Good morning or good evening. Welcome to Everest Medicines' Full Year 2024 Financial Results Conference Call. Please be advised that today's conference is being recorded. During the Q&A session, the 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. We'll task your questions as messages. For participants who dialed in, please press star one to queue up for questions. I would now like to hand the conference over to your speaker today, Ms. Leah Liu . Please go ahead.
Thank you, Operator. Good morning and good evening, everyone. Welcome to our Full Year 2024 Financial Results Conference Call. Joining us today are Mr. Rogers Luo , our Chief Executive Officer; Mr. Ian Woo , our President and CFO; Mr. Rico Liang, our Chief Product Officer; Dr. Jennifer Yang, our Chief Scientific Officer; and Sandra Zeng, our Chief Medical Officer.
Before we get started, I'd like to remind you that the speakers on this conference 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, intent, plans, belief, estimates, confidence, 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 statement as a result of various factors and assumptions. The company or any of its affiliates, directors, officers, advisors, or representatives may have no obligation and does not undertake to revise forward-looking statements to reflect the new information, future events, or circumstances after the date of this conference call, except as required by law. I will turn the call over to Rogers to provide you with more details on our business updates and 2024 full year results. Rogers, please. Thank you.
Thanks, Leah. Thank you, everyone, for joining this call. 2024 was an exceptional year of where we generate strong revenue while improving operational efficiency and ended the year with very solid balance sheets. Our full year 2024 revenue of RMB 706.7 million reflected significant 461% year-on-year growth and exceeded our guidance of RMB 700 million revenue. Gross margin on a cash basis were an impressive 83% for the full year 2024, backing out non-cash amortization of capitalized expenses, which we think is a better reflection of the true picture of the company's operations.
As a reflection of our highly efficient organization, our operating expenses as a percentage of revenue reduced 562% year-on-year by delivering strong revenue growth with lower R&D spending and increase in commercialization and G&A expenses. We continue to achieve profitability at the commercial level. Our non-IFRS net loss was approximately RMB 537.6 million, down by 25% year-on-year.
We have consistently provided non-IFRS disclosures, which backs out one-time items and non-cash charges and believe that this is the best measurement of the company's operations. Our cash balance of RMB 1.6 billion remains strong and provides significant flexibility to fund the continuing growth of our business. We will target to achieve cash level break-even by the end of 2025.
Together, this combination of high revenue growth, optimized operational efficiency, and strong cash positions puts us at a strong position to execute on our dual engine growth strategy, which focuses on strong commercial execution in parallel with internal development and in licensing initiatives. Also, we are glad to share that with the release of 2024 annual results, we will be qualified for removal of "B" marker to the company's English and Chinese stock name, which can be seen as a recognition of our progress from biotech to a biopharma company.
Our total product revenue reached RMB 706.7 million for the full year of 2024, marking a remarkable 461% increase compared to the full year of 2023. Nefecon, which was launched in May, generated revenue of RMB 353.4 million, representing a staggering year-on-year growth of 1,581%. This outstanding performance was achieved with the support of a dedicated team of 150 sales reps, covering 600 to 700 hospitals, which represents around 60% of the market potential.
Meanwhile, XERAVA, introduced in March with approval in March 2023 and launched in late July of 2023, continued its strong trajectory, contributing RMB 352.8 million in revenue. This growth amounted to a 256% increase year-on-year. This was driven by our focused commercial team of 120 sales representatives, covering 300 core hospitals. We also started working with two CSOs in the second half of 2024, which may contribute more to our revenue growth in 2025 onwards.
Next slide. Throughout 2024, we have had multiple record-three achievements for Nefecon and etrasimod, extending the availability of these products to patients in our territories. 2024 was a big year for Nefecon. Nefecon was successfully listed in the National Reimbursement Drug List as the only approved IgA therapy. The NRDL listing, which was officially implemented on 1 January 2025, makes Nefecon affordable to the majority of patients in China and thus lays the solid foundation for rapid growth in the next few years.
The SNDA for full approval of Nefecon in China has been accepted by CDE, expecting to receive approval in 2025. We believe we are well situated as a leading IgA treatment in China. Besides China, Nefecon also gained NDA approvals in Singapore, Hong Kong, Taiwan, and South Korea. On proximity, it was approved in Macau and Singapore in 2024.
