Good day. Thank you for standing by. Welcome to the Everest Medicines earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question- and- answer session. If you wish to ask a question, please press star one on your telephone. Please be advised that today's conference is being recorded, and if you require any further assistance, please press star zero. I would now like to hand the conference over to your host today, Mr. Ziyi Chen, China Healthcare Analyst, Goldman Sachs. Please go ahead.
Sure. Thank you. Good morning, everyone, welcome to Everest Medicines Interim Results 2021 Corporate Update Earnings Call. Goldman Sachs as a producer hosts this call. This is Ziyi Chen, China Healthcare Analyst at Goldman Sachs. As a reminder, this call is being recorded. Before we kick off the session, I have to read out a disclaimer. This call is strictly for clients of Goldman Sachs only, and this conversation is not intended for the media and is off the record. Participants will be removed from the call if they cannot be properly identified.
T his call webcast is not for the purpose of sharing or receiving non-public or otherwise confidential information. Attendees are publicly assigned market participants who may not receive and should not request non-public or otherwise confidential information about issuer or security or about markets for securities. Joining me today from the company are CEO Kerry Blanchard, President and CFO Ian Woo, and our COO Neo Zhang, will also be joining us for the Q&A portion of today's call. I would now like to turn the call over to Yihang Zhu, the Manager of Investor Relations from Everest Medicines. Please proceed.
Thank you, Ziyi, and good morning, everyone. We issued a press release with half Year 2021 interim results before the call, and it is available in the investors section of Everest Medicines website. Speakers of this conference call may make statements that constitute to forward-looking statements, including descriptions regarding the intent, beliefs, or current expectations of the company or its officers with respect to the business operations and financial condition of the company.
Which can be identified by terminology such as will, expect, anticipates, future intent, plans, believes, estimates, confident, and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual results may differ from those in the forward-looking statements as a result of various factors and assumptions. The company or any of its affiliates, directors, officers, advisors, or representatives has no obligation 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.
I will now turn the call over to Everest CEO, Kerry, to discuss our business update and outlook.
Thanks, Yihang. Good morning, everyone. Thank you for joining us today to review Everest's 2021 interim results and recent business highlights. 2021 has been a highly productive year for Everest Medicines. As we continue to drive progress toward our corporate goals across all pillars of our business, we have successfully submitted an NDA for eravacycline in complicated intra-abdominal infections and a BLA for sacituzumab govitecan in second line plus metastatic triple-negative breast cancer.
Meanwhile, we are rolling out our commercialization plan and building up our commercialization infrastructure to ensure the successful launch of our products as they receive regulatory approval. We are also making good progress advancing our other pipeline products into and through clinical development. In addition, we have hired Dr. Jennifer Yang as our Chief Scientific Officer to lead the establishment of a robust discovery organization. Furthermore, we are well on track for the construction of our GMP production site in Jiaxing in Zhejiang Province of China.
Looking ahead, we are very excited for several key near-term milestones and the next phase of growth as a commercial stage company. Finally, we continue to be active on the business development front, evaluating multiple strategic opportunities and hope to complete two to three in-licensing deals and R&D partnership and other strategic transactions before the end of the year. To start with our anchor product in the oncology therapeutic area, sacituzumab govitecan, our BLA submission for the treatment of second line plus metastatic TNBC was accepted by the China NMPA in May of 2021, and we received priority review for the submission.
We're very excited to prepare for a potential launch in China anticipated in the first half of 2022. We believe sacituzumab govitecan has been significantly de-risked after our partner, Gilead, received full U.S.A. FDA approval for the treatment of adult patients with second-line plus metastatic triple-negative breast cancer in April of 2021. Our phase IIB bridging study of sacituzumab govitecan in metastatic triple-negative breast cancer in China completed enrollment well ahead of schedule. We expect to announce top-line results in the second half of 2021.
In addition, we received pediatric and rare severe disease priority review designations by the Taiwan FDA for sacituzumab govitecan in second-line triple-negative breast cancer and orphan and fast track designations for metastatic triple-negative breast cancer from the Ministry of Food and Drug Safety in South Korea in May 2021. In January 2021, we submitted an NDA to the HSA of Singapore for sacituzumab govitecan for the treatment of second-line triple-negative breast cancer, and are preparing NDA submissions for the same indications in South Korea and Taiwan in the second half of 2021.
