid tumors.
Expected Milestones
Complete the patient enrollment of the Phase 1 trials in advanced solid tumors in the second half of 2020.
IBI-110, a novel anti-LAG-3 monoclonal antibody
Announced first patient dosed in a Phase 1 clinical trial for treatment of advanced solid tumors in China in December 2019.
IBI-322, a first-in-class anti-CD47/PD-L1 bispecific antibody
Filed an IND application with each of the NMPA and the FDA to evaluate IBI-322 in solid tumors in China and in US in October and December 2019, respectively.
Post-Reporting Period Milestones
Received IND approvals from the NMPA and U.S. FDA respectively in January 2020. We are actively preparing the initiation of the study in patients in China and in US.
IBI-939, a novel anti-TIGIT monoclonal antibody
Submitted an IND application for IBI-939 to the NMPA in September 2019.
Post-Reporting Period Milestones
Received IND approval from the NMPA in advanced solid tumors and hematological malignancies in January 2020.
IBI-362, an oxyntomodulin analog (OXM3) in-licensed from Lilly, potentially best-in-class clinical-stage diabetes drug candidate
Submitted IND applications to the NMPA in both Type II diabetes and obesity in December 2019.
Lilly completed the patient enrollment of a Phase 1b study in US to evaluate IBI-362 in patients with Type II diabetes in 2019.
Post-Reporting Period Milestones
In January 2020, the NMPA accepted the IND application.
Lilly has initiated a Phase 2 study in Europe in Type II diabetes.
Manufacturing Facilities
Completed GMP commissioning and process validation of second phase manufacturing facilities housing six 3,000L stainless steel bioreactors. This expansion increased our total production capacity to 23,000L, one of the largest in China, and further boosted our manufacturing capacity per batch.
Corporate Development
Expended collaboration with Eli Lilly for the development and commercialization in China of a potentially best-in-class clinical-stage novel diabetic therapy, OXM3, in August 2019.
Entered into an out-license agreement with Coherus to commercialize our IBI-305 (bevacizumab biosimilar) in the U.S. and Canada in January 2020.
Entered into an in-licensing agreement with Alector to develop and commercialize AL008, a first-in-class anti-SIRP-alpha antibody for the treatment of oncology indications in China in March 2020.
Raised approximately HK$2.4 billion and HK$2.3 billion through new shares placement in October 2019 and February 2020 respectively.
Innovent’s stock was included in both the MSCI China Index and the Hang Seng Hong Kong-Listed Biotech Index in 2019.
Financial Performance Summary
Total revenue was RMB1,047.5 million for the year ended 31 December 2019, including RMB1,015.9 million attributable to sales of Tyvyt, as compared with total revenue of RMB9.5 million for the year ended 31 December 2018.
Gross profit margin was 88.1% for the year ended 31 December 2019, reflecting the Company’s ability to leverage our fully-integrated multi-functional platform and carry out efficient, high quality production of Tyvyt at commercial scale.
Research and development expenses were RMB1,294.7 million for the year ended 31 December 2019, as compared with RMB1,221.7 million for the year ended 31 December 2018. The spending was mainly attributable to expenses incurred for our key ongoing pivotal or registration trials of Tyvyt in China.
Direct selling and marketing expenses were RMB692.5 million, or 66.1% of total revenue, for the year ended 31 December 2019, as compared with RMB270.1 million, or 78.2% of total revenue, for the six months ended 30 June 2019, and as compared with RMB136.0 million for the year ended 31 December 2018. The year-over-year increases were primarily attributable to the successful launch of Tyvyt in March 2019. To support the commercialization efforts, the Group expanded its sales and marketing team from a total of 264 employees as of 31 December 2018 to a total of 688 employees as of 31 December 2019, which was one of the major contributors to the increase in the selling and marketing expenses.
Payments under Collaboration Agreement were RMB499.7 million for the year ended 31 December 2019, represents the milestone payments for the various licensing-in products as well as royalty and profit sharing payments to third parties.
Loss and total comprehensive expenses were RMB1,719.9 million for the year ended 31 December 2019, representing a significant decrease of 70.7% from RMB5,873.0 million for the year ended 31 December 2018 during which, as required under the International Financial Reporting Standard ("IFRS"), the Group recorded a non-cash, non-recurring loss of RMB4,338.0 million on the fair value changes of preferred shares upon their conversion into ordinary shares at the Company’s initial public offering.
Net cash from financing activities for the year ended 31 December 2019 was RMB2,109.3 million, principally attributable to net cash generated from our successful placement in October 2019. For the balance sheet at December 31, 2019, the company’s total cash and cash equivalent was 4,695.2 million. In February 2020, we raised additional HK$2.3 billion through new shares placement, our cash position at the end of February 2020 was about US$950 million.
For more detail review of Innovent’s operation for 2019, 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. March 31, 2020 Beijing time to review its financial results and provide a general corporate progress.
Please call 4001200657 (Mainland China), +852 30186779 (Hong Kong), +18664819184 (U.S.), 08081016564 (United Kingdom), or +65 67135381 (Singapore) to listen to the conference call. The conference ID password for the live call is Innovent. The replay may be accessed by visiting the Company’s website at www.innoventbio.com shortly after the call.