Q2 2020 FibroGen Inc Earnings Call
Since I know listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
Operator: in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to hand the conference over to your host, Michael Tung. Please go ahead.
If anyone should your car assistance during the conference. Please press Star is Andrew on your such don't telephone.
I would now like to have the conference over to your host Michael Tom. Please go ahead.
Thank you Ashley and good afternoon, everyone Im Michael time, Vice President of corporate strategy in it and Investor Relations at Fibrogen.
Michael Tung: Thank you, Ashley, and good afternoon, everyone. I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibroGen. Joining me on today's call are Enrique Conterno, our Chief Executive Officer; Thane Wettig, our Chief Commercial Officer; Pat Cotroneo, our Chief Financial Officer; Dr. Peony Yu, our Chief Medical Officer; Chris Chung, our Senior Vice President of China Operations; and Dr.
Joining me on todays call, our Enrique Conterno, Chief Executive Officer thing wedding, our Chief commercial officer.
Our country Dale our Chief Financial Officer, Dr. Peony, Yu, our Chief Medical Officer.
Chris Chung, our senior Vice President of China operations.
Dr at least khashoggi, our senior Vice President of clinical development drug safety and pharmacovigilance.
Michael Tung: The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call for Q&A. I would like to remind you that remarks made on today's call include forward-looking statements about FibroGen. Such statements may include, but are not limited to, our collaborations with AstraZeneca and Astellas, financial guidance, Regulatory Strategies and Potential Regulatory Results of Clinical Trials Are Regulatory Strategies and Potential Regulatory Results of the Research and Development Act, commercial results and results of operations, risks related to our business, and certain other business matters. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in FibroGen's filings with the SEI, including its most recent Form 10-K and Form 10-Q.
The format for todays call includes prepared remarks from Enrique impact after which we will open up the call for QNX.
I would like to remind you that remarks made on today's call include forward looking statements about fibrogen such statements may include but are not limited to a.
Our collaborations with Astrazeneca and Astellas financial guidance.
Initiation enrollment design conduct and results of clinical trials.
Our regulatory strategies, a potential regulatory results.
Our research and development activities.
Commercial results and results of operations risks related to our business and certain other business matters.
Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.
For more complete description of these and other material risks can be found in fibrogen filings with the SEC.
Including its most recent form 10-K and form 10-Q.
Beverage and does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.
Michael Tung: FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. The press release reporting our financial results and business update and a webcast of today's conference call can be found on the investors section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Conterno, our CEO.
The press release reporting our financial results in business update in a webcast of today's conference call. It can be found on the Investor section of five regions website at Www Fibrogen Dot com.
With that I would like to turn the call over to Enrique Conterno, our CEO Enrique.
Thank you Mike good afternoon.
Everyone and welcome to our second quarter 2020 earnings call.
Despite the challenges presented by the cover 19 pandemic on behalf of Fibrogen I'd like to reassure patient health care providers investigators and stake holders of our continued commitment to bring our potential first in class medicines to patients suffering from chronic on life threatening condition.
Enrique A. Conterno: Thank you, Mike. Good afternoon, everyone, and welcome to our second quarter 2020 earnings call. Despite the challenges presented by the COVID-19 pandemic, on behalf of FibroGen, I'd like to reassure patients, healthcare providers, investigators, and stakeholders of our continued commitment to bring our potential first-in-class medicines to patients suffering from chronic and life-threatening conditions. We continue to monitor the situation closely, with our employees and our patients. And to the healthcare providers, regulators, and countless others who interact with FibroGen, please know our thoughts are with you and your families. I want to take a moment to welcome both Dr. Aoife Brennan and Dr. Ben Cravat to our Board of Directors at this exciting point in FibroGen's history. Ifa's experience in rare diseases and clinical development and Ben's world-class expertise in biology and chemistry will provide invaluable perspective to our board. With today's earnings call, we are implementing a new format with a goal of improving communications with the investment community and other stakeholders. I will begin by providing a high-level summary of the most important accomplishments and developments from the second quarter. Pat Cottroneo, our CFO, will then review the financials, after which we will open up the call to your questions.
Yes.
We continue to monitor the situation closely.
Our employees and our patience and to the healthcare providers regulators and countless others, who interact with Fibrogen. Please know our thoughts are with you and your families.
I want to take a moment to welcome.
Our Bose.
Dr. If a brennan.
I'm Dr. Ben provide to our board of directors at these exciting point in five regions history.
The first experience in rare diseases and clinical development.
I'm bands World class expertise in biology, and chemistry will provide invaluable perspective to our board.
[noise], we todays earnings call.
We are implementing a new format with the go to improving communications with the investment community and other stakeholders.
I will begin by providing a high level summary of the most important accomplishments and development from the second quarter.
Good for now our CFO will then review the financials after which we will open up the call to your questions. Today's updates will include our China results you asked the regulatory review on our clinical trials.
We hope this new format would result in more time for us to have a constructive.
Dialogue.
So, let's get started with our strong China resorts.
With a return to a new normal business environment in China.
We are pleased to report net sales of Roxadustat of 15.
Point $7 million for the second quarter.
This represents an increase from the $5 million in China net sales reported the first quarter.
We are most encouraged by the trajectory of the launch which is being driven by both an expansion the hospital listings and continued adoption.
Hospitalist things continue to be a key focus of our launch efforts.
Notably.
As of the end of the second quarter.
Roxadustat was listed as hospitals.
We presented over 45% of the CKD anemia market opportunity in China.
This is in comparison to the over 30% reported at the end of the first quarter.
We're especially pleased.
With the penetration at top tier class three a institutions.
Enrique A. Conterno: Today's updates will include our China results, U.S. Regulatory Review, and our clinical trials. We hope this new format will result in more time for us to have a constructive dialogue.
Which are generally the larger ones on the hospitals were key opinion leaders on early adopters practice.
We continue to see berard roxadustat utilization across different patient populations.
Including in the hemo dialysis peritoneal dialysis and non dialysis populations.
Enrique A. Conterno: So let us get started with our strong China results. With a return to a new normal business environment in China, we are pleased to report net sales of Roxadustat of $15.7 million for the second quarter. This represents an increase from the $5 million in China net sales reported the first quarter. We are most encouraged by the trajectory of the launch, which is being driven by both an expansion in hospital listings and continued adoption. Hospital listings continue to be a key focus of our launch efforts. Notably... As of the end of the second quarter, Roxette-Dustan was listed in hospitals, representing over 45% of the CKD anemia market opportunity in China. This is in comparison to the over 30% reported at the end of the first quarter.
Utilization across these different patient populations bodes well for long term success and provides important learnings as we prepare to launch roxadustat in the U.S. and other countries.
Finally, we recently amended our China collaboration with extra Seneca.
The new agreement more optimally aligns both fibrogen, an extra seneca to maximize the economic value of their Roxadustat franchise, and will result in improved and more predictable economics and profitability for Fibrogen.
