Corporate Presentation

Jan 15, 2021

Hi, everyone. Welcome to the Innovent session. My name is Lin Zhang. I'm Managing Director and Head of China Healthcare at JP Morgan. So here, I would like to introduce Innovent, one of the most successful fire product companies in China and Michael Yu. Doctor. Yu is the Co Founder, Chairman and CEO of the company and he built Innovent into a very, very successful company in China. So I will let Doctor. Yu to make the presentation. Over to you, Michael. Thank you. Thank you, Vin. Thank you and JP Morgan for the opportunity. I would like to take this opportunity to share with you what we have done in last year, particularly a few business highlights. And at the same time, I would like to also share with you our perspective and what we are doing in terms of how we can build Innovent to be a global company for innovation. So can I have the second slides, please? This slide show that the 2 sections, which I'm going to share with you. Let me start with the first part. Slides next slide, Slide 3. This is a very brief capture of the key milestones, which we was able to accomplish in last 9 years since the company was incepted in 2011. And currently, we have 4 products on market and we have a pipeline with over 20 product candidates under the development at a different stage of clinical trials. And our first product, which is PD-one monoclonal antibody, we call TIVR. Since we launched in March 2019, we was able to generate over RMB2.5 billion by the end of Q3 last year. And we have successfully built our manufacturing infrastructure and now become one of the company who has the largest manufacturing capacity for antibody production in China. And by end of last year, our market capitalization has reached over $14,000,000,000 and with over 3,000 employees as a company. Particularly, I would like to highlight a few accomplishments in last year 2020. And we was able to receive approval for 3 biosimilars, biosimilar to bevacizumab, adarizumab as well as lutuximab, which actually has made Inovant to be the only company in China who has successfully developed and launched 4 monoclonal antibodies and also become one of very few companies to launch 4 monoclonal antibody products within 9 years of copper history. Additional to those 4 products, in 2020, we was able to find 2 supplement NDA for TIVR, specifically for the first line non squamous squamous non small cell lung carcinoma. And we anticipate to receive approval sometime this year for those 2 important indications. Meanwhile, we was able to match primary endpoint of Phase III trial of first line hepatocell carcinoma, which being a trial that TIVRA was combined with our biosimilar, which is to bevacizumab biosimilar. And we plan to file NDA earlier this year. In the pipeline, we also achieved a few very critical milestones, particularly with one of novel antibody, which is against CD47. And we have showed that this monoclonal antibody is well tolerated in a patient with cancer, but we already started to see strong antitumor activities in some indications. And we anticipate to accelerating to pivotal trial for this molecule. And a few more detailed indications, data I'm going to share with you in next couple of slides. We also was able to successfully build 7 additional business collaborations in 2020, including our expanded partnership with Eli Lilly and initiate a partnership, which reached more than $2,000,000,000 with Roche as well as with a few other organizations from Alector to Coherus to MD Anderson Cancer Centers. So 2020 was a very accomplished year, which we have made a significant progress in drug development, commercialization capability building up as well as the growing of our business. Particularly, I would like to highlight a few specifics for you about our leading product, which is Chivir. This molecule was approved in the latest end of 2018, was quickly approval for inclusion in the drug reimbursement, which is sponsored by Chinese government for the classic high single lymphoma. And as mentioned earlier that we have more than 10 registration trial ongoing for these products and a 2 NDA under review and additional few NDA under preparations. At same time, we have clinical trial for registration in patient with esophageal carcinoma and as well as the gastric cancers. So those trial going to add additional value if data met our preset defined endpoint going to further expansion the potential market of these products. During the commercial year of 2019 and early in most half of the last year, because of the inclusion in the NRDL of the products, tibre remaining to be a leading PD-one antibody in China. And we are the number one products, brand products in terms of patient shares for this PD-one products categories in China. And we also further expanded our second facility, which to adding it up together of 24,000 liters now, which is dedicated to the production of TIVR as well as the additional newly approval products. So capacity we have for this product become a very important elements for competition in this space. Same time, we believe that TIVRA is best positioned to explore the huge potential for global markets because of our partnership with Eli Lilly. So later last year, we entered a partnership with Eli Lilly to commercialize this product for global markets. And La Lily plan to file BOA for first line non small cell lung carcinoma sometime this year, which going to unlock the value of this product outside of China. So TIVRA remains to be our backbone products