Q1 2022 FibroGen Inc Earnings Call
Enrique Conterno: And I want to thank our clinical development team for their efforts.
Enrique Conterno: Moving now to locally advanced pancreatic cancer.
Enrique Conterno: As discussed previously, we plan an interim analysis of event-free survival in the second quarter. Depending on the results and in consultation with the FDA, we will decide whether to file for accelerated approval.
Enrique Conterno: After making this decision, we will provide an update later this year.
Enrique Conterno: Regardless, the trial will continue to the primary endpoint of overall survival, and we expect top-line data in the first half of 2024.
Enrique Conterno: I'd now like to spend a few minutes highlighting our perspective on the significant commercial opportunity we see with panbrevimab in each of the three disease areas.
Enrique Conterno: On slide five, beginning with IPF.
Enrique Conterno: 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 a sentiment in the IPF community of limitations with the current therapies, and a desire for additional therapeutic options.
Yeah.
Ladies and gentlemen, thank you for standing by and welcome to five regions first quarter 'twenty to 'twenty two earnings conference call. At this time all participants lines are in a listen only mode. After the speaker's presentation, there will be a question and answer session.
I'll take questions. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your first speaker for today Michael Tung. Thank you. Please go ahead Sir.
Enrique Conterno: If the Phase III Cephris program produces similar results to the Phase II PRACE trial, we believe Pandrelumar has the potential to help a sizable number of patients with IPF and be a very significant product for FibroGen.
Thank you Jay and good afternoon, everyone I'm, Michael Tang Vice President of corporate strategy and Investor relations of fiber Gen.
Joining me on todays call are Richard can turn out our Chief Executive Officer, Dr. Mark Eisele, our Chief Medical Officer.
Enrique Conterno: In the middle column, you can see the locally advanced pancreatic cancer opportunity.
One Graham our Chief Financial Officer, Dr. John Hunter, our Chief Scientific Officer.
Enrique Conterno: Pancreatic cancer represents one of the greatest unmet needs in oncology, given the diagnosed prevalence of almost 140,000 patients across the major regions, combined with a low five-year disease-free survival rate of around 10%.
Thing Wedig, our chief commercial officer, and Chris Chung, our senior Vice President of China operations.
The format for today's call includes prepared remarks, and then regained one 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 ballpark Virgin such statements may include but are not limited to.
Enrique Conterno: There have been limited treatment advances in the non-metastatic setting over the last two decades, with the immune oncology therapies failing to demonstrate survival benefits over the current standard of care.
Our collaborations with Astrazeneca and Astellas financial guidance.
The initiation enrollment design conduct and results of clinical trials.
Enrique Conterno: Similar to IPF, there is limited late-stage development activity in non-metastatic pancreatic cancer, which creates a meaningful opportunity for Pandrelumar if it can demonstrate an improvement in overall survival.
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.
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.
Enrique Conterno: As we said earlier, the LAPIS Phase III trial is fully enrolled, and we look forward to seeing, if Pandrelumar could provide an important new treatment option.
A more complete description of these and other material risks can be found in <unk> filings with the SEC, including our most recent 10-K and Form 10-Q.
Enrique Conterno: And finally, in the third column, we wrap up the Pandrelumar market section with a snapshot, of the DMD opportunity.
<unk> does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.
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 <unk> Dot com.
Enrique Conterno: While the prevalence of DMD is the lowest, while the prevalence of DMD is the lowest of the three indications we're pursuing, given the devastating nature of its diagnosis and the relentless disease progression, we're hopeful that the Lelantus Clinical Trial Program can lead to an approved therapy that is so needed by the DMD community.
With that I would like to turn the call over to Richard can turnover, our CEO Enrique.
Thank you, Mike and good afternoon, everyone and welcome to our first quarter.
2022 earnings call.
Enrique Conterno: With corticosteroids as the current standard of care, patients commonly deal with troublesome side effects as they continue to experience disease progression and loss of ambulation.
On today's call I will provide a high level summary of the most important accomplishments and developments in the first quarter of 2022.
Well I'm Graham our CFO will then review the financials after which we will open the call for your questions.
Starting with slide three.
<unk> is positioned to create significant value for patients and shareholders by executing on our three areas of focus.
Enrique Conterno: While the current approved excellence-keeping therapies produce an increase in dystrophin levels, they are targeted at a small portion of DMD patients and have yet to demonstrate a meaningful clinical improvement in symptoms or disease progression.
Number one.
Accelerating the development of bread roadmap in three indications with significant unmet medical need.
Enrique Conterno: There's a clear need for therapies that can improve muscle function and prolong ambulation, by targeting the downstream pathological changes of DMD.
Idiopathic pulmonary fibrosis or IPF.
Locally advanced Unresectable pancreatic cancer or L. A P C.
Enrique Conterno: We believe the antifibrotic mechanism of Pandrelumar may be a solution, that can help these patients and their families.
And duchenne muscular dystrophy or D M D.
Number two.
Ensuring commercial success of <unk> in patients with chronic kidney disease outside the U S. Well continue to spur our path forward in the U S.
Enrique Conterno: Now let's move to Roxa Dustan on slide 6.
Enrique Conterno: Following the European Commission approval of Evrenso for the treatment of adult patients, with symptomatic anemia associated with chronic kidney disease, Astellas has launched in Germany, the UK, Netherlands, Austria and Nordic countries.
And number three.
Increasing our research productivity to advance novel programs, the leverage internal expertise and accessing external innovation for additional pipeline opportunities.
Now, let's move to our clinical trials focusing on umbrella map on slide four.
Enrique Conterno: While uptake has been slower than expected, the early feedback from healthcare providers, prescribing Evrenso has been positive.
Hi, Brennan with a wholly owned asset in phase III clinical trials for.
Enrique Conterno: The anemia of CKD opportunity in Europe is significant and Evrenso has an important first, mover advantage relative to other HIF-PHIs. Launches will commence in the other major EU markets later this year, pending positive, reimbursement decisions.
Four three high value indications Ibs L. A b C and D M D.
Each one of these diseases represent an important.
Unmet medical need.
Each constitutes a significant market opportunity.
As we recently announced we have completed enrollment of our surface.
Enrique Conterno: Despite significant discussions with AstraZeneca, we have not been able to find a path forward, for AstraZeneca to fund further Roxa Dustan development of anemia of CKD in the US.
One phase III study of 356 patients with idiopathic pulmonary fibrosis.
The first one phase III study.
Enrique Conterno: We continue to believe Roxa Dustan can address an admin need for patients with CKD anemia.
It's largely based on our phase two study.
Which demonstrated a meaningful reduction in lung function decline.
Enrique Conterno: It's important to note that we continue development of Roxa Dustan in MDS with top line phase, three data expected in the first half of 2023.
And roaming continues in our second separate phase III study.
This is the first two and.
And we look for we look forward to updating you on that trial progresses.
Enrique Conterno: Moving now to China.
Yaron Werber: Enrique, if I can sneak in a question, maybe just on China.
We.
Bleeding in enrollment over the Atlantis, one phase III clinical trial of umbrella in Nonambulatory patients with Duchenne muscular dystrophy BMD in the first quarter and expect to complete enrollment of the Atlanta too.
