Good day, and thank you for standing by. Welcome to Everest Medicines' New Corporate Strategy Launch Conference Call. Please be advised that today's conference is being recorded. Later in the Q&A session, for participants joined through PC or APP, please click the Raise Hand button at the bottom of the screen to queue up for voice questions or type your questions as messages. For participants dialed in, please press star one to queue up to ask a question. At this time, I would like to hand the conference over to your speaker today, Ms. Leah Liu, VP of Corporate Affairs. Please go ahead. Thank you.
Thank you, operator. Hi, everyone. Welcome to our new corporate strategy launch conference call. Joining us today are Mr. Rogers Luo, our new CEO of Everest Medicines, Mr. Ian Woo, our President and Chief Financial Officer, and Dr. Zhengying Zhu, our CMO for Internal Medicine. Before we get started, I would like to remind you that the speakers of this conference call may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief, or current expectations of the company or its officers with respect to the business operations and financial conditions of the company, which can be identified by terminology such as will, expects, anticipates, future, intends, plans, believes, estimates, confident, and similar statements.
Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual results may differ from those in the forward-looking statements as a result of various factors and assumptions. The company or any of its affiliates, directors, officers, advisors, or representatives has no obligation, does not undertake to revise forward-looking statements to reflect new information, future events, or circumstances after the date of this call, except as required by law. I will now turn over the call to Rogers to give you more details on our new corporate strategy. Mr. Luo.
Thanks, Leah. Hello, everyone. Good morning and good afternoon. Good evening. It's my great pleasure to invite you to join this call, and thank you all for attending the meeting. I am going to present our new corporate strategy, and followed by Ian and Zhengying to present other parts of presentation. The first slide actually shows our pathway to our final goal to become a leading Asia-based global biopharma company. We have been went through this journey. In the first stage, in the last five years, we build a solid foundation in the last five years, where we licensed 11 assets across five therapeutic areas and get IPO in the Hong Kong Stock Exchange and divested to date up to $480 million . Those are key achievements in the last five years.
Between now and the goal in 2025 and beyond, last year, 2023, which is this year, and next year, 2024, which is the year of transformation. The company will transform from a fully kind of licensing company model to a licensing plus self-discovery R&D to driver growth strategy, where we will be focusing on renal disease and mRNA vaccines and therapeutics. Also, the company will transform from a clinical stage company to full value chain coverage, starting from R&D to commercialization to manufacturing, full value chain kind of capability. We are aiming to successful launch, XERAVA and NEFECON, where we can bring more revenue and profit. That will help us to transform from a purely financial market funding kind of mode, gradually become a commercial revenue and profits self-support mode in the last two or three years.
These two years will be critical as they are transforming the whole company to a very different stage. Once we achieve that, then we will go beyond and become a leading Asia-based global pharma company, a biopharma company. Next slide. In last three months, we have reviewed our strategy. Here is the outcome. The number one strategy actually is refocusing. The company will be focusing on three things.
Number one is on the renal disease. In renal disease, we already submit our NDA for NEFECON, and also we have other assets in our pipeline, including a BTK inhibitor currently in phase II for glomerular disease and several other preclinical candidates. We will also be looking into also licensing opportunities to further develop our whole renal disease portfolio. While we are focusing on this, I think later on, Dr. Zhu will explain why we are focusing on this.
At least we have one cornerstone product will be launched next year, and we will build on that and gradually build our whole pipeline in the renal disease area. Another focusing area is the mRNA platform. With that platform, we already transferred technology from Providence, and now we already have built our manufacturing site in the Jiashan City, which is near Shanghai City, a full kind of GMP, GXP qualified manufacturing sites.
We already have done our testing round, familiar batch. The product is highly qualified and similar kind of quality, which shows that we already fully transferred the technology to a kind of commercial site. With that technology, we will be developing bivalent COVID-19 vaccine and also we will discovery pipelines also for the therapeutic cancer vaccines, and expand to other infectious disease vaccines for prevention. That is another strategic focusing area is mRNA platform.
That area will be our fully support our investments. The third one is we will also maximize the value of infectious disease, including XERAVA, where we already submitted our NDA and expected to launch products and get approval in the first half of next year. Also be accelerating the development of taniborbactam and a new generation of polymyxin. With all this focus as strategic priorities, we have currently pro forma cash balance of $430 million, which we can support all these strategic priorities.
Next slide. We also have a very strong leadership team, including, I would say, world-class scientists, including our CMO, Dr. Zhu, and also Sunny Zhu, and also our CSO, who is Jennifer Yang, with a very broad experience and comprehensive tracking record in many multinational companies.
And we also have Ian and Neil, has many years' experience in the financial market as well as in the BD area. So we also have a strong leadership team support our strategic focus. Next slide, please. So these are the assets we already have. So I listed the assets we have currently in order of short-term, mid-term, and long-term. As I just mentioned, we have two assets already submitted our NDA and expected to be launched next year.
