At this time, I would like to hand the conference over to speaker today, Ms. Leah Liu. If you could please go ahead.
Thank you, operator. Good morning or good evening, everyone, and welcome to our 2023 full year financial results conference call. Joining us today are Mr. Rogers Luo, our Chief Executive Officer of Everest Medicines; Mr. Ian Woo, President and CFO; Dr. Jennifer Yang, Chief Scientific Officer; and Sandra Zhao, Chief Medical Officer. Before we get started, I'd like to remind you that the speakers on this call, conference call, may make statements that constitute forward-looking statements, including references to broadly the tangible use or current expectations of the company or its officers with respect to the business operations and financial positions of the company, which can be identified by terminology such as will, expect, anticipate, future, intent, plan, believe, estimate, confident, and such similar terms.
Such forward-looking statements are not guarantees of the future performance and involve risks and uncertainties, and actual results may differ from those in the forward-looking statements as a result of various factors and assumptions. Company or any of its affiliates, directors, officers, advisors, or representatives have no obligation and does not undertake to revise forward-looking statements due to lack of new information, future events, or circumstances after the date of this conference call, except as required by law. And now, I will turn over the call to our CEO, Mr. Rogers Luo, to provide you with more details on our business update and the 2023 full year results. Rogers?
Thanks, Leah, and hello to everyone. Thank you all for joining us on this call. I would like to start with a broad overview of our goals and what we achieved across discovery, clinical development, regulatory approval, commercialization, and business development in 2023. We aim to become a leading bio-pharma in Asia Pacific by 2030. Towards that goal, we have four products launched or near commercial launch, which aggregate peak sales potential of RMB 10 billion. Beyond these products, we have a clinically validated, in-house mRNA platform that will support our future pipeline growth. We plan to develop multiple prophylactic and therapeutic vaccines from this platform, which not only can potentially contribute to our future commercial sales, but also generate global value as these programs advance in development and from potential partnerships.
From 2023- 2025, we will witness Everest's transformation from a biotech company to a fully integrated bio-pharma, with a dual engine approach towards building a differentiated pipeline. We will leverage our scientific expertise and thorough understanding of Chinese market, to licensing products that can leverage the current commercial platform to generate maximum synergies. While simultaneously, we will develop proprietary products generated from our in-house discovery platform. We will plan to use this comparative approach to drive significant global value creation, going forward. We strongly believe in our blue ocean strategy in product selections from both the commercial and R&D perspective.
Our core strategy will continue to focus on less crowded, high-value, through the therapeutic areas of infectious disease, renal disease, and other immune diseases, while adding cancer vaccine from our advanced mRNA technology platform with full intellectual property rights and global rights. We also adopt a lean and highly efficient commercialization model to maximize productivity and profitability. Strategically, our goal is clear: to establish a leading position in Asia across carefully chosen, less crowded, high-value therapeutic areas. We are well on our way to achieving this goal with our core portfolio of four near-term commercial products. Here you can see, Xerava is already commercially launching in China. Nefecon to be launched the first half of this year, the Velsipity and the cefepime-taniborbactam kind of a vector.
We also have four nearly, you know, earlier stage therapeutics in the pre-clinical to phase 2 development stage, set to launch in, you know, 2026 and beyond, which continue to drive revenue generation besides the four near-term, you know, commercial stage products. Furthermore, we'll continue to advance the discovery of vaccines and therapeutics through our mRNA technology platform, propelling long-term value creation. We have a very solid balance sheet of RMB 2.35 billion cash as of the end of 2023, which will provide the cash needed to support our strategic development. With our current product portfolio, we anticipate to achieve cash flow breakeven in 2025. As we speak today, Everest has transformed into a biopharma that has the full value chain of capabilities, from discovery, pre-clinical to clinical developments, regulatory filing, manufacturing, supply chain, and commercialization.