for the oncology areas, which is one of the major focuses for Innovent business. Because of those significant progress we've made and accomplished for those milestones. The Innovent since IPO in 2018 October, we was able to generate a very significant return for our investors. The market cap at IPO was over HKD10 1,000,000,000, now is over HKD100 billion, which is represents by over 600% increase. Similarly for share price as well, compared to the IPO, we have generated over 480% for our investors in last 2 years. So we are very grateful to our investors for their support and looking forward to work with you for the years to come. So next slide, which is Slide 7, which show you the pipeline that was able to build in the last couple of years. So additional to those 4 products, which is already on markets, we have 4 additional products now under development for registration, which including IPI-three seventy five, which is small molecule for FGFR-one hundred and twenty three as inhibitors. And we started the legislation trial in China with NDA filing in Taiwan. And hopefully, the data we generate in China will enable us for NDA filing with Chinese regulatory agency sometime this year. And the same is true for 306, IBI-three zero six. This is a PCSK9 monoclonal antibody. We are in the multiple Phase III trials. Hopefully, we can quickly enroll the patient and release sometime late this year or early next year, we have a data available for you to review. We also have a 3 IBI-three seventy six and IBI-three ten, both now in the legislation trial. So those are 4 leading products beyond those 4 approval antibodies, which hopefully will become products sometime in next couple of years. And we also have more than 10 products under development. Those are in early stage. If we if we classify them into 2 categories, the first of all is oncology pipeline, which we have a 3 product launch and 15 assets in development. And have a few leading molecule currently under development, including 6 of them as a bispecifics from 3:15, which is a PD-one HER2, 3:18, which is PD-one and PD L1. And we hopefully that the ongoing studies will generate interesting data and so that we can share with you in the scientific conference in this year or years to come. We also started expanding into a new category, which is cell therapy with our partnership with domestic Chinese company based on the human BCMA antibody. Same is true for the our partnership with Roche. Middle of last year, we signed a deal with Roche with the deal size is a little bit over more than $2,000,000,000 Those that enable us to not only doing bispecifics, we're also expanding into a sales therapy space. And the second disease area we're working also we call non oncology, which including the ophthalmology, the autoimmune as well as metabolic diseases. And in this category, we have one product launch and four assets is under development, particularly for PCSK9 antibody and GLP-one and glycon bispecific inhibitors. Those may potentially unlock huge values for our patient population in China with millions of patients from diabetes to obesity to a patient who has NASH condition. Here, I would like to share with you two examples by starting with CD47 family. In this family, we have a 3 product candidate, started with a molecule called IBI-one hundred and eighty eight, which is fully human monoclonal antibody against CD47. And we have completed clinical study of Phase 1 trial in U. S. And in China. The patient we have treated over 70 patients show that this product is well tolerated. Now we are in the studies with the patient with AML and MDS. Very preliminary data is very encouraging and hopefully at upcoming scientific conferences, we can share with you this early start early data from those studies with you. And we also in this category, we have a bispecific molecule we call IBI-three twenty two, which is anti PD L1 and anti CD47 as dual inhibitors. This molecule have potentially further reduced the cytotoxicity of CD47 because of target expression of this target expressed in the normal bladder cell. And I can concentrate this bispecific molecule to the cell, which express PD L1, which is tumor cell. And we have started clinical study in U. S. And in China. Hopefully, currently, it's at a dose escalation study and hopefully that we can found a dose to move into a patient for testing of biological activities. Additionally, we have monoclonal antibody against the ligand part of this pathway, which is SIRP alpha. In this molecule, we have designed that so that antibody can specifically target the cell express SIRP alpha, so that the toxicity due to the side of effect on the blood red cell and further reduce the toxicity. So Inovent, I believe is one of the very few company is well positioned in this very promising CD47 areas. And the second molecule I would like to highlight with you is in the ophthalmology space. As you know that in the my early career, I was able to successfully develop the very first innovative antibody products in China for ocular diseases, including AMD and diabetic edema. And we believe that for anti VEGF agent during the treatment, some of the patient population is not responsive. And some of the responder, they will become unresponsive following a few cycle of treatment. More and more data have generated because of the inflammation involved in the disease progression of the ocular diseases. So based on that, we have designed a bispecific molecule we call IBI-three zero two. This molecule not only blocking