And we have several assets in the phase III, including taniborbactam antibiotic, etrasimod already in the phase III, and also our ranelpat. So they will have three in late-stage assets. And we also have early assets where we are looking for global rights. You can see some of the assets we have global rights, including some early-stage mRNA vaccines and future cancer vaccines. We are looking for worldwide rights.
So we kind of balance the short term, kind of short term, mid-term, looking for certainty, return, and high possibility of success, and also looking for future potentials with global rights. For example, the mRNA technology-based assets. So we have a kind of, I would say, a very broad spectrum of these assets. Next slide. Then I turn over to Dr. Zhu. She will going to talking about our renal strategy and details. Dr. Zhu, please.
Yeah. Thanks, Rogers. I think as Rogers mentioned that Everest company is a strategic focus. One of the strategic focus will be focusing on renal disease. So my part will introduce highly unmet needs in renal disease, mainly here referred to glomerular disease area in China and in this region. And then we're focusing on NEFECON as a product, the product profile, as well as development status and our prep for commercial launch in this year, hopefully later this year.
Then the last part, I will introduce our assets, our current assets on renal pipeline expansion, mainly on the internal discovery part. So we all know that different kinds of assaults to the kidneys will cause irreversible damage to the kidney cells and will lead to a final complete loss of renal function we call end-stage renal disease. And in China, on the left side of the panel, we know that the leading cause actually for ESRD, the most common cause in China, is primary glomerular disease, which accounts for more than half of the patients in ESRD, leading to ESRD, followed by diabetes and hypertension.
Such pattern is very different from Western side. In the U.S. and U.K., the leading cause is diabetes, then followed by hypertension and glomerular disease, which indicates this is indeed a lack of effective treatment, as it has a very high unmet need area. So looking at IgA nephropathy, we know that IgA nephropathy, the diagnosis of disease relies on biopsy. So in the biopsy samples in a large study that's collecting more than 40,000 samples indicates that IgA nephropathy accounts for half of all glomerular diseases.
So we estimate every year in China, it is around 100K newly diagnosed biopsy-proven IgA nephropathy, and accumulated, it accounts for 45 million patients in prevalence. For the patient profile, usually the patients will be diagnosed at a fairly early young age. 80% of the patients were diagnosed between age 15 to 44, with the median diagnosed age as 30 to 35 years old. This population has a very strong desire to receive innovative therapy.
The next slide. This slide indicates that in glomerular diseases, there are many major types of different disease led by IgA nephropathy. In China, we roughly estimate it will be 45 million population disease in IgA nephropathy itself. If we adding up to membranous nephropathy, minimal change diseases, and FSGS, adding up will close to 10 million disease population. It is a fairly large population that is suffering this disease.
Yet, NEFECON is the first and only approved drug indicated in treating IgA nephropathy, and besides that, there is no approved therapy so far globally. In Everest, we fortunately have NEFECON in China and in the surrounding regions, and we are hoping to bring this product soon into this region. At same time, we are committed to bringing more products, promising treatment targets in treating these different types of diseases. Including our phase I-B, phase II development stage EVER001 and other preclinical candidates as well.
The next slide. Yeah, so let us refocusing back to IgA nephropathy. You may notice that in this region, the prevalence rate of IgA nephropathy is a lot higher comparing to Western side. There are some genetic predisposition of the risk allele may play some role in some environment factors. Indeed, IgA nephropathy is not a benign disease.
So depending on the proteinuria level and depending on the renal insufficiency disease, there are up to 60% of the patients may progress to ESRD within a timeframe of 10 to 20 years. The right-hand side of the figure actually indicates proteinuria is an independent risk factor may impact on the prognosis of IgA nephropathy. In that particular study, which is a Toronto Glomerulonephritis Registry study, showed at a proteinuria level greater than 3 grams per day for that population, if you are comparing to the group with proteinuria less than 1 gram per day, the speed of progressing into end-stage renal disease is 25 times faster. Indeed, together with other meta-analysis study, it strongly indicates that proteinuria reduction actually is a very important factor that impacts on the renal function preservation.
That is the whole goal, I think is for NEFECON and for other future products, is the goal and aim to control, to reduce the proteinuria level and in order to preserve the long-term renal function. Next slide. NEFECON is a product specifically designed to treat the disease, IgA nephropathy. Currently, the predominant hypothesis of the disease is the origin is from the gut. It is the distal part of the intestine ileum.
There are certain lymphoid-like tissues called Peyer's patch, which is a major site of produced IgA1. In IgA nephropathy patients, the baseline level of galactose-deficient IgA1 is higher than normal population. Indeed, NEFECON is designed to deliver the highly potent local access budesonide to the Peyer's patch in order to inhibit overproduction of gdiV1, and it expects to perform as a disease modifying impact in the disease treatment. NEFECON is a capsule.
It is a capsule containing beads, and the beads have triple layers of various kinds of polymers, as well as the active ingredient, budesonide. The capsule has an enteric coating, which will make the capsule intact to go through stomach and the majority of the first part of the intestine, until it gets to the ileum, where the beads will be coming out and release locally of budesonide with the aim to reduce the gdiV1 production in that particular part. The effect of the drug is really aiming on the disease modifying and not only just the symptom control or supportive care. Next slide. This is a Part A result of the NEFECON study, which is a pivotal phase III registration trial globally.