Moving to a hormone receptor-positive, HER2-negative breast cancer, we expect to complete patient enrollment of our full-powered phase III Asia study in early 2022. This trial is currently enrolling across sites in Mainland China, Taiwan, and South Korea. For urothelial cancer, Gilead received accelerated approval from the U.S. FDA in April 2021 for locally advanced or metastatic urothelial cancer following a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
As part of the collective effort to make this innovative drug available to patients around the world, we started patient enrollment in China as part of Gilead's global phase III confirmatory trial in August of 2021. Working with our partner, Gilead, we endeavor to develop sacituzumab govitecan broadly across a number of additional cancer types that overexpress Trop-2. In March, China's NMPA approved a CTA for a phase II basket trial in 180 patients with relapsed/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer. We expect to initiate this study in the second half of 2021.
Looking at our cardio-renal therapeutic area, we completed Chinese patient enrollment as part of our partners, Calliditas' phase III global registration trial to evaluate NEFECON as a treatment for IgA nephropathy. We expect to have primary data readout in Chinese patients in the first half of 2022 and are preparing to file an NDA in China following the readout in 2022. I also would like to highlight that our partner, Calliditas, submitted an NDA to the U.S. FDA for NEFECON for the treatment of primary IgA nephropathy with a PDUFA date of September 15th, 2021.
Calliditas also filed an MAA to the EMA for NEFECON for the same indication. If approved, NEFECON would be the first ever drug with a label for IgA nephropathy. Moving to our infectious disease portfolio. First, we have eravacycline. As I previously mentioned, the NDA for eravacycline in complicated intra-abdominal infections was accepted by the China NMPA in March of 2021. China NMPA approved the CTA for eravacycline for the treatment of community-acquired bacterial pneumonia.
We expect to have top-line results readout for taniborbactam, a novel injectable beta-lactamase inhibitor, in the first half of 2022. For corporate updates, in the first half of 2021, we have also focused on initiatives in three key areas: commercialization, discovery, and manufacturing. We are building an industry-leading commercial team with 3 business units in Mainland China focused on oncology, internal medicine, and infectious disease under the leadership of Kevin Guo, who joined us as Chief Commercial Officer in February of 2021.
We have also expanded our geographical footprint with newly established offices and general managers in South Korea, Taiwan, and Singapore to ensure commercial success in those markets. With Jennifer Yang, our Chief Scientific Officer, joining us in April, we're actively building our discovery team by recruiting experienced talents in drug discovery and translational medicines and exploring new modalities and technology platforms to accelerate our discovery efforts. Our new research laboratory in Zhangjiang, Shanghai, is expected to be fully operational in the first quarter of 2022.
Furthermore, we are making steady progress on the construction of our global manufacturing site in Jiashan, Zhejiang. Phase I-A of the facility construction, including quality control and the office building, is expected to be completed in 2022, and phase I-B, containing production, repackaging, and warehouse, is expected to be complete in 2023. We will continue to expand our innovative drug portfolio in areas of high unmet medical needs through in-licensing and building of organic discovery capabilities.
Our business development team is actively working on a number of licensing, some research collaborations, and partnership transactions across our therapeutic areas of focus, which complement our existing portfolio and offer opportunities for commercial synergy. With that, I will now turn the call over to Ian Woo to review our financial highlights. Ian?
Great. Thank you, Kerry. I will now review the financial results for the six months ended June 30th, 2021. Please refer to our interim results announcement from yesterday for some of the detailed numbers. As of June 30th, 2021, the group's cash and cash equivalents was RMB 3,971,000,000. Net loss for the period decreased from RMB 240.4 million from RMB 623.5 million for the six months ended June 30th, 2020, to RMB 283.1 million for the six months ended June 30th, 2021. This is primarily attributable to changes in fair value of financial instruments issued to investors.
Adjusted loss for the period increased by RMB 57.2 million, from RMB 245.9 million for the six months ended June 30th, 2020, to RMB 303.1 million for the six months ended June 30th, 2021. This is primarily attributable to increase in R&D expense and distributions and the selling expenses related to the build-out of our commercial organization. Moving on to specific line items. Research and development expense increased by RMB 89.8 million from RMB 161 million for the six months ended June 30th, 2020, to RMB 250.8 million for the six months ended June 30th, 2021. This is attributable to three factors.
