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Earnings Call: H2 2022

Mar 31, 2023

Operator

At this time, I would like to hand the conference over to speaker today, Ms. Leah Liu, VP of Corporate Affairs. Please go ahead.

Leah Liu
VP of Corporate Affairs, Everest

Thank you, operator. Good morning, everyone, and welcome to our Everest 2022 full year financial results conference call. Joining us today are Mr. Rogers Luo, our Chief Executive Officer, Mr. Ian Woo, our President and Chief Financial Officer, Ms. Sunny Zhu, Chief Medical Officer, Infectious Diseases, Ms. Dr. Zhengying Zhu, Chief Medical Officer of Internal Medicine, and Dr. Jennifer Yang, our Chief Scientific 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, current expectations of the company or its officers with respect to the company operations and financial conditions of the company, which can be identified by terminology such as will, expect, anticipate future intent, plans, beliefs, estimate, confident, and similar statements.

Such forward-looking statements are not guarantees of for 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, representatives has no obligation, does not undertake to revise forward-looking statements to reflect new information, future events, or circumstances after the date of this conference call, except as required by law. Now, I would like to go over to Rogers Luo, our CEO, to provide more information on business update and our 2022 full year financial results. Mr. Luo.

Rogers Luo
CEO, Everest

Thanks, Leah. Good morning, good afternoon, good night, everyone. I would like to introduce the first several slides and followed by Ian present the details of the corporate financial result and the pipeline advancing. This slide shows our, you know, roadmap for Everest in the past 5 years and in the 5 years down the road. Everest was founded 5 years ago and has built a solid foundation during our five-year history with 11 first-in-class and best-in-class assets across 5 therapeutic areas, licensing. NDA approvals received from Trodelvy in China and XERAVA in Singapore. In 2022, we divested Trodelvy in the transaction, valued at up to $480 million , strengthening our balance sheet in order to advance our new strategy strategic visions.

2023 to 2024 will be a key period of transformation for Everest as we shift from a licensing model to a licensing plus discovery, in-house discovery and new pipeline generation model. At the same time, we are also evolving from a clinical-stage biotech company into a biopharma company with comprehensively integrated capabilities from drug discovery, manufacturing, to commercialization. Starting with the approval and commercialization of XERAVA and NEFECON, which we will address a little bit later in more details by Ian. Looking beyond these 2 years, we'll continue to expand our product pipeline with global rights, leveraging our in-house R&D and business development capabilities and maximizing commercial opportunities as we strive to become a leading Asia-based global biopharma company. Next slide. This is actually the key strategic priorities for Everest.

In the beginning of this year, we announced our new strategic priorities, which are highlighted in these slides. We will be focusing on three strategic areas of renal diseases, mRNA platform, and infectious disease. For renal disease, we anticipate receiving approval from NEFECON in the second half of this year. We have a study to build an in-house commercial team to prepare for its launch this year. NEFECON is a first-in-class, first in disease innovative therapeutics for IgA nephropathy, a debilitating disease affecting between 4 to 5 million patients in China, with no approved therapeutics up to date. We also have BTK inhibitors EVER001 in a phase II trial for glomerular diseases, and we expect to have preliminary clinical proof of concept data by the end of the year.

Our discovery team is working on multiple renal disease-related projects. We expect to file an IND for our most advanced internal discovered renal disease program in 2024. At the same time, we are actively seeking complementary renal disease opportunities through in-licensing, leveraging our global business development platform. We have full discovery and development capabilities for our clinical validated mRNA platform. We are developing our bivalent COVID-19 vaccines, which is currently undergoing IND submission in China. Our discovery team is also working on several mRNA prophylactic vaccines, major infectious disease, and multivalent therapeutic cancer vaccines. Our most advanced non-COVID mRNA program is our rabies vaccine, which has achieved preclinical proof of concept. Our important investment we made for our mRNA platform is our manufacturing site for mRNA vaccines in Jiangshan, which is designed with a capacity of 700 million doses.

Our manufacturing facility is now operational. We have 3 assets infectious disease portfolio that we purposefully assembled to address the key unmet needs in the market. Multidrug -resistant Gram-negative infections. This is the sub-sector within China's antibiotics market that is the fastest-growing and has the most attractive commercial dynamics. Our 3 antibiotics are expected to launch over the next 2-3 years, starting from XERAVA, which has already approved in China and in early this month. Taniborbactam, which are targeting to file an NDA in the 2nd half of this year and approval next year. We're also expecting to advance SPR206, which is a new generation of vaccine, into phase III clinical trials end of this year. Next slide, please. This slide shows our comprehensive pipeline that many of you may be familiar.

