Good morning or good evening. Welcome to Everest Medicines 2024 Mid-Year Financial Results Conference Call. Please be advised that today's conference is being recorded. During the 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 text your questions as messages. For participants who dialed in, please press star one to queue up for questions. And finally, I would like to hand the conference over to your speaker today, Ms. Leah Liu. Please go ahead.
Hi, good morning, everyone. I'm Leah Liu from Everest Medicines. Thank you, operator, and, you know, everyone, welcome to our 2024 first -half -year financial results conference call. Joining us today are Mr. Rogers Luo, our Chief Executive Officer, Mr. Ian Woo , President and CFO, Dr. Jennifer Yang, our Chief Scientific Officer, Sandra Zeng, our Chief Medical Officer, and Rico Liang, our Chief Product Officer. Before we get started, I'd like to remind you that the speakers on 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 intents, plans, beliefs, estimates, confident, and such similar statements.
Such forward-looking statements are not guarantees of 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. The company or any of its affiliates, directors, officers, advisors or representatives have no obligation and does not undertake to revise forward-looking statements to reflect 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 Mr. Ian Woo to provide you with more details on our business update and the 2024 mid-year results. Ian?
Thank you, Leah. Thanks everybody for joining this call. We are very pleased with what we achieved in the first half of 2024 , with strong revenue growth as well as operational efficiency improvements. With the first full six months of XERAVA sales and the launch of NEFECON in mid-May, we have seen a rapid buildup of our commercial platform that supported a 158% revenue increase compared to the second half of 2023 , when we first launched XERAVA in July of last year. Our overall gross margin remains at more than 80%. In fact, it's at 83%.
This is inclusive of our royalty obligations to our partners, and, you know, but it does back out non-cash amortization of capitalized expense, which we think is a better reflection of, the true picture of the company's operations. As a reminder, 80% is our long-term guidance for cash growth margin across our commercial business. Meanwhile, our efficient and focused commercial model led to a 249% reduction in operating expenses as a percentage of revenue, as we delivered strong revenue growth, with much more modest increases in commercial expense, lower R&D spending and stable G&A expense. For the first time in our corporate history, we achieved profitability at a commercial level.
As a result of increasing top line, healthy growth margin, and increasing operating efficiency, our non-IFRS loss narrowed by 35% in the first half of 2024 compared to the first half of 2023. We have consistently provided non-IFRS disclosures, which backs out one-time items and non-cash charges, and believe that this is the best measure of the company's operations. Our cash balance of RMB 1.93 billion remains strong and provides significant flexibility to fund the continuing growth of our business. Together, this combination of high revenue growth, optimized operating efficiencies, and strong cash position puts us at a strong position to execute on our dual engine growth strategy, and this strategy is coming together nicely.
On the one hand, we will continue to drive stable and healthy revenue growth from our existing late-stage portfolio of differentiated products, while leveraging our commercial platform to bring in synergistic assets that drive scale and efficiency. On the other hand, our discovery platform, which we started building three years ago, is starting to bear fruit with the initiation of clinical development of our first mRNA therapeutic vaccine program. Everest owns global rights to these discovery candidates, which creates optionality for global value creation. So let's first take a closer look at our revenue growth. Our total product revenue grew to RMB 301.5 million in the first half of 2024. Again, this is 158% growth over the second half of 2023.
NEFECON, which only launched in May of this year, delivered RMB 167.3 million , and XERAVA, which launched last year, continued its strong ramp and contributed RMB 134.2 million . With a full six months of sales from NEFECON and XERAVA in the second half of 2024, we are well on track to deliver on our full year revenue guidance of RMB 700 million . Next, I'll take you through some major operational achievements that we made in the first six months. First, on NEFECON. We secured regulatory approvals in both Singapore and Hong Kong, and our supplemental NDA application seeking full approval of NEFECON in China was accepted by the NMPA. Our partner, Calliditas, secured full regulatory approval in Europe through its EU partner, Stada.