We look forward to keeping you updated as we advance our long term goal of making roxadustat the standard of care, including China CKD anemia patients.
Let us turn now to the U.S. regulatory review and commercial preparation for Roxadustat.
We had our mid cycle review with the FDA in June.
And continue to expect and if the decision on the Roxadustat in D.A. by the PDUFA date of December 20 Twentytwenty.
The FDA has indicated that an advisory committee meeting is snap plan at this time.
Enrique A. Conterno: We're especially pleased with penetration at top-tier Class 3A institutions, which are generally the larger ones, and the hospitals were key opinion leaders and early adopters. We continue to see broad Roxadusta utilization across different patient populations, including in the hemodialysis, peritoneal dialysis, and non-dialysis populations. Utilization across these different patient populations will vote well for long-term success and provide important learnings as we prepare to launch Rokta Dusted in the U.S. and other countries.
Overall, we're pleased with the cadence off and engagement with the FDA.
Well future interaction with the FDA our plan.
Given the proximity label discussions we will no longer be commenting on those interactions until the PDUFA dates.
On the commercial front.
We appointed Sane wedding.
For the newly created position of Chief commercial officer, where he will lead fibrogen commercialization efforts.
Same brings more than 30 years of global biopharmaceutical leadership experience and we welcome. His leadership in this area thing is working closely with our partners Astrazeneca and Astellas to ensure a producer will reach as many CKD anemia patients as possible on a worldwide base.
Yes.
We continue to work closely with Astrazeneca regarding us launch preparation activities.
Within the next few months, we expect to have submitted up to 10 manuscripts covering the phase three data.
Enrique A. Conterno: Finally, we recently amended our China collaboration with AstraZeneca. The new agreement more optimally aligns both FibroGen and AstraZeneca to maximize the economic value of the Roxas-Dustat franchise and will result in improved and more predictable economics and profitability for FibroGen. We look forward to keeping you updated as we advance our long-term goal of making Roxodusta the standard of care in treating China's CKD anemia patients. Now, let us turn now to the U.S. Regulatory Review and Commercial Preparation for Roxaduce. We had our mid-cycle review with the FDA in June, and we continue to expect an FDA decision on the Roxaducer NDA by the PDUFA date of December 20, 2020. The FDA has indicated that an advisory committee meeting is not planned at this time.
Both individual trial ample datasets.
At the upcoming American Society of Nephrology Congress in October we expect to present, a meaningful number of abstracts on Roxadustat and Keith P.H.I. Science.
We continue to engage with CMS on the transitional drag on payment adjustment or to adapt them.
Finally disease awareness activities imperative to re framing the primary defect of CKD anemia from one of.
People and therein deficiency to an oxygen sensing deficits.
Our underway in the U.S.
In Europe.
The filing for Roxadustat for the treatment of anemia in adult patients with chronic kidney disease was accepted by the European Medicines agency in May.
Our partner Astellas.
Expects a European approval decision meat 2021.
Moving now to our pipeline the starting with newly initiated clinical trials.
In June.
We initiated two separate trial, starting pamrevlumab in patients hospitalized hospitalized with Cowen 19.
In the U.S., we initiated a phase two study.
Investigating the efficacy and safety of umbrella mapping hospitalized patients with acute corner virus infection.
Enrique A. Conterno: Overall, we are pleased with the cadence of and engagement with the FDA. While future interactions with the FDA are planned, given the proximity of label discussions, we will no longer be commenting on those interactions until the PDUFA deadline. On the commercial front... We appointed Thane Wettig to the newly created position of Chief Commercial Officer, where he will lead FibroGen's commercialization effort.
These multi center trial will enroll approximately 130 patients would cover 19, and we'll assess patient time too and on ventilator support.
In Italy, a phase two three investigator initiated trial.
Investigating the efficacy and safety of Pamrevlumab in approximately 68 patients hospitalized with cover 19 was started.
The primary objective of this study is to assess the effect of Pamrevlumab on blog oxygenation in patients with covenant in infection in the acute and post acute settings.
The majority of patients suffering from that from severe forms of cover 19 have bilateral Easter Titian pneumonia.
Enrique A. Conterno: Thane brings more than 30 years of global biopharmaceutical leadership and experience, and we welcome his leadership in this area. He is working closely with our partners AstraZeneca and Astellas to ensure Roxet Duster will reach as many CKD anemia patients as possible on a worldwide basis. We continue to work closely with AstraZeneca regarding U.S. launch preparation activities. Within the next few months, we expect to have submitted up to 10 manuscripts covering the Phase 3 data, both individual trial and pooled data. At the upcoming American Society of Nephrology Congress in October, we expect to present a meaningful number of abstracts on RoxaDustar and HIF-PHI science. We continue to engage with CMS on the Transitional Drug Atom Payment Adjustment, or TADAPA. Finally, disease awareness activities imperative to reframing the primary defect of CKD anemia from one of epinephrine deficiency to an oxygen-sensing deficit are underway in the U.S., and in Europe. The filing for roxadustat for the treatment of anemia in adult patients with chronic kidney disease was accepted by the European Medicines Agency in May. Our partner, Astelas, expects a European approval decision in mid-2021.
Causing a reduction in oxygenation and severe respiratory failure.
The administration.
Of our anti city, Jeff antibody Pamrevlumab could protect the line from the immediate consequences of the inside of the infection presented as acute respiratory distress syndrome.
Now moving to an update of our ongoing clinical trials.
Covered 19 pandemic continues to present challenges to the conduct of clinical trials across our industry.
The most effective over trial continues to be Pamrevlumab suffers IP AF trial.
In which we temporarily pasta enrollment for two months due to the vulnerability of these patients with severely compromised lung function.
We have reopened suffers for enrollment.
And the remainder of our studies.
In locally advanced Unresectable pancreatic cancer.
Hello, this plastic syndrome and chemotherapy induced anemia.
Continue enrollment, albeit at lower rates.
We expect to initiate Lantus, our phase three trial of umbrella mapping patience, we non ambulatory duchenne muscular dystrophy this quarter.
And we plan to publish updated two year data from a recently completing phase two DMD study before yearend.
We remain focused on accelerating enrollment of all of our ongoing clinical trials, while ensuring patient safety I will now turn the call over two part because they're now our CFO to review the financials Pat.
Thank you and everything as announced today total revenue for the second quarter of 2020, plus $42.9 million as compared to $191.6 million for the second quarter of 29 team.
The current quarter revenue consists of net product revenues of $15.7 million for Roxadustat sales in China.
Enrique A. Conterno: Moving now to our pipeline, starting with newly initiated clinical trials. In June... we initiated two separate trials studying panbrevimab in patients hospitalized with COVID-19. In the U.S., we initiated a Phase 2 study investigating the efficacy and safety of pambrevimab in hospitalized patients with acute coronavirus infection. This multi-center trial will enroll approximately 130 patients with COVID-19 and will assess patient time to and on ventilatory support. In Italy, a Phase II-III investigator-initiated trial investigating the efficacy and safety of panbrevimab in approximately 68 patients hospitalized with COVID-19 was started. The primary objective of this study is to assess the effect of panbrevimab on blood oxygenation in patients with COVID-19 infection in the acute and post-acute settings.
