On August 28, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported its interim financial results for the six months ended June 30, 2019 (Press release, Innovent Biologics, AUG 28, 2019, View Source [SID1234539079]).
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HIGHLIGHTS AND OTHER RECENT UPDATES
Total revenue was RMB345.5 million, including RMB331.6 million attributable to sales of Tyvyt (sintilimab injection), which is Innovent’s first commercial drug product, received marketing approval from the National Medical Products Administration ("NMPA") for relapsed/refractory classical Hodgkin’s lymphoma ("r/r cHL") in December 2018, and commenced sales on 9 March 2019.
Gross profit margin was 88.1%, reflecting the ability of the company to produce Tyvyt (sintilimab injection) with consistent quality, even at its initial phase of commercial production.
Tyvyt (sintilimab injection) continues to progress through the broad clinical development program targeting an array of cancer indications, with more than 20 ongoing trials, including eight pivotal registration trials (three completed patients enrollment; three Phase III and one Phase II/III trials completed first patient dosing).
Submitted NDAs and received priority review status for: IBI-303 (adalimumab biosimilar), IBI-305 (bevacizumab biosimilar), and IBI-301 (rituximab biosimilar).
Completed Phase II clinical trial of IBI-306 (novel anti-PCSK9 monoclonal antibody) in Chinese patients with hypercholesterolemia and initiated a Phase III clinical trial for the same disease indication.
Completed first patient dosing in Phase I clinical studies for innovative drug candidates IBI-188, a novel anti-CD47 monoclonal antibody; IBI-302, a first-in-class anti-VEGF/anti-complement bispecific fusion protein; IBI-318, a first-in-class, novel anti-PD-1/anti-PD-L1 bi-specific antibody; and IBI-101, a novel anti-OX40 monoclonal antibody.
Expanded more drugs into metabolic disease therapeutic area by entering into a license agreement with Eli Lilly and Company ("Eli Lilly"), for IBI-362, a novel OXM3 peptide and a potentially global best-in-class clinical-stage diabetes drug candidate.
Second stage manufacturing facilities, housing six 3,000L stainless steel bioreactors, which completed Good Manufacturing Practice ("GMP") commissioning and validation, increased total production capacity to 21,000L.
"In the first half of 2019, Innovent has achieved significant milestones with respect to our drug pipeline and business operations, which brought the Company to another stage of development. We are very pleased to report a successful launch of our first commercialized drug product Tyvyt (sintilimab injection), which is a strong testament to the power of our fully-integrated platform, as well as our ability to translate our well tested research and development capabilities into commercial success," said Dr. Michael Yu, Founder, Chairman and Chief Executive Officer of Innovent. "Leveraging our platform and through the expansion of our partnership with Lilly, we have further strengthened our portfolio to cover diabetes and built a robust pipeline of 21 innovative assets. The rapid clinical advancement showcased by our three biosimilar NDA submissions, the completion of enrollment in three Phase III pivotal trials, the initiation of Phase I clinical trials of our novel bispecific drug candidates, as well as the smooth GMP commissioning validation of our newly-built manufacturing facilities, all empower us in the execution of our long-term growth strategy."
"Looking ahead, we will maintain the focus of our efforts on the commercialization of Tyvyt (sintilimab injection), and make sure the progress goes along well with the upcoming product launch preparations," said Dr. Yu. "With emerging opportunities from the development in the Chinese pharmaceutical industry, we will continue to expedite our clinical programs, extend our product portfolio to cover therapeutic areas with immense unmet clinical needs, and to develop and commercialize high quality drugs to benefit our patients."
FINANCIAL PERFORMANCE SUMMARY
Total revenue for the six months ended 30 June 2019 was RMB345.5 million, including RMB331.6 million attributable to sales of Tyvyt (sintilimab injection), which is the company’s first commercial drug product and commenced sales on 9 March 2019, as compared to total revenue of RMB4.4 million for the six months ended 30 June 2018. The successful launch of Tyvyt (sintilimab injection) has propelled the company to the commercial phase of the business cycle and has unleashed the full power of its fully-integrated multi-function platform for the discovery, development, manufacture and commercialization of innovative drugs in a variety of therapeutic areas.
Gross profit margin was 88.1% for the six months ended 30 June 2019, reflecting the Group’s ability to produce Tyvyt (sintilimab injection) consistently at a high quality, even at its initial phase of commercial production.
Research and development expenses increased by RMB250.7 million to RMB670.7 million for the six months ended 30 June 2019 from RMB420.0 million for the six months ended 30 June 2018. The increase was primarily attributable to (i) a milestone payment of RMB164.4 million made to Incyte Biosciences International Sàrl ("Incyte") under its collaboration and license agreement with Innovent, and (ii) increased clinical trials expenses as more of Innovent’s drug candidates progressed into late-stage clinical development in the first half of 2019.
Selling and marketing expenses increased by RMB269.5 million to RMB279.6 million for the six months ended 30 June 2019, from RMB10.1 million for the six months ended 30 June 2018. The increase was primarily due to the successful commercial launch of Tyvyt (sintilimab injection) in the first half of 2019.