Calliditas also reported positive results from the NefIgArd open label expansion trial, which showed a treatment response consistent with the NefIgArd study across endpoints of UPCR and eGFR after repeat treatment of nine months across all IgAN patients. These results supported the study thesis that a response to retreatment with NEFECON was unaffected by previous treatment cycles, providing a solid scientific foundation for the potential long-term treatment with NEFECON. Moving on to XERAVA or eravacycline. Earlier in the year, eravacycline's clinical breakpoint was officially approved in China to support precise use of eravacycline in clinical practice in China based on drug sensitivity. Then there was the announcement of positive interim results from the largest real-world evaluation of eravacycline to date by the expert committee on clinical use of antimicrobials and evaluation of antimicrobial resistance.
This is actually a part of the Ministry of Health, so it's, you know, quite well respected within China, within the China medical community. So this study showed strong efficacy and safety of XERAVA in Chinese patients across IAI and other infections. The results shows the overall efficacy of eravacycline was 89%, and the incidence of adverse events was only 2.9%. XERAVA was also included in multiple treatment guidelines and was the subject of multiple medical journal publications. For VELSIPITY or etrasimod, we're proud to have secured regulatory approval in Macau and Singapore, which marked its first approvals in Everest, in Everest territories. Additionally, we announced positive top-line data, of the maintenance period from a multicenter phase III clinical trial of etrasimod in Asia for the treatment of moderately to severely active UC.
After forty weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in all primary and secondary endpoints. On to zetomipzomib, our most recently licensed renal product from Kezar Life Sciences. We dosed the first Chinese patient in the global Phase 2b PALISADE trial for the treatment of active lupus nephritis. Other than the late-stage products that we just discussed, we continue to make progress on assets where we have global rights. Our first therapeutic mRNA vaccine program, EVM16, a personalized mRNA cancer vaccine, has started an investigator-initiated trial in two top cancer hospitals in Beijing and in Shanghai. Personalized mRNA cancer vaccine programs from Moderna and BioNTech have demonstrated clinical proof of concept and increases our confidence in this therapeutic approach. We intend to leverage our proprietary mRNA technology platform to advance multiple additional programs into clinical development.
We also continue to enroll patients for EVER001, our covalent reversible BTK inhibitor. In the Phase 1b trial in membranous nephropathy, we expect to report preliminary results from this program in the second half of 2024. Sandra Zeng, our Chief Medical Officer, and Dr. Jennifer Yang, our Chief Scientific Officer, will describe these assets in more detail later in the presentation. On this slide, let us delve a little bit deeper into the NEFECON opportunity in China, and why we believe this product is such a significant growth driver for Everest. First, IgAN is a disease where there is a large base of approximately five million patients and significant unmet medical needs in China.
Diagnosis rates are still low, as biopsy is generally required, but we estimate that there are approximately one million biopsy-diagnosed patients in China and approximately 100,000 newly diagnosed IgAN patients each year. What is remarkable about this disease is that it impacts people in the prime of their lives. Most are diagnosed under the age of 45, when they are at their prime working age and raising families. These patients have both more urgent needs, and also, higher willingness for treatment. Based on a large body of research, and as we have seen in our own clinical trials, disease progression in Chinese patients is more rapid than global patients if left untreated. NEFECON is the only approved IgAN therapy in China and the only fully approved treatment globally.
Current treatment options, which are off label, such as JAK inhibitors or SGLT2, are non-targeted and do not alter disease progression. In phase III clinical trials, NEFECON demonstrated 66% less deterioration of kidney function over two years. Nine months of treatment with 15-month follow-up, which could translate into potentially disease, delaying disease progression to end-stage renal disease by 12.8 years. Let us look at the launch of NEFECON, which happened in May of this year in China. So we have developed a strong plan for the launch of NEFECON, deploying significant commercial efforts, and innovative sales and marketing tactics towards the launch. We combine traditional approaches of in-person detailing at hospitals with the more novel approaches of online platforms to make the medicine more quickly and broadly accessible to patients.