China is part of the study, and this slide shows the Part A results. If you are familiar with the study design, the study has three parts. In Part A, the patients on optimal dose of the RAS inhibitor stable dose for three months or above, the patients will be randomized to receive NEFECON 15 mg of placebo treatment for nine months, and followed by three months off drug, and that is composed of Part A.
Once the Part A finishes, the patient will go through the observational Part B follow-up care results an additional 12 months. For the Part A results, which is the first 200 patients, the primary endpoint is a urinary protein to creatinine ratio, UPCR. You see the intended patient population, the UPCR has a significant and a clinical impactful UPCR reduction to 34% versus baseline.
Notably, when the patient is off drug and continues to follow until 12 months, you will see continuous proteinuria reduction effect to 52%, which is a notable effect, and it is a strong indicator of the disease-modifying effect of NEFECON as well. The key secondary endpoint is the estimated eGFR level. In the NEFECON treatment group, you see very stabilized renal function with almost unchanged. While in the placebo group, you see a very dramatic eGFR decrease with the absolute value close to 4 mL per minute at nine-month treatment, which is really a very early positive signal showing that with the reduction of proteinuria, the renal function has been preserved to a very clinical meaningful level.
For the safety side, as expected, budesonide has a very high first pass effect, so very low minimum systemic exposure, which is a key difference from the routine or conventional systemic glucocorticoid use. We expect to see a very well-tolerated safety profile, OA, mild to moderate. There is no severe infection, and there were no adverse clinical effects on cardiovascular or other metabolic response. Overall profile is very favorable in treating IgA nephropathy patient. Next slide. As I mentioned, China and the region, Everest Medicines, Taiwan, and Korea, are all part of pivotal phase III NEFECON study. We opened the sites and had the first patient enrolled in September 2020.
At time of December 2020, China, as NDA, as the first time opened the channel for breakthrough therapy designation, and NEFECON very luckily got the breakthrough therapy designation at that time, which I think is a recognition from NMPA side as a highly huge analysis in this disease area. In April 2022, we had our Chinese subpopulation phase III Part A result readout, which composed 62 subjects. We are very pleased to see the top-line results in proteinuria reduction and eGFR stabilization. The result is highly consistent with overall Part A results. That's indeed the base. Complementary global Part A results, we filed China NDA and got accepted in November 2022.
This is actually the first product in this area that has been able to submit based on surrogate proteinuria and endpoint to get conditional approval regulatory pathway, which will substantially accelerate the regulatory process of NEFECON in China. In just the past month, we got a priority review grant in China as well, which another sort of regulatory pathway will enable us to bring this product sooner to the patients.
In parallel with the China NDA submission, we also submitted a Singapore NDA in December last year. We are fully prepared for submission for Hong Kong and South Korea and Taiwan in 2023. We expect the first wave of NDA approval in China, Hong Kong, Singapore later this year. We are hoping that we can get NDA approval in South Korea and Taiwan in 2024, next year.
Yeah, having NDA submitted and accepted in China in this region. Next slide. Everest is gearing up to prepare for the commercial launch for this product. As I mentioned that IgA nephropathy diagnosis rely on biopsy examination. We believe that in this disease, in this hospital, it's fairly concentrated market potential, and the top 11 provinces may represent majority of the market potential.
We think that will facilitate our assets in commercial promotion. We know that almost two-thirds of the subjects may not be able to have biopsy results. We are thinking that we will roll out medical educational program to enhance the disease management as well at a pre-launch stage. So far, we know that NRDL is critical so that we can have the country more as patients in the region.
We will closely work with all the key stakeholders and to hopefully to get the NRDL listing in first half of 2025. Next slide. As I mentioned that Everest is committed in the renal disease area. We are actively building our knowledge in the disease biology area. We know that although in different types of glomerular diseases, some of the pathophysiology concepts are actually shared between different disease types. This includes the autoantibody production. In IgA nephropathy, as I mentioned that, we know that GdiV1 is a sort of a defect. Autoantibody trigger the downstream complement activation and cause the cell damage, similar as membranous nephropathy that autoantibody anti-PLA2R receptor actually attacks the podocyte and trigger the complement pathway.
So we know that the autoantibody production, downstream complement pathway activation, and the critical target cells in the glomerular, especially the podocyte, are very attractive disease targets for us. So we are generating or accumulating our knowledge and understanding for the different disease pathway. For example, for our EVER001, which is a BTK inhibitor, which has a potential to interfere B cell function and interfere the autoantibody production, which may have potential to treat membranous nephropathy.
We are indeed hoping to initiating our phase I-B study soon in this year and generating some early signal data readout in the later part of this year. Also we have other preclinical candidates addressing the podocyte morphology and podocyte function, which is a sort of a common defect in the glomerular filtration barrier, which is a defect present in different kinds of glomerular disease. We continue this aspect, and we are hoping that we can bring more promising targets, and can share more news with you in the future. Okay. I may stop here, and hand over to Ian.
