Q2 2022 FibroGen Inc Earnings Call
[music].
Operator: Welcome to the FibroGen's second quarter 2022 earnings call.
Good day and thank you for standing by welcome to the five <unk> second quarter 2022 earnings call. At this time, all participants are in a listen only mode.
Operator: At this time, all participants are in a listen-only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press TAR11 on your telephone. You will then hear an automated message advising your hand is raised.
Michael Yee: And one final question as a follow-up.
Operator: The conference will begin shortly.
To raise your hand during Q&A, you can dial star 1 1.
After the speaker's presentation, there will be a question and answer session to ask a question. During this session you will need to press star one one on your telephone.
Operator: Please be advised that today's conference is being recorded.
I'll then here an automated message advising your hand is Li.
Operator: I would now like to hand the conference over to your speaker today, Michael Tong.
Michael Yee: With the DMD studies, appreciating your novel endpoints, and this is sort of an untraveled path, have you talked with FDA on these endpoints and what you need to show and what data is required there to be deemed a successful study?
Please be advised that today's conference is being recorded I would now.
Michael Tong: Please go ahead.
Now like to hand, the conference over to your Speaker today, Michael Tung. Please go ahead.
Michael Tong: Thank you, Bella, and good afternoon, everyone.
Michael Yee: Thanks.
Michael Tong: I'm Michael Tong, Vice President of Corporate Strategy and Investor Relations at FibroGen.
Dr. Mark Eisner: Yes.
Thank you Bella and good afternoon, everyone I'm, Michael Tang Vice President of corporate strategy and Investor relations at fiber to join.
Michael Tong: Joining me on today's call are Enrique Quintero, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer,
Dr. Mark Eisner: So we do have endpoints for both the non-ambulatory and ambulatory studies.
Joining me on todays call are Richard can turn out our Chief Executive Officer, Dr. Mark Eisele, Our Chief Medical Officer, One Graham our Chief Financial Officer, Dr. John Hunter, Our Chief Scientific Officer, <unk>, <unk>, our chief commercial officer.
Michael Tong: Juan Graham, our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer, Thane Wettig, our Chief Commercial Officer,
Michael Tong: and Chris Chong, our Senior Vice President of China Operations.
Chris Chung, our senior Vice President of China operations.
Michael Tong: The format for today's call includes prepared remarks from Enrique and Juan, after which we will open up the call for Q&A.
Format for todays call includes prepared remarks from and regain one after which we will open up the call for Q&A.
Michael Tong: I would like to remind you that remarks made on today's call include four looking statements about FibroGen.
I'd like to remind you that remarks made on today's call include forward looking statements about fiber Gen. Such statements may include but are not limited to our collaborations with Astrazeneca and Astellas financial guidance.
Michael Tong: Such statements may include but are not limited to our collaborations with AstraZeneca, and Astellas, financial guidance, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results and results of operations, risks related to our business, and certain other business matters.
The initiation enrollment design conduct and results of clinical trials.
Our regulatory strategies and potential regulatory results our.
Our research and development activities.
Commercial results and results of operations.
Risks related to our business and certain other business matters.
Michael Tong: 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 SEC, including our most recent Form 10-K and Form 10-Q.
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 <unk> filings with the SEC, including our most recent Form 10-K and Form 10-Q.
Michael Tong: FibroGen does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise.
Robinson does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.
Michael Tong: The press release reporting our financial results and business update in a webcast of today's conference call can be found on the, investor's section of FibroGen's website at www.fibrogen.com.
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 <unk> website at www fiber Gen Dot com.
Michael Tong: With that, I would like to turn the call over to Enrique Quintero, our CEO.
Dr. Mark Eisner: We have discussed those with FDA.
With that I would like to turn the call over to Enrique Conterno, our CEO and regain.
Enrique Quintero: Enrique?
Dr. Mark Eisner: The performance of the upper limb score is the endpoint for the non-ambulatory.
Very good thank you, Mike and good afternoon, everyone and welcome to our second quarter 2022 earnings call.
Enrique Quintero: Very good.
Dr. Mark Eisner: And for ambulatory, it's the North Star ambulatory assessment.
Enrique Quintero: Thank you, Mike, and good afternoon, everyone, and welcome to our second quarter of 2022 earnings call.
Enrique Quintero: On today's call, I will provide a high-level summary of the most important accomplishments and developments in the second quarter of 2022.
On today's call I will provide a high level summary of the most important accomplishments and developments in the second quarter of 2022.
Enrique Quintero: Juan Graham, our CFO, will then review the financials, after which we will open the call for your questions.
One Gram our CFO will then review the financials after which we will open the call for your questions.
Enrique Quintero: Starting with slide three.
Starting with slide three.
Enrique Quintero: FibroGen is positioned to create significant value for patients and shareholders by executing on our three areas of focus.
Dr. Mark Eisner: These are standardized measures for both types of DMD patients.
Hydrogen is positioned to create significant value for patients.
And shareholders by executing on our three areas of focus.
Enrique Quintero: Number one, accelerating the development of panbrevimab in three indications with significant unmet medical needs.
Dr. Mark Eisner: So we expect that if we demonstrate efficacy based on these endpoints, that there will be a path forward for filing an approval.
Number one.
Accelerating the development of umbrella.
In three indications with significant unmet medical need.
Enrique Quintero: Number two, ensuring commercial success of Roxodusta in patients with chronic kidney disease outside the U.S., while continuing to explore a path forward in the U.S. 3.
And your party pulmonary fibrosis or IPF.
Locally advanced Unresectable pancreatic cancer or L. A P C.
And duchenne muscular dystrophy or DMD.
Number two.
Ensuring commercial success of <unk>.
In patients with chronic kidney disease outside the U S. While continuing to explore a path forward in the U S.
Enrique Quintero: Increasing our research productivity to advance novel programs that leverage internal, expertise and accessing external innovation for additional pipeline opportunities.
Three increasing our research productivity to advance novel programs to leverage internal expertise and accessing external innovation for additional pipeline opportunities.
Enrique Quintero: Let's move to our clinical trials, beginning with PAMBRELOMAP on slide 4.
Michael Yee: Okay.
Let's move to our clinical trials, beginning with ambarella map on slide four.
Enrique Quintero: PAMBRELOMAP is a wholly owned asset in Phase III clinical trials, for three high-value indications, IPF, LAPC, and DMD. Each one of these diseases represents an important unmet medical need, and each constitutes a significant market opportunity. As we recently announced, during the second quarter we completed enrollment of the Avalanthus, II Phase III clinical trial of PAMBRELOMAP in ambulatory patients with DMD.
Operator: Thank you.
But it's a wholly owned asset in phase III clinical trials for three high value indications IPF.
Operator: And your next question comes from the line of Annabelle Samimou with People.
L a b C and D&B.
Each one of these diseases represent an important unmet medical needs.
Our niche constitutes a significant market opportunity.
Operator: Your line is now open.
As we recently announced during the second quarter, we completed enrollment of the relentless two phase III clinical trial of controller map in ambulatory patients with DMD.