Enrique Conterno: Roxa Dustan was renewed in the NDRDL for another two years beginning January 2022. As expected, this relisting was accompanied with a price reduction.
<unk> III clinical trial.
Enrique Conterno: As you can see on slide seven, we are reporting first quarter total Roxa Dustan nail cells, in China of $43.5 million by Fibrogen and the joint distribution entity which is flat compared to the first quarter of 2021. This was driven by a greater than 70% increase in volume offset by the recent NDRDL price, reduction.
Enrique Conterno: Is there any thought to monetize that JV, either by spinning it out or selling it to Zeneca?
Upon blow up in ambulatory patients with DMD in the second quarter.
Yaron Werber: Is there any discussion, or is that core to your business and you'll keep it?
It is very exciting to be expecting data readouts.
For Atlantis one.
<unk>.
Enrique Conterno: Yeah, I think we clearly have a very strong business in China right now, so there are no such plans at this stage.
And so for US one in 2023.
Mark Eisner: I'm going to have now Mark answer the second part of your question on IPF.
Mark Eisner: Right, so just to remind everyone, the Zephyrus IPF Phase III program is pemrevelamab monotherapy, but it does enroll treatment-naive and treatment-experienced patients in the program.
And I want to thank our clinical development team for their efforts.
Moving now to locally advanced pancreatic cancer.
Mark Eisner: Zephyrus I explicitly allows treatment-naive.
Mark Eisner: Zephyrus II is going to be mostly treatment-experienced patients who have discontinued therapy.
Enrique Conterno: We expect Roxa Dustan nail cell growth for the full year in China driven by significant, growth in volume.
As discussed previously we plan on interim analysis of event free survival in the second quarter.
Depending on the results and in consultation with the FDA.
Enrique Conterno: Fibrogen's portion of Roxa Dustan nail product revenue in China was $18.9 million for the, first quarter on a US GAAP basis. Juan will dive into further details in the finance update.
We will decide whether to file for accelerated approval.
After making these decision we will provide an update an update later this year.
Mark Eisner: I think it's worth noting, though, that most patients discontinue standard of care with Esbrid or OFEV because of tolerability from GI side effects and other things, rather than treatment failure, per se, or progression of their lung function.
Regardless the trial will continue to the primary endpoint of overall survival and we expect topline data in the first half of 'twenty 'twenty four.
Enrique Conterno: Turning now to updated external market data on slide eight, Roxa Dustan continues to be, the number one branded treatment for anemia CKD as measured by value sharing the category which includes all ESA products on Roxa Dustan.
I'd now like to spend a few minutes highlighting on our perspective.
On the on the significant commercial opportunity, we see with umbrella them up in each of the three disease areas.
Enrique Conterno: We expect this category leadership to continue as Roxa Dustan volume continues to grow at, a fast pace.
Mark Eisner: So we actually expect both naive and experienced patients to potentially respond to pemrevelamab similarly. This is our theory based on what we know about the disease.
On slide five.
Mark Eisner: So thanks for your question.
Beginning with I P F.
Enrique Conterno: Next slide nine provides a snapshot of Roxa Dustan 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.
Operator: Operator?
With a diagnosed prevalence of approximately 330000 patients.
Operator: Yes, sir.
Across the U S.
<unk>, China, and Japan, I P F represents a significant opportunity.
Operator: Your next question comes from the line of Annabelle Samimi with Stiefel.
Enrique Conterno: Of note is a consistent unit growth of Roxa Dustan while the leading ESA brand is slightly, and others.
With the two approved IPF therapies generating almost $4 billion in net revenue in 2020 one.
Despite this market size there remains significant unmet need with these two approved therapies.
Enrique Conterno: It is worth taking a minute to comment on the Covid situation in China. As you are aware, lockdowns have been implemented to reduce the spread of Covid in a number, of cities, including Shanghai and Beijing.
As characterized by continued disease progression and challenging tolerability.
There is a sentiment in the IPF community of limitations with the current therapies and their desire for additional therapeutic options.
Enrique Conterno: Thus far, we have not seen an impact on Roxa-Tusta demand in China.
If the phase III set first program produces similar results.
Enrique Conterno: Where we have seen an impact is in some of our clinical trial involvement in China.
So the phase II price trial, we believe pantry Lamar has the potential to help a sizable number of patients would they be F.
Enrique Conterno: We are and we will continue to monitor the situation closely as it evolves and our thoughts, are with our China employees during this difficult time.
Can be a very significant product for fiber.
In the Middle column, you can see the locally advanced pancreatic cancer opportunity.
Juan Graham: I will now turn the call over to our CFO, Juan Graham, for the financial update.
Operator: Your line is open.
But kartik cancer represents one of the greatest unmet needs in oncology.
Juan Graham: Juan?
Juan Graham: Thank you, Enrique.
Annabelle Samimi: Hi.
Juan Graham: Before I provide my financial remarks, I would like to thank the FibroGen team in continuously, challenging themselves to move our clinical trials forward.
Annabelle Samimi: Thanks for taking my question.
Given the diagnosed prevalence of almost 140000 patients across the major regions combined with a low five year.
Juan Graham: Despite an evolving and challenging Covid environment, our team has been able to complete, enrollment of Forcephorus-1, a clinical trial for the treatment of idiopathic pulmonary fibrosis, as well as for Lelanthus-1 clinical trials for treatments of Duchenne muscular dystrophy.
Annabelle Samimi: I had a couple.
Disease free survival rates of around 10%.
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.
Juan Graham: I also want to acknowledge the efforts of our team in China that has been working tirelessly, to support patients with CKD anemia in China.
The current standard of care.
Similar to I P F.
There is limited late stage of development activity in non metastatic pancreatic cancer, which creates a meaningful opportunity for <unk>. If it can demonstrate an improvement in overall survival.
Juan Graham: As mentioned, volume and access to Roxa-Tusta has significantly increased offsetting the, NRDL price impact.
Juan Graham: While this result was what we had expected, I nonetheless want to acknowledge the efforts, in this achievement during the first quarter.
As we said earlier.
The LAPIS phase III trial is fully enrolled and we look forward to see Nippon <unk> could provide.
Juan Graham: Now getting into our results for the quarter, total revenue for the first quarter was as, planned at $60.8 million compared to $38.4 million for the same period in 2021, and representing a growth of 58% quarter over quarter.
Annabelle Samimi: So for the LAPIS trial in the pancreatic cancer, when you go to FDA to discuss the trial results, I guess, if it's supportive, is there any overall survival that you can draw from from the prior resected patients or resectable patients from earlier trials that potentially support that acceleration?
An important new treatment option.
And finally in the third column.
Annabelle Samimi: And can you share any data from those patients now?
We'll wrap up on railroad market's section with a snapshot of the D. M D opportunity.
While the prevalence of D M D.
Juan Graham: The breakdown of revenue sources are as follows.
Is the lowest of the three indications we're pursuing.