With the Macau approval, we could benefit from Hong Kong and Macau medicine and equipment connect policy, which leads to the launch of the product in multiple hospitals in Guangdong Province. This NDA has also been accepted in mainland China and Hong Kong. We expect China approval in late 2025 to early 2026 and a full product launch next year.
Next slide. We also have major clinical advancements in 2024. From data publications to guideline inclusions, let's take a look by product. First, in Nefecon, we presented additional positive results on Nefecon at ERA. WCN and two-year Chinese subpopulation data was published in the Kidney 360 magazine, which shows faster and more severe disease progression in Chinese population. Our partner, Calliditas, announced positive Nefecon open label extension result, which provides a solid scientific foundation for the potential long-term maintenance treatments.
Besides, Nefecon was included in the clinical drugs guidelines last year, with the official publication expected in 2025. For Velsipity, we launched positive induction phase data and maintenance data from our Asian multi-center Phase III clinical study and presented such data at the AOCC 2024, 32nd UEGW 2024, and Chinese ECCO 2025, respectively.
This positive data demonstrated etrasimod has the potential to be a breakthrough option for UC patients. For XERAVA, clinical breakpoints were approved by Chi CAST, which gives doctors increased guidelines on using this important anti-infective drug. We generated new clinical evidence supporting increasing utilization, such as the real-world data from the National Health Commission, demonstrating an overall efficacy rate of 90.1%, with a very low 2.7% AE rate. On the CHINET 2024, XERAVA susceptibility rates of 98%, 97.5%, and 96.4% against E. coli, Acinetobacter baumannii, and Klebsiella pneumoniae, respectively.
XERAVA data were included in the three treatment guidelines and 14 medical journal publications in 2024. Cefepime-taniborbactam , the second product in our infectious disease portfolio to be launched, showed superiority to meropenem in the phase III, CERTAIN-1 study published on the New England Journal of Medicine by our partner, Venatorx.
Besides our commercial or near-commercial stage products, I wanted to draw your attention to the amazing progress we were making in our pipeline with global rights EVER001. Our BTK inhibitor generated positive clinical POC results and announced encouraging results last December. We plan to report more data from this program this year. On our mRNA platform, we recently held an investor call to highlight our very exciting pipeline of mRNA cancer vaccines.
I'm proud to report that we have dosed our first patients in the personalized cancer vaccine program, EVM16, and IND application in the US for EVM14 has been approved. This is Everest's first in-house developed product to receive US IND approval. Lastly, our highly promising in vivo CAR-T program generated POC in animal models.
Next slide. Diving a little bit deeper, I would like to share again the key highlights of EVER001 , positive results we announced in December. In conclusion, EVER001 induced early onset of high risk of immunological and clinical response. In cohort one, 90% of subjects achieved ICR at week 28. In cohort two, all subjects reached ICR at week 24. Of course, if we look at their percentage change, close to 100% reduction in both cohorts by the data cut-off date.
If we look at their clinical response in quarter one at week 36, 82% of subjects already experienced proteinuria remission. For cohort two by week 24, 86% of subjects already experienced proteinuria remission. In addition, the serum albumin levels returned to normal or near normal range in cohort one by week 36, in cohort two by week 24.
Besides efficacy, safety is also very important for a new drug in autoimmune disease. For both cohorts, EVER001 treatment was well tolerated and safe. Most AEs were just grade one or grade two, and also these AEs are transient. No clinically meaningful adverse events typically associated with BTK inhibitor, such as serious neutropenia, hemorrhage, and cardiac arrhythmias, have been observed. Through these assets, we have demonstrated our capability to quickly move an in-licensed global asset to clinical proof of concept.
We believe these and other drugs in our pipeline, with global rights, have the potential for forming global partnerships and become a significant future value driver for Everest. Next, I'll turn over to Ian, and he will go through our financial performance for 2024.
Thank you, Rogers. Next, I would like to take a closer look at our financial statement. The most important takeaway I would like to highlight is our ability to substantially increase operating efficiency while driving rapid revenue growth. 2024 full-year revenue increased significantly by RMB 580.7 million, or 461%, to RMB 706.7 million, driven primarily by the strong growth of XERAVA and the successful launch of Nefecon in Mainland China. I will also highlight that RMB 706.7 million exceeds our revenue guidance for last year. The cost of revenue was RMB 179.8 million, excluding non-cash items. Our gross margin was 83%.