Jack: Hi.
Enrique Quintero: This brings the number of fully enrolled pivotal PAMBRELOMAP trials to four, the Cephrus I trial, in IPF, the Avalanthus I and Avalanthus II trials in non-ambulatory and ambulatory DMD respectively, and the LAPIS trial in LAPC.
This brings the number of.
A fully enrolled pivotal umbrella trials two four.
The <unk> one trial in IPF.
The Atlantis, one and Atlantis two trials.
Enrique Quintero: Enrollment continues in our second Cephrus, Phase III study in IPF, and we look forward to updating you as the trial progresses.
In non ambulatory ambulatory DMD, respectively.
And the LAPIS trial in <unk>.
And bromine continues in our second separate phase III study in IPF.
We look forward to updating you as the trial progresses.
Enrique Quintero: Moving now to locally advanced pancreatic cancer.
Jack: This is Jack calling in for Annabelle.
Moving now to locally advanced pancreatic cancer.
Enrique Quintero: As previously discussed, we set a very high bar, for event-free survival that would have enabled us to file for accelerated approval. An independent interim analysis of event-free survival in the LAPIS Phase III study was, conducted in the second quarter.
Jack: Thanks for taking our question.
As previously discussed and we set a very high bar for event free survival.
Would have enabled us to file for accelerated approval.
An independent interim analysis of event free survival in the LAPIS Phase III study was conducted in the second quarter based on the interim analysis, we will not be filing a BLA for accelerated approval.
Enrique Quintero: Based on the interim analysis, we will not be filing a BLA for accelerated approval. As planned, the study will continue to its primary endpoint of overall survival with top-line data expected in the first half of 2024.
The study will continue to its primary endpoint of overall survival with topline data expected in the first half of 2024.
Enrique Quintero: It is very exciting to be expecting data readouts from four pivotal Phase III trials in 2023, the Cephrus I Phase III trial in IPF mid-2023, the Avalanthus I and Avalanthus II Phase III trials in DMD in the first half of 2023 and the second half of 2023 respectively, and the Matterhorn Phase III trial of Roxas-Dustat in MDS in the first half of 2023.
Jack: For Pam, could you provide a little more color on how we should think about the IPF opportunity in the context of the current treatments available, what background treatments are allowed in those trials, and how you expect to eliminate the noise around that?
It is very exciting to be expecting data readouts from four pivotal phase III trials in 2023.
The <unk> one phase III trial in IPF mid 2023.
The Atlantis one in Atlanta, two phase III trials in BMD.
In the first half of 2023, and the second half of 2023, respectively.
And the Matterhorn phase III trial of <unk> in Mds in the first half of 2023.
Enrique Quintero: I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity we see with panbrelumab in each of the three disease areas on Slide 5, beginning with IPF.
Jack: Thanks.
I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity, we see with pan blow up in each of the three disease areas on slide five.
Enrique Quintero: With a diagnosed prevalence of approximately 330,000 patients across the U.S., EU, China, and Japan, IPF represents a significant opportunity, with the two approved IPF therapies generating almost $4 billion in net revenue in 2021. Despite this market size, there remains significant unmet need with these two approved therapies, as characterized by continued disease progression and challenging tolerability. There is sentiment in the IPF community of limitation with the current therapies and a, desire for additional therapeutic options.
Jack: Very good.
Beginning with IPF.
Jack: Thank you for the question.
With a diagnosed prevalence of approximately 330000 patients across the U S EU, China and Japan.
<unk> represents a significant opportunity.
Jack: And I'm going to ask Mark to discuss our trial design for IPF.
With the two approved IPF therapies generating almost $4 billion in net revenue in 2021.
Dr. Mark Eisner: I'm saying to share a bit about what we've learned about the opportunity that we would have.
Despite these market size.
Main significant unmet need.
With these two approved therapies.
Characterized by continued disease progression and challenging tolerability.
Dr. Mark Eisner: All right, so thanks for the question.
Dr. Mark Eisner: So for the Zephyrus Phase III program of PAM-REVL-NAB, it is placebo-controlled trials of PAM versus placebo for the treatment of IPF. Patients are not to be on background therapy when they enter the trial.
Dr. Mark Eisner: We do allow both treatment-naive and treatment-experienced patients on the trial, but when they enter the study, they're not on either profenadone or nintendine, so it's a monotherapy trial design.
There is sentiment in the IPF community of limitation with the current therapies and a desire for additional therapeutic options.
Enrique Quintero: Pancreatic cancer represents one of the largest unmet needs in oncology, given the diagnosed, prevalence of over 90,000 patients across the major regions, combined with a low five-year disease-free survival rate of around 10%.
Thane Wettig: Thane?
Thane Wettig: Yeah, thanks, Mark.
In the phase III <unk> program for this is similar results.
Two breast trial, we believe <unk> has the potential to help.
A sizable number of patients with IPF.
We are very significant medicine for fiber.
In the Middle column, you can see the locally advanced pancreatic cancer opportunity.
A great concert represents one of the largest unmet need in oncology given the diagnosed prevalence of over 90000 patients across the major regions combined with a low five year disease free survival rate of around 10%.
Thane Wettig: So as we think about the commercial opportunity, I think there's a couple, of things to keep in mind.
Thane Wettig: You know, first is that, you know, we were able to replicate in our Phase III Zephyrus program what we've seen in the Phase II PRAISE trial, and we would expect an indication for PAM-REVL-NAB for the treatment of patients with IPF.
Thane Wettig: As we have investigated the current state related to the current standards of care, it's pretty clear, and this is based upon published literature, that, you know, given the tolerability challenges associated with both ILFEV and ESPRIT, upwards of 40 to 50 percent of patients who start on either of those therapies, have stopped taking it by the end of the first year, and so there's a significant unmet need, not only as it relates to disease progression, but really as it relates to keeping patients on therapy.
Thane Wettig: And again, if we reflect on the PRAISE Phase II data and we look at the tolerability profile, while not head-to-head against either ILFEV or ESPRIT, we're pretty confident that we've got a product that not only demonstrated very significant efficacy, but also a tolerability profile that we think could lead to differentiation relative to the two current available therapies.
Thane Wettig: Great.
Enrique Quintero: There have been limited treatment advances in the non-metastatic setting over the last two decades, with immuno-oncology therapies failing to demonstrate survival benefits over the current standard of care.
Jack: Thanks so much.
There have been limited treatment advances in the non metastatic setting over the last two decades.
Operator: And your next question comes from the line of Andy Hsieh with William Blair.
With immuno oncology therapies, failing to demonstrate survival benefits over the current standard of care.
Enrique Quintero: There is limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful commercial opportunity for panbrelumab in LAPC if it can demonstrate a significant improvement in overall survival.
Operator: Your line is now open.
There is limited late stage development activity in non metastatic pancreatic cancer, which creates a meaningful commercial opportunity for <unk> in let me see if it can demonstrate a significant improvement in overall survival.
Andy Hsieh: Oh, great.