Juan Graham: We recorded $25 million in milestone payments from Astellas related to the Russian Federation, approval of Roxa-Tusta, or Evrenso, for the treatment of adult patients with symptomatic anemia associated with CKD. This amount is allocated as $22.6 million in licensed revenue and $2.4 million at development, revenue.
Given the devastating nature of his diagnosis.
And our relentless disease progression, we're hopeful that they'll Atlantis clinical trial program.
Kind of lead to an approved therapy that is so needed by the DMD community.
With corticosteroids are the current standard of care.
Patients commonly deal with probably some side effects.
Juan Graham: We recorded $18.9 million net product revenue for Roxa-Tusta sales in China compared to, $15.4 million in the first quarter of 2021. During the quarter, we also recorded development revenue of $11.8 million associated with co-development, efforts for Roxa-Tusta with our partners as compared to $14.6 million during the first quarter of 2021.
As they continue to experience disease progression and loss of ambulation.
While the current approved exon skipping therapies produce.
An increase in.
In dystrophin levels. They are targeted at the small portion of DMD patients.
And how would you have to demonstrate a meaningful clinical improvement in symptoms for disease progression.
Theres a clear need for.
Juan Graham: Finally, we recorded $7.6 million in drug product revenue for Roxa-Tusta drug or active, pharmaceutical ingredients sold to Astellas as compared to $8.5 million in the same period last year.
For therapies that can improve muscle function.
Prolong emulation by targeting the downstream puzzle logical changes from Dnb.
We believe.
The anti fibrotic mechanism of umbrella mind may be a solution.
Juan Graham: Diving deeper into the operating results of our Roxa-Tusta business in China, as previously, stated by Enrique, total Roxa-Tusta net sales from the joint distribution entity jointly owned by AstraZeneca and Fibrogen, or JDE, was $43.5 million for the first quarter in, 2022, remaining flat as compared to the first quarter of 2021. This revenue is resulting from a significant volume increase of roughly 70% offsetting, the recent price reduction due to the NRDL renewal.
That can help these patients and their families.
Now, let's move to rocks at those 10 on slide six.
Following the European Commission approval.
Okay brand so for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease.
Astellas has launched in Germany.
The U K, Netherlands, Austria, the Nordic countries.
Well uptake has been slower than expected.
Early feedback from health care providers prescribing of Bristow has been positive.
Juan Graham: We continue to be encouraged by the growth for China operations and expect continued, strong market penetration as experienced during this quarter.
The anemia of seeking the opportunity in Europe is significant.
And the rest of it as an important first mover advantage relative to other if bhi's.
Juan Graham: Flowing from the total ROXADUSTA net sales in China, FibroGen's net transfer price, from sales to the JDE was $13.9 million for the first quarter, consistent with the 30-45% range of the JDE's ROXADUSTA net sales, which we have continuously guided.
Launches will commence.
In the other major EU market later this year.
Pending positive reimbursement decisions.
Despite significant discussions with Astrazeneca.
We have not been able to find a path forward for Astrazeneca to fund.
Juan Graham: During this quarter, we recorded $2.3 million released from deferred revenue due to change, in our future estimates as per U.S. GAAP. As we have communicated in the past, the deferred revenue balance in FibroGen China fluctuates, based on estimates of future revenue.
Further a rockstar said development of anemia of CK Din the U S.
We continue to believe rocks, a booster can address and admin needs for patients with C. J D anemia.
It is important to note that we continue development of Brooks do study in Mds with top line phase III data expected in the first half of 2023.
Juan Graham: As a result, FibroGen recorded $16.2 million in net revenue for the quarter from ROXADUSTA, sales to the JDE and $2.7 million of direct-to-distributor sales from FibroGen China.
Moving now to China.
Brooks do set was renewed.
Juan Graham: As we continue down the P&L, operating costs and expenses were $123.8 million compared, to $108.9 million for the first quarter in 2021. This increase in operating costs is primarily driven by R&D expenses supporting our Phase, III clinical trials, including drug supply costs associated with our Pembrevima programs.
In the end there D L for another two years beginning January 2022.
I suspect it.
This re listing was accompanied with a price reduction.
As you can see on slide seven.
We are reporting first quarter total rocks that boosts, our new associate China of 43, and a half million.
Dollars by five region.
Juan Graham: While we continue to look for ways to accelerate activities related to our Pembrevima program, we also continue to maintain a strong focus on cost control, as evidenced by our flat year-over-year FG&A line.
And the joined distribution entry D, which is flat compared to the first quarter of 2021.
This was driven by a greater than 70% increase in volume.
Offset by the recent NRT L price reduction.
Juan Graham: In the first quarter of 2022, net loss was $63.2 million or $0.68 net loss per both basic, and diluted shares, as compared to net loss of $71.8 million or $0.78 per basic and diluted shares for the first quarter last year. At March 31st, we reported $565.4 million in cash, cash equivalents, investments and, accounts receivable.
We expect rocks are due starting their source of growth for the full year in China.
Driven by significant growth in volume.
Okay.
Fiberglass portion of Brooks and boost our net product revenue in China was $18 $9 million for the first quarter on a U S GAAP basis.
One will dive into further detail in the finance update.
Turning now to updated external market data on slide eight.
Juan Graham: As we look forward, we estimate our 2022 ending balance of cash, cash equivalents, investments, and accounts receivable to be in the range of $310 to $340 million, which is an improvement over the previously communicated range of $270 to $300 million.
<unk> continues to be the number one branded treatment for anemia CPD.
As measured by body is sharing the category, which includes all aesop products on Brooks at this stage.
We expect this category leadership to continue on his roof reduced our volume continues to grow at a fast pace.
Juan Graham: While we believe we are appropriately financed through key initial Pembrevima data readouts, we are privileged with a wide array of options to consider as we continue to look for opportunities to strengthen our cash position over time.
Next slide nine.
Provides a snapshot of Brookside boosted junior gross.
I was indexed to December 'twenty 'twenty on the chart on the left.
As well as year over year growth in the table on the right.
Juan Graham: Thank you.
Juan Graham: And now I would like to turn the call back over to Enrique.
Annabelle Samimi: Are there any updates from those patients?
Of note.
Is that consistent unit growth of <unk> was the leading EASA, Brian is slightly up.
Enrique Conterno: Very good.
Enrique Conterno: Thank you, Juan.
Enrique Conterno: In closing, we remain committed to advancing Pembrevima as a potential first-in-class medicine, in phase 3 development in three indications with significant admin medical needs, idiopathic pulmonary fibrosis, locally advanced and reseptible pancreatic cancer, and Eugene muscular disease.
Reflecting the anemia of CBD market expansion.
Has it been driven by rocks that boosted since its original enter their listing in 2020.
Now it is worth taking a minute to comment on the COVID-19 situation in China.
As Youre aware lockdowns have been implemented to reduce the spread of COVID-19 in a number of cities.
Enrique Conterno: Roxadustat continues to perform very well in China. Our partner Astellas is moving forward, with commercialization of Roxadustat in Europe and we have additional regulatory submissions under review in other geographies.
Including Shanghai and Beijing.
Thus far we have not seen an impact on brooks that boosted demand in China.
Where we have seen any impact you're seeing some of our clinical trial involvement in China.