This is inclusive of royalty obligations to our licensing partners. G&A expense increased RMB 84.9 million to RMB 250.1 million, primarily attributable to higher compensation and professional services expenses as we grow into a larger organization with broader business operations. R&D expense was RMB 528 million. This amount is a slight decline from 2023, as the company remains committed to strategic R&D investments across its various product pipelines for long-term sustainable growth.
Distribution and selling expenses increased by RMB 276.7 million to RMB 508.1 million. This increase coincides with the growth of existing product sales and the launch of new products as we expand our commercial team and increase our commercial activities.
However, if you look at commercial expense to revenue ratio, which represents the efficiency with which we generate our revenue, it decreased significantly year- over- year by 111.9 percentage points, showing that we are able to generate more with less capital. We expect to continue to improve commercial expense to revenue ratio in 2025.
This leads to our non-IFRS net loss for the period narrowing by RMB 176.1 million, or 25%, to RMB 537.6 million. To arrive at the non-IFRS net loss number, we back out non-cash and one-time items from the 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 in the first half of 2024. The COVID program has now been fully impaired.
At the same time as our loss narrowed, we maintained a healthy cash position with RMB 1.6 billion in cash and cash equivalents as of 31 December 2024. We believe this provides sufficient funds for the company to support growth initiatives. Our goal remains to reach cash flow break-even by year-end 2025. With these financial results, we now qualify for the removal of "B" marker to the company's English and Chinese stock name. It is a testament to our ability to generate revenue from continuing operations.
As Rogers mentioned earlier, it reflects our transformation from a biotech to a biopharma company. If we are looking at this slide, you can see that building on our strong performance in 2024, Everest is well on track to become a leading integrated biopharma company in the Asia-Pacific region. Our dual engine strategy will continue to fuel sustainable revenue and pipeline growth.
The first engine is our China-focused commercial platform that currently houses three key products: Nefecon, XERAVA, and Velsipity. Our proven licensing capability allowed us to quickly build a unique pipeline and leadership position in core therapeutic areas. Around these assets, we have established a highly efficient and lean commercial infrastructure that drives revenue growth and cash generation. We have been able to achieve commercial-level profitability and expect cash flow generation to accelerate as we increase in size and scale.
We will continue to leverage this platform to launch more pipeline assets. The second engine is our in-house R&D platform, where we have made tremendous progress building a portfolio of and generating clinical proof of concept data on assets where we have global rights. We will continue to advance EVER001 and our mRNA therapeutics targeting cancer and autoimmune indications.
We believe these assets can generate significant value for Everest, either from future data generation or through external partnerships. We expect that this parallel approach to pipeline development, combined with our strong commercial growth and existing infrastructure, will drive sustainable growth for Everest in the coming years. Next, I will highlight some of Everest's core therapeutic areas and related product portfolio.
Everest is well known for our strategic focus on renal diseases, and we look to both strengthening our position in IgAN following the strong Nefecon commercial launch in China and expanding presence in indications beyond IgAN. Our second clinical asset in this space is EVER001, which, as Rogers mentioned earlier, has already delivered exciting clinical proof of concept data in primary membranous nephropathy, or PMN.
Similar to IgAN, PMN is an orphan disease in the U.S. and Europe, but our research shows that there are 2 million patients in China. There are no approved therapies for PMN, and we believe that EVER001 represents an attractive treatment option for PMN patients. EVER001 also has potential in other autoimmune renal diseases, including IgAN, lupus nephritis, MCD, and FSGS.
These are diseases with critical unmet needs, with a total addressable patient population of over 10 million in China and over 300,000 in the US. We own global rights for renal and intend to explore these additional indications in parallel with PMN. As part of our efforts to build an ecosystem around renal diseases, we are also developing a Gd-IgA1 diagnostics kit to provide IgAN patients with a tool to enhance disease diagnosis and track disease progression without biopsy.
This is expected to be approved and marketed in 2026. Finally, renal is an area of active BD activities, and we are committed to building a pipeline of innovative therapeutics in this space. Let's talk about Nefecon in a little bit more detail.