Enrique Quintero: In addition, the Pancreatic Cancer Action Network's Precision Promise Adaptive Trial Platform, evaluating panbrelumab in combination with standard of, care for patients with metastatic pancreatic cancer, continues to progress.
In addition.
The pancreatic cancer action networks precision promise.
<unk> platform evaluating umbrella in combination with standard of care.
For patients with metastatic pancreatic cancer continues to progress.
Enrique Quintero: And finally, in the third column, we wrap up the panbrelumab market section with a snapshot of the DMV opportunity.
And finally in the third column, we wrap up umbrella market section with a snapshot of the DMD opportunity.
Enrique Quintero: Given the devastating nature of DMV and the relentless progression of the disease, we are hopeful that the Lelantu Phase III program can lead to an approved therapy that is desperately needed by the DMV community.
Given the devastating nature of DMV.
And the relentless progression of the disease.
We're hopeful that they'll Atlantis phase III program can lead to an approved therapy that is desperately needed by the DMD community.
Enrique Quintero: While the currently approved excellence-keeping therapies produce an increase in the dystrophy levels, they are targeted at a small proportion of DMV patients.
While the currently approved exon skipping therapies produced an increase in the dystrophin levels.
Enrique Quintero: There is a clear need for therapies that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function and prolong ambulation.
Turning to at a small proportion of DMD patients.
There is a clear need for therapies that can have a disease progression.
<unk> targeting the downstream pathological changes to improve muscle function and prolong ambulation.
Enrique Quintero: We believe the antifibrotic mechanism of panbrelumab may be a solution that can help these patients, and their families.
We believe the anti fibrotic mechanism.
<unk> may be a solution that can help these patients and their families.
Enrique Quintero: Now let's move to Roxadusta on slide 6.
Now, let's move to <unk> on slide six.
Enrique Quintero: Roxadusta continues to be approved in additional countries and was recently approved in Mexico and South Africa. It is now approved in China, Europe, Japan, and numerous other countries for the treatment of CKV patients on dialysis and not on dialysis.
It looks like this there continues to be approved in additional countries.
It was recently approved in Mexico and in South Africa.
It is now approved in China, Europe , Japan, and numerous other countries for the treatment of CTV.
Enrique Quintero: Evrenso has an important first-mover advantage in the EU relative to other HIF-PHIs, and Astellas recently received positive reimbursement decisions in the UK, Finland, Slovakia, and Sweden.
<unk> on dialysis and not on dialysis.
<unk>.
Important first mover advantage in the EU.
Relative to other <unk> and Astellas recently received positive reimbursement decisions in the U K, Finland, Slovakia in Sweden.
Enrique Quintero: We believe the anemia of CKV opportunity in Europe is significant. Our initial uptake has been slower than expected in the EU countries, where Evrenso has launched. The early feedback from healthcare providers prescribing Evrenso has been positive.
We believe the anemia of seeking the opportunity in Europe is significant.
Our initial uptake has been slower than expected in the EU countries, where <unk> has launched the early feedback from healthcare providers prescribing of Rancho has been positive.
Enrique Quintero: As noted earlier, we continue development of Roxadusta in MDS with our partners, AstraZeneca and Astellas.
As noted earlier, we continued development of <unk> study in Mds with our partners Astrazeneca and Astellas.
Enrique Quintero: I'm moving now to China.
Andy Hsieh: Thanks for taking my questions, and congratulations on the very robust China launch, or continued China launch, and also the clinical progress with PenRevlimab.
Okay.
I'm moving now to China.
<unk> continues its strong performance.
Enrique Quintero: Roxasdustra continues its strong performance.
Andy Hsieh: I have two questions, both on PenRevlimab.
As you can see on slide seven.
We are reporting second quarter thorough looks at this 10 net sales in China.
Enrique Quintero: As you can see on slide 7, we are reporting second quarter total Roxasdustra net sales in China of $53.1 million by FibroGen and the joint distribution entity compared to $52.8 million in the second quarter of 2021. This was driven by an increase of over 80% in volume offset benefiting from the price reduction of the NRDL.
Andy Hsieh: So, the first one has to do with the futility analysis from the lapis study.
$53 $1 million by Fibrogenesis.
John distribution entity compared to $52 8 million in the second quarter of 2021.
Andy Hsieh: I'm just curious about how de-risking is that, the futility analysis.
This was driven.
By an increase of over 80% in volume offset benefiting from the price reduction of the <unk> deal.
Enrique Quintero: We continue to expect Roxasdustra net sales growth for the full year in China driven by significant growth in volume.
Andy Hsieh: So, is that kind of like a garden variety has a ratio greater than one, or it's more intricate than that?
Yes.
We continue to expect net sales growth for the full year in China, driven by significant growth in volume.
Andy Hsieh: And also, when looking at the futility analysis, is that based on EFS or OS?
Fiber dense proportion.
Enrique Quintero: FibroGen's proportion of Roxasdustra net product revenue in China was $23.3 million for the second quarter on a, U.S. gap basis.
Andy Hsieh: And my second question has to do with also the lapis study design.
Overall, our net product revenue in China was $23 3 million for the second quarter on a U S GAAP basis.
Juan Graham: Juan will elaborate further in the financial update.
Andy Hsieh: I noticed that in 2019, when the trial was first initiated, only gemobraxine was included. Subsequently, forferinox was added.
Ron will elaborate further.
Further in depth financial update.
Juan Graham: Moving now to the updated external market data on slide 8.
Andy Hsieh: And so, I'm just trying to get an appreciation about how the incorporation of forferinox might affect, the primary analysis down the road.
Turning now to the updated external market data on slide eight.
Juan Graham: Roxasdustra continues to, be the number one branded treatment for anemia of CKD as measured by the value shared in the category which includes all ESA products and Roxasdustra.
Andy Hsieh: Thanks for taking my questions.
Rockford does that.
To be the number one branded treatment.
For anemia of <unk>.
Juan Graham: We expect this category leadership to continue as Roxasdustra volume continues to grow at a fast pace.
Enrique Quintero: Thank you, Andy.
As measured by the value share in the category, which includes all ease up products on Brexit the steps.
Dr. Mark Eisner: I'm going to have Mark answer both of your questions on the futility analysis, for lapis, and then on the incorporation of forferinox as accepted background therapy for that trial.
We expect this category leadership to continue as.
I was wrong, because we said volume continues to grow at a fast pace.
Juan Graham: Next, slide 9 provides a snapshot of Roxasdustra unit growth as indexed to December 2020 on the chart on the left as well as year-over-year growth in the table on the right.
Dr. Mark Eisner: Sure, so the independent statistician conducted an analysis of event-free, survival and that was actually to look for efficacy that could have supported an early accelerated filing.
Next slide nine provides a snapshot of <unk> unit growth as index through December 2020 on the chart on the left as.
As well as year over year growth in the table underwrites.
Juan Graham: Of note is a significant unit growth of Roxasdustra while the leading ESI brand is slightly up, reflecting the anemia of CKD market expansion that has been driven by Roxasdustra since its original NRDL listing in 2020.