$19 million in development revenue and $8.2 million of Npis sales in Japan.
For the same period operating costs and expenses were $128 million and net loss was $85.3 million or 95 cents per basic and diluted share.
As compared to operating costs and expenses of $78.7 million and net income of $116 million or $1.44 cents per basic and $1.26 cents per diluted share for the second quarter last year.
Included in operating cost and expenses for the quarter ended June 30 2020.
It was an aggregate non cash portion totaling $23.6 million.
Which $17.6 million was the result of stock based compensation expense as compared to an aggregate non cash portion of $21.9 million of which $17.6 million was a result of stock based compensation expense.
For the same period in the prior year.
At June 30, Fibrogen had $716 million in cash.
Cash equivalents restricted time deposits investments and receivables.
During the second quarter of 2020, we were seeing $50 million for a milestone payments from Astra zeneca relating to the FDA acceptance of our U.S. Anda filing.
And $130 million of milestone payments from the style us in connection with the you may all filings.
Enrique A. Conterno: The majority of patients suffering from severe forms of COVID-19 have bilateral insertionitious pneumonia, causing reduction in oxygenation and severe respiratory failure. The administration of our anti-CTGF antibody PAM Revlimab could protect the lung from the immediate consequences of the infection presented as acute respiratory distress syndrome.
Both of these milestones were recognized as revenue in the prior year when achievement became probable.
Based on these milestone payments and our latest forecast data, we continue to estimate our 2020 ending balance cash cash equivalents restricted time deposits.
<unk> expense and receivables to be in the range of 720 $730 million.
Assuming you asked and the approval in Q4 2020.
Looking ahead, we have a total of $245 million an anticipated milestones expected over the next 12 months.
Enrique A. Conterno: Now moving to an update on our ongoing clinical trials. The COVID-19 pandemic continues to present challenges to the conduct of clinical trials across our industry. The most effective of our trial continues to be Pambrellumab's Zephyrus IPF trial, in which we temporarily postponed enrollment for two months due to the vulnerability of this patient with severely compromised lung function. We have reopened CEPHRS for enrollment, and the remainders of our studies, in locally advanced and resectable pancreatic cancer, myelodysplastic syndrome, and chemotherapy-induced anemia, continue enrollment albeit We expect to initiate Lelanthus, a phase 3 trial of pambrelumab in patients with non-ambulatory Duchenne muscular dystrophy this quarter, and we plan to publish updated 2-year data from a recently completed phase 2 DMD study before year-end. We remain focused on accelerating enrollment in all of our ongoing clinical trials while ensuring patient safety. I will now turn the call over to Pat Cotroneo, our CFO, to review the financials. Pat?
We anticipate a U.S. and new approvals and horse commercial sale in the U.S.
At this point in time, we have no changes in our expectations in any of the anticipated milestones over the next 12 months.
Thank you and I would now like to turn the call back over to Enrique.
Very good thank you Pat and in summary, Fibrogen is well position.
Our business continuity plans are in effect.
On what we're seeing some impact to our operations, resulting from carbon 19, we have that capabilities and resources to navigate through this uncertain times and achieve our stated goals.
As roxadustat sales ramp up in China.
Our financial position is strong.
With approximately $716 million in cash at the end of the second quarter.
The year Mace acceptance of the Roxadustat filing for treatment of the EMEA in adult patients with CKD.
Triggered milestone payments of 130 million from Astellas to Fibrogen.
In addition, we have a total of $245 million in anticipated approval on first commercial sale milestones expected over the next 12 months.
We receive full partner reimbursement.
For all development and commercialization of Roxadustat in all geographies, except China.
Where we shared these expenses 50 50 with extra Seneca.
Based on our current forecast, we're reiterating our estimated 2020 ending cash to be in duration 700 to 730, 220 December $130 million, where well financed for years to come.
Actually.
If you could now open the lines for questions.
Ladies and gentlemen, thank you have a question.
These past few star and then the number one key on your touched on telephone.
If your question has been okay are you the screen softened.
Boston farms.
Your first question comes from Johnson. Please please ask maybe Leerink. Your line is now.
Pat Cotroneo: Thank you, Enrique. As announced today, total revenue for the second quarter of 2020 was $42.9 million, as compared to $191.6 million for the second quarter of 2019. The current quarter revenue consists of net product revenues of $15.7 million for Roxadustat sales in China, $19 million in development revenue, and $8.2 million in API sales in Japan. For the same period, operating costs and expenses were $128 million, and the net loss was $85.3 million, or $0.95 per basic and diluted share. Compared to operating costs and expenses of $78.7 million and a net income of $116 million, or $1.34 per basic and $1.26 per diluted share for the second quarter last year. Included in operating costs and expenses for the quarter ended June 30, 2020, was an aggregate non-cash portion totaling $23.6 million, of which $17.6 million was a result of stock-based compensation expense as compared to an aggregate non-cash portion of $21.9 million, of which $17.6 million was a result of stock-based compensation expense for the same period in the prior year.
Thank you very much and look congratulations on the positive regulatory interactions.
Have you asked a little bit about about that so perhaps enrique you could give us a sense of how important to the commercial opportunity is whether or not you get a black box warning CV risk of and then secondly could you give us a little bit more color, how the China our agreement with Astra Zeneca has changed.
Particularly how it may have influence.
Your flexibility with respect to the ownership.
Integration of that business unit.
Thanks very much appreciate the question.
Very good Jeff Thank you for.
For your questions, let me try to.
Answer first Youre your Ah the second part of your question related to the updates in our China agreement with extra Seneca.
Clearly.
We believe that de sub data agreement.
Best aligns I think both our organizations to maximize the economic value of Roxadustat.
Importantly, this agreement.
Allows us to.
Half both more predictable, but also improved economics for Fibrogen.
So we are I'm excited about.
Having.
Been able to update disagreement and.
Given the significant opportunity there with the we see we'd roxadustat that cause a very good chance of becoming a blockbuster product in China.
I think you were referring how this impacts other future plans I think is.
As I mentioned.
In the past, we're not prepared to comment on that but I think if anything.
Having this agreement I think gives us more flexibility to do anything because I think we have great Foundation for our business in Roxadustat.
As it relates to a.
Books, a warning as I mentioned, we're not planning to make comments when it comes to labeling going forward, but clearly we view that reduced the will be successful I think I've mentioned this to you and others in the past varies.
Successful regardless.