Most people on this call are probably familiar with Nefecon as the first and only approved drug for IgAN in China, where there is a large addressable patient population of approximately 5 million patients for IgAN , among which about 1 million are biopsy diagnosed and with roughly 100,000 newly diagnosed patients every year. In phase III clinical trials, Nefecon demonstrated 66% less deterioration of kidney function, which could translate into potential delaying disease progression to end-stage renal disease by 12.8 years.
The KDIGO guideline update draft published in 2024 for public review recommends a nine-month initial course of treatment with Nefecon for patients who are at risk of disease progression and recommended repeated nine-month treatment cycles or a reduced dose maintenance regimen after the first nine months of treatment to achieve desired levels of proteinuria reduction or stabilization of eGFR.
The most significant driver for Nefecon is its inclusion in the 2025 NRDL in China, which increases affordability for patients and opens the door to significant patient volume growth. Now, less than three months after the NRDL initiation on 1 January 2025, we are seeing rapid implementation across our target hospitals earlier, either through formal hospital listings or dual-channel pharmacies. We will continue to enhance physician and patient awareness through a combination of education and RWE data generation.
The expected addition of Nefecon to the updated KDIGO guideline and China's first guideline for IgAN in 2025 will also drive broader commercial adoption. To broaden our coverage of hospitals and physicians, we intend to expand our sales organization to 200 sales reps in 2025 and believe that we can reach 80% of the addressable market potential. Now, switching to our infectious disease area, the WHO updated its bacterial priority pathogens list in 2024 to reflect recent trends in global microbial resistance.
CRAB and CRKP continue to be listed as critical priorities, highlighting the substantial unmet needs in this area. In China, antibiotic resistance is a major issue, with 65% of the Acinetobacter baumannii cases resistant to carbapenems, and a significant number of Klebsiella and Pseudomonas cases showing resistance as well. Additionally, the detection rate of metallo-beta-lactamases in carbapenems-resistant E. coli and CRKP is alarmingly high.
There are limited available treatment options prior to XERAVA, each with its downsides. Consequently, there is strong demand for new, efficacious, and safe treatment options like XERAVA. Behind XERAVA, we have two pipeline products in the infectious disease space. Cefepime-taniborbactam is a best-in-class beta-lactam/beta-lactamase inhibitor for empirical treatment of multidrug-resistant infections. We plan to submit the NDA for this product to the NMPA in mainland China for the treatment of cUTI this year.
If approved, we believe that there are synergies with XERAVA in terms of both spectrum of coverage and the ability to leverage our existing infectious disease commercial infrastructure. In 2025, Everest looks to deepen XERAVA's role in combating multidrug-resistant infections by strengthening the position of XERAVA as the foundation for early-aligned empirical treatment regimen for MDR infections and increasing efforts to enhance adoption in our 300 high-priority target hospitals.
Our efforts are supported by strong surveillance studies from CHINET, which shows close to 100% susceptibility rates to XERAVA across commonly seen resistant pathogens. RWE data covering 3,300 cases analyzed by the China's National Health Commission showed XERAVA with 91% efficacy in CRAB and CRKP infections with a very low 2.7% adverse event rate.
This combination of potency and safety positions XERAVA as a best-in-class option in China. In terms of commercial efforts, we continue to leverage a hybrid model, a dedicated lean team of 150 sales reps covering 300 target hospitals, and strategic partnerships with two leading CSOs to broaden reach. Turning to our autoimmune franchise and lead program, Velsipity or etrasimod , the third commercial product in our portfolio. Velsipity was approved in Macau in 2024 for the treatment of moderately and severely active ulcerative colitis.
Velsipity is an effective, safe, and orally available, convenient UC treatment well-suited for first-line use. UC represents an attractive and sizable market in China that is expected to grow to 1 million patients in 2030. Additionally, the target physicians are concentrated in approximately 100 IBD centers in China, making it easier to target these prescribers with a lean sales footprint.
To date, Velsipity has been made available in five medical institutions in Guangdong Province under the Greater Bay Connect policy, which allows us to start physician and patient education. We are expecting more significant contributions from this product in mainland China, with NDA approval expected in late 2025 or early 2026. I will now hand the mic to Sandra to talk more about EVER001.