Note. These are significant unit growth, so brooks that boost that.
While the leading ESI, Brian slightly up.
Reflecting.
The anemia, the anemia of <unk> market expansion has been driven by <unk> its original and leasing in 2020.
Juan Graham: I will now turn the call over to our CFO, Juan Graham, for the financial update.
Dr. Mark Eisner: So we are, based on that analysis, we're moving forward with the overall survival endpoint as planned, which was and remains the primary endpoint for the trial.
I will now turn the call over to our CFO one ground for the financial update.
Juan Graham: Juan?
Juan Graham: Thank you, Enrique.
Dr. Mark Eisner: So it wasn't really a futility analysis as much as it was an early look at efficacy based on the surrogate endpoint of event-free survival. Now recall we've said previously that we saw this as a very high bar to cross over and we thought it was unlikely that we would hit the event-free survival, but given the just very high unmet medical need in pancreatic cancer and the desperate need patients have for chemotherapy, we did put this interim EFS analysis in place.
Thank you Enrique.
Before jumping into my financial remarks, I would like to highlight the remarkable effort by our team in China. Despite COVID-19 lockdown challenges. They continue to put patients with CK DNA at the forefront of everything they do enabling the outstanding financial results for the quarter.
Juan Graham: Before jumping into my financial remarks, I would like to highlight, the remarkable effort by our team in China that despite COVID lockdown challenges, they continue to put patients with CKD anemia at the forefront of everything they do, enabling the outstanding financial results for the quarter.
Juan Graham: As mentioned by Enrique, we continue to build momentum on our clinical trial execution and enrollment for Pembreglimat.
As mentioned by Enrique we continued to build momentum on our clinical trial execution and enrollment apart from regular map.
Juan Graham: I also want to take some time to thank our colleagues for the day-to-day energy and passion to move our clinical trials forward, which we hope will have a significant impact on patients suffering from idiopathic pulmonary fibrosis, locally advanced and respectable pancreatic cancer, and Duchenne muscular dystrophy.
Dr. Mark Eisner: But we are moving forward with the OS, which was our base case and what we were planning.
I also want to take some time to thank our colleagues for their database energy and passion to move our clinical trials forward, which we hope will have a significant impact on patients suffering from idiopathic pulmonary fibrosis locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy.
Dr. Mark Eisner: In terms of the background chemotherapy, you're quite right.
Dr. Mark Eisner: The initial design was a GEM NAB and now it allows, it also allowed for a full Firinox as well.
Dr. Mark Eisner: So a third of, the patients I think are on full Firinox as a background chemotherapy. The rationale is that this is a commonly prescribed chemotherapy regimen.
Dr. Mark Eisner: It's particularly favored by oncologic surgeons, so we thought it'd be important to allow both of these commonly used backbone chemotherapy regimens into the trial of PAM versus placebo on top of backbone chemotherapy.
Juan Graham: Now getting into our financials, total revenue for the quarter was $29.8 million compared to $24.4 million for the same period in 2021. This represents growth of 22% quarter over quarter.
Dr. Mark Eisner: So we'll be able to look at both the overall population and the subgroups with both of the individual chemotherapy backgrounds.
Now getting into our financials.
Andy Hsieh: That's very helpful.
Total revenue for the quarter was $29 8 million compared to $24 4 million for the same period in 2021.
Andy Hsieh: Thank you so much.
This represents growth of 22% quarter over quarter.
Juan Graham: Breakdown of revenue sources is as follows.
Operator: Sure.
Breakdown of revenue sources is as follows.
We recorded $23 $3 million of net product revenue for <unk> sales in China compared to $13 4 million in the second quarter of 2021.
Juan Graham: We recorded $23.3 million of net product revenue, for Roxa-Dustat sales in China compared to $13.4 million in the second quarter of 2021.
Operator: Your next question comes from the line of Aaron Weber with Cohen.
Juan Graham: During the quarter, we also recorded development revenue of $5.5 million, associated with co-development efforts for Roxa-Dustat with our partners as compared to $19.6 million during the second quarter of 2021. Given the stage of Roxa-Dustat development and as anticipated, we expect a reduction in co-development revenue in the coming quarters.
Operator: Your line is now open.
Brendan: Hi, guys.
Brendan: This is Brendan on for your own.
During the quarter. We also recorded development revenue of $5 5 million associated with co development efforts for Rockford boost that with our partners as compared to $19 6 million during the second quarter of 2021.
Brendan: Thanks for taking the question.
Given the stage of <unk> development and as anticipated we expect a reduction in co development revenue in the coming quarters.
Brendan: Just a, couple quick ones on DMD from us as well.
Juan Graham: Finally, we recorded $1.1 million in drug product revenue for Roxa-Dustat bulk drug, or active pharmaceutical ingredient sold to Estelas as compared to a negative $8.6 in the same period last year.
Brendan: I guess looking ahead to those readouts next year, and maybe also at the evolving treatment landscape that I know you acknowledged in your prepared remarks, that I guess are more so for the specific DMD genotypes.
Finally, we recorded $1 $1 million in drug product revenue for Rockford leaseback bulk drug or active pharmaceutical ingredient sold to astellas as compared to a negative eight six in the same period last year.
Brendan: I guess first, are you all tracking the different subtypes of patients in your study and the different background therapies they're on?
Juan Graham: Diving deeper into the operational results of our Roxa-Dustat business in China, total Roxa-Dustat net sales from the joint distribution entity jointly owned by AstraZeneca and FibroGen, or JDE, was $53.1 million this quarter compared to $52.8 million in the second quarter of 2021. It is worth noting that this quarter's sales include a one-time gross to net adjustment resulting in a net sales reduction of $3 million related to distributor adjustment due to the new NRDL price. Excluding this impact, underlying Roxa-Dustat sales growth versus Q2 2021 was 6%. Further, this sales performance is the result of a significant volume increase of over 80% offsetting the 2021 NRDL price renewal.
Brendan: Can you just remind us, do you require them to come off of maybe some of the exon skipping therapies?
Brendan: And I guess kind of related to that, based on your conversations with regulators up to now, do you expect any additional studies might be necessary to incorporate chemo labs into the current paradigm, maybe where there are genetically targeted therapies available?
Diving deeper into the operational results of our <unk> reduced our business in China.
Total <unk> reduced our net sales from the joint distribution entity jointly owned by Astrazeneca and fiber, Jim or J D E.
Brendan: And maybe just let us know if that's something you're considering moving, forward.
Brendan: Thanks very much.
Was $53 $1 million this quarter compared to $52 8 million in the second quarter of 2021.
Enrique Quintero: Very good.
It is worth noting that this quarter sales include a one time gross to net adjustment, resulting in a net sales reduction of $3 million related to distributor adjustment due to the new <unk> price.
Dr. Mark Eisner: I think those are questions for Mark.
Dr. Mark Eisner: Mark, could you address the, questions around DMD?
Excluding this impact underlying <unk> sales growth versus Q2, 2021 or 6%.