BGF, but also inhibit the activity of complement. In the preclinical study, both in the in vitro and in vivo in this animal model, particularly in Slide 13, you see that our molecule IBI-three zero two at a relatively low level show very promising biological activities compared to Avastin in the same setting of modeling, we see a much better anti CMV activities. And based on that, we have moved into clinical studies as shown in the Slide 14, both in terms of vision acuity and the change in CST, both parameters indicate IBI has very strong biological activities. This activity reflects in the best correction and vision acuity and the reduction in renal sickness. However, as a dose escalation up to 4 milligram per injection, we found this molecule to be well tolerated. So based on that, this data has been disclosed at the last year's AAO Conference. And as of today, we have initiated a multiple clinical trial, including the multiple dose escalation in the patient with wet AMD. And we would like to found a very specific patient population who will be benefit from this molecule and by reduce the percentage of a patient who are non responder or become a non responsive following the treatment of anti VEGF agents. If we can demonstrate that this molecule could become a very valuable assets for our pipelines because of the huge unmet medical needs. So those are just the two examples that we would like to share with you the progress we have made in last 1 years in the early stage of product development. So Slide 16, this slide show that the capacity manufacturing capacity Innovent has invest and built in last couple of years. Currently, we have 2 facilities with a total manufacturing bioreactor volume of 24,000 liters that's been certified for GMP productions. Currently, it's under in operations for the commercial supplies. Additionally, we are building a larger scale facility with a capacity of total of 36,000 liters. We anticipate the construction will be completed and they will be validated sometime later this year. Once we complete that suite of facility, Inovent may become the company who has the largest manufacturing infrastructure in China, which will enable us to continue production of for commercialization and a significant reduction in the cost of goods, the product we produced. And with so that's the summary of our ongoing business and the highlights for the significant milestone we have achieved in 2020. Next few slides, I would like to share with you the strategy for the growth of our next phase of business. Next slide, which is Slide 19. As we share with you couple of weeks ago at our R and D date, our development strategy for the next phase of our business is 2 steps. 1 is by focus on innovation. 2nd aspect is focus on globalization. Those are 2 become 2 major aspects of our business now. First of all, for innovation, as we discussed the last time, now with Doctor. Yongjun Liu leading us for the R and D organization, who now have over 1,000 staff in the discovery and the development functions. We have established our discovery lab, not only in China, but also expanded into outside of China, so that we can access to more talents in the world to establish the platform technology, particularly in the protein and antibody areas. So it become one of the best labs in the world. By focusing on biologic and precision medicine and we established in our academy to complete our mission for the innovations. That will be based on or focus on the technology, which is enabling us for the true innovation, at the same time can quickly develop the product globally. The disease area we are focused are remaining to be the same as we indicate to you earlier. The oncology and the non oncology with different modalities from monoclonal antibody to bispecific, multiple specific antibody to cell therapy and as well as ADC. And non oncology disease areas will remain to focus on ophthalmology and metabolic diseases. And some of the products in the early stage under development and you're going to hear more from those clinical studies. And additional to the product development capability in China, in the last 6 months, we are actively expanding our organization into ex China space, including in the San Francisco Bay Area as well as in UK. And now we have physically have Innovent staff and colleagues to who are taking care of product development for the global markets. Currently, we have multiple products under development outside of China. Additional to PD-one, now IBI-one hundred and eighty eight, which is CD47 and PD L1 CD47 with IBI-three twenty two. Both are in the CD47 areas now are actively developed in U. S. We are going to move more product into the ex China space once we believe that those product will commit unmet medical needs for the patients outside of China. Additional to the discovery efforts we have in China, we are also actively expanding into look spending lots of time and efforts for partnerships, which including the 7 partnership we established in 2020, which I described to you earlier. Partnership collaborations is one of strengths Innovent has built our business in last couple of years. We will continue to do that. So this will be a conclusion slides, which is 26, a summarize for you for where we are, which is by the end of 2020. And it gives here with you the perspective how the company looks like by 20252030. And Innovate is determined to be a leading biopharmaceutical company in the world by focus on innovation and globalization. Thank you for your attention.