Thank you, Zhengying. As Zhengying just spent some time going through a core priority of Everest, our NEFECON and the renal disease space, I think I will continue the presentation by talking about another priority for the company, which is developing our mRNA vaccines and therapeutics based on the platform that we brought in from Providence. What we have today, we believe is a leading mRNA platform that is clinically validated, and that has end-to-end capabilities. What we have today is the ability to design antigens and the mRNA sequence in a way that can quickly produce highly effective mRNA candidates. We also have access to a LNP system, which we are actually working with Providence to continue to improve, with the desired characteristics such as enhancing cell-mediated immunity.
We also have a production process that is well-validated and have brought in a group of R&D team that has a couple of decades of experience in virology, immunology, bioinformatics, structural biology, and clinical research. This is a platform that we are continuing to improve upon. But today, I think we are very confident that we have the foundation set for the ability to develop and research and discover new vaccines and therapeutics out of this platform.
Next slide. This is our current mRNA pipeline. You can see that the most advanced programs are our COVID-19 mRNA vaccines. The first generation PTX-COVID19-B product is getting ready for a phase III clinical trial globally. This will be run by Providence Therapeutics, our partner, and Everest will also contribute and participate in that phase III study. In China, we are focused on advancing our bivalent COVID-19 vaccine.
This is the product where we have announced that we have initiated rolling IND submissions. We are expecting to receive IND approval in the first quarter of this year, and initiating phase I and phase II studies shortly thereafter. On the non-COVID-19 mRNA product side, we have announced that we have received preclinical proof of concept with a rabies vaccine candidate. This is in a 50/50 collaboration globally with Providence. We look forward to continue to advance this product, and hope to start filing an IND on this product before the end of 2023. At the same time, we are working on multiple preventive and therapeutic mRNA products. Some of these are in collaboration with Providence, others where we have full global rights.
The cancer vaccine programs is an important effort for us because we really believe the potential for the mRNA platform, not just for prophylactic vaccines, but also for therapeutic vaccines. On the bottom of the page is the production process that we have localized at our manufacturing facility in Jiashan, including DS and DP production, and fill finish. Next slide.
This is a picture of our Jiashan facility, which we started building in March of 2020. The phase I, the construction has completed in September of 2022. This facility is built to the global standards. We certainly hope when this is fully operational, when our products are approved, we will be able to supply out of this facility for China as well as ex-China market. We announced that we commenced operations at this facility in December of last year.
We have run a number of familiar batches at the facility and are quite confident that we have been able to successfully tech transfer industrial scale production from our partner to this Changchun facility. This facility is designed for an annual capacity of 700 million doses of mRNA vaccine. Next slide. When we say we have a clinically validated mRNA platform, this is part of the reason why we are so confident about the technology that we have. Providence has run a phase II study for PTX-COVID19-B. This is our first generation COVID-19 vaccine, head-to-head against Pfizer's first generation COVID-19 vaccine, COMIRNATY. This trial was run in Canada and in South Africa. You can see that this is a two to one randomization with a safety follow-up for 12 months.
What we have been able to show is that we are able to deliver a non-inferiority in terms of the level of antibody generated against the COVID-19 vaccine. This is the analysis on the bottom. You can see that two weeks after the second vaccination, that we are able to deliver similar levels of neutralizing antibody levels as COMIRNATY. Next slide. This slide shows the safety data of PTX-COVID19-B versus COMIRNATY.
You can see that the systemic and local adverse reactions after the second dose between the two vaccines are quite similar. Our PTX-B vaccine candidate, you can see that actually has a numerically better safety profile as COMIRNATY. From a statistical basis, it is non-inferior. We are quite confident that not only do we have an effective COVID-19 vaccine, we have one that is quite safe to use.
This is really, we think it is quite differentiated, because a number of our competitors in China have had pretty significant safety signals with their mRNA vaccine candidate. Next slide. This is some preclinical data from our bivalent COVID-19 vaccine. You can see that in the chart on the left that we are comparing to boosting with PTX-COVID19-B, our first-generation monovalent vaccine, versus the dark blue bar, which is the BA.2.12.1 monovalent COVID-19 vaccine, versus the light blue bar, which is the bivalent vaccine candidate. The bivalent vaccine candidate is a mixture of PTX-COVID19-B and the Omicron specific monovalent vaccine against BA.2.12.1.
You can see that the bivalent vaccine is able to generate much higher neutralizing antibody titers in this pseudovirus challenge study in mice. Next slide. This is the development timeline for our COVID-19 vaccines. We are enrolling IND submission for our bivalent candidate. We expect to initiate phase I and II studies in the second quarter of this year. We hope to be in a position to submit EUA for this candidate before the end of 2023.
On the bottom of the slide, this is the PTX-COVID19-B first generation product, which we intend to initiate a booster study against Pfizer's COMIRNATY. This phase III study will be led by Providence and run outside of China. Next slide. We are quite excited about the potential for COVID-19 vaccines going forward. Clearly, China has reversed on the zero COVID policy, and we believe this will drive an attractive seasonal market going forward.