We have completed the build-out of the NEFECON sales force at around 120 reps, plus regional and district managers. This team will cover around 500 core hospitals and represent about 60% of the addressable IgAN patients in China. The commercialization platform also includes innovative programs such as patient early access and assistant programs. Our medical affairs team is working to build physician awareness, including through medical publications such as the inclusion of NEFECON in IgAN treatment guidelines. We expect inclusion of NEFECON in KDIGO 2024, as well as in the first Chinese guideline for IgAN in the second half of this year. Equally important, we are working to improve market access and affordability through hospital listings and NRDL negotiations. NRDL negotiations this year will be important for NEFECON revenue growth next year.
We expect results of NRDL listing to be announced in November, followed by listed price announcements in January of next year. We're also working to establish an innovative ecosystem for kidney disease diagnosis and treatment, with the aim of providing IgAN patients tools to enhance disease diagnosis and track disease progression without biopsy, so let's look at the anti-infectives therapeutic area. Similarly, we see significant unmet needs. As you can see in China, antibiotic resistance is a major issue, with 80% of Acinetobacter baumannii cases resistant to carbapenems, and a significant number of Klebsiella cases showing resistance as well. Additionally, the detection rate of metallo-beta-lactamases in carbapenem-resistant E. coli is alarmingly high at 94%, and 22% in Klebsiella. Consequently, there's a strong demand for new, efficacious, and safe treatment options.
Prior to the launch of XERAVA, the main treatments for MDR infections include tigecycline, Zavicefta, which is priced at RMB 4,000 a day, and colistin, which is priced at about RMB 3,000 a day. However, each of these have their downsides. Tigecycline has low tissue concentration and comes with a black box warning label by the FDA. Zavicefta does not cover metallo-beta-lactamases, and colistin has very high incidence of nephrotoxicity. XERAVA is a novel first-in-class fluorocycline antibiotic with broad-spectrum coverage of Gram-positive, Gram-negative, anaerobic pathogens and atypicals. Given its superior efficacy and safety, it is priced at approximately RMB 5,500 a day. Since launching the product in July 2023, XERAVA has achieved aggregate revenue of RMB 233.2 million.
So as a first-in-class antibiotic to offer new solutions for Chinese hospitals battling multi-drug resistant infections, we have been, you know, actively deepening the penetration of the product into our 300 core hospitals with our own sales team of around 120 reps. This year, we have added two CSO partners to expand the coverage in non-core markets. We're generating highly encouraging results, with a 300% increase in the number of treated patients and a 75% increase in the number of hospital listings since the second half of 2023. XERAVA has also been included in three treatment guidelines, as well as published in five medical journals as we continue to build awareness of this important medicine in the community. So turning now to VELSIPITY, the third product in our portfolio.
VELSIPITY, or etrasimod, was approved in Macau in April for the treatment of moderately to severely active UC. VELSIPITY is an effective, safe, and orally available, convenient UC treatment, well-suited for first-time use. We're actively preparing to commercialize this product in Macau and making the medicine accessible to in some of the 19 designated medical institutions in the Greater Bay Area in the second half of 2024, by leveraging preferential policies in the region. By increasing physician and patient awareness, we will pave the way for the full launch of the product in China, which we expect towards the end of 2025.
The commercial infrastructure necessary in ulcerative colitis or UC in China is relatively limited, as patients are concentrated in approximately 100 IBD centers across the country. As we have just presented our three commercial or near commercial products and their progress, you can see that we are well on our way to achieving our vision of becoming a leading biopharma in Asia by 2030. We're focused on three core therapeutic areas, with four on-market or near-market products, with aggregate peak sales potential of over RMB 10 billion. We have three clinical stage products, including Zeto, in a global phase III trial, a Phase 2b trial in lupus nephritis, with data expected in 2026, and EVER001, our BTK inhibitor in a Phase 1b in membranous nephropathy.
All of these candidates target diseases where there is currently no approved standard of care, and we will continue to advance discovery of therapeutic mRNA vaccines for long-term value creation. As we mentioned on the last slide, we have four products that are expected to drive revenue growth for the next few years. We achieved a revenue of RMB 126 million in 2026 from just five months of XERAVA sales as well as NEFECON sales in Macau. For 2024, we are confident in achieving our revenue guidance of RMB 700 million. Looking ahead in 2025 and beyond, we'll have four products on the market, with etrasimod and cefepime-tanibobactam joining the lineup, driving strong revenue growth to eventually reach combined peak sales of RMB 10 billion.