Further the sales performance is the result of a significant volume increase of over 80% offsetting the 2021 <unk> price renewal.
Juan Graham: As I previously mentioned, the growth experienced by our China operations continues to be strong, and in line with our expectations of year-over-year growth and sales.
Dr. Mark Eisner: Sure.
Dr. Mark Eisner: So both Lolanthus 1 and 2 patients are on background corticosteroids as per, standard of care, but they're not on exon skipping therapies or other gene therapies.
As I previously mentioned the growth experienced by our China operations continues to be strong and in line with our expectations up year over year growth in sales.
Juan Graham: Moving from total Roxa-Dustat net sales in China, FibroGen's net transfer price from sales to the, JDE was $18.2 million for the second quarter, consistent with the 30-45% range of the JDE's Roxa-Dustat net sales which we have continuously guided.
Moving from total rux reduced that net sales in China.
<unk> net transfer price from sales to the JV was $18 2 million for the second quarter consistent with the 30% to 45% range of the JD <unk> net sales, which we have continuously guided.
Juan Graham: During this quarter, we released $1.5, million from deferred revenue due to the change in our future estimates as per US GAAP. As we have communicated in the past, the deferred revenue balance in FibroGen China fluctuates based on management estimates of future revenue. It is worth highlighting that we expect further release of deferred revenue in future quarters.
During this quarter, we released $1 $5 million from deferred revenue due to the change in our future estimates for U S. GAAP as we have communicated in the past the deferred revenue balance and fiber Qian, China fluctuates based on management estimates of future revenue.
Juan Graham: As a result, FibroGen recorded $19.7 million in net revenue for the quarter from Roxa-Dustat sales to the JDE and $3.5 million of direct-to-distributor sales from FibroGen China.
It is worth highlighting that we expect further release of deferred revenue in future quarters.
As a result fiber general recorded $19 7 million in net revenue for the quarter for <unk>.
Two the J D E and $3 $5 million of direct to distributor sales from fibers in China.
Juan Graham: Making our way down to P&L, operating costs and expenses were $108 compared to $158.2 million for the second quarter in 2021. This decrease in operating costs is driven by a one-time charge of $25 million related to our partnership with HiFiBio incurred in the prior year period.
Making our way down the P&L.
<unk> costs and expenses were $108 million compared to $158 $2 million for the second quarter in 2021.
This decrease in operating.
<unk> cost is driven by a one time charge charge of $25 million related to our partnership with high fiber you incurred in the prior year period.
Juan Graham: Lower R&D expenses with our Phase III clinical trials, including drug supply costs associated, with our PEMREGLIMAT programs, and overall cost management efforts in our infrastructure despite inflationary pressures.
Lower R&D expenses with our phase III clinical trials, including drug supply costs associated with our prime revenue map programs and overall cost management efforts and our infrastructure despite inflationary pressures.
Juan Graham: During the second quarter of 2022, net loss was $72.6 million, or $0.78 net loss per both, basic and diluted shares, as compared to net loss of $134 million, or $1.45 per basic and diluted shares for the second quarter last year.
During the second quarter of 2022, net loss was $72 6 million or.
78, <unk> net loss per both basic and diluted shares.
Compared to a net loss of $134 million or $1 45 per basic and diluted shares for the second quarter last year.
Juan Graham: At June 30th, we reported $517.6 million in cash, cash equivalents, investments, and accounts, receivable. We estimate our 2022 ending balance of cash, cash equivalents, investments, and accounts, receivable to be in the range of $330 to $360 million. This is a significant improvement to our initial 2022 ending cash guidance.
At June 30th we reported $517 $6 million in cash cash equivalents investments and accounts receivable.
We estimate our 2022 ending balance of cash cash equivalents investments and accounts receivable to be in the rates of $330 million to $360 million.
This is a significant improvement to our initial 2022 ending cash guidance.
Juan Graham: This improvement has been driven through execution, enhancements, unlocking efficiencies, as well, as investment prioritization throughout the organization.
This improvement has been driven through execution enhancements unlocking efficiencies as well as investment prioritization throughout the organization.
Juan Graham: As I have mentioned in prior quarters, we believe we're appropriately financed through, key initial PEMREGLIMAT data readouts, and we are privileged with a wider array of options to consider as we continue to look for opportunities to strengthen our cash position over time.
As I have mentioned in prior quarters. We believe we are appropriately finance sort of key initial term revenue map data readouts and we have privilege with a wide array of options to consider as we continue to look for opportunities to strengthen our cash position over time.
Juan Graham: I will conclude my financial remarks by mentioning that today we are refreshing our S3 shelf, registration statement and have filed a prospective supplement for an at-the-market or ATM equity offering.
We will conclude my financial remarks by mentioning that today, we are refreshing our S. Three shelf registration statement and have filed a prospectus supplement for an aftermarket or ATM equity offering.
Juan Graham: We have no near-term plans to utilize the ATM.
We have no near term plans to utilize the ATM.
Juan Graham: We view this as good corporate housekeeping and financial management.
We view this as good corporate housekeeping and financial management.
Juan Graham: Thank you.
Dr. Mark Eisner: So those are the exclusion criteria for our trial.
Enrique Quintero: And now I would like to turn the call back over to Enrique.
Dr. Mark Eisner: And then in terms of your question about will additional studies be necessary for approval, we don't think additional studies would be necessary for approval.
Thank you and now we would like to turn the call back over to Enrique.
Enrique Quintero: In closing, and thank you, Juan, we remain committed to advancing PEMREGLIMAT as a potential, first-in-class medicine in phase 3 development in three indications with significant unmet medical needs, idiopathic pulmonary fibrosis, locally advanced and respectable pancreatic cancer, and Euchene muscular dystrophy.
Dr. Mark Eisner: We think the Lolanthus 1 and 2, either individually or together, could serve as the basis, for an approval for DMD.
Dr. Mark Eisner: There are, of course, other interesting clinical questions that we are thinking about that we could be answering down the road, but those would not be necessary for the initial approval.
In closing.
Thank you Juan.
We remain committed to advancing <unk> as a potential first in class medicines in phase III development in three indications with significant unmet medical needs.
Operator: And your next question comes from the line of Paul Choi with Goldman Sachs, your line is now open.
Operator: Hi, thank you.
Patrick pulmonary fibrosis.
Locally advanced Unresectable pancreatic cancer, and Duchenne muscular dystrophy.
Enrique Quintero: Notably, we expect top-line data in 2023 from PEMREGLIMAT Cepherus 1 phase 3 trial in IPF, and Alelantus 1 and Alelantus 2 phase 3 trials in non-ambulatory and ambulatory DMV, respectively, as well as Roxedusa's Marajon phase 3 trial in MDS.
Notably, we expect top line data in 2023.
From railroad maps set first one phase III trial in IPF.
And then Atlanta as one in Atlanta, two phase II trials in non ambulatory and ambulatory DMD respectively.
Well as Russell do says Matterhorn phase III trial in Mds.
Enrique Quintero: Roxedusa continues to perform very well in China.