Our assumption is that approximately 30% of the population will take annual boosters. This will translate to 400 million-500 million doses. Our assumptions for pricing is roughly RMB 100 per shot. This is a mix of public and private markets, and we believe that the public government procurement markets will be slightly lower than RMB 100 per shot, but the private pay market will be higher than that. So on a blended basis, our assumption is RMB 100 per shot, which will drive a market of RMB 40 billion-RMB 50 billion. We believe that mRNA vaccines as a class should be able to capture about 50% of this. We think these numbers are reasonable, especially compared to how we expect the flu vaccine market to evolve in China.
Currently, the flu vaccine market is roughly about RMB 5 billion, but this is growing at a double-digit CAGR. For the next five years, it will grow to about RMB 10 billion, which translates to a 10% penetration in China. Given the severity and the disease awareness for COVID, we believe that it is reasonable to assume that the penetration for COVID-19 vaccines should be two to three times higher than flu, and hence these numbers is our current assumption.
Next slide. Switching gears a little bit to our antibiotics portfolio. We are quite excited about our antibiotics portfolio because we have three products that have complementary spectrum of coverage across multi-drug resistant Gram-negative infection. The latest stage product, eravacycline, is a fully synthetic tetracycline that we believe will be the third MDR Gram-negative antibiotic approved in China in the last 10 years.
There is a significant unmet medical need for these type of products. I can show you some revenue data on the next slide. Taniborbactam is our second product in the antibiotics portfolio. This is a novel beta-lactamase inhibitor that will be used in combination with cefepime. The spectrum of coverage across beta-lactamases is very attractive with taniborbactam. For example, it has very good coverage against the metallo-beta-lactamases. We think this drives the best-in-class profile for this product. We have announced a positive global phase III study for taniborbactam in complicated UTI. We are negotiating with the regulatory authorities and hope to submit NDA for taniborbactam in 2023. The last asset in the antibiotics portfolio is SPR206.
This is a novel polymyxin derivative that has significantly reduced the renal tox, which has been a key issue with the broader commercial adoption of polymyxins in the past. We think this profile will drive significant commercial potential for SPR206, if this can be repeated in the phase III study, which we intend to start this year as well. If you look at the next slide, you can see that polymyxins, tigecycline, and avibactam, which is another beta-lactamase inhibitor marketed by Pfizer, together drive significant revenue increase in China.
These are the life-saving drugs in the ICU. When you come down with infections against Pseudomonas or Acinetobacter baumannii infections that are resistant to carbapenems, you really don't have other options, and these are the only products you can use. Hence, you see the significant increase in revenue over the last few years. The pricing for these products are also quite attractive. Polymyxins are dosed at about RMB 6,000 to RMB 9,000 per day. Avibactam, the beta-lactamase inhibitor from Pfizer, has a daily cost about RMB 4,000.
Other than, I think, the overall attractive antibiotics market in China, we actually have had some experience with eravacycline, the trade name here is XERAVA, sales in Singapore. We have been commercializing in Singapore for about 12 months now. For the hospitals that we have been able to get listings in, we have been able to replace 80%-100% of the tigecycline volume. In some hospitals, we have been able to expand on that.
We certainly feel that given our own experience in Singapore and the market research that we have done in China, the potential for XERAVA and for the rest of the Gram-negative antibiotics portfolio that we have is very attractive. Next slide. Last but not least, we wanted to just spend a couple of minutes talking about etrasimod. This is a potentially best-in-class therapy for ulcerative colitis and other autoimmune diseases.
This is a S1P modulator that we brought in from Arena Pharmaceuticals that was subsequently purchased by Pfizer for $6.7 billion. We are in collaboration with Pfizer to advance the development of this product in UC, but also in other autoimmune diseases. You can see here that in terms of where we are in development, etrasimod NDA has been submitted for UC in the U.S. and EU.
In China, we have a regional phase III study that is ongoing. We expect to complete enrollment for this study in the second quarter of this year and have data starting to come in for 12-week and 52-week towards the end of this year and into next year. We are working with Pfizer closely on defining the development strategies and plans for Crohn's disease, atopic dermatitis, and other autoimmune diseases.
You can see that these are diseases that the prevalence and incidence rates in China are growing quite rapidly. With atopic dermatitis, the number of patients is very significant. We believe that etrasimod has the best profile to be able to target these diseases and offer an attractive option for patients. The next slide shows the data that we have for etrasimod.
You can see that on the left. These are not head-to-head, but just data received from different trials. You can see that for etrasimod, at 52 weeks, is able to deliver about 27% of the subjects to have a clinical remission. That is quite attractive compared to the biologics, which are really in the high teens. Really, the only product that has a higher efficacy is the JAK inhibitor, slightly higher.
But the JAK inhibitors, as you all know, come with black box warning labels and have a lot of safety considerations. Again, what we believe is that etrasimod has the best combination of safety, efficacy, and convenience, which we believe is the right profile for these autoimmune diseases. Next slide. This is just to share with you some of our track records with our business development activities in the last four to five years.