Pat Cotroneo: At June 30, FibroGen had $716 million in cash and cash equivalents, Restricted Time Deposits, Investments, and Receivables. During the second quarter of 2020, we received $50 million for a milestone payment from AstraZeneca relating to the FDA's acceptance of our U.S. NDA filing, and $130 million in milestone payments from Estelas in connection with the EU MAA filing. Both of these milestones were recognized as revenue in the prior year when achievement became probable. Based on these milestone payments and our latest forecast data, we continue to estimate our 2020 ending balance cash, Cash Equivalents, Restricted Time Deposits, Investments, and Receivables to be in the range of $720 to $730 million, assuming U.S. NDA approval in Q4 2020. Looking ahead, we have a total of $245 million in anticipated milestones expected over the next 12 months, for anticipated U.S. and EU approvals and first commercial sale in the U.S. At this point in time, we have no changes in our expectations for any of the anticipated milestones over the next 12 months. Thank you, and I would now like to turn the call back over to Enrique.
Clearly.
We need to look at the entire label and when we look at the level for Roxadustat, including.
Potential box warning its is gonna be.
What does the labeling totality hsas and our ability to fully commercialized roxadustat given all the benefit that that he can provide.
We can continue to view that our data shows up a very positive benefit risk profile for the product.
Great. Thank you.
Your next question comes from Michael You with Jefferies. Your line is open.
Hi, there good afternoon, and thanks for the question Congrats on the progress two questions for me.
Thank you I know you can't comment specifically on after discussions show I guess my question is more about what sort of the key takeaways are from war mid cycle, you meeting and what are the key email or shall I say gating steps for you as you lap as you get too.
To the end the year.
On the review our second question is on.
China, maybe you can make a comment or krish can make a comment obviously, a pretty strong number in the second quarter.
Maybe you could just shed a little more light on that is there anything, particularly surprising that could be a read through to the United States et cetera, et cetera in the United States in the different reimbursement.
Model of course show, maybe you could talk to how much can we read too early to thanks. Thanks, so much.
Very good.
Thank you Michael Big basically on the mid cycle review I think.
Clearly it is let me talk reviews, another update of our submission.
But when it comes to news as we've shared the FDA indicated to us that there's no outcome that is planned.
At this stage.
Clearly you are asking about other types of.
Interaction with the FDA going forward. They think it's it should be no surprise, but clearly label labeling discussions are critical and those will be starting soon and of course, we need preapproval inspections, and so forth, but our engagement on our interaction with the FDA was positive.
Enrique A. Conterno: Very good. Thank you, Pat.
Operator: And in summary, FibroGen is well positioned. Our business continuity plans are in effect. And while we're seeing some impact to our operations resulting from COVID-19, we have the capabilities and resources to navigate through these uncertain times and achieve our stated goals. As Roxodusta cells ramp up in China... Our financial position is strong, with approximately 716 million dollars in cash at the end of the second quarter. The EMA's acceptance of the Roxadustan filing for treatment of edema in adult patients with CKD triggered milestone payments of $130 million from Astellas to FibroGen. In addition, we have a total of $245 million in anticipated approval and first commercial sale milestones expected over the next 12 months. We received full partner reimbursement for all development and commercialization of Roxodustat in all geographies except China, where we share these expenses 50-50 with AstraZeneca. Based on our current forecast, we are reiterating our estimated 2020 ending cash to be in the range of $720 to $730 million, and we're well financed for years to come. Ashley, if you could open the lines for questions now,
So we feel good about the progress that we are making.
As it relates to China, I'm going to allow Chris to give us a little more.
Detail on color on our strong results there Chris.
Thank you Enrique Hello, Michael.
Obviously, we're very pleased with the results of the second quarter it.
Jump from Q1 that is primarily due to increases in teaching hospitals listings and market adoption.
We look at channel sales this nothing spectacular about it we believe it's very consistent with the market.
So in terms of reading through to the future of China and the U.S. I think it just tells you the strength of the Rhapsody is that as a drastic deliver significant benefits and efficacy to multiple patient populations.
Profile and in particular in pair two year dialysis and non dialysis. The oral convenience is a very attractive feature Olson.
Yeah, I think where do you see good adoption non dialysis I guess I wish that sort of a back but the real we're going to question too.
We have been very encouraged by the adoption and non dialysis, we had anticipated from onto market with the in dialysis, but the non dialysis adoption has placed us in in a very positively yeah, I think Michael I'm, clearly I think where you're sensing from atsis.
Got a bit of optimism no I think probably you sensed that.
During the last earnings call, but now we have some good sales results to show the progress that we're making.
We're very pleased with the adoption of Roxadustat in different patient populations and are you using you spoke about.
Operator: Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered, or you wish to remove yourself from the queue, please press the pound key. Your first question comes from Jeffrey Porgs with SVB Lear, Inc. Your line is now open.
You know what are the implication for these two other countries of course different countries have including the U.S.
Different reimbursement schemes and.
But when it comes to physician adoption I think.
We we we see a lot of read through in terms of the benefits that the healthcare professionals are seen would roxadustat.
Okay. Thank you very much.
Your next question comes from Amabelle from Stifel. Your line is now.
Hi, Hi, Thanks for taking my questions. On this is Adam alone will enable our first maybe to follow Mike's questions on China.
Enrique A. Conterno: Thank you very much. And look, congratulations on the positive regulatory interaction. I have to ask a little bit about that. So perhaps, Enrique, you could give us a sense of how important it is to the commercial opportunity whether or not you get a black box warning for Stevie Risk. And then secondly, could you give us a little bit more color on how the China agreement with AstraZeneca has changed, and particularly how it may have influenced your flexibility with respect to the ownership and integration of that business unit? Thanks very much. I appreciate the question.
We learned that in the first half or about.
For the saw than patients treated this logs.
Hi, good enough for them.
TV or indeed efficient if you could just split them up.
And how many new patients added in the second quarter.
What is the launch curve to purchase in the coming quarter.
And then I have a follow up if I may.
Yeah, I'm going to ask Chris to answer that question in China. As you know we don't provide a forward looking forecast when it comes to Roxadustat at this time, but maybe Chris you can provide some additional color around.
Our on China.
Absolutely Hello, Edwin at this point in time in terms of the segments. We believe two thirds of the patients currently using roxadustat aren't dialysis patients.
Which is obviously hemo dialysis and parents and you know dialysis with the other third which is a very strong third being from non dialysis.
Enrique A. Conterno: Very good, Jeff. Thank you for... for your questions.
At this point in time to 40000 number is an estimate based on sales.
Enrique A. Conterno: Let me try to answer first. The second part of your question related to the update to our China agreement with AstraZeneca. Clearly, we believe that this updated agreement best aligns both organizations to maximize the economic value of Roxaduza. Importantly, this agreement allows us to have both more predictable but also improved economics for FibroGen. So we are excited about having been able to update this agreement and given the significant opportunity that we see with Roxadusta, which has a very good chance of becoming a blockbuster product. I think you were referring to how this impacts other future plans. I think it's... As I mentioned in the past, we're not prepared to comment on that. But I think, if anything, having this agreement gives us more flexibility to do anything because I think we have a great foundation for our business in Roxbury.