Let's talk a little bit about our investments in two of our core therapeutic areas. Renal disease is one of these. Aside from NEFECON, we have a pipeline of other promising drug candidates with a total addressable patient population of over 10 million. The most advanced of these is zetomipzomib, which is in a global Phase 2b trial in lupus nephritis, with data expected in 2026 . Zetomipzomib is a potential candidate for other autoimmune diseases, and our partner, Kezar Life Sciences, is currently conducting a Phase 2a study evaluating it in autoimmune hepatitis. We talked about EVER001, you know, already, and Sandra will talk about the membranous nephropathy in a little bit more detail later.
We think this is a potentially a pipeline-winning product as well, right? Even though our first indication is MN, it has potential for other autoimmune renal diseases also. Next slide. Let's talk a little bit about our investments in the infectious disease space. MDR infection is a key area of focus for us, and we have a portfolio of antibiotics that offer differentiated and complementary activity. XERAVA offers broad-spectrum coverage with strong activity against the Acinetobacter baumannii. Cefepime-tanibobactam is a best-in-class beta-lactam/beta-lactamase inhibitor with strong coverage of Pseudomonas infections. EVER206 is earliest stage in our pipeline, but is designed to reduce nephrotoxicity of polymyxin, which is an effective class of antibiotic, with its use limited by significant renal tox.
We intend to position these products as foundations for empirical treatment for MDR infections, and expect to be able to leverage our existing hospital anti-infective sales organization to commercialize and create significant synergies. So while we have a robust pipeline, we'll continue to look for ways to further bolster our product portfolio for future growth and value creation of the company. Our dual engine approach is focused on in-licensing of attractive late-stage development or commercial-stage assets in our four therapeutic areas. When we have an existing sales force, we are therefore able to create commercial and clinical synergies and build scale for our entire organization. The second approach is our proprietary discovery platform. We are using our mRNA platform to develop therapeutic vaccines and other programs where we have global rights that can create more value for the company and potentially unlock global partnerships.
Here's our current pipeline of assets where we have global rights. This is increasingly an important part of the Everest story as these programs advance through clinical and preclinical development. So in addition to EVER001 in membranous nephropathy, with four mRNA therapeutic vaccine programs under development for various solid tumor indications and autoimmune diseases. The IIT for our personalized cancer vaccine was launched last week. This is the first therapeutic product independently developed by Everest based on our mRNA technology platform to enter into clinical development. Other cancer vaccine programs, including a tumor-associated antigens cancer vaccine, we aim to submit for U.S. and China IND in early 2025, and a immunomodulatory cancer vaccine that we target for IND filing in 2025 as well.
We are also expecting preclinical proof of concept data in our in vivo CAR-T program, hopefully before the end of this year. This can be developed for both cancer and the autoimmune diseases. Next, we'll take a deeper dive into these pipeline products with global rights. I'll hand over to Sandra to talk about EVER001 first.
Yes, Ian. So EVER001 is our new pipeline. We have the global rights for all the immune renal indications. As Ian just mentioned, that the first indication we're developing is primary membranous nephropathy. And actually, as you know, the PMN, the indication, is the most common cause for the nephrotic syndrome in the non-diabetic adults worldwide. In China, this disease is highly prevalent with approximately two to three million patients, and while in USA, this is a rare disease, still accounts for 80 to 100 thousand patients. In terms of current available treatment, more than 30% of patients do not respond to the standard of care. With the patient that achieve the remissions, still around 30% patients will relapse. In addition, the current treatment are associated with substantial side effects.
Therefore, there is a highly unmet medical needs to develop new therapies which are more efficacious and safer. So EVER001 is a novel and unique BTK inhibitors, and then this compound selectively forms a covalent reversible binding with the C481 in BTK kinase domain, which differentiated EVER001 from other BTK inhibitors on the market. The covalent binding ensures strong BTK inhibition, while the reversibility prevent the prolonged BTK inhibition, which would compromise, you know, the immune response. Therefore, the BTK EVER001 has unique features of high selectivity, potent target binding, and also less on target, off-target toxicity. As you may be aware, BTK inhibitor has demonstrated clinical benefits in B-cell malignancy. BTK is an essential component for BCL receptor signaling pathway.