Five of the products that we have brought in have been in a global sale or acquisition by larger entities. Our partners span across the globe in Europe, North America, and in Asia. Certainly, I think we have a proven track record in our ability to bring in assets that create value and deliver on value creation. This is important because, as Zhengying and Rogers mentioned, we will continue to use business development to complement our internal discovery platform.
Being able to expand our pipeline through both organic and inorganic means, I think will continue to remain our strategy. Next slide. We are looking at a catalyst-rich 2023. Hopefully, this will certainly keep us busy and hopefully will create the value inflection points that we are all looking for. First, we are very excited to look for the NDA approvals for NEFECON in IgAN and XERAVA in complicated IAI across our territories in Greater China and in South Korea.
We are looking forward to receiving the IND approval for our bivalent mRNA COVID-19 vaccine and initiating phase I and phase II studies towards a possible EUA in China. We are looking to complete our phase III UC trial enrollment in the second quarter of this year and working with Pfizer on additional indications. We are looking to start our phase III study for SPR206 in China. We are looking for IND filing for our first non-COVID mRNA product, our rabies vaccine. We are looking to submit the NDA for taniborbactam, our second antibiotic product in China as well. Okay. With that, I will wrap up and, Leah, I will pass it on to you for managing the Q&A.
Okay, thanks. We are now open for Q&A session. For participants joined through PC or APP, please click the Raise Hand button at the bottom of the screen to queue up for voice questions or type your questions as messages. For participants dialed in, please press star one to queue up to ask questions. We are now open for Q&A session. For participants joined through PC or APP, please click the Raise Hand button at the bottom of the screen to queue up for voice questions. I will type your questions as messages. For participants dialed in, please press star one to queue up to ask questions. The first question comes from Goldman Sachs. Your line is open. Thank you.
Hello, can you hear me?
Yeah.
Hey, Ian. Thank you for giving me the opportunity for the questions. This is Ziyi Chen from Goldman Sachs. I think the strategy has been becoming very clear after the reorganization and the new strategy launches. Just one question on the prioritization, because you mentioned about the key focus in the future is going to be on renal diseases, on mRNA platform, and also potentially some on antibiotics. What about the products and the candidates in the pipeline that also looks pretty promising, including etrasimod, including ranelpat, particularly with those have late-stage data? What is going to be your plan? Are those assets ready to sell, or you are actually looking for some of the partnerships? Thank you.
Ian, you go first. Yeah.
Sure. Okay. Ziyi, thank you for the question. I think for etrasimod, I think what we have is we have a little bit more time to really figure out your questions. At the moment, I think, we have no plans to divest any other products. Okay? What we think is that over the course of 2023, we will be building out our commercial organization. For sure, we will be commercializing NEFECON on our own. With XERAVA, I think what we say is we want to maximize the commercial potential. I think what that means is it may be a combination of our own internal efforts, as well as help from third parties, maybe a CSO that can help us go deeper and broader. But those discussions are still ongoing, right?
What we will have coming out of 2023, is a robust and active commercial platform, which can certainly commercialize etrasimod on our own if we choose. Okay? You should think of that as our base case. If somewhere along the line, somebody makes an offer that we cannot refuse, or that we think can put more resources behind a product like etrasimod to benefit patients, it is clearly something that we will consider, but our base case is to commercialize our pipeline on our own.
Yeah. I think Ian's statement is pretty clear. I think that when I joined Everest, I think we have a kind of good problem to have. We have so many late-stage assets, and then it's hard to decide whether we want to do all by ourselves, or we just focus on maximize the value. I think Ian just mentioned our strategy. I think it's in time, once we have our full capability of commercialization, and now along the way, we will be thinking about which is the best way to maximize the value. Thank you.
Got it. Thank you, Ian and Rogers. Also another question is really on the commercialization strategy for NEFECON, and also the renal disease for sure. We do see a huge amount of IgA nephropathy patients in China. Of course, biopsy or diagnosis probably still will be one of the hurdles. We try to understand about the opportunity is pretty significant there, but we haven't seen any of the major drug in the space yet. What have been the hurdles to achieve a blockbuster kind of a sales milestone for any of the renal disease drug? Is this not good enough or for NEFECON, it's going to be a very different story?
I think, I go first. I think it depends on the product itself. As you mentioned, in the past several years, I would say there is no true innovation in these sectors. As Dr. Zhu mentioned, in the last probably 50 years, there is no innovative drug being approved in this IgAN nephropathy. Even in other renal disease, I do not think we can find any other truly innovative product in this sector.
That is the number one reason why you do not see a huge blockbuster, which means this exceeding RMB 3 billion sales in China alone. That is, I would say, the biggest reason. Another one is that I think there is not, even for me better or kind of me too drug in this sector, there is very few. I think the reason, as Dr. Zhu mentioned, there is two major reasons. Number one is that for glomerular disease is not a focus area for much national big pharma companies. Number two is that the FDA used to use outcome-based endpoint to approve a drug. There is no surrogate endpoint to be validated for approval. That is probably is the first one, I would say. That is the drivers. There is not much innovation in this area.