Enrique Conterno: We are exploring options for Roxadustat in the U.S, and believe patients would benefit from having access to this treatment.
We are and we will continue to monitor the situation closely closely as it evolves and our thoughts are with our China employees. During this difficult time.
Enrique Conterno: As shown on slide 10, we continue to have a strong financial position with approximately $565.4 million, in cash and expect to end 2022 with $310 to $340 million in cash. We have a strong cash position and have multiple options to consider to further strengthen our balance sheet to ensure our long-term success.
I will now turn the call over to our CFO , one gram for the financial update.
<unk>.
Thank you Enrique.
Before I provide my financial remarks, I would like to thank the fiber gentium and continuously challenging themselves to move our clinical trials forward.
Enrique Conterno: While we are properly financed, we are privileged while we compile the Q&A roster.
Despite an evolving and challenging COVID-19 environment, our team has been able to complete enrollment of four separate one.
Clinical trial for the treatment of idiopathic pulmonary fibrosis as well as for Lantus, one clinical trials for treatment of Duchenne muscular dystrophy.
I also want to acknowledge the efforts of our team in China that has been working tirelessly to support patients with CK D anemia in China.
As mentioned volume and access to rux at Neustar has significantly increased offsetting DNR D L price impact.
Operator: Your first question comes from the line of Michael Yee
Annabelle Samimi: And then the second question I have, obviously, it seems like you're having trouble coming to an arrangement with AstraZeneca on the U.S. side.
Annabelle Samimi: And, you know, it seems like maybe the competitive landscape has improved a bit with the Acubia CRL.
While this result was what we had expected.
The last one to acknowledge the efforts and this achievement during the first quarter.
Operator: with Jeffress.
Annabelle Samimi: So can you maybe go into some detail about what options you may be exploring?
Now getting into our results for the quarter.
Operator: Your line is open.
Total revenue for the first quarter was as planned at $68 million compared to $38 $4 million for the same period in 2021, and representing a growth of 58% quarter over quarter.
The breakdown of revenue sources are as follows we recorded $25 million in milestone payments from Astellas related to the Russian Federation approval of rux or do stop or a brand. So for the treatment of adult patients with symptomatic anemia associated with C. J D.
Annabelle Samimi: And is there any kind of clause for non-performance from on the AstraZeneca side?
This amount is allocated at $22.6 million in license revenue and $2 $4 million of development revenue.
We recorded $18 $9 million net product revenue for <unk> sales in China compared to $15 $4 million in the first quarter of 2021.
Michael Yee: Hey, Marike, thanks.
During the quarter. We also recorded development revenue up 11 $8 million associated with co development efforts for at Rockford do step with our partners as compared to $14 $6 million during the first quarter of 2021.
Michael Yee: I appreciate the update.
Annabelle Samimi: You know, given that they have exclusivity, do they have some kind of onus to proceed or let it go?
Michael Yee: We have two questions.
Enrique Conterno: Yeah, thank you for your question, Annabelle.
Finally, we recorded $7 $6 million in drug product revenue for <unk> bulk drug or active pharmaceutical ingredients sold to astellas as compared to $8 $5 million in the same period last year.
Diving deeper into the operating results of our <unk> business in China.
As previously stated by Enrique total rux induced that net sales from the joined distribution entity jointly owned by Astrazeneca and fiber Jen or J D. E was $43 $5 million for the first quarter in 2022 remaining flat as compared to the first quarter of 2021.
This revenue was resulting from a significant volume increase of roughly 70% offsetting the recent praising the reduction due to the N R. D a renewal.
We continue to be encouraged by the growth for China operations, and expect continued strong market penetration as experienced during this quarter.
Enrique Conterno: I'm going to ask Mark to answer the first, question on LAPIS, and I will answer the second question on Roxybustec.
Flowing from the total <unk> sales in China fiber Jens met transfer price from sales to the J D. E was $13 $9 million for the first quarter consistent with the 30% to 45% range of the JD East <unk> reduced that net sales, which we have continuously guided due.
Mark Eisner: Yeah, thanks for the question.
Mark Eisner: So just to remind everyone, the primary endpoint of the, LAPIS trial is overall survival, and regardless of the EFS outcome, we will continue the trial until the OS endpoint.
Michael Yee: With respect to pemrevlimab, in pancreatic cancer, I know there is an interim coming up shortly.
Mark Eisner: But it's important to note that OS is part of the EFS endpoint.
During this quarter, we recorded $2 $3 million released from deferred revenue due to changing our future estimates as per U S. GAAP.
Mark Eisner: Mortality is part of it, so that will be part of the evaluation at the interim analysis.
Mark Eisner: And in terms of your specific question about updates on OS from earlier trials, we don't, have any specific updates at this time, but we'll be able to share that in the future.
As we have communicated in the past the deferred revenue balance and fiber Qian, China fluctuate based on estimates of future revenue.
As a result fiber Gen recorded $16 $2 million in net revenue for the quarter from <unk> sales to the J D E and $2 $7 million of direct to distributor sales from fibers in China.
Michael Yee: Can you just remind us if it is positive, you would announce and say something and say you are going to go talk to the FDA and then you would have to come back to us later with what the FDA says.
Michael Yee: If it is not positive, then you would hear nothing.
As we continue down the P&L operating costs and expenses were $123 $8 million compared to $108 9 million for the first quarter in 2021.
Michael Yee: Just remind us of the scenario tree, there.
This increase in operating cost is primarily driven by R&D expenses supporting our phase III clinical trials, including drug supply costs associated with our <unk> programs.
Michael Yee: The second question is on roxodustat.
Enrique Conterno: Regarding the second part of your question, you are correct.
While we continue to look for ways to accelerate activities related toward from Revlimid program.
We also continue to make training maintaining strong focus on cost control as evidenced by your flat year over year SG&A line.
Michael Yee: You made a very important comment about AstraZeneca, and not having an agreement yet to fund another phase 3.
During the first quarter of 2022, net loss was $63 $2 million or <unk> 68 cents net loss per both basic and diluted shares as compared to net loss of $71 $8 million or 70 cents 78 cents per basic and diluted shares for the first quarter last year.
Michael Yee: What is the next step there if there is a disagreement or what is the next step and what would be an update?
Michael Yee: Thank you.
Enrique Conterno: Very good.
Yeah.
At March 31st we reported $565.4 million in cash cash equivalents investments and accounts receivable.
Enrique Conterno: Thank you for your question, Michael.
As we look forward, we estimate our 2022, ending cash ending balance of cash cash equivalents investments and accounts receivable to be in the range of $310 million to $340 million, which is an improvement over the previously communicated range of $270 million to $300 million.
While we believe we're appropriately finance through key initial <unk> data Readouts, we are privileged with a wide for a wide array of options to consider as we continue to look for opportunities to strengthen our cash position over time.
Thank you and now we'd like to turn the call back over to Enrique.
Yeah.
Very good thank you one on and.
In closing.
We.
We remain committed to advancing <unk> as a potential first in class medicine.
Phase III development in three indications with significant unmet medical needs idiopathic pulmonary fibrosis locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy.
Brooks at Vista continues to perform very well in China.