BTK can influence production of messenger molecules, which can abnormally activate the B-cell receptor signaling pathway and transform B cells to self-reactive B cells responsible for the autoimmune renal disease, such as PMN. You know, PMN occurs when the B cells produce pathological autoantibody against the antiphospholipids on podocytes targeting glomerulus. Then, therefore, you know, BTK inhibitors can inhibit the activation, differentiation, and proliferation of B cells to reduce the autoantibody produced by B cells. So that's why we are developing the EVER001 in, you know, the first indication is through PMN. So, the first in human study of EVER001 conducted actually is in the healthy subjects. The data already published, you know, in general, EVER001 was well tolerated after single and multiple exposures. There's no serious adverse events were re-reported.
The most frequently reported adverse events actually are increased blood triglyceride, and the decreased neutrophil count and decreased lymphocyte count. And also from PK perspective, EVER001 exhibited a dose proportion increase in Cmax and AUC curve for in single and multiple dose administration. Regarding the BTK receptor occupancy, under the multiple dose of 400 mg and 600 mg QD for 10 days, the receptor occupancy remained above 80%, which suggests a sufficient BTK inhibition for all the immune renal disease. But actually, we are very excited about our phase 1b study, which is conducted in PMN patients with positive autoantibodies. The study was designed with different dose cohort. The cohort was starting with dose 100 mg QD for four weeks, followed up by 100 mg BID, followed by 100 mg BID for 32 weeks.
The cohort 2 actually is 200 milligram BID for 36 weeks. The primary endpoint is the safety and tolerability, and of course, the second endpoints are the efficacy, including percentage change from baseline of proteinuria, you know, autoantibody level, and UPCR and the eGFR. We are expecting the preliminary result from phase 1b study in the second half of 2024. Simultaneously, we are planning to initiate the phase 2 study trial in the early 2025. So right now, I turn to the Jennifer, talking about the mRNA.
... Thank you, thank you. So we are very proud that we have established a fully integrated and clinically validated mRNA platform with end-to-end capabilities across the whole value chain of this platform. We believe using this platform will be able to help us discover and develop more novel drug candidates, which will create value for our shareholders. Many of the capabilities along this platform stem from internal innovation. For example, we have a proprietary active design algorithm that can ensure high expression of target antigen or target protein. We are also developing next generation LNP delivery system to further enhance T-cell immunity. Our CMC team is capable of developing a robust process to ensure high quality mRNA DS/DP production.
Last but not least, our self-owned manufacturing facility in Jiaxing has successfully produced GMP material to support clinical trials, with the full capability of scaling up to produce commercial scale material down the road. Next slide, please. Based on this platform, we've built multi-product therapeutic cancer vaccine pipeline. The most advanced program is EVM16. This is a personalized neoantigen cancer vaccine. As you probably know, personalized neoantigen cancer vaccine developed by BioNTech and Moderna have shown promising clinical results in early trials. As a matter of fact, Moderna, along with its partner, Merck, initiated several big trials, including two phase three trials, suggesting that this type of modality can bring clinical benefit to patients. Back to our EVM16. Once a tumor sample is obtained, next gen sequencing will be carried out to identify specific mutations.
And then our proprietary neoantigen prediction algorithm will further identify those neoantigens with high immunogenicity potential and assemble them into a vaccine design. Once this vaccine is manufactured, it will be given back to patient along with anti-PD-1 antibody. Our self-developed algorithm has gone through several rounds of validation. First of all, in preclinical animal models, our algorithm is able to identify known and previously unreported tumor antigens. All of those antigens are proved to be highly immunogenic in mouse, and our algorithm also has superior performance in several multiple independent validation studies. Preclinical data also demonstrated synergistic effect of combining EVM16 with checkpoint inhibitors, which supports application of this combination in an upcoming clinical study.