And assumptions about pricing compliance and the LTE.
The increase has been from about 15000 at the ended the first quarter to 40000 now the very nice trajectory, obviously looking into the second half a 2020 therapy changes in duration of treatment because many hospitals are just getting listed.
And reimbursement has just been implemented by the end of Q1. So at this point in time will be very difficult for us to project.
But we continue to be very optimistic about the upward trajectory, we're seeing in China.
Hey, good grid system for the color.
Tool regulatory question.
And do think the term for possible outcome is significantly reduced at this point.
And secondly on CMS negotiation.
Have you got any preliminary agreements with CMS on the bundling issue.
When do we expect any clarity on on the progress with CMS before or after Iraq's approval.
Yes.
Very good.
Let me.
Let me try to.
Provide a maybe a reinforcement on the question related to the outcome.
So clearly with the indication of.
Enrique A. Conterno: As it relates to a, um... Boxed warning, as I mentioned, we're not planning to make comments when it comes to labeling going forward. But clearly, we view that Roxadusta will be successful, I think I've mentioned this to you and others in the past, very successful regardless. Clearly, we need to look at the entire label. And when we look at the label for Roxadusta, including a potential boxed warning, it's going to be... What does the label in totality say? And our ability to fully commercialize Roxaduza would give it all the benefits that it can provide. We continue to believe that our data shows a very positive benefit-risk profile for the.
The FDA that no outcome is planned at this time I think the likelihood of having an outcome has decreased significantly.
It doesn't mean that an outcome could not be called or.
It it's but it is no. This is not planning for one at this stage based on.
Engagement that we had with them at the Beach cycle review.
In terms of CMS discussions clearly we have those discussions, but there's no such a thing that's an agreement other than we will have to summit.
Once we get approval, we will have to submit too.
CMS for Oh, the inclusion on that path and that can be done as soon as we get approval and then if da with the CMS will basically process that.
As quickly as possible.
And we are a we've done all the homework to ensure that we are ready and that we're hopeful that we can get expedited approval I'm going to ask maybe a sane weyrich, our chief our newly.
Enrique A. Conterno: Thank you.
Operator: Your next question comes from Michael Yee with Jefferies. Your line is open.
Appointed Chief commercial officer, maybe to make some additional common thing yeah. Thanks Enrique.
I think just to add to what Enrique said, they're the most important date for us as approval and once we get approval.
Enrique A. Conterno: Hi there. Good afternoon, and thanks for the question. Congratulations on the progress. I have two questions for you. Enrique, I know you can't comment specifically on FDA discussions, so I guess my question is more about what sort of key takeaways there were from your mid-cycle review meeting and what are the key, you know, shall I say, gating steps for you as you get to the end of the year on the review. My second question is on China. Maybe you can make a comment or Chris can make a comment. Obviously, a pretty strong number in the second quarter. You know, maybe you could just shed a little more light on that. Is there anything particularly surprising that could be a read-through to the United States, et cetera, et cetera? You know, the United States has a different reimbursement model, of course, so maybe you could talk about how much we can read through into things. Thank you so much.
Astrazeneca and fibers in will offer Hicks fixed code and then that starts the today to review process now CMS goal.
But to the App is to make the product available as quickly to their beneficiaries as they possibly can and they state and their regs that their their goal is to make a to data available within 90 days or within a quarter within 90 days and so thats the expectation that we haven't and rest assured that we and astrazeneca are doing everything in our power.
Sure sure the earliest possible availability to the APA for Roxadustat.
Great. Thanks Hello.
Your next question comes from Joel Beatty Cds Your line is open.
Hi, Thanks for taking the questions and I guess installing after the last question on to adapt and 90 day window.
I'll provide some context is that kind of the K limiting factor to launching in dialysis centers or are there other.
Thanks, I need to take place such as negotiations with the dialysis centers and in order to starts on creditor.
Yeah, I'm Gonna are great great. Great question I'm going to have a same comment, but you really need both right you really need that up and you really need to have the discussion with the Dallas organizations. Yeah. That's exactly right and in addition for the dialysis dependent patient population you know our estimate is about two thirds of those pay.
Enrique A. Conterno: Very good. Thank you, Michael.
Enrique A. Conterno: Basically, on the mid-cycle review, I think... Clearly, the Mitzvah Review is an overall update on our submission. But when it comes to news, as we've shared, the FDA indicated to us that there's no outcome that is planned at this stage. Clearly, you're asking about other types of interaction with the FDA going forward. I think it should be no surprise, but clearly, labeling discussions are critical, and those will be starting soon. And, of course, we need pre-approval inspections and so forth. But our engagement and our interaction with the FDA has been positive, so we feel good about the progress that we are making. As it relates to China, I'm going to allow Chris to give us a little more detail and color on our strong results there. Okay, Chris?
Patients will are currently being treated through the SRT prospective payment system and so there's about a third of the patients that also go through Medicare advantage as well as commercial and so we'll be working actively with the priority payers between now and not just a win.
Product is available that between now and even launched having those conversations to set the stage for a availability of roxadustat not only through the to that but designation, but also through the the private sector as well.
Great and then maybe just one follow up to that.
How important are agreements such as the one the Akiva has with device for two the dialysis market is that something that would be an impediment to your launch or is that the type of agreement that you maybe exploring as well.
No we honestly, we do not view.
The we have a a restriction or any type of limitation for us to be able to have a agreements with any of the dialysis organizations. So.
At this point in time, we we feel we're in a very good.
Christine L. Chung: Thank you, Enrique. Hello, Michael. Obviously, we're very pleased with the results of the second quarter.
In a very good position.
Hey, Thank you.
Your next question comes from Jason Gerberry. This bank of America. Your line is open.
Yeah.
Yeah, Jason Gerberry with Bank of America.
Okay.
Sorry, sorry, as Amit Thanks for taking my questions guys. Enrique just a follow up on that last comment what do you think the value is that having a contractual arrangement with the dialysis organization for a company like a key VIP. If you don't view it as an impediment or your ability to garner uptake in the market.
Christine L. Chung: From Q1.
Christine L. Chung: That is primarily due to increases in two things, hospital listings and MarketAdoption. We looked at our channel sales; there's nothing spectacular about it. We believe it's very consistent with the market. So in terms of reading through to the future of China and the U.S., I think it just tells you the strength of roxidusedat as a drug that delivers significant benefits and efficacy to multiple patient populations, profile, and in particular in peritoneal dialysis and non-dialysis, the oral convenience is a very attractive feature over EC.
And then my other questions can you talk a little bit about how you see the China Hospital listing.
Progressing in the second half is kind of curious how you're seeing that progression going <unk> versus the benefit we saw one Q from two tier thanks.
Yeah I think on thank you for your question I think on the first question is really I'm not sure. This is a question for Fibrogen is probably a question for a caveat even did there the one the pursued that agreement.
When it comes to hospitalist things a as we mentioned we went from.