Loss and total comprehensive expenses increased by RMB656.8 million to RMB714.4 million for the six months ended 30 June 2019, from RMB57.6 million for the six months ended 30 June 2018. The increase was mainly attributable to (i) a one-time, non-cash adjustment of RMB448.8 million on recognized fair value gain of preferred shares as required under the International Financial Reporting Standard ("IFRS"), and (ii) the increase of the adjusted loss and total comprehensive expenses loss in the amount of RMB203.2 million primarily due to the increase in research and development expenses.
BUSINESS PERFORMANCE SUMMARY
During the six months ended 30 June, 2019, Innovent has continued to make significant progress with respect to its drug pipeline and business operations, including the following milestones and achievements.
Commercialized Product and Related Late-stage Clinical Development
Tyvyt (sintilimab injection), Innovent’s innovative anti-PD-1 monoclonal antibody co-developed with Eli Lilly, was granted marketing approval by the NMPA of the People’s Republic of China ("China") for r/r cHL in December 2018. Sales commenced on 9 March 2019 and, as of 30 June 2019, total revenue reached RMB331.6 million.
– Innovent is conducting more than 20 clinical studies for Tyvyt (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials. Three of these trials, evaluating Tyvyt (sintilimab injection) in second-line squamous non-small cell lung cancer ("NSCLC") (ORIENT-3), first-line squamous NSCLC (in combination with gemcitabine and platinum, ORIENT-12) and first-line non-squamous NSCLC (in combination with pemetrexed and platinum, ORIENT-11), respectively, have completed patients enrollment.
– Innovent has completed first patient dosing in (i) a Phase III clinical trial (ORIENT-15) to evaluate Tyvyt (sintilimab injection), in combination with paclitaxel and cisplatin, as first-line treatment in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma, (ii) a Phase III clinical trial (ORIENT-16) to evaluate sintilimab injection, in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma, (iii) a Phase II/III clinical trial (ORIENT-32) to evaluate Tyvyt (sintilimab injection), in combination with IBI-305 (bevacizumab biosimilar), as first-line treatment for patients with advanced hepatocellular carcinoma, and (iv) a Phase III clinical trial (ORIENT-31) to evaluate Tyvyt (sintilimab injection) with or without IBI-305 (bevacizumab biosimilar), in combination with pemetrexed and cisplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have progressed from prior treatment with EGFR-TKI.
– To further develop and optimize the value of Tyvyt (sintilimab injection) in combination therapies, Innovent reached (i) a collaboration agreement with Chipscreen Biosciences to evaluate the combination therapy of Tyvyt (sintilimab injection) and IBI-305 (bevacizumab biosimilar) with Chipscreen Biosciences’ Chidamide in advanced colorectal cancer patients in China; and (ii) a collaboration agreement with Shenogen to evaluate the combination therapy of Tyvyt (sintilimab injection) with Shenogen’s SNG1005, in patients with advanced cancer in China.
– Key clinical results of Tyvyt (sintilimab injection) in r/r cHL (ORIENT-1) were published in The Lancet Haematology and featured as a cover story.
– Presented key results update of six clinical studies of Tyvyt (sintilimab injection) at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), including oral presentation of the results from the study of Tyvyt (sintilimab injection) in relapsed/refractory extranodal natural killer (NK)/T cell lymphoma (ORIENT-4).
– Tyvyt (sintilimab injection) has been listed into the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies.
Other Late-stage Clinical Development
IBI-303 (adalimumab biosimilar): NDA submitted to the NMPA for IBI-303 for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis, which was accepted on 12 November 2018, and granted priority review status on 6 March 2019 by the NMPA.
IBI-305 (bevacizumab biosimilar): NDA submitted to the NMPA for IBI-305 for the treatment of metastatic colorectal cancer and advanced, metastatic or recurrent NSCLC, which was accepted on 28 January 2019, and granted priority review status on 29 April 2019 by the NMPA.
– Presented the clinical efficacy and safety results of IBI-305 compared with bevacizumab in advanced, first-line, non-squamous NSCLC patients at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
IBI-301 (rituximab biosimilar): NDA submitted to the NMPA for IBI-301 for the treatment of non-Hodgkin’s lymphoma (NHL), which was accepted on 28 June 2019, and granted priority review status on 16 August 2019 by the NMPA.
IBI-306 (novel anti-PCSK9 monoclonal antibody): Phase II clinical trial of IBI-306 in Chinese patients with hypercholesterolemia has completed and about to enter a Phase III clinical trial for the same disease indication.
Early-stage Key Products Development
IBI-375, pemigatinib, a novel FGFR inhibitor in-licensed from Incyte, has an IND filed with the NMPA. This product candidate is in a Phase II study in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma including FGFR2 translocations who failed previous therapy in the U.S. There are Phase III trials ongoing as well in patients with first-line advanced/metastatic cholangiocarcinoma. Incyte has planned to file an NDA with the United States of America (the "U.S.") Food Drug Administration (the "FDA") in September 2019.