<unk> continues to perform very well in China.
Enrique Quintero: Our partner, Astellas, is moving forward with commercialization of Roxedusa in Europe, and, in addition to the recent regulatory approvals, we have additional regulatory submissions under review in other geographies.
Our partner Astellas is moving forward.
With the commercialization of <unk> in Europe .
And in addition to the recent regulatory approvals, we have additional regulatory submissions under reviewing other geographies.
Enrique Quintero: We continue to have a strong financial position with $517.6 million in cash and expect to, end 2022 with $330 to $360 million in cash. Additionally, we have multiple options to consider to further strengthen our balance, sheet to ensure our long-term success.
We continue to have a strong financial position.
With $517 $6 million in cash and.
I would expect to end 2022.
With $330 million to $360 million in cash.
Additionally, we have multiple options to consider to further strengthen our balance sheet to ensure our long term success.
Enrique Quintero: Now I would like to turn the call back to the operator for questions.
Paul Choi: Good afternoon and thanks for taking our questions.
Now.
I would like to turn the call back to the operator for questions Bella.
Operator: Bella?
As a reminder to ask a question you will need to press star one on your telephone you will then hear an automated message advisory your hands free.
Operator: As a reminder, to ask a question, you will need to press star 11 on your telephone.
Operator: You will then hear an automated message advising your hand is raised.
Operator: Please stand by while we compile the Q&A roster.
Paul Choi: I had one question on the commercial side, perhaps for either Enrique or Chris, just, as you think about the impact from COVID during your Q2 performance, can you maybe just quantify for us, you know, how many patients or any, you know, slowdown in treatment you may have observed and how you're thinking about that impact on the forward here over the balance of 2022.
The standby, while we compile the Q&A roster.
And our first question comes from the line of Michael <unk> with Jefferies. Your line is now open.
Operator: And our first question comes from the line of Michael Yee with Jeffries.
Paul Choi: And my second question is on pemrevlimab.
Hey, guys. Thank you for the update we had two questions I appreciate in the <unk> study I guess past.
The.
Paul Choi: You completed enrollment for the Zephyrus 1 trial, but I was just wondering if you provide, a status update on the second trial, its enrollment status, and whether if Zephyrus 1 is successful, whether that plus your Phase 2 study could potentially serve as a basis, for a filing.
The initial analysis and it's going to continue can you tell us if the IPF Jefferies. One study has any sort of interim or what can you say about what you are looking at is the SMB looking at it or is there any interim on that study.
Paul Choi: Very good.
And with the DMD studies that are reading out what can you say about it.
John those studies as well thank you.
Michael Yee: Your line is now open.
Enrique Quintero: Thank you, Paul.
Thank you Michael I'm going to ask Eisner too.
Michael Yee: Hey guys, thank you for the update.
Chris: And I'm going to ask Chris to answer the first question on China and Mark to answer the question, around Zephyrus 2 and the ability to file with Zephyrus 1 plus PRACE.
For your questions.
Thanks for the questions appreciate it.
The answer is no. There is no further interim analysis or any of the studies, including IPF for DMD.
All of them of course have independent DMC is to monitor safety with no planned interim analysis.
Okay and one final question as a follow up.
With the DMD studies I appreciate Youre novel endpoints and this is sort of a.
Travelled path have you talked with FDA on these endpoints and what you need to show them. What data is required there too to be deemed a successful study.
Yes, so we do have end points for both the non ambulatory and ambulatory studies, we have discussed those with FDA.
The performance of the upper limb score is the endpoint for the non ambulatory and for ambulatory. It's the Northstar ambulatory assessment. These are standardized measures for both.
Types of DMD patients. So we expect that if we demonstrate efficacy based on these endpoints that there would be.
Forward for filing and approval.
Enrique Quintero: Chris?
Okay. Thank you.
Yeah.
Yeah.
Michael Yee: We had two questions.
Chris: Thank you, Enrique.
And your next question comes from the line of Annabel <unk> with Stifel. Your line is now open.
Chris: Thank you, Paul, for the question.
Michael Yee: Appreciating the LAPC study, I guess, passed the initial analysis and it's going to continue.
Chris: I believe you asked if there's a way for us to quantify the impact of COVID on our first, half performance.
Hi, This is Jack calling in for Annabel, Thanks for taking our question.
For Pam could you provide a little more color on how we should think about the IPF opportunity in the context of the current treatments available.
What background treatments are allowed in those trials and how you expect to eliminate the noise around that thanks.
Very good thank.
Thank you for that question.
I'm going to ask Mark to discuss our trial design for IPF, I'm, saying to share a bit about what we've learned about the opportunity that we would have with pumps.
Michael Yee: Can you tell us if the IPF Zephyrus 1 study has any sort of interim or what can you say about what you're looking at?
Chris: So, as background, and this is publicly available information, the multinationals in China have, just disclosed on average they have lost about 10% of revenues for the first half of the year due to COVID.
Chris: Obviously, Roxadustat has seen an uptake involving not a decrease.
Chris: It'd be very difficult for us to tell you net-net what we would have done had it not, been for COVID.
Chris: However, I believe generally the market sees the oral administration of Roxadustat as a, significant advantage, so we suspect we've benefited from it.
Chris: We also came out of the NLDL price reduction with tremendous momentum, and that accounts, for a lot of the market uptake.
Alright. So thanks for the question so for the Zephyrus Phase III program of <unk> now, but it is placebo controlled trials of Pam versus placebo for the treatment of IPF patients are not to be on background therapy. When they entered the trial.
Chris: And generally, we have a team between AstraZeneca and Fibrogen who are experienced, now almost, three years after launch, and executing very well.
Michael Yee: Is DSMB looking at it or is there any interim on that study?
Dr. Mark Eisner: Yeah, so back to Pam Rebel now.
Chris: So, on the positive side, there were many things going for us.
Dr. Mark Eisner: For Zephyrus 2, we have not yet provided guidance on when we anticipate enrollment to complete, but we are making very good progress, and we're very excited about our efforts there.
Chris: It's hard for me to tell you how much more business we would have done without COVID, but we're obviously very pleased with the results.
Chris: And I don't think those factors I just mentioned would continue to bring us a good, good top, line in the second half of the year.
We do allowed both treatment nave and treatment experienced patients on the trial, but when they enter the study they're not on either pirfenidone or <unk> them. So it's a monotherapy trial design.
Yeah. Thanks, Mark so as we think about the commercial opportunity I think there's a couple of things to keep in mind. The first is that we were able to replicate in our phase III <unk> program, what we've seen in the phase II <unk> trial, we would expect a an indication for <unk> for the treatment of patients with IPF.
Dr. Mark Eisner: In terms of the filing strategy, I think as we've said before, our base case is Zephyrus, 1 and Zephyrus 2 will be needed to file.
As we have investigated the current state.
Related to the current standards of care, it's pretty clear and this is based upon published literature.
Given the tolerability challenges associated with both the <unk> spreads upwards of 40% to 50% of patients who start on either of those therapies have stopped taking it by the end of the first year and so there's a significant unmet need not only as it relates to disease progression, but really as it relates to keeping patients on therapy and again if we.