Basically over 30% to 42 over 45%. So we were at over 30 on the end of Q1, we are now over 45 at the end of Q2.
If we if if we work to benchmark some of the blockbuster products in China innovative blockbuster products in China, I think you will see that this level of penetration and when it comes through the overall opportunity in China to be at 45% or that opportunity I think is very significant.
Christine L. Chung: I think
Christine L. Chung: Do you see good adoption in non-dialysis? I guess that was sort of the real-world question too.
Christine L. Chung: We have been very encouraged by the adoption of non-dialysis. We had anticipated that the launch market would be in dialysis, but the non-dialysis adoption has pleased us in a very positive way.
Milestone achievement basically at the second quarter post launch so we feel a extremely good the we expect to continue to make progress, but we do not provide a formal forecast whether it comes to either.
Enrique A. Conterno: Yeah, I think Michael, clearly, I think what you're sensing from us is quite a bit of optimism. I think you probably sensed it during the last earnings call, but now we have some good sales results to show the progress that we're making. We are very pleased with the adoption of Roxadustat in different patient populations, and you spoke about what the implications of this are for other countries. Of course, different countries have, including the U.S., different reimbursement schemes, but when it comes to physician adoption, I think we see a lot of read-through in terms of the benefits that healthcare professionals are seeing with Roxadustat. Thank you so much.
Revenue or listing for for future quarters at this stage.
Okay, great. Thank you.
Your next question comes from DC <unk> Securities.
Your line is now open.
Hi, good afternoon, and thanks for taking my question, just a couple things, where I'm rock certain time or I know you've seen anybody that's what that Allison patient population do you see most of the prescription going to yes a.
Failure patients or do you see adoption across the board.
In that population.
Yeah.
Let me once again call on Chris to give us.
Some additional color on some of these dialysis dependent patients are they easy failures or treatment naive for what can you tell us.
So we are seeing adoption across all those patients segments to give you little bit of color to first look at the hemo dialysis population, we are getting inflamed.
Operator: Your next question comes from Annabel Samimy with Staple. Your line is now open.
Hi, Paul responses, and I into fishing patients and hemo dialysis.
Operator: Hi, thanks for taking my questions. This is Edwin from Ennabel.
We have not seen a very large conversion for E.
Operator: First, maybe just follow Mike's questions on China. We learned that in the first half, there were about 40,000 patients treated with Roxas. How many of them are... D.D. or N.D.D.
Absolutely. So in terms of percentage right now the pair Tony your dialysis population is around 14% to 15%. The government is trying to increase it but it's been stable at around that percentage. China. Currently has 800000 dialysis patients expected to exceed 1 million in the next couple of years. So if you just take 15.
Christine L. Chung: patients, if you could split them up, and how many new patients were added in the second quarter. What is the launch curve do you project in the coming quarters? And then I have a follow-up, if I may.
Percent of 800000 patients. There are currently over a 100000 perito dialysis population patients in China, we've seen very very strong adoption in both the installed base and new patients.
Christine L. Chung: Yeah, I'm going to ask Chris to answer that question. In China, as you know, we don't provide a forward-looking forecast when it comes to ROXADUSTAT at this time. But maybe, Chris, you can provide some additional color on China.
And the initiation rate into PD is actually higher than hemo dialysis Interestingly Covidien has played a factor in it because many new patients prefer cannot be going to hemo dialysis centers three times a week.
Christine L. Chung: Absolutely. Hello, Edwin.
Unexpected trend of course.
Christine L. Chung: At this point in time, in terms of the segments, we believe two-thirds of the patients currently using Roxaducedat are dialysis patients, which is obviously hemodialysis and peritoneal dialysis, with the other third, which is a very strong third, being from non-dialysis. At this point in time, the 40,000 number is an estimate based on sales, and assumptions about Pricing, Compliance, and DOT. The increase has been from about $15,000 at the end of the first quarter to $40,000 now. It's a very nice trajectory. Obviously, looking into the second half of 2020, there will be changes in duration of treatment because many hospitals are just getting listed, and reimbursement has just been implemented by the end of Q1. So at this point in time, it will be very difficult for us to project, but we continue to be very optimistic about the upward trajectory we're seeing in China.
But very very positive for adoption of Roxadustat in China.
Thank you Chris.
Your next question comes from Yaron Werber with Cowen Your line is now open.
Hi, guys as Brendan luxury around thanks, very much for taking the question and congrats on the progress I'll just a couple of quick ones from us.
First I, just really one of the outside of both on the top level, our key learnings you've picked up from the China launch, so far and how you're thinking about applying some of the U.S. launch, particularly in light of what's going on here and all the challenges just kind of most important considerations your bearing in mind and.
And then I also wanted to just quickly ask the but the Mds CA trials that you can give us anymore.
Granularity on where you're at enrollment respective timeline than what we might get them data from either of those thanks very much.
Yes.
Let me try to address your first question I'm going ask Piani to discuss both the Mds and the CIA trials.
When it comes to.
Learnings from China, So you can imagine them.
It's probably not on our best interest to be discussing those given the competitive environment. The we have in other markets.
But I think youve heard to say I think the one other thing that we've learned is that.
Christine L. Chung: Great, thanks for the color. And two regulatory questions. Do you think the chance for a possible outcome is significantly reduced at this point? And secondly, on the CMS negotiation, have you got any preliminary agreement with CMS on the bundling issue? When do we expect any clarity on the progress with CMS, before or after ROCSA approval? Thanks.
Though we have the.
Our ability to be able to grow roxadustat in different patient populations. I think this is important because you give you a number of different ways to grow.
And.
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Given where when we think about hemodialysis Bertone Dallas is.
Non dialysis patients is just the broad spectrum of patients that can give us.
Sure two legs for growth in into the future. So very excited about what that could do for us in the us for us to saying, yes short term when it comes to the launch borrow so longer term in terms with this product.
Enrique A. Conterno: Very good. Let me, um... Let me try to provide maybe a reinforcement on the question related to the outcome. So clearly with the indication of the FDA that no outcome is planned at this time, I think the likelihood of having an outcome has decreased significantly. It doesn't mean that an outcome could not be called, but DFDS is not planning for one at this stage based on the engagement that we had with them at the B-Cycle. In terms of CMS discussions, clearly we have those discussions, but there's no such a thing as an agreement other than we will have to submit, Once we get approval, we will have to submit to CMS for the inclusion on TADAPA, and that can be done as soon as we get approval, and then the CMS will basically process that as quickly as possible. And we've done all the homework to ensure that we are ready, and that we are hopeful that we can get expedited approval. I'm going to ask maybe Thane Wettig, our newly appointed chief commercial officer, maybe to make some additional comments, Thane.
Could become.
And I'm going ask you wanted to give us an up to now on both Mds and CA.
Thank you, both the Mds and CIA trial going well Oh, the coal that inevitably have had some impact on some of the study site.
So, but we were able to work with our investigators in ensuring patient safety, while optimizing our patient enrollment at the same time, we have instituted.