IBI-376, parsaclisib, a novel PI3Kδ inhibitor in-licensed from Incyte, has an IND filed with the NMPA. This product candidate is in a Phase II study in patients with relapsed or refractory marginal zone lymphoma in the U.S. There are 2 Phase III trials as well planned in 1H 2020 in patients with second-line follicular lymphoma & marginal zone lymphoma and first-line mantle cell lymphoma. Incyte has planned to file an NDA with the U.S. FDA in Q2 2020.
IBI-377, itacitinib, a novel JAK1 inhibitor in-licensed from Incyte, has an IND filed with the NMPA. This product candidate is in a Phase III study in patients with first-line acute graft-versus-host disease in the U.S., Incyte has planned to file an NDA with the U.S. FDA in January 2020.
IBI-188, a novel anti-CD47 monoclonal antibody, has achieved first patient dosing in a Phase I clinical trial in patients with advanced malignancies both in China and the U.S.
IBI-302, a first-in-class anti-VEGF/anti-complement bispecific fusion protein, has achieved first patient dosing in a Phase I clinical trial in patients with a type of age-related macular degeneration ("AMD") called wet AMD in China.
IBI-318, a first-in-class, novel anti-PD-1/anti-PD-L1 bispecific antibody under co-development with Eli Lilly, has achieved first patient dosing in a Phase I clinical trial in patients with advanced malignancies in China. Our co-development partner Eli Lilly also had first patient dosing in the U.S.
IBI-101, a novel anti-OX40 monoclonal antibody, has achieved first patient dosing in a Phase Ia study as monotherapy and a Phase Ib study in combination with Tyvyt (sintilimab injection) in patients with advanced solid tumors in China.
IBI-315, a first-in-class, novel anti-PD-1/anti-Her2 bispecific antibody, co-developed with Hanmi Pharmaceutical Co., Ltd., has received IND approval from the NMPA.
IBI-110, a novel anti-LAG-3 monoclonal antibody, has received IND approval from the NMPA.
IBI-326, a novel fully-human anti-B cell maturation antigen ("BCMA") chimeric antigen receptor ("CAR") T cell therapy, co-developed by Innovent and Nanjing IASO Biotherapeutics ("IASO BIO") has an IND filed with the NMPA.
– Presented the clinical results of IBI-326 (previously designated as CT103A) for the treatment of relapsed/refractory multiple myeloma ("RRMM") by oral presentation and poster at two of the most prestigious clinical meetings in the worlds of hematology and oncology, the 24th Congress of the European Hematological Society (the "EHA") and the ASCO (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago, Illinois. The data of IBI-326 presented at both conferences show an impressive efficacy results, persistence and safety profile and an objective response rate ("ORR") of 100%.
IBI-362, an oxyntomodulin analog, OXM3, is a potentially global best-in-class clinical-stage molecule for diabetes that we in-licensed from Eli Lilly in order to strategically enhance the Company’s drug offering in the metabolic disease therapeutic area.
Manufacturing Facilities
Innovent’s first facility with three 1,000L bioreactors supporting production of Tyvyt (sintilimab injection) and other product candidates in the pipeline, achieved 100% production success rate.
Innovent’s second manufacturing facility, housing six 3,000L stainless steel bioreactors, which have completed GMP commissioning and validation, will increase our total production capacity to 21,000L and will provide us with additional capacity to support commercial production as well as clinical trials of our drug products.
Awards and Recognitions
Received the IFR Asia-Pacific IPO of the Year award, IFR Asia Review Hong Kong Equity Issue of the Year award, and the 10th Anniversary China Healthcare Investment Conference (CHIC) "IPO of the Year" Award.
Substantially expanded the patent portfolio. As of the date of our results announcement, we owned 21 issued patents and 48 patent applications in China, 4 issued patents and 7 patent applications in the United States, and 19 issued patents and 97 patent applications in the rest of the world relating to our products and technologies. These patent applications included 32 international patent application under the Patent Cooperation Treaty, or PCT.
FUTURE DEVELOPMENT
We will continue our unwavering quest to build a world-class China-based biopharmaceutical company that develops and commercializes high quality innovative drugs that are affordable to ordinary people. We will continue to roll out the commercialization of our Tyvyt (sintilimab injection) for the remainder of 2019. We expect that the strong sales momentum we have created during the first approximately four months of sales of Tyvyt (sintilimab injection) will continue for the remainder of 2019 and beyond. Our newly built additional manufacturing facilities have completed GMP commissioning and validation and will deliver sufficient manufacturing capacity to support our growing production needs and continued business expansions. In the meantime, we will continue to prepare the commercialization of our late-stage pipeline assets after receipt of marketing approvals, and to rapidly advance both ongoing and planned clinical programs for our pipeline products both in China and in the U.S. We will seek both expedited regulatory review of our upcoming NDAs and ultimately marketing approvals. We will cooperate with partners around the world who share our vision and will spare no efforts to fulfill people’s shared dream of combating diseases and living a better life.