Reflecting on the praise phase II data and we looked at the Tolerability profile, while not head to head against either <unk>, we're pretty confident that we've got a product that not only demonstrated very significant efficacy, but also tolerability profile that we think could lead to differentiation relative to the two current available therapies.
Okay.
Great. Thanks, so much.
Yes.
And your next question comes from the line of Andy <unk> with William Blair. Your line is now offering.
Oh, great. Thanks for taking my questions and congratulations on the very robust China launch or continued China launch and also the clinical progress with Penn rebel Matt I've two questions both on and rebel Matt. So the first one has to do with the facility.
Dallas is from the LAPIS study I'm, just curious about how de risking is that.
The futility analysis, so is that.
Kind of like a garden variety hazard ratio greater than one.
Or it's more intricate.
Then that.
<unk>.
When looking at the utility analysis is that based on yet or.
And my second question has to do with the also the LAPIS study design I noticed that in 2019 when the trial was first initiated only Jim that <unk> was included subsea.
Sequentially for you or not Thats added and so I'm just trying to.
Depreciation about how the incorporation of the paradox.
Affect the primary analysis down to road.
Thanks for taking my questions.
Thank you Andy I'm going to have Mark answer both of your questions on <unk>.
Futility analysis for LAPIS, and then on the incorporation of <unk> us background accepted background therapy.
For that trial.
Sure so.
The independent.
Tissue conducted an analysis of event free survival.
And that was actually to look for efficacy that could have supported.
In early accelerated filing so based on that analysis.
We're moving forward overall survival endpoint as planned.
Which was and remains the primary.
Endpoint for the trial so it wasn't really a futility analysis as much as it was early.
Look at efficacy based on the surrogate endpoint of event free survival.
We have said previously that we saw this as a very high bar to cross over and we thought it was unlikely that we would hit the event free survival of given that just very high unmet medical need in pancreatic cancer and the desperate need patients out for therapy.
I'd put this.
Interim analysis in place, but but we are moving forward with <unk>, which was our base case of what we are.
We're planning in terms of the background chemotherapy, you're quite right. The initial design was.
Jim now and now it allows us it also allowed for fulfill remarks as well.
Third of the patients I think are unfulfilled <unk> chemotherapy. The rationale is that this is a commonly prescribed chemotherapy regimen, it's particularly.
Favored by Oncologic surgeons. So we started the important to allow both of these commonly used backbone chemotherapy regimens into the trial Pam versus placebo on top of background chemotherapy. So so we'll be able to look at both the overall population and subgroups with both.
Individuals' chemotherapy backgrounds.
That's very helpful. Thank you so much.
Sure.
Yeah.
Okay.
Your next question comes from the line of Erin <unk> with Cowen. Your line is now open.
Hi, guys. This is brendan on for your own and thanks for taking the question just a couple of quick ones on DMD from us as well I guess looking ahead to those Readouts next year and maybe also the evolving treatment landscape that I know you you acknowledged in your prepared remarks.
Michael Yee: And with the DMD studies as well that are reading out, what can you say about interims on those studies as well?
Then I guess are more so for the specific deal.
DMD genotype.
I guess first are you all tracking the different subtypes of patients in your study and the different background therapies. They're on can you just remind us do you require them to kind of offset or maybe at the end of the exon skipping therapies.
Kind of related to that.
Based on your conversations with regulators up to now do.
Do you expect any of this in our studies might be necessary to incorporate came out of the lab into the current paradigm, maybe where there are genetically targeted therapies available.
And maybe just let us know if that's something you are considering moving forward. Thanks very much.
Very good I think those are questions for Mark Mark could you address the question around <unk> sure. So both <unk>, one and two patients are on background corticosteroids as per standard of care, but theyre not on exon skipping therapies or other gene therapies.
Those are the exclusion criteria for our trial and then in terms of your question about will additional studies would be necessary for approval and we don't think just additional studies would be necessary for approval we think.
The Olympus one and two.
Either individually or together could serve as the basis for an approval for DMD.
There are of course other interesting clinical questions that we are thinking about that we could be.
Entering down the road, but those would not be necessary for the initial approval.
Okay, great. Thanks very much.
And your next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.
Michael Yee: Thank you.
Dr. Mark Eisner: Thank you, Michael.
Yeah.
Hi, Thank you good afternoon, and thanks for taking our questions.
Dr. Mark Eisner: I'm going to ask Dr. Eisner to answer your questions.
One question on the commercial side, perhaps for either Enrique aircrafts just.
When you think about the impact from Covid. During your Q2 performance can you maybe just quantify for us.
How many patients are any.
Slowdown in treatment you may have observed and how youre thinking about that impact on the forward here over the balance of 2022.
Dr. Mark Eisner: That said, if we have strong Zephyrus 1 data, because those data will be coming first, we, would potentially explore with FDA whether that Zephyrus 1 trial could be filed with the Phase 2 PREIS study for an initial approval, as you've suggested.
And my second question is on <unk>.
Paul Choi: Okay, thank you very much.
<unk> completed enrollment for that is the first one trial, but.
Just wondering if you can provide a status update on the second trial.
It's enrollment status and whether suffers.
The first one is successful whether that plus your phase II study could potentially serve as a basis for a filing.
Operator: And your last question comes from the line of Jason Gerberry with Bank of America.
Very good.
Thank you.
Paul and I'm going to ask.
Chris to start the <unk>.
First question on China on Mark to answer the question around surface too.
The ability to file with separate one plus price Chris.
Operator: Your line is now open.
Jason Gerberry: Okay guys, thanks for taking my questions.
Chris Thank.
Thank you and we can thank you Paul for the question.
I believe you asked if there's a way for us to quantify the impact of Covid on all.
First half performance service background and this is publicly available information the multinationals in China have just disclosed on average they have lost about 10%.
Revenues for the first half of the year due to Covid.
Obviously <unk> has seen an uptake in volume not a decrease.
Very difficult for us to target a net net what we would have done had it not been for Covid. However, I believe generally the market sees the oral administration braskem reduced assets it can be.
So we suspect we benefit from it. We also came out of <unk> and LDL price reduction with tremendous momentum and that accounts for a lot of the market uptake and generally we have 18 between astrazeneca and fibre Jean Hu our experience now almost three years after launching executing very well so on the positive side.
Many things going for us it's hard for me to tell you how much more business, we would have done.
Without.
I'm very pleased with the results and I don't think those factors I just mentioned.
With continued to bring US good good top line in the in the second half of the year.
So Beth Penn level now.
Or is there for us to we have not yet provided guidance on when we anticipate enrollment to complete but we are making very good progress and we're very excited about our efforts there.
In terms of the filing strategy I think as we have.
We have said before our base cases efforts one in zephyrus, two will be needed to file that said if we have strong is our first one data because those data will be coming first we would potentially explore with FDA whether that Jeff first one trial could be filed with the phase III <unk> study for an initial appeal.
<unk>.
<unk> suggested.
Okay. Thank you very much.
Yes.
And your last question comes from the line of Jason <unk> with Bank of America. Your line is now open.
Oh, Hey, guys. Thanks for taking my questions.
Jason Gerberry: Just first on DMV, apologies if I missed this, it was stated in the past, but are the ambulatory, and non-ambulatory populations potentially like separate, the basis of separate filings if one works versus another not working, just curious how that would pan out and just wanted to get your views.
Just first on DMD apologies if I missed this.
Stated in the past, but already ambulatory and non ambulatory populations potentially like separate.
The basis of separate filings if one work versus another not working just curious how that would.
Jason Gerberry: Is it sort of the non-ambulatory, the higher risk trial of the two from your perspective?
Pan out and I, just wanted to get your views sort of them non ambulatory that the higher risk trial of the two from your perspective, and then shifting over to rocks just commercially as we think ahead to Kennedys. This growth dynamic where you kind of work through with the higher volume to offset the <unk> impact we have maybe a one.
Jason Gerberry: And then shifting over to Roxa, just commercially, as we think ahead to kind of this growth dynamic, where you kind of work through with higher volumes, offset the NRDL impact, and you have maybe a one or two year period of no NRDL comp to deal with, you expect the NRDL cuts to get smaller with each successive cut, if you have a perspective on that or any analog that you think are relevant, that would be helpful, thanks.
On a two year period of knowing our Dl.
Comp to deal with do you expect the NR Dl cuts to get smaller with each successive cut if you have a perspective on that or any analogs that you think are relevant that would be helpful. Thanks.
Enrique Quintero: Very good, why don't we start with the China question first, I'm going to have Chris tackle, that one, and then Mark, you can address the question about the Atlantis I and Atlantis, II and the potential of filing those based on independent results.
Very good why don't we start with the China question first I'm going to have Chris.
Tackle that one and then mark.
You can address the question about the.
Atlanta is one Olympus too.
The potential filing dose based on independent results.
Chris: So first I want to make sure I understand the question correctly, we did state that, we believe part of the volume uptake in the current calendar year is due to the NRDL price cut, and the question is whether we expect subsequent price cuts to be of a lower range.
So so first I wanted to make sure I understand the question correctly, we did state that we believe part of the volume uptake in the current calendar year is due to the price cut.
The question is whether we expect subsequent price cuts to the lower range, so not talking about <unk>, specifically, but about NR daily generally the industry expects the first cut to be most significant which is why we experienced in 2019, you have to concede a certain amount on ICT.
Chris: So not talking about ROXA-B specifically, but about NRDL generally, the industry expects, the first cut to be the most significant, which is what we experienced in 2019, we have to concede a certain amount on pricing to get into the NRDL.
Chris: And pricing cuts are dependent on a variety of factors, first, the rules for price cuts, change every single year, many will tell you, and this is publicly disclosed, that the 2020 round, 2021 round was significant because budget allocations were diverted to COVID controls.
Get into the NRT out subsequent.
Pricing cuts are dependent on a variety of factors first the rules for price cuts change every single year.
He will tell you and this is perhaps we didn't disclose that the 2020 round 2021 round was significant because budget allocations were converted to Colgate controls. So it's hard to predict but as a general rule. The price cuts is a decrease with time just hard for us to predict if our next cut would be less than what we saw.
Chris: So it's hard to predict, but as a general rule, the price cuts do decrease with time, it's hard for us to predict if our next cut would be less than what we experienced in the past, that's certainly what we would hope for.
<unk> in the past that certainly what we would hope for.
Chris: It would depend on how much volume we actually uptake, and how much of the national budget, we actually take.
It would depend on how much volume, we actually uptake and how much of the national budget, we actually take.
Chris: The pricing of our competitors at that time, which is ESAs, a variety of factors, but we're, certainly hopeful that the next cut would be smaller than the one we just experienced.
The pricing of our competitors at that time, which is he says a variety of factors, but we're certainly hopeful that the next cut would be smaller than the one we just experienced I hope I answered your question.
Jason Gerberry: I hope I answered your question.
Chris: Yep, and that's helpful.
Jason Gerberry: Thank you.
Dr. Mark Eisner: And then your question about DMD, I think it's a really good question about the ambulatory, and non-ambulatory populations.
Yeah. That's helpful. Thank you.
And on your question of our DMD and I think it's a really good question about the ambulatory and non ambulatory populations. I mean, if you think about deferrals to date right.
Dr. Mark Eisner: I mean, if you think about the approval to date, right, based on skipping therapies that, have been approved on biomarker data, without any real clinical evidence besides the biomarker, I think we'd have a very good chance at filing either the Lelanthos 1 or 2 studies, non-ambulatory, or ambulatory, alone, together, just depending on the data.
I'm skipping therapies have improved approved on biomarker data without any real clinical evidence. Besides the biomarker I think we'd have a very good chance that filing either.
Either it will lead to us one or two studies non ambulatory or ambulatory alone together, depending on the data if the data are strong I think.
Dr. Mark Eisner: If the data are strong, I think they could support a filing.
Dr. Mark Eisner: So it's something we're actively discussing internally.
They could support a filing so that's something we're actively discussing internally we will see what the data show of course non ambulatory.
Dr. Mark Eisner: We'll see what the data show.
Dr. Mark Eisner: Of course, non-ambulatory Lelanthos 1 is coming first.
Dr. Mark Eisner: But the unmet need here is so high, and the patients and their parents are so desperately, in need of new therapies that we would do everything possible with positive data in hand to try to get that approved as expeditiously as possible.
This one's coming first but.
The unmet need here is so high and the patients and their parents or so so desperately in need of new therapies that we would do everything possible.
With positive data in hand to try to get that approved as expeditiously as possible.
Operator: And I see no further questions at this time.
Okay. Thanks.
Yeah.
Yeah.
And I see no further questions at this time I would now like to turn the conference back over to Enrique Conterno.
Enrique Quintero: I would now like to turn the conference back, over to Enrique Conterno.
Enrique Quintero: Thank you, Bella, and thank you to everyone for your participation in today's investor call and your interest in FibroGen.
Enrique Quintero: Enjoy the rest of your day.
Thank you Bella.
Thank you to everyone for your participation in today's Investor call and your interest in five region enjoyed the rest of your day. Thank you very much.
This concludes today's conference call. Thank you for your participation you may now disconnect.
Dr. Mark Eisner: Thanks for the questions.
Enrique Quintero: Thank you very much.
Operator: This concludes today's conference call.
Yeah.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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Dr. Mark Eisner: Appreciate it.
Operator: Thank you for your participation.
Dr. Mark Eisner: The answer is no.
Operator: You may now disconnect.
Dr. Mark Eisner: There's no further interim analysis for any of the studies, including IPF or DMD. All of them, of course, have independent DMCs to monitor safety, but there are no planned interim analyses.
Michael Yee: Okay.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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[music].
Okay.
Mhm.
Okay.
Okay.
Okay.
Yes.
Okay.
Okay.