This month, we've launched a IIT study in two top cancer hospitals in China, Fudan University Shanghai Cancer Center, as well as Beijing Cancer Hospital. In this first in human phase one A trial, we'll be evaluating safety, tolerability, immunogenicity, as well as preliminary efficacy of EVM16. And in phase one B, we plan to apply EVM16 or test EVM16 in multiple tumor types with high unmet medical needs, including HCC, CRC, or pancreatic cancer. Clinical results will become available starting from 2025. Next slide. The second program from our pipeline is EVM14. This is an off-the-shelf tumor-associated antigen TAA vaccine. TAA type of vaccine has its own advantages while maintaining good tumor specificity, because these TAAs are highly expressed in tumor, whereas no expression or very limited expression in normal tissues.
EVM14 can cover more T-cell epitopes, and there is no need for HLA selection of patient. So, this type of vaccine can be applied to a broader patient population. Due to its off-the-shelf nature, this type of vaccine, EVM14, can be applied to multiple clinical settings, especially well-suited for advanced stage disease. Compared to personalized cancer vaccine, it also has reduced manufacturing cost, and has the potential to be applicable to multiple cancer indications. Last month, BioNTech announced a positive top-line phase two results of their TAA vaccine, indicating TAA vaccine can bring benefit to late-stage cancer patients. Currently, EVM14 and enabling studies are ongoing. We anticipate IND filing in early 2025 . With that, I'm gonna hand over to Ian to talk about financial numbers.
Thank you, Jennifer. So let's take a look at our financial summary. I think the most important takeaway I would like to highlight is our ability to substantially increase operating efficiency while driving rapid revenue growth. First half of 2024 revenue was RMB 301.5 million. It's a significant increase over the approximately RMB 9 million reported in the first half of 2023, and RMB 126 million in the second half of 2023. This is mainly contributed by the sales ramp-up of XERAVA and the successful launch of NEFECON. The cost of revenue was RMB 70.4 million. Excluding non-cash items, our gross margin was 83%. This is inclusive of royalty obligations to our licensing partners.
G&A expenses were mostly stable at RMB 87 million, which means that we were able to support our growing operations and revenue base without substantially increasing our corporate expense. R&D expense decreased by 4% to RMB 253 million in the first half of 2024. This is due to lower clinical trial expenses in our programs. However, we continue to invest into our wholly owned discovery programs, and those costs were steady. Distribution and selling expenses increased by RMB 36 million to RMB 200 million. The expenses in the first half of 2023 occurred prior to our commercial launch in China. XERAVA, our first product commercialized in China, was launched in the second half of last year, and this year we launched NEFECON. We expanded our commercial activities to support both products.
However, if you look at commercial expense to revenue ratio, which represents the efficiency with which we generate our revenue, it decreased significantly both year -over -year by 645.4% and over second half of 2023 by 76%, showing that we are able to generate more revenue with less expense. This leads to our non-IFRS net loss for the period, narrowing by RMB 114.3 million, or 35%, to RMB 212.6 million. To arrive at the non-IFRS net loss number, we backed out non-cash and one-time items from IFRS measures. The most significant of which is a one-time, non-recurring, intangible asset impairment loss on the mRNA COVID-19 vaccine program, which we have deprioritized due to declining economic and social benefits.
I would like to just add here that, clearly, when we brought in the mRNA platform in, towards the end of 2021 , you know, we intended to develop not just COVID-19 mRNA vaccines, we also wanted to leverage the platform value of mRNA towards other wholly owned mRNA programs. And you can see the early milestones that we have been able to achieve in that based on what Jennifer have talked about earlier today. So, you know, at the same time as our losses narrowed, we maintained a healthy cash balance of RMB 1.93 billion in cash and cash equivalents as of June thirtieth, 2024 .
We believe this provides sufficient amount of funds for the company to support current growth. Our goal remains to get to cash flow break even in 2025. So we're extremely proud of you know what we have been able to achieve in the first half, and these are focused on executing a number of key goals for the second half of the year. So for NEFECON, we're just in the early days of our launch, and are focused on building sales momentum with our newly onboard sales team and stepping up medical education to raise awareness of NEFECON among physicians and patients. The top priority for the second half of 2024 is the NRDL negotiation, which we've spent tremendous efforts on.