Number one, additional clinical trials for our drug candidates. Number two, continued expansion of our R&D team. Number three, the establishment of our internal discovery platform for in-house R&D capabilities. General and administrative expenses increased by RMB 6.1 million from RMB 101.3 million for the six months ended June 30th, 2020, to RMB 107.4 million for the six months ended June 30th, 2021. This is primarily due to increases in employee remuneration in connection with organization expansion.
Distribution and selling expenses increased by RMB 32.9 million from RMB 9.2 million in the six months that ended June 30th, 2020, to RMB 42.1 million for the six months ended June 30th, 2021. This is primarily due to the build-up of our commercial team and pre-launch activities for the commercialization of upcoming products that we expect to be approved and launched in 2022. Finally, I would like to just highlight the fact that the company stock was included as a constituent stock of the small-cap index, the FTSE All-Cap Index, and the FTSE Total Cap Index in the Global Equity Index Series.
This concludes our prepared remarks for today. I will now pass the call back over to the operator for questions.
Thank you. Thank you, Kerry and Ian. Operator, please remind participants how to raise questions. Thank you.
Certainly. As a reminder, to ask question, you will need to press star one on your telephone, and to withdraw your question, please press the pound or hash key. Once again, it is star one for questions.
Alternatively, if you wish for me to raise a question on behalf of you can also send the questions over to me through email. My email address is Ziyi.Chen@gs.com. Before we're waiting for questions, I actually got two questions to start with. Number one is definitely a lot of investors looking forward to more BD deals. As Kerry just mentioned that we're looking at potential two to three more BD deals in the second half of this year. Well, I think it's more like in the upcoming four months. Any color on that? Could you elaborate a bit more about what kind of specific areas you will be looking at?
What kind of stage of assets we'll be looking at? Any potential timeline for that? I think this is one of the questions we have keeping asking. Broader, on top of that, I think still we're trying to understand a bit more on the overall BD strategy over the next few years, and also things company also ramping up the in-house discovery capability. Try to understand a bit more about how you're going to balance the resources between those two efforts, the BD and also in-house discoveries. Also in the in-house discovery part, any progress on the team build-up and also any specific areas we'll be looking at for the in-house discovery? Thank you.
Okay. Thank you, Ziyi. This is Kerry. I will start with these questions. I will start with the second question first, which is the overall BD strategy and portfolio expansion strategy over the next few years and the balance between organic and inorganic growth. From the licensing perspective, we have not changed our direction substantially in that we still firmly believe that a global innovation with first-in-class or best-in-class assets is the target zone that we pursue. We also spend most of our attention on assets that have achieved a clinical proof of concept.
These are later-stage assets, usually in phase II, or even early in phase III. As in the past, 6/8 of our assets fall into those categories. I would say we maintain that same kind of ratio. We are spending some time looking at earlier assets, things that are in phase I or early in phase II. These carry a higher risk profile, but also have a substantially different value proposition in taking assets to POC and with the opportunity with earlier assets to try to gain access to some of the global economics, rather than just China and regional economics.
From the discovery side, the team is growing well. Jennifer Yang has hired the bulk of her leadership team. This is today about 10 -1 1 people. Of course, we have to build out our wet lab in Zhangjiang Hi-Tech Park in Pudong, Shanghai. That space has been acquired and is being fitted out now. Currently the team is working on their early projects and starting the strategy for the discovery area. We are really modality agnostic with my experience and Jennifer's experience across small molecules, large molecules, ADCs, and even nucleic acids.
We're much more focused on the target category than we are on the modality, because modality changes depending on the target. We do have interest in ADCs. We have one of the leading ADCs in the world today with TRODELVY, or sacituzumab govitecan, we would like to enhance our capabilities in that area. That team is growing quickly, and I think in the right direction. The balance between licensed and in-licensed, of course, the next two or three years will be largely in-licensing. Discovery takes some time to move from projects initiation to clinic.