Compared to 2022, we newly added discovery capabilities with global rights in renal disease, and so our MRA technology platform, as you can see from the slides that are left behind. Entire commercial franchise comprised of seasoned professionals who have led the successful commercialization of multiple products at various multinational pharmaceutical companies with adopt a lean and highly concentrated agile commercialization team. We will continue to upgrade and improve our capabilities in each of these functions along the value chain to solidify our position as a leading biopharma in China. Now, I will hand over to our President and CFO, Ian, to discuss the future, the further details of our 2023. Ian, please.
Thank you, Rogers. So in the next couple of slides, you know, I'll take you through achievements that we met in 2023 across multiple functional areas. So first, in commercial, 2023 was the first year of commercialization in China for Everest. We launched two products, instituted a focused commercialization model driven by product clinical value, and built a lean and efficient commercial team. We are thrilled to announce that we generated total revenue of RMB 126 million. This is achieved under a challenging macro environment in China, and is based on only five months of Xerava sales, because it was launched at the end of July of last year, and Nefecon was launched in Macau in December. Xerava's prescription has been accelerating.
This antibiotic, this high-end antibiotic product has been prescribed by over 4,000 physicians in more than 200 top-tier hospitals across 22 provinces in China. And, in Macau, Nefecon was launched, and, the Nefecon will soon be launched in mainland China as well. We are excited to see over 20,000 patients in China, having registered in our innovative pre-launch charity program, that it's a very good tool to warehouse patients that we believe will drive quick ramp up, of Nefecon when it is available, in China. It is also worth noting that from submission to approval, in Macau, it only took about 2 months.
Now, you know, we believe that's a record, you know, although, you know, it's clearly two months from submission to approval is a reflection of our execution capabilities. So here, let's talk about our regulatory and clinical achievements. We are exceedingly proud of our achievements in these areas. First of all, we saw six regulatory approvals last year. And there is a seventh, the approval of Nefecon in Singapore, which was achieved in early 2024. These included the Xerava approvals in China and in Taiwan. This also included multiple approvals for Nefecon, including in Mainland China and Macau, and also the U.S. full approval that our partner Calliditas was able to achieve.
We also saw the approval for Velsipity in the U.S. by our partner Pfizer. In addition to approvals, we have advanced all of these products in regulatory development as well. You also see that in for our pipeline product, zetomipzomib, we have received the China IND acceptance, and we will be initiating our part of the clinical development in the global phase 2b study this year. Now, clinically, Nefecon, we were able to complete the patient enrollment of the China open-label extension study. This is important because we want to generate more data to support the long-term use of Nefecon for IgA nephropathy patients.
We have presented multiple posters, including at the ASN Kidney Week, for Nefecon in Chinese patient subpopulation. I think you know a lot of people on this call is aware that IgA nephropathy progression in Chinese patients are different from the global population. We believe that the disease progresses faster, and we believe this will lead to you know patients willingness and interest in in treating, in seeking treatment. Velsipity, we were excited to announce the top line data from the 12-week induction phase of the phase 3 study in Asia. We will be announcing the full 52-week maintenance data later this year as well.
Of course, our partner Pfizer is conducting clinical trials for etrasimod over multiple indications. For Xerava, we were able to generate clinical breakpoint for the product that was approved by EAP. This is actually quite important because in the past, you know, breakpoints in China, we just use the global breakpoints, but as most people know, the antibiotic infection dynamics in China is vastly different from the global. So this is a small detail, but it is very reflective of our ability to execute commercially and putting together all of the tools necessary to help with the commercialization effort. Let's look at financial and the BD achievement.
So here, first of all, we executed a number of business development transactions. The Kezar collaboration around zetomipzomib is right down the fairway of what we used to do, the licensing of regional rights for an exciting product that we believe has generated a very interesting early clinical proof of concept, is being developed in a pivotal study for a severe disease, Lupus Nephritis, where, you know, there's high unmet medical needs.