What I want to highlight here is that we have 4 to 5 products that are expected to launch in 2023 and in 2024. Those are NEFECON, XERAVA, Taniborbactam, and etrasimod, as well as our bivalent COVID-19 vaccine. We expect these near-term commercial products to build a solid foundation. For 2025 and beyond, our pipeline is increasing products with worldwide rights focused on the strategic priority areas that I mentioned on the last slide. To leverage our commercial platform in China and other Asia Pacific regions and to drive global value upside. Next slide. Last year and year today, this year, we have made many achievements in clinical development, regulatory submissions and approval, and drug discovery across key strategic focus areas. We achieved NDA approval for XERAVA and had 2 NDA submissions accepted by regulatory authorities.

We reported positive top-line results from six clinical trials and achieved the first preclinical proof of concept milestones among our internal discovery platform. We started off in 2023 with positive momentum, including NDA approval of XERAVA early this month in China and positive phase III trial results for NEFECON in IgA nephropathy, the most robust phase III data ever generated in the IgAN. Let me pass on to Ian to discuss more details, developments at the company. Ian, please.

Ian Woo
President and CFO, Everest

Thank you, Rogers. I'll take over here, let's start with XERAVA, eravacycline. First, we are thrilled to have received the NDA approval in China for XERAVA for the treatment of complicated intra-abdominal infections on March 16th. We expect to launch XERAVA under the Chinese brand name YIJIA in the third quarter of 2023. Next slide. This is a little bit busy slide, and the words are, some of the text is small, but what we want to show you on the slide on the bottom is that there are critical unmet medical needs in multidrug-resistant gram-negative infections in China. As you can see, carbapenem-resistant gram-negative pathogens, especially Klebsiella pneumoniae and Acinetobacter baumannii, continue to rise over the last 15 years.

When we speak to KOLs and ICU physicians, we understand that often patients with severe infections under critical care, have only 1 round of antibiotics or have time to use only 1 round of antibiotics. Given this backdrop of increasing carbapenem resistant rates, there is an urgent clinical need for novel, safe and effective antibiotics. Next slide. This we think is a very important study. you know, a number of studies conducted in China and globally have demonstrated the XERAVA's differentiated profile against Gram-negative pathogens, especially those commonly found in China. It's impressive to see XERAVA retain strong activity in carbapenem and tigecycline-resistant Acinetobacter baumannii strains, as well as other commonly seen pathogens in China.

These in vitro susceptibility studies are especially clinically important and meaningful for us in Asia and clearly demonstrate the higher potency and differentiated profile of eravacycline. Next slide. These are the data that were that formed part of the global approval and also the China approval. We have demonstrated that XERAVA is as effective as carbapenems in cIAI as a monotherapy in 2 pivotal global clinical trials. In the IGNITE 1 study, eravacycline was non-inferior to ertapenem, and in the IGNITE 4 study, eravacycline was non-inferior to meropenem. We conducted a China bridging study which completed in March 2021 and demonstrated consistent efficacy and safety of XERAVA in China and globally. Data from these global pivotal studies and the China bridging study formed the basis of the China NDA approval. Next slide.

With such a differentiated profile and the substantial unmet needs in China, we're quite optimistic about XERAVA's market potential in China for multidrug-resistant Gram-negative infections. Effective antibiotics for MDR Gram-negative infections is the most attractive antibiotics subsegment in China with a 45% CAGR, as you can see in the chart on the bottom left, and attractive daily pricing. As you can see in the table on the bottom right, Zavicefta daily pricing is at about RMB 4,000, and polymyxins daily pricing is between RMB 6,000- RMB 9,000 per day. We believe that XERAVA will bring similar clinical benefits to patients, and we intend to price in a similar range. Tigecycline has significant drawbacks in terms of its tox profile and a much lower lung penetration than eravacycline.

It's often used in multiple doses above approved levels to drive efficacy due to lack of alternative options. Nevertheless, tigecycline sales was about RMB 2 billion and its volume was over 4.5 million doses in China last year across branded and multiple generic versions. In Singapore, where Everest has been commercializing XERAVA, we have seen 80% replacement rate of tigecycline in 2022 in those hospitals where we have been listed. In China, if we are able to replace just 10% of the tigecycline's volume, we believe that the peak sales of XERAVA will easily reach about RMB 1.5 billion. Next slide. In preparation for our Q3 launch of XERAVA, we have been rapidly building our commercial infrastructure.

We intend to build a highly efficient commercial team with central leadership covering medical affairs, marketing, market access, sales and channel, and commercial operations excellence. Most of this leadership team is already in place, and they bring to Everest decades of MNC and biotech experience. I will also add that we intend to leverage the same leadership team for the launch of NEFECON as well, so there will be synergies across these products. We have started hiring sales reps, and the initial team will be around 100 to 120 FTEs to cover 300 to 500 hospitals with a focus on top-tier hospitals in core markets. As we approach the launch of Taniborbactam and SPR206, we will continue to further expand this commercial team.