We think our first assets will approach clinic in the next two to three years. I would say if we think about the whole size of the discovery organization, we expect it to be in the neighborhood of 40 - 60 people when it is complete. That's my answer to the second question. To the first question on some more character about the near-term deals, we have a very active duty plate right now with multiple deals that we are in or have completed due diligence. These deals cross all the therapeutic areas with a focus on renal disease and on oncology and on infectious disease.
We are looking and have very active deals in all of those areas. The spectrum of the deals range from a clinical development perspective, from assets that are in early phase II to assets that are ready to go to phase III. That's about the answer to question one to me. Ian, Neo, do you have anything to add to the questions or to the answers?
Yeah, maybe I'll just add a couple of quick points. One is that I think as the management team think about our approach to business development, I think maybe two years ago, we would just be talking about in-licensing transactions. Today, we still talk about in-licensing, I think what we can do on the business development front is a lot broader, right? We could do R&D collaborations. We could explore more strategic transactions. We can still look at late-stage assets. We could also look at earlier stage opportunities.
Whereas the last four years, we were really looking at assets with regional rights, today there are a number of opportunities that we're in late-stage discussions with that will have a global upside or global rights. I think this is just because of the scale and the expertise that the company has gained over the last four years, and really has accelerated with the build-out of our discovery organization. That allows us to expand really the range of opportunities that we could look at. That will also allow us to create shareholder value, not just from our core regional territories, but potentially with global upside as well.
Now, these sort of R&D collaborations that potentially could allow us to access to enabling technologies could be very strategic and really position the company well for the next phase of growth.
Sure. Thank you. Thank you, Kerry, and Ian. Operator, let's open the line.
Certainly. The first question we have is from Sean Wu from Morgan Stanley. Your line is now open.
Hello. Thank you for hosting this company call, and thanks in advance for taking my questions. Congratulations on all the progress and recently. I have two quick questions. The first is about your commercialization plans for all your assets in China and in Korea and other places. Do you envision like a multiple chief medical officer, you will have multiple chief commercial officers to be in charge of selling products in different areas or for some of the products, you may keep maybe paying third party to sell your product. That's number one.
Number two, it's about your buyback plan. You just announced very big plan, I think, for our company, $100 million. I understand you and many people think stock is undervalued, but I'm just not sure. What's your timeline? You could deploy this HKD 100 million. I suppose if the stock is going up, you may cancel at certain point, and I hope it happens soon. On the other point, buyback stock may not always be best-rated idea. When Bill Hwang bought stock, Tencent Music and VIPS announced a huge buyback in the stock and now kind of less than half of when they announced the buyback.
Of course, I think that this should happen to our company because our fundamental is strong, and we are not in some sense in a cost of this government. I'm just curious to see for us, we have a lot of usable cash and HKD 100 million can get us bringing up a lot of use. Okay. Thank you.
Thank you so much for your questions. I'll take the second question first on the stock repurchase. Just to be clear, it's HKD 100 million, not $100 million. It's a substantially smaller amount.
My bad. Sorry.
Yeah. It's Hong Kong dollars. You covered the points well, I think. We certainly believe our stock is significantly undervalued, and that our board believes that the share repurchase under these current conditions demonstrates our confidence in our business outlooks and the prospects for the company. We're authorizing just 2% of our cash balance for repurchase, and we believe that we can replenish cash balance in the future at a lower cost of capital. I think those are the sort of the simple answers to that question. From the first question about our commercialization and general approach.
Without question, we will only have one Chief Commercial Officer, that's Kevin Guo. A very talented, very experienced gentleman, was the previous BU2 leader at Roche and was an executive at Eisai in China and globally. Decades of experience in many therapeutic areas. One of the benefits of Kevin is that he has been in the antibiotic area, he's been in vaccines, he's been in cancer, he's been in renal disease. He has a broad experience, including deep experience from Roche in breast cancer, where he led the commercialization efforts for Herceptin and for Xeloda.
We believe he's the right person. He certainly demonstrated that in his time here in putting together a great team. Our team structure under Kevin is set up in a BU fashion for oncology, for infectious disease, and for internal medicine. The international group comes in through under Kevin which is led by Alex Wang, a talented experienced person with a background in Asia. That's how our structure will work in China. Certainly for oncology, we intend to build that sales force entire and commercialization force ourselves. Same for NEFECON.