Yeah, as we presented in our call last December, EVER001 is a covalent reversible BTK inhibitor that we are developing for autoimmune renal diseases. EVER001 can selectively form c reversible covalent bond with Cysteine -481 in the BTK kinase domain, which is distinguished from other BTK inhibitors currently marketed for other indications. Those BTK inhibitors are either covalent irreversible inhibitors or non-covalent reversible inhibitors. For EVER001, the covalent binding with Cysteine-481 in the kinase domain ensures a strong BTK inhibition, while its irreversibility and selectivity leads to less off-target toxicities. These features may particularly fit for patients with autoimmune diseases who likely need a long-term treatment. Right now, we are currently running our phase Ib and the phase IIa trial in the patients with primary membranous nephropathy, which we reported a preliminary result in December.
The study enrolled PMN patients with positive anti-PLA2R autoantibody, and they evaluated the two dose levels. The low dose level is the cohort one starting with 100 mg QD for four weeks, followed by 100 mg BID for 32 weeks. For the cohort two, which is the higher dose level, 200 mg BID was administered for 36 weeks. Both groups, all the patients are being followed for up to two years. Next one, please. In December, we reported data of total 31 patients at the data cut of September 13, 2024. We were pleased to observe that EVER001 induced immunological complete remission, ICR, as early as week eight. As shown in the graph, the blue bars represent the result from the cohort one, the low dose, and the red bar represents the high dose cohort two.
In the cohort one, by week 16, more than 50% of subjects already experienced immunological complete remission, ICR, and by week 36, as many as 90% of patients achieved ICR. For the cohort two, 67% of subjects experienced ICR at week eight, but by week 24, all seven subjects achieved immunological complete remission. Next one. If we look into the clinical efficacy endpoint, the 24-hour proteinuria reduction is very important for the patients of CAST. The preliminary analysis showed a remarkable proteinuria reduction during the treatment period for both cohorts. In the cohort one, 73% of subjects experienced proteinuria remission at week 28, with one subject achieving complete remission. By the week 36 time point, 82% of subjects experienced proteinuria remissions, with two subjects achieving complete remission. The median time to the proteinuria remission was about 20 weeks.
For the cohort two, as early as week 20, we already observed 86% of subjects experienced proteinuria remissions, and by week 28, all four subjects achieved proteinuria remission. The time to proteinuria remissions in this cohort was much more rapid, with a median time of 16 weeks. Besides this impressive efficacy result, with respect to the safety, as Rogers already mentioned, EVER001 was safe, and we are tolerated in both those levels. We did not observe any clinically meaningful adverse events typically associated with BTK inhibitors, such as serious neutropenia, hemorrhage, and cardiac arrhythmia. Now I am turning to Jennifer, who will be presenting to you about our mRNA platform. Thank you, Sandra. Earlier this month, we held a conference call to present to you our mRNA technology platform, progress made on our cancer vaccine and in vivo CAR-T programs.
At Everest, we have a fully integrated and clinically validated mRNA platform with end-to-end capabilities across the whole value chain. Our proprietary antigen design algorithm can ensure high expression of target protein. Our proprietary LNP delivery systems lead to enhanced T cell immunity, which is well suitable for cancer vaccine programs. Our CMC process development capabilities can ensure high-quality mRNA DS/GP production. Last but not least, our self-owned manufacturing facility in Jiangshan has successfully produced GMP-grade materials. Next slide. We have developed a proprietary LNP delivery system with novel ionizable lipids, while AI has been used in our efforts for the lipid screening. With the help of AI, we are able to expand the diversity of the lipid library as well as enhance or increase the screening efficiency. Next slide.
To enable our personalized cancer vaccine program, we developed a proprietary machine learning-based neoantigen prediction algorithm named EVER-n eo 1. This algorithm takes into consideration many aspects of a strong immunogenic neoantigen, and it identifies and generates those immunogenic neoantigens that we can assemble into a vaccine. This algorithm has identified multiple known and previously unreported tumor antigens in our preclinical animal models, and it has been well validated using human clinical data. Next slide. With this platform, we have established a pipeline of mRNA therapeutics. The most advanced one is our personalized cancer vaccine program, EVM16. EVM16 preclinical data demonstrated strong anti-tumor effects, both as a monotherapy as well as in combination with PD-1 antibody. Recently, we have commenced an investigator-initiated trial in two top cancer hospitals in China, Fudan University Shanghai Cancer Center and Beijing Cancer Hospital.