XERAVA has been recommended in multiple global treatment guidelines issued in China, the United States, and EU. We'll continue our efforts on additional guideline inclusions in China. Next slide. In addition to China, we also hold rights for XERAVA in Singapore, Taiwan, Hong Kong, South Korea, and certain Southeast Asian markets. Our in-house team have already launched XERAVA in Singapore. As I mentioned before, replaced 80% of tigecycline's volume in listed hospitals. In Taiwan, we expect to receive NDA approval in the second half of this year and have already signed a strategic agreement to commercialize XERAVA with our partner, TTY Biopharma. We also expect to launch XERAVA by the end of this year in Hong Kong and are under discussions with local authorities on regulatory pathway for South Korea and other Southeast markets.

Overall, we expect sales in these APAC territories to reach approximately 10% to 15% of the Mainland China camera levels. Next slide. This is our full antibiotics portfolio. We believe we have three best-in-class antibiotics with complementary spectrum of coverage across multidrug-resistant Gram-negative infections. Other than XERAVA, we have Taniborbactam, a novel beta-lactamase inhibitor with strong activity against Pseudomonas infections, which is a dominant clinical Gram-negative pathogen in China. And we also have a next-generation polymyxin derivative, SPR206 or EVER206 that has a reduced renal tox profile. Renal tox has been a key impediment to broader use of the polymyxin class of antibiotics. We expect to launch Taniborbactam in 2024 and SPR206 1 to 2 years thereafter. Our in-house commercial team will be efficiently mobilized around this complementary portfolio. Next slide.

Let's switch to NEFECON, our first-in-disease therapy for the treatment of IgA nephropathy. We expect NDA approval in the second half of 2023 under the Chinese brand name NEFECON. Next slide. This is the data that our partner Calliditas announced on March 12th. We think this is a very exciting top-line 24-month part B phase III NefIgArd trial data for NEFECON in IgA nephropathy. The analysis, this trial included 364 patients diagnosed with primary IgAN who were on a background of optimized and stable RAS inhibitor therapy. The patients were randomized in a 1-to-1 ratio into 1 of 2 treatment groups, NEFECON 16 mg per day orally or placebo, and treated for 9 months daily, then monitored for 15 months off drug.

This is the largest registrational trial for IgA nephropathy patients, and the longest, in, you know, globally thus far. A total of 364 patients were included for efficacy analysis, and the 2 treatment groups were balanced with regards to baseline characteristics. The primary endpoint for this, the part B of the phase III study was a time-weighted average of eGFR observed over 2 years, and this primary endpoint was met with highly statistical significance. Here, on the chart on the left, what we're showing is the eGFR outcome at both 9 months and 24 months in parallel. So to be able to get a more direct readout on the effect on renal functions by NEFECON treatment.

You can see that in the placebo group, placebo plus RAS inhibitors, eGFR declined continuously at 9 months and then declined further at 24 months. It was a total loss of renal eGFR of 12 mL/min . This corresponds to a 21.5% decline from baseline over 24 months. In contrast, in the NEFECON-treated group, eGFR was essentially stable in 9 months, and by 24 months, we saw a loss of 6 mL/min , and this corresponded to 11% decline from baseline. What this really means, in summary, is that 9 months of dosing with NEFECON resulted in a 50% less loss of kidney function compared to placebo at month 24.

It is worth mentioning here that the treatment effects, or the treatment benefits on eGFR was observed across study population regardless of baseline proteinuria levels. This leads to the confidence that we have that in pursuing for regulatory filings for full approval for the entire study population. Next slide, please. This slide shows a different analysis of eGFR. This shows the 2-year total eGFR slope analysis. This was done as a supportive analysis. What this shows is a statistical significant improvement in slope, estimated, you know, to fall in the range of approximately 1.8 to 3 mL/min/yr . This is fairly significant amount of savings in eGFR decline per year.

This difference in the 2-year eGFR slope observed between NEFECON and placebo, we believe is highly clinically relevant. With this observed difference between 1.8 mL/min/yr to 3 mL/min/yr , the estimated hazard ratio of clinical outcome is less than 0.5, and the estimated median time delay to clinical outcome attributed to NEFECON by our calculation is greater than 11.2 years. In other words, 9 months of treatment with NEFECON could potentially lead to a much longer timeline of progression into, you know, end-stage renal disease by over 11 years.

We're very keen to see more detailed deep data coming from part B in future conferences and publications. This is the first drug treating IgA nephropathy that have disclosed, that have published, you know, top-line, two-year eGFR data. This is, you know, very meaningful for the community. With what we know of, NEFECON is that it has an impressive safety and efficacy profile. We believe that there are, you know, a few important directions that we can go in to further explore this product, especially with clinical use experience.