Lastly, we expect to have NEFECON included in the new legal treatment guideline and the Chinese IgA treatment guidelines to further raise awareness in the medical community. For XERAVA, we continue to focus on commercial execution, deepening our penetration of our 300 core target hospitals, as well as leveraging our partnerships with CSOs to expand into regions beyond our own sales coverage. For VELSIPITY or etrasimod, we look forward to beginning our commercial efforts in the Greater Bay Area, as well as submitting for an NDA approval in China. Clinically, we will continue to advance multiple cancer vaccine programs towards IND filing in 2025, and intend to make significant preclinical progress with our in vivo CAR-T programs as well.
...We also expect to read out results from multiple important trials and real-world studies, including phase 1b data from EVER001 in membranous nephropathy, data from an open-label extension trial of NEFECON in Chinese patients, and real-world evidence studies from both NEFECON and XERAVA, including an analysis of NEFECON's Boao early access program. So let me wrap up on this slide and say that we're off to a very good start in this first half of 2024 , but we'll continue to be focused on revenue growth and operating efficiency in the second half of this year and beyond. We hope to deliver on our full-year revenue guidance of RMB 700 million and build a solid foundation for 2025 , including turning cash flow positive by the end of that year.
So with that, let me ask the operator to start the Q&A session.
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 text your questions as messages. For participants dialed in, please press star one to queue up for questions. The first question comes from Goldman Sachs, please.
Good morning. Thanks for taking my question. I have two questions regarding NEFECON. The first one is, congratulations that we achieved a very encouraging early ramp-up within two months of selling, and now at the end of August, we have accumulated around four months of selling. Can you share a bit more colors on the real-world usage of NEFECON, particularly, I'm interested on the patient profiles. How many patients have we treated, and among the patients, what are the percentage that have kidney biopsy tested, and what is the average DOT that has been observed so far, and also interested on any breakdown on the online and offline prescription trends. That's the first question.
And the second question is, I know that most recently, Novo Nordisk filed NDA for semaglutide for chronic kidney disease in China. How do you see potential impact from GLP-1 in CKD on NEFECON? Thanks.
Thank you for your question. So probably I can answer your question. First of all, the performance of the first several months of NEFECON met our expectation as we forecast building our assumption of this year's performance and the guidance. With regards to the patient types who have been using NEFECON, I think there are several patient types. Of course, 100% of them are being diagnosed with kidney biopsy, definitely. Some of them the early stage, some of them are old patients who has been diagnosed again for many years and seeking for treatment which can delay their delay the progression of the to ESRD.
Some of them are, of course, some of the newly diagnosed patients who are, you know, seeking for innovative treatments with the indication and benefit on their renal function preservation. So that's both are these two types of patients. 100% of them are, you know, diagnosed by kidney biopsy. So with regard the split of online, offline at the early stage, most of the patients are, I would say, as warehouse patients, you know, we have a EAP program since last April from Boao and Macau. At that time, some of the patients are, you know, went to Boao and Macau to have NEFECON for treatment. And once we commercialize the products, some of them are warehouse patients.
As we disclosed before, there are more than 20,000 patients registered for their PAP and free consultation services program in China. So some are from those warehouse patients, and those patients at the early stage are online more than offline. And in the later stage, currently it's about, I would say, most are from offline, so from the hospitals and pharmacies patients get the product. So that's about the. I think in the future probably more and more patients get the products in the hospital rather than on online platform, because online platform, you have to the patient has to be diagnosed in the hospital, get a prescription, and with that prescription, you can get a product online. So that's a change.
Looking forward, if in next year, if we can get a reimbursement, I think most of the patients will from the hospital channel. So that's about the state of the breakdown of online, offline, product delivery. And with regard, you asked a question about this GLP-1. I think, IgANs are immune, kind of, autoimmune disease. So it's, we don't see any evidence those GLP-1 products can be effective in those patient groups. Of course, you can see as GLP-1 of those kind of, products, was being used in this IgAN patient group, but without label, it's so off -label, and also it's been defined as, supportive care. It's not a kind of, treating the origin of this disease, which is, immune disorders.