[noise] remote monitoring process and remote data review to ensure our data integrity.
And Oh, we're not seeing.
Increase in Mis subject visits are turned a pandemic because.
Our investigators are managing the study so well.
And.
We anticipate that with all the some of these adaptational and continue strong effort that.
These two studies will continue to be or be able to be executed successfully.
Yeah, we feel good about.
Enrollment with both of those trials despite the impact the thing that themes as abruptly adapted to ensure that we can enroll very well.
Okay, great. Thanks very much.
Thane Wettig: Thanks, Enrique. You know, I think just to add to what Enrique said, the most important date for us is approval. And once we get approval, AstraZeneca and FibroGen will file for a HCPCS code, and then that starts the Tadapa review process. Now, CMS's goal with Tadapa is to make the product available as quickly to their beneficiaries as they possibly can, and they state in their regulations that their goal is to make Tadapa available within 90 days or within a quarter within 90 days. And so that's the expectation that we have. And rest assured that we and AstraZeneca are doing everything in our power to assure the earliest possible availability of Tadapa for Oxidustat. Great, thanks a lot.
Your next question comes from partially with Goldman Sachs. Your line is open.
Hi, Thank you are good afternoon, everyone and thanks for taking your questions.
For me please.
Enrique maybe could you comment on how you see the role of rock star and the into home dialysis setting here in the U.S. that out commercial priority for you and how are you thinking about potentially marketing.
Market.
Second your partner presented updated.
NPD data from the Dolomite study at a recent medical meeting.
Just wondering if you could also maybe commented on your updated thoughts with regard to to the base and nice plus endpoints and how that adds to the totality of the other existing CV data.
And then third.
Given the uptick if you've had in China, So far Enrique how do you think about potentially unlocking shareholder value their front from that business and.
Neither monetizing it or thinking about potentially as a separate entity. Thank you.
Yes.
Very good.
Operator: Your next question comes from Joel Beattie on the CD. Your line is open.
Let me try to.
Have different people answered your the opportunities maybe on a roxadustat the opportunity comes out or someone ask pain to maybe provide a few comments.
Operator: Hi, thanks for taking the questions. And I guess it's probably up to the last question on TODAPA and that 90 day window. Can you help provide some context on that kind of the gate limiting factor to launching in dialysis centers? Or are there other things that need to take place, such as negotiations with the dialysis centers in order to start selling the product there?
On Dolomites I'll ask Piani to comment and then I'll answer the question around China, and unlocking shareholder value thing that sure as it relates to home dialysis. It's it's clearly not the priority segment.
As the the LDR or the MTO or the other dialysis centers are the hospital based dialysis centers same thing with the NDD population, we're taking a look at it right now to determine what level of presence we need in order to take advantage of that but I think it's a different dynamic than it is in China.
Enrique A. Conterno: Yeah I'm going to have a great, great, question. I'm gonna have Thane comment, but you really need both, right? You really need the DAPA, and you really need to have the discussion with the dialysis organizations.
Thane Wettig: Yeah, that's exactly right. And in addition, for the dialysis-dependent patient population, you know, our estimate is that about two-thirds of those patients will or are currently being treated through the ESRD prospective payment system. And so there's about a third of the patients that also go through Medicare Advantage as well as commercial. And so, you know, we'll be working actively with the priority payers between now and not just when the product is available, but between now and even launch, having those conversations to set the stage for availability of Roxadustat, not only through the TADAPA designation, but also through the private sector as well. Great. And then maybe just one follow-up to that. How important are agreements such as the one that Akiva has with ViFOR to the dialysis market? Is that something that would be an impediment to your launch, or is that the type of agreement that you may be exploring as well?
Yes, we we have.
I had a very favorable product profile, but the relative size of the opportunity smaller here and then in China.
Bernie on NV.
And Dolomites Ah yes.
So just a and Ah on M.D.D. dolomite, Oh, we believe that this active control a study of roxadustat being compare against Apple play attend Oh.
Provides a further confidence on roxadustat.
In fact, we demonstrate efficacy in comparison to the active comparator and and importantly.
Hazard ratio of Mace is 0.8, and so this oh in you know business incremental confidence building on top of the non dialysis pull analysis.
Yeah.
Keep in mind ball as we've shared before I think.
The dare I use agreement with the FDA on the studies that are the people to studies to be pool for the mace analysis in the U.S. Dolomites was not part of that but of course.
Thane Wettig: No, we honestly do not view that we have a restriction or any type of limitation for us to be able to have agreements with any of the dialysis organizations. So at this point in time, we feel we're in a very good and very good position. Great, thank you.
You see what the results are and they are I think we can say encouraging.
When it comes to your question on unlocking value a in China.
The best way for us to ensure that we gonna look as much value in China Faso is to make roxadustat as large as possible as we can.
Operator: Your next question comes from...
Operator: Your next question comes from Jason Gerberry with Bank of America. Your line is open. You have Jason Gerberry with Bank of America.
So for US I think having a great launch.
I I think is.
Enrique A. Conterno: Sorry, I was on mute. Thanks for taking my questions, guys. Enrique, just to follow up on that last comment, what do you think the value is of having a contractual arrangement with a dialysis organization for a company like Akebia if you don't view it as an impediment to your ability to garner uptake in the market? And then my other question is, can you talk a little bit about how you see the China hospital listing progressing in the second half? I'm just kind Thanks.
Is critical.
Keep in mind that when we look I'm going to mentioned this again when we look at benchmarks of products that are innovative blockbusters in China.
When we look at either their revenue uptick or lift synaptic reflect those studies comparing extremely well. So clearly I think this is priority one as I've mentioned I think we are gonna be looking at all opportunities for us to ensure that are our China business is fully appreciate it.
Bye bye.
By our shareholders given the huge value that we believe that we have there.
Yeah those lists.
Well. Thank you Ms. Allison I will now technical or was it and you can tell them for closing remarks.
I I want to thank everyone for joining us on this.
Earnings call.
And once again all of our collaborators or whether there are patients or healthcare professionals investigators regulators that are allowing us to progress our agenda, but in particular I want to thank the entire fibrogen.
Enrique A. Conterno: Yeah, I think on, thank you for your question, I think the first question is really, I'm not sure this is a question for FibroGen, it's probably a question for Akiva, even though they're the one that pursued that agreement. When it comes to hospital listings, as we mentioned, we went from basically over 30% to over 45%. So we were at over 30 at the end of Q1, and we are now over 45 at the end of Q2. If we were to benchmark some of the blockbuster products in China, innovative blockbuster products in China, I think you will see that this level of penetration and when it comes to the overall opportunity. China. To be at 45% of that opportunity, I think is a very significant milestone and achievement, basically at the second quarter post-launch. So we feel extremely good. We expect to continue to make progress, but we do not provide a formal forecast, whether it comes to either revenue or...
Team for their commitment to the type of brokers and though we are seeing today. So thank you very much everyone.