The first patient was dosed with EVM16 on March 4th. In the first phase Ia part of the study, we are evaluating safety and tolerability of EVM16 monotherapy, as well as in combination with anti-PD-1 antibody to identify the RP2D in order to advance this program. We will provide more updates on this program over the course of the year. The second program is tumor-associated antigen TAA cancer vaccine, EVM14. This is an off-the-shelf cancer vaccine. It has several advantages. First, this type of cancer vaccine would usually have good tumor specificity, as the antigens are only highly expressed in tumor tissues, with very limited expression in normal tissue. Second, because there are more T cell epitopes in such vaccine, there is no HLA selection needed for patients. Due to its off-the-shelf nature, this type of vaccine is well suited for advanced stage disease.
Compared to PCV, the TAA vaccine has lower manufacturing cost, and it has the potential to be applicable for multiple cancer indications. Our EVM14 is a bivalent vaccine designed to target five TAAs highly expressed in squamous non-small cell lung cancer and squamous head and neck cancer. The combination of EVM14 with immune checkpoint inhibitors, including anti-PD-1 antibody or anti-CTLA-4 antibody, can significantly enhance anti-tumor activity in preclinical models, supporting the exploration of this combination regimen in future clinical development. Preclinical data not only showed immune response, but also showed that EVM14 can potentially induce immune memory cells and prevent tumor recurrence. Recently, FDA approved our US IND, marking the first US IND for Everest. We are in the process of submitting the IND in China this year. Next slide.
In addition to these cancer vaccine programs, we've also developed an in vivo CAR-T program based on our mRNA platform. As you all know, in recent years, CAR-T has expanded its application beyond liquid tumor to other disease indications, including B-cell mediated autoimmune disease. There was highly encouraging early clinical data generated on refractory lupus patients that suggests that CAR-T therapy can potentially reset the immune system. At Everest, we used the mRNA technology platform to enable in vivo CAR delivery. We conjugate a T cell recognizing antibody to the surface of mRNA LMP. Once in vivo, this LMP can then bind to the surface of T cells. After endocytosis, the CAR-encoding mRNA is released in the cytoplasm of T cells and translated into CAR protein, which can then be expressed on the surface of T cell, turning a normal T cell into a CAR-T cell.
We believe that in vivo CAR-T can address many of the challenges encountered in the traditional CAR, including high cost of production and patient lymphodepletion. Our in vivo CAR-T is off-the-shelf, therefore can be easily scalable. There is no lymphodepletion required, and hospitalization may not be needed for the patient. Additionally, the PK/PD are more predictable, and quality is more controllable. Last year, we've made significant progress for our mRNA in vivo CAR-T program. We've now developed a robust conjugation method to ensure high efficiency and consistent conjugation. We've also identified appropriate targeting moiety that can allow specific and high expression of CAR in T cells. In the humanized mouse tumor model, we've demonstrated anti-tumor efficacy and target cell depletion. We've also completed a study in non-human primates, demonstrated good T cell transfection and high CAR expression.
We are working towards a candidate selection this year for further development of this program. Now, I'll hand over to Ian for a summary on future outlook.
Thank you, Jennifer. Over the last few years, as you can see on this pipeline chart, we have built a broad pipeline with multiple first-in-class or best-in-class products through both in-licensing and our discovery engine. The four commercial stage or near-commercial stage products in the pipeline have the potential to generate RMB 10 billion in combined peak sales. On earlier stage clinical products, we have zetomifumib, which our partner Kezar is developing in autoimmune hepatitis. AIH is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients' physical health and quality of life. The study has completed enrollment of 24 patients, and Kezar just announced today positive top-line data.
We congratulate our partner on this milestone, and we'll work with them to formulate future development plans. We have discussed EVER001 in depth with you, and EVER206 is the third product in our infectious disease portfolio currently in phase I development. Our self-discovery pipeline is growing. Listed are some of the key products that Jennifer just shared with you. We will continue to build our pipeline through business development and internal discovery to ensure continued solid growth for Everest. This will be an exciting year where we have a multitude of catalysts listed on this slide. My colleagues and I have discussed all of this, so I will not read these again, but I would like to highlight that it is very clear what we need to do in 2025.