For the commercialization of this kind of, I would say, breakthrough innovation product like NEFECON in China, I think that will be a different commercial approach, as you just mentioned. As we have this very strong data, I would say NEFECON is not a kind of a drug lowering their proteinuria. It is a disease-modifying potential mapping for this disease, which means it is not only a load proteinuria, but also stabilize the eGFR, decrease the, I would say, delay the progress to the end-stage renal disease.
That would be the foundation therapy for this disease. In terms of commercialization, I think basically it is three things. I will always say there is three things about commercialization. Number one is the medical affair, disease education, medical education. Number two is about market access. Number three is about promotion, sales, marketing. If you are looking at this product profile, I think it is very heavily rely on market access and also medical affairs.
Sales, marketing, also important, but may not as important as other products like you may remember in other diseases, you have thousands of sales rep on the ground. But this product, I think, is a kind of first in disease, breakthrough, those kind of things. You need a lot of medical drive, guideline promotion, guideline drive, education, plus reimbursement, which is market access. In terms of reimbursement, affordability, those kind of things.
Sales, marketing, of course, important, but we will not hire a thousand sales rep on the ground. Which means we are looking for higher kind of return on investment. It is a very highly concentrated market, as Zhengying mentioned. We are not only looking into those patients with biopsy proven kind of IgAN nephropathy, but also looking to those patients highly likelihood of IgAN nephropathy with other clinical diagnosis and not quite a respond to the, of course, sub-optimal kind of response to RAS inhibitors.
That is a huge population. If you are looking at the biopsy in China, it is about 300,000 patients a year. There would be another 600,000 or even more patients who are very reluctant to have the biopsy, but they are highly likelihood of being IgAN nephropathy patients. That is an even bigger patient pool to tap into. I think this product has huge unmet needs, and then we will apply a different approach for the product for the much higher, I would say, blockbuster kind of potential materialization. Thank you.
Got it. Thank you. That's all my questions.
The next question comes from Hua Zhang of Credit Suisse.
Thanks. Thanks for the presentation, and thanks for the opportunity to allow me to ask questions. Basically, I have two questions. First, to my understanding, Everest partner, Calliditas, guided their 2022 last year's full-year revenue for NEFECON is about $35 million-$40 million . If we assume the price of NEFECON in the U.S. is about $100,000, that means a few hundred patients were treated last year. Based on that number, what can we see for NEFECON after approval for NEFECON's first year in China itself? That's my first question.
Rogers, you are on mute.
Probably, Zhengying, you can answer the first part of the question about the prevalence in the U.S. and what is their kind of market potential in the U.S., and I can comment on the China part.
Yeah. Okay. In terms of the patient number, I think, if we are looking at the prevalence or the accumulated IgA nephropathy patient in the U.S., it is around 150K, in that range, from 100K- 200K. But of course, these are maybe including number of proven patients as well. From that number size, it is a lot smaller than China's size. That is the epidemiology part.
Yeah, please.
Yeah. That's it.
Yeah. I saw some data that newly diagnosed yearly, kind of, newly diagnosed IgA nephropathy in the U.S. is about 7,000 or something like that.
Yeah.
I would say it's in a very kind of a rare disease status in the U.S. As Zheng mentioned in the presentation, it's a very low prevalence rate, and also, the NEFECON launch in the U.S. is in a very short time. It's a very short period. I think, probably with their, I hope there is a new guideline in the U.S. that probably will change even the status of NEFECON in the U.S. Ian, you want to comment on that?
No, I think you both covered it. Hua Zhang , it's a great question. I don't think there's. The market's entirely different in the U.S. versus China. I think the kind of conversations that we have with KOLs in the U.S. versus in China, the level of enthusiasm there is here. And I think what Rogers pointed to the right numbers. 7,000 biopsy-proven new IgA nephropathy patients in the U.S. versus 100,000 in China.
And there are many more that have decided not to do a kidney biopsy, but are most likely IgA nephropathy patients as well. Right? And the pricing is also going to be very different. Because this is a rare disease, and because in the U.S. there is the orphan drug type of commercial opportunity, it's sold in a way that's very different in the U.S. than how I think Rogers, and we intend to commercialize it here.
I think our expectations for the number of addressable patients is very, very different. I think one statistic that I heard from our commercial teams was interesting. I think they surveyed about 20 nephrologists in Shanghai, in some of the coastal cities. Across these 20 nephrologists, they have, collectively, a database of about 70,000 IgA patients. That is huge, and it's highly concentrated, right? To be able to tap into these kind of patient resources across a relatively concentrated commercial effort, I think that's quite unique to China and that drives a very differentiated commercial potential that we expect here.
Yeah. Okay. For the second part of the question, I think in China, the goal for Everest is to treat every IgA patient in China, whether it is biopsy-proven or it's highly likely IgA nephropathy patients, we want to treat everyone so that you can count on the numbers. So yearly, hundreds of thousands of new patients diagnosed and cumulatively is 4 million or 5 million. If you're only looking at the biopsy-proven patients cumulatively, that could be 900,000 or close to 1 million historically. So you can easily calculate the sales revenue potential. So that's how it'll go. Clear.