But we also believe that this product has the potential to be developed across multiple autoimmune indications, and in fact, our partner, Kezar, is developing this product in an early study in autoimmune hepatitis, where we believe the unmet need in China in particular is very high. So we look forward to working with Kezar to advance this product in LN, as well as potentially additional indications. This is also an in-licensing transaction that we believe we negotiated very attractive terms. The upfront and the future milestone obligations are, you know, quite attractive, we believe, for Everest and the ongoing royalty obligations starts in the single digits.
In fact, it's probably one of the most attractive licensing deals we negotiated in terms of economic terms. Secondly, I'd like to highlight that we terminated the collaboration with Providence Therapeutics. This is an important step that we believe now clears the path that provides us with full flexibility to leverage the mRNA platform for discovery products that we own full global rights and upside. Now, this termination, the key terms are really that we you know for $4 million we were able to have you know Providence forfeit any and all future milestone and royalty obligations that we you know owe them.
But you know, more importantly, this gives us the full freedom to operate with this platform. And you know, over the last 2.5 years, our discovery team, our CMC team, and our manufacturing team has localized this platform in China, you know, which we think you know provides the foundations for us to really leverage this clinically validated platform, you know, vaccine development. Last but not least, you know, on the financial side, I think the key message here is that we saw significant increases in revenue, and we have been laser focused on controlling our operating expense. In fact, compared to 2022, our operating expense was reduced by RMB 476 million.
This will be a continued drive to drive efficiency that we will continue in 2024 and beyond. And of course, in March of last year, we received the full upfront payment of $280 million from Gilead Sciences for the divestiture transaction around Trodelvy. So let's take a look at our income statement. Again, the key message here is revenue ramp and operating expense rationalization, right? So let's first look at the revenue. Revenue was $125.9 million in 2023. This is almost 10x the 2022 levels. The 2023 revenue was driven by Xerava in Mainland China and in Hong Kong, as well as in Singapore.
And it was also driven by the launch of Nefecon in Macau. There's also a small amount of legacy Trodelvy sales in Singapore, you know, at the very beginning of 2020. The cost of revenue was 34.4 million RMB. Now, this includes non-cash items that were amortization expense from some of these licensing costs that were capitalized. If we take out the impact of these items, then our gross margin was greater than 80%, which has always been our guidance, okay? And we believe that, in the long run, our steady-state gross margin will be between 80%-85%. That's inclusive of the royalty obligations that we owe our licensing partners.
G&A expense, moving on to operating expense, decreased by RMB 111.3 million. That's a 40.3% reduction compared to 2022. This is entirely due to the optimization and rationalization of the organizational structure, and part of the cost controls that I think you know Rogers and I have you know both highlighted. R&D expense increased by a significant amount, RMB 270 million. That's a 33% increase. This is attributed to a number of our drug candidates moving through clinical and regulatory development, so they are you know advanced to the commercial stage, so no longer clinical development expense attached to them.
As well as the rationalization of our discovery efforts and R&D efforts, so that we are focused on the products that we believe, you know, drive, are aligned with our new corporate strategy, and, you know, provide the highest risk-adjusted return for our shareholders. Moving on to distribution and selling expense. These declined by about almost 30%. Again, this is due to the focus on driving a lean and efficient commercialization model. In 2022, we were not commercial in China. 2023, we are commercial- we were commercial, and we were able to do it at a more efficient way. Okay. Other income increased by about RMB 7 million, you know, 8 million RMB.
This is primarily due to an increase in government grants received. The other losses was 100 million RMB in 2023 versus a significant gain in 2022. This is primarily due to the 2022 number is due to the one-time disposal gain from the Trodelvy transaction, which contributed a one-time gain of 1.32 billion RMB. There was also, you know, the loss was actually, you know, primarily due to the disposal of Ralinepag, which is a program that we've decided to terminate for a number of reasons. So, moving on to financial income.