Ladies and gentlemen, this concludes todays conference call. Thank you for participating in a disconnect.
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Oh.
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[noise] Oh.
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Enrique A. Conterno: Okay, great. Thank you.
Operator: Your next question comes from B. Faye Young with Missoula Security. Your line is now open. Hi, good afternoon, and thanks for taking my questions. Just a couple. The first one, on Roxa in China. I know it's in the early days, but for the dialysis patient population, do you see most of the prescriptions going to ESA failure patients, or do you see adoptions across the board in that population?
Operator: Let me once again call on Chris to give us some additional color on some of these dialysis-dependent patients. Are they ESE failures or treatment-naive, or what can you tell us?
Christine L. Chung: So, we are seeing adoption across all those patient segments, to give you a little bit of color, to first look at the hemodialysis population. We are getting inflamed..., hyporesponsive, and iron deficient patients on hemodialysis. We have not seen a very large conversion for each. Absolutely.
Christine L. Chung: So in terms of percentage, right now, the peritoneal dialysis population is around 14 to 15%. The government is trying to increase it, but it's been stable at around that percentage. China currently has 800,000 dialysis patients, and it is expected to exceed a million in the next couple of years. So if you just take 15% of 800,000 patients, there are currently over 100,000 peritoneal dialysis patients in China. We've seen very, very strong adoption in both the installed base and new patients, and the initiation rate into PD is actually higher than hemodialysis. Interestingly, COVID has played a factor in it because many new patients prefer to not go to a hemodialysis center three times a week. Unexpected trend, of course, but very, very positive for the adoption of Roxaducet in China.
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Christine L. Chung: Thank you. Thank you, Chris.
Operator: Your next question comes from Yarin Werber with Kauan. Your line is now open.
Enrique A. Conterno: Hi guys, this is Brendan on for your own. Thanks very much for taking the question. And congrats on the progress. Just a couple quick ones from us. You know, first, I just really wanted to ask kind of about some of the top level kind of key learnings you've picked up from the China launch so far and how you're thinking about applying some of these to the US launch. Particularly in light of what's going on here and all the challenges, just kind of the most important considerations you're bearing in mind. And then I also wanted to just quickly ask about the MDS and CIA trials, if you can give us any more granularity on where you're at in enrollment, respective timelines, and when we might get some data from either of those. Thanks very much. Yeah,
Enrique A. Conterno: Let me try to address your first question. I'm going to ask Peony to discuss both the MDS and the CIA trials. When it comes to learnings from China, as you can imagine, it's probably not in our best interest to be discussing those given the competitive environment that we have in other markets.
Enrique A. Conterno: But I think it's fair to say that one of the things that we've learned is that we have the ability to grow Roxodustan in different patient populations. I think this is important because it gives you a number of different ways to grow Roxodustan in non-dialysis patients. It's just a broad spectrum of patients that can give us huge legs for growth into the future. So, very excited about what that could do for us in the U.S., for us to think, yes, short term when it comes to the launch but also longer term in terms of what this product could become. And I'm going to ask Peony to give us an update now on both MDS and CIA.
Peony Yu: Thank you. Both the MDS trial and the CIA trial are going well. The COVID inevitably had some impact on some of the study sites, but we were able to work with our investigators to ensure patient safety while optimizing patient enrollment. And we are not seeing an increase in subject visits or during the pandemic because our investigators are managing. We anticipate that with some of these adaptations and continued strong effort, these two studies will continue to be able to be executed.
Peony Yu: We feel good about our enrollment in both of those trials; despite the impact, I think the team has appropriately adapted to ensure that we can enroll very well.
Operator: Okay, great. Thanks very much.
Operator: Your next question comes from Paul Choi with Goldman Sachs. Your line is open.
Operator: Hi, thank you. Good afternoon, everyone, and thanks for taking our questions. A few from me, please.
Enrique A. Conterno: Enrique, maybe could you comment on, you know, how you see the role of Roxa in the home dialysis setting here in the U.S.? Is that, you know, a commercial priority for you? And how are you thinking about, you know, potentially marketing to that market? Second, your partner presented updated NDD data from the dolomite study at a recent medical meeting. I was just wondering if you could also maybe comment on your updated thoughts with regard to the MACE and MACE Plus endpoints and, you know, how that adds to the totality of the existing CV data. And then, thirdly, Given the uptick you've had in China so far, Enrique, how do you think about potentially unlocking shareholder value there from that business and either monetizing it or thinking about it potentially as a separate entity? Thank you.
Enrique A. Conterno: Very good. Let me try to...
Enrique A. Conterno: I'll have different people answer the opportunities, maybe on Rocks at Dustas and the opportunity in Home Douses. I'm going to ask Thane to maybe provide a few comments on Dolomites. And on Dolomites, I'll ask Peony to comment, and then I'll answer the question around China and unlocking shareholder value. Thane.
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Thane Wettig: Sure, as it relates to home dialysis, it's clearly not the priority segment as the LDO or the MDO or the other dialysis centers are, the hospital-based dialysis centers. Same thing with the NDD population. We're taking a look at it right now to determine what level of presence we need in order to take advantage of that, but I think it's a different dynamic than it is in China.
Thane Wettig: Yeah, we have a clearly very favorable product profile, but the relative size of the opportunity is smaller here than in China. Peony on NVD, and Dolomites.
Peony Yu: Yes, so on MDD-Dolomite, we believe that this active control study of Roxidustat being compared to dopamepoietin provides further confidence in Roxidustat in that we demonstrate efficacy in comparison to the active comparator. And importantly, the hazard ratio of MACE is 0.8. And so this is incremental confidence building on top of the non-dialysis pool analysis.
Enrique A. Conterno: Keep in mind, Paul, as we've shared before, I think... The, uh, agreement with the FDA on the studies that are the pivotal studies to be pulled for the MACE analysis in the U.S. Dolomites was not part of that, but of course, you see what the results are, and they are, uh, I think we can say encouraging.
Enrique A. Conterno: When it comes to your question on unlocking value in China... The best way for us to ensure that we can allocate as much value to China as possible is to make Roxadustan as large as possible as we can. So for us, I think having a great launch is critical. Keep in mind that when we look at benchmarks of products that are innovative blockbusters in China, and when we look at either their revenue uptake or listing uptake, Rosagdo's study is comparing extremely well. So clearly, I think this is priority one. As I've mentioned, I think we are going to be looking at all opportunities for us to ensure that our China business is fully appreciated by our shareholders, given the huge value that we believe that we have there.
Enrique A. Conterno: That brings us to the end of the Q&A session. I will now turn the call over to Enrique Conterno for closing remarks.
Enrique A. Conterno: I want to thank everyone for joining us on this earnings call. And once again, all of our collaborators, whether they are patients or health care professionals, investigators, or regulators, who are allowing us to progress our agenda. But in particular, I want to thank the entire FibroGen team for its commitment to the type of progress that we are seeing today. So thank you very much, everyone.
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Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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