We will continue to expand our commercial revenue base and ensure that Nefecon is successful in its first year under NRDL coverage. We will advance our pipeline, especially EVER001 and our emerging mRNA pipeline, all of which we have global rights, and we will actively look for synergistic and value-enhancing business development opportunities. We are confident that if we continue to execute in these areas, we will drive substantial and sustained shareholder value. I'd like to thank you for attending our call, and now we'll open it up to Q&A.
Hi, operator. Can you announce the way to ask a question, please?
Sure. We will now open for 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. We'll type your questions as messages.
For participants who dialed in, please press star one to queue up for questions. Okay. The first question comes from Goldman Sachs, Linh ai Zhao. Please go ahead.
Hey, good morning. Thanks for taking my question. I'm Linh ai from Goldman Sachs, and congrats for a great year in 2024 and very inspiring results, both for the top line and bottom line. I think I have three questions that would appreciate management insight. The first question is on Nefecon. As mentioned, it's been three months after the NRDL inclusion for Nefecon. Can you share a bit more on the NRDL implementations in terms of the percentage of hospital listing or the number of pharmaceutical pharmacies' progress, and also in terms of the observed patient usage and ramp-up of Nefecon in the three months in the NRDL coverage?
In addition, would you comment on the evolving competition in IgAN , particularly with multiple drugs with different MOAs coming into the market for the ETA antagonist, CFB, and APRIL/BAFF ? Would you share your view on the potential clinical preferences for different drug classes potentially by different patient subgroups? That is the first question. I'll stop here. Thank you.
Thank you, Lin Hai. You have three questions, but there are three parts to each question. I appreciate it. Thank you for asking this. I think Nefecon's first NRDL implementation, I think it is still early days, but we are very pleased with how the NRDL implementation is progressing. It has been less than three months, right? We are well on our way of making sure that all of our 800 target hospitals have NRDL implementation, either through formal hospital listing or through the dual-channel pharmacies.
I think maybe one number that I can give you is that since January 1, there has been over 10,000 new IgAN patients that have been prescribed Nefecon. We think that is a good foundation to have as we progress through the rest of the year. In terms of prescription, maybe just a little bit more details. Oftentimes, every prescription is for one to two bottles of Nefecon. Again, that's one to two months of a drug product, but there are patients that have been prescribed as many as three bottles at a time. Again, we are expanding our sales team. We still have a very high standard for hiring salespeople, but we are expanding from about 140-150 people to, I think as we go through the year, we will get to 200 people, which will allow us to better cover the 800 target hospitals.
In terms of the evolving competition, we're obviously monitoring that very carefully. We do think that, first of all, Nefecon has a unique opportunity as not just as the first IgAN product approved in China, but we really don't see any other IgAN products, even if they are approved later this year or next year, to have NRDL coverage until the earliest 2027, right? We will have a two-year exclusivity, if you will, with NRDL coverage. I think that will allow us a sufficient amount of lead time to position Nefecon appropriately. The second is that the profile of Nefecon with the clinical data that it has generated, the more data that we will generate, right, through RWE and IIT studies and by ourselves and together with Calliditas and their new owners, Veloxis and Asahi, right, will position this product.
We will just have a lot more data than the competition. The profile of this as an oral agent that's convenient to take with benign safety profile, right, it just positions this very well as a first-line therapy and as a foundation in potential combinations. The third point I would make is the treatment guideline, right? I think there, as both Rogers and I mentioned, we're quite pleased with how the clinical guideline positions Nefecon really as the only product in the category of being able to reduce potential pathogenic IgAs and pathogenic IgA immune complexes, right? We believe that positioning is unique. The guideline to really suggest repeated dosing with Nefecon beyond the nine-month treatment period that's in the approved label, we think also allows a lot of flexibility in how patients can be managed by their physicians.
Yeah. Yeah. Okay. Thanks.
I can add some more points here regarding Nefecon. As Ian just mentioned, there are more than 10,000 new patients currently on the therapy of Nefecon. Talking more about the data we are generating, there are more than 20 new studies in China now using Nefecon for the IgAN patients. Those studies will generate more data on repeated treatment costs or combining with different regimens they are currently using. Some of the studies also will show the benefit of early use, long-term use, or repeated use in different patient groups. Those data will support Nefecon for the expansion to more patient segments. If you are looking at the clinical guideline, clearly Nefecon has this very unique position. As we are already on the market for several months, some KOLs, doctors are kind of trying to use Nefecon combining with other regimens you just mentioned.