This increased to RMB 84.6 million. Compared to 2022, this is a significant increase. And, you know, the reason is really a concerted effort to manage our cash to drive for interest income, but of course, with the proviso that we protect our principal amount. And we were able to do that in an increasing interest rate environment, and we generated a significant amount of financial income. So, loss for the year by IFRS measures increased by RMB 597 million to RMB 844 million in 2023. I'm looking at the third line from the bottom now.
You know, again, compared to 2022, this is an increase because the 2022 numbers were impacted positively by the disposal of Trodelvy, right? As we always do at these annual results disclosures and, you know, interim results disclosures, we also look at a non-IFRS measure, where we back out non-cash items, and we back out one-time items. So if you look at the bottom line, right? This is the number that we believe is a truer reflection of our, you know, financial results, comparing apples to apples between 2022 and 2023. So you can see that by the non-IFRS measures, our loss was RMB 713.6 million.
This is a reduction of, you know, over RMB 600 million, over RMB 600 million compared to 2022, which was a loss of RMB 1.33 billion. You know, again, in this number, we have backed out the impact, the positive impact from the Trodelvy transaction, which we believe is the right measure to look at. Now, on a cash balance basis, we ended the year with RMB 2.35 billion in cash and cash equivalents, which we believe provides sufficient amount of funding-...
For the company to continue the transformation journey that we have been on, in 2024, and we will drive towards the, we'll fund the company through what we have, guided the Street that we intend to, you know, get to cash flow, cash flow breakeven in, 2025, right? So with our current portfolio of products, we do not need to raise additional capital, but of course, you know, if we see interesting strategic opportunities for us to execute on, we will try to raise the capital in, you know, appropriately. So next, let's talk about 2024. So, 2024 will be, will continue the transformation journey that we have been on, and we will continue to execute.
We, as Rogers has mentioned, we are on this path to transform from a biotech to a bio-pharma, and to become a leading bio-pharma company in Asia. And we believe this requires two different components. First is our commercialization efforts, which we'll continue to advance. Second is the establishment and hopefully this year, where we will disclose more information about what we have been doing with our in-house R&D capability, right? So if you look at the low on the commercial side, we are truly excited and you know, highly expect the launch of Nefecon in Mainland China, which we believe will be in the second quarter of this year. The product again is already launched in Macau.
We have also received the approval of Nefecon in Singapore, and we intend to launch, you know, there as well as Hong Kong. We will also be disclosing the results of our open-label extension study. I think, you know, that, that'll really help us inform how patients ought to use the product long term. For Xerava, you know, I think we're coming on the back of a successful execution on the launch over the five years, five months in 2023. We intend to continue to ramp up the sale of Xerava. And, you know, we look forward to submitting the NDA in China for our second high-end antibiotic product, cefepime-taniborbactam, this year as well.
And last but not least, for Velsipity, we have submitted for the NDA for NDA approval in ulcerative colitis in Macau, and we look forward to launching the product in Macau, which will also allow us to get, you know, to provide access to patients in China through the Greater Bay Area, you know, policy arrangement. As I mentioned before, we look forward to announcing the Asia phase 3 full 52-week data, and then submitting the NDA in China in Q2 as well. Now, on the discovery side, you know, this may be the first time we're disclosing a product name, EBM-16. This is our first mRNA cancer vaccine program.
It is our personalized cancer vaccine program, and we intend to take this into the clinic this year. So look for that, you know, I would say in the second half of 2024. And then, you know, I'll go into this in a little bit more detail, but we will be advancing additional programs as well. We're also hoping to deliver pre-clinical proof of concept for our in vivo CAR T programs as well. Finally, I think all of the commercial achievements that we intend to execute on this year hopefully will lead to us, you know, meeting and exceeding the revenue guidance that we have provided.
This has been consistent over the last, you know, six months or so, that our guidance remains at the R&D RMB 700 million for 2024. This is the commercial, a little bit more details, right? So we currently have a 150-person ICU hospital sales force to detail Xerava. We only—when we launched, we covered 300 hospitals, and this year we will continue to cover 300 hospitals. However, we do intend to work with CSOs potentially, to help us go deeper and broader into more into areas that we are not currently covering. Month-on-month growth in 2023 has been very attractive.