In other therapeutic areas, we have not completely decided the model, but the central marketing access, in government affairs and medical affairs, all those functions will be internal to our company. Ian and Neo, any clarifications on these answers?
Not from me.
No, I think you answered great. Yeah.
Okay. Thank you for the questions.
Yeah, I would like to apologize. I think I've seen you with $100 million with the U.S., which won't be happening if I settle down.
No problem.
Thank you. Once again, ladies and gentlemen, you may press star one for questions.
Let's move to the next one. Thank you.
Next one is from the line of Yang Wang from Credit Suisse. Your line is now open.
Thanks. Thanks for giving me the opportunity to ask questions. I have two. First one is about our TRODELVY clinical development strategy in China or in Asia. We can see for HER2-positive and HER2-connected breast cancer, we are working on phase III trials in Asia, China, and other countries. It seemed to be our partner, Gilead, is also running a phase III global trial, which is going to have a readout in the second half of this year. My question is, why do we want to run an independent second phase III trial in Asian countries? Of course, we hope that both trials will be positive, what if two trials give us different results, will that affect our rotation strategy?
They seem to be the only phase III trial we are running independently in Asia for TRODELVY. That's the first one. Second one is related to our NEFECON drug. We see early this year, FDA approved SGLT2 drug for CKD patients for slowing their kidney function deterioration. I want to understand the SGLT2 drug approval in CKD approval, how much indication overlapping with our NEFECON potential indication. Thank you.
Yeah, great questions. Thank you very much. For the TRODELVY question, we certainly prefer, when possible, to join global trials and to have China contribute 15%-20% of the patients or maybe more, depending on the indication to the global trial. I think that this is the most efficient way to do development. There are some situations where that's not possible. One of the common situations is that a comparator drug or standard of care may be different between China and the rest of the world, and that is part of the case with hormone receptor-positive, HER2-negative.
At the time when that trial started globally, the CDK4/6 inhibitors had not penetrated well. The only approved one at the time was palbociclib from Pfizer, and it had been approved but had very low penetrance in China. The treatment paradigm is actually quite different. In China, patients fail hormonal therapy, and then they go directly onto single-agent chemotherapy. Whereas in the United States and Europe and Japan, they're treated either sequentially with hormonal therapy and CDK4/6 inhibitors or in parallel and fail, and then they go on to chemotherapy. The patient populations are slightly different.
That's caught up with time, but the trials have to start when the trials start, and that was the predominant behavior clinically in China at the time. It was quite a difference. We elected to do a local trial or regional trial, where we can interrogate both the population that is CDK4/6 experienced and CDK4/6 inexperienced. We think that will give us great data to add to the global data that we're expecting will read out sometime in the next few months from the Gilead side. That was the reason. In the future, unless the cancer is a predominantly Chinese cancer, where it may not make sense to run a global trial.
If it's a part of the global CDP, clinical development plan, we would prefer to join the global trials and help with global enrollment. The second question about NEFECON and SGLT2 inhibitors, that's a great question. As you probably remember, I helped with the development of empagliflozin, one of the SGLT2 inhibitors, and they're a great addition to the armamentarium for the treatment of both cardiac failure and chronic kidney disease. The overlap with IgA nephropathy is minimal or nonexistent. IgA nephropathy is a very particular type of kidney disease caused by an abnormal IgA that leads to glomerular damage.
This is very different than the types of kidney disease that are being treated with SGLT2 inhibitors. We don't expect there to be substantial overlap. Great question.
Yeah.
Okay, bye.
I just want to add on the answer to the SGLT2 question, I guess. What we think, and we're preparing a launch for NEFECON, but as we look at the market, it's a very, very deep market. Currently, the suboptimal standard of care treatment that primarily lacks in efficacy, the proteinuria of average patients is very high. Then the physicians as they see it in China, don't really have a treatment goal. Then it would be very easy for us to push down the treatment goals from somewhere above 1 g of proteinuria per day, to say, like 0.5 g/day .