So I don't see, at least as of now, we don't see any impact for those kind of products.
Thanks for the very comprehensive answers, and thanks for your time.
For 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 dialed in, please press star one to queue up for questions.
So, you know, while we are, you know, looking at the questions from the audience, I have a couple of questions that were emailed to us before the call that, you know, I'd like to read and ask the management, you know, for their answers. So the first question is that, we're excited to see Everest's first mRNA vaccine going into clinical development. When do you plan to release first human results? And are you under BD discussions with global partnering?
Yeah, well, certainly to ask the question first, yes.
Yeah. Thank you for the question. As we just disclosed, the first cancer vaccine program, EVM16, personalized, you know, engineered cancer vaccine, just entered clinical trials this year. We do anticipate more clinical results, you know, coming out next year. You know, because in this phase 1a, the main purpose, primary objective is actually to evaluate the safety, tolerability, immunogenicity, as well as preliminary efficacy of this product. So, 1a data, we do expect, you know, next year, we should be able to obtain some 1a data. And then we're going to launch 1b in particular tumor types later on.
We are also, you know, we will be seeking a potential collaboration, partnership opportunities, for these, you know, novel therapeutic vaccines. Do you have any additional comment?
Sure. Yes. Thank you. You know, I think first of all, I think our discovery strategy is that we want to advance globally differentiated and competitive programs. Right? So clearly for us, you know, when we think about discovery pipeline products, it's we don't have just the Chinese market in mind. We want to eventually be able to create value globally and benefit more patients. Second, you know, at the moment, we do not. We have very limited infrastructure outside of China. So, you know, exactly how we realize those global value, you know, we think that, you know, partnership is probably something that we will explore to maximize that.
But exactly when and, you know, what it looks like, is something that, you know, we are evaluating. What we can probably disclose is that, both, you know, Jennifer, as well as Sandra, as well as our business development team, you know, have been working to make sure that, the key players globally are aware of what we are doing, in this space. So that they can, you know, start to monitor us, and at the right time, you know, we can, you know, unlock these potential partnerships.
Thanks, Dan. Thanks, Jennifer. And the other question that I had received online is that: What is the outlook for your expenses, you know, with the push for the self-developed mRNA platform, are you planning to spend more on R&D?
Yeah. Sure. Thanks for the question. I think, you know, we, as you have seen, with our first half, 2024 financial results, you know, we have reduced the spending on the clinical trials front as a lot of our late-stage products exit clinical development into commercialization.
... whereas our spending on the discovery piece remains stable, right? So clearly, we are committed to investing into this area, which we see as a, you know, tremendous area for potential shareholder value creation. However, we approach R&D expense the same way as we approach G&A expense and, you know, commercial expense. We will do so in a highly effective and efficient and focused way. And so, you know, do not look for R&D expense to, you know, increase significantly. You know, but we do intend to continue to invest into the space.
Thanks, Ian. Operator, can I ask again if there's any more questions online?
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Okay, thank you, operator. I think we are at time, actually. I'd like to ask Rogers to give a few, you know, words to conclude this call. Rogers?
Great. Thank you. Thank you, everyone, for attending our 2024 half-year results conference call. I think we're very pleased that at the first half of this year, we achieved strong revenue growth, at the same time, you know, optimize our operational efficiency, and with a very strong, you know, cash balance. At the same time, I think we start to you know, have to see the early result of our in-house innovation. So, in our mRNA, you know, we started first in our mRNA cancer vaccine trial, IIT, this year as well. We are, you know, doing well in our BTK inhibitor with global rights. So I think this is very consistent with our New Engine growth strategy.
With the good results, strong results of the first half of the year, we're committed to deliver RMB 700 million sales this year, and with all the key milestones meet this year. We are very confident, and thank you for all your support. Thank you.
Thanks, everyone, for your attendance. This concludes today's conference call.