I don't think we will commit to doubling our sales every month, but we certainly do believe, you know, Xerava sales to increase in 2024. For Nefecon, we will start with 120 persons, they'll aim to cover 600 hospitals. We believe that covers about 60% of the addressable patient population. And as I mentioned, we already have a patient program registered in the charity program of over 20,000 members. Pricing-wise, Xerava is priced at RMB 5,500 a day, and the Nefecon EAP program is priced at RMB 18,600 per month on a net basis.
We've not disclosed the launch price for Nefecon yet in China, but we will be doing that in due course. Now on the bottom, you see just the, you know, the commercial platform that we have built up and that we suddenly, you know, we'll expand our reach, and, you know, maximize patient access through strategic partnerships and the innovative programs that we will make available. I'll probably go through the next few slides very quickly because I think most of you have heard this multiple times. Nefecon it's the first and only fully approved treatment targeting IgA nephropathy globally.
We believe it's the first product that truly have demonstrated the ability to control this disease progression, and you know, delay the deterioration in kidney function. And it's because it's a mechanism of action for the cause of the disease, right? And the data that we have announced has been reflective of this profile.
And clearly, you know, and just as a reminder, right, you know, in Chinese patient populations, the efficacy of Nefecon is more pronounced, and Nefecon over a nine-month treatment period and 15-month follow-up demonstrated 66% less deterioration in kidney function compared to placebo plus background RAS therapy. And this is consistent for proteinuria and microhematuria. And of course, I mean, I think it's also, you know, important to note that, safety-wise, it's a very safe product. This is actually quite important because, you know, the KDIGO treatment guidelines are being updated. You know, these are, you know, being put out for comment.
And you can see that, we're quite excited about this, because what this shows is that the recommendation is to use Nefecon for all patients that have a proteinuria of greater than 0.75 milligram per day. And we believe it's likely that the China treatment guideline will follow the global guidelines as well. For Xerava and cefepime-carbapenem, you know, we think we have an optimal portfolio, right, in for treating multi-drug resistant gram-negative infections or just treating multi-drug resistant infections in the ICU setting. They have complementary spectrums of coverage and are both very safe products, right?
that are amendable for empirical treatment in the ICU, right, in a combination setting. Cefepime-taniborbactam, we're super excited about this product as well. We believe it's a best-in-class BLBLI. And you know, in particular, its activities against both serine and metallo beta-lactamases is a true differentiation factor for this product. Velsipity, again, a really exciting product. And we'll be launching this product this year, right? Our partner, Pfizer, has been able to get a very good label for Velsipity in UC. This is approved as a first-line therapy. It is oral, convenient, safe, and effective.
So you know, again, we believe this has the best-in-class characteristics for the treatment of first line advanced UC and potentially in additional autoimmune diseases as well, which Pfizer is you know running phase 2 trials for. You know, we have end-to-end capabilities in mRNA. We've done a lot of work over the last two and a half years since we brought in this platform to establish a R&D team in Shanghai that have developed a number of capabilities, including AI and machine learning capabilities to optimize the design of mRNA sequences that deliver the desired characteristics, whether it's maximizing immunogenicity and others, we have that capability.
We are working on next-generation delivery system that gives us additional optionality, in terms of, you know, designing for, mRNA, products... of manufacturing. And this manufacturing facility is in, Jiaxing, which is right on the borders between, the Zhejiang Province and, Shanghai. It's about one hour drive from the, center of, from downtown, Shanghai. You know, we have, we have commercial scale, you know, the, the facility is built for commercial scale, but of course, you know, we will be using the first, for, clinical development, of our, programs. Again, just to give a teaser on what we are, working on, EBM-16 is our personalized cancer vaccine. It's probably our most advanced therapeutics, therapeutic vaccine program.