We would love to, you know, understand better retreatment during the disease course, the impact of a longer treatment duration of longer than 9 months, et cetera. You know, all of these will hopefully lead to further delaying disease progression in a clinically meaningful way. Next slide. As we all know, that proteinuria is a important risk factor in disease progression for IgA nephropathy patients. It is, you know, quite impressive to us that NEFECON has been able to demonstrate very significant reduction in proteinuria during the treatment period, and this effect seems to be durable even after 15 months of treatment discontinuation.

e left, you see that this is the proteinuria levels at 9 months, and we are seeing a reduction of 33.6% with NEFECON plus RAS inhibitors versus a reduction of 5.2% for placebo plus RAS inhibitor. At 24 months, for NEFECON, you know, that reduction is reduced slightly to 30.7%, whereas placebo plus RAS has essentially no decline in has not able to generate any decline in proteinuria at all. This result, you know, we believe provides further support of the disease-modifying effect of the NEFECON treatment in IgAN patients

Finally, I think, you know, as I mentioned before, NEFECON was generally well-tolerated by patients, with the majority of treatment adverse effects rated as mild to moderate in terms of severity. Next slide. In terms of the timing of regulatory development, you know, we filed the NDA for NEFECON in China, and the NDA filing was accepted in November of 2022, and the priority review was granted by the NMPA in January of this year. We expect to receive the first wave of approvals for NEFECON in Mainland China and Singapore this year, followed by NDA approvals in South Korea, Hong Kong and Taiwan in 2024. Next slide. We believe there is a substantial market opportunity for IgA and treatment in China.

According to our research, an estimated 350,000 kidney biopsies are performed in China each year, among which around 1/3 are diagnosed with IgAN. There are approximately 200,000-300,000 existing diagnosed IgAN patients currently using various treatment options. Apart from IgAN patients diagnosed through biopsy, there is a significant number of people with renal issues who are not willing to undergo a biopsy. Physicians may consider treating them with NEFECON for a period of time, given that there is no approved therapy for most glomerular diseases in China. If NEFECON reduces a patient's proteinuria, it is likely that this patient suffers from IgA nephropathy. Altogether, we think there are 4 million-5 million existing cases of IgAN in China.

The market for IgAN treatment is fairly concentrated geographically to the coastal provinces, we believe that 60% of the potential patients are concentrated in less than 700 hospitals. Therefore, we will only have a focused sales team of a few hundred people to launch and commercialize NEFECON if and when it is approved. As NEFECON targets a disease with significant prevalence and incidence rates, we will be working with key stakeholders to get the treatment listed on the National Reimbursement Drug List as soon as possible so that we may provide more patients with access to NEFECON. We hope to get onto the NRDL in 2025. Next slide. Expanding our leadership position in the treatment of renal diseases, especially for common glomerular diseases, is a key strategic priority for Everest.

The top four glomerular diseases in China are listed here. In addition to IgAN, you have membranous nephritis, minimal change disease, and FSGS. Combined, these four types of glomerular diseases represent a substantial patient population of around 10 million. Currently, there are no approved therapies in China for any of these diseases. In our pipeline, you know, other than NEFECON, we have a covalent reversible BTK inhibitor, EVER001, which will begin phase II studies soon in glomerular diseases, and we expect to have top-line data by the end of this year. We also have preclinical candidates in our discovery pipeline, and we will continue to expand the renal portfolio through internal discovery and in licensing. Next slide. This is an org chart of our commercial organization.

As XERAVA is already approved and NEFECON is expected to be approved in the second half of this year, we're putting together our commercial team, and the leadership team is in place. We will have two business units, an internal medicines unit and an infectious disease unit, both under the leadership of Wenfei Cao. We expect to have a team of 80 to 100 in our internal medicines unit initially to support the launch of NEFECON and around 100 to 120 employees in our infectious disease unit. This is in 2023. In 2024, we will continue to expand the size of the team as more products are approved.

You can see that those leading the commercial team have extensive experience working with both MNCs and local biotechs in China. Next slide. Next, I would like to turn to our mRNA platform. You know, we believe that we have a clinically validated mRNA platform that has end-to-end capabilities covering the full value chain from antigen design to commercial production. You know, the platform's mRNA sequence design has been proven in a number of our, you know, clinical and preclinical stage assets. Our bioinformatics team uses a state-of-the-art algorithm to improve antigen design and facilitate vaccine discovery.

With the full technology platform transfer of this platform from Providence Therapeutics, we have developed a full production process and are, you know, have begun operations at our manufacturing facility in Jiaxing and expect to be, you know, up to commercial scale production, you know, by the end of this year. Next slide. This is a picture of our Jiaxing facility. It's near Shanghai. Currently, it's dedicated to mRNA vaccine production. We began, you know, operations in December 2022. The facility was built to global standards and was designed to enable an annual manufacturing capacity of 700 million doses of mRNA vaccine.