I would say, if you're looking at their clinical back to the guidelines, if you back to the guidelines, clearly classified all these different product categories into two categories. One is on the treatment, the root cause of the disease. Another category is the products treat the symptoms of the disease. Where Nefecon belongs to their product category treating the root cause of the disease, especially for long-term use. I think some of the products you just mentioned, probably they do not have any data to show eGFR benefits, though they already show some benefit on the proteinuria reduction, but not the eGFR case because the study ongoing, they do not have data on if you stop the treatment, whether their proteinuria will come back or the eGFR will come back again. That is also an advantage of Nefecon.
Number one, we have a study showing that if you're using Nefecon for nine months and stop for 15 months, you still have the benefit, right? Number two, I think that's the base for future combination therapy as a foundation. Number two is the oral, which is very convenient. Not like others, you have to do the injection. From these two perspectives, I think Nefecon has this very unique position at the whole treatment algorithm to be the first line and foundational therapy for most of the patients. I just add this. Thanks.
Great. Thank you so much for the comprehensive answer. My two follow-up questions. One is on etrasimod. Since you have been launching the product in the Greater Bay Area since October 24, can you share a bit more color on the observed patient usage and the feedback from the early adopters?
How is the patient baseline we see so far? It does not seem to have a clear guidance that etrasimod should be used in the late line or the front line, as you mentioned in the presentation. How are we seeing the potential that we are launching them or promoting them in earlier usage before patients are using biologics, for example? The final question is on the EVER001 on the one-year follow-up data. Do we plan to provide more detailed safety data for the one-year follow-up data update? Thanks.
Okay. For the first question regarding etrasimod, Sandra can provide some background, then probably others can add on. For the EVER001, also on the safety data, probably. Yeah.
EVER001? Yeah. Yeah. I can quickly give an update about EVER001.
As I just stated in the presentation, actually, we intended to follow up those patients up to two years. Yes, exactly. You're right. We are going to have first, I would say we already submitted some new data to the coming congress in Europe. We're waiting for the acceptance. Second, you're right. By September, we are going to have the full one-year follow-up data for both cohorts. We definitely will be able to share with you guys by that time. Yes. Exactly. Right. Also, probably between that, we also have some new data cut-off. For example, for the mid-year report, we probably will share with you the new safety and efficacy data. Yes. Thanks.
Thanks, Sandra. On a etrasimod , I mean, I think it's early days, right? I think the position of the product is for first-line use.
I mean, if you look at the patient population that we enrolled in our phase III study, most of the patients were biologics naive, right? We do think, and the label does not require any—the label in Macau and in the U.S. does not require any prior therapies to start treatment with etrasimod. It is early days yet, but that is the positioning that we are implementing right now.
Maybe I can add one more point. You just asked about the feedback of the doctors and some patient cases already used in the Greater Bay Area. We received some, I would say, very good feedback from their doctors and some from patient feedback through the doctors. It is quite positive.
We are doing some kind of real-world study in the Greater Bay Area, which will provide some more details and data to support our after-launch kind of guidance on the positioning of the product. As Ian mentioned, this product has been positioned as a first-line for naive patients. That is pretty clear first-line. Thank you.
Great. Thank you all for the answers. I have no further questions. Thank you.
Thank you.
Hi. I guess, operator, can you ask again and see if there are any questions? Actually, we are about at time, but just for one last chance.
Sure. 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. Okay.
Like I said, I think we're about time. Thank you, everyone, for your participation. Actually, last thing I wanted to ask Rogers to make a quick conclusion about the call and just review what we had said.
Yeah. I think probably you already know that with the very good year of 2024, we are on the way, it's already on the way to be the biopharma company, as we mentioned in the presentation. This is a very important transformation from the biotech company to a transformation in terms of revenue, in terms of their self-funding, in terms of their kind of in-house R&D capabilities, which will lead us to be the leading biopharma company in Asia in 2027, which is our mission and goal for the company. Thank you.
Thank you, Rogers. Thank you all, good management. Thank you for all the participants.
We will conclude the call here. Thank you.