It is, we're expecting to initiate clinical development through a IIT this year. Our second program is called EBM-14. It's a tumor-associated antigen cancer vaccine program, so this is an off-the-shelf Allo program. We are looking to—I think the timing from this, for this is the IND submission in early 2025, in the US. We have a third program in immunomodulatory cancer vaccine program, and we're expecting to submit IND for this program in 2025. Last but not least, I think this is really at the cutting edge of the mRNA technology, is our, you know, ability to deliver mRNA coding CAR T in a targeted vaccine fashion in people, right?
We are working on generating clinical proof of concept for this program, which will have very interesting utilities for autoimmune diseases as well as oncology. 2024 is a catalyst-rich year. You know, we have a lot of, and we have already achieved quite a number of these in the first few months of 2024, but we look forward to continuing to advance them across our region. But most importantly, getting the product launched in mainland China. We look forward to the phase 1b interim data for EVER001. This is our covalent reversible BTK inhibitor that we are developing for autoimmune renal disease. Again, as a reminder, we have global rights for this product, for renal indication.
And if our phase 1b data is positive, right, this could be a very interesting product where we will be discussing global development plans, right? And the potential partnership option. I think I have covered the other products quite well, but we're truly excited for 2024 and to continue the transformation that the company has started, you know, over the last 18 months. Thank you.
Thanks. We will now open for Q&A session. For participants who joined the call 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 who dialed in, please press star one to queue up to ask questions. For participants who joined the call 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 who dialed in, please press star one to queue up to ask questions. The first question comes from Goldman Sachs, please.
Hey, thanks for taking my question. This is Linhai Zhao from Goldman Sachs. Congratulations on the 2023 earnings results. I have two questions. One is about the Nefecon launch in China. So particularly, I've noticed that you're targeting to recruit up to 120 sales reps by the end of 2024. I believe previously our target was to recruit around 180-200. Can you explain what has been the changes, if any? Or do you feel that to cover the 600 hospitals, you don't necessarily need 200 sales reps? That's the first question. And the second question, I'm just curious about our recent plan to develop the IVD test for IgAN.
How do you plan to position this test along the patient journeys particularly? I believe that currently the patients are using the blood test, urine test to determine their disease progression. What kind of gap do you expect that the test that we are targeting to develop would fulfill? Thanks.
... Okay, thank you for the question. So I can go first, and then Ying can add on. So for the first question, you know, about the sales rep numbers. We believe that 120 sales rep on the ground covering close to 600 hospitals, that's the first step. As you know, that for this year, that count will be the self-pay products, and this product has very, I would say, very popular, and it has a very high awareness, patient awareness in multiple patient communities. If you look at a lot of patient online communities, a lot of patients is queue up. You know, there's more than, you know, it's close to 10,000 patients waiting for the product.
So I think for this year, you know, 120 probably is a good number. But of course, if we see there's opportunities beyond these 600 hospitals or, yeah, in other markets, in all markets, then we can, you know, of course, add more sales reps for this year. But this product is not a, I would say, not a, you know, promotion kind of heavy kind of products as it is a rare disease, and has a very high awareness before, even before product, you know, approval in China.
I think, you know, and, and as we emphasize many times, we even for Xerava, we apply with adopt a very lean and efficient business model, which is focusing on high potential hospitals and customers. You know, you know, clinical value-oriented promotion model, which combining with sales, marketing, medical affairs, and access. So that's so sales reps, I, I don't think we need, at least as of now, we will testing this 120 sales reps, covering close to 600 hospitals. That's already cover more than 60% of the market potential. For the second question, you know that currently the gold standard for diagnosis, IgAN, is you know, kidney biopsy, which is painful, and with a risk, right? Bleeding, those kind of risks.
If you can see, actually, every year, there's more than kind of 300,000 patients went through this painful, you know, diagnosed to about 100,000 patients being diagnosed as IgAN. But, you know, we see a lot of patients are not willing to take this kidney biopsy to diagnose the disease. Because number 1, this is painful and with a risk. Number 2, even if they diagnose with this disease, there is no kind of approved treatment, so they are reluctant to take the biopsy.