We intend to use this facility for both domestic and global markets. It can also accommodate production of our prophylactic vaccines as well as our therapeutic cancer vaccines under development. Next slide. Last year, we saw stellar results from our first-generation COVID-19 vaccine generated from our mRNA platform. We think, you know, this validates our platform in both efficacy and safety. This is a comparison study of our first generation COVID-19 vaccine versus Pfizer's COMIRNATY. It is the only head-to-head study done globally versus existing approved COVID-19 vaccine.

As you can see, efficacy was non-inferior to COMIRNATY, and safety was even numerically better than Pfizer in many cases. Next slide. We're targeting to use our clinically validated mRNA platform to generate a series of in-house discovery vaccines in both infectious diseases as well as cancer vaccines against solid tumors. Our first non-COVID mRNA vaccine, a vaccine for rabies, achieved preclinical proof of concept, demonstrated demonstrating our ability, our abilities in mRNA discovery. We look forward to sharing more information about the progress of our non-COVID mRNA projects in the near future. Next slide. We will now review our financial data for full year 2022.

First, revenue was RMB 12.7 million. Sorry, 12.8 million, and this is an increase of 12.7 million from 2021. This is primarily driven by the sales of XERAVA in Singapore, as well as the sales of Trodelvy in Singapore prior to the return of this product to Gilead. Cost of revenue was about 4.6 million RMB, and our gross profit was 8.1 million RMB. General and administrative expense increased by 33.8 million RMB to 276.5 million for the year ended at 2022. This is primarily due to increases in one-time professional service expenses that we incurred in 2022.

R&D expense increased by RMB 196 million to RMB 809.7 million for the year ended December 31, 2022. This is primarily due to additional clinical trials for our drug candidates, expansion of our internal discovery team to build up in-house R&D capabilities, and then the increased costs during tech transfer of our drug candidates. I will say that this is a gross number. The actual number is going to be lower than this because R&D expenses related to Trodelvy following, you know, after August 1, 2022, are reimbursed by Gilead. Okay?

Similarly, the next line item, distribution and selling expense related to Trodelvy after August 1st, 2022, will also be reimbursed by Gilead. Distribution and sales increased to RMB 326.7 million in 2022. This is primarily due to the increase in costs in preparation for the launch of Trodelvy, and most of those expenses are no longer with the company going forward. The next line item I will explain is other gains. Other gains you see here, other gains is RMB 1.1 billion for the year in 2022. This is primarily attributable to the disposal gains from the Trodelvy transaction.

It is a net number that includes, you know, a number of other items. The number related to Trodelvy is about RMB 1.3 billion, and then there's about, you know, RMB 150 million of foreign exchange losses that we incurred throughout the year and some other smaller items. The loss for the year by the IFRS measure narrowed by RMB 761.4 million. This is primarily attributable to the disposal gains from the Trodelvy transaction.

If we look at it on a non-IFRS measure, the losses also narrowed by about RMB 760 million due to the other gain from the Trodelvy transaction. It's, you know, I think this is the Trodelvy transaction is a pretty big has a pretty big impact in the financial position for the company in 2022. If we look at the cash balance, we ended the year with RMB 1.65 billion of cash and cash equivalents and the bank deposits on our balance sheet.

On a pro forma basis, we are guiding to a pro forma cash balance of $342 million. The difference between the balance sheet cash balance and the pro forma cash balance is $196 million of upfront payment from Gilead, that we received in January of 2023. Next slide. Looking forward to this year, we have a strong list of catalysts lined up. You know, we expect to receive NDA approval in China and Singapore for NEFECON, and expect to file NDA for NEFECON in Hong Kong, Taiwan, and South Korea. We, for EVER001, our BTK inhibitor, we anticipate to have top-line data readout by the end of this year.

XERAVA has already received NDA approval for complicated cIAI in China, and we anticipate NDA approval in Taiwan will follow shortly. For Taniborbactam, we will file the NDA in China, and our partner in the U.S., Venatorx, is expected to file the NDA in the U.S. We will be initiating the phase III trial for SPR206 or EVER206 this year. On the mRNA side, we expect that our bivalent COVID-19 vaccine will receive IND approval, and then we will initiate the phase I/ II trials and a potential EUA towards a potential EUA in China.

Last but not least, we have Etrasimod, which we expect to complete our phase III enrollment shortly, and have the 12-week induction of remission data from this trial at the end of this year as well. Additionally, we expect that our partner, Pfizer, will receive the FDA approval for Etrasimod in ulcerative colitis. This will potentially happen before the end of this year in the US. Okay, next slide. Finally, we just want to reiterate some of our key investment highlights. First, I think it's quite unique a position that we find ourselves that we have four near-term product launches that we believe have an aggregate peak sales potential of about RMB 10 billion.