Okay. That's helpful. My second question is also on commercial, but more on commercial side, outside of mainland China. As I understand, for NEFECON, company also has commercial rights for NEFECON in Taiwan and South Korea, and then for MI platform, company has rights in a few other Asian countries. Can you tell us more about commercial strategy outside mainland China for in-licensed products? Thanks.
Yeah. For NEFECON, clearly, for the markets such as South Korea, Hong Kong, think about those markets, I think has, I would say, good market access policy, as well as for their price. So I think in those markets, our intent is to do it by ourselves. So we'll commercialize by ourselves, those markets. Given that the prevalence rates in this East Asian region and the countries has kind of similar incidence rates and prevalence rates of IgA nephropathy, we do think there's a high unmet need there.
You also know that in South Korea and Taiwan, we get the kind of fast approval track. It's already done. So we think that we will do it by ourselves. For other products, we may look for, open for partnership opportunity. But for NEFECON, I think we would like to do it by ourselves.
Okay. Got it. That is clear.
Yeah.
Yeah, Hua Zhang, we have already built out a lot of that, or at least the beginnings of the platform, right? I think what happened after Trodelvy is that we optimized our international commercial organization. A lot of what we built is still here with Everest. But those specific to Trodelvy and to the oncology effort is no longer with us. We will continue to build out what is appropriate to commercialize products like NEFECON and others in our current portfolio.
Oh, by the way, a quick follow-up. Since we kind of narrowed down or kind of reprioritized our kind of therapeutic areas, do we expect in 2022 second half and also in 2023, the mean cost will get down significantly or not really?
Yeah. Maybe I will take this one.
Yeah.
I think clearly there will be some reprioritization of resources. Clearly, I think a lot of the resources allocated to oncology, and not just specifically with oncology commercial and oncology development, but all of the resources that support this from the corporate and the platform level will also be adjusted appropriately. So there should be a reduction in some of the admin costs. Obviously at the same time, we will also see as we pivot to other areas that we highlighted today, there will be appropriate amount of investments there. But clearly, I think we have been and intend to run Everest as a much more leaner and efficient organization from a capital perspective.
Yeah. I can provide you a number. So before I joined the company, I think last September, the total employee number is 485 or something. Around 480. Now we have about only 300 right now. So excluding those Trodelvy deal related, we about optimizing about 50 more additional. So as Ian mentioned, we are much more efficient, effective, and a lean organization than before, I would say.
Okay, great. That's very helpful. Thank you.
Finally, we have a question from, a written question from Philip Lam of Valiant Capital. The question is: how do you see the COVID mRNA vaccine opportunity evolving in China given the recent raft of vaccine approvals?
Ian, you can take this one.
Sure. I think the way we've always thought about the COVID-19 vaccine opportunity in China is we think about the pandemic phase opportunity, then the endemic and the seasonal market opportunity, right? I think the pandemic opportunity right now is quite dynamic because of China reversing on the zero COVID policy and a number of products were approved under the EUA at the end of last year.
But still today, there are not any mRNA vaccines approved in China. We feel that as we have seen in the rest of the world, right, when you have spikes in COVID-19 infections, they don't just come in one wave and then just disappear. They come in multiple waves. So we could still be in the pandemic phase for quite a bit longer. We hope not, right? But there's a lot of uncertainties with that.
There is a chance for us to catch up to the pandemic opportunity. But what we're also very excited about is the ongoing seasonal market. I think within the seasonal market, which I highlighted earlier, that we really do believe that a significant portion of the population will be taking annual booster shots for the variants that are appropriate for that year, similar to a flu vaccine.
We think mRNA vaccines given, especially with our technology platform, where we think we can produce highly effective and safe mRNA vaccines, is the right profile for the seasonal vaccine market and perhaps especially for the higher priced private pay seasonal vaccine market. We think the market's big enough. We don't think we will be the only mRNA COVID-19 vaccine player in China, but we certainly feel that we can be a significant player and one of the top players in that space.
Yeah. Thank you.
Thank you.
That concludes today's question and answer session. Mr. Luo, I will turn the call back to you. Thank you.
Okay. Thank you everyone for attending this meeting. I think Everest is in a new stage. As I mentioned at the beginning of the call, I think for this year, next year, we are in the year of transforming the company to a kind of fully covered, from R&D to manufacturing, to commercialization, kind of full value chain covered stage. With this two engine kind of strategy, not only about licensing but also in-house R&D, organic growth of this company, also we are more and more rely on our commercialization, revenue generation, and also profit generate from our own kind of pipeline, not fully 100% rely on external financing.
I think the year of 2023 will be a year of transformation, and there will be a lot of catalysts along the way. I hope every one of this meeting, attending this meeting, can continue to support us. You will see 2023 as a tipping point for the Bio interacting. Thank you for everyone. Thank you. Bye-bye.
Thank you.
Thanks. Thanks, everyone, for your attendance. This concludes today's conference call. Thank you.