If you look at other renal diseases, for example, DKD, there are drugs out on the market that are pushing for a treatment goal of less than 0.3 g/day of proteinuria. That's minimal proteinuria. There's abundant scientific data showing for proteinuria targets, the lower the better. To get to an optimal treatment, we think the market is big enough to allow multiple agents to play. We're actually looking at other very promising treatment modalities for IgA nephropathy, specifically. It will be a market that eventually allow even three or four modalities to play out there to achieve optimal treatments for patients.
Okay, that's interesting. Thank you.
Thanks.
Another question we have is from the line of Chen Jiang from BofA Securities.
Hi, thank you for giving me this opportunity. We have two small questions regarding manufacture and commercialization. The first one is if our understanding is correct, that we are building our own facilities for manufacture, but we expect the TRODELVY and XERAVA to be approved in 2021, 2022, which will be happening very soon. Is there a small gap, a time gap, between our manufacture facility to put into production and the product approval? Will that be ready for the launch of these two commercial stage products? That's the question for our manufacturer. The second one for our commercialization team.
We understand that we're building our own sales team in China. Could you please share more details on whether, for example, the team size, how many people will be included in the sales team, and also the first year penetration target for hospitals. Details like that. Thank you.
Sure. Thank you for the questions. For the manufacturing question, I think the most facile way of transferring manufacturing is post-approval, and with manufacturing license change. That would be the approach that would be taken. The first molecule that we pursue manufacturing of in Jiashan will not be TRODELVY or eravacycline. I think we have time to build out our facilities and get ready for subsequent launches. We have the tech transfer rights in many of our contracts, this will be going forward for the right profile of a molecule, like sterile pharmaceuticals and more difficult molecules.
We believe that local manufacturing under our control is still the appropriate direction. For the second question about commercialization and size of organizations, the central commercialization team, I think will top out around 75 or 80 people.
For the sales force side for oncology, we expect a sales force in the neighborhood of 250-300 medical reps. With this, we believe we can cover 85% of the important hospitals in China. I would expect a similar size for NEFECON at NEFECON launch. With eravacycline, that as well, it will not require a broad market sales team because it's a medicine that's used in very seriously ill patients, mostly in surgical intensive care units. It's a much more concentrated population of doctors and hospitals and patients that we need to cover.
I wouldn't see any of the sales forces being any bigger than 200-300 medical reps. Ian, Neo, would you like to add to those answers?
I think that's pretty much the details that we have guided externally. I think maybe just to add a couple of points. For oncology, we think we want to cover 80% of the breast cancer patients in China. As you guys know, the first and second indications for TRODELVY is going to be TNBC first, and the second is likely to be HR-positive, HER2-negative breast cancer. To cover this, we think a sales force of 200-250 people should be able to cover about 700 hospitals, and that should be able to allow us to reach about 80% of the patients in China.
We will, of course, as we get additional indications into different cancer types, we will be expanding the team accordingly. I think for NEFECON, it's similar as well. I think AstraZeneca for roxadustat started with 200 persons in their team and very quickly built out to 500 +. I think a similar type of build is probably appropriate. Although we think for IgA nephropathy, the end clients or markets is a little bit more concentrated than the dialysis segment in the hospitals.
We can potentially start out and the speed of the ramp may not have to be as fast as AstraZeneca did with roxadustat. That's just to provide a little bit more color on the sales force side.
Thanks a lot. That's very comprehensive.
Thanks.
Thank you. The next question we have is from the line of Colin Ju from CICC. Please proceed with your question.
Hello. Thank you for taking my questions. Yes, it's Colin Ju from CICC. I have two small questions. The first one is about NEFECON. What's your status now for NEFECON in China? What about our communication with CDE? Can we see the facilities and the FDA approval? Happy to see that the IgA nephropathy is attracting more attention. We can see many companies are entering into the areas also, just like we have molecular [inaudible] .
Thanks for the questions. We'll start with the NEFECON question. From the regulatory end, NEFECON was granted breakthrough therapy designation by CDE, which does make it eligible for accelerated conditional approval. We will have our first Chinese data in the first half of next year, and we think that is the data that we want to build our NDA on. Currently, the data is all outside of China. Other than our PK data in Chinese patients. Our expectation is that China will want to see a preliminary data, which is what the readout that will happen beginning of next year, and safety data.