The first is XERAVA, which we have received approval and will launch in the third quarter of this year. Next is NEFECON. Approval is anticipated in the second half of 2023. Next year, we expect approval of Taniborbactam and potentially etrasimod. There is also the potential for COVID-19 vaccine approval during that time period. We have at least 4, you know, product approvals over the next 2 years, which we believe is very significant for any biopharma company and particularly for a biopharma company of our size. Second, we have differentiated ourselves from other biotech and biopharma companies by focusing on renal diseases and on infectious diseases.

We fully intend to build ourselves into a leader in these areas by continuing to expand the pipeline and our ecosystem through a combination of internal discovery and in-licensing. Third, we have built a strong in-house discovery capability or expertise, right? Our capabilities are anchored in our clinically validated mRNA technology platform. We have multiple prophylactic and therapeutic vaccines under development. Last but not least, our robust balance sheet with a pro forma cash balance of over $430 million will support our development as we transform our company into a fully integrated Asia-based biopharma company. Now I will hand over to the operator to start the Q&A. Thank you very much.

Operator

Thanks. We will now open for Q&A session. For participants who joined us 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, messages. For participants who dialed in, please press star 1 to queue up for questions.

Leah Liu
VP of Corporate Affairs, Everest

Yes, operator, please go ahead and take the question on the line. Thank you.

Operator

The first question comes from Arthur He , please.

Arthur He
Senior Biotech Analyst, H.C. Wainwright

Hi. Good morning, Rogers, and good evening. This is Arthur He from H.C. Wainwright , and thanks for taking my question. My first question regard the launch of the eravacycline. First of all, how is the readiness for the sales team, and besides the building of the sales team, could you give us more color on your preparation for launch in the third quarter this year?

Rogers Luo
CEO, Everest

Okay, I take this question first. If anything to be added, Ian please can chime in. As we already get approval early this month, you know, we are preparing for the launch, commercial launch of XERAVA in several aspects. Number one, we are hiring our, you know, sales marketing team. Currently we the team size by the end of this year is around 100, 150 to 200. You know, we have targeting about 500 hospitals or around 500 hospitals because in the self-pay markets, about 500 key hospitals account for more than around, you know, 70%-80% of the market potential in the self-pay market. In then we are working on the...

Because this product is made in outside of China, we are preparing for the importation, supply chain, make sure we're getting product, you know, distributed widely in China. We are working with one of the biggest importer in China to get product available in China. Certainly, we are also preparing, you know, as we get our approval, we are doing a lot of promotion activities to the key hospitals. We are also planning for reimbursement negotiation end of this year. We are collecting datas, we are educating doctors, and also, we are generating pharmacoeconomic datas to support our pricing.

Because the product approved before July 1st, the product XERAVA is eligible for reimbursement negotiation, we are planning for that reimbursement negotiation. Hopefully, we can get the reimbursement if we have a good price. Once that's done, you know, we also, number 4 is about medical fair preparation, which means we are collecting in vitro and we're doing some real-life studies to generate more data as well as for, you know, generate more doctor use experience for this product in ICU settings. Generally data is also gaining more doctors experience. In these four aspects, we are now pretty very actively, you know, doing that those four in those four aspects.

Arthur He
Senior Biotech Analyst, H.C. Wainwright

Thanks, Rogers for the color. My second question is, regarding the NEFECON. As we see, this robust, Part B data, from NEFECON, presented by your partner, I just wonder, have you guys speak with the physicians in China and what's the feedback and the perspective from them regarding the eGFR data?

Rogers Luo
CEO, Everest

Okay. I go first then, Dr. Zhu can add on. I actually you're right. It's thanks for the very good question. Actually, we had several KOL meetings after phase III Part B data readouts. The feedback actually is quite positive, actually. I just cited some of the quotes from KOLs. Number 1 is that, with that data, once the product approved in China, there will be a very big change I would say. They say they call it a revolutionary change in the IgAN treatment because this is the first approved drug in IgAN, right? With that data, doctor literally said it can be used for any patients diagnosed with IgAN.

Actually, they are probably more aggressive than we expected, because you can see with nine months treatment and 15 months follow up without treatment actually show very impressive benefit in terms of eGFR savings, in terms of proteinuria reduction. Theoretically, it can delay about 10 years progression to end stage renal disease, which is a huge benefit. Doctors and patients are expecting this product, you know, available in China as soon as possible. We are planning to early access provide in Hainan Boao Lecheng International Medical Tourism Pilot Zone. It going to be available, going to be launched pretty soon, I would say. Address there are huge unmet needs here in China. Probably, Zhengying, you can add on some, put a more comments.

Yeah.

Zhengying Zhu
Chief Medical Officer of Internal Medicine, Everest

Sure. thank you, Rogers. Thank you for the good question. I think, obviously, for nephrologists in the community, you know, are very excited to see, you know, the early release of Part B data. It is indeed the first study having shown the long-term eGFR benefit, followed by a proteinuria reduction. This is the other third trial that, you know, links this proteinuria reduction with the long-term renal function protection. That's. I think the more exciting thing data point to see is on top of the impressive renal function loss benefit, you know, protective of the renal function benefit.