You know, that's why we develop and, you know, we are looking at this IVD testing, Gd-IgA1, which is a very important biomarker to diagnose and monitor the disease progression. I think this is, this diagnosis can, you know, help to diagnose IgAN, even without, you know, with or without kidney biopsy. If the patients, you know, they refuse to do the kidney biopsy, the doctor still can use this as a tool to help them diagnose with the patient's history, symptoms, and all the other lab test results. That's number one, which is improving the diagnosis rates without a painful kind of kidney biopsy.
Number 2 is that I think this helps to differentiate Nefecon from other products already in the market. We know there is no other, at least as of now, there's no other data to show those supportive therapies like galactose inhibitors or other hemodynamic modulators can help to decrease the level of Gd-IgA1. And the Gd-IgA1, as you know, is the one biomarker shows the disease progression. You can see from our phase 3 trial as well. So this can differentiate Nefecon from other therapies, and also monitor the disease progression when you want to test once the patient stop treatment after 9 months with Nefecon.
Once, let's say, if the patient stop the treatment for three or five months, you can see gradually the Gd-IgA1 level picks up, then hopefully that helps doctors to decide restart the treatment, right? So this is how, you know, have the doctors to keep the patients on therapy. You know, usually for those chronic disease, patients are, you know, reluctant to take the drug for quite a long time, right? But this biomarker testing can help to help doctors to decide when to restart, when to stop, and whether the patient should, and, you know, if any stop the treatment. So that's from my side. Yeah, you can add.
Well, maybe just one thing. I think that was already very comprehensive. I think maybe one thing is that, you know, you think that somebody who doesn't wanna go through a biopsy, you know, maybe in the self-pay setting, right? If they can, they can just buy Nefecon and give it a try. And we think if they have a positive, you know, Gd-IgA1 test, maybe they're more willing to try Nefecon.
But when we're in the NRDL, and NRDL requires a definitive diagnosis for reimbursement, then this may push somebody to, you know, if they have Gd-IgA1, it may actually encourage them to get over their fears of doing a biopsy to seek a definitive, you know, diagnosis, and then they can continue their disease management journey this way. So, I mean, overall, I think, you know, in the long run, we certainly want to see that once we have this product on the market, and if we see an opportunity to establish this as a diagnostic, as a definitive diagnosis, in addition to kidney biopsy, that will be the best outcome.
But that requires a longer-term development and use, right, and the collection of data to get to that point.
Thanks, Ian and Rogers. A quick follow-up. You said that once we get into the NRDL, the reimbursement will require the definitive diagnosis of IgAN, and which is the biopsy right now. Is that right?
Yeah, we do not know as of now, but, let's see, because we haven't got into that reimbursement negotiation part. Once we have that chance, then can we, that will be clear.
Got it. Thanks.
Even, maybe I can add one more point here. Even with, you know, the kidney biopsy, you know, they, they are close to, you know, around about 700,000-900,000 pat ients already being diagnosed historically. So that's also a very, already a very big number.
Yeah, and 100,000 newly diagnosed every year.
Yeah.
Okay, and-
4 million-5 million, you know, additional patients out there.
Okay, and for participants who joined the call through PC or app, please click the Raise Hand button at the bottom of the screen to queue up for voice questions or text your questions as messages. For participants who dialed in, please press star one to queue up to ask questions. For participants who joined the call through PC or app, please click the Raise Hand button at the bottom of the screen to queue up for voice questions or text your questions as messages. For participants who dialed in, please press star one to queue up for questions.
I think if we don't have any more questions for this call, then we can wrap up here. Thank you everyone for joining us this morning, evening, and please, you know, do let us know, you can send by a message or email or any other form, if you have any other follow-up questions to our IR team. Thank you very much.
Thank you.
Thank you.
Thanks everyone for your attendance.