From the competition side, I think we've raised a lot of awareness, and Calliditas has raised a lot of awareness around this disease around the world, and in particular in China, and people are interested. It's a complicated disease and complicated clinical path. Our early-phase clinical data needs to be confirmed in large randomized trials that take years to run. I think that those agents are somewhat behind. I think the biology is fascinating, those T-cell modulators, although there are a few other mechanisms, and we think that B cells make IgA. That's an interesting direction for IgA nephropathy, and we follow these assets closely.
As Neo suggested in an earlier question or earlier answer, we believe that IgA nephropathy will require multiple medicines. I think that medicines like an APRIL antibody or APRIL binder will likely be used in combination with other medicines, and we think that the standard medicine to combine with, because it will be the front-runner and the standard of care, will be NEFECON.
We expect much like cancer, this is a serious life-threatening chronic disease that has lots of disability that people will want to push protein very down to very low levels and try to preserve as much kidney function as possible, and this will require multiple agents. I think it's just a good thing for the patients to have more agents. For the TRODELVY question, in sacituzumab govitecan, as I should call it, for that molecule, there's lots of questions around hormone receptor-positive, HER2-negative.
Most of those based off of a small phase II trial with difference in response to seeing a difference in response duration between CDK4/6 naive and CDK4/6 failure patients. I think we have to think about the time frame in which that trial was done. Actually, if we look at the duration response data for CDK4/6 failures, it's actually quite good.
It's just this, in CDK4/6 naive, it's even better. It's not that either of the data points are bad data points. They're just different times in the natural history of a patient. If a patient has only failed hormonal therapy and hasn't seen CDK4/6 drugs or a lot earlier in their disease than patients who've failed them serially. There could be a two to three-year difference in that type of patient. I think the expectation is that in patients who have failed more agents, the survival benefit will be shorter. I think this is expected, and Daiichi Sankyo has publicly reaffirmed their confidence in this trial, and we look forward to the results soon.
Okay, next.
Yeah, thank you for the questions. Great questions.
Thank you. There are no further questions at this time. Presenters, you may continue.
Sure. I think, probably given the time limit, probably I get a last question from email I'm going to ask is, investors start to see emerging new players to get into the Trop-2 ADC space. Try to get a sense from the company that whether you're going to see any of the major threats coming from upcoming players in the space or any differentiations we'll be talking about here.
Certainly. Trodelvy is quite different than other ADCs. None of the competitors look like Trodelvy. Sacituzumab govitecan, one uses a moderately toxic cytotoxic load, not a highly toxic one. It has a very unique linker. It has a very high DAR between 7.5 and 8, where most of the other Trop-2 ADCs are, they have a different antibody. They have a stable linker. They have highly toxic toxins of different classes. Some are topo inhibitors, but others are tubulin inhibitors and other mechanisms.
These are all new molecules. I think you're probably all aware that one of the molecules failed in phase I just recently because of intolerable toxicity related to the linker payload combination. I do believe that with any active blockbuster drug, there'll be lots of people who try to capitalize on the target and the approach.
I think the biggest competitor today is Daiichi Sankyo and AstraZeneca with DS-1062. At this point, they're still behind substantially. I like the position we're in. We fully expect there will be competition. The science will have to sort out. We've had two big failures, one from Pfizer and now one from this Chinese company just recently, both in phase I, both with stable linkers and very highly toxic toxins with lots of Trop-two-related toxicity that's just not tolerable by patients. I haven't seen anything that really copies sacituzumab govitecan today. I think we're quite differentiated.
Got it. Great. I think we're getting close to the end of the call. I'm now going to turn the call back to Kerry for any closing remarks.
Okay, just very quickly, thanks for all the questions. I'd like to thank you for joining us on the conference call today. We look forward to keeping everyone updated on our progress, and we look forward to demonstrating our business development acumen over the next several months. Thank you very much and take care. Be careful.
Thank you, Kerry. Thank you, Ian, and thank you the management team for attending the call, and thank you everyone for dialing this call. We're definitely looking forward to more milestone events happening to Everest. Thank you very much for dialing. Have a good day. Thank you.
Great. Thanks.
Thanks.
Bye-bye.
Thanks, everybody. Bye-bye.
Thank you. Ladies and gentlemen, that concludes our conference call today. Thank you all for participating. You may now disconnect.