I think the sustained proteinuria reduction over the course, you know, for 2 years, is another very strong indicator for the disease modifying effect of this product. This is, you know, we know that proteinuria is a strong predictor for long-term renal function protection. which will, you know, lead to say, even, you know, we will see considering, you know, longer term of the renal function protection. That said, the business are very eager to having the product, you know, be available to the patients soon, very soon. Yeah. Thank you.

Arthur He
Senior Biotech Analyst, H.C. Wainwright

Okay. Thanks, Rogers, and thanks, Dr. Zhu. Appreciate it. Congrats on the progress.

Zhengying Zhu
Chief Medical Officer of Internal Medicine, Everest

Thank you.

Rogers Luo
CEO, Everest

Thank you.

Operator

The next question comes from Lin Hai of Goldman Sachs, please.

Lin Hai
Senior Analyst, Goldman Sachs

Hello, is that me?

Rogers Luo
CEO, Everest

Yes, I guess. Please.

Lin Hai
Senior Analyst, Goldman Sachs

Hi. I was confused about names. I'm actually Lin Hai from the GS research team. Hi Rogers and hi everyone from the management team. I really appreciate taking my questions. I actually have two questions. The first question is, previously, I think Everest has been expressing flexibilities in terms of how to commercialize on our infectious disease franchise, right? Now we have just stated that we are planning on building our internal in-house sales team for XERAVA launch. Can you elaborate more or can you share more colors behind the scene to show to us about what are the major drivers for us to thinking about adopting the commercialization in-house versus finding a partner on that? That's my first question.

The second question is, most recently, CStone... Sorry. Most recently, the CSPC has announced that their messenger RNA for the COVID vaccine is approved for EUA use in China. How do you see the perspectives of getting approval in China as another messenger RNA, and how should we look at our current plans for the messenger RNA platform beyond the COVID? Yeah. Thanks.

Rogers Luo
CEO, Everest

Thank you. Very good questions. I take the first one, Ian, you take the second one. About their in-house commercialization team versus their CSO or partnership with other CSO companies. Why we should build our in-house commercialization capability in infectious disease is a critical strategic question as for us. The advantage of in-house commercialization capability is pretty clear. We, number 1, we have a pipeline instead of we just have one product, right? We have Taniborbactam, we have the new generation of Polymyxin. Those two products expected to be approved in next 2 or 3 years.

Which means we have a pretty good synergistic effect in terms of hospital listing, in terms of promotion, in terms of the same group of target doctors and departments. We have a lot of synergistic effects because those three, you know, very potent antibiotics are, you know, treating severe multi-resistant, multi-drug resistant Gram-negative bacteria. They're treating almost the, I think, in the same kind of setting. For example, ICU setting or treating HAP or VAP patients. We have a lot of synergetic effect in this area. These three product can be combined in some settings as a combination therapy.

For example, Polymyxin, the new generation polymyxin can be combined with tigecycline or, you know, Taniborbactam can also be combined with tigecycline as well. We have these, you know, synergistic effects. That's number one. Number two, I think these, the commercialization capability build up also benefit other therapeutic areas. For example, the renal, future renal portfolio, because in terms of the hospital listing, the pharmacist, they are in the same group. Basically, we can leverage these two groups together. If you're looking at our current commercialization structure, we have one BU head. They have, you know, two therapeutic area sales team. You know, they have also internally we have the synergistic effect internally.

Certainly, I think we have a commitment in infectious disease. If we, you know, let's say if we partner with someone, I think there's a lot of uncertainties in and around. Most important, I would say number 4 is the most important, I think we have the confidence, right? We, if you're looking at the commercial team, you know, the leadership of the commercialization team, you can see many of them, I would say, all of them have very comprehensive experience in the past, in their past careers, in infectious disease. We are quite confident because these three products has huge potential with this huge unmet needs in this area.

We all have a very comprehensive experience in our past career, and we believe we can, you know, maximize the value of the infectious disease pipeline. Also probably Sunny, you can add some color here. Sunny Zhu, please. You mute. Sunny, you're mute. Yeah, please.

Sunny Zhu
Chief Medical Officer of Infectious Diseases, Everest

Right. I agree with you, Rogers. I think the portfolio advantage is really, really key here. If you see the synergy in the user end, they are tackle with the same kind of disease, which is we call a multi-drug resistant problem and also difficult to treat infections.

They are very, very difficult to treat. Usually you need multiple drugs to synergize together. It is very lucky for Everest, from portfolio-wide, we have a 3 unique product. They can really be troop there for tackle the important unmet needs. Also from the coverage of this kind of difficult to treat, maybe in the hospital, there are small unit ICU and very focused and also infectious disease department where they, their expertise in managing those prescriptions. It makes a lot of sense to have a very specialized expertise team in-house and to leverage the portfolio advantage. Also, it is for infectious disease, particularly in the antibacterial area, we need monitoring the trend of the pathogen and also surveillance study.

It makes a lot of sense to do, internal, cross-functional collaboration, with the development team, with the medical team together. I just, want to highlight that. It make a lot of, sense.

Rogers Luo
CEO, Everest

Thank you, Sunny. Before Ian answer the second question, I think I can add two more points here. Number one is that I think it's also benefit our clinical development, right? We have, you know, ongoing phase III trial. Once we have a team in the hospital, then definitely, we have that relationship. We have that, you know, insights from doctor's sides, which can benefit the clinical development pipeline in the future, ID, programs. Number two is that we are, you know, having said that, I think we're also open to a partnership for CSO in the, you know, kind of say, in the broad, remote areas because, the potential of antibiotics is very broad, right? It's very huge.

We have, you know, we will have a very lean team, you know, in some remote area, probably we do not have the capability to or capacity to cover those areas. In those areas, we'll also be open to partnering with some local CSO. That's also an option. Thank you. Ian, you. It's your turn.

Ian Woo
President and CFO, Everest

Great. Okay. Yeah. Thanks. So to your second question about the CSPC, I think we view this as a positive development for mRNA COVID-19 vaccine space in general. I mean, this is the we, you know, congratulate CSPC for getting the first, you know, COVID-19 mRNA vaccine approved under the EUA pathway in China. You know, I think that's what this, you know, tells us is that, you know, there is a pathway forward for mRNA vaccines. You know, this is, you know, beneficial to us as we are in the rolling IND submission process at the moment.

You know, I would like to point out one, you know, significant difference between our bivalent candidate, EVER-COVID19-M1.2, is just that, right? You know, we have a bivalent vaccine. It's a combination of the wild type and a vaccine against Omicron BA.2.12.1. You know, we think this is the direction that, you know, global leading mRNA companies are headed. You know, as you know, I'm sure you're aware, you know, bivalent vaccines are the only vaccines, you know, being administered in the U.S. and in Europe. We think we have the right product for the China market as well.

you know, what this CSPC approval also shows that because they got the vaccine approved under the EUA pathway, that there is clearly a need in the market for new mRNA vaccine options, right? Also that there is still the EUA pathway that exists. you know, I think what we are hoping to do is quickly get the IND approval and quickly progress through phase I and phase II studies and be in a position to apply for EUA approval for our bivalent COVID-19 vaccine candidate. We expect to be able to do this in the second half of this year.

You know, of course, I mean, for us, we are using our mRNA platform to develop a variety of other non-COVID programs. For that, you know, I will have, you know, our Chief Scientific Officer, Jennifer Yang, to just say a few words about the mRNA discovery capabilities and efforts underway.

Jennifer Yang
Chief Scientific Officer, Everest

Thank you, Ian. Yes, we are utilizing this mRNA platform to work on, you know, additional infectious disease prophylactic vaccines as well as therapeutic vaccines, mainly therapeutic cancer vaccines. At the same time, we continue to innovate based on the first generation platform. You know, we evolve and optimize the antigen design, you know, algorithm.

To come up with a better antigen that can elicit higher immunogenicity. At the same time, along with our partner, we also continue to innovate on the delivery system so that we have a diversity of different delivery systems tailored towards either prophylactic or therapeutic use. As you can see from previous presentation, we do have internal CMC as well as manufacturer capability, you know, in the mRNA vaccine space. This will give us further competitive advantage as we are a fully integrated research and manufacture unit. Yeah. Thank you.

Rogers Luo
CEO, Everest

Got it. Thanks Roger, Ian, and Sunny for the answers. Appreciate it. Thanks.

Operator

Okay. That concludes today's Q&A session. Mr. Luo, I will turn the call back to you.

Rogers Luo
CEO, Everest

Is there any other questions?

Leah Liu
VP of Corporate Affairs, Everest

No, Rogers, I think we're out of time as well. If we can ask you to, give a, you know, final wrap-up of the call, that would be great. Thank you.

Rogers Luo
CEO, Everest

I just show the last slides of the presentation. I think that, you know, reflect all the key message we want to deliver here. Can you put on the last slide? Last slide, please. I think that's the all the highlights for this last year's annual report. I think we are at the transforming periods and also the period of value-increasing critical year for this year and next year. 4-year term product launches with Aggrenox, peak sales. Sorry. Potential of RMB 10 billion. Therapeutic leadership in renal disease, infectious disease, which is large, huge market in Asia and strong discovery capabilities anchored in clinical validated mRNA tech technology.

Very importantly, we have very strong balance sheet, with cash of $4.32 million, which can support us to achieve all the key milestones and strategic priorities. Thank you.

Operator

Thanks everyone for your attendance. This concludes today's conference call.

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