Our partner Astellas is moving forward with commercialization of up to the study in Europe .
And we have additional regulatory submission under review in other geographies.
We're exploring options for Roxanne do start in the U S and believe patients would benefit from having access to this treatment.
Enrique Conterno: Let me first address the second part of your, question on roxodustat in the U.S. Clearly, AstraZeneca has exclusive rights in the U.S, for roxodustat.
Enrique Conterno: So, Fibrogen and AstraZeneca have to work together to find a path forward for this product in the U.S. in anemia of CKD.
As shown on slide 10, we continue to have a strong financial position.
Enrique Conterno: Keep in mind that our phase 3 trial for anemia due to myelodysplastic syndromes continues.
With approximately $565 4 million in cash and expect to end 2022 with $310 million to $340 million in cash.
Enrique Conterno: As we related in this call, we expect a readout in the first half of next year.
We have a strong cash position.
Enrique Conterno: As we look at roxodustat, and as we mentioned before, we have had meetings with the FDA.
Enrique Conterno: So, we do think there is a path forward in terms of what is the clinical trial that would be required, but we clearly need to be able to agree with this plan with AstraZeneca and fund it in order to move forward.
I have multiple options to consider to further strengthen our balance sheet to ensure our long term success.
But we are properly finance we are privileged.
Enrique Conterno: I'm going to allow now Mark Eisner, Dr. Eisner, to provide an answer to your question on the interim of LAPC on event-free survival and what are the different scenarios here.
To to be able to look at a number of those opportunities now I would like to turn the call back to the operator for questions.
Mark Eisner: So, he will provide a little more color.
Thank you.
Mark Eisner: Yeah, thanks for the question, Michael.
Ladies and gentlemen, if you would like to ask a question. Please press star followed by the number one on your telephone keypad again that is star then the number one.
Mark Eisner: So, as you said, we plan an interim analysis in Q2 of event-free survival. This will be conducted by an independent statistician, as we at Fibrogen will remain blinded, and the independent DMC will receive this analysis. The DMC will then be able to inform us whether or not the data meets stringent predefined efficacy and safety criteria.
Mark Eisner: If so, they will inform me as CMO, and I will review the data and potentially consult with FDA about next steps. So, if the data meets these predefined criteria and FDA is agreeable, we would then consider filing for an accelerated approval.
Question. Please press the pound or he has seen the standby, while we compile the Q&A roster.
Your first question comes from the line of Michael Yee with Jefferies. Your line is open.
Hey, Enrique Thanks Al appreciate the update we have two questions.
With respect to Pam Revlon Mab in pancreatic cancer I know there is an interim coming up shortly can you just remind us if it's positive you would announce and say something and say youre going to go talk to the FDA and and then you'd have to come back to US later with what the FDA says if it's not positive.
Then you would hear nothing or what.
Minus at this scenario tree there and then second question is on rock should use that you made a very important comment about astrazeneca and not having an agreement yet to fund another phase III, what what is the next step there.
If there is a disagreement or what is what is the next step and one would be an update thank you.
Very good let me.
Thank you for your question, Michael Let me first address the second part of your question.
On rocks at those that are in the U S. Clearly.
Astrazeneca has exclusive rights in the U S for rux and do stuff. So we five Virgin in Astro setting you have to work together to find a path forward for these product.
And in the U S in anemia of <unk> keep in mind that our phase III trial.
For mirrored spots anemia, Mila dysplastic syndrome.
<unk>.
Enrique Conterno: Clearly, AstraZeneca has, exclusive rights in the U.S., and as part of that, which is very uncommon in this type of agreement, they need to make commercially reasonable efforts.
Now as we are.
Relating to this call we expect a readout in the first half of next year.
Enrique Conterno: So thank you for your questions, Annabelle.
Operator: Your next question comes from the line of Jason Gerberi with Bank of America.
Operator: Your line is open.
Operator: Hi, this is Perry on the line for Jason.
We as we look at Rockstar boost that and as we've mentioned before we have had meetings with the FDA. So we do think there is a.
Perry: Thanks for taking our questions.
Path forward in terms of a.
What what is the clinical trials that will be required, but we clearly need to be able to.
Agree with this applying with Astrazeneca.
Unfunded in order to move forward.
Allow now Mark Eisner to provide.
The threatened to provide a answered to your question on the interim of L.
L. A P C on event free survival.
What are the different scenarios here. So he will provide a little more color yeah. Thanks for the question Michael So as you said we plan an interim analysis in Q2 of event free survival. This will be conducted by an independent statistician has we have fibre Jean will remain blinded and the independent D. M C.
We will receive this analysis.
The DMC will then be able to inform us whether or not the data meet stringent predefined efficacy and safety criteria.
If so they will inform me as CMO and I will review the data and potentially consult with F. D. A about next steps. So if the data meet these predefined criteria in F. D. A is agreeable. We would then consider filing for an accelerated approval if not.
Then we would just continue the trial to overall survival and just to clarify regardless to travel will continue to overall survival and we should be able to update you later in the year.
Got it thank you.
Your next question comes from the line of Andy Hsieh.
William Blair Your line is open.
Oh, great. Thanks for taking my question, so I have two.
One is.
I really appreciate the granularity you provided across the three indications for rebel Mad.
Looking at the for the pancreatic cancer specifically.
There are two standard of care is.
As we kind of think about the potential Tam for <unk> I'm. Just wondering is there any sort of market.
Research done on the distribution between.
Jim Braxy usage, and the porphyria Nox usage.
Yeah that is that is a really.
A really important question.
Clearly those are the background therapies that are being.
Utilized in the trial. So it is spam on top of a Brexit jam or fulfilling ox.
Hum.
In one of the arms vis avi fulfilling logs or a braxton.
Jim India.
In the control arm so.
Clearly that is something that is evolving.
Really matters, whether it's metastatic or locally advanced unresectable.
Pancreatic cancer, but what we're seeing is is basically a <unk>.
Somewhat of a split it varies with geography.
Fulfilling Nox usage has been increasing over time, which is why we made an amendment in a clinical trial to ensure that the background therapy was available for patients.
So we we've conducted some more research and we will provide a further update in more detail in this maybe during our next earnings call. Thank you for your interest.
Got it thanks, and then for my second question.
Obviously for US who are more familiar with the western pharmaceutical markets.
It's.
Kind of a 70% increase in usage is kind of unheard of.
Just looking at.
<unk> eight about the USA in his market dynamics in China.
There appears to be kind of an inflection point as we go from Q4 to Q1, just curious about any additional information you could provide us with the it market dynamics. It seems like the Esa usage has been picking up.
As we head into 2022, Rockford going down so so any sort of.
Additional contact that you could provide would be much appreciated there.
Yeah, I I think as we mentioned we've seen in China continued growth.
In our overall volume the reason why you see a slight decline is because we are measuring value share and when it comes to value share given the price reduction of Brooks do studying and are there that impact that impacts the overall value share for.
Rock for <unk>, but he is not a reflection of the overall growth that we're seeing with Brooks huh.
In the market in China, I'm going to ask Chris Chung I know cheese cheese in China now and she is on the call on the phone someone ask Chris would you like to provide maybe some more color on our performance in China, How we started the year in Q1.
Absolutely. Thank you Enrique.
So we started very strongly.
My name is in 2020.
The price decrease as a result and are now.
It's all of you know, what's the decent was priced above.
There is a very strong value proposition.
Affordability issues that I think with the lower pricing has been addressed the volume uptick of 70% of clients. So it's very well for the rest of the year and so we continue to be very optimistic about what we could do that.
Mark Eisner: If not, then we would just continue the trial to overall survival. And just to clarify, regardless, the trial will continue to overall survival, and we should be able to update you later in the year.
Extra keep asking.
We believe this momentum is durable and we are expecting net growth.
22 over 2000.
Yeah.
Got it. Thank you very much I know, it's difficult for you, Chris though are hanging in there.
Best wishes to you.
Thank you.
Your next question comes from the line of ear wherever with Cowen Your line is open.
Great. Thanks for taking a couple of questions maybe just.
To start with on China can you give us a sense, maybe where you are now in terms of placement in the hospitals in the community based on.
Operator: Got it.
CK Din dialysis may be as a percentage of your targeted.
<unk> targeted market.
Operator: Thank you.
Perry: First, I just wanted, to get an idea of the volume increase from 4Q21 to 1Q22.
And then secondly.
And when you think about moving to unravel a mab for IPF in the zephyrus.
Perry: I know you said 70 percent increase in volume from the previous year, but could you discuss the difference between the previous quarter and this quarter?
<unk> study when you look at the phase two.
I believe about 8% to 12% of patients were <unk>.
Receiving pirfenidone or TK I previously.
What do you expect some of it was much more of a naive population what do you expect that distribution to be in the phase III in the zephyrus, one and two studies. Thank you.
Perry: And then also, whether the volume growth you're seeing is, I guess, what the breakdown between non-dialysis patients and dialysis patients is.
Okay.
A very good I'm going to ask Chris Chung too.
Perry: And then I just have one other brief question on PAMREV and IPF after that.
I answered the first question on China, and then a doctor Eisner will answer the second question on Ips on our phase III study.
Enrique Conterno: Yeah.
Thank you Enrique so with respect to adoption and market potential.
One thing if you look at the slide five at G is provided over time since <unk> launch in China, where total market I E.
Enrique Conterno: I'll ask Chris to start with a question to talk about maybe some of the color in China, when it comes qualitatively, to talk about where are we seeing the business increase.
Enrique Conterno: And then I'll have Juan comment on the first part of your question.
Rockies has actually increased so.
We believe the market is not the same as <unk>.
Operator: Your next question comes from the line of Andy Hsieh with William Blair.
Chris Chan: Sure.
In some markets.
Medical need there was previously not.
Operator: Your line is open.
Chris Chan: Thank you, Enrique, and thank you for the question.
Addressable with <unk>.
So we think there's a growth.
Growth in market size.
Three segment can you think we're still very early in the adoption curve.
Andy Hsieh: Oh, great.
Chris Chan: So with respect to the spike, in January, it is a significant spike.
The opportunity in front of us.
Terms of what percentage of the market. We currently have.
Andy Hsieh: Thanks for taking my question.
Chris Chan: We believe this is unit growth.
In the dialysis market honestly, the easiest market to get the hypo responders people, who are not performing as well as one would like.
Andy Hsieh: So, I have two.
Andy Hsieh: One is, you know, I really appreciate the granularity that you provided across the three indications for, PenrevoMab.
Andy Hsieh: Looking for the pancreatic cancer specifically, there are two standards of care, you know, as we kind of think about the potential TAM for PenrevoMab, I'm just wondering if there's any sort of market research done on the distribution between Jim Abraxane usage and the Fulfurinox usage?
He says we are doing very very well in that market.
Enrique Conterno: Yeah, that is a really important question.
In today's market.
The peritoneal dialysis market.
Enrique Conterno: Clearly, those are the background therapies that are being utilized in the trial.
Administration nature of oxygen.
Enrique Conterno: So, it is spam on top of Abraxane gem or Fulfurinox in one of the arms vis-a-vis Fulfurinox or Abraxane gem in the control arm.
Enrique Conterno: So, clearly, that is something that is evolving and it really matters whether it's metastatic, or locally advanced and resectable pancreatic cancer.
A clear advantage.
The wide open market is non dialysis.
Enrique Conterno: But what we're seeing is basically somewhat of a split.
In the past, but it's very difficult for us to penetrate it and we have a clear I think you can take advantage of the agent.
Enrique Conterno: It varies with geography.
So I think we're still very early on in the adoption curve.
The total market can grow and adoption continues.
Yeah.
Enrique Conterno: Fulfurinox usage has been increasing over time, which is why we made an amendment in our clinical trial to ensure that that background therapy was available for patients.
Chris Chan: So the NLDL crisis was implemented and effective January 1st.
So regarding your Enrique if I can sneak in a question maybe just on China is there any thought to monetize that JV either by spinning it out or selling it to two zeneca is there any discussion or is that is that core to your business and you will keep it.
Enrique Conterno: So, we've conducted some more research and we will provide a further update and more detail on this maybe during our next earnings call.
Chris Chan: We believe that created a spike in demand, which we've seen to be durable.
Chris Chan: The percentage of growth continued January into February into March, which is something we're very happy about.
Yeah, I think we clearly have a very strong business in China right now so there are no such plants.
At this stage.
I'm Gonna have now mark are uncertain.
The second part of your question on IPF right. So just to remind everyone. The zephyrus phase III program is perm rebel that Pam level now mono therapy, but it does enroll.
Chris Chan: In terms of the volume increase of the first quarter relative to before, I believe was the question, it was over 30 percent.
Enrique Conterno: Thank you for your interest.
Treatment naive and treatment experienced patients and the program suffers one explicitly allows treatment naive suffers two is going to be mostly treatment experienced patients who have discontinued therapy I think it's worth noting though that most patients discontinue standard of care with Asbury at her own fab because of Tolerability from GE.
Operator: Got it.
Operator: Thanks.
Andy Hsieh: And then for my second question, you know, obviously, for us who are more familiar, with the Western pharmaceutical markets, you know, kind of a 70% increase in usage is kind of unheard of.
Andy Hsieh: So, just looking at slide number eight about the ESA and HIF market dynamics in China, there appears to be kind of an inflection point as we go from Q4 to Q1.
Andy Hsieh: Just curious about, any additional information you could provide us with the market dynamics.
Andy Hsieh: It seems like, you know, the ESA usage has been kicking up as we head into 2022.
Andy Hsieh: ROXA has been going down.
Andy Hsieh: So, any sort of, you know, additional context you could provide would be much appreciated there.
Side effects and other things rather than treatment failure per se or or progression of their lung function. So we actually expect both naive and experienced patients to <unk>.
Enrique Conterno: Yeah.
Enrique Conterno: I think as we mentioned, we've seen in China continued growth, in our overall volume.
Chris Chan: So we're just getting growth quarter to quarter. Just to be clear, the reason why we don't, do quarter to quarter comparison is because there's tremendous seasonality in the calendar in China because of national holidays, because of how the reimbursement budget is done at the local level.
Enrique Conterno: The reason why you see a slight decline is because we are measuring value share. And when it comes to value share, given the price reduction of ROXA-Doostad in the NRDL, that impacts the overall value share for ROXA-Doostad.
Chris Chan: So I really did not focus on that.
Enrique Conterno: But it's not a reflection of the overall growth that we're seeing with ROXA in the market in China.
Chris Chan: This is why we choose to compare quarter one 2021 over quarter one 2020.
Chris Chan: In terms of the adoption, we were very pleased to see an adoption in NDD, which we believe, is the growth segment for this population.
Potentially respond to Panama will that are similar.
Chris Chan: The number of patients treated on NDD picked up much more significantly than in dialysis, which would make sense because dialysis is about 90% reimbursed by the government, so it tends to be much less price sensitive.
Similarly, this is our theory based on what we know about the disease. So thanks for your question.
Enrique Conterno: I'm going to ask Chris Chang.
Chris Chung: I know she's in China now and she is on the call on the phone.
Yeah.
Operator.
Operator, yes, Sir your next question comes from.
Enrique Conterno: So, I'm going to ask Chris, if you'd like to provide maybe some more color on our performance in China as how we started the year in Q1. We started off very strongly in China this year, 2022, with the price decrease as a result, of NRBL.
Chris Chung: As all of you know, Rokta Visa was priced above Visa.
Chris Chan: NDD is about 50 to 60% reimbursed, and also the oral feature is very advantageous if the, affordability equation could be addressed.
Annabel Sammy with Stifel. Your line is open.
Chris Chung: There's a very strong value proposition.
Chris Chan: So we're very happy to see what we expected the lowering price to bring, which is a very, high adoption increase in NDD.
Hi, Thanks for taking my question I had a couple.
Chris Chung: There's been affordability issues that I think with the lower pricing has been addressed.
Chris Chung: The volume uptake of 70% of course, so it's very well for the rest of the year.
So.
Yes.
This trial in pancreatic cancer.
Chris Chung: So we continue to be very optimistic about what we could do for the rest of 2022.
When you go to.
Scott.
I guess that's it.
Supported.
Is there any overall survival you can draw from from the prior recession patients resectable patients from earlier trials.
Chris Chung: We believe this momentum is durable, and we are expecting net growth of 2020 to over 2021.
It could potentially support that acceleration and can you share any data from those patients.
Are there any updates for those patients.
And then the second question I have.
Obviously, it seems like you are having trouble getting coming to arrange with astrazeneca.
On the U S side.
And.
You know it seems like maybe the competitive landscape has improved.
Yeah.
So.
Can you maybe go into some detail about what options you may begin.
Alright, and is there any kind of clause for.
Nonperforming.
On the Astrazeneca side.
Given that they have exclusivity.
Some kind of bonus to proceed or let it go.
Yeah. Thank you for your question Annabel I'm going to ask Mark to answer the first question on LAPIS and Uh Huh.
I'm sorry, the second question on <unk>, Yeah. Thanks for the question. So just to remind everyone. The primary endpoint of the rocket trial is overall survival and regardless of the U S. S outcome, we will continue the trial until the OS endpoint, but it.
Operator: Got it.
Operator: Thank you very much.
Andy Hsieh: I know it's difficult for you, Chris, so hang in there.
Important to note that as part of E. S. S. Endpoint mortality is part of it so that will be part of the evaluation at the interim analysis and in terms of your specific question about updates on O. S. From earlier trials, we don't have any specific updates at this time.
But we'll be able to share that in the future.
Yeah.
Regarding the second part of your question you are correct.
Clearly astrazeneca has exclusivity rights in the U S and as part of that which is very common in these type of agreements they need to make commercially reasonable efforts.
So thank you for your questions Annabel.
Your next question comes from the line of Jason <unk> with bank of.
America Your line is open.
Hi, This is Perry on the line for Jason Thanks for taking our questions.
First I just wanted to get an idea of the.
Volume increase from <unk> 22, though.
<unk> or <unk> 21 to <unk> 22, I know you said, 70% increase in volume from the previous year, but could you discuss the difference between the previous quarter and this quarter.
And then also whether.
The volume growth Youre seeing is I guess, what the breakdown between non dialysis patients and dialysis patients and then I.
I just had one one other brief question on.
On Pam Rev in IPF after that.
Yeah.
I'll ask.
Chris to start with a question to talk about maybe some of the coloring China when he comment qualitatively to talk about the where are we seeing business.
Andy Hsieh: Best wishes to you.
Chris Chan: I hope I answered your question, Enrique, actually.
Increase and then I'll have one comment on the first part of your question.
Operator: Thank you.
Enrique Conterno: Thank you.
Juan Graham: Juan?
Sure I think you had weekly and thank you for the question so with respect to the Spike in January .
Juan Graham: Yeah.
Juan Graham: Sorry, Perry.
Juan Graham: I think Chris highlighted some of the major points related to the dynamics of ROXA and, Q1. I think another point to highlight, as you may have seen in performance for ROXA and, its sales in China as well in Q4, was an anticipation and as well movement in terms of revenue associated with an impending NRDL renewal.
Operator: Your next question comes from the line of Yaron Werber with Cowin.
Mark Eisner: I assume your first question refers to IPF.
Juan Graham: It's difficult to compare Q4 to Q1, given all the dynamics, in addition to, as Chris, mentioned, the seasonality of revenue due to holidays and so on that happens in Q1.
Mark Eisner: In terms of looking at the treatment of the current standard of care and what are some, of the failure rates, and I'm going to have Zane Wittig answer your second question on the commercial side.
Juan Graham: But please, I think we will continue to analyze this piece and provide perspectives as we, move forward.
Mark Eisner: Yeah.
Operator: Okay.
Mark Eisner: It's a really good question.
Operator: Thanks.
Mark Eisner: I mean, I think, as you can appreciate, given that it's an ongoing Phase III trial, we really, don't have, you know, firm estimates of the different patient subgroups, but we will do by the end of SEPHIRIS-1 and, of course, the program overall.
Perry: That's very helpful.
Spike.
Mark Eisner: And I think we'll be able to speak to all of those subgroups with the data that we generate, so stay tuned.
Perry: And then just a brief question on PAMREV.
Zane Wittig: Hi, Perry.
Perry: I'm just curious about the proportion of patients that typically are either unsuccessful in, treatment with current standard of care, or it sounds like the majority of patients that move off therapy are due to intolerance.
Part of the difference because you make.
Operator: Your line is open.
Operator: And there are no further questions, over the phone line at this time.
Zane Wittig: This is Zane.
Perry: And then, so I guess the proportion of patients that that covers.
Yaron Werber: Great.
Enrique Conterno: I would now like to turn the call back to Enrique, for any additional and closing remarks.
Zane Wittig: And just to follow on to what Mark just said and your question around, you know, patients, who aren't able to tolerate it, I think there's pretty good documentation that says, you know, within a year after starting either one of the antifibrotics, about 40% of patients have stopped due to tolerability or other reasons, primarily due to tolerability, but there are a whole host of other reasons associated with taking a chronic therapy, especially when it involves multiple pills multiple times a day.
Perry: And then, in terms of the $4 billion market size, do you expect that, you know, the entry, of PAMREV to increase that market size, or is it more kind of taking away share from the current standard of care, the current standard of care?
Yaron Werber: Thanks for taking.
Zane Wittig: And that's where we think we could have a really nice advantage for Pamreblumab, based, upon its administration.
Perry: Yeah.
Yaron Werber: I have a couple of questions.
Enrique Conterno: Very good, thank you very much to everyone.
So the pricing was implemented.
Zane Wittig: In terms of where we believe the patients will come from, we think we have the ability, to both capture share from existing antifibrotics, as well as expand the market.
Mark Eisner: I'm going to ask Dr. Eisner to answer the first question.
Yaron Werber: Maybe just to start with on China, can you give us a sense maybe where you are now in, terms of placement in the hospitals and in the community based on CKD and dialysis maybe as a percentage of your targeted market?
Enrique Conterno: We appreciate your participation in today's investor call, and your interest in Fibrogen.
Zane Wittig: It's pretty clear that there are a number of patients who are categorized as mild who, don't get treated with antifibrotics, primarily because clinicians have indicated to us, at least in a research setting, that they are weighing the benefits of the antifibrotic therapy relative to then the downsides of issues with tolerability, and they want to make sure that they understand how quickly a patient is progressing, but it's really because they think that the downsides outweigh the potential benefits, and so there are.., probably 45% of mild patients with IPF who are not treated with current antifibrotics.
Yaron Werber: And then secondly, when you think about a moving to Pumrevalumab for IPF and the Zephyrus, 1 study, when you look at the phase 2, I believe about 8 to 12% of patients were receiving profanidone or TKI previously.
Enrique Conterno: Please enjoy the rest of your day.
Zane Wittig: There's also a decent portion, of the moderate categorized patients who are also not treated, and then an even larger portions of the patients who have progressed to the severe stage of the disease that aren't treated with the current antifibrotics, either because clinicians, again, don't view the risk-benefit as being favorable or because they've fallen off therapy for tolerability or other reasons.
Zane Wittig: So we think we've got an ability, both to capture patients who would have otherwise gone on to an antifibrotic once PAMREVIMAB was available, as well as capture patients who would not have gone on to an antifibrotic.
Kurtz.
Operator: Got it, thank you, that's very helpful.
We believe that created a spike in demand.
To be durable alright percentage growth continued in January into February into March.
It's something we're very happy about.
In terms of volume increase from first quarter relative to Q4 I believe was the question if it's okay.
Yaron Werber: So it was much more of a naive population.
Enrique Conterno: Thank you very much.
Yaron Werber: What do you expect that distribution to be in the phase 3 and the Zephyrus 1 and 2 studies?
Okay.
So listen significant growth quarter to quarter just to be clear. The reason why we don't give quarter to quarter comparison is because there is tremendous seasonality in the calendar in screening.
National holidays, because of how the reimbursement is done at the.
At local levels.
On that which is why we choose to compare quarter, one 2021 according to that.
Great.
In terms of the adoption.
<unk> adoption.
<unk>, which we believe is happening but its population.
Patients treated on MTBE.
More significantly than imbalances.
It makes sense because dialysis.
About 90% reimbursed by the government.
Thank you Andy D is about 50 to 60, new burst and also the oral feature.
Barry I think T J the affordability equation cathedral. So we're very happy to see what we expected increased spring which is high.
Adoption increase.
I hope I answered your question.
Thank you I'm sorry.
Yes, I'm, sorry, Perry just I think I think Chris highlighted.
Some of the major points related to the dynamics of Rux in Q1, I think another point to highlight as you may have seen in performance for Roxanne net sales in China as well in Q4 was and then Theres, a patient and as well move men in terms of revenue associated with an impending and our D. L renewal right so difficult to compare Q4 to Q1.
Given all those dynamics in addition to as Chris mentioned, you know the seasonality.
Revenue.
Due to holidays and so on that happens in Q1.
But yeah. Please.
Yeah, I think we will continue to analyze this piece and provide perspective as we move forward.
Okay. Thanks, that's very helpful. And then just a brief question on Cameron.
So the so it sounds like the I'm just curious about the proportion of.
Patients that are that typically are either unsuccessful in treatment with current Sam central care or it sounds like you know the majority of patients that move off therapy or do the intolerance.
And then.
So I guess the proportion of patients that that covers and then in terms of the.
A $4 billion market size do you expect that.
The entry of cameras to increase that market size or is it more kind of taking away share from the current standard of care.
Uh huh.
The current standard of care.
Yeah, I'm going to ask a doctor either to answer the first question I assumed your first question refers to IPF.
Uh huh.
In terms of looking at that.
Yes treatment are of the current standard of care and what are some of the.
Failure rates and I'm Gonna have feigned work I'm sorry, your second question on the commercial side.
Yeah. It's a really good question I mean, I think as you can appreciate given that it's an ongoing phase III trial, we really don't have.
Firm estimates of the different patient subgroups, but we will we will do but by the end of surface one and of course the program overall and I think we'll be able to speak to all of those subgroups with with the data that we generate so stay tuned.
Hi, Barry this is a thing.
And then just a follow on to what Mark just said in your question around the patients who aren't able to tolerate it gets pretty good documentation that says you know within a year after starting either one or the anti fibrotic about 40% of patients have stopped due to tolerability or other reasons, primarily due to tolerability, but there.
A whole host of other reasons associated with taking a chronic therapy, especially when it involves multiple pills multiple times a day.
And that's where we think we could have a really nice advantage for Perm rebel Mab based upon its administration.
In terms of where we believe that patients will come from we think we have the ability to to.
To both capture share from existing anti fibrotic <unk> as well as expand the market. It's pretty clear that there are a number of patients who are categorized as mild who don't get treated with anti fibrotic, primarily because because clinicians have indicated to us at least in a research setting that they are weighing the benefits of the anti fibrotic.
Therapy relative to then the the downsize of issues with Tolerability and they want to make sure that they understand how quickly are patients is progressing but it's really because they think that the downsides outweigh the potential benefits and so there are.
Probably 45% of mild patients with IPF, who are not treated with current anti fibrotic.
There's also a decent portion of the moderate categorized patients who were also not treated and then an even larger portion so that patients who have progressed to the severe stage of the disease that arent treated with the current anti fibrotic cedar because clinicians again don't view, the risk benefit as being favorable or because they've fallen off therapy for tolerability or other reasons. So.
We think we've got an ability both to to capture patients who would have otherwise gone onto an anti fibrotic once Pam rebel that was available as well as capture patients who would not have gone onto an anti fibrotic.
Got it. Thank you that's very helpful.
And there are no further questions over the phone line at this time I would now like to turn the call back to Enrique for any additional and closing remarks.
Very good. Thank you very much to everyone. We appreciate your participation in today's investment Investor call and your interest in five Virgin. Please enjoy the rest of your day. Thank you very much.
Ladies and gentlemen, this concludes today's conference call. We thank you all for participating